User Manual
89891 - EN
V1902 – 0801-1
Revision of the manual: January 2008 - English
Software version: 1.90
We reserve the right to make changes in the course of technical development without prior
notice.
Software-copyrights
TM
analyzer has been
The software for the EVOLIS
licensed to Bio-Rad for worldwide distribution.
The EVOLISTM software is the intellectual property of
STRATEC Biomedical Systems AG. Intellectual property
rights shall remain with STRATEC Biomedical Systems
AG.
You are entitled to use the EVOLISTM software and the
printed accompanying material at your place of work only.
Any violations of property rights or copyright or trademark
may be subject to legal action.
MicrosoftTM and WindowsTM are registered trademarks of
Microsoft Corporation.
Bio-Rad
3, boulevard Raymond Poincaré - B.P. 3
92430 Marnes-la-Coquette - France
Phone: +33 (0)1 47 95 60 00
Fax: +33 (0)1 47 41 91 33
EVOLIS
Table of Contents
Bio-Rad EVOLIS Version 1.90, Instrument Code 89601, User manual
Table of Contents
About This Manual......................................................................................... XI
Bio-Rad Technical Support ........................................................................... XI
Typographical Conventions.......................................................................... XII
Safety Instructions ....................................................................................... XIII
Last modification : 01 – 2008
User manual code : 89891 - EN
1
Getting Started ..........................................................15
1.1
1.1.1
1.1.1.1
1.1.1.2
1.1.1.3
1.1.1.4
1.1.1.5
1.1.1.6
1.1.1.7
1.1.1.8
1.1.1.9
1.1.1.10
1.1.2
1.1.3
1.1.4
1.1.5
Instrument Overview ...................................................................15
Individual Instrument Modules .......................................................15
Tray for Tip Racks and Dilution Plates...........................................17
Sample and Reagent Unit..............................................................17
Test Plate Compartment and Pipetting Position ............................20
Barcode Readers ...........................................................................21
Pipettor...........................................................................................21
Tip Ejection Station and Waste Container .....................................21
Bottom Drawer ...............................................................................22
Wash Unit.......................................................................................23
Photometer.....................................................................................24
Incubator Unit.................................................................................24
LED Displays..................................................................................26
Connections ...................................................................................27
System Liquid.................................................................................29
Accessories and Consumables......................................................30
1.2
1.2.1
1.2.2
1.2.2.1
1.2.2.2
1.2.3
1.2.3.1
1.2.4
1.2.4.1
1.2.4.2
1.2.4.3
1.2.4.4
1.2.5
1.2.6
1.2.6.1
1.2.6.2
1.2.6.3
1.2.7
1.2.7.1
1.2.7.2
1.2.7.3
1.2.7.4
1.2.7.5
Initial System Set-Up ...................................................................31
PC Requirements...........................................................................31
System Start...................................................................................31
Logging In ......................................................................................32
Simulation (Demo) Mode ...............................................................34
Initialization and Selftest ................................................................36
Selftest Failure ...............................................................................38
Software Layout .............................................................................39
The EVOLIS Screen ......................................................................39
Toolbar ...........................................................................................40
Menu Guidance..............................................................................41
The File | New Menu Item ..............................................................43
Software Language ........................................................................44
Reviewing Default Settings ............................................................46
Laboratory Details ..........................................................................46
File Types and Location.................................................................47
Other Default Settings....................................................................49
Defining User Rights and User Groups..........................................50
Defining the Rights of Individual Users..........................................50
Creating and Editing User Groups .................................................52
Special Authorizations for Users with Restricted Rights................54
Password Settings .........................................................................55
Troubleshooting/FAQ.....................................................................56
III
Table of Contents
EVOLIS
Bio-Rad EVOLIS Version 1.90, Instrument Code 89601, User manual
IV
1.2.8
Connection to a Host Computer.....................................................57
2
Processing Pre-Defined Assays ..............................59
2.1
Overview .......................................................................................59
2.2
2.2.1
2.2.2
Loading Patient Samples ............................................................60
Loading Process ............................................................................60
Problems that May Occur while Loading .......................................61
2.3
2.3.1
2.3.1.1
2.3.1.2
2.3.2
2.3.2.1
2.3.2.2
2.3.2.3
2.3.3
2.3.4
2.3.5
Assigning Assays to Patients.....................................................63
Pre-Defined Assays .......................................................................63
Reviewing Pre-Defined Assays......................................................63
Processing Several Assays in the Same Test Run .......................63
Assigning Assays to Individual Patients.........................................64
Standard Procedure .......................................................................64
Importing Patient Data through Host Connection ..........................67
Manual Patient Data Entry and Test Assignment ..........................70
Managing Patient Details ...............................................................73
Pipetting and Report order.............................................................74
Patient Editor Clean-Up .................................................................74
2.4
2.4.1
2.4.2
2.4.3
2.4.4
2.4.4.1
2.4.5
2.4.6
2.4.6.1
2.4.6.2
2.4.7
2.4.7.1
2.4.7.2
2.4.7.3
2.4.7.4
2.4.7.5
2.4.7.6
2.4.7.7
2.4.7.8
2.4.8
Creating the Worklist...................................................................76
The Set-Up Panel Dialog Box ........................................................76
Basic Worklist Creation Method.....................................................79
Worklist Generated by the System ................................................82
Creating a Worklist from an Existing Panel File.............................83
Problem solving..............................................................................85
Editing the Plate Layout .................................................................85
Worklist and System Verification ...................................................87
Specification of Reagents and Liquids...........................................87
Error Detection ...............................................................................91
The Worklist Window .....................................................................93
Worklist Parameters.......................................................................94
Schedule ........................................................................................94
Plate Layouts .................................................................................97
Reagent Requirements ..................................................................97
System Status ................................................................................98
Active Event Log ............................................................................99
Job List........................................................................................ 102
Archiving ..................................................................................... 102
Worklist Options .......................................................................... 103
2.5
2.5.1
2.5.1.1
2.5.1.2
2.5.2
2.5.2.1
2.5.2.2
2.5.3
2.5.3.1
Loading the Required Resources............................................ 107
Basic Principles........................................................................... 107
Load and Allocate ....................................................................... 107
The Load Dialog Box .................................................................. 108
Patient Samples .......................................................................... 109
Load ............................................................................................ 109
Allocate ....................................................................................... 110
Reagents..................................................................................... 113
Load ............................................................................................ 113
Last modification : 01 – 2008
User manual code : 89891 - EN
EVOLIS
Table of Contents
Bio-Rad EVOLIS Version 1.90, Instrument Code 89601, User manual
Last modification : 01 – 2008
User manual code : 89891 - EN
2.5.3.2
2.5.3.3
2.5.3.4
2.5.3.5
2.5.4
2.5.5
2.5.5.1
2.5.5.2
2.5.6
2.5.7
Allocate ....................................................................................... 114
Unstable Reagents ..................................................................... 115
Other Special Cases ................................................................... 118
Save Reagent Layout ................................................................. 120
Dilution Plates ............................................................................. 121
Tip Racks .................................................................................... 123
Basic Tip Loading Procedure...................................................... 123
Tip Management Options............................................................ 125
Wash Buffer and Clean Fluid ...................................................... 127
System Liquid.............................................................................. 129
2.6
2.6.1
2.6.2
2.6.3
2.6.4
Loading Test Plates .................................................................. 130
The Load Plate dialog box .......................................................... 130
Preparing the Test Plates ........................................................... 131
Loading the Test Plates .............................................................. 132
Special Cases ............................................................................. 133
2.7
2.7.1
2.7.2
2.7.2.1
2.7.2.2
2.7.2.3
2.7.2.4
2.7.3
2.7.4
2.7.5
2.7.5.1
2.7.5.2
2.7.5.3
2.7.6
2.7.7
2.7.8
Processing the Run .................................................................. 134
System and Cover Lock.............................................................. 134
Pre-Run Checks.......................................................................... 135
Wash Buffer / Clean Fluid Volume Check .................................. 135
Reagent Volume Check .............................................................. 136
Sample Volume Check ............................................................... 137
Tip Size Check ............................................................................ 137
Steps of a Typical Test Run........................................................ 138
What You Can Do While the Run is Being Processed ............... 139
System / Pipetting Errors ............................................................ 141
The System Paused Dialog Box ................................................. 142
Consequences of a System Pause............................................. 142
Pipetting Errors (Manual pipetting) ............................................. 143
Emergency Stop/Canceling a Run.............................................. 144
Emergency Test Plate Removal ................................................. 144
Partial Processing / Recall Plate Map......................................... 146
2.8
2.8.1
2.8.2
2.8.3
2.8.3.1
2.8.3.2
2.8.3.3
2.8.3.4
2.8.4
2.8.5
2.8.6
2.8.7
2.8.7.1
2.8.7.2
2.8.7.3
2.8.7.4
2.8.7.5
End of Run/Result Display ....................................................... 150
Structure of the Result Report .................................................... 150
Result Interpretation.................................................................... 152
Editing / Recalculating the Results ............................................. 155
Editing Outliers............................................................................ 155
Changing the lot specific parameters.......................................... 157
Recalculation with another assay ............................................... 157
Recalculating the results............................................................. 157
Saving the Result Report ............................................................ 158
Printing the Result Report........................................................... 158
Exporting the Results.................................................................. 159
Comparing Current and Former Results..................................... 159
Creating a Patient Result Report ................................................ 159
Editing the Patient Result Report................................................ 160
Using the Patient Result Report to Search the Result Database 163
Update in Case of Recalculated Results .................................... 163
Print / Export the Patient Result Report...................................... 164
V
Table of Contents
EVOLIS
Bio-Rad EVOLIS Version 1.90, Instrument Code 89601, User manual
VI
2.8.7.6
Summary View of the Patient Result Report .............................. 164
2.9
2.9.1
2.9.2
2.9.3
2.9.4
2.9.5
Unloading................................................................................... 165
Test Plates .................................................................................. 165
Sample Racks and Reagent Racks ............................................ 167
Tip Racks and Dilution Plates ..................................................... 168
Other Resources ......................................................................... 168
Waste Disposal ........................................................................... 169
3
Advanced Features Guide ......................................171
3.1
3.1.1
3.1.2
3.1.3
3.1.4
3.1.5
3.1.6
3.1.7
Processing Several Assays per Plate..................................... 172
Compatible Assay Structure / Parameters.................................. 172
Assay Combination Groups ........................................................ 173
Manual Worklist Definition .......................................................... 174
Automatic Worklist Definition ...................................................... 175
Strip Management / Optimizing the Plate Layout ....................... 175
Test Plate Scan........................................................................... 177
Results ........................................................................................ 178
3.2
3.2.1
3.2.2
3.2.3
3.2.4
3.2.5
Continuous Loading ................................................................. 179
Check Reloading Time(s) ........................................................... 179
Preparing and Loading the New Patient Samples ...................... 180
Redefining the Worklist ............................................................... 181
Reloading other Resources ........................................................ 182
Reloading Test Plates and Further Processing of the Worklist .. 183
3.3
3.3.1
3.3.2
3.3.3
3.3.4
3.3.5
3.3.6
Processing Externally Dispensed Plates ............................... 185
Match Dispensing and Processing Layouts / Volumes............... 185
Copy and Edit EVOLIS Assays................................................... 186
Enable the Plate Layout Import Option ....................................... 186
Process the Pre-dispensed Plates on EVOLIS........................... 189
Validate the Total Processing Time for each Plate..................... 191
Troubleshooting .......................................................................... 192
3.4
3.4.1
3.4.2
3.4.3
3.4.3.1
3.4.3.2
3.4.3.3
3.4.3.4
3.4.4
3.4.5
3.4.6
Using the Reagent Database ................................................... 196
Viewing the Contents of the Database ....................................... 196
Selecting Reagents for an Assay................................................ 197
Creating and Editing Reagents ................................................... 198
The Edit Reagent Details Dialog Box.......................................... 198
Creating Reagents ...................................................................... 200
Editing User-Defined Reagents .................................................. 201
Editing Bio-Rad Reagents........................................................... 201
Updating the Reagent Database................................................. 202
Buffer Database .......................................................................... 203
Troubleshooting .......................................................................... 204
3.5
3.5.1
3.5.1.1
3.5.1.2
3.5.2
Kit Lot Tracking......................................................................... 206
Enabling / Disabling Kit Lot Tracking .......................................... 206
General Enable / Disable Option ................................................ 206
Individual Enable / Disable Option .............................................. 207
Entering a New Kit Lot ................................................................ 208
Last modification : 01 – 2008
User manual code : 89891 - EN
EVOLIS
Table of Contents
Bio-Rad EVOLIS Version 1.90, Instrument Code 89601, User manual
Last modification : 01 – 2008
User manual code : 89891 - EN
3.5.2.1
3.5.2.2
3.5.2.3
3.5.3
3.5.4
3.5.5
Handheld Barcode Scanner Configuration ................................. 208
Basic Procedure (for Bio-Rad Kits Only) .................................... 208
Specific Procedures .................................................................... 211
Barcode Format Definition .......................................................... 216
Kit Tracking Errors ...................................................................... 218
Lot Tracking and Unity Real Time (URT).................................... 220
3.6
3.6.1
3.6.2
3.6.3
3.6.4
3.6.5
3.6.6
3.6.7
3.6.8
3.6.8.1
3.6.8.2
3.6.9
Archiving Samples.................................................................... 223
Independent Sample Archiving ................................................... 223
Archiving Samples within a Normal Run..................................... 227
Imported Worklists with Sample Archiving Orders...................... 228
Archiving Parameters.................................................................. 229
Archiving in Archive Plates ......................................................... 231
Archiving in Secondary Tubes .................................................... 232
Archiving Information and Archiving Report ............................... 235
Testing Archived Samples .......................................................... 237
Samples Archived on the EVOLIS System................................. 237
Samples Archived on Another System ....................................... 239
Tips and Troubleshooting ........................................................... 240
3.7
3.7.1
3.7.2
Retesting Samples .................................................................... 243
Case-by-Case Retest Orders...................................................... 243
Automatic Retest Procedure ....................................................... 244
3.8
3.8.1
3.8.2
3.8.3
3.8.4
Using External Controls ........................................................... 246
Defining the External Controls .................................................... 246
Including External Controls in a Worklist .................................... 248
Loading External Controls........................................................... 249
Tracking External Controls with Unity Real Time (URT)............. 249
3.9
3.9.1
3.9.2
3.9.3
3.9.4
Pressure Monitoring (APM)...................................................... 250
Pressure Monitoring Device........................................................ 250
Purpose....................................................................................... 250
Enable / Disable Pressure Monitoring Function.......................... 251
Pressure Monitoring Errors ......................................................... 252
3.10
3.10.1
3.10.2
3.10.3
3.10.3.1
3.10.3.2
3.10.4
3.10.4.1
3.10.4.2
3.10.4.3
3.10.5
3.10.5.1
3.10.6
3.10.6.1
3.10.6.2
3.10.6.3
Customizing the System .......................................................... 254
System ........................................................................................ 256
Incubators ................................................................................... 257
Photometer.................................................................................. 259
Photometer Settings ................................................................... 259
Luminometer ............................................................................... 261
Pipette Parameters ..................................................................... 262
The Pipette Tab........................................................................... 262
Pipetting Profiles ......................................................................... 265
Pipetting Direction ....................................................................... 266
Washer........................................................................................ 268
The Washer Tab ......................................................................... 268
Barcode Settings......................................................................... 270
Rack Barcodes............................................................................ 270
Sample Barcodes........................................................................ 270
Reagent Barcodes ...................................................................... 273
VII
Table of Contents
EVOLIS
Bio-Rad EVOLIS Version 1.90, Instrument Code 89601, User manual
3.10.6.4 Test Plate Barcodes.................................................................... 274
VIII
3.11
3.11.1
3.11.2
Upgrading the System.............................................................. 276
Software and APF upgrades....................................................... 276
Instrument and Firmware Upgrades ........................................... 276
3.12
3.12.1
3.12.1.1
3.12.1.2
3.12.1.3
3.12.1.4
3.12.1.5
3.12.2
3.12.2.1
3.12.2.2
3.12.2.3
3.12.3
3.12.3.1
3.12.3.2
3.12.3.3
3.12.3.4
3.12.3.5
3.12.4
Programming Assays ............................................................... 278
Introduction ................................................................................. 278
The Assay window ...................................................................... 278
Opening and Printing Assay Files............................................... 279
Basic Structure of Assay Files .................................................... 281
Basic Rules on Inserting and Editing Assay Steps ..................... 282
Assay Password Protection ........................................................ 284
Editing Pre-Defined Bio-Rad Assays .......................................... 285
General Rule on Editing Bio-Rad Assays ................................... 285
Authorized Editing ....................................................................... 285
"Open" Assay Files ..................................................................... 286
Creating New Assays.................................................................. 287
Assay Header.............................................................................. 289
Assay Layout............................................................................... 291
Assay Steps before Read (Processing Steps)............................ 295
Read/Evaluation Settings............................................................ 323
Report and Export Settings......................................................... 360
Verifying and Saving Assay Files................................................ 373
3.13
3.13.1
3.13.1.1
3.13.1.2
3.13.1.3
3.13.1.4
3.13.2
3.13.2.1
3.13.2.2
3.13.2.3
3.13.2.4
3.13.2.5
3.13.2.6
Connection to a Host Computer.............................................. 375
ASCII File Transfer...................................................................... 375
Hardware Configurations ............................................................ 375
Importing Patient Data and Worklist Files................................... 376
Defining Import Parameters ........................................................ 377
Export of Test Results................................................................. 385
Communication through an ASTM Link ...................................... 391
ASTM Link Set-Up ...................................................................... 391
Definition of LIS Assay Names ................................................... 392
Communication Procedure ......................................................... 394
Low-Level Protocol...................................................................... 395
Logical Structure of the Message Level Protocol ....................... 396
Incoming and Outgoing Transmission Examples ....................... 397
4
System Maintenance and Cleaning .......................404
4.1
Important Safety Precautions .................................................. 404
4.2
Maintenance Overview ............................................................. 405
4.3
4.3.1
4.3.1.1
4.3.1.2
4.3.1.3
4.3.2
4.3.2.1
Regular Maintenance................................................................ 407
Daily Maintenance....................................................................... 407
Start-Up Maintenance ................................................................. 407
After Each Run............................................................................ 407
Shut Down Maintenance............................................................. 407
Weekly Maintenance................................................................... 411
Run the WasherClean Assay...................................................... 411
Last modification : 01 – 2008
User manual code : 89891 - EN
EVOLIS
Table of Contents
Bio-Rad EVOLIS Version 1.90, Instrument Code 89601, User manual
Last modification : 01 – 2008
User manual code : 89891 - EN
4.3.2.2
4.3.2.3
4.3.2.4
4.3.2.5
4.3.2.6
4.3.2.7
4.3.3
4.3.3.1
4.3.3.2
4.3.3.3
4.3.3.4
4.3.3.5
4.3.3.6
4.3.4
4.3.5
Clean the Instrument Surfaces and Work Areas ........................ 411
Decontaminate the Sample and Reagent Racks........................ 412
Decontaminate the Test Plates Carrier Frames ......................... 412
Decontaminate the Tip Ejection Slide (Ramp)............................ 413
Decontaminate the Pipettor Wash Station.................................. 413
Clean the Plate Transport Unit.................................................... 413
Monthly Maintenance.................................................................. 413
Decontaminate the Washer Manifold.......................................... 413
Decontaminate the System Liquid Container ............................. 415
Clean the Wash Buffer/Clean Fluid Bottles ................................ 416
Clean the Test Plate Compartment............................................. 416
Clean the Room-Temperature Incubators .................................. 416
Backup System Files .................................................................. 417
Six-Month Maintenance .............................................................. 419
Automated Maintenance Tasks and Reminders......................... 419
4.4
4.4.1
4.4.2
4.4.3
4.4.4
4.4.5
4.4.6
4.4.7
4.4.8
4.4.9
4.4.10
4.4.11
Special Maintenance Procedures / Emergencies .................. 424
Stains and Small Spills ............................................................... 424
Heavy Liquid Overflow ................................................................ 424
Pipettor Decontamination............................................................ 425
Washer Malfunction .................................................................... 425
Washer Calibration...................................................................... 427
Vacuum and Trap Flask Maintenance ........................................ 428
Reagent Bottles........................................................................... 429
Photometer Maintenance and Servicing..................................... 430
Damaged Parts ........................................................................... 432
Power Supply Problems.............................................................. 433
Disposal of the Instrument .......................................................... 434
4.5
4.5.1
4.5.2
4.5.3
4.5.3.1
4.5.3.2
4.5.3.3
4.5.3.4
4.5.4
4.5.4.1
4.5.4.2
4.5.4.3
4.5.4.4
4.5.5
Performance Evaluation Procedures ...................................... 435
Performance Evaluation Timetable............................................. 435
General Performance Evaluation Guidelines.............................. 435
Monthly PE Procedure ................................................................ 436
Pipettor – Washer PE Kit ............................................................ 436
Pipettor Precision Evaluation ...................................................... 436
Washer Aspirate Evaluation........................................................ 438
Combined Pipettor - Washer Monthly Procedure ....................... 440
Twice-a-year PE Procedure........................................................ 440
PE Plate Transport Check .......................................................... 440
Photometer Verification............................................................... 442
Pipettor Accuracy Evaluation ...................................................... 445
Washer Aspirate / Dispense Evaluation ..................................... 448
Yearly PE Procedure (Incubators) .............................................. 450
5
Error Messages .......................................................455
A.
Appendices..............................................................468
A 1.
Technical Data........................................................................... 469
A 2.
Data Label .................................................................................. 473
IX
Table of Contents
EVOLIS
Bio-Rad EVOLIS Version 1.90, Instrument Code 89601, User manual
X
A 3.
Accessories and Consumables (Ordering Information) ....... 474
A 4.
Return Tag ................................................................................. 478
A 5.
Do’s and Don’ts......................................................................... 480
A 6.
Rack Layout............................................................................... 482
A 7.
Flags........................................................................................... 486
A 8.
Maintenance Checklists ........................................................... 487
A 9.
Service Information .................................................................. 491
A 10.
Index........................................................................................... 493
Last modification : 01 – 2008
User manual code : 89891 - EN
EVOLIS
About This Manual
Bio-Rad EVOLIS Version 1.90, Instrument Code 89601, User manual
About This Manual
Important Notice
This manual is the copyright of Bio-Rad Laboratories and must not be
copied or reproduced in any form without prior consent.
Although every effort has been made to ensure the accuracy of this manual,
please report any discrepancies or omissions to your Bio-Rad
representative.
All first-time users should have read this manual carefully before operating
the EVOLIS system.
This manual supersedes all previous editions.
Bio-Rad Technical Support
Worldwide technical support for Bio-Rad products is available on the Web
at: http://www.consult.bio-rad.com
For information on how to contact directly your local Bio-Rad representative
or service engineer, please visit also the above website and select your
country.
Last modification : 01 – 2008
User manual code : 89891 - EN
XI
Typographical Conventions
EVOLIS
Bio-Rad EVOLIS Version 1.90, Instrument Code 89601, User manual
Typographical Conventions
Warning messages are indicated by this symbol and printed in boldface italics. Non compliance with these instructions may result in the
operator getting hurt or contracting an infection, or the instrument
being damaged.
Notes are indicated by this symbol and printed in bold-face type. Non
compliance with these recommendations may result in false or
unreliable results or having to abort a run.
Menus
Are printed in bold-face type.
Example: File menu
Menu items
Are printed in bold-face type, separated from the menu by a vertical line.
Example: File | New
Buttons
Are printed in bold-face type with < > signs.
Example: <Open> button
‰
LEDs
XII
Identifies the description of actions.
(Light-Emitting Diodes) are printed in bold-face type.
Example: PWR LED, ERR LED
Last modification : 01 – 2008
User manual code : 89891 - EN
EVOLIS
Safety Instructions
Bio-Rad EVOLIS Version 1.90, Instrument Code 89601, User manual
Safety Instructions
EVOLIS is a fully automated microplate analyzer including functions such as
sample preparation, test performance, photometric measurement and data
evaluation.
EVOLIS is designed and manufactured in accordance with the safety
requirements for electronic and medical measuring devices. If the law lays
down regulations on the installation and/or operation of microplate analyzers,
then it is the operator's responsibility to adhere to them.
The manufacturer has done everything possible to guarantee that the
equipment functions safely, both electrically and mechanically. The systems
are tested by the manufacturer and supplied in a condition that allows safe
and reliable operation.
The user has to observe the information and warnings contained in this
manual in order to ensure safe operation of the instrument.
Please adhere to the following safety instructions when handling or
operating the system:
•
•
•
•
•
•
•
•
•
•
•
Last modification : 01 – 2008
User manual code : 89891 - EN
The instrument may only be operated by specialized personnel who
have been trained on the use of the system.
The instrument may only be operated by specialized personnel who are
aware of the potential risks connected with the use of hazardous
chemical and microbiological agents. Adequate personal protective
equipment should be worn at all times.
Use the system only for the designated application.
Use only the consumables described herein (microplates, primary tubes,
pipetting tips, etc.).
The manufacturer assumes no liability for any damages, including those
to third parties, caused by improper use or handling of the system.
The system is designed according to the regulations of IEC 1010-1 or
EN 61010-1 for electrical measuring systems.
The instrument should be opened, serviced and repaired by qualified
personnel only.
The operator may only perform the maintenance work described in this
manual. Use only the parts described in this manual for servicing.
The instruments are live. Improper handling may cause damage.
Do not take off the protective cover during a run and do not reach into
the working area. If you open the flap of cover, verify that the movement
of the pipettor has stopped before you reach in the working area.
Use grounded connectors to connect all instrument and peripherals to
mains supply.
XIII
Safety Instructions
EVOLIS
Bio-Rad EVOLIS Version 1.90, Instrument Code 89601, User manual
•
•
•
If you can see that the unit has become unsafe to use, switch it off and
disconnect it from the power supply.
If liquid gets inside the instrument (drawer/tip tray), disconnect the power
cord and clean the respective parts using appropriate cleaners (in
particular those spots that are crucial to operation).
Spare fuses must match the values specified by the system
manufacturer.
The tests and maintenance work recommended by the manufacturer
should be performed to make sure that the operator remains safe and
that the instrument continues to function correctly.
Any service and maintenance work not described in this User Manual
must be performed by Bio-Rad Service Engineers and Technicians.
XIV
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1. Getting Started
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1 Getting Started
EVOLIS is a fully automated microplate analyzer performing complete
sample processing (sample pre-dilutions, sample and reagent dispensing,
incubations, wash processes, plate transports) as well as photometric
measurement and evaluation. The instrument is controlled via the
Windows ® PC software EVOLIS. This software, which was specifically
designed for this purpose, allows the user to process the pre-defined assays
of Bio-Rad as well as assays programmed by the user. The clear structure
with intuitive user-guidance allows simple and quick operation of daily
routine jobs as well as programming of user-specific assays.
1.1 Instrument Overview
1.1.1 Individual Instrument Modules
Figure 1: Instrument modules
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1
Dilution area, tray for tip racks
2
Sample and reagent unit
3
Pipetting area, tip eject station
4
Test plate compartment, plate transport unit
5
Waste container for tips
6
Position of incubators
7
Bottom drawer with wash unit and photometer
8
Guide rail for pipettor (X and Y movement)
9
Pipettor (movement in Z-direction)
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1. Getting Started
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
A plastic hood protects the visible working area. The closed position
of this hood is monitored by a contact switch. In order to avoid any
interference with the working area during a run, the EVOLIS instrument
cannot be operated without this hood. If these safety precautions are
not strictly observed, the operator may get hurt or contract an
infection, or the instrument may get damaged.
Figure 2: EVOLIS top level (work area)
16
1a
Dilution area
1b
Tip racks
2
Sample and reagent unit
3a
Tip ejection station
3b
Pipettor prime position and wash station
3c
Test plate pipetting area
4a
Test plate compartment
4b
Plate transport unit
5
Waste container for tips
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1.1. Instrument Overview
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1.1.1.1 Tray for Tip Racks and Dilution Plates
The tray is accessible via a drawer on the left-hand side of the instrument.
This drawer is automatically locked as soon as a run has been started.
The dilution plate positions are located on the left half of the tray (Figure 2
(1a)). There are 3 dilution plate positions; behind the plate positions are 4
additional reagent positions (for 4 x 125 ml bottles).
Some instruments have 4 positions for dilution plates and no additional
reagent positions. Upgrades to 3 dilution plate positions and 4 additional
reagent positions are possible. Please contact your Bio-Rad Service
Engineer.
The tray also includes 5 positions for tip racks (300 µl or 1100 µl tips, Figure
2 (1b)).
For instructions on how to load tip racks and dilution plates, see Section
2.5.4.
1.1.1.2 Sample and Reagent Unit
This unit, accessible via a door, includes 12 tracks for sample and reagent
racks.
Keep the door of this unit closed during a run. Opening the door while
transfer steps are being performed results in an immediate stop of the
pipettor and entry in the event log. Opening the door to load new
samples is possible but only at certain times (see Section 3.2.2).
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Figure 3: Sample and reagent unit
1
3-track reagent rack
2
Contact tappet
3
2-track reagent rack
4
Control rack
5
Red LED
6
Sample rack
Each rack includes a contact tappet. On racks occupying one track, this
tappet is located at the top center, and on the broader racks, at the top right.
Red LEDs on the rear side of the unit light up to indicate where each new
rack has to be loaded. For racks occupying more than one track, the contact
tappet has to be aligned with the lighted LED. For more information on how
to load patient samples racks, see Section 2.2, and on how to load reagent
racks, see Section 2.5.3.
On some instruments, additional reagent positions are found next to the tip
rack tray (Figure 2 (1a)).
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1.1. Instrument Overview
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Rack types – Reagent racks
-3
-2
-1
-0
Figure 4: EVOLIS reagent racks
Rack code
-0
-1
-2
-3
-4
Description
Large reagent rack. Occupies 3 tracks. Includes 21 positions
of various sizes. Only 12 positions are barcoded and
barcode-readable.
Medium reagent rack. Occupies 2 tracks. Includes 12
identical positions, all barcoded and barcode-readable. With
rack position adaptors, this rack can be also be used to load
smaller vials (see Section 2.5.3.4.2).
Small reagent/control rack. Use this rack for controls in small
reagent vials. Includes 20 identical positions, all barcoded
and barcode-readable.
Small reagent/control rack. Use this rack for controls
transferred into hemolysis tubes. Includes 20 identical
positions, all barcoded and barcode-readable.
Small 22-position reagent/control rack. All positions are
barcoded and barcode-readable.
The "-2" and "-3" reagent/control racks are similar visually to "T"
sample racks (the depth of the tube positions is shorter on "-2" racks).
They are, however, identified differently by the system. Do not confuse
them and do not try to load controls on a "T" sample rack instead of on
a "-2"/"-3" rack.
T sample racks can be converted into -3 reagent racks (if more -3 racks are
required). This can only be done by your Bio-Rad Service Engineer.
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Rack types – Sample racks
T
B
Figure 5: EVOLIS sample racks
Rack code
T
B
Z
S
U, V, W, Y
Description
Standard sample rack. Occupies 1 track. Includes 20
identical positions, all barcoded and barcode-readable.
Sample rack with 22 positions. Use this rack for 5 to 7 ml
sample tubes. Occupies 1 track. All 22 positions are
barcoded and barcode-readable.
Sample archiving rack. Use this rack when archiving
samples in secondary tubes (see Section 3.6.6). Occupies 1
track. Includes 20 identical positions, all barcoded and
barcode-readable.
Sample archiving rack with 22 positions. Use this rack for 5
to 7 ml archiving tubes. Occupies 1 track. All 22 positions
are barcoded and barcode-readable.
Racks for specific-size sample tubes (optional).
Visually, U, V, W, Y and Z rack types are identical to the standard T sample
racks but they are identified by colored stickers (and a corresponding display
color in the software, see Section 2.5.1.2). These adapted racks have
specific coordinate files and need an individual alignment procedure before
they can be used.
In the same way, S archiving racks are visually identical to B (22 positions)
sample racks but are identified by a different label (and a corresponding
display color in the software).
Different types of sample racks can be combined in the same run.
1.1.1.3 Test Plate Compartment and Pipetting Position
The test plates are positioned by the system. The test plate compartment
(Figure 2 (4)) can be opened only upon request by the software (the LD LED
lights up green). The LD LED will otherwise be off.
Each test plate is to be placed with its holding frame onto the transport unit
which automatically moves them from the plate compartment to the correct
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1.1. Instrument Overview
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
working position (Figure 2 (3c)), then to the various instrument modules
where they are processed further, and then back again to the plate loading
position.
For more information on how to load test plates, see Section 2.6.
1.1.1.4 Barcode Readers
Barcode readers are found both in the sample and reagent unit (Figure 2 (2)
and in the test plate compartment (Figure 2 (4)). For more information on
barcode types, scanners and use, see Section 3.10.6.
Figure 6: Scanning sample tubes
1.1.1.5 Pipettor
The pipettor (Figure 1 (9)) includes a complex sensory mechanism. It works
with disposable tips. On some instruments, the pipettor is also equipped with
a pressure monitoring device (see Section 3.9.1).
The guide rail (Figure 1 (8)) is used to move the pipettor in the X and Y
direction. The pipettor also moves in the Z direction.
The pipettor home position is located above its wash position (Figure 2 (3b)).
Pipetting into the test plates is done when these are in their working position
(Figure 2 (3c)).
Any physical interference in the work area while pipetting is in progress
should be strictly avoided. Opening the door of the sample and reagent unit
will automatically stop the pipettor.
The pipettor is connected via tubing to the syringe (1000 µl) located in the
rear panel of the instrument and to the system liquid container via the
system liquid port (Figure 11 (10)). The pipettor is automatically primed with
system liquid during a run.
On maintenance of the pipetting system, see Section 4.2.
1.1.1.6 Tip Ejection Station and Waste Container
To eject the tips, the pipettor uses the steel cylinder located at the front of
the work area (Figure 2 (3a)). The ejected tips are transported into the waste
container via a slide which is attached to the front side of the instrument. The
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1. Getting Started
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
slide and its cover can be taken out (pull strongly on the handle) for
maintenance purposes (see Section 4.3.2.5) or to check if anything is
blocked.
The waste container has a transparent cover plate and a grey protection
panel which can both be removed to take out and replace the waste bag
(see Section 4.3.1.3.7).
The biohazard label on the protection panel reminds users that the
contents of the waste bag is contaminated and should be dealt with as
biological hazardous waste.
1.1.1.7 Bottom Drawer
6
7d
7c
4b
7b
7a
Figure 7: Bottom drawer pulled out
4b
6
Plate transport unit
Incubators
7a
Wash unit for test plates
7b
Wash buffer bottles
7c
Trap and vacuum flasks
7d
Photometer
The bottom drawer of the EVOLIS instrument can be opened only when the
green INSTR LED is on (see Figure 10 for location). During a run, the
INSTR LED goes off and the door is automatically locked.
The bottom drawer has two opening positions. In standard everyday use, the
drawer only needs to be opened up to its first opening position: this enables
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1.1. Instrument Overview
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
the operator to load, unload or refill wash buffer and clean fluid bottles, and
to perform the standard maintenance tasks.
The second opening position allows the operator to access the rear part of
the drawer. This is necessary only in limited circumstances (e.g. to replace
the photometer lamp bulb, to clean-up severe spills...).
When the bottom drawer is fully open, strictly avoid leaning on it. The
drawer and/or the instrument may tip over!
This is why, in normal use, a safety catch stops the drawer from being
opened all the way up to this second position. The safety catch is located on
the left-hand side of the drawer, behind the wash buffer bottles (see Figure
8).
Figure 8: Unlocking the safety catch
Move it to the right to unlock it.
When opening the bottom drawer, pull evenly with both hands, one on each
side of the drawer.
When closing the bottom drawer, push evenly with both hands, one on
each side of the drawer until you hear it click. Both sides should be
properly clicked in, otherwise the system will not be able to lock the
drawer and will not allow the run to start.
1.1.1.8 Wash Unit
Test plate washer (Figure 7 (7a))
The test plates are moved into the washer automatically by the plate
transport unit. The wash process and the height adjustment of the washer
manifold can be checked via a small window located in the front panel of the
drawer. The manifold includes 8 aspirate (long) and 8 dispense (short)
needles. It is automatically flushed with deionized water following each wash
step.
Liquid waste is evacuated first into a vacuum flask located in the drawer and
then pumped out to the main waste container (see Figure 11).
For information on the maintenance of the wash unit, see Section 4.2.
Wash buffer and clean fluid bottles (Figure 7 (7b))
A maximum of three bottles (3 x 2-liter) can be used for various buffers;
another position (1 x 1-liter bottle) is reserved for the cleaning fluid to clean
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
the washer head. On some versions of the EVOLIS instrument, this unit
includes two 2-liter bottles and two 1-liter bottles.
Each bottle is fitted with a level sensor and connected to the washer by a
color-coded line (tubing + filter). The level sensors in the wash buffer/clean
fluid bottles monitor the volume in 500 ml increments only (see Section
2.7.2.1).
For information on loading wash buffer or clean fluid, see Section 2.5.6.
Trap and vacuum flasks (Figure 7 (7c))
The two small bottles at the back of the bottom drawer are also used by the
wash unit. One is a vacuum flask; it receives the liquid waste from the
washer. The liquid waste is then pumped further to the main liquid waste
container via the waste outlet on the rear panel (Figure 11(14)). The second
bottle is a trap flask (foam flask) which is used as overflow protection.
Both flasks should drain properly; otherwise, refer to instructions in Section
4.4.6.
1.1.1.9 Photometer
The photometer is located at the back of the bottom drawer (Figure 7 (7d)).
To gain access to the photometer, the bottom drawer has to be pulled out up
to its second opening position (see Section 1.1.1.7).
The photometer can be equipped with up to 8 filters (both endpoint or kinetic
evaluation are possible). Standard equipment is 6 filters (see technical data
in Appendix A 1).
On photometer filters and settings, see Section 3.10.3.1.
On photometer verification, see Section 4.5.4.2.
On photometer maintenance, see Section 4.4.8.
1.1.1.10 Incubator Unit
Four independent heatable incubators are located horizontally, below the
test plate pipetting area (Figure 7 (6)).
The instrument is also equipped with four light-protected room-temperature
incubators. The room-temperature incubators are located below the heated
incubators.
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1.1. Instrument Overview
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Figure 9: Incubators (side view - left-hand side of the test plate
compartment)
3c
Test plate pipetting area
6a
Heated incubators
6b
Room-temperature incubators (light-protected)
When room-temperature incubation is required but does not necessarily
have to be in the dark, the system can also incubate the test plates on the
plate pipetting area (the system then uses the back plate slots so that the
first plate slot may still be used for pipetting operations).
For more information on incubation parameters, see Section 3.10.2.
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1. Getting Started
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1.1.2 LED Displays
Green and yellow LEDs
Five green and one yellow LEDs (Light Emitting Diodes) are located on the
instrument front panel.
PWR
LD
RDY
INSTR
ERR
DWR
2
1
5a
4
Figure 10: LEDs on instrument front panel
1
Dilution and tip rack drawer
2
Sample and reagent unit
4
Plate loading door
5a
Waste slide
These LEDs are used to warn the operator of the status of the instrument,
especially when certain operations (e.g. loading/unloading) are to be
performed.
PWR (Power)
RDY (Ready)
ERR (Error)
DWR (Drawer)
Green when the instrument is turned on, otherwise
off.
Green when ready for a run, otherwise off (e.g. in
case of error or during initialization)
Yellow when an instrument error has occurred,
otherwise off.
Green when the dilution and tip rack drawer can be
opened for loading or unloading, otherwise off.
Green when the test plate loading door can be
opened, otherwise off.
INSTR (Instrument) Green when the instrument bottom drawer can be
opened.
LD (Load)
Red LEDs
Red LED displays are found inside the instrument, at the back of the sample
and reagent unit (see Figure 3). These red LEDs are used by the system to
direct the loading (and unloading) of patient sample racks or reagent racks
(for details, see Section 2.2).
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1.1. Instrument Overview
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1.1.3 Connections
Figure 11: Instrument rear panel with connections
10
Tubing connection for system liquid
11
Electrical connection for system liquid level sensor
12
PC port (RS 232, 9 pole)
13
Mains fuses, mains switch and mains connection
14
Liquid waste outlet
15
Electrical connection of waste container level sensor
16
Waste from pipettor wash station
17
Bow protecting waste tubing
18
Ventilation channels
19
System liquid
20
Liquid waste
The system liquid (fluid) and the liquid waste containers are equipped with
level sensors informing the operator about the status (full/empty) of the
respective container. A corresponding message appears on the screen.
Visual checks are recommended when starting (system liquid) or shutting
down (liquid waste) the system.
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
(17) - Pass waste tubing through below the bow. The liquid waste
container must be placed lower than the EVOLIS instrument.
(18) - The ventilation channels must not be blocked. Observe
minimum distance of 15 cm from a wall or other structure!
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1.1. Instrument Overview
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1.1.4 System Liquid
The system liquid (fluid) container is located beside or behind the instrument
and connected through tubing (see Figure 11). The system liquid container
is fitted with an electric level sensor.
The system liquid can be filled as soon as the instrument is properly
installed.
To fill system liquid:
‰
Prepare the system liquid (add 2 ml of Tween 20 to 10 liters of deionized
water).
‰
Open the container screw cap and pour in the system liquid.
‰
Close the screw cap and make sure the level sensor and connections
are correctly set.
The level sensor is used by the system to check the available quantity of
system liquid. This check is performed each time a selftest is conducted (see
Section 1.2.3). The system will also warn the operator if the level of system
liquid becomes insufficient during a run.
Figure 12: Refill system fluid warning
A visual check of the system liquid container is recommended every morning
before starting the system (see Section 4.3.1.1).
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1.1.5 Accessories and Consumables
The necessary accessories and the following consumables can be
purchased from Bio-Rad:
• Patient sample and reagent racks (with barcodes).
• Barcode labels for reagent and sample racks.
• Holding frames for test plates.
• Tip racks with 300 µl / 1100 µl disposable tips.
• Waste and system liquid containers with or without level sensors and
tubing connections.
• Wash buffer and clean fluid bottles.
• Trap flask and vacuum flask.
• Spare reagent bottles.
• Barcode labels for reagent bottles.
• Various tubings.
• Filters for the photometer.
• Halogen lamp for the photometer.
• Sample rack storage tray.
• RIVASCOP ® (decontamination solution)
For details and ordering information, see Appendix A 3.
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1.2. Initial System Set-Up
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1.2 Initial System Set-Up
1.2.1 PC Requirements
•
•
•
•
•
•
IBM compatible Pentium PC with:
Windows® 2000
2 COM ports
Color monitor
Keyboard and mouse
Min. 150 MB free hard disk space
The EVOLIS computer is part of the EVOLIS system supplied by BioRad. It is recommended not to replace it with another computer.
The EVOLIS user program is a PC software that runs on Microsoft®
Windows® 2000. The usual Windows conventions apply. Deviations from
these conventions are described where appropriate.
It is strongly recommended that you disable any screen saver or
energy-saving monitor shut-off option on the computer on which the
EVOLIS software is installed as these may interfere with the EVOLIS
Scheduler and affect the run.
1.2.2 System Start
If you intend to use both the software and the instrument, always turn on
the instrument first and then the computer.
ON/OFF switch
On the instrument, the ON/OFF switch is located on the rear panel (see
Figure 11). When facing the instrument, you reach the switch from the lefthand side.
When you have started the computer, double-click on the program icon to
start the EVOLIS software.
Figure 13: EVOLIS Program Icon
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1.2.2.1 Logging In
You will then be prompted for user name, password and demo mode.
Figure 14: Password prompt
1.2.2.1.1 Registered Users
If you are a registered user:
‰
Enter your user name. By default, the software displays the user name
of the previous user; delete it if necessary.
‰
Enter your password.
‰
Check the Demo Mode item if you intend to work with the software only.
Do not check this item if you intend to work on the instrument.
‰
Click <OK>.
Do not click the <OK> button without checking the Demo Mode item if
the computer is not connected to an instrument or if the instrument is
not turned on!
If you do, the system tries to initialize and perform a selftest (see
Section 1.2.3). But, because the system cannot access the instrument
modules it is supposed to check, this stalls the system.
1.2.2.1.2 Unknown User Name / Unregistered Users
If you do not have a user name or do not know it, you cannot set one for
yourself directly in the Log-On dialog box.
You have to refer to an authorized supervisor (i.e. an EVOLIS registered
user who is allowed to Administer Users) in your laboratory who will
declare you as a registered user and define your access rights according to
the procedure described in Section 1.2.7.
Then, when you first log-in under your new user name, you will have to set
your first password as described below.
1.2.2.1.3 First-Time Use (password registration)
If you are a registered user but this is the first time you use the EVOLIS
system:
32
‰
In the Log-On dialog box, enter your user name in the User Name field.
‰
DO NOT enter anything in the Password field.
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1.2. Initial System Set-Up
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
‰
Check the Demo Mode item if you intend to work with the software only.
Do not check this item if you intend to work on the instrument.
‰
Click <OK>. The system initializes and the selftest report (see Figure 17)
is displayed.
‰
Select the Utilities | Options menu item. This opens the Options dialog
box (click on the Password tab if it is not already displayed).
Figure 15: New password definition
‰
Check that your user name is correctly displayed (automatically) in the
User Name field.
‰
DO NOT enter anything in the Current Password field.
‰
Choose a password and enter it in the New Password field, then
confirm it in the Retype Password field.
‰
Click the <Change> button. A message is displayed confirming your
password change (in this case, your first password definition).
‰
Click <OK>.
When you next start the EVOLIS software, you will have to enter this
password in the Password field of the Log-On prompt. If, later, you want to
change it, you can do so as described above except that you first have to
type in your current password in the Current Password field before defining
a new password.
Any alphanumeric chain of characters can be used as password.
1.2.2.1.4 Incorrect password
If the password you entered in the Log-On dialog box does not match the
password which has been defined for that particular user name, the system
displays the following message:
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1. Getting Started
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Figure 16: Incorrect password
‰
Click <OK> and try entering the password again.
If you have forgotten your password, see Section 1.2.7.4.
1.2.2.1.5 Successive Users
The user name entered when logging in will automatically appear in the
Operator field in the selftest report and also in the header of the result files
and result reports. It ensures a better traceability of tests performed.
Therefore, if the system has been started by one user and another user
wants to take over, the second user should log-in under his/her own user
name. To do so, it is not necessary to shut down the system and restart it.
You only need to :
‰
Select the File | Close menu item to close all open windows (including
the selftest report). You should see only the menu bar and toolbar above
a gray screen.
‰
In the Utilities menu, select Log-Off/Log-On. The Log-On dialog box is
displayed.
‰
Enter the User Name and Password of the second user.
‰
Click <OK>.
This cannot be done when a worklist is being processed. You have to wait
until the processing is over.
1.2.2.1.6 Users with Restricted Access Rights
The EVOLIS system allows the creation of various user groups with different
access rights, e.g. users belonging to one group may be allowed only to run
the system while users with more extensive rights will be allowed to define
assays or change the system set-up.
Users with restricted access rights can always start the system and log-in as
long as they are registered users (have a valid user name and password).
For more information on defining user groups and assigning each user to a
specific group, see Section 1.2.7.
1.2.2.2 Simulation (Demo) Mode
The Simulation/Demo Mode allows you to work with the EVOLIS software
even if no instrument is connected or turned on.
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
To do this, check the Demo Mode item in the Log-On (Password prompt)
dialog box (Figure 14) and click the <OK> button.
The COM port between the PC and the instrument is then disabled.
The Demo Mode allows you to access and use all the functions that you
would normally use.
You can, for instance, use it to create a worklist and check, on the Schedule
view (see Section 2.4.7.2) how it would actually be performed on the
instrument. The only difference is that the time scale is changed (one minute
of a real process is rendered as one second in Demo Mode) and that no
reading values are returned in the results.
You can also use the Demo Mode to edit the system parameters, edit
assays, create panels, access and print former results, etc. Changes made
or files created while in Demo Mode are saved on the system just as they
would be normally.
It is therefore a very useful (and safe) mode to use for all operations for
which you do not need to use the instrument.
To change back from Demo Mode to the normal operating mode:
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‰
Select File | Exit to quit the EVOLIS software.
‰
Turn on the instrument.
‰
Restart the software and do not check the Demo Mode item in the LogOn dialog box.
35
1. Getting Started
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1.2.3 Initialization and Selftest
A selftest is performed each time you start the EVOLIS software. The
system is initialized and checks all instrument modules. These are checked
as follows:
COP (Command
Operating Processor)
An EEPROM checksum is created. The serial connection to all modules of
the EVOLIS is verified.
Pipettor
The pipettor is initialized. The movement in x-, y-, z-axis is checked, the
encoders and the home sensors in these directions are tested. The pipettor
is primed with system liquid five times.
Washer
The home sensors, encoders, aspirate and dispense pump are checked.
Photometer
An EEPROM checksum is created. The plate transport inside the reader is
checked. The reference voltages of the front end and also the photodiode
dark background signals is measured.
Each filter is tested to choose the optimum read gain and for noise at
optimum gain. The optic channel transmissions are measured.
Plate Transport
A EEPROM checksum is created. The movement in x-, y-, z-axis is
checked and the encoders in these directions are tested.
Incubators
A EEPROM checksum is created. The temperature sensors are tested and
it is checked if the heater drives are not in open circuit.
The results of this instrument check is then displayed on the screen.
Figure 17: Selftest report
The result of the selftest is satisfactory if the word "Passed" is displayed for
each instrument module.
The Maintenance field remains empty unless you have defined specific
maintenance checks to be performed by the system (see Section 4.3.5).
Under default settings, selftests are performed only each time you start the
software. But other options are available.
36
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
To request a selftest at another time
The EVOLIS system allows the user to request a selftest punctually at any
other time (not, however, while a worklist is being processed). This is useful,
for example, if you suspect that an instrument module is not responding or
functioning correctly.
To do this:
‰
Select Selftest in the Utilities menu.
Figure 18: Utilities | Selftest menu
A selftest will be immediately performed and the results shown as above.
To program a selftest before each run:
‰
Select the Utilities | System Set-Up menu item to open the System tab
of the System Set-Up dialog box.
‰
Check the Perform self-diagnostics before a run item in the Selfdiagnostics box.
Figure 19: Self-diagnostics box
This dialog box also lets you program the software to automatically print a
report each time a selftest is performed.
To do this:
‰
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Check the Auto print self-diagnostics report item in the Self-diagnostics
box.
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1. Getting Started
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
If this item is not checked, select File | Print or click the <Print> button in
the toolbar to print a selftest report.
Performing a selftest check before each run is a good safety
procedure. However, it takes time (approx. 2 minutes), and is
recommended mostly for operators who are not familiar with the
system.
1.2.3.1 Selftest Failure
If one or more of the instrument modules that are checked during the selftest
are found to be not responding correctly, a corresponding error message will
be displayed in the selftest report.
Before interfering with the faulty or non-responding module, try to perform
the selftest again by selecting Selftest in the Utilities menu.
If this also fails, refer to the error message list in Section 5 and check what
corresponding action can be undertaken to solve the problem.
38
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1.2.4 Software Layout
1.2.4.1 The EVOLIS Screen
When assay files, worklist files or result files are open, the EVOLIS main
screen is divided in two :
• On the left-hand side is an Explorer Tree (assay tree, worklist tree, result
report tree). Clicking on the plus (+) sign of a folder in the Explorer Tree
opens the folder to show its contents. Clicking on the minus (-) sign
closes the folder.
• On the right-hand side, a detailed view of each step of a process or part
of a document is displayed. Clicking on an item in the Explorer Tree will
bring up the corresponding detailed view in the right-hand side of the
screen.
Figure 20: Example - Assay window
To move the dividing line between the two parts of the screen:
‰
Click on it with the mouse and pull it to the left or to the right while
keeping the left mouse button held down.
To adjust the left margin of the detailed view (right-hand side of the
screen):
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‰
Select Options in the Utilities menu.
‰
Click on the Preferences tab.
‰
Enter the desired margin size in the Left Margin field.
‰
Confirm with <OK>.
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1. Getting Started
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1.2.4.2 Toolbar
1
2
3
4
5
6
7
8
9
10
11
12
Figure 21: Toolbar
1
2
3
4
5
6
7
8
9
10
11
12
<New>
<New Worklist>
<Open>
<Save>
<Print>
<Import>
<System Maintenance>
<Lot Specific Information>
<Start>
<Stop> (<Pause>)
<Load Tips>
<Backup>
On menu equivalents and on the functionality of each button, refer to the
"Menu guidance" table (next page).
40
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1.2.4.3 Menu Guidance
The following table describes the various menus and individual menu
items available when a worklist file is open.
Note that if the EVOLIS system has been started by a user with
restricted access rights (see Section 1.2.7.2), not all these menu items
will be accessible. Some will be visible but disabled.
Menu
Item
File
New
Icon
Creates new files, see Section 1.2.4.4.
New | Worklist
Opens the Set-Up Panel dialog box to create a new
worklist.
Open
Opens an existing file, e.g. an assay protocol file, a
report file, etc. (for file types and location see Section
1.2.6.2).
Close
Closes the displayed file.
Save
Saves the active file.
Saves the active file under a name defined by the
user. By default, the file is saved under a name that
combines file type and a consecutive number.
Save as
Print….
Edit
Function
Prints the active document.
Print Preview
Print preview.
Print Setup….
Defines the printer and printing options.
Recent Protocols
¾
Allows direct access to the last-opened and already
saved assay protocol files.
Recent Results
¾
Allows direct access to the last-opened and already
saved result files.
Recent Worklists
¾
Allows direct access to the last-opened and already
saved worklist files.
Exit
Terminates the program.
Panel Definition...
Opens or re-opens the Set-Up Panel dialog box
allowing you to edit the current worklist.
Panel Options
Opens the Worklist Options dialog box allowing you
to change the worklist processing options (see
Section 2.4.8).
Lot specific values
Display and input of the lot specific information and
the required reagents for the displayed worklist.
Start
Starts the loading dialog; once the loading dialog has
been completed, a run using the current worklist can
be started.
Stop
Pauses the current run. The run can be resumed and
one or several plates can be removed from
processing. Or the entire run can be aborted.
Unload Finished
Plates
Allows you to unload fully processed plates before the
end of the run (see Section 2.9.1 b)).
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Menu
Item
Icon
Load additional tips
View
Utilities
Allows you to reload disposable tips.
Toolbar
Shows/hides toolbar.
Status Bar
Shows/hides status bar at the bottom of the screen.
Module schedule
Graphical display of the processing of a worklist
(module-specific).
Plate schedule
Graphical display of the processing of a worklist
(plate-specific) (see Section 2.4.7.2)
Layout Label
In the worklist screen, view the Plate layout with
layout labels.
Patient IDs
In the worklist screen, view the Plate layout with
Patient IDs (see Section 2.4.7.3).
System Utilities
Manual plate control.
System setup
Definition of instrument parameters.
Selftest
Performance of a selftest (initialization).
Maintenance
Allows you to execute predefined maintenance tasks
(see Section 4.3.5).
Verify
¾
Allows you to check the photometer (see Section
4.5.4.2).
Patient Details
Allows you to view or edit patient data.
Options...
Allows you to view or edit the software parameters.
Volume Offset...
Not available for users of the system.
Kit Database
Review or edit kit lot tracking database information.
Add Kit…
Enter a new kit lot in the kit database (see Section
3.5.2.3.1).
Window New Window
Opens a new window.
Cascade
Cascades the active windows.
Tile
Tiles the active windows.
Arrange Icons
The icons can be rearranged.
*.*
Shows the names of all currently active windows.
Help Topics
Calls the on-line help.
About EVOLIS
Displays the software version.
---
(no corresponding
menu item)
Allows you to manually force the automatic import of
test orders (see Section 3.13.1.3.2).
---
(no corresponding
menu item)
Opens the System Backup dialog box allowing you
to create backup files (see Section 4.3.3.6).
Help
42
Function
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1.2. Initial System Set-Up
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1.2.4.4 The File | New Menu Item
If you select the File | New menu item, the following dialog box is displayed.
Figure 22: New dialog box
In this dialog box, you select the type of file you want to create (scroll down
the list if necessary) and click <OK>.
Available choices are:
Assay
On creating assay files, see Section 3.12.3.
Worklist
On creating new worklists, see Section 2.4.
Spectral Response
Patient Results
Report
QA Analysis Report
Job List
Archive Report
Volume Offset
Report
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If you select Spectral Response and click <OK>, the system asks you to
load a test plate. The photometer then performs readings of the 96 wells on
the plate using all the installed filters. From these readings, the system
produces a spectral response curve. Suggested test and reference filters
are displayed on the screen. Double-click on a specific well to display the
curve recorded for this well.
On creating patient result reports, see Section 2.8.7.
On QA analysis reports, see Section 2.4.6.1.
If you select Job List and click <OK>, the system displays a list of Patient
IDs with the assays to be performed for each patient, i.e. patient data and
test orders already stored in the system and not yet processed. This
corresponds to the data currently available in the Patient Editor dialog
box. This function is useful because it allows you to know rapidly if there is
any "back log" or if there is a lot of work remaining to be done. This Job
List can be printed by clicking the <Print> button or selecting the File |
Print menu item. This Job List is different from the Job List displayed in the
Worklist window. The Job List displayed in the Worklist window shows the
Patient IDs and assays included in that worklist (see Section 2.4.7.7).
Disabled.
Volume offset parameters are used to optimize pipetting accuracy. They
are defined by Bio-Rad Engineers only and cannot be edited by users.
Users are only allowed to view the Volume offset report by selecting this
item and clicking <OK>.
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Reagent Parameters
Report
If you select Reagent Parameters Report and click <OK>, you can display
(and print) a complete list of all the reagents included in the current reagent
database (see Section 3.4.1).
APM Report
If you select APM Report and click <OK>, you can display (and print) a
complete list of all threshold sets used by the air pressure monitoring
system (see Section 3.9.2) for the various liquid types, volumes, tip sizes.
Abbreviations used in the APM Report:
SA = Single aspirate (aspirate only one liquid and dispense it).
MA = Multi aspirate (dilution in tip: aspirate diluent first, then sample or
control or calibrator and dispense both).
Dil = diluent (also used for blanks in SA).
Ctrl = control Ctrl pur = undiluted control Ctrl dil = diluted control
Spl = sample Spl pur = undiluted sample Ctrl dil = diluted sample
p max, p min, etc = APM thresholds (see Section 3.9.2).
1.2.5 Software Language
It is possible to choose the language in which to use the EVOLIS software.
This will affect the software layout (menus, dialog boxes, buttons) but also
the documents (assay files, result reports, event logs...) used or generated
by the system.
To select the language:
‰
Select the File | Close menu item to close all open windows (including
the selftest report). You should see only the menu bar and toolbar above
a grey screen.
‰
In the Utilities menu, click on Select Language.
‰
In the Select Language dialog box, select one of the available
languages from the dropdown list.
‰
Click <OK>.
‰
Close the EVOLIS software and restart it.
Figure 23: Select Language dialog box
If you have changed the software language but some elements
continue to be displayed in English, this may be because:
•
44
you are using an English-language version of Windows ® (in this
case, some buttons will be in English).
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1.2. Initial System Set-Up
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
•
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you are using assays that were defined in English.
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1. Getting Started
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1.2.6 Reviewing Default Settings
1.2.6.1 Laboratory Details
The lab details entered here are included in the result reports (see Section
2.8.1).
To enter, review or edit the laboratory details:
‰
Select the Utilities | Options menu item to open the Options dialog
box.
‰
Click on the Laboratory tab.
Figure 24: Laboratory tab
46
‰
Under default settings, all fields are blank except the ID field which is set
to "0".
‰
Enter your laboratory's details. If your laboratory details have already
been entered by your Bio-Rad Service Engineer when installing the
system, review them and edit them if necessary. Any chain of
alphanumeric characters can be entered in the Name, Address,
Telephone and FAX fields (no specific format is required by the
system). An integer value is required in the ID field (otherwise, keep the
default value "0"). If you use EVOLIS in conjunction with Unity Real Time
(see Section 3.5.5) the laboratory ID entered here has to be your Unity
Real Time laboratory ID.
‰
Click <OK> to save the changes.
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1.2.6.2 File Types and Location
Under default settings, the directory structure of the EVOLIS software is as
follows:
Figure 25: EVOLIS default directories
The EVOLIS software uses a number of different file types. Under default
settings these files are saved in the following directories:
Extension
*.apm
*.asy
*.dat
*.log
*.mpc
*.pan
*.rac
*.rea
*.res
*.spe
*.tst
*.txt
*.txt
*.txt
*.ver
*.wor
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File types
File polling format setting of the import
file for host systems.
Assay protocol files.
System and kit database coordinate files.
Active event log files (documenting daily
data communication between PC and
EVOLIS instrument as well as error
messages).
Coordinate files for test plates or dilution
plates.
Panel files.
Coordinate files for rack types.
Reagent layout files.
Result files.
Spectrum files (contain data of a
spectrum acquisition).
Selftest report files with information about
the selftests that were performed.
Export files in ASCII format
ASCII patient data import files can be
downloaded from a host computer to the
EVOLIS software (patient with
associated assays).
Duplicate log file in (*.txt) format.
Photometer verification report files.
Worklist files.
Path
C:\BioRad\System
C:\BioRad\Resources\Apf
C:\BioRad\System
C:\BioRad\Resources\Event log
C:\BioRad\System
C:\BioRad\Resources\Apf
C:\BioRad\System
C:\BioRad\System
C:\BioRad\Resources\Result
C:\BioRad\System
C:\BioRad\System
C:\BioRad\Export
C:\BioRad\Import or selected
directory on host computer
C:\BioRad\Resources\Event log
C:\BioRad\System
C:\BioRad\System
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
The system uses also some other file types (*.rec, *.db, *.mdb, *.lsv,
*.con) but these are "transparent" for the user.
When installing the software, you can choose to install it in a different
directory than the default BioRad directory. In this case, the same subdirectory structure (Backup, Import, Export, Resources, System…) is applied
but relatively to the installation folder you selected.
In any case, it is always possible, later, to edit manually the default directory
in which each file type is saved as described below.
To change the default directory in which each file type is saved:
‰
Select the Utilities | Options menu item to open the Options dialog
box.
‰
Click on the Directories tab.
Figure 26: Directories tab Select the respective file type and click on the
<Browse> button.
48
‰
In the Browse dialog box, find the directory where you want to save this
file type.
‰
In this directory, select any file and click <Open> (see Note below).
‰
Back in the Directories tab, check that the corresponding change has
been taken into account.
‰
Confirm with <OK>.
‰
Repeat this procedure for the other file types if necessary.
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
If this new target directory in which you want to save certain file types
is empty just copy or create any file into it, so you can select it for that
purpose (you can later delete it). If you select only the directory (and
no file) and click <Open>, the change will not be retained.
1.2.6.3 Other Default Settings
Other default parameters applying to the various instrument modules are set
by your Bio-Rad Service Engineer upon installation. Some of these default
settings can be edited to suit user-specific needs. However, that does not
generally need to be done before first-use of the system. To check these
parameters and how to edit them, see the following sections of the
Advanced Features Guide.
Instrument units
Incubators
Photometer
Pipettor
Sample and reagent
racks
Washer
Plate transport
Maintenance
Parameters
Number of units in use, pre-heating, shaking.
Number of filters in use, order of the filters,
photometer verification.
Pipetting profiles, plate and tube types to be
used.
Rack types, barcode types, loading
parameters.
Bottle parameters, calibration.
Enable/Disable test plate barcode scanner.
Maintenance jobs to be performed.
See Section
3.10.2
3.10.3
3.10.4
3.10.6.1
3.10.5
3.10.6.3
4.3.5
These settings are accessed through the Utilities | System Set-Up menu
item.
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1.2.7 Defining User Rights and User Groups
The purpose of user groups is to allow the laboratory supervisor to
individually define the rights of each user. For example, it makes it possible
to specify that some technicians will only be allowed to use the EVOLIS
system to process pre-defined assays but not to program new assays or
change the system settings. It also makes it possible to ensure that only
authorized personnel can access patient data or validate results before they
are exported to a host computer.
Under default settings, two pre-defined user groups are available:
Supervisors
Full access group. Members of this group are allowed to use all the
functions available on the EVOLIS system.
Users
Restricted access group. Members of this group are only allowed to Start
Worklists, Edit Worklist Options and Post Results to LIMS. For details
on these and other access rights, see table in Section 1.2.7.2.
1.2.7.1 Defining the Rights of Individual Users
To define the access rights of a user, you need first to register that user
(specify his/her user name) and then assign him/her to an existing user
group.
To do this:
‰
Select the Utilities | Options menu item to open the Options dialog
box.
‰
Click on the Users tab.
If this tab is not available, this means that you are not allowed to
Administer Users (see Section 1.2.7.2). Please refer to someone who is
(e.g. your laboratory supervisor or your Bio-Rad Service Engineer).
50
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Figure 27: Users tab
‰
Enter a name for your new user in the first User Name field. Any
sequence of alphanumeric characters (spaces are allowed) can be
entered as a user name.
‰
Click the <Add User> button. The new user name is then automatically
displayed in the lower User Name drop-down list.
‰
In the Available Groups list, select the appropriate user group for this
user.
‰
With the arrow buttons (>, >>, <, <<) transfer it to the Member Of list. By
doing this you specify that your new user is a member of this group.
‰
Confirm with <OK>.
The same user can belong to more than one user group. In this case, his/her
access rights are the same as those defined for members of that user group
with the most extensive access rights (e.g. if User A belongs to both the
Users and the Supervisors groups, User A will have the same access rights
as Supervisors).
The Users tab also allows you to check which group(s) a given user belongs
to and, if necessary, change it.
To check or change the groups which a user belongs to:
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‰
In the Users tab, in the Existing Users box, use the User Name dropdown list to select the desired user.
‰
The group(s) this user belongs to is(are) now displayed in the Member
Of list.
‰
Using the arrow buttons (>, >>, <, <<) you may now, if you want, change
the user group(s) to which this particular user belongs by transferring
items from the Available Groups list to the Members Of list (or viceversa).
‰
Confirm with <OK>.
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1.2.7.2 Creating and Editing User Groups
To open the User Groups tab:
‰
Select the Utilities | Options menu item to open the Options dialog
box.
‰
Click on the User Groups tab.
Figure 28: User Groups tab
If this tab is not available, this means that you are not allowed to
Administer Users (see list on next page). Please refer to someone who
is (e.g. your laboratory supervisor or your Bio-Rad Service Engineer).
This tab includes a list of access control items. When an item is checked,
this means that members of the respective user group (highlighted in the
Groups list) are allowed to use the corresponding functions. The example
above shows that members of the Supervisors group can use all the
EVOLIS functions (no restrictions apply).
52
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
List of definable access control items
Items
Create assays
When item is checked, members of this user group can...
...create new assays.
Edit assays
...edit assays. Note however that even if a group of users is allowed to edit
assays, assays themselves can be individually protected by a specific
password set by the person or company which created the assay (e.g. BioRad pre-defined assays are password protected).
Change preferences
...access the Preferences tab in the Options dialog box and change the
settings on this tab (see Figure 196).
Manually remove
outliers
Edit patient details
...remove outliers manually (see Section 2.8.3).
...access and edit patient personal information (see Section 2.3.3).
Change system
setup
...open the System Set-Up dialog box and change the settings on any of
the tabs (see Section 3.7).
Edit running
worklists
...access the Edit | Panel Definition menu item in order to change the
settings of an existing worklist (e.g. to add new plates – see Section 3.2 on
Continuous Loading).
Administer Users
...register new users and define their rights. Define, edit or delete user
groups. Clear user passwords.
Edit Worklist
Options
...open the Worklist Options dialog box and decide on a number of
operations to be performed (or not) as the worklist is being processed (e.g.
pre-run checks, sample archiving, tip management, reagent reloading,
result printing - see Section 2.4.8)
Start Worklists
...define a worklist, load the instrument and start the processing (perform a
run). This is one of the basic rights. For users who are not allowed even to
start worklists, a special authorization procedure may apply, see Section
1.2.7.3.
Post Results to LIMS
...allow test results to be exported to a host computer. Note that for users
who are not generally allowed to undertake this action, a special
authorization procedure may apply, see Section 1.2.7.3.
Restore Backups
…replace current set-up by files resulting from a previous back-up operation
(see Section 4.3.3.6).
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
To define a new user group:
‰
Enter the name of the new user group in the field at the bottom of the
dialog box (instead of New Group).
‰
Click the <Add> button. Your new user group is entered in the Groups
list. A new user group is always entered at the bottom of the list. If you
want the user groups to be displayed in the list according to a specific
order (e.g. those with extensive rights at the top and those with more
restricted rights down the list), you have to define them in that order!
‰
Check the appropriate items in the list to specify which actions members
of this group are allowed to undertake (e.g. you may want to create an
Advanced Users group in which users will be entitled to all the above
rights except Administer Users and Edit Patient Details).
‰
Confirm with <OK>.
To delete a user group:
‰
In the Groups list, select the user group which you want to delete.
‰
Click the <Delete> button.
‰
Confirm with <OK>.
To edit the rights assigned to an existing user group:
‰
In the Groups list, select the desired user group.
‰
Check items on the right-hand side of the dialog box if you want to allow
members of this group to undertake actions which they were not
formerly allowed to do (e.g. you may decide to allow Users to Ignore
Errors if you think it is more important that runs be fully processed).
Uncheck items if you want to restrict the rights of this user group.
‰
Confirm with <OK>.
1.2.7.3 Special Authorizations for Users with Restricted Rights
Normally, if a user belongs to a group which is not authorized to undertake a
given action, this user will not be able to even access the corresponding
menus or dialog boxes. There are, however, two exceptions which apply to
the Start Worklists and to the Post Results to LIMS items.
A user who is not allowed to start a worklist will be nevertheless allowed to
define a worklist and load the instrument accordingly. When he/she attempts
to start the worklist, the Log-On dialog box will be displayed. This user then
has to seek the assistance of a supervisor or of another user who is allowed
to Start Worklists. This other user will then log in under his/her own name
and authorize the start of the worklist. This is only a log-on for authorization
purposes. It is recorded as such in the event log (mentioning the user name
of the person who gave the authorization). The original user remains logged
in and will continue to appear as Operator in the result report for instance.
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
The same applies to Post Results to LIMS. If this action is requested by a
user who is not allowed to undertake it, the Log-On dialog box is displayed
and a supervisor or a more advanced user has to authorize the transfer.
These special authorizations allow supervisors to let even new users work
on the system while still making sure they themselves can verify the
processing and validate the results. Do not confuse this situation with the
"successive users" case described in Section 1.2.2.1.5.
1.2.7.4 Password Settings
Although user registration (i.e. defining the user name and user group of a
new user) has to be done by a supervisor or another user entitled to
Administer Users (see Section 1.2.7.2), password definition can only be
done by the user himself/herself.
This is done, as described in Section 1.2.2.1.3, when the user logs in for the
first time under his/her new user name. Similarly, only a user himself/herself
can change his/her password (as explained in the same Section).
This ensures that nobody, even supervisors, can have knowledge of
someone else's password and, consequently, that nobody can use the
EVOLIS system under someone else's user name.
Forgotten password
The only situation in which supervisor intervention is required is when a user
has forgotten his/her password. In this case, the user has to seek the
assistance of a supervisor or of another user who is allowed to Administer
Users.
This supervisor has to:
‰
Log in under his/her own user name and password.
‰
Select the Utilities | Options menu item to open the Options dialog box
and select the Users tab (see Figure 27).
‰
In the Users tab, display the User Name drop-down list and select the
user name of the user with the forgotten password.
‰
Click the <Clear Password> button. The following message is
displayed.
Figure 29: Password cleared
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‰
Click <OK> to close the message, then click <OK> again to close the
Users tab.
The next time the user logs in under his/her own user name, he/she has to
define a new password exactly as if he/she was defining his/her first
password (refer to the procedure described in Section 1.2.2.1.3 for defining
a first password).
1.2.7.5 Troubleshooting/FAQ
1) Can I keep a blank password ?
Technically, yes. However, this is NOT recommended.
When a new user has just been registered, he/she can open the EVOLIS
software without a password until he/she has defined his/her first password
as described in Section 1.2.2.1.3. As long as this has not been done, this
user will remain able to open the EVOLIS software (and work on the system)
without a password. But it also means that anybody else may be able to
operate the system under this user name.
2) As a supervisor, can I set temporary passwords for the new users I
register ?
Yes.
If you want to do so, once you have registered a new user you have to:
‰
Log in under the name of the new user you have just registered.
‰
Enter the temporary password as if you were the new user entering
his/her first password (see procedure described in Section 1.2.2.1.3).
‰
Let the new user know this temporary password. When that user logs in
under his/her own user name, he/she will be able to change this
password as explained in that same Section.
3) Can I use some restricted functions in Demo Mode ?
No.
If you belong to a user group for which access to some functions is
restricted, these restrictions will apply in Demo Mode as they apply if you
are working with the instrument. For example, if you are not allowed to
change the system set-up, the Utilities | System Setup menu item will be
disabled even if you start the system in Demo Mode.
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1.2.8 Connection to a Host Computer
In most cases the EVOLIS system is integrated into a wider laboratory
environment. The PC that operates the instrument then has to be also
connected to a host computer. This connection enables data to be imported
or exported from the host to the EVOLIS system, and back (e.g. download of
patient data to the system, upload of test results to the host computer).
For a detailed description of how to enable this connection and specify its
parameters, refer to Section 3.13, Connection to a host computer.
EVOLIS
Computer
Network link (ASCII files)
COM Port 2 (ASTM)
COM Port 1 (RS 232)
EVOLIS Instrument
USB or
Parallel
Port
Host Computer
Printer
Figure 30: Connection to a host computer
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
2 Processing Pre-Defined Assays
2.1 Overview
1
Start the system
Turn on the instrument and start the EVOLIS
software.
Section 1.2.2
2
Load the patient samples
Place the patient sample tubes into the racks
and insert the racks in the instrument.
Section 2.2
3
Assign assays to patients
On the computer, define the tests that have
to be performed for each patient.
Section 2.3
Create the worklist
Define how the test run will be performed:
the sequence in which the assays will be
processed, how the samples will be arranged
on the test plates, etc.
Section 2.4
5
Load the required resources
Allocate the patient samples and load the
various other resources (reagents, wash
buffer, dilution plates, tip racks) into the
instrument.
Section 2.5
6
Load the test plates
When prompted by the software, load the
test plates using the plate transport unit.
Section 2.6
4
7
Pre-run checks
(Optional) The system carries out a number
of checks (e.g. reagent volume check) before
processing the run.
Follow through as the system performs the
various steps of the test run. Pause the
system if necessary (emergencies).
Section 2.7.2
Section 2.7.3
8
Process the run
9
End of run/Results display
The system displays the Result Report.
Validate, edit or export the results.
Section 2.8
10
Unload
Unload used resources (test plates, patient
samples, reagents, dilution plates,).
Section 2.9
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2.2 Loading Patient Samples
Figure 31: Sample rack
Figure 32: Patient sample unit
2.2.1 Loading Process
Check visually the quality of the samples you are intending to process
(clots, foam…). To avoid clots, proper treatment (e.g. centrifugation) of
patient samples is recommended.
To load patient samples:
60
‰
Place the sample tubes in the sample racks as follows:
a) if you are using barcoded sample tubes, make sure that the barcode
labels on the individual patient samples face right so that they can be
scanned by the barcode reader when the rack is inserted.
b) if you are using non-barcoded sample tubes AND you want to use
the <Auto Arrange> function to allocate samples, be sure to place the
samples in the racks in the order that will be used by the system to
allocate the samples (see Section 2.5.2.2 b)).
‰
Open the door of the samples and reagents unit (second door from the
left in the front panel of the instrument).
‰
Insert the first rack on the track marked by the red LED on the rear
panel. Place the rack in front of the track and then push evenly up to the
limit stop (with the tappet in the contact opening on the rear panel).
‰
The rack barcodes (and the individual sample barcodes if you are using
barcoded sample tubes) are read. If the rack has been inserted properly
all the way, the LED goes off for this position, and turns on at the next
position that can be loaded.
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‰
If applicable, fill out the Patient Editor dialog box for that rack as
described in Section 2.3.2.1.
‰
Insert the other sample racks in the same manner.
‰
After loading, close the door again (audible click).
2.2.2 Problems that May Occur while Loading
1) Racks tend to tip over sideways
When inserting a sample rack onto a track, make sure to keep your rack
strictly level while pushing it in. If you push down on the end that you are
holding, the other end may lift out of the track and the rack may tip over. If
this happens, please refer to the clean-up and decontamination procedures
described in Section 4.4.
2) Using different sizes of sample tubes
The standard T sample racks (see Section 1.1.1.2) usually accommodate
tubes with a diameter between 9 and 16 mm and a height not to exceed 10
cm.
If you need to use smaller size tubes (e.g. Eppendorf tubes), narrower tubes
or tubes with a specific shape, contact Bio-Rad Technical Support to adapt
and re-align your racks accordingly. The adapted racks will be identified by
colored stickers and, in the Load dialog box, these racks will be displayed in
the corresponding color and identified by a different code letter (U, V, W, Y
and Z).
The EVOLIS system will not accommodate sample tubes that exceed 10 cm
in height; therefore, these samples must be transferred into smaller tubes to
be processed.
3) There is not enough space to fit all the sample tubes
Each sample rack can accommodate 20 or 22 tubes (see Section 1.1.1.2).
The sample and reagent unit includes 12 rack tracks, some of which are
reserved for the reagents. Therefore, the maximum number of sample tubes
that you may load at the beginning of a run is:
• 198 (22 x 9 racks) or 180 (20 x 9 racks) sample tubes if you intend to
process one or two assays;
• 132 (22 x 6 racks) or 120 (20 x 6 racks) sample tubes if you intend to
process more than two assays.
The continuous loading system may allow you to insert new samples at a
later stage. The continuous loading system is explained in Section 3.2.
4) The sample tubes have barcode labels but you do not know the
barcode type that has been used
See Section 3.10.6.1 on how to set the scanner parameters and determine
the type of barcode used.
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5) The system has not been able to read some of the patient sample
barcodes
Either the problem is also a problem of barcode settings (i.e. the barcode
scanner has not been set to read the type of barcode that is actually used on
the tubes), then the answer is the same as in question 4) above, or the
setting are correct but the scanning fails for another reason (e.g. the barcode
printing is fuzzy); in this case, see Section 2.3.2.1.
6) The system always requires that the loading process be carried out
from right to left
Under standard scanner settings, loading will always be directed from right
to left, i.e. the LED to the very right will light up red.
To change this (e.g. if you want to load from left to right):
‰
Select the Utilities | System Setup menu item.
‰
Click on the Sample Rack tab.
‰
In the Auto Load field, enter the first track to be loaded.
‰
Confirm with <OK>.
7) You want to process two tubes of each sample (duplicate sample
tubes)
You are not allowed to load sample tubes with identical barcodes. If you do,
an error message is displayed:
"Duplicate patient ID ………!
Edit the patient IDs so that only one tube is used per patient."
If you really want to process two tubes of each sample, you have to use
different barcode labels for each tube.
What the system does allow you to do is to test the same sample twice with
the same assay on the same plate (replicate wells), by using the Multiple
determination option of the Add Patient dialog box (see Section 2.4.2
under 2)). In that case, the sample will be pipetted twice out of the same
tube and dispensed into two consecutive wells of the same plate.
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2.3 Assigning Assays to Patients
2.3.1 Pre-Defined Assays
In this chapter, it is assumed that the tests are performed using pre-defined
assays supplied by Bio-Rad. For a complete up-to-date list of Bio-Rad predefined assays, please refer to the current version of the EVOLIS APF
Manual, which is available on the EVOLIS APF CD (87774).
However, the EVOLIS system also allows users to create and use their own
assays. This is explained in Section 3.12. Users may also choose to edit
pre-defined assays to suit their specific needs, see Section 3.12.2.
2.3.1.1 Reviewing Pre-Defined Assays
Before processing an assay (especially if it is the first time you are using this
assay), you may want to review the various steps to be performed, the task
sequence, the incubation times, the reagents used, etc.
To do this, open and print the assay file as described in Section 3.12.1.2.
2.3.1.2 Processing Several Assays in the Same Test Run
The EVOLIS instrument and software allow the user to process different
assays in the same test run.
In most cases, a different test plate will be used for each assay. This is
described in this chapter.
However, the EVOLIS system is flexible and also allows the user to combine
several assays on the same test plate. This subject is dealt with separately
in the Advanced Features Guide (see Section 3.1).
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2.3.2 Assigning Assays to Individual Patients
2.3.2.1 Standard Procedure
Each time you load a sample rack as described in Section 2.2, the following
dialog box is automatically displayed.
Figure 33: Patient Editor (column layout)
1) To display this dialog box, the software has to receive the
appropriate information from the instrument. It sometimes takes a little
while for the box to appear on the screen.
2) The system displays one dialog box per inserted rack (if you insert
three racks, the system will display this dialog box three times).
3) This dialog box is not displayed if you use the system in Demo
Mode; in this case, please refer to the manual procedure described in
Section 2.3.2.3.
Barcoded samples
If you are working with barcoded patient samples, column 1 shows the
Patient IDs as read on the barcodes.
Non-barcoded samples
If you are working with non-barcoded samples, you have to enter the Patient
IDs manually in column 1. If you have a lot of non-barcoded samples to
process, you may prefer to close this dialog box (click the <Close> button)
and do the assay assignments using the manual procedure described in
Section 2.3.2.3.
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If you have both barcoded and non-barcoded samples on the same rack, the
barcoded positions in column 1 will be filled while the non-barcoded
positions will be blank. You have to enter the (non-barcoded) Patient IDs
manually in column 1 as described below for unreadable barcodes.
A blank position can also indicate either that a position is empty (no test tube
was inserted) or that the system has not been able to read the sample
barcode correctly.
Unreadable barcodes
If the system has not been able to read one or several barcodes:
‰
Close the Patient Editor dialog box by clicking the <Close> button.
‰
Remove the inserted rack.
‰
Check the barcode labels on the tubes that the system failed to read.
Make sure the labels are facing on the right-hand side and are not
damaged or dirty. Make sure the barcode type is the same as on the
tubes that were correctly read (otherwise, you may need to change your
barcode settings, see Section 3.10.6.1).
‰
Try to insert the rack again. The Patient Editor dialog box is displayed
again.
‰
If the system still fails to read these barcodes, remove the rack once
more (without closing the Patient Editor dialog box).
‰
Enter the unreadable Patient IDs manually. Do not remove or exchange
any of the barcoded samples (the system compares successive
readings).
‰
Insert the rack again.
‰
Close the Patient editor dialog box by clicking the <Close> button.
In the results, all manually entered patient samples will be flagged
("ManID" flag, see Section 2.8.2).
Troubleshooting
Each time you re-insert a rack on the same track, the system compares the
data read by the barcode scanner during two successive readings. If any
difference is found between the first and the second reading, the system
assumes that tampering may have occurred and:
• All Patient IDs entered manually between the first and second reading
are deleted.
• Rack positions that returned discrepancies between the first and the
second reading are signaled visually (see example below) and the
corresponding data is cleared.
• Rack positions for which the second reading is identical to the first are
retained.
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Example
You insert a rack with 6 barcoded sample tubes for Patient IDs "000001" to
"000006". The barcode scanner fails to read the barcode label on sample
"000001". When the Patient Editor table is displayed, the first Patient ID is
missing.
Figure 34: Result of the first reading
You remove the rack, type in the missing Patient ID "000001" (or scan it with
the handheld scanner) and click <Close> to close the Patient Editor.
Then you re-insert the rack on the same track. When the Patient Editor is
displayed again, if nothing else has changed, all 6 Patient IDs are listed in
the Patient ID column.
Figure 35: Result of the second reading (no errors)
But, if you changed anything else on that rack, the manually entered ID(s)
are deleted and any sample for which the barcode read in the second
reading is not identical to the first barcode is cleared. For example, if you
inadvertently exchanged sample tubes "000002" and "000003" between the
first and second readings, the Patient Editor displayed after the second
reading looks like this:
Figure 36: Result of the second reading (with errors)
You can see that the manually entered ID ("000001") has been deleted.
Changed Patient IDs "000002" and "000003" have also been cleared and
small boxes around position numbers 2. and 3. indicate that these
positions have been changed between the first and the second readings.
To correct this:
‰
66
Click <Close>, remove the rack and insert it once more.
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‰
Enter the missing IDs manually without changing anything else.
‰
Click <Close> and remove then re-insert the rack. All Patient IDs should
now be displayed. You can assign assays to each patient sample as
described below.
To assign one or more assays to each patient:
‰
Using the Assays drop-down lists at the top of column 2, 3, 4 or 5,
select the assays to be processed in this test run. If you have filled in
column 2, 3, 4 and 5 and want to assign more assays, additional
columns will be automatically displayed (to the right of column 5).
‰
Check the boxes in column 2, 3, 4 or 5 for the patients who are to be
tested with the assay you selected in the corresponding drop-down list.
‰
Click <Close>.
‰
If you inserted more than one rack, the system displays the dialog box
for the next rack (it may take a little while to show on the screen).
Repeat the procedure for each rack.
2.3.2.2 Importing Patient Data through Host Connection
If the EVOLIS PC is connected to a host computer, Patient Data can be
downloaded to the system via this connection. These downloads can be
requested by the user or performed automatically as described in Sections
3.13.1.2 and 3.13.2.3.
The downloaded data can include the patient personal details (ID Code,
Name, Birth date, Sex) and the tests required for each patient if these have
already been assigned (at the host computer level).
If the data was imported before the racks were loaded
If the rack(s) you inserted correspond to a test order that has already been
imported into the EVOLIS system, the Patient Editor dialog box will be
automatically displayed with all the appropriate fields already filled in, as
illustrated below.
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Figure 37: Patient Editor dialog box after data import through host
connection
‰
Just check that everything is correct and click the <Close> button.
‰
If you have inserted more than one rack, the Patient Editor dialog box
corresponding to the next rack will be displayed. Check it and close it.
‰
Repeat this for each inserted rack.
If you have inserted the rack(s) before importing the data and are using
ASCII file imports:
‰
The Patient Editor is blank when it is displayed. Click the <Close>
button to close it. Repeat this step, if you had inserted more than one
rack, to close all Patient Editor dialog boxes.
‰
Import the desired file as described in Section 3.13.1.3.2.
‰
When you have obtained a message indicating that the file has been
successfully imported, click <OK>.
‰
Pull out your sample racks and load them again as described in Section
2.2.
‰
Wait until the Patient Editor is displayed again with the appropriate data
already entered. This may take some time.
‰
Check that everything is correct and click the <Close> button.
‰
If you have inserted more than one rack, the Patient Editor dialog box
corresponding to the next rack will be displayed. Check it and close it.
Repeat this for each inserted rack.
On importing multiple test order requests for the same patient, see
Section 3.13.1.3.5.
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If you have inserted the rack(s) before importing the data and are using
an ASTM connection:
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‰
If you had checked the Query Host For Test Orders item in the ASTM
dialog box (see Section 3.13.2.1) the software will automatically
interrogate the host for test orders related to the patient samples you
have just loaded.
‰
If you had not previously checked this item, you can check it now and
then reload your samples.
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2.3.2.3 Manual Patient Data Entry and Test Assignment
The manual patient data entry and test assignment procedure can be used
in the following cases:
• if you prefer to assign tests before loading the patient samples on the
instrument.
• if you have already created a new panel (worklist) (see Section 2.4.2)
and have not yet assigned tests to some patients.
• if you are reusing a formerly saved panel or worklist and want to assign
the tests to some new patients.
• if you are using the software in Demo Mode.
To enter patient data manually:
‰
Select the Utilities | Patient Details menu item. This opens a blank
Patient Editor dialog box
Figure 38: Blank Patient Editor dialog box
‰
Click the <Add Patient(s)...> button to open the Add Patient(s) dialog
box.
Figure 39: Add Patient(s) dialog box
70
‰
Enter the first patient ID (e.g. 000001) and the number of patients (e.g.
50).
‰
Confirm the entries with <OK>. The dialog box is closed and the
respective patient numbers are added to the Patient Editor dialog box
(e.g. 000001, 000002...000010).
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Figure 40: Patient Editor dialog box after manual entry of patient IDs
The patient folders displayed in the Patient Editor dialog box do not have
plus (+) signs, which means that no assays have yet been assigned to the
patients.
To assign tests to manually entered patients:
‰
In the Patient Editor dialog box, click on the <Add Test(s)...> button to
open the Add Tests dialog box.
Figure 41: Add Tests dialog box
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‰
In the Select Patient(s) list, select the Patient ID(s) to which you want to
assign the same test(s). Click on <Select All> if you want to select all
patients.
‰
In the Select Assay(s) list, select the test(s) you want to assign to the
selected patients.
‰
Click <OK>. The program returns to the Patient Editor dialog box and
adds the tests (you can check that the tests have correctly been
assigned by clicking on the plus (+) signs of the respective patient
folders).
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When in the Add Tests dialog box, you can use the Control key on the
keyboard to assign several assays to several patients. Hold down the
Control key, select the desired patients, then select the individual
assays you intend to assign to those patients. Confirm with <OK>.
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2.3.3 Managing Patient Details
Only the Patient ID is absolutely needed to process a test run. However, the
EVOLIS system also allows the user to enter and store the following patient
details:
• first and last name.
• birth date.
• sex.
The EVOLIS software includes access control options that can be used
to allow only certain categories of users to access, enter or edit patient
details (see Section 1.2.7.2).
To edit patient details:
Figure 42: Patient Editor dialog box (selected patient)
‰
Select the Utilities | Patient Details menu item (or click on the <Patient
Details> button in the Set-up Panel dialog box) to open the Patient
Editor dialog box.
‰
In the Patient Editor dialog box, select the Patient ID whose details you
want to edit.
‰
Click on the <Edit...> button to open the Patient Details dialog box.
Figure 43: Patient Details dialog box
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‰
Here you can check, enter or edit Patient ID, name, birth date and
patient sex.
‰
Click <OK> to save your changes (otherwise click <Cancel>). The
program returns to the Patient Editor.
If you are using barcodes or importing test orders from a host computer, the
patient details can be entered automatically provided the pertinent
information is included in the barcode or in the imported file/data.
2.3.4 Pipetting and Report order
The Sort Order field in the top right-hand corner of the Patient Editor dialog
box allows you to define the order in which the samples will be pipetted from
the tubes.
The Sort Order selected also serves to determine:
• the samples' order for the Auto-Arrange function in the Load dialog box
(see Section 2.5.2.2)
• the order in which samples are listed in the results (in the Combined
Report, see Section 3.12.4).
• the order in which sample IDs will be sorted in the Patient Editor after a
successful worklist import (see Section 3.13.1.3.3).
Ascending
If you check this item, the samples will be pipetted from the tubes in
alphanumeric ascending order (based on the sample IDs entered or read by
the barcode scanner). In the Combined Report, the samples will also be
listed in alphanumeric ascending order.
Descending
If you check this item, the samples will be pipetted from the tubes in
alphanumeric descending order (based on the sample IDs entered or read
by the barcode scanner). In the Combined Report, the samples will also be
listed in alphanumeric descending order.
None
This is the default setting. If you keep this item checked, the samples will be
pipetted from the tubes in the order in which they are placed in the racks.
The same order (rack order) will apply to the sample list in the Combined
Report.
2.3.5 Patient Editor Clean-Up
Once entered in the Patient Editor (either manually or through LIS import)
patient data and test orders remain there until the corresponding samples
are actually processed. Once processed, they are automatically removed
from the Patient Editor.
In some cases, it may become no longer necessary or even impossible to
process all the test orders that were originally entered. To avoid keeping
irrelevant data in the Patient Editor for ever, it is possible and
recommended to perform a manual clean-up from time to time.
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To do this, the Patient Editor includes four "Delete" buttons.
<Delete>
Deletes only the highlighted item (Sample ID or test). A warning message
prompts you to confirm the deletion.
<Delete (Date)>
Opens the following dialog box and allows you to delete simultaneously all
patient data and test orders entered/received before a specified date.
Figure 44: Delete (Date)
Use the drop-down list to specify the date in the pop-up calendar and click
<OK>. A warning message prompts you to confirm the deletion.
<Delete (Test)>
Opens the following dialog box and allows you to delete simultaneously all
test orders for a specific assay.
Figure 45: Delete (Test)
Use the drop-down list to select the assay to be deleted and click <OK>. A
warning message prompts you to confirm the deletion. Note: Sample IDs
with only that one assay are deleted completely.
<Delete All>
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Deletes all Sample IDs and test requests. A warning message prompts you
to confirm the deletion.
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2.4 Creating the Worklist
The worklist is at the core of how the EVOLIS system operates.
In the Patient Editor dialog box, you defined the tests (assays) to be
performed for each patient (e.g. patient 000001 must be tested for HIV and
Hepatitis, patient 000002 must be tested for HIV only, patient 000003 must
be tested for HIV, Hepatitis and Toxoplasmosis, etc.).
Now, you will use the worklist to define how these tests will
implemented on the test plates (e.g. Plate 1 will be used to
000001, 000002 and 000003 for HIV, Plate 2 will be used to
000001 and 000003 for Hepatitis, and Plate 3 will be used to
000003 for Toxoplasmosis …).
Once the worklist is defined, the system checks all parameters
any error. Errors must be corrected before you start a run.
actually be
test patient
test patient
test patient
and signals
A new worklist is generally created for each test run but if similar test runs
are performed regularly, the system allows the user to save and re-use
previously defined panels.
2.4.1 The Set-Up Panel Dialog Box
The main element of worklist definition is the Set-Up Panel dialog box. Here,
the user organizes the test run to be performed: which assay on which plate
and the order of the plates.
Figure 46: Set-Up Panel dialog box with a finished worklist (3 plates)
Figure 46 shows what the Set-Up Panel dialog box should look like with a
completed worklist.
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Plate Tree
The window on the left-hand side of the Set-Up Panel dialog box, shows the
Plate Tree (this worklist example is implemented on three plates).
Clicking on the plus (+) sign next to a plate will show which assay(s) are to
be tested on this particular plate (in this example, only one assay per plate).
Clicking on the plus (+) sign next to an assay will show which patients are to
be tested for this assay on this plate.
When a folder is opened, the plus (+) sign changes to a minus (-) sign. Click
on the minus (-) sign to close a folder.
Plate Matrix
The right-hand side of the Set-Up Panel dialog box shows the Plate Matrix
(or Plate Layout). The 96 cells in this table represent the actual test plate
with its 96 wells. Columns are numbered from 1 to 12, and rows are lettered
from A to H so that each individual cell/well has a unique location (e.g. E5).
The Plate number and assay name for the current plate appear above the
table. To view another plate, select it in the Plate Tree on the left.
In the Plate Matrix, sample types are precisely labeled (B1, NC1, T3, etc.).
B
Blank value for background reading
S
Standard
T
Test (sample)
NC
Negative control
PC
Positive control
CO
Cutoff
Etc.
...
To help distinguish them visually, a set color is generally assigned to each
sample type, e.g. NC wells are green, PC wells are red, T wells are black,
etc. The labels and colors are assigned when the assay is defined (see
Section 3.12.3.2.2).
Buttons of the Set-Up Panel dialog box
<Add Plate...>
<Add assay...>
Adds a new plate to the Plate Tree.
Assigns an assay to the plate selected in the Plate Tree.
The <Add assay...> button is active if a plate has already been defined
and is selected.
<Add Patient...>
Assign patients to the assay selected in the Plate Tree.
The <Add Patient...> button is active only when an assay has already
been assigned to a plate and is selected.
<Archived Patient…>
Assign archived samples to the assay selected in the Plate Tree (when
samples are to be pipetted out of an archive plate, see Section 3.6.8.1).
<Load Plate Map...>
Recall a partially processed plate map for further processing (see Section
2.7.8).
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<Edit>
If more than one plate has been defined in the worklist, you can edit the
plate name. Click <Edit> to open the Plate dialog box and you can
overwrite the old name.
Default is Plate 1, Plate 2, Plate 3….
<Delete>
Deletes the branch highlighted in the Plate Tree (plate, assay or patient).
The deleted component is removed from the presentation of the Plate
Matrix.
<Move Up>
Moves the highlighted plate further up by one plate or the highlighted assay
further up by one assay.
<Move Down>
Moves the highlighted plate further down by one plate or the highlighted
assay further down by one assay.
<Undo>
Revokes the last action. Up to 10 actions can be undone.
<Redo>
Restores the action previously undone (also possible up to 10 times).
<Open Panel>/
<Save Panel>
<Patient Details...>
<Edit Layout>
Opens the Patient Editor dialog box; if this has not been done before, you
can use this button to manually create Patient IDs and assign tests to
patients (see Section 2.3.2.3).
This button opens the Assay Layout dialog box (see Section 2.4.5).
Start assay with a
new strip
Use this item only if you intend to run several assays on the same plate
(see Section 3.1.5).
<OK>
Confirms the defined worklist and opens the Lot Specific Values dialog
box (see Section 2.4.6.1).
<Cancel>
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These buttons allow you to save a panel definition and use it again for
other (future) worklists. For more information on this function, see Section
2.4.4.
Closes the Set-Up Panel dialog box without saving entries or changes.
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2.4.2
Basic Worklist Creation Method
The following worklist creation method is the "basic" method. It applies
whenever the Set-Up Panel dialog box is blank when it opens, i.e. when the
system does not yet have the required information on the patients or on the
tests to generate a suggested worklist.
Use this method particularly if:
• you create a worklist before loading the sample racks onto the
instrument.
• you do not import data from a host computer.
• you are using the system in Demo Mode.
If you have already loaded the sample racks and assigned assays to
patients as described in the previous sections, or if you have imported
patient data and test orders from a host computer, the system will
automatically suggest a worklist; you can refer directly to Section 2.4.3.
To open the Set-Up Panel dialog box:
‰
‰
Click on the <New Worklist> button
or,
Select the File | New menu item, then select Worklist in the New dialog
box and click <OK>.
The Set-Up Panel dialog box is blank when it opens.
Figure 47: Blank Set-Up Panel dialog box
To define the worklist, complete the following steps:
1) Add (the first) plate
‰
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Click on <Add Plate...>. This will display Plate1 in the Plate Tree and
enable the <Add Assay...> button.
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2) Add assay
‰
Click on <Add Assay...> to open the Open dialog box, showing the
assay files (*.asy) available in the pre-defined subdirectory (see Section
1.2.6.2).
‰
Select the desired assay file and click <Open>. The selected assay is
inserted in the Plate Tree. The Plate Layout defined in the selected
assay protocol is displayed in the Plate Matrix.
Note that only the control wells (NC, PC and, if any, B, S, CO) are
depicted at that stage. The test wells (T) will be shown only once the
Add patients step is completed.
Figure 48: Set-Up Panel dialog box with one plate and one assay
3) Add patients
‰
Click on <Add Patient...>. The Select Patient(s) dialog box is displayed
listing all patients to whom the selected assay has been assigned.
Figure 49: Select Patients dialog box
‰
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Select Patient IDs with the mouse and click <OK>. Use the Ctrl key on
your keyboard and the mouse to select several non-consecutive
samples.
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The <Select Loaded> button allows you to select automatically those
samples that are already loaded on the instrument. In the list, those samples
are indicated by a (*) sign next to the sample ID.
The <Select All> button allows you to select all the samples in the list.
If a sample is already assigned to the worklist (e.g. has already been
selected on another plate), it no longer appears on the list. To test the same
samples with the same assay twice in the same run, check the Allow
multiple determinations item. Already assigned samples are displayed
again in the list and can be reselected.
To select samples that were previously archived on an archive plate, see
Section 3.6.8.
In the Set-Up Panel dialog box the selected patients are displayed in the
Plate Tree under the selected assay folder. In the Plate Matrix, the test wells
(T) are now also shown.
Figure 50: Set-Up Panel dialog box with one completed plate
If the Select Patient(s) dialog box is empty when it opens, this means
that you have not already assigned this particular assay to any
patients as explained in Section 2.3.2.3. You can click the <Patient
Details…> button and do this now. If necessary, refer first to the
explanations given in that Section.
4) Add and define more plates
‰
Click on <Add Plate...> again to add another plate.
‰
Repeat steps 2) Add assay and 3) Add patients to define this new
plate.
‰
Repeat these steps for each new plate.
By default, plates will be named Plate 1, Plate 2, Plate 3… You can change
the plate names by clicking on the <Edit> button (you will still be able to
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change the plate name at a later stage, when loading each plate, see
Section 2.6.1).
A new plate is always added under the selected plate. The EVOLIS will
process plates in order from top to bottom as shown in the Plate Tree. The
order of the plates within the Plate Tree can be edited by clicking on the
<Move Up>/<Move Down> buttons.
Figure 51: Worklist with 3 defined plates
Maximum number of plates included in a worklist
It is normally possible to add up to 7 plates in the same worklist. This
depends, however, on the assays and on the number of samples to be
processed. In most cases, the system will then schedule the run so that the
processing of the last plates begins only when the processing of the first
plates is finished.
If you need to process heavy workloads, it is sometimes preferable to do two
consecutive runs (see the end of Section 2.4.7.2 on how to optimize your
workflow) or to rely on continuous loading (see Section 3.2) rather than add
a maximum number of plates in the same worklist.
2.4.3 Worklist Generated by the System
If you have already loaded the patient samples racks onto the EVOLIS
instrument and if you have assigned assays to the corresponding patients as
described in Section 2.3.2.1, the system automatically suggests a worklist in
which the number of plates used and their layout is in accordance with these
data.
The system also automatically generates a worklist when you load barcoded
samples corresponding to test orders received from the LIS.
In this case, when you click on the <New Worklist> button to open the SetUp Panel dialog box (or select the File | New menu item and then Worklist
in the New dialog box and click <OK>), the automatically generated worklist
is already displayed in the Set-Up Panel dialog box.
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Figure 52: Set-Up Panel with automatically generated worklist
‰
If you wish to retain this suggested worklist, click <OK> to accept it and
go directly to Section 2.4.6.
‰
If you wish to alter some elements of the suggested worklist, highlight
the items which you want to change and edit them using the dialog box
buttons, e.g. use <Move Up>/<Move Down> to change the order in
which the plates will be processed. For a complete description of how to
use the buttons, refer to the Section 2.4.1. When you are satisfied with
the worklist, click <OK>.
If the assays included in the worklist belong to the same combination
group and if the assay parameters (incubation time, shaking
parameters…) are compatible, the system will automatically try to
combine several assays on the same plate (provided the number of
samples allows this). For more information on processing several
assays on one plate, see Section 3.1.
2.4.4 Creating a Worklist from an Existing Panel File
If you generally use the EVOLIS system for the same assays or for repetitive
jobs, you can shorten the worklist creation process by reusing previously
defined (and saved) panels.
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Figure 53: Set-Up Panel with defined panel
To save a panel:
‰
Once you have defined your plate and assay arrangement as explained
in the previous sections, click the <Save Panel> button at the bottom of
the Set-Up Panel dialog box.
‰
In the Save As dialog box, enter the name under which you intend to
save the panel and click <Save>.
Panel files have a (*.pan) extension. By default, they are saved in the
C:\BioRad\Resources\Apf directory.
To create a new worklist from a previously saved panel:
84
‰
Click on the <New Worklist> button (or select the File | New menu item,
then select Worklist in the New dialog box and click <OK>).
‰
In the Set-Up Panel dialog box, click the <Open Panel> button.
‰
In the Open dialog box, select the desired (*.pan) file and click <Open>.
The formerly defined plates are displayed in the Plate Tree part of the
Set-Up Panel dialog box.
‰
Click on the plus (+) sign next to the first plate and select the assay on
this plate.
‰
Add patients for this assay as described in Section 2.4.2, paragraph 3).
‰
Repeat the last two steps for each plate.
‰
Click <OK>.
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2.4.4.1 Problem solving
1) The Patient IDs that were defined in the original panel were not
retained when the panel was saved
This is normal. When a panel is saved, the system stores only the plate and
assay arrangements but not the Patient IDs. This is because it is assumed
that if the panel is used again in a new worklist and for a new test run, it will
normally be for a new set of patients. This is why, even if you use an existing
panel file to create a new worklist, you have to redo the Add patient step.
2) Why is it not possible to save and re-use a worklist file instead of
panel files ?
It is possible to save a worklist file but worklist files are saved mainly to
ensure that a test run can be resumed and performed entirely as planned
even if interrupted. Also, the necessary verification of a worklist, of the
required resources and of the current system status has to be performed
separately for each worklist and this verification is launched when the SetUp Panel dialog box is confirmed (by clicking <OK>). This is why you should
not try to re-use a worklist file directly.
3) Opening the panel file deleted the plates that were already defined
If you want to create a worklist by using a formerly saved panel, you have to
click the <Open Panel> button before defining other plates because the
saved panel will replace anything that has already be defined in the Plate
Tree of the Set-Up Panel dialog box. After you have opened your panel, you
can freely edit or add any element (e.g. if the saved panel included only two
plates, you can add more plates, or add another assay on a plate, etc.).
4) Error message when opening panel files directly
Panel files are meant to be opened only from the Set-Up Panel dialog box
(with the <Open Panel> button). If you try to open them using the File |
Open menu item an error message saying "Unexpected File Format" will be
displayed.
2.4.5 Editing the Plate Layout
The Plate Layout is the way in which the different samples (patient samples
(T) but also negative control (NC), positive control (PC), standards (S), blank
samples (B), etc.) are arranged on a test plate.
This arrangement is specifically defined for each assay when the assay is
created, as described in Section 3.12.3.2.1.
When you create a worklist to process an assay, this pre-defined layout is
automatically displayed in the Plate Matrix section of the Set-Up Panel
dialog box.
If you are using a Bio-Rad pre-defined assay, you should not attempt
to edit the Plate Layout at this stage.
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Even if you are using your own assays, it is generally not recommended to
alter the Plate Layout at this stage as any changes made will apply only to
this run (the assay file itself will not be changed so that if you process the
assay again later, the original layout will apply). If you still want to do so,
click the <Edit Layout> button in the Set-Up Panel dialog box to open the
Assay Layout dialog box and refer to Section 3.12.3.2.1 on how to use it.
At this stage, the best way to optimize the Plate Layout, if you are not
processing full plates, is to process several assays per plate and
eliminate "empty" wells as explained in Section 3.1.5. This is possible
whether you are processing Bio-Rad pre-defined assays or any other
assays.
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2.4.6 Worklist and System Verification
Once you have defined all the plates in your worklist and confirmed the SetUp Panel dialog box by clicking <OK>, the EVOLIS performs an internal
check of the worklist, of the assay protocols and of the required resources.
It prompts the user to enter the specifications of the reagents, controls and
buffers required for that particular worklist.
2.4.6.1 Specification of Reagents and Liquids
The Lot Specific Values dialog box is automatically displayed for Plate 1 of
the active worklist. It lists the reagents (diluent, conjugate, substrate, stop
solution, etc.) as well as controls, standards, wash buffers and clean fluid
required for the first assay.
Figure 54: Lot Specific Values dialog box
Successive assays / plates
If the worklist has been defined with one assay per plate, each time you click
<OK> to confirm the entries for one plate, the Lot Specific Values dialog
box is displayed again for the next plate.
If several assays have been defined on the same plate, the Lot Specific
Value dialog box includes several tabs. Each time you click <OK> after
entering the data for one assay, the next tab is displayed to let you enter the
data for the second assay, etc. After the last assay of each plate, the Lot
Specific Value dialog box is displayed again for the next plate (or the first
assay of the next plate).
When you confirm the entries for the last plate of the worklist, then the
system performs the complete internal check and displays the Worklist
window (see Section 2.4.7).
Clicking <Cancel> brings you back to the Set-Up Panel without saving the
entries.
At any other time, the Lot Specific Values dialog box can be opened from a
Worklist window by selecting the Edit | Lot Specific Values menu item or
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by clicking the <Lot specific values> button. To open this dialog box from a
result file, see Section 2.8.3.2.
1) Batch Numbers and Expiry dates
Figure 55: Lot Specific Values dialog box
What you enter in the Batch Number and Expiry Date fields depends on
whether you want to use the kit lot tracking function or not.
If you want to use the kit lot tracking function:
88
‰
Click on the Batch Number drop-down list and select the kit lot number
corresponding to the number printed on the kit box you are intending to
use (next to the LOT indication).
‰
If this number is not available in the list, click <Add Kit…> and add the
kit lot information in the kit database now as described in Section
3.5.2.2.
‰
When done, click <OK> to close the Kit Information dialog box and
come back to the Lot Specific Values dialog box.
‰
The kit lot number for the kit you are intending to use should now be
included in the Batch Number drop-down list. Select it. The kit Expiry
Date is automatically updated.
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Figure 56: Kit lot data
Note, however, that the batch numbers and expiry dates of the
individual kit reagents are not displayed even if they have been
entered in the kit lot database.
If you see batch numbers and expiry dates listed for individual kit
components, these are from the batch used in the last run! Make sure
you select the correct kit batch number in the drop-down list, this will
clear the data display.
If you do not want to use the kit lot tracking function:
‰
You can enter the Batch Number and Expiry Date for the kit and/or for
individual components manually if you want.
Note that in that case, the data entered will only be saved for that run
but will not be entered in the kit database.
2) QA Labels
Entering QA labels is optional. It allows you to later track controls for quality
analysis purposes, either via the EVOLIS quality report (see below) or by
transferring data to Bio-Rad's QC On Call or URT software (see Section
3.5.5).
QA labels can only be entered manually.
To enter the QA labels:
‰
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Select the first control in the list of kit components and enter its label in
the QA Label field.
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Figure 57: QA Labels
‰
The abbreviations you enter in the QA Label field have to correspond to
the layout labels (see Section 3.12.3.2.2) used in the actual plate layout
for that assay.
For example:
For
"GESU R3 Neg Ctrl Genscreen Ultra"
"GESU R4 Ab Pos Ctrl Genscreen Ultra"
"GESU R5 Ag Pos Ctrl Genscreen Ultra"
‰
Enter
NC
PC Ab
PC Ag
Repeat for each control/reagent you want to track.
3) Batch-specific values
If the assay includes standards for which the concentration is batch
dependent or if control/calibrator value ranges are batch-dependent, these
items are listed in the Assay Protocol Parameters list with their respective
batch-specific values/data (otherwise the list is blank).
Figure 58: Batch-specific values
‰
90
Review the values listed (if any) and compare them with the values
provided in the kit documentation or on the kit vials.
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‰
If necessary, edit them. Select an item in the list and edit the Value field.
When you select another item in the list, the value entered for the
previous item is automatically displayed.
‰
Click <OK> to confirm.
‰
Repeat for each plate (and each assay if testing several assays per
plate).
QA Analysis Report
Entering QA labels for controls allows you to follow the results obtained with
a particular control over a period of time by compiling a QA Analysis Report.
To compile a QA Analysis Report:
‰
Select the File | New menu item.
‰
In the New dialog box, scroll, select QA Analysis Report and click
<OK>.
‰
This opens the Q A Analysis dialog box:
Figure 59: Q A Analysis dialog box
Here you can specify the control you want to observe:
Controls
Batch
Date from / Date to
Select the control.
Select the batch.
Define the period of time over which you want to compare the results.
When you click <OK> in the QA Analysis dialog box, the software will
calculate and display the respective curve (Levey-Jennings Plot).
2.4.6.2 Error Detection
If, while conducting its verification process (after you click <OK> in the Lot
Specific Value dialog box), the system does not identify any problem, the
Worklist window will be displayed and the status of the plates in the Worklist
Parameters will be Not loaded (see Section 2.4.7.1).
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Conversely, if the system detects a problem, a corresponding error message
will be displayed.
If the error is related to the way you defined your worklist (e.g. if you tried to
combine too many assays and patients and the system cannot find a way to
schedule them adequately), correcting the source of the error will involve
going back to the Set-Up Panel dialog box. To do this:
‰
Click <OK> in the error message box. The Worklist window appears but
Error is displayed (instead of Not loaded) as the status for that plate. If
the status for a plate appears as Error, the respective plate cannot be
processed.
‰
Select Panel Definition in the Edit menu. This takes you back to the
Set-Up Panel dialog box.
‰
Carry out the necessary changes and click <OK> again. If you have
successfully corrected the problem, the Worklist window will be
displayed again but this time the status for this plate in the Worklist
Parameters is Not loaded.
If the error is related to the assay file you are using (e.g. if the reading
parameters refer to a photometer filter not available on the instrument or if
one of the reagents required for the assay has not been entered in the
reagent database, see Section 3.4.6), open your assay file as described in
Section 3.12.1.2 and check it thoroughly (edit it if necessary). If you use only
Bio-Rad pre-defined assays validated for EVOLIS, you should not
encounter this kind of problem (unless the Apf version you are using does
not correspond to your software version, see Section 3.11.1).
If the error is related to a problem in the system itself, please refer to the
error message list in Section 5.
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2.4.7 The Worklist Window
Figure 60: Worklist window
The Worklist window is displayed:
‰
when you have created a worklist file in the Set-Up Panel,
‰
have clicked <OK>,
‰
have entered the Lot Specific Values,
‰
and the verification is completed.
The Worklist window includes the Worklist Tree on the left-hand side and
the Worklist Display Area on the right-hand side. Next to the folder icon of
the Worklist Tree you see the name of the worklist. If the worklist file has
been saved under a specific name, you see the file name; otherwise, you
see a provisional name which is made up of Work and a consecutive
number.
Click on the plus (+) sign next to the worklist folder to open the Worklist
Tree. The Worklist Tree includes eight elements:
• Worklist parameters
• Schedule
• Plate layouts
• Reagent requirements
• System status
• Active event log
• Job List
• Archiving
These elements cannot be edited directly, but only by going back to the SetUp Panel dialog box (select Edit | Panel Definition in the menu bar).
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Selecting one of these elements in the Worklist Tree will display the
corresponding information in the Worklist Display Area.
The information displayed in the Worklist Display Area (Plate Layouts,
Schedule, Reagent Requirements, etc.) can be printed but each
element has to be printed separately. Unlike for assay files (see
Section 3.12.1.2), no global printing option is available.
2.4.7.1 Worklist Parameters
This shows the parameters of the worklist in the following columns:
Plate ID
List of defined plates and indication of the plate names.
Start
Start time of run. This is the time at which you have quit the Set-Up Panel
dialog box by clicking <OK> and the worklist was displayed.
Finish
Time at the end of the run, calculated using the work steps and their
duration. Note: The actual Finish time depends on when the run is actually
started. The time displayed here allows you to calculate how long the run
will take.
Status
Shows the status of each plate. If Error is displayed, see Section 2.4.6.2.
Otherwise, you see Not loaded as long as the test plates have not yet
been loaded. The status then changes to Processing and finally to
Finished (or Aborted if the processing of that plate has been stopped and
not resumed).
Assay
Shows the name of the respective assay file. If there are more than one
assay on a given plate, all the names are listed one below the other.
#Patients
Shows the number of patient samples per plate (and per assay if there are
more than one on the same plate) as defined in the worklist.
2.4.7.2 Schedule
The Schedule element shows how the test will actually be performed. This
allows the user to get an accurate view of the duration of each step and the
sequence in which they will be conducted, as well as how the system will
combine the processing of all the plates that are to be processed in the
same run (interlacing). It is therefore a good idea to check the Schedule
before starting the run (the Schedule is also useful afterwards, when the run
is being processed, to follow how the test run is executed and which step is
currently being performed on which plate).
Plate Schedule or Module Schedule
There are two different ways to view the Schedule.
When Plate Schedule is selected (via the View menu), each plate is shown
as a horizontal strip. The various steps of the process (pipetting, incubation,
reading, washing) are shown as segments on this strip (each step marked
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by a different color). The run time scale is on a horizontal line above the
strips. Double-clicking on a step displays the duration of that step as well as
processing details, e.g. incubation temperature for an incubation step,
reagent and volume/profile for a dispense step, etc. Double-click again to go
back to the Schedule view.
When the test run is started, the vertical line on the left will move forward
(towards the right), allowing the user to check at any given time what part of
the run is currently being processed.
Figure 61: Plate Schedule view
Below the strips, additional information is displayed.
System
Shows when the sample archiving operations (if any, see Section 3.5) will
be performed.
Additional
resources
Shows when additional resources such as tips or reagents are to be
loaded. If such reloading is necessary, a line saying "Operator intervention
required in X minutes" will also displayed.
Additional plates
Shows the time periods when it is possible to reload test plates
(corresponds to periods when all the plates being processed are
incubating).
When Module Schedule is selected (still via the View menu), each strip or
segment shows at which time each instrument module (pipettor, washer,
colorimeter, incubator, plate transport unit) will be used for each plate. Each
plate is depicted in a different color. As in the Plate Schedule view, the time
scale is at the top and the vertical line on the left will move forward once the
run is started.
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Figure 62: Module Schedule view
When processing a run in Demo Mode (see Section 1.2.2.2) the run
time displayed in the Schedule window will be accelerated, i.e. 1
second in the Schedule window = 1 minute in a real run.
Optimizing the Schedule
When you have finished defining your worklist (in the Set-Up Panel dialog
box) and your worklist options (see Section 2.4.8), the EVOLIS system
calculates the best way to combine the various steps of each process, while
maintaining the plate processing sequence you defined.
If you want to try and optimize this process even further by changing the
order in which the various plate are going to be processed:
‰
Select the Edit | Optimise menu item. The system tries all possible
plate orders and automatically reschedules the run using the plate order
with the shortest overall processing time.
For very complex worklists, the optimization process may take a long
time while the system calculates all possible combinations. If no
solution has been reached within a few minutes, it is recommended to
abort the process (click the <Abort> button in the Optimizing dialog
box) and reschedule the worklist manually if necessary.
If you want to optimize the processing manually:
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‰
Go back to the Set-Up Panel dialog box by selecting the Edit | Panel
Definition menu item.
‰
Edit the worklist by highlighting the elements you want to change and
using the <Edit>, <Delete>, <Move Up>/<Move Down> buttons (see
Section 2.4.1 for more information on these buttons).
‰
Click <OK>.
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Planning a daily workload
Optimizing the schedule is particularly important if you want to process a
large number of samples in a minimum time (e.g. processing 500 samples
with several assays and within an 8-hour work shift). In such cases,
determining the best schedule may require you to try out many different
solutions (Some assays are easier to combine than others. Sometimes it is
better to do two runs. Sometimes it is better to load three plates and then
reload three more plates each time one is fully processed. Sometimes you
want to avoid operator intervention at a certain time of day, etc.).
If finding the right schedule is not obvious, you can use the Demo Mode
(see Section 1.2.2.2) to do all your planning/optimizing and to simulate the
various possibilities.
2.4.7.3 Plate Layouts
Selecting Plate Layouts in the Worklist Tree will show the exact Plate
Layouts in the Worklist Display Area. All Plate Layouts defined in the current
worklist are displayed one below the other.
Figure 63: Plate Layout of each plate in the worklist
Use the View | Layout Label menu item to display the plate layouts with
layout labels (T1, T2, etc.) or the View | Patient IDs menu item to replace
these labels with the actual sample IDs (000001, 000002, etc.).
Both layouts can be printed (use File | Print in the menu bar or the <Print>
button).
2.4.7.4 Reagent Requirements
Selecting Reagent requirements in the Worklist Tree shows the list of all
reagents required for the tests.
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Figure 64: Reagent requirements
Position
Indicates where each reagent has been loaded on the instrument. This
column remains empty until all reagents are loaded and allocated (see
Section 2.5.3).
Reagent
List of all the required reagent. The order of the list follows the order of the
assays to be processed. Clean fluid and wash buffers are listed separately
at the bottom.
Required
Left
Volume of each reagent required for the run.
Volume available. This entry will decrease as the run is being performed.
By default, the volume that is displayed before the worklist begins and
which will be used to calculate the available volume while the run is being
performed is the volume of the respective reagent bottle when full. If you
want the system to determine the exact volume that is actually available in
the bottles, you have to enable the Check reagent levels before a run
option in the Worklist Options dialog box (see Section 2.4.8). This will
then be used as the starting basis.
It is a good idea for the operator to print this list and use it as a
checklist when preparing the various reagent and control bottles
before loading them onto the reagent racks.
2.4.7.5 System Status
The System status branch of the Worklist Tree displays a graphical
presentation of the work area.
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Figure 65: Graphical presentation of the work area
From left to right: dilution plates (or archive plates) and additional reagent
positions, tip racks, sample and reagent racks, incubators.
Below: clean fluid and wash buffers.
This display is useful to check the status of the incubators. If they are
functioning correctly, they appear in green; if any problem is detected, they
appear in red. The temperature of each incubator is displayed, as well as the
room temperature (below the incubators).
2.4.7.6 Active Event Log
The Active event log lists in real time the steps of the run as they are
performed. The screen is blank when viewed before the start of the run. The
scripting is always done at the top of the list, i.e. the step currently being
performed is always at the top of the list while already completed steps are
further down.
Contents
The wording used in the log file is generally simple and descriptive, making it
easy to follow for any operator after minimal use of the EVOLIS system. If
you require assistance in understanding a particular log file, you can easily
save it (see below) and mail it to your Bio-Rad Service Engineer.
Colors
Different colors are used in the log.
Black
Used to describe steps that have been correctly performed.
Red
Signals any problem occurring during the run (e.g. incorrect dispense,
system paused, errors...)
Green
Signals actions taken by the operator to enable the system to resume or
continue the run.
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Example
09:32:22 <System>: Error opening coordinate file 'C:\BioRad\System\Koordina.dat'.
09:32:30 <System>: OK button pressed.
10:37:12 <System>: Starting worklist.
10:40:22 <System>: Starting worklist.
10:42:32 <System>: No disposable tips left.
10:42:42 <System>: System paused.
10:42:43 <System>: Additional tips loaded.
10:42:48 <System>: Stopping worklist.
11:06:32 <System>: Starting worklist.
11:07:58 <System>: Please close the Plate Load/Unload door.
11:08:03 <System>: OK button pressed.
11:09:54 Plate 1: Starting to pipette 'NC'.
11:09:57 Plate 1: No liquid detected for 'Demo R3, 0.3ml'.
11:10:17 Plate 1: RETRY button pressed.
11:10:17 Plate 1: Finished pipetting 'NC'.
11:10:30 Plate 1: Starting to pipette 'PC'.
11:10:40 Plate 1: Finished pipetting 'PC'.
11:10:43 Plate 1: Starting to pipette 'sample'.
11:10:43 Plate 1: Pipetting 100ul of SA01.
11:10:55 Plate 1: Pipetting 100ul of SA02.
11:11:08 Plate 1: Pipetting 100ul of SA03.
11:11:20 Plate 1: Pipetting 100ul of SA04.
11:11:31 Plate 1: Pipetting 100ul of SA05.
11:11:43 Plate 1: Pipetting 100ul of SA06.
11:11:52 <System>: System paused.
Backwards line-wrap. Generally, each operation or user intervention
starts on a new line. When the line is too long, it wraps automatically.
Note, however that when the log file is "active" (during the actual run) ,
the scripting is done from bottom to top, so that the end of a line will
be above the beginning of the line instead of below. In a saved log file
on the contrary, the correct line-wrap order (with the end of the line
below) is restored.
Use
The Active event log is an important document. It can:
‰
Be followed while the run is being processed so that the operator can act
rapidly to correct any malfunction of the system.
‰
Be used, after the run is over, to check whether all steps have been
properly performed. If, for example, some results are flagged, the Active
event log enables the user to understand why this is so.
‰
Be printed.
‰
Be used at a later date to check how the run was processed.
Event log files are automatically saved by the system. By default, they are
saved in the C:\BioRad\Resources\Event_log directory. They have a (*.log)
extension and the file name corresponds to the date on which the run(s) was
(were) performed:
e.g. "20060228.log" (YYYYMMDD)
The logs of all the test runs performed on the same day are aggregated
in the same log file.
Access to the event log file of the current day is restricted. It can only
be viewed from the Worklist window. It cannot be opened through the
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File | Open menu item as indicated below.
To open a formerly saved Event log file:
‰
Select the File | Open menu item.
‰
In the Open dialog box, select the correct directory and file type.
‰
Select the desired (*.log) file and click <Open>.
When the log file is created, the scripting is done in a way that the current
step is always at the top while earlier steps are further down. But when you
open a formerly saved event log, the daily chronological order is rearranged
from start-up to shutdown.
Event log filter
To open the Event Log Filter dialog box:
‰
Open an Event log file as described above.
‰
In the View menu select Filter.
Figure 66: Event Log Filter dialog box
The purpose of the Event log filter is to allow the user to find in the log file all
the lines related to one specific worklist, one specific plate or even one
specific patient.
The Event log filter is available only if you open a formerly saved event log
with the File | Open menu item. It is not available from the Worklist window
or when the run is being processed.
Event log in (*.txt) format
Each time a log file is created in (*.log) format, an identical file is created
with a (*.txt) format with the same filename and in the same directory
(C:\BioRad\Resources\Event_log).
e.g. "20060228.log"
"20060228.txt"
The (*.txt) file can be viewed with any text editor.
The (*.txt) version of the log may be changed, even inadvertently. As a
result, if you need to send a log file back to your Bio-Rad Service
Engineer for troubleshooting or expertise, always send a copy of the
actual (*log) file rather than the (*.txt) version.
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Separate pipetting log files (PipLogs)
A separate daily pipetting log is also created. This log includes the details of
each pipetting (aspirate/dispense) operation. The "PipLog" files are (*.txt)
files stored in the event log folder with a “PipLog_YYYYMMDD.txt” filename.
This monitoring is intended for EVOLIS specialized technicians only.
General users can safely rely on existing flags to detect and signal pipetting
errors (Clot, NoLiq, InsLiq, see Section 2.8.2).
2.4.7.7 Job List
Selecting Job List in the Worklist Tree will show in the Worklist Display Area
a reminder of which test(s) are to be performed for which Patient IDs.
Example
JOB LIST
Patient ID
01912276510
01912276511
01912276512
01912276513
01912276514
01912276515
01912276516
01912276517
01912276518
01912276519
01912276520
01912276521
01912276522
01912276523
Assay(s)
HBc+ Ab 1P BR V2
HBc+ Ab 1P BR V2
HBc+ Ab 1P BR V2
HBc+ Ab 1P BR V2
HBc+ Ab 1P BR V2
HBc+ Ab 1P BR V2
HBc+ Ab 1P BR V2
HBc+ Ab 1P BR V2
HBc+ Ab 1P BR V2
HBc+ Ab 1P BR V2
HBc+ Ab 1P BR V2
HBc+ Ab 1P BR V2
HBc+ Ab 1P BR V2
HBc+ Ab 1P BR V2
HBs+ Ag 1P BR V2
HBs+ Ag 1P BR V2
HBs+ Ag 1P BR V2
HBs+ Ag 1P BR V2
HBs+ Ag 1P BR V2
HBs+ Ag 1P BR V2
HBs+ Ag 1P BR V2
HBs+ Ag 1P BR V2
HBs+ Ag 1P BR V2
HBs+ Ag 1P BR V2
HBs+ Ag 1P BR V2
HBs+ Ag 1P BR V2
HBs+ Ag 1P BR V2
HBs+ Ag 1P BR V2
This list can be printed (use File | Print in the menu bar or the <Print>
button).
2.4.7.8 Archiving
On sample archiving, see Section 3.5.
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2.4.8 Worklist Options
After a worklist has been prepared and before it is started it is possible to
check and/or edit the worklist processing options. By default, the system
uses the previously defined worklist options. Some options are locked and
cannot be changed even by supervisors (users with full access rights).
To open the Worklist Options dialog box:
‰
Select Panel Options in the Edit menu (this menu item is active only if a
Worklist window is open).
Figure 67: Worklist Options dialog box
If you cannot access the Worklist Options dialog box, this means that
you belong to a user group not authorized to edit worklist options (see
Section 1.2.7.2).
Scheduling gap
Enter the scheduling gap in seconds. The scheduling gap can be used to
introduce a short time tolerance in the scheduling of the run.
For example, if you set the scheduling gap value at "30" (seconds), the
software schedules all operations that use the same module (e.g. the
washer) to ensure that at least this gap is present between operations on
different plates. The purpose of this additional time is to increase the
possibility for the operator to solve errors that may occur during the
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processing (e.g. no liquid, wash buffer empty) without flagging or aborting
subsequent plates because of the delay.
Entries between 0 and 10000 seconds are acceptable (default = 0). Note,
however, that setting a long scheduling gap will increase significantly the
global duration of your worklist. If you change the scheduling gap value, it is
recommended that you closely review the worklist Schedule (see Section
2.4.7.2) before actually starting the worklist.
The scheduling gap should be not set to increase the duration of the
processing in a way that would be incompatible with the duration
prescribed in the respective kit inserts. If in doubt, retain the default
value ("0") or call Bio-Rad Technical Support for assistance.
Reagent load time
Enter the maximum reagent load time in seconds. This applies when
unstable reagents have to be loaded while a worklist is being processed
(see Section 2.5.3.3). The system will warn the operator beforehand
(warning message in the software and acoustic signal) and pause the
system during the specified load time. This load time should be long enough
to allow correct loading but not so long as to affect the processing of the run.
Recommended time is 180 seconds (3 minutes). Entries between 0 and
1000 are acceptable.
Abort plate if reagent is not loaded within the time specified above
Aborts the respective plate processing if the reagent is not loaded within the
time specified above. Check this item if you intend to use EVOLIS as a "walk
away" system (e.g. at night). That way, the respective plate will be aborted
but the rest of the run will continue.
Allow assay protocols with different wash buffers to be run on the
same plate
Worklist definitions are permitted where different wash buffers are being
used. This option is always checked and may not be unchecked (even by
users with supervisor status).
Automatically print results
Check this option if you want the system to print the result file as soon as it
is generated, i.e. as soon as the processing of the respective plate is over.
Multi-pipetting mode
Use this item to define parallel sample dispensing into several wells. In the
drop-down list, select one of the following options.
Disabled: no multi-pipetting is allowed. Samples and controls are pipetted
into the microplates one by one.
Same microplate only: parallel sample dispensing is allowed on the same
microplate only.
All microplates: parallel sample dispensing is allowed on the same
microplate or across microplates.
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If multi-pipetting is enabled, you have to set the aspirate and dispense
profiles to be used when samples are pipetted in parallel.
Note that if multi-pipetting is enabled (within one plate or across
microplates), samples that are pipetted in parallel will generally be
pipetted before other samples.
This can induce unsuitable pipetting sequences when:
• only some samples are assigned to several tests and need to be
multi-pipetted.
• or, the multiple determination option (see Section 2.4.2 under 3))
has been used for some or all samples.
• or, the assays include a predilution step.
• or, the order in which the controls have to be dispensed (i.e.
strictly before or strictly after the samples) must not be changed.
• or, if the assays to be processed include the "assay drift
compensation" feature (see Section 3.12.3.3.1 paragraph 7)).
This can also induce unsuitable delays between the moment when the
samples are pipetted and the beginning of the processing of each
plate. It is the user's responsibility to determine what is the maximum
acceptable delay for each assay. An excessive delay can lead to a
absence of results or to false results. It is the user's responsibility to
control that this period was not exceeded each time the assay is
performed. The exact time between the end of the sample pipetting and
the beginning of the processing is traced in the event log.
If in doubt, disable the multi-pipetting option or call Bio-Rad Technical
Support for assistance.
Re-use partial disposable tip racks
Partially used tip racks are registered and re-used for later worklists. See
Section 2.5.5 on when to select this option or not.
Verify disposable tip racks
When starting to process the worklist, the system checks the size of the first
tip of each rack to make sure the racks have been loaded as displayed in the
Load dialog box (i.e. long tips and short tips have not been mixed up). See
Section 2.7.2.4.
If tips run out
This item allows you to choose what happens if the system runs out of small
tips (300 µl), see Section 2.5.5.2 paragraph 5).
Check reagent levels before a run
See Section 2.7.2.1.
Check patient sample levels before a run
See Section 2.7.2.3.
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Tip size to use for checks
The drop-down list allows you to select the kind of tips (300 µl or 1100 µl)
you want to use when checking reagent and/or sample levels before a run.
Default setting is 300 µl.
Archive patient sample during the run and <Archiving Parameters...>
See Section 3.5.
Verify strip presence before a run
Each time a test plate is loaded, it is first moved into the photometer so that
the system can check that it includes the correct number of strips. This is
useful especially when using plates with removable strips (see Section
2.6.4). This item is checked by default and may not be unchecked (even by
users with supervisor status).
Pause worklist if system cover is open
Stops the instrument immediately when the instrument cover has been
opened. This item is checked by default and may not be unchecked (even by
users with supervisor status).
Play sound when additional plates can be loaded
If this item is checked, an acoustic signal and a message on the screen will
warn the operator when additional plates can be loaded to a running
worklist. This item applies to Continuous Loading (see Section 3.2.1).
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2.5 Loading the Required Resources
2.5.1 Basic Principles
If the loaded worklist is error-free, the <Start> button in the toolbar at the top
of the Worklist window is enabled (appears in green instead of gray). If you
click this button, the system prompts you to load the instrument with the
required resources (samples, reagents, dilution plates, tip racks, wash
buffer, clean fluid…) and opens the Load dialog box.
Test plates are loaded at a later stage, see Section 2.6.
2.5.1.1 Load and Allocate
The loading process on the EVOLIS system includes two stages:
‰
The actual (physical) loading of reagents, racks and accessories in the
instrument.
‰
The allocation of these resources in the software.
The purpose of the allocation process is to enable the software to track
whether each sample, each reagent and each of the other required
resources has been loaded, and where it has been placed in the instrument.
When using barcoded components, part of the allocation process is done
automatically since the system can then identify each component and
monitor its location through the barcode.
For items that are not barcoded, the allocation process is done on the
screen (using the mouse) in the Load dialog box (for samples and
reagents).
For those elements that have a set location on the instrument (dilution
plates, tip racks, wash buffer, system liquid) the system is able to monitor
directly through other devices (e.g. sensors) which quantity is available on
the instrument and if more is required for the current worklist, this is
displayed in the Load dialog box. For those elements, no allocation process
as such is necessary but they should be loaded on the instrument in strict
accordance with what is displayed in the Load dialog box.
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2.5.1.2 The Load Dialog Box
Figure 68: Load dialog box
The Load dialog box illustrates the top level of the instrument (work area).
From left to right:
• Dilution plates (or archive plates) and additional reagent positions.
• Tip racks.
• Patient sample racks, identified by a code letter (T, U, V, W, Y or Z) and
by different colors (T = black, U = red, V = blue, W = green, Y = purple, Z
= blue-green).
• Reagent racks, identified by a code digit (3, 2, 1 or 0).
• Test plates.
A blank space remains on the right. Unallocated resources (i.e. resources
which are necessary to perform the test run defined in the worklist but which
are not yet loaded) are shown in the top corner of this space. Moving the
mouse pointer over one of these samples or reagents will show its name or
ID.
At the bottom of the work area, four containers with color-coded lids are
depicted:
• The first container on the left is the clean liquid container.
• The other containers are the wash buffer containers.
Buttons of the Load dialog box
<Auto Arrange
Samples>
Click this button to allocate all patient samples in the Unallocated
resources column in ascending order on the sample racks (see Section
2.5.2.2 under b) on when to use this button).
<Scanner Setup...>
Opens the Scanner Configuration dialog box and you can view and edit
the scanner parameters or the rack types and positions (see Section
2.5.2.2 under c) on when to use this button).
<Open Reagent
Layout>
Opens the Open dialog box and you can open a reagent layout file (*.rea)
(on reusing a previously saved reagent layout file, see Section 2.5.3.5).
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<Save Reagent
Layout>
Saves the current reagent layout.
<Refill Partial Tip
Racks>
Allows you to choose to work only with complete tip racks. Note: This
button is visible only if the Re-use partial disposable tip racks item had
previously been checked in the Worklist Options dialog box. For more
information, see Section 2.5.5.
<Redraw
Unallocated
Resources>
Re-arranges the unallocated resources displayed in the top right corner per
assay.
<OK>
<Cancel>
Saves the information and opens the Load Plate dialog box.
The entries are discarded and the program returns to the Worklist window.
Editing the worklist after the Load dialog box is displayed
Sometimes, it is only when the Load dialog box is displayed that you realize
that some elements of your worklist have not been correctly defined. In this
case, you need to go back to the Set-Up Panel dialog box and change what
you need to change.
To do this:
‰
Close the Load dialog box by clicking the <Cancel> button (NOT the
<OK> button!). This takes you back to the Worklist window.
‰
In the Edit menu, select Panel Definition to open the Set-Up Panel
dialog box.
‰
Change what you need to change and click <OK>. A new Load dialog
box is displayed, reflecting the changes you made.
The same applies for Worklist Options. If you want to change them (e.g. if
you have forgotten to specify that you wanted to archive some samples or if
you want to work with full tip racks only), repeat the steps described above
but select Panel Options in the Edit menu instead of Panel Definition.
2.5.2 Patient Samples
2.5.2.1 Load
At this stage, the patient sample racks should already have been loaded in
the instrument as described in Section 2.2 (it is usually the first thing to do
when starting a test run). However, if it has not been done, you can refer to
that section and load them now.
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2.5.2.2 Allocate
a) Barcoded racks and individual samples.
If the racks AND the individual samples were barcoded, they should now
appear in the central section of the Load dialog box as rows of small dots.
Moving the mouse pointer over a dot will show the Patient ID of each
sample. The color of each dot indicates the status of each sample.
Colored
Indicates samples that have been correctly loaded by the operator and
correctly identified by the system through their barcodes. No further
allocation is needed. The actual color used depends on what has been
specified in the Pipette tab of the System Set-Up dialog box (see Section
3.10.4.1).
Blank
Signals either an empty position (i.e. partially full racks) or a sample tube
without barcode (or a barcode the system cannot read). Allocate manually
if necessary (see Section 2.5.2.2 under b))
Black
Indicates a sample that has been loaded but which is not required for the
run, i.e. no assay is assigned to that sample. Either remove the sample
from the rack or go back to the Set-Up Panel dialog box to check why this
is so and correct the assay assignment for this patient.
For more details on barcode settings, see Section 3.10.6.
b) Barcoded racks and non-barcoded individual samples
If the racks were barcoded but not the individual samples, the racks are
depicted as empty (rows of blank dots) in the central section of the Load
dialog box while the samples are depicted as Unallocated resources in the
top right-hand corner of the dialog box. You now need to allocate them either
manually or automatically.
Manual allocation
To allocate patient samples manually:
‰
In the Unallocated resources, identify the first sample (colored dot) you
want to allocate by moving the mouse pointer over it. This will shows its
code name/ID.
‰
Click on that sample and move it to the desired location (position in the
rows of blank dots in the central section) while keeping the mouse button
held down.
‰
Release the mouse button (when releasing the mouse button, make
sure your mouse pointer/arrow tip is exactly at the center of the desired
blank dot; otherwise, the sample will not “stick” but return to its initial
location in the Unallocated resources).
‰
Repeat for each sample.
Make sure that the position to which you allocate a sample on the
screen corresponds exactly to the real position of the corresponding
patient tube in the rack! This is very important as wrong allocation is
equivalent to mixing up samples.
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<Auto Arrange Samples>
To allocate samples automatically:
‰
Click on the <Auto Arrange Samples> button in the bottom left-hand
corner of the Load dialog box.
The unallocated samples are then allocated to the available sample racks,
from the top down and starting with the first rack on the right. The order in
which samples are allocated to the consecutive rack positions (position 1,
position 2, etc.) follows the order selected in the Patient Editor dialog box
(Ascending, Descending or None – see Section 2.3.4) as illustrated below.
6030
6073
6087
6229
6291
6921
6929
6947
6954
6073
6921
6030
6229
6087
6929
6954
6291
6947
Figure 69: Auto-arrange samples
1) Automatic allocation is a timesaving option if you have a lot of nonbarcoded samples to allocate. It implies that the person who actually
places the sample tubes in the racks and the racks in the instrument
does it in strict compliance with the order resulting from the automatic
allocation.
2) From software version 1.90, the auto-arrange function allocates
samples from the top down and from right to left. In previous software
versions, samples were allocated still from the top down but from left
to right.
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c) Non-barcoded racks and samples
If you are using non-barcoded racks (or racks with damaged or dirty
barcodes), the central section of the Load dialog box is empty when it
opens:
‰
Click on the <Scanner Setup> button at the bottom of the Load window.
This will open the Sample Rack tab in the System Set-Up dialog box.
‰
In the Rack Types field, use the drop-down lists to specify which type of
rack you have loaded or intend to load on which track. Sample racks can
have a T, U, V, W, Y or Z code, reagent racks can have a -0, -1, -2 code
(for descriptions of Bio-Rad rack types, see Section 1.1.1.2).
‰
Confirm with <OK>.
Now the racks are depicted as empty (rows of blank dots) in the central
section of the Load dialog box. The required samples are depicted as
Unallocated resources in the top right hand corner of the dialog box.
Allocate the samples as described above in b) Barcoded racks and nonbarcoded individual samples).
Replacement barcode labels for sample racks can be ordered from Bio-Rad.
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2.5.3 Reagents
2.5.3.1 Load
a) Placing the reagents on the racks
On the EVOLIS system, there is no need to transfer the kit reagents into any
particular container before loading them on the instrument. The EVOLIS
reagent racks have been specially designed to accept all Bio-Rad kit bottles
as well as most types of kit bottles, vials or tubes available on the market.
The reagents can therefore generally be placed directly in the racks.
There are only a few cases where this is not possible: unstable reagents
which have to be prepared separately, kit bottles too large (e.g. 125 ml
bottles) or too small for the racks, controls which have to be decanted in
hemolysis tubes. These cases are dealt with in Sections 2.5.3.3 and 2.5.3.4.
For more information on Bio-Rad rack types, see Section 1.1.1.2.
Do not refrigerate reagent racks! Because they are made of metal,
excessive cooling of the racks could influence the temperature of the
reagents and of the work area inside the instrument.
Using the Reagent requirements checklist (see Section 2.4.7.4), check that
you have fitted all the required reagents on the racks. If you need a reminder
of where you placed each reagent/control, you can copy and fill in the Rack
layout forms provided in Appendix A 6.
When opening the reagent bottles, be careful not to mix the bottle caps as
these may be needed again after the run and should not be exchanged from
one bottle to another.
b) Loading the racks on the instrument
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‰
Once you have fitted all the required reagents on the racks, open the
door of the sample and reagent unit.
‰
Insert the first rack on the track that is marked by a red LED on the rear
panel. Place the rack in front of the track and then push evenly up to the
limit stop (with the tappet in the contact opening on the rear panel). A
reagent rack occupying 2 or 3 tracks must be inserted so that the
contact tappet is opposite the lit up LED. The barcode labels (if any)
must face right towards the barcode reader.
‰
The LED goes off and moves to the next position that can be loaded. A
graphical representation of the correctly inserted rack appears in the
Load dialog box on the screen.
‰
Insert the next reagent racks (if any) as described.
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2.5.3.2 Allocate
a) Barcoded racks and barcoded reagent containers
If both the racks AND the individual reagent containers, vials or bottles were
barcoded and were correctly inserted, the racks and the reagent containers
should now be displayed on the screen in the central section of the Load
dialog:
• The reagents that are required for the run and have been correctly
loaded and identified (through their barcodes) are automatically
allocated and appear in the racks as larger or smaller colored dots (a
different colour is used for each reagent) with a cross.
• Loaded reagents that are on the instrument and have already been
identified through their barcodes (or otherwise allocated) but are not
needed for the current worklist are presented in black.
For more details on barcode settings, see Section 3.10.6.
b) Non-barcoded individual reagent containers
Unlike patient samples, reagent containers usually have barcodes. Reagent
barcode stickers can also be ordered separately from Bio-Rad.
However, it can happen that a barcode is missing, damaged or illegible.
When a container with a missing or damaged barcode is loaded and the
system is not able to identify the reagent, the corresponding rack position is
displayed as empty (larger blank dot) and the required reagent remains
depicted in the Unallocated resources at the top right-hand corner of the
Load dialog box. It has to be manually allocated.
Manual allocation of reagents:
‰
In the Unallocated resources, identify the reagent you want to allocate
by moving the mouse pointer over it. This shows its code name/ID.
‰
Click on that reagent and move it to the desired location (corresponding
blank position in the reagent racks in the central section of the Load
dialog box) while keeping the mouse button held down.
‰
Release the mouse button (when releasing the mouse button, make
sure your mouse pointer/arrow tip is exactly at the center of the desired
blank dot; otherwise, the reagent will not “stick” but return to its initial
location in the Unallocated resources).
‰
Repeat for each unallocated reagent.
The user has to make sure that the manually allocated positions
correspond to the actual placement on the reagent rack. Manually
allocated reagents are not crossed. In the log file, manually allocated
reagents can be tracked as such.
The <Auto Arrange…> function (automatic allocation of non-barcoded
resources) is not available for reagents (only for samples, see Section
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2.5.2.2 under b)). For reagents, a similar function is provided by the <Save
Reagent Layout>/<Open Reagent Layout> buttons (see Section 2.5.3.5).
c) "Blind" reagent positions
Manual allocation is also necessary when reagent bottles (whether barcoded
or not) are placed in any of the nine "blind" positions included on larger (3
track) Bio-Rad racks. These positions are located on the left-hand side of
the rack and cannot be scanned for barcodes. As a general rule, avoid using
these positions if other positions of the same size are still available.
d) Non-barcoded reagent racks
If the reagent racks do not have barcodes, you can identify them manually
as described for non-barcoded patient sample racks (see Section 2.5.2.2
under c)).
Replacement barcode labels for reagent racks can be ordered from BioRad.
Figure 70: Load dialog box when samples and reagents have been loaded
and allocated
2.5.3.3 Unstable Reagents
Some unstable reagents have to be prepared separately and loaded on the
instrument only after the test run has begun.
a) Preparing the reagent
The preparation procedure depends on the reagent required. Please refer to
the appropriate documentation.
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However, the following recommendations apply to all separately prepared
reagents:
‰
Do not fill the bottle above the shoulder level.
‰
If a bottle for this preparation is not included in the kit but a specific
bottle type is recommended, always use the recommended type.
‰
Follow strictly the manufacturer's recommendations on reusing the
bottles. Even if reusing a bottle is allowed, never use the same bottle for
different reagents and follow strictly the recommended maintenance
procedure.
‰
Attach a barcode label to the bottle (barcode stickers can be ordered
from Bio-Rad). Using non-barcoded bottles for unstable reagents is not
recommended (see below under c)).
b) Loading the reagent
If an unstable reagent is required for a test, it will be listed in the Reagent
requirements list.
When the Load dialog box opens for the first time, load all required reagents
except the unstable reagent. Allocate the unstable reagent manually, i.e. use
the mouse to drag it from the Unallocated resources corner to the rack
position where you will later load it.
Because the properties of this reagent have been included in the reagent
database (see Section 3.3), the system knows that this reagent requires a
preparation time. Before the reagent is actually needed, the system prompts
the operator with an acoustic signal and a message on the screen to prepare
and load the reagent ("Prepare [name of reagent] and load in xxx minutes").
Figure 71: Prepare unstable reagents
The time span specified in this message to prepare the reagent is a
theoretical time span determined by the system from the data included
in the reagent database (see Section 3.4.3.1).
It is recommended that you do not wait until this message is displayed
to prepare the reagent (i.e. you should anticipate its preparation).
‰
116
Click <OK> to close this message. The processing of the worklist
continues and when the indicated time span is over, the Load dialog box
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is displayed again with an additional message "Please load the
requested items as soon as possible as the system is paused".
Figure 72: Load unstable reagents
‰
Open the door of the sample and reagent unit.
‰
Remove the reagent rack in which you initially allocated the unstable
reagent.
‰
Place the reagent bottle in the position indicated in the Load dialog box.
‰
Reinsert the rack and close the door of the sample and reagent unit.
‰
Then click on <OK>.
The time span available to actually load the reagent has been defined in the
Worklist Options dialog box (see Section 2.4.8). Recommended time is 180
seconds (3 minutes). If the reagent has not been loaded within that time, the
system will either:
• abort the plate for which this reagent is required if this option has been
checked in the Worklist Options dialog box, or
• pause the system until an operator loads the required reagent.
Never click on <OK> before loading the reagent! Even if you could do
it, the system would not take it into account and would not dispense
the reagent.
c) Troubleshooting - Non-barcoded unstable reagents
If the unstable reagent you loaded is not barcoded (or has an incorrect
barcode), an error message is displayed:
"Error! Barcode "…" is not correct for reagent "(reagent name)".
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You can click <OK> to close the message but it will appear again and again
until the end of the preset preparation time. When the preparation time is
over, the system assumes that you have not loaded the required unstable
reagent and that you need to abort the plate for which this reagent was
required. It therefore opens the System Paused dialog box (see Section
2.7.5.1) to allow you to abort this plate.
At this stage, if you had actually loaded the required unstable reagent, DO
NOT abort any plates and just click <Resume>. The run continues normally
(the system actually dispenses the unstable reagent) but in the log file, a
warning is included stating that the reagent was not loaded on time and the
volume of the unstable reagent is not checked. This procedure is therefore
not satisfactory. This is why it is recommended to always use barcoded
unstable reagents.
2.5.3.4 Other Special Cases
2.5.3.4.1 Additional Positions for Large Reagent Bottles
Additional reagent positions are provided in the top left-hand corner of the
instrument to accommodate large reagent bottles (125 ml) that do not fit in
the normal reagent racks. These positions are often used for diluents.
Figure 73: Additional positions for large reagent bottles
To use these additional positions:
‰
Open the dilution plate drawer. The DWR LED must be on.
‰
Place the bottle(s) in the desired slot(s) and close the drawer (audible
click).
‰
In the Load dialog box, allocate this reagent manually; with the mouse,
click and drag it from the Unallocated resources corner to the
appropriate position above the dilution area.
No barcode scan is available for these reagent positions. Only manual
allocation is possible.
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2.5.3.4.2 Rack Adaptors for Small Reagent Bottles
Small reagent bottles that are too wide to be loaded in a -2 control rack can
be loaded in the medium-size -1 reagent rack thanks to specially designed
rack adaptors.
Figure 74: Rack adaptors from small reagent bottles
The rack adaptors help keep the bottles correctly centered within each rack
position. The rack adaptors can be ordered from Bio-Rad (for ordering
information, see Appendix A 3).
2.5.3.4.3 Identical Reagent in Two Separate Bottles
In some cases, two separate bottles of the same reagent are required for the
same assay. If this has been taken into account in the assay definition and
when entering the reagent in the reagent database (see item Allow
changing of bottles during a dispense in Section 3.4.3.1), the pipettor will
automatically switch from one bottle to the other during the run avoiding
having to pause the run, exchange bottles, etc.
To make sure this switch is correctly performed:
‰
Make sure to fill each bottle with the appropriate volume (as specified in
the Reagent Requirements list). At any rate, the total volume should
equal the total volume specified in the list.
‰
Load both bottles on the rack before the start of the run.
‰
If the bottles are non-barcoded, allocate them manually in the Load
dialog box to the respective rack locations (if the bottles are barcoded,
they should already be allocated when the Load dialog box is
displayed).
2.5.3.4.4 Controls in Hemolysis Tubes
In some assays, controls have to be transferred and decanted in hemolysis
tubes before being loaded.
Do not attempt to load these on the instrument using ordinary sample racks
(T racks)! Use a -3 reagent rack.
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-3 reagent racks are T racks that have been specially converted and
realigned to that effect. If you do not have a -3 reagent rack, please contact
your Bio-Rad Service Engineer. Do not attempt to do this conversion
yourself!
2.5.3.5 Save Reagent Layout
If you are using non-barcoded reagent bottles and if you are generally
repeating the same tests over and over, you may try to shorten the reagent
allocation process by using the <Save Reagent Layout> function.
To do this:
‰
The first time you use the desired worklist, load the reagents on the
instrument and allocate them manually in the Load dialog box as
described in Section 2.5.3.2 under b).
‰
Click the <Save Reagent Layout> button.
‰
The Save As dialog box is displayed. Enter an appropriate file name and
click <Save>. Reagent layout files have a (*.rea) extension and are
saved by default in the C:\BioRad\System directory.
‰
The next time you want to process exactly the same tests with the same
reagents (and new patients samples of course), in the Load dialog box,
click the <Open Reagent Layout> button.
‰
In the Open dialog box which is then displayed, select the desired
(*.rea) file and click <Open>.
‰
All the reagents are automatically allocated. Now fit the reagent bottles
in the racks making sure you reproduce exactly the layout which is
displayed in the Load dialog box.
If you intend to use this function on a standard basis, include small
labels on the rack itself or copy and fill in the Rack layout forms
provided in Appendix A 6 in order to keep a "reference picture" of each
saved layout.
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2.5.4 Dilution Plates
Types of dilution plates
Various types of dilution plates may be used on the EVOLIS system:
flat bottom plates, round bottom plates or deepwell dilution plates.
The specifications of each plate type are stored in a coordinate file. Plate
coordinate files have a (*.mpc) extension; by default, they are saved in the
C:\BioRad\System directory. They cannot be opened directly.
A default dilution plate type is selected at system level in the Pipette tab of
the System Setup dialog box (Dilution Plates field).
Default dilution plate type
Figure 75: Default dilution plate type
When loading the required resources for your worklist, you can check which
type of dilution plate is required by moving the mouse pointer over the
dilution plate in the Load dialog box.
Figure 76: Checking the required dilution plate type
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If you want to change the type of dilution plate used (for example, if you want
to use a deepwell dilution plate instead of a flat bottom standard dilution
plate):
‰
Click <Cancel> to close the Load dialog box and go back to the Worklist
window.
‰
Select the Utilities | System Setup menu item.
‰
Click on the Pipette tab.
‰
In the Dilution Plates field, use the drop-down list to select the desired
coordinate file (e.g. "deepwell.mpc").
‰
Click <OK> to confirm.
To load the dilution plates:
‰
Pull very left drawer out. The DWR LED must be on.
‰
Place as many dilution plates as required in the Load dialog box (in the
corresponding locations). Position A1 should be at the rear left. The
plates are automatically adjusted and fixed by small side springs on the
instrument.
1
A
1
A
1
A
Figure 77: Loading dilution plates
‰
Push in drawer again up to the limit stop (audible click), overcoming a
slight resistance. The DWR LED is turned off.
When loading dilution plates, make sure not to mix pre-dilution plates
(for assays which require a pre-dilution step) and archive plates (for
sample archiving). In the Load dialog box, these are identified by
different colors and moving the mouse pointer over each plate will also
let you identify which kind of plate it is. For more information, see
Section 3.6.5.
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2.5.5 Tip Racks
The tip racks are in the same drawer as the dilution plates. They can be
loaded at the same time.
2.5.5.1 Basic Tip Loading Procedure
Tip types
The pipettor on the EVOLIS system operates with disposable tips. Two
different types of tips can be loaded on the instrument:
• 1100 µl tips (long tips).
• 300 µl tips (small tips).
Because the pipettor on the EVOLIS system is also used for liquid level
detection, clot detection, etc., the tips have to enable conductivity. Therefore
do not replace the Bio-Rad tips by other tips with different conductivity
properties.
Ordering information for Bio-Rad tips is available in Appendix A 3.
Tip rack display in the Load dialog box
The Load dialog box shows the number of tips of each size required to
perform the current worklist.
The colors in which the tip racks are displayed vary not only according to the
required tip size but also according to whether racks are already available on
the instrument.
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Color
Tip size
Status
Gray
1100 µl
Load a full new tip rack with 1100 µl tips.
Red
1100 µl
An incomplete tip rack is already loaded. The
number of tips that are still available is taken
into account by the software.
Green
300 µl
Load a full new tip rack with 300 µl tips.
Red
300 µl
An incomplete tip rack is already loaded. The
number of tips that are still available is taken
into account by the software.
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Example
Red
Green
Gray
Green
Green
Figure 78: Tip rack display in the Load dialog box
The Load dialog box in Figure 78 indicates that:
• One partially used rack with 300 µl tips should already be on the
instrument (left over from the previous worklist).
• You have to load 3 new 300 µl tip racks.
• You have to load 1 new 1100 µl tip rack.
The small number on each rack indicates the number of tips the system will
use from each rack to process the current worklist.
Tip loading procedure
‰
Check the Load dialog box to see how many tip racks and how many
tips are required.
‰
Pull very left drawer out. The DWR LED must be on.
‰
Place the tip rack into the holding device of the instrument, so that the
pin sits in the groove of the tip rack. Repeat for all tip racks required in
the Load dialog box.
Pin
Figure 79: Loading a tip rack
‰
Push in drawer up to the limit stop (audible click). The DWR LED is
turned off.
Always observe the position of the tip racks defined in the Load dialog
box! Using a short tip instead of a long one may cause splashing and
contamination. Using a long tip instead of a short one may cause the
pipettor to crash and be damaged. Note that the EVOLIS system can be
configured to perform an automatic tip size check (see Section 2.7.2.4).
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2.5.5.2 Tip Management Options
The EVOLIS system offers several tip management options depending on
whether you want to be able to reuse partial tip racks and whether you are
prepared to reload tips during a run or want the system to operate
unattended as much as possible.
1) Use only full tip racks
If you prefer starting a run with only full tip racks:
‰
From the Worklist window, select the Edit | Panel Options menu item.
‰
In the Worklist Options dialog box (see Section 2.4.8), make sure the
Re-use partial disposable tip racks checkbox is deselected.
‰
Click <OK>.
Worklist options settings are retained until they are edited again. This means
that you do not have to do this before each run (the option continues to
apply to all later runs unless you decide to change it).
When you actually load the tip racks on the instrument, make sure to unload
all partially used tip racks and load only full tip racks (in the Load dialog box,
only gray and green tip racks should be displayed).
2) Reuse partially used tip racks
To allow the system to start a run using partially used tip racks (i.e. the tips
left over from the previous runs), repeat the steps described above but, in
the Worklist Options dialog box, make sure the Re-use partial disposable
tip racks checkbox is selected (instead of deselected).
This is possible because, while it operates, the system monitors the number
of tips used. At the end of a run, it knows how many tips of each size are still
available. If the Re-use partial disposable tip racks option is selected,
when the system calculates the number of tips required to perform the next
worklist, it takes into account the number of tips still available on the
instrument. In the Load dialog box, partially used tips racks are displayed in
red.
3) Refill Partial Tip Racks
The Load dialog box includes a <Refill Partial Tip Racks> button.
Use this button if:
‰
The system has been configured (by you or by any other previous user)
to reuse partial tip racks.
‰
But you now want to use full tip racks only (e.g. because the previously
used tip racks have been unloaded from the instrument and it is easier
for you to start with new tip racks rather than try and load partial racks
exactly as they were at the end of the previous worklist).
If you click this button, you will notice that the tip racks that were displayed in
red (partial tip racks) in the Load dialog box are now displayed in green /
gray (full racks: short / long tips).
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A similar result could be achieved by going back to the Worklist
Options dialog box and deselecting the "Re-use partial disposable tip
racks" option. Note, however, that the <Refill Partial Tip Racks> button
can be used even by users who are not authorized to edit worklist
options. Also, when you use the <Refill Partial Tip Racks> button, you
affect only the current worklist; the option to re-use partial tip racks
remains selected for later worklists.
4) Reload tip racks during a run
If you want to try and avoid having to reload tips during the run, it is
recommended to work only with full tip racks, i.e. to deselect the Re-use
partial tip racks option. However, even if you started the run with only full
tip racks, it may still be required to reload tips during the run if you are
processing "heavy" worklists (e.g. with several tests, many patient samples,
a predilution and/or a sample archiving step).
If tip reloading is going to be required in the course of a run:
‰
At the bottom of the Schedule display (from the Worklist window, click
on Schedule in the Worklist Tree to view the Schedule), the system
displays the following indication: "Operator intervention required in X
minutes".
‰
A message on the screen and an acoustic signal warns you when it is
time to get ready to reload.
‰
The <Load Tips> button on the toolbar is then enabled.
‰
Click on that button and reload the tips as described in Section 2.5.5.1.
5) Options if small tips run out
The Worklist Options dialog box (see Section 2.4.8) includes a drop-down
list in which you can select what happens when the system runs out of small
tips (300 µl).
Raise alarm and stop. The system pauses the processing and prompts you
to load more tips.
Abort plate. The system aborts the current plate (and any plate that still
requires 300 µl tips) but the processing of other plates, e.g. plates that are
already dispensed, can continue as planned.
Log and continue. The system automatically skips any processing steps
that require 300 µl tips and removes any affected wells from the results.
Note that the wells are simply removed but not flagged. This option is useful
when the system operates mostly unattended (e.g. at night).
This option is available for small tips (300 µl) only as these are the tips used
for sample dispensing and likely to run out. Generally, the rest of the
processing (e.g. reagent dispensing using large tips – 1000 µl) can continue
unaffected. Note that it is not possible for the system to switch to large tips if
it runs out of small tips as this would alter the pipetting accuracy negatively.
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6) Tip pickup failure / Tip eject failure / Tip lost error
If, during a run, the pipettor fails to pickup or to eject a tip correctly, a specific
error message is displayed. On recovery options and procedures, see
Section 5 under 45 and 49.
If the pipettor accidentally looses the tip during a pipette or dispense step, an
error message is displayed stating:
"Pipettor error 0x70 - Disposable tip dropped.
Please remove the tip from the system."
Available recovery options are <Retry> or <Abort Plate>. If you click
<Retry>, the pipettor picks up another tip and repeats the pipetting or
dispensing operation that was being performed when the previous tip was
lost.
Apart from the hazard of erroneous results that may be caused by the
dropped tip itself (e.g. depending on where it fell), it should be noted
that clicking <Retry> may result in the same pipetting or dispensing
operation being actually performed twice.
2.5.6 Wash Buffer and Clean Fluid
Instrument
In the instrument, the wash buffer bottles are located in the bottom drawer.
Three 2-liter bottles can be used for various buffers.
Another position (1 liter bottle) is reserved for the clean fluid used to clean
the washer head.
The connection fitting consists of 4 color-coded lines (cap, tubing, filter)
allowing a better identification of each one as well as level sensor per bottle.
Load dialog box
In the Load dialog box, when you have loaded a correct worklist and clicked
the <Start> button, the required wash buffer(s) and clean fluid are displayed
in the respective containers in the bottom left-hand corner. The containers
are identified through colored screw caps.
Under default settings, the clean fluid bottle is the first bottle on the left. For
wash buffers, the system determines what buffer should be put in each
bottle. Moving the mouse pointer over each bottle lets you see the name of
its corresponding buffer.
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Figure 80: Wash buffer containers in the Load dialog box
If, for some reason, you do not wish to fill a buffer in the bottle specified by
the system (e.g. if the blue-capped bottle is damaged) you can "click and
drag" the desired buffer to the desired bottle. If you want to always use the
same bottle for the same type of wash buffer (e.g. blue-capped bottle for
Bio-Rad WB R2 wash buffer), you can do so by changing the washer default
settings (see Section 3.10.5.1).
In any case, make sure that when you actually fill the bottles, you do it in
strict compliance with what it set in the Load dialog box.
To fill in wash buffer/clean fluid:
‰
Hold the bottom drawer with your hands on both sides (bottom corners)
and pull it out gently. The INSTR LED must be on.
‰
Unscrew the cap of the respective wash buffer bottle. Refill it or replace
it with another full wash buffer bottle.
‰
Screw the cap back on carefully and watch out for correct seat of level
sensor and connections.
‰
Close the bottom drawer making sure both sides click shut. The INSTR
LED is turned off.
Type of wash buffer/clean fluid
The type of wash buffer to be used for a test is specified during assay
definition (see Section 3.12.3.3.2). The properties of each wash buffer are
stored in the reagent database and can (in some cases) be edited (see
Section 3.4.5).
Deionized water is used as clean fluid.
Quantity of wash buffer/clean fluid
The Reagent requirements list (see Section 2.4.7.4) lets you know the
quantity of wash buffer and clean fluid required for the respective worklist. If
you have filled in the correct quantities, then no refill should be needed
during the run.
The system automatically monitors the quantity of wash buffer left and warns
the operator before each run or before each wash cycle, if the quantity still
available is not sufficient (see Section 2.7.2.1).
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2.5.7 System Liquid
Normally, system liquid can be filled in as soon as the instrument is installed,
as described in Section 1.1.4. Checking the level of system liquid (and
refilling the container if necessary) is also prescribed as part of the daily
start-up maintenance routine (see Section 4.3.1.1). If this has been done as
prescribed, no additional refilling should be required before each run.
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2.6 Loading Test Plates
When all the required resources (samples, reagents, dilution plates, tip
racks, wash buffer/clean fluid and system liquid) are properly loaded and
allocated, close the Load dialog box by clicking the <OK> button.
2.6.1 The Load Plate dialog box
This automatically opens the Load Plate dialog box. The software uses this
dialog box to request the test plates that are needed to perform the current
worklist.
Test plates can only be loaded when this is requested by the software!
Figure 81: The Load Plate dialog box
Plate ID
Shows the name of the requested plate as defined in the Set-Up Panel
dialog box.
If you use non-barcoded plates and have not yet defined a plate ID, delete
"Plate 1" (Æ "Plate n") and enter a plate ID of up to 20 characters/digits. At
the end of this plate ID the software will automatically add an 8-character
“YYMMDDNN” identifier (with YY = year, MM = month, DD = day and NN =
“00” for the first plate of the day, "01" for the second plate, etc.).
If you are using barcoded test plates, do not enter anything. The plate will
be identified by the system through its barcode.
Assay(s)
Plate Layout
130
Shows the assay(s) used on the displayed plate.
Shows the sample/well allocation on the plate.
Barcode
This field is used only when a barcode scanner is used for reading the
plate names by means of barcode labels.
<Scan>
Click on <Scan> when you have inserted each requested barcoded test
plate onto the plate transport unit.
Verify during
processing
If this item is checked, the system will scan the plate barcodes again during
the processing to be sure each plate is being moved in the right order and
to the correct location.
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<OK>
When using non-barcoded test plates, click on <OK> once you have
inserted each requested (non-barcoded) test plate onto the plate transport
unit.
After the last (barcoded or non-barcoded) test plate defined in the active
worklist has been loaded, clicking <OK> will start the downloading process
for the run to begin.
<Cancel>
Aborts the plate loading process and the program returns to the Worklist
window.
2.6.2 Preparing the Test Plates
Test plates used on the EVOLIS system are 96-well microplates (8 rows of
12) with or without removable strips. The precise type of plate used for a test
is specified during assay definition (see Section 3.12.3.1.1).
When using Bio-Rad pre-defined assays, the test plate type specified in the
assay header corresponds to the plate(s) included in the kit for that assay.
Before the test plates can be loaded into the instrument, each plate has to
be placed in a metallic holding frame. To do so, fit the plate into the frame so
that the A1 corner of the plate matches the A1 inscription on the frame, then
push it in, overcoming a slight resistance.
Figure 82: Test plate with holding frame
Barcoded test plates
The plate-loading compartment is fitted with a barcode scanner (see Section
3.10.6.3) located on the left-hand side within the plate loading compartment
(when facing the instrument).
As a consequence, plate barcodes can only be read if they are attached to
the left hand-side of the microplate (side with the A to H letters) as shown
below. Be careful also to attach the barcode label so that it does not lift off
above the side of the microplate (improperly placed label can get jammed in
incubators, reader and washer causing transport errors).
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Correct
Incorrect
Figure 83: Position of plate barcode
2.6.3 Loading the Test Plates
To load the test plates:
‰
In the Load Plate dialog box, the first plate (of the current worklist) is
requested for loading. Check the Plate Layout displayed in the righthand side of the dialog box.
‰
The LD LED of the plate loading compartment (on the instrument front
panel next to the right door) lights up green. Open the door of the plate
loading compartment (very right). The plate transport unit should be
there, ready for loading.
‰
Place the requested test plate (on its holding frame with position A1
located at the rear left) correctly onto the plate transport unit. To do this
correctly, both pins of the holding frame must fit into the corresponding
holes of the plate transport unit slide.
a) Barcoded test plates
‰
132
As soon as you have inserted
the plate, click <Scan>. The test
plate is pulled in and the plate
name is read by the barcode
scanner.
b) Non-barcoded test plates
‰
As soon as you have inserted
the plate, enter the plate name
and then click <OK>. The test
plate is pulled in.
‰
In both cases (barcoded or non-barcoded plates) the test plate is then
moved first into the photometer to check that the correct number of strips
is present. The plate is then moved to the first plate position (all the way
at the back of the instrument). Meanwhile the Load Plate dialog box is
closed.
‰
The plate transport unit moves back to the load position and the Load
Plate dialog box prompts you to insert the second plate.
‰
Repeat the procedure for each requested plate.
‰
When you have loaded the last plate, close the door of the plate loading
compartment. The LD LED is turned off.
‰
Click <OK> to start the run.
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2.6.4 Special Cases
1) Loading incomplete plates
If you use microplates with removable strips, you can remove some strips as
long as the microplate you load includes enough strips for all the samples
programmed on that plate in the current worklist (compare with the Plate
Layout displayed in the Load Plate dialog box).
Always load full strips! Even if you use microplates with breakable
wells and only some wells are required on some strips, do not remove
unrequired wells. Optimize the plate layout beforehand as described in
Section 3.1.5.
In any case, each time a test plate is loaded, it is first moved into the
photometer so that the system can check that it includes the correct number
of strips. If not, or if an incomplete strip is detected, an error message is
displayed.
"Strip/well verification error!
Please ensure that a well has been inserted into the plate for each assay as
shown in the plate load dialog box."
2) Loading multi-assay plates
When processing several assays per plate, use non-barcoded plates or, if
you use only barcoded plates, load them as non-barcoded plates (click
<OK>, not <Scan>, see Section 3.1.6).
3) Loading pre-dispensed plates
Specific precautions apply when you load plates that have been predispensed on an external dispenser; see Section 3.3.4
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2.7 Processing the Run
Once all the prerequisites steps (load patient samples, assign assays to
patients, define worklist, load required resources, load test plates) have
been completed and you have clicked <OK> in the Load Plate dialog box,
the software downloads all the processing information to the instrument and
the test run starts.
Figure 84: Downloading Progress
2.7.1 System and Cover Lock
The EVOLIS instrument is locked during a run.
The loading doors and drawers are automatically locked before the
processing can start. When closing the loading doors and drawers, make
sure to hear them click (on both sides for the bottom drawer). Otherwise, the
system cannot be locked and the processing cannot start.
The only loading door which remains unlocked during a run is the door of the
sample and reagent unit. Opening this door will automatically stop the
pipettor (but not the processing if, for example, all plates are in the
incubators).
The system cover is also locked. If the system has been configured so that a
selftest is performed before each run (see Section 1.2.3) the cover is locked
after this pre-run selftest has been performed. Otherwise, the cover is locked
before the Downloading Progress dialog box is displayed. The cover is
unlocked at the end of the worklist.
It is possible to disable the automatic cover lock (in the System Set-Up
dialog box, in the System tab, uncheck the Lockable flap item – see
Section 3.10.1). This, however, is not recommended and may be done only
by supervisors or users who are authorized to change the system set-up
(see Section 1.2.7.2). Even if the cover may be opened, opening it will
automatically stop the processing (pause the worklist). It is not possible to
disable the loading doors/drawers locking system.
Both the cover and loading doors will automatically unlock if an error occurs
or if the <Stop> button is clicked (see Section 2.7.6). They will be locked
again when the error is cleared or when the <Resume> button has been
clicked. If the cover is opened, patient samples that had not yet been
pipetted before the pause will be flagged (CovOp flag - see Section 2.8.2)
and the results for these samples will not be calculated.
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Because of mechanical tolerances, pulling the cover handle during a
running worklist may deactivate temporarily the cover sensor and
cause all not yet pipetted samples to be flagged CovOp (cover opened)
even if the cover actually remained closed.
As a result, it is recommended to avoid touching or pulling the cover
handle during a run unless this is requested by the software.
LEDs on the front panel of the instrument indicate if loading doors/drawers
are locked or may be opened (see Section 1.1.2).
2.7.2 Pre-Run Checks
Before actually processing the assays, the system will perform pre-run
checks. The wash buffer / clean fluid volume check is performed
automatically. The three other pre-run checks (reagent volume check,
sample volume check and tip size check) are optional. They are performed
only if the user has requested them by checking the corresponding items in
the Worklist Options dialog box, see Section 2.4.8.
2.7.2.1 Wash Buffer / Clean Fluid Volume Check
The level of liquid in the wash buffer / clean fluid containers is monitored through
level sensors. If the level detected in a container is not sufficient for the current
worklist, the following message is displayed.
Figure 85: Insufficient wash buffer message
The message tells you which buffer is required in which container (color
indication).
To refill the container:
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‰
Open the instrument lower drawer.
‰
Unscrew the cap of the specified container (follow the color indication).
‰
Refill the container (or exchange it with another, properly filled
container).
‰
Screw the cap back on.
‰
Close the instrument lower drawer.
‰
Click <Retry>. The system rechecks the volume and, if satisfactory,
goes on to check the volume of the next wash buffer.
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If you click <Ignore>, the system lets you start the run but some strips will
not be washed. The <Ignore> option is available only if the currently loggedin user has the right to "ignore errors" (see Section 1.2.7.2).
The level sensors in the wash buffer/clean fluid bottles monitor the
volume in 500 ml increments only. This means that, for example, if
1850 ml are required for the run and only 1600 ml are available, the
system will not return an "Insufficient volume" warning message.
Because of the 500 ml steps, the system will only warn the operator if
the available volume is lower than 1500 ml. This is a design limitation
of the sensors.
2.7.2.2 Reagent Volume Check
The systems checks that all the reagents needed for the current worklist
have been loaded in sufficient quantity. To do this, the pipettor actually
checks every reagent bottle until the tip touches the surface of the reagent
and the system calculates the volume that is available.
If the system finds that the volume of a reagent is lower than what is required for
the current worklist, the following System Error message is displayed.
Figure 86: Insufficient reagent message
The message shows the name and the location of the reagent to be restocked.
To refill the respective reagent or to replace it by a new bottle:
‰
Open the door of the sample and reagent unit.
‰
Move out the respective reagent rack.
‰
Refill the respective reagent container or replace the bottle.
‰
Insert the rack again. If the reagent was allocated manually, the position
in the rack has to be allocated again.
‰
Click <Refill Bottle…>. The system rechecks the volume of this reagent
and, if satisfactory, goes on to check the volume of the next reagent.
If the reagent cannot be supplied:
In this case there are two possibilities. Either,
‰
Click the <Abort Worklist> button. This will abort any further volume
check but it will also abort whole the test run.
or
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‰
Click the <Ignore Reagent> button. This skips the volume check for this
specific reagent only and continues with the reagent check for the next
one. The insufficient volume is logged. With this option, you may decide
to start the run and load the missing reagent at a later stage. If you do
not refill the corresponding reagent, then some wells will not have
reagent dispensed.
The Reagent volume check is a good option if you intend to use the
EVOLIS as a "walk away" system (e.g. at night). However, it takes time
and uses several tips (one per reagent bottle or control vial).
Delayed volume check for unstable reagents
Unstable reagents have to be prepared and loaded just before use, i.e. while
the run is already being processed (see Section 2.5.3.3). As a consequence,
they cannot be included in the pre-run reagent volume check. If the reagent
volume check option has been selected for a run including unstable
reagents, the system will perform the pre-run check for all other reagents but
will also perform a volume check on the unstable reagents later, once these
have been loaded.
If the volume detected is not sufficient, the available options are:
• <Ignore Reagent> to continue the worklist and flag the corresponding
results (option is available only if the currently logged-in user has the
right to "ignore errors").
• <Refill Bottle…> to load additional reagent and allow the system to
continue the worklist without flagging the results
• <Abort Plate(s)> to abort all plates that require this particular unstable
reagent.
2.7.2.3 Sample Volume Check
The Sample volume check is very similar to the Reagent volume check.
Obviously (depending on the number of patient samples you intend to test),
it is likely to take even longer than the Reagent volume check and use even
more tips (one per sample tube). It is therefore recommended only as a
response to specific sample volume problems.
2.7.2.4 Tip Size Check
If the Verify disposable tip racks item in the Worklist Options dialog box
(see Section 2.4.8) has been checked, the system automatically checks the
size of the first tip of each rack to make sure the racks have been loaded in
the correct locations.
The consequence of this verification depends on whether the tip checked
corresponded (or not) to the type of tip the software expected to find on that
rack (as displayed in the Load dialog box).
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Tip size
Expected Detected
300 µl
300 µl
Consequence
The pipettor uses this tip normally for the pipetting step.
300 µl
1100 µl
The pipettor ejects the tip. The system
telling the user to go back to the Load
order the tip racks should be loaded and
the instrument. When the user closes
system checks the tip size once more.
1100 µl
1100 µl
The pipettor ejects the tip. It will use the next tip on the same rack to
perform the next pipetting step.
1100 µl
300 µl
The pipettor ejects the tip. The system
telling the user to go back to the Load
order the tip racks should be loaded and
the instrument. When the user closes
system checks the tip size once more.
displays an error message
dialog box, check in which
change them accordingly in
the Load dialog box, the
displays an error message
dialog box, check in which
change them accordingly in
the Load dialog box, the
Long tips have to be systematically discarded after a check because the
checking process is a mechanical process, which means that long tips come
in contact with the stopper (but not small tips).
The system keeps track of all tips retained or discarded during this process
when calculating the number of tips left in the partially used racks.
To change incorrectly loaded tips:
‰
Pull very left drawer out. The DWR LED must be on.
‰
Remove the rack with the wrong-size tips and replace it with a correct
rack.
‰
Close the drawer (audible click). The DWR LED is turned off.
2.7.3 Steps of a Typical Test Run
The different steps (also their duration and sequence) that will be performed
by the instrument during a run depend on which assays are to be tested in
the run.
In a typical test run:
138
‰
The test plate will be transported to its working position.
‰
The pipettor will aspirate the samples from the tubes (in the order
defined in the Patient Editor Section 2.3.4) and the controls from their
respective bottles. It will then dispense them into the test plate.
‰
The plate will be transported to the photometer for dispense verification.
‰
The plate will go through an incubation period.
‰
The plate will be transported to the wash unit for washing.
‰
The pipettor will dispense the reagent.
‰
The plate will be transported to the photometer for dispense verification.
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‰
The plate will go through a second incubation period and a second
wash.
‰
The pipettor will dispense the substrate.
‰
The plate will go through a third incubation period.
‰
The pipettor will dispense the stop solution.
‰
The plate will be transported back to the photometer for the final read.
In some cases (depending on the assay):
‰
A pre-dilution step will be performed at the beginning. This pre-dilution
can take place either directly in the test plates or in dilution plates.
‰
Shaking steps will also be included. The test plates can be shaken either
when they are in the heated incubators or on the plate transport unit or
in the reader.
When several assays are combined in the same worklist, the system does
not process one plate after the other but optimizes the process so as to
shorten the total processing time (see Section 2.4.7.2).
When sample archiving has been specified (see Section 3.5), the pipettor
will transfer some samples to the dilution plates at any time during the run
when it is not busy performing other pipetting steps.
On partial processing (i.e. processing only some steps of an assay), see
Section 2.7.8).
2.7.4 What You Can Do While the Run is Being Processed
The EVOLIS system has been designed as a "walk-away" system, which
means that if everything has been correctly planned it can operate
unattended.
Four exceptions, however, require the intervention of an operator during the
run:
• When tips need to be reloaded.
• When an unstable reagent needs to be loaded.
• When a reagent bottle needs to be refilled.
• When a system error or a pipetting error occurs.
If you wish to monitor the run process:
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‰
Click on Schedule in the Worklist Tree to follow the run on the Schedule
screen (see Section 2.4.7.2).
‰
Check the Active event log (see Section 2.4.7.6) to see if the different
steps are correctly executed.
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While the run is being processed DO NOT interfere in any way with the
process unless it is requested by the software.
For the emergency stop procedure, see Section 2.7.6.
On removing sample or reagent racks before the end of a run, see
Section 2.9.2.
On reloading patient samples or test plates, refer to Section 3.2
(Continuous Loading).
1) Reloading tips
If tip reloading is going to be required in the course of a worklist:
‰
At the bottom of the Schedule display (from the Worklist window, click
on Schedule in the Worklist Tree to view the Schedule), the system
displays the following indication: "Operator intervention required in X
minutes".
‰
A message on the screen and an acoustic signal will warn the operator
when it is time to get ready to reload.
‰
The <Load Tips> button on the toolbar is then enabled.
‰
Click on that button and reload the tips as described in Section 2.5.5.1.
Having to reload tips during a run can in most cases be avoided by selecting
the correct tip management options (see Section 2.5.5.2).
2) Loading an unstable reagent
If a specific reagent needs to be prepared after the run has been started, the
software will warn you in advance and direct you to load it as described in
Section 2.5.3.3.
3) Refilling a reagent bottle
Refilling a reagent bottle during a run should remain an answer to an
exceptional event (i.e. a situation where it was impossible to load the
required volume before the beginning of the run)! Otherwise, it is
always recommended to load a sufficient volume of each reagent
before starting the run.
If, during the run, the system detects that there is not enough reagent left in
a bottle to perform the programmed pipetting operation, an error message is
displayed stating which reagent is required and in which position. The
pipettor is paused above the reagent bottle that is insufficiently filled and the
LED at the back of the rack containing this bottle lights up.
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The error message includes the following buttons.
<Refill Bottle>
If you click this button, the Load dialog box is displayed, showing exactly
where the bottle to refill is located. Open the door of the sample and reagent
unit, move out the respective reagent rack, refill the respective reagent
bottle and insert the rack again. Do not remove or change the position of
any other reagent bottle (even if it is no longer needed)!
Click <OK> to close the Load dialog box. The system checks that all
required reagents have been correctly reloaded and retries the level
detection in the refilled bottle before resuming the run.
If some reagent bottles have been moved and incorrectly reloaded, another
error message is displayed and you need to reload the rack with all bottles
in their correct (initial) positions.
If the system was unable to read the barcode on a refilled / reloaded bottle,
the corresponding reagent is moved to the Unallocated resources corner
of the Load dialog box and you can allocate it manually.
<Retry>
<Abort Plate>
If you click this button, the system retries the same aspirate operation.
If you click this button, the system aborts the processing of the whole plate,
i.e. even the wells dispensed before the interruption are not further
processed.
2.7.5 System / Pipetting Errors
The system automatically pauses the run when system errors are detected.
Check the error message list in Section 5.
Depending on the kind of error detected the system will either display a
specific error message, describing the problem, or open the System
Paused dialog box and describe the problem detected in the status bar.
When specific pipetting errors occur, the system can also pause the run and
request the intervention of an operator.
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2.7.5.1 The System Paused Dialog Box
This dialog box is displayed either when a system error occurs (see above)
or if you click the <Stop> button in the toolbar (see Section 2.7.6).
Figure 87: System Paused dialog box
Plates
<Resume>
Shows the plates that have yet to be processed. Plates that have not yet
been completely processed are displayed as well.
Continue the run.
<Abort Plate(s)>
In the Plates list, select the plate(s) that you do not want to process any
more. Then click on this button to delete them from the worklist. You can
then continue the run with the remaining plates only.
<Abort All Plates>
The run is over. None of the plates listed in the Plates list will be
processed any more.
When you click the <Abort Plate(s)> or the <Abort All Plates> button,
the system will take some time to respond because it has to
communicate with the instrument to alter all the processing
information that has been downloaded to the instrument at the start of
the run.
2.7.5.2 Consequences of a System Pause
If the system is paused and you open the system cover, all the patient
samples which had not yet been pipetted when you open the cover will be
flagged in the results (CovOp flag) and the results for these samples will not
be calculated (see Section 2.8.2) even if you later resume the run and if
these samples are normally processed.
If the system is paused and you remove some sample or reagent racks
before their processing is completed, see Section 2.9.2.
If the system is paused but you resume the run without opening the
system cover and without removing any racks, the processing continues
normally (for all non-aborted plates).
The pause duration is mentioned in the Title Block section of the Result
Report. These results should be closely examined by a biologist who will
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validate them or not, depending on why the system was paused and for how
long, and on whether the samples may have been tampered with.
The Event Log lets you know at which stage of the process a pause
occurred. Taking into account the results obtained on the control wells
and/or on the standards and referring to the kit insert may also be helpful in
assessing the potential impact of the pause on the analysis.
2.7.5.3 Pipetting Errors (Manual pipetting)
Depending on what has been defined in the assay (see Section 3.12.3.3.1),
when pipetting errors (insufficient liquid, clot, pipettor hardware error…)
occur, the system will either:
• Raise alarm and stop. In this case, a specific error message is
displayed on the screen explaining the problem and what the operator
can do (e.g. Abort, Retry, Continue…).
• Log and continue. In this case, the error is documented (log and flag)
but the run continues without any operator intervention.
• or order the operator to Manually pipette at end of step (see below).
Whatever the case, the pipetting error is entered in the Event log and the
affected samples / controls are flagged in the Combined Report (see Section
2.8.2).
Manual Pipetting
When manual pipetting is required, the system displays the following
message indicating precisely what to pipette and where.
Figure 88: Manual pipetting
If the manual pipetting needs to be done into a test plate, the appropriate
plate is automatically moved to its load / unload position next to the door of
the plate loading compartment.
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The instrument is unlocked and you can access other resources (dilution
plates, sample racks…) as required to perform the manual pipetting.
If you need to pull out racks, please make sure to put them back
exactly in the same position!
Make sure everything is reloaded before clicking <OK> in the above
message.
2.7.6 Emergency Stop/Canceling a Run
If you need to stop the processing immediately, what you can do is:
‰
Open the door of the sample and reagent unit. This will automatically
stop the pipettor.
‰
In the software, click on the <Stop> button in the toolbar. This will open
the System Paused dialog box (see Section 2.7.5.1) and unlock the
instrument (audible click) so that you can open the various drawers or
open the cover flap and access the upper work area (in case of liquid
overflow, see Section 4.4.2).
‰
If the problem can be corrected, you can choose to continue the
processing by clicking the <Resume> button of the System Paused
dialog box.
‰
If the problem cannot be corrected rapidly, you can choose to abort the
processing of one plate (highlight the plate and click the <Abort
Plate(s)> button) or to cancel the run altogether by clicking <Abort All
Plates>.
2.7.7 Emergency Test Plate Removal
If you notice a serious problem on one plate while the run is being
processed, you can use a special procedure to remove this plate from the
instrument.
This is an emergency procedure only. It should not be used on a standard
basis. Removing the plate may affect the results.
To remove the plate:
‰
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From the Worklist window, select System Utilities in the Utilities menu.
The System Utilities dialog box is displayed.
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Figure 89: System Utilities dialog box
‰
In the System Control field, click the <Pause> button.
‰
In the Move Plate field, use the two drop-down lists to specify how to
move the plate.
‰
In the From field, select the present location (washer, colorimeter,
incubator, pipetting area...) of the plate you want to remove from the
system.
‰
In the To field, select Load/Unload so that the plate transport unit brings
the plate to its unloading position, next to the door of the plate loading
compartment.
‰
Click the <Move> button.
‰
Open the door of the plate loading compartment and remove the plate.
‰
In the System Control field, click the <Resume> button.
‰
Close the System Utilities dialog box with the <Close> button.
If you are able to correct the problem rapidly enough and you think it is worth
reloading this plate and processing it further:
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‰
From the Worklist window, select System Utilities in the Utilities menu.
The System Utilities dialog box is displayed.
‰
In the System Control field, click the <Pause> button.
‰
Open the door of the plate loading compartment and place the plate (in
its carrier) on the transport unit.
‰
In the From field, select Load/Unload.
‰
In the To field, select the module where the transport unit should move
the plate to resume its processing (if you did not close the System
Utilities dialog box after unloading the plate, the From and To fields
should already be correctly set - by default, the system reverses the
locations selected when unloading the plate).
‰
Click the <Move> button.
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‰
Click the <Resume> button and then the <Close> button.
2.7.8 Partial Processing / Recall Plate Map
1) Partial processing
It is possible to use the EVOLIS system to process only some steps of an
assay.
To do this:
‰
Open the desired assay file. Select the File | Open menu item.
‰
In the Open dialog box, select the (*.asy) assay file and click the
<Open> button. (If it is a password protected assay, click the <Don't
Know Password> button.) This opens the Assay window.
‰
In the Assay Tree, click on the desired step with the right mouse button
(or select the desired step and open the Edit menu).
Figure 90: Execute current / remaining steps
‰
Click on Execute Current Step if you want to process only the step you
had selected in the Assay Tree, or on Execute Remaining Steps if you
want to process that step and the following steps until the end of the
assay.
‰
Follow the directions displayed by the software.
These will depend on the step you have selected, on whether a worklist for
that assay already exists and on which required resources are already
present on the instrument.
The Execute Current Step function allows you to use just one of the
modules of the EVOLIS instrument (typically, the washer or the reader).
The Execute Remaining Steps function can allow you to complete the
processing of a plate if its original processing was interrupted for some
reason or other (e.g. if you or another user had decided to abort it or after a
system crash or a power cut...).
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Note however, that if you reload a plate after a crash using only the
procedure described above, the system does not keep track of the
sample locations on the plate. If you want the system to complete the
processing of the plate while retaining the initial sample IDs and run
processing data, you have to recall the initial plate map as described
below.
2) Recall plate map
To restart the processing after an interruption while retaining the initial
sample IDs and run processing data:
‰
Review the current Event log to determine precisely at what stage the
plate processing was interrupted.
‰
Select the File | Open menu item and open the (*.asy) assay file
corresponding to the test processing that was interrupted (do not try to
go back to the worklist file!).
‰
If it is a password protected assay, click the <Don't Know Password>
button.
‰
In the Assay Tree, right-click the step from which you want to resume
the processing of the plate.
If the processing was interrupted during an incubation step, please
read the Warning section below first!
‰
In the context menu, click on Execute Remaining Steps. The Set-up
Panel dialog box opens automatically with a "new" plate and the assay
you selected.
Figure 91: Recall plate map
‰
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Click the <Load Plate Map…> button. This opens the following dialog
box.
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Figure 92: Select plate and assay
‰
Select the Plate ID of the plate that was interrupted and the relevant
assay (see also Warning section below), then click <OK>. The recalled
plate map is automatically displayed.
Figure 93: Recalled plate map
‰
Click <OK> and follow the directions displayed by the software.
In the result report, the following warning will be included in the Title Block
section:
"WARNING! Results obtained from a recalled plate map".
Note that any flags assigned during the first part of the run (typically
flags for wells that could not be correctly dispensed) are NOT retrieved
when the plate data is recalled! If you use this function, it is therefore
essential that you examine closely the Event Log entries from the start
of the run to the moment when it was interrupted.
3) Important warnings
The "recall plate map" function is provided as a way to allow users to "save"
a plate when an exceptional event occurred during the processing.
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It is not, however, a very easy function to use.
• It requires a very good understanding of the Event log and of the way
the EVOLIS system operates. For example, if the processing of a plate
was interrupted half-way through an incubation step, it may be
necessary to edit the original assay (using the "Open" file) in order to
shorten the incubation step from which to resume the processing.
• It requires a very rigorous approach to avoid any mix-up in case several
plates were interrupted at the same time.
• It requires a precise knowledge of the tests involved. It is not worth
"saving" a plate when the delay already incurred means that there is little
chance that the results can be correctly evaluated.
This is why, whenever the Result Report includes this warning line
("WARNING! Results obtained from a recalled plate map") it is the
biologist's or lab supervisor's responsibility to check and validate the
results for that plate.
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2.8 End of Run/Result Display
On EVOLIS, it is not necessary to wait for the entire processing to be
finished to view the results. As soon as the processing of one test plate is
finished, the system generates the result file for this plate.
The system generates one result file per plate (not per worklist or per
assay). When several assays have been processed on the same plate,
see Section 3.1.7.
Figure 94: Display of test results
On the left-hand side of the screen you see the Result Tree with the report
sections. On the right-hand side is the Result Report.
Click on the plus (+) sign next to the folder to view the contents of the folder.
Clicking on a section in the Result Tree takes you directly to the respective
part of the Result Report. You can also scroll through the Result Report.
2.8.1 Structure of the Result Report
The exact structure of the Result Report (and printout) depends on what has
been specified for that particular assay when it was defined (see Section
3.12.3.5.1).
A description of each section of the Result Tree is as follows:
Title Block
The Title Block section identifies the test that has been performed. It
provides information on:
• The Plate ID.
• The person responsible for running the test.
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•
•
•
The assay used.
The date and time of the test performance.
Certain default settings such as the upper cut-off and the wavelength as
well as the reference wavelength of the photometric measurement.
Important error messages that come up in the course of processing
the worklist are also displayed here.
Laboratory Details
This section provides information on the laboratory where the test has been
performed.
The information displayed (e.g. name, address) reflects the data that has
been entered in the Laboratory tab of the Options dialog box (see Section
1.2.6.1).
Lot Specific Values
This section shows the reagent lot tracking information.
If the reagent lot tracking function was disabled, the information viewed here
is limited to the information entered in the Lot Specific Values dialog box
(see Section 2.4.6.1).
If the reagent lot tracking function was used, see Section 3.5.4 for details.
Incubation Results
This section shows the incubation parameters. If incubation problems
occurred during the run, this is shown directly in the Title block part of the
report.
Reader
This section shows the OD values read by the photometer.
Validation Criteria
The data displayed in this section indicate if the control values of the test
meet the defaulted criteria.
If the values of the control wells are within the limits specified by the formula
in this field, the test is considered valid and can therefore be evaluated. The
word "PASSED" is displayed next to each criteria.
If one of the criteria failed, the test will not be evaluated. In this case, the
word "FAILED" is displayed next to each criteria.
Quantitative Results
This section shows the graph which is created with the standards defined in
the assay (see Section 3.12.3.4.5).
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Qualitative Results
This section provides information regarding the cut-off value of the test. The
parameters and terms used are set during assay definition (for details, see
Section 3.12.3.4.4).
In Bio-Rad assays, three options are available:
REACTIVE
NEG
???
Reactive result.
Negative result.
Result in the gray range.
REACTIVE indicates a positive result on this test. However, in some
countries, a result is deemed positive only after more than one test. In this
case, samples with a first reactive result should be re-tested (see Section
3.7).
Spreadsheet Results
This section shows the results calculated according to the rules specified in
the assay but on the basis of reference values entered by the user instead of
values read by the photometer (see Section 3.12.3.4.6).
The data reduction of an assay can use up to four spreadsheet settings.
Each individual result of the four spreadsheet settings can be included in the
Result Report.
Events
This section displays error messages as well as messages about user
interaction taken from the Active event log (see Section 2.4.7.6).
Combined Report
The Combined report is an important part of the Result Report because it
gives a view of the results per patient sample (Patient ID); see Section 2.8.2.
Verify Dispense
If one or more Dispense verification steps were included in the assay
processed on the plate, the Result Report includes a corresponding number
of Verify Dispense sections. In these, you can check if some wells have not
been correctly pipetted/dispensed into.
In any section, one or more wildcard signs, (*) or (*****) generally
indicate that no value could be read (e.g. if you are using the system in
Demo Mode or if some wells were inadequately dispensed...) or that no
result could be calculated/evaluated (e.g. if the values read were not
with the set validation criteria).
2.8.2 Result Interpretation
Accurate result interpretation depends on the assay that was processed in
the test run. Only a general outline is given here.
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Per Plate
The first part of the Result Report (all sections except the Combined Report)
gives you a global view of the test run per plate. You can trace who the
operator was, what reagents and batches were used, you can check if the
incubation steps were correctly carried out, you can detect any discrepancy
in the OD values (e.g. according to the locations of the wells on the plate),
you can check if controls met the validation criteria, if some wells were
removed due to bad pipetting, etc.
Make sure to note any WARNING! line(s) in the Title Block section. If your
Result Report includes an Events section, check the red lines to see if any
critical event occurred during the run.
Per Patient
The Combined Report, on the other hand, gives you the results per Patient
ID. The precise data fields included in the Combined Report depend on what
has been specified for each assay (see Section 3.12.3.5.2). The order in
which patient samples are listed in the Combined Report depends on the
option selected in the Patient Editor dialog box (see Section 2.3.4).
Generally, for each Patient ID, the Combined Report lists: the Layout Label
(e.g. PC, NC or T), the Well Location (e.g. E 5), the OD Value, the
Quantitative Value (Ratio), the Qualitative Value (e.g. REACTIVE, NEG or
???) and the Flag (if any).
Flags
Flagged results are not necessarily wrong results. A flag indicates that
something happened during the run that may have affected the result on this
patient sample.
The software uses 13 general flags and 6 pressure monitoring flags to give
an indication of the type of problem encountered (a flag table is included in
Appendix A 7). When results in the Combined Report are displayed in Matrix
format, if a sample has multiple flags (e.g. ManID and NoLiq), it will be
signaled only as "flagged" (displayed in red) instead of a list of the actual
flags.
SplRem
Sample rack removed. This flag is used if a sample rack has been
removed before it had been completely pipetted (see Section 2.9.2 under
1)). No results are calculated for samples that had not yet been pipetted at
that stage.
RgtRem
Reagent rack removed. This flag is used if a reagent rack has been
removed during processing (see Section 2.9.2 under 2)). This does not
affect result calculation (the results are calculated).
CovOp
Cover open. This flag is used if the instrument cover has been opened
during a run (see Sections 2.7.1 and 2.7.5.2). No results are calculated for
samples that had not yet been pipetted at that stage.
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ManID
Manual ID. This flag is used if a sample ID has been manually assigned
(see Section 2.3.2.1). This does not affect result calculation (the results are
calculated).
If a manually assigned sample is used for several assays (through direct
pipetting or through pipetting of the same predilution made from this
sample), the ManID flag is included in the Result Report for each assay.
NoLiq
No liquid detected. Results for flagged samples are not calculated.
InsLiq
Insufficient liquid detected. Results for flagged samples are not calculated.
Clot
PipErr
ManPip
Clot detected. Results for flagged samples are not calculated.
Pipettor hardware error. Results for flagged samples are not calculated.
Manually pipetted resource. This flag is used when controls or samples
have been manually pipetted into the test plate (see Section 3.12.3.3.1).
This does not affect result calculation (the results are calculated).
VCFail
Validation criteria failure. Results for flagged samples are not calculated.
VDFail
Verify dispense failure. This flag is used when a reagent / sample / control
has not been correctly dispensed into a well (see Section 3.12.3.3.5).
Results for flagged samples are not calculated.
IncKo
Incubation overrun. This flag is used when there is a discrepancy between
the incubation temperature / time actually observed during a run and the
incubation temperature / time defined in the assay (see Section 3.12.3.3.3).
Results for all samples on an incorrectly incubated plate are not calculated.
REAG EXP
Reagent Expired. This flag is used when a reagent was used after its
expiry date (see Section 3.5.4). When an expired reagent is loaded and
identified, the user is warned that the expiry date has been
reached/exceeded but can choose to override the warning and still use the
reagent for the run.
This does not affect result calculation (the results are calculated).
P_max_high,
P_min_low,
P_stop_high,
P_static_high,
P_static_low,
P_mean_low
Pressure monitoring flags. These flags can be reported only if the pressure
monitoring function is enabled (see Section 3.9.4).
flagged
(displayed in red) This flag replaces multiple flags when results in the
Combined Report are displayed in Matrix format.
When results are flagged but calculated, it is the biologist's responsibility to
check the Result Report and the Active event log, to find out precisely why a
particular result was flagged. Only then will it be possible to determine
whether the result can be accepted as valid or if the patient sample must be
re-tested.
When results are flagged and not calculated, it is possible, in some cases, to
force the system to calculate the results in spite of the problem that
occurred. This is done via the Edit | Outliers function (see Section 2.8.3.1).
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2.8.3 Editing / Recalculating the Results
If you think the results are not entirely satisfactory, the EVOLIS software
allows you to edit and/or recalculate them before saving, printing or
exporting them.
To edit the results, select one of the following items in the Edit menu: Edit |
Outliers, Edit | Parameters or Edit | Assays. These items are enabled only
when a result file is open.
2.8.3.1 Editing Outliers
The Edit | Outliers function allows you to manually remove from the results
some OD values which you think are not consistent with the test (e.g. if
some samples were not properly treated or processed) and should not be
taken into account when calculating the results.
Figure 95: Editing outliers
You cannot edit the values but only remove them. A removed value is
displayed crossed out. Conversely, if a value was removed from the
calculation automatically by the software (for example, because of bad
pipetting or dispense verification errors), you can choose to restore it.
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‰
To remove (or restore) a value, select it with the mouse and then click
the <Remove> (or <Restore>) button. You can select several values by
moving your mouse pointer over them while keeping your mouse button
pressed. You can select all the values by clicking the <Select All>
button.
‰
Click <OK>. The program returns to the result report. Removed (or
restored) wells are listed at the bottom of the Title Block section.
‰
Select the View | Recalculate menu item to recalculate the results
taking into account the changes you made. The new result report
includes the following comment: "WARNING! Results have not been
processed using the original assay."
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If several assays were processed on one plate, you can view the value for
each assay by using the Assay Protocol drop-down list. The Reading field
shows the filter(s) used for the reading.
1) If the Edit | Outliers menu item is not active, this means that you
belong to a user group not authorized to "Manually remove outliers"
(on access control and user groups, see Section 1.2.7.2).
2) Even if you belong to a user group authorized to edit outliers, the
Log On dialog box (see Section 1.2.2.1) will be displayed again and you
will have to log yourself on again before you can access the dialog
box.
Recalculating flagged results
The <Restore> button of the Edit | Outliers function can be used to force
the system to calculate results for flagged samples that have automatically
been removed from result calculation (e. g. if you opened the instrument
cover during a run but still want to know the results for those samples
pipetted after you opened / closed the cover).
This possibility should only be used for samples with the following
flags: SplRem (Sample rack removed), CovOp (Cover open), VDFail
(Verify dispense failure) or IncKo (Incubation overrun).
Results that have been eliminated because of NoLiq (No liquid
detected), InsLiq (Insufficient liquid), Clot (Clot detected), PipErr
(Pipettor hardware error), VCFail (Validation criteria failure) cannot be
recalculated!
To do so:
‰
In the original Result Report, display the Combined Report part.
‰
Check the flagged samples.
‰
If you want to recalculate some of these flagged samples, note their
locations on the plate (layout labels).
‰
Open the Outliers dialog box and restore the corresponding wells
(layout labels) as described above.
‰
Recalculate the Result Report as described above.
‰
In the recalculated Result Report, the selected flagged results are now
calculated but the original flags remain. It is the biologist's
responsibility to check and validate such recalculated results.
In general, when a result is exported to the LIS, in case a second
discordant result is re-exported, due to the use of the Restore or
Remove outliers function, the user shall inform the laboratory’s IT
manager who shall undertake any action required by the situation,
because there is a risk that the LIS only takes in account the first
transfer.
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2.8.3.2 Changing the lot specific parameters
The Edit | Parameters function opens the Lot Specific Values dialog box
(see Section 2.4.6.1), showing the data of the reagents used for each assay.
This lets you correct possibly incomplete lot data or edit some parameters.
When you click <OK>, the results are recalculated taking into account the
changes you made. The new result report includes the following comment:
"WARNING! Results have not been processed using the original
assay."
2.8.3.3 Recalculation with another assay
The Edit | Assays menu item opens the following dialog box.
Figure 96: Change Assay Protocol dialog box
This function allows you to recalculate the results with another assay
protocol while retaining the original OD values of your plate. This can be
useful, for instance, if you have several versions of the same assay, all with
the same processing steps but with different evaluation steps or validation
criteria.
‰
Click the <Change> button to open the Open dialog box where you can
select a different assay protocol file and click the <Open> button..
‰
When you click the <Close> button in the Change Assay Protocol
dialog box, the results are recalculated. The new result report includes
the following comment: "WARNING! Results have not been
processed using the original assay."
2.8.3.4 Recalculating the results
A recalculation of the results is performed automatically each time you use
some of the editing functions described above.
But the EVOLIS software also allows you recalculate results independently
from the above editing operations.
To do so:
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‰
Select the View | Recalculate menu item or press the F9 key.
This function is useful if you are editing or defining an assay. If you change
the assay evaluation parameters and recalculate, the data reduction of the
raw data will be done using the new parameters (you need to save your
assay changes before recalculating).
2.8.4 Saving the Result Report
The Result Report is automatically saved to a result file. By default, this
result file is saved in the C:\BioRad\Resources\Result directory. By default,
the name of the result file is the name of the Plate ID (see Section 2.6.1),
plus a (*.res) extension.
To save the result file under a specific name:
‰
Select the File | Save Results As menu item. This opens the Save As
dialog box.
‰
Enter a name for the file in the File Name field.
‰
Click the <Save> button.
To open a formerly saved result file:
‰
Select the File | Open menu item and then the file type Result Files
(*.res). The result files are displayed in the Open dialog box.
‰
Select the desired file and click <Open>. The file is loaded and the
calculation is performed again before it is displayed.
File name in case of recalculated / changed results
If the results are changed for any reason and the file is saved again then the
software creates a backup of the original result file before saving the
changes. The backup shall have the same basic filename but with a revision
index appended. The revision index shall start at “0” and shall automatically
increment whenever a new file is saved.
For example, if “Plate 105110700.res” is changed and saved again the
original result file shall be backed up as “Plate 1051107000.res”.
2.8.5 Printing the Result Report
To print the complete Result Report:
‰
Make sure the complete Report is displayed in the right-hand side of the
screen (if it is not, select the top folder in the Result Tree to display the
entire Report).
‰
Select Print in the File menu or click the <Print> button.
To print only one section of the Report:
‰
158
In the Result Tree, select the desired section. It is then displayed in the
right-hand side of the screen.
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‰
Select Print in the File menu or click the <Print> button.
If you had checked the "Automatically print result" item in the Worklist
Options dialog box (see Section 2.4.8), the Result Report will be
automatically printed each time it is generated.
2.8.6 Exporting the Results
The EVOLIS system can export test results to a host computer either
through an ASTM link or as a (*.txt) file.
The export of test results can be ordered individually by the operator once a
result report is displayed on the screen. Each time you close a result report,
the system also prompts you to export the results.
For more information on result exports, see Section 3.13.1.4. On the format,
structure and contents of (*.txt) export files, see Section 3.12.3.5.3. On
ASTM export of test results, see Section 3.13.2.6.2.
It is possible to restrict the right of some users to export test results. In that
case, the intervention of a supervisor is needed as described in Section
1.2.7.3.
2.8.7 Comparing Current and Former Results
2.8.7.1 Creating a Patient Result Report
A patient-oriented result report can be created. This allows you to view the
results of tests performed for one (or more) given patient(s) over a period of
time. Thus you can compare the current results with results obtained in
earlier tests.
To create a Patient Results Report:
‰
In the File menu, select New. This opens the New dialog box.
‰
In the New dialog box, select Patient Results Report and click <OK>.
This opens the Patient Results dialog box.
Figure 97: Patient Results dialog box
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In this dialog box, you can define which results you want to include in the
Patient Result Report:
‰
In the Assays list, select the appropriate tests (use the CTRL key for
multiple selection).
‰
If you click <OK> directly, you will obtain a default Patient Result Report,
a report of all Patient IDs tested with the assays you selected and
generally the result obtained.
Figure 98: Basic report
2.8.7.2 Editing the Patient Result Report
Now you can use two following functions to edit the report format so that it
includes exactly the information you need.
• Edit the report format. This allows you to insert new columns in the
report (e.g. display flags, display Plate IDs or well locations, display
qualitative mean results in case of retests, etc.).
• Use the filter options. This allows you to focus on specific information
(e.g. display all tests for one patient, display all patients tested with a
specific kit lot, display all tests done by a specific operator, etc.).
To edit the report format:
‰
160
Select the Edit | Report Format menu item. This opens the Patient
Results Report dialog box.
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Figure 99: Patient Results Report dialog box
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‰
In the Available Fields list, select the items corresponding to the
columns that you want to add in the Patient Result Report. For example,
if you want the report to show the date of the test and flags returned (if
any), select Date and Flag (use the CTRL key for multiple selection),
then click the arrow button in the center of the dialog box to add them to
the Selected Fields list.
‰
By default, new items at the end of the list. Use the <Move Up> / <Move
Down> buttons if you want to change the list order. For example, if you
want the Date and Flag columns to be included after the Assay column
but before the OD value column (Reader mean item).
‰
In the Column Title field, you can change the name under which this
item is displayed the actual report. For example, you can choose to
replace "Reader mean" by "OD Value" as Column Title. You can also
use this field to change the language of the column title in the Report
(default is English).
‰
Adjust the Column Width if necessary.
‰
Repeat for other items if you want to add more information.
‰
When you click <OK> to save the new settings, the Patient Result
Report is automatically updated to show the additional information.
These settings are saved for later reports.
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Figure 100: Edit report format
To edit the filter options:
‰
If the Patient Result Report is displayed on the screen select the Edit |
Parameters menu item, then click <New…>. If you are still in the
Patient Results dialog box, just click <New…>. This opens the Filter
dialog box. The drop-down list in this dialog box allows you to configure
the contents of the Patient Result Report in a lot of different ways.
Figure 101: Edit report format
162
‰
Select an item from the Filter On drop-down list, then specify it using the
Containing or Between / and fields. For example, if you want to show
all tests performed by a specific operator, select "Operator" from the
drop-down list and enter the user name in the Containing field. Click
<OK> to close the Filter dialog box.
‰
You can now either click <OK> to view the results of your
reconfiguration of the Patient Result Report or click <New…> again to
add a new filter. For example, if you want to know which samples have
been tested by the selected operator on a specific day, add a new filter,
select "Date" from the drop-down list and specify a date in the Between /
and fields.
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‰
When you click <OK> to close the Filter dialog box you can see that
both filters have been added to the Filter(s) field of the Patient Results
dialog box.
Figure 102: Filters in Patient Results dialog box
‰
When you click <OK> again in this dialog box, the contents of the
Patient Result Report will be updated to show only the data specified via
the filter options.
2.8.7.3 Using the Patient Result Report to Search the Result Database
The combination of the two functions (Edit Report Format and Edit
Parameters + Filter options) described in the above Section allows you to
conduct elaborate searches within the result database.
For example, you can:
• show all Plate IDs on which a specific Kit batch number was used,
• show all samples processed before a certain date,
• show all flagged samples on various plates with well locations,
• etc.
Of course, this only possible if the appropriate data type has been
recorded in the first place. For example, if you generally work on
EVOLIS without tracking kit lot data, you will not be able to use the Kit
batch number as a relevant filter option. Similarly, if you use only
Patient IDs and not Patient names in EVOLIS test orders, even if you
include a Patient name column in the Patient Result Report, this
column will remain empty.
2.8.7.4 Update in Case of Recalculated Results
Each time you open a Result file, it is recalculated but the original result in
the Result database is not overwritten.
If you display a Patient Result Report for a sample included in this Result
file, you will still have only one result, i.e. the original result.
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But if you:
• recalculate and export a Result Report, or
• recalculate and print a Result Report
the Patient Result Report will be updated to include the recalculated result
(whether it is identical or not).
The original result obtained for each patient will, however, not be overwritten
by the recalculated result. In the Patient Result Report, a new line will be
added for each patient and for the same assay for each export or each
printout.
If you edit the Report Format of the Patient Result Report to include an
Evaluated column, lines that were added as a result of a "recalculate and
export" or a "recalculate and print" operation are signaled by a "#" sign.
Figure 103: Update in Case of Recalculated Results
2.8.7.5 Print / Export the Patient Result Report
To print the Patient Result Report, select File | Print or click the <Print>
button.
To save the Patient Result Report as a (*.txt) file, select Edit | Export and
enter a file name. By default, the file is saved in the Export directory.
2.8.7.6 Summary View of the Patient Result Report
A Summary view of the Patient Result Report is also available (select the
View | Summary menu).
In the Summary view, the Report Format cannot be edited (Patient ID,
Patient name, Qual. mean for Assay 1, Qual. mean for Assay 2, etc.) but the
filter options are active.
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2.9 Unloading
2.9.1 Test Plates
a) At the end of the run – Basic procedure
By default, fully processed plates ("finished plates") are stored on the
instrument: up to 4 plates in the room-temperature incubators plus up to 3
plates on the plate pipetting areas.
Then, once the processing of the complete worklist is finished, the system
prompts you to start unloading the plates by displaying the following
message.
Figure 104: Remove Plate dialog box
To remove the test plate:
‰
The LD LED of the plate loading compartment (on the instrument front
panel next to the right door) lights up green. Open the door of the plate
loading compartment (very right). The plate transport unit with the test
plate to be unloaded is already in a position directly next to the door of
the plate compartment.
‰
Remove the test plate with its holding frame and take the plate out of the
frame.
‰
Click <OK> to confirm removal in the software.
‰
Repeat for each plate.
‰
When the last plate has been unloaded, close the door of the plate
loading compartment (audible click).
b) Before the end of the run – Fully processed plates
If some plates are already fully processed and you want to unload them
before waiting for the end of the run:
‰
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Select the Edit | Unload Finished Plates menu item. This opens the
Unload Plates dialog box.
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Figure 105: Unload finished plates
‰
In the list, select the plate or plates that you want to unload and click
<Unload Plate(s)> or simply click <Unload All> if you want to unload all
the plates listed. Only fully processed plates are shown in the list.
‰
The first plate to unload is brought to plate loading compartment and the
plate unload prompt is displayed.
Figure 106: Remove Plate dialog box
‰
Open the door of the plate loading compartment and unload the plates
(one by one) as described above in the basic procedure.
Choosing to unload finished plates before the end of the run can be useful
for example if you want to visualize a plate in which some wells have been
incorrectly pipetted or if you want to further process a plate manually or on
another instrument. You do not need to use this procedure if you intend to
reload additional samples and plates using the "Continuous Loading"
feature. In this case, the system automatically lets you remove fully
processed plates before allowing you to reload new plates (see Section
3.2.5).
c) Before the end of the run – Unfinished plates
The only way to remove plates that are not fully processed is by using the
Emergency test plate removal procedure (see Section 2.7.7).
d) Next day removal
There is no set time to remove the plates. Even though the system prompts
the operator to remove the plates once the run is finished, it is not necessary
to do so immediately.
If the system is operating unattended it is possible to leave up to 7 finished
plates on the instrument. If a test run is performed overnight, all the test
plates can be unloaded the next morning.
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2.9.2 Sample Racks and Reagent Racks
1) Sample racks
At the end of the run
To remove/unload a rack at the end of a run:
‰
Open the door of the sample and reagent unit (second door from the
left).
‰
Pull out the rack(s) designated by a flashing red LED.
Before the end of the run
Technically, it is possible to remove a rack from the instrument even while
the run is still being processed. This is possible because the door of the
sample and reagent unit is the only part of the instrument which remains
unlocked during the processing (see Section 2.7.1). However, opening this
door immediately stops the pipettor (it will start again when you close the
door), which interferes with the way the run is processed.
Two cases have to be considered: either the rack which you want to remove
is fully processed or it is not.
A rack is fully processed when all the pipetting operations out of that rack
has been completed (i.e. that rack will not be needed for the rest of the run).
You know that a rack is fully processed when the corresponding red LED on
the far side of the sample and reagent unit starts flashing. Removing fully
processed racks is necessary for instance if you want to reload new samples
(see Section 3.2.2 on Continuous Loading).
If the rack is fully processed (and the red LED is flashing):
‰
Open the door of the sample and reagent unit (second door from the
left). Wait for the pipettor to stop.
‰
Pull out the rack(s) designated by a flashing red LED.
‰
Close the door of the sample and reagent unit as soon as you have
removed the rack(s). Do not leave that door open even if you intend to
reload new racks. The pipettor remains stopped as long as the door is
open.
If the rack is not yet fully processed (the corresponding red LED is not
flashing) you should NOT remove it. If there is a specific problem and you
absolutely have to remove it, do so as described above (except that no red
LED is flashing).
Note, however, that if you remove and reload a sample rack that was
not fully processed, any sample that will be pipetted from that rack
after you have removed and reloaded it will be flagged SplRem and
that the respective results will not be calculated (see Section 2.8.2).
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2) Reagent racks
Basically, the rules that apply to reagent racks are equivalent to those
described for sample racks, i.e.:
• Technically, it is always possible to remove a reagent rack, even while
the run is being performed.
• You should not remove a reagent rack before it is fully processed (i.e.
the corresponding red LED is flashing) unless you absolutely need to do
so or are prompted to do so by the software (see below).
However, the following differences apply:
• If you remove a reagent rack before it is fully processed, all the samples
which had not yet been pipetted when the rack was removed will be
flagged RegtRem but the corresponding results will still be
calculated.
• If you need to load an unstable reagent, the system will direct you to do
so as described in Section 2.5.3.3 and the samples will not be flagged.
Unloading a reagent rack (during or at the end of a run) is done as described
above for sample racks.
2.9.3 Tip Racks and Dilution Plates
The drawer in which the dilution plates and tip racks are located is normally
locked during the whole run (it can be unlocked only for a short time when it
is necessary to reload tip racks, see Section 2.7.4 under 1)).
You will have to wait until the end of the run to unload dilution plates and tip
racks.
To remove them:
‰
Check that the DWR LED is on.
Open the left drawer.
‰
‰
Take dilution plate(s) or empty tip racks out of the respective holding
devices.
‰
Push drawer in again (audible click).
If you are using the "Re-use partial tip racks" option (see Section
2.4.8), remove tip racks only if they are completely empty. DO NOT
remove partially empty racks! The system monitors the number of tips
left and will include them in planning the next worklist.
2.9.4 Other Resources
Clean fluid and system liquid do not need to be emptied or unloaded after
each run. For wash buffers, follow the storage conditions in assay kit inserts.
For additional information, refer to the maintenance plan and procedures.
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2.9.5 Waste Disposal
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‰
Dispose of test plates, dilution plates and sample tubes in accordance
with legal regulations for biological hazardous waste.
‰
Visually check the contents of the tip ejection waste container. There is
no sensor for this container. If full or nearly full, replace as described in
Section 4.3.1.3.7.
‰
Check the liquid waste level in the liquid waste container. If full or nearly
full, empty and clean as described in Section 4.3.1.3.6.
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3. Advanced Features Guide
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3 Advanced Features Guide
This Part covers the following topics:
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Processing several assays per plate
Section 3.1
Continuous loading
Section 3.2
Processing externally dispensed plates
Section 3.3
Using the reagent database
Section 3.3
Kit lot tracking
Section 3.5
Archiving samples
Section 3.6
Retesting Samples
Section 3.7
Using external controls
Section 3.8
Pressure monitoring (APM)
Section 3.9
Customizing the system
Section 3.10
Upgrading the system
Section 3.11
Programming assays
Section 3.12
Connection to a host computer
Section 3.13
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3.1 Processing Several Assays per Plate
Combining several assays on the same plate is a way to save time (and test
plates) if you intend to test several different assays on a fairly small number
of patients (e.g. 8 assays on 20 patients). It is also done on a regular basis
for some tests, e.g. Toxo IgG and Toxo IgM.
The EVOLIS system allows you to combine several assays on the same test
plate but only if the following conditions are met.
Assays can be combined on the same plate only if:
• They have a compatible assay structure, i.e. compatible parameters for
incubation steps, shake steps, conditional delay (if any), reading
parameters, etc.
and
• They belong to the same assay group.
3.1.1 Compatible Assay Structure / Parameters
To check whether the assays you intend to combine on the same plate have
compatible assay structures, you can either open these assays and review
their respective parameters as described in Section 2.3.1.1 or use the
system to check their compatibility automatically as described below.
To check if some assays can be combined on the same plate:
‰
Create a worklist combining these assays on one plate.
Figure 107: Defining several assays on the same test plate
172
‰
Click <OK> to close the Set-up Panel dialog box. The Lot Specific
Values dialog box is displayed.
‰
Click <OK> again to close the Lot Specific Values dialog box. The
system then performs an internal verification of the worklist you have
defined (see Section 2.4.6).
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If the assays you have tried to combine on the same plate are compatible,
the Worklist window is displayed normally (plate status is Not Loaded).
If the assays you have tried to combine are not compatible, a warning
message such as the one below is displayed telling you why these assays
cannot be combined on the same plate.
Figure 108: Warning message
If you click <OK>, Error will appear as the status of the respective plate in
the Worklist window. To correct the worklist definition and assign each assay
to a different plate, go back to the Set-Up Panel dialog box as described in
Section 2.4.6.2.
3.1.2 Assay Combination Groups
Assay combination groups are intended for assays that are commonly
processed together. Assigning assays to the same assay group serves to
confirm to the system that these assays can be combined on the same plate.
Conversely, if assays belong to different combination groups, the system will
never allow them to be processed on the same plate (even if their
parameters are compatible).
To review which group an assay belongs to:
‰
Open this assay as described in Section 3.12.1.2.
‰
Check the "Combination group" information at the end of the assay
header information (first paragraph at the top of the page) as shown on
the example below.
Example
Bio-Rad PLATELIA ASPERGILLUS
Use with 1 plate (96 tests) kits, cat. no. 62797 (A3)
This protocol is an official Bio-Rad protocol.
Password protected.
Written by Bio-rad GIS.
Date created: mercredi 15 novembre 2000 15:59:42.
Last edited: lundi 13 décembre 2004 10:14:09.
Plate ID Check: *
Bio-Rad Flat Nunc 300ul indice3 plate type.
Maximum tolerable ambient temperature is 30,0°C.
Combination group: 20
Microplate lot tracking enabled.
By default, all assays which have not been assigned to a specific
combination group belong to the same group (group "0").
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To change the group an assay belongs to:
‰
Open the assay file. If it is a password protected assay (e.g. a Bio-Rad
assay), you need to use the "Open" version of that assay (see Section
3.12.2.3) and save it under a new name.
‰
Double-click on the Assay Header information to display the Assay
Protocol Header dialog box.
Assay group definition
Figure 109: Assay Protocol Header dialog box
‰
Enter a new group number in the Combination group field (digits only;
no letters, no spaces, no wildcards…).
‰
Click <OK> to close the dialog box.
‰
Save the assay.
3.1.3 Manual Worklist Definition
When several assays are to be combined on the same test plate, the manual
worklist definition process is similar to what has been described in Section
2.4.2 except that:
‰
In the Set-Up Panel dialog box, once you have clicked <Add Plate…>,
you have to repeat the <Add Assay…> and <Add Patient…> steps for
each assay that you wish to test on the same plate.
You have to check the Start Assay with a new strip item at the bottom
of the Plate Layout grid (for more information on strip management, see
below).
If you have combined several assays on one plate, you can change the
order in which these will be performed by using the <Move Up>/<Move
Down> buttons (in the Plate Tree, select the assay which you want to move
up or down). You will note that the assay sequence in the Plate Layout grid
on the right is changed accordingly.
‰
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1) If one of the assays you intend to combine requires the use of
unstable reagents, it is best to place it as the first assay on the plate.
2) Avoid combining assays with Plate wash mode and assays with
Strip wash mode on the same plate! This could result in a delayed final
aspiration including on the Plate wash mode assay.
3.1.4 Automatic Worklist Definition
If you import worklists / test orders from the LIS and you use barcoded
samples, as soon as you load new samples on the instrument, the system
automatically suggests a suitable worklist to process the samples you just
loaded (see Section 2.4.3). This also true when you reload samples in an
on-going worklist using the Continuous Loading procedure (see Section 3.2).
Under default settings, whenever a worklist is thus automatically generated
by the system, the system always tries to combine as many assays as
possible on each plate (provided, of course, that assay parameters are
compatible and that the assays belong to the same assay combination
group).
If you do not want to process several assays per plate:
‰
Select Edit | Panel Definition to go back to the Set-up Panel dialog box
and redefine the worklist on a one-assay-per-plate basis.
Note, however, that this redefinition applies to the current worklist
only. If you decide that there are some assays which you never want to
combine on the same plate (even though they have compatible
structures), you have to change their combination group as described
in Section 3.1.2 so that they belong to different groups.
3.1.5 Strip Management / Optimizing the Plate Layout
If you use coated microplates with removable strips (as is generally the case
with the microplates supplied in Bio-Rad kits), when combining several
assays on the same plate, you have to make sure that:
‰
In the software, each assay starts on a new strip.
‰
You rearrange the microplate you intend to load so that the strips
correspond exactly to what has been defined in the software.
New strip
The Set-up Panel dialog box includes a Start assay with a new strip
checkbox.
If you combine two assays on the same plate without checking this box, the
second assay starts immediately after the last well of the first assay as
shown below: Assay 2 starts in well B4, immediately after the last sample
well for Assay 1.
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Assay 1
Assay 2
Figure 110: New strip item disabled
If you enable the Start assay with a new strip checkbox, you can see that
Assay 2 now starts on Strip 5 only.
Assay 1
Assay 2
Figure 111: New strip item enabled
This is required if you use coated plates with removable strips. You can then
prepare your microplate accordingly.
1
A
Assay 1
Assay 2
No strip
(or blank strips)
Figure 112: Microplate preparation
Layout Optimization
However, starting each assay on a new strip means you may have unused
wells on a test plate, as in the example above where only one well is used
respectively on Strip 4 and Strip 8. This means that you will "loose" the
seven unused wells located on each of these strips. In that case, it may be
worth it to decide to test sample T21 (for each assay) in a later run.
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To do this:
‰
In the Plate Tree of the Set-up Panel dialog box, select the last sample
of Assay 1 and click <Delete>.
Figure 113: Optimizing the plate layout
‰
Then, select the last sample of Assay 2 and click <Delete>.
Assay 1
Assay 2
Figure 114: Optimized plate layout
You now have an optimized layout and you can prepare your microplate
accordingly.
1
A
Assay 1
Assay 2
No strip
(or blank strips)
Figure 115: Optimized microplate
3.1.6 Test Plate Scan
When combining several assays on the same plate, it is recommended that
you use non-barcoded plates. This is because there is a risk of error if the
barcode refers to one assay and the system processes several assays on
that plate.
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Even if your test plates are barcoded, avoid any problem by loading them as
if they were non-barcoded. In the Load Plate dialog box, click on <OK> and
not on <Scan> (see Section 2.6.3).
3.1.7 Results
If you process several assays on the same plate, the system will still
generate only one result file per plate. The results corresponding to each
assay will be displayed in this file one after the other, with the same order
that they had on the plate (i.e. full results for Assay 1, then full results for
Assay 2...).
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3.2 Continuous Loading
Continuous Loading is the process by which new patient samples and new
test plates are inserted into the instrument while the instrument is running a
worklist. The EVOLIS system allows this but only at certain times and under
specific conditions.
The main advantage of continuous loading is that it allows the user to test
more samples and/or to use more than 4 test plates in a single test run.
An absolute maximum of seven plates can be in the instrument at the
same time. If you want to process more than seven plates in the same
run, you will first have to unload completely processed plates (the
system will prompt you to do so).
3.2.1 Check Reloading Time(s)
The first thing to do if you intend to add new samples and new plates to an
already running worklist is to check when this will be possible.
Reloading sample racks can be done at any time as soon as a red LED
opposite an already loaded sample rack is flashing. But the actual reloading
process, in which the system recalculates the worklist and directs the
operator to load (and allocate) the other required resources and the test
plates, and unlocks the instrument accordingly, this can only be done when
the pipettor is not busy. The only time this is allowed is when all the plates
on the current worklist are incubating.
To check the reloading intervals:
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‰
In the Worklist window of the running worklist, click on the plus (+) sign
to unfold the Worklist Tree.
‰
Click on Schedule in the Worklist Tree.
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Figure 116: Plate Schedule showing reloading times
‰
In the Additional Plates line, the brown sections indicate the time
intervals when reloading will be possible. This line is displayed both in
the Module view and in the Plate schedule view.
The more complex your current worklist, the more restrictive the available
reloading intervals will be.
If the appropriate item has been checked in the Worklist Options dialog
box (see Section 2.4.8), an acoustic signal and a message on the
screen will also warn you when additional plates can be loaded.
3.2.2 Preparing and Loading the New Patient Samples
180
‰
Place your new samples in sample racks. If you are using barcoded
sample tubes, make sure the barcode labels face right so that they can
be scanned by the barcode reader when the rack is inserted.
‰
As soon as a red LED opposite a sample rack is flashing, you can open
the door of the sample and reagent unit, remove the respective rack (the
flashing red LED indicates that the pipetting is over for this rack) and
load the rack with your new samples.
‰
Repeat this step if you are loading more than one additional sample
rack.
‰
Close the door of the sample and reagent unit.
‰
The system will display the following dialog box. If the samples were
barcoded, the Patient IDs are already entered in the first column. If
samples were not barcoded or the barcodes could not be read, you have
to enter the Patient IDs manually.
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Figure 117: Patient Editor (column layout)
‰
Using the drop-down lists, select the appropriate assays and assign
them by checking the corresponding lines (for details on how to do this,
see Section 2.3.2.1).
‰
Click the <Close> button. If you reload more than one new sample rack,
the system will display the Patient Editor dialog box again for each
rack.
For this step, you do not need to wait until all the currently loaded plates are
incubating. Opening the door of the sample and reagent unit will
automatically stop the pipettor and let you remove/load the racks. Because it
stops the pipettor, it is important not to keep the door of the sample and
reagent unit open for too long. Therefore:
‰
Make sure all your sample racks are ready before you open the door.
‰
Operate rapidly.
‰
Close the door as soon as the loading is done.
3.2.3 Redefining the Worklist
Once you have loaded the additional sample racks and assigned assays in
the Patient Editor dialog boxes as described above, the system
automatically reschedules the current worklist to include the additional
plates.
If the additional samples you loaded correspond to samples included in test
orders downloaded from the LIS, assays are already assigned in the
successive Patient Editor dialog boxes and you just need to close these
dialog boxes by clicking the <Close> button.
You now need to confirm the automatically redefined worklist and specify the
reagent lots for the additional tests.
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To do so:
‰
Select The Edit | Panel Definition menu item. This opens the Set-up
Panel dialog box. In the left-hand side window, you can see the new
plates that have been automatically added to the worklist.
By default, when the systems reschedules the worklist to include the
additional samples you have loaded it systematically tries to combine
several assays on each plate (provided these assays have compatible
processing parameters).
‰
If you are satisfied with the automatically redefined worklist, click <OK>
to close the Set-up Panel dialog box. If not, edit the worklist and then
click <OK>. The Lot Specification dialog box is displayed for the first
additional plate.
‰
Identify the lot numbers and expiration data for all assay kits and assay
components for this plate and all additional plates and click <OK>.
Automatic rescheduling is available only from software version 1.60. If
you use an earlier software version, you need to redefine the worklist
manually. To do this, in the Set-up panel dialog box, you need to add
the additional plates manually.
3.2.4 Reloading other Resources
After you have clicked <OK> in the Lot Specific Values dialog box, the
system checks its current status.
1) If the system is currently going through an incubation phase (for all
plates)
Reloading is allowed, the worklist is paused and the following message is
displayed.
Figure 118: Worklist paused message
182
‰
Click <OK> to close this message.
‰
The Worklist window is displayed. If needed, you can review/print the
updated Reagent requirements' list (see Section 2.4.7.4).
‰
Click <Start>. The Load dialog box is displayed.
‰
Refill or add the resources (reagents, dilution plates, tip racks, wash
buffer) required for the additional processing as shown in the Load
dialog box.
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‰
Allocate them as if you were starting a new run (for details, refer to
Section 2.5). The new samples should already be allocated. If not,
allocate them manually if they are not barcoded. If they are barcoded,
open the door of the rack unit, withdraw the new racks and insert them
again, see Section 3.2.2.
‰
After loading and allocation of all required resources, click <OK>. The
Load Plate dialog box is displayed.
It is important that you load these resources as quickly as possible so
that the processing is not paused for too long.
2) If the system is currently performing other steps (e.g. pipetting)
The reloading cannot be started until all plates are incubating. The following
waiting message appears.
Figure 119: System busy message
‰
Click <OK> to close this message.
‰
When you reach the allowed reloading time, select the Edit | Panel
Definition menu item once more and confirm it with <OK>. The system
is then paused and you can now follow the procedure described in
paragraph 1) above.
3.2.5 Reloading Test Plates and Further Processing of the Worklist
When the Load Plate dialog box is displayed:
‰
Load the required additional test plate(s) in the same way as done at
start of run (as described in Section 2.6) and confirm with <OK>.
‰
Make sure that all unit doors and drawers are properly closed.
If some of the plates of the initial worklist are already fully processed
when you are ready to reload additional test plates, the system
automatically brings them forward to the loading/unloading
compartment so that you can remove them before loading the
additional plates.
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When you click <OK> in the Load Plate dialog box, the system recalculates
and reschedules the worklist (interlacing or adding new plates/assays to be
processed).
Further processing is then carried out in accordance with this new
rescheduled worklist.
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3.3 Processing Externally Dispensed Plates
Depending on your laboratory organization (availability of large dispensing
equipment, heavy workloads…), you may want to pre-dispense samples and
controls into microplates on an external dispensing system and then transfer
the plates on EVOLIS to complete only the rest of the processing: reagent
dispensing, incubation, washing, reading and result evaluation.
The EVOLIS system includes a plate layout import function that allows you
to do this without losing the dispense data generated by the external
dispensing system: sample list and locations on the plate, control positions,
assay names and flags that may have been assigned by the dispensing
system.
This function can be used only if the output files generated by your
external dispensing systems are in AT_Barco or NSP file formats.
For details on these file formats (data structure, data fields) or on how
to configure these external systems to export these files to the
required directories, please refer to the documentation provided with
these systems or ask your Bio-Rad Service Engineer for assistance.
To use this function, you need to:
• Match the plate layouts and volumes dispensed on the external systems
with the assay-specific layout and volumes expected by EVOLIS.
• Copy and edit the corresponding EVOLIS assays (delete the Pipette
step for samples and controls).
• Enable the plate layout import option and define the assay links.
• Include the pre-dispensed plate data in the worklist definition.
• Validate the total processing time for each plate.
These steps are described in the following Sections. It is essential that
you read and understand the complete procedure and validate your
settings in Demo Mode before attempting to process real samples from
pre-dispensed plates.
If in doubt, ask your ask your Bio-Rad Service Engineer for assistance.
3.3.1 Match Dispensing and Processing Layouts / Volumes
For the plate layout import function to work correctly, it is essential that the
sample and control dispense step (and dilution if any) parameters
programmed on the external dispenser correspond exactly to what is
expected by EVOLIS for each assay type.
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To do this:
‰
Identify the EVOLIS assay that you want to pre-dispense on another
system.
‰
Open the assay file and print the assay description (see Section
3.12.1.2).
‰
On the external system which you are intending to use to pre-dispense
the samples and controls, program the dispense routine for this assay in
accordance to the plate layout and dispense / dilution information
(volumes dispensed, pre-dilution if any, shake step if any) required for
the EVOLIS assay.
‰
Repeat for other assays as needed.
3.3.2 Copy and Edit EVOLIS Assays
‰
Back on EVOLIS, identify the "Open" version (i.e. non passwordprotected, see Section 3.12.2.3) of the assay that you want to predispense on another system and open it.
‰
Delete all steps corresponding to the initial sample and control dispense
(which will be performed on the external system). The number of steps
you have to delete depends on the type of assay. For assays without
pre-dilution, this may be just a single "Pipette" step. For assays with predilution, this may be two consecutive "Pipette" steps or one "Pipette" and
one "Dispense" step, etc.
‰
Save the assay file under a new name. It is recommended to include an
indication in the filename and/or in the Assay header to allow all
operators to identify easily that this assay has been edited for external
pre-dispense.
Example
Edit assay file: "Open HIV Ultra Ag-Ab 1P BR V12.asy"
and save it as: "Pre-dispensed HIV Ultra Ag-Ab 1P BR V12.asy"
‰
Repeat for other assays as needed.
3.3.3 Enable the Plate Layout Import Option
186
‰
Select the Utilities | Options menu item.
‰
Click on the Plate Layout Import tab.
‰
Define the plate layout import parameters as explained below.
‰
When done, click <OK>.
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Figure 120: Plate Layout Import tab
Enable Plate Layout
Import
Check this item if you want to be able to work with imported plate layouts. If
you select this item, the other boxes on this tab are enabled.
File Format
In the drop-down list, select the file type corresponding to the output file
format used by the system on which the plate you intend to process was
pre-dispensed. Currently available formats are: AT_Barco and NSP (see
Note in Section below).
Directory
Define a list of one or more directories (up to 6 - local import directory,
linked computer, other network location, host computer…) in which the
system shall search for new plate layout files.
Log/Backup
<Assay Links…>
Define a log / backup folder.
See below.
EVOLIS and the external dispenser must be part of the same computer
network. It is essential that the plate layout file imported by EVOLIS is
the exact original file produced by the external dispenser, and not a
copy. Do not copy-paste the file from the external dispenser to
EVOLIS.
If EVOLIS and the external dispenser are not part of the same
computer network, and if the file are transferred between EVOLIS and
the external dispenser by copying and pasting, then the time indicating
the delay between the end of the pipetting on the external dispenser
and the start of the process in EVOLIS is not accurate.
Define links between external and EVOLIS test names
In most cases, the test names that will be included in the output file
transferred by the external dispenser will not correspond exactly to the
actual assay protocol file names used on EVOLIS.
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Example
Test name included in AT_BARCO file = "BR HIV ULTRA"
EVOLIS assay file name = "Pre-dispensed HIV Ultra Ag-Ab 1P BR V12.asy"
You then need to establish a link between the two designations. To do this:
‰
In the Plate Layout Import tab, click the <Assay Links…> button. This
opens the Assay Links dialog box.
‰
To define a new link, click <Add…> and enter the respective test / assay
names (use the <Browse…> button to enter the EVOLIS assay name –
see also below)).
Figure 121: Link external and EVOLIS assay names
‰
When done, click <OK>.
‰
Repeat for other assays as needed.
1) Make sure that you set the links to the edited EVOLIS assays
(without the dispense step – see Section 3.3.2) not to the original
EVOLIS assays.
2) Be extremely careful when defining the links between assay names
used on the external dispenser name and EVOLIS assay names. A
wrong assignment can lead to either absence of, or false results.
Note also that the <Browse…> button retrieves only the assay name, not
the full path. This means that if your general directory for assay files is the
default BioRad\Resources\Apf directory (see in Section 1.2.6.2), this is also
where the EVOLIS system will look for the linked "Pre-dispensed" assay file
when the plate layout import file is imported.
In other words, avoid saving the "Pre-dispensed" assay files in
subdirectories or in network locations other than your general Apf directory
(otherwise, when you perform the plate layout import the error message
described in Section 3.3.6, paragraph 3) will be displayed).
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3.3.4 Process the Pre-dispensed Plates on EVOLIS
When transferring the pre-dispensed plate(s) from the external
dispenser to EVOLIS, it is essential to handle the plates as gently and
carefully as possible in order to avoid any cross-contamination
between wells.
Also avoid any operator contamination by wearing appropriate
personal protection equipment (gloves, lab coat, etc.).
‰
Pre-dispense the plate(s) on the external dispensing system.
‰
When the first plate has been dispensed, go to your EVOLIS system and
click the <New Worklist> button to open the Set-up panel dialog box.
‰
Click <Add Plate…>. Instead of directly adding a plate in the window of
the Set-up Panel dialog box, the system displays the Plate dialog box.
Figure 122: Import the plate layout in a worklist
‰
Scan the plate barcode with a hand scanner or enter it manually via the
keyboard and click <OK>. The system searches the predefined import
directory to find the corresponding plate layout import file.
‰
If everything has been correctly defined, the complete plate layout and
test information is automatically added to the worklist.
Figure 123: Successful plate layout import
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‰
If some things have not been correctly defined, various messages are
displayed depending on which information could not be found (for
details, see Section 3.3.6).
‰
If other plates have now also been dispensed and are ready for
processing, you can add them now using the same procedure.
When a plate layout is imported, the layout cannot be edited manually
by the operator. The system therefore locks (disables) the following
buttons: <Add Assay…>, <Add Patient…>, <Archived Patient…>,
<Edit…>, <Edit Layout…>. Only the <Delete> button can be used to
delete the whole plate.
‰
When done, click <OK> and continue until you reach the Load dialog
box.
‰
In the Load dialog box, in the Unallocated resources corner, you
should see only reagents such as substrate, conjugate and stop
solution. No samples and controls!
Figure 124: Load reagents
190
‰
Load these reagents (and other required resources: e.g. tips) and click
<OK>. The Load Plate dialog box is displayed. In the Plate ID zone, the
plate ID expected by EVOLIS should already be displayed, below the
entry field.
‰
With the hand scanner, scan the plate barcode (or enter the plate ID
manually in the entry field).
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Figure 125: Comparing actual and imported plate IDs
‰
Make sure both plate IDs displayed are identical.
‰
Insert the plate in the metal holding frame.
Figure 126: Test plate with holding frame
It is essential that you make sure the A1 corner of the plate is placed
on the A1 corner of the holding frame! If you insert the plate the wrong
way round, all results on this plate will be erroneous.
‰
Load the plate and its frame on the EVOLIS plate transport and click
<OK>.
‰
The system controls that the Plate ID you scanned or entered is identical
to the expected Plate ID. Otherwise, an error message is displayed, see
Section 3.3.6.
‰
Repeat for the other pre-dispensed plates.
If you pre-dispense several plates, it is essential that you identify and
load each plate one by one in order to avoid any mix-up!
3.3.5 Validate the Total Processing Time for each Plate
When a plate is processed on EVOLIS after being pre-dispensed on an
external dispenser, the Title Block section of the Result Report includes a
special line:
"ATBarco time difference: hh:mm:ss"
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This line indicates (in hours [hh], minutes [mm] and seconds [ss]) the time
elapsed between:
• the end of the dispense on the external dispenser and
• the beginning of the actual processing of the plate on EVOLIS.
An excessive time difference between the dispense and the processing
(depending on what type of test was programmed on the plate) may
lead to erroneous results (or no results).
For pre-dispensed plates, it is therefore the biologist's responsibility to
review the Result Report and to validate whether the time difference
reported can have no adverse effect on the processing and result
calculation. See also Note in Section 3.3.3.
If you want to calculate the "total processing time" (i.e.
plate's actual processing time on EVOLIS), the EVOLIS
you to determine the plate's actual processing time on
Event Log filter to view log entries for that specific plate
2.4.7.6).
time difference +
Event Log allows
EVOLIS (use the
only, see Section
3.3.6 Troubleshooting
The explanations below are supplied as general guidance only. If you
experience problems in configuring data transfers between your
external dispenser and your EVOLIS system, please contact Bio-Rad
Technical Support for assistance.
It is essential that you validate your plate layout import process in
Demo mode before using it with real samples! Trying to solve
problems while the plates are already dispensed will cause delays
incompatible with a correct processing of the plates and lead to
erroneous results!
1) Reverting to the basic worklist definition process
Figure 127: Plate Layout Import tab
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If you click <Add Plate…> and instead of adding a plate the system opens
the above dialog box while you actually want to add a plate as in the basic
worklist definition process (i.e. disable the plate layout import function):
‰
Click <Cancel> to close the Plate dialog box.
‰
Click <Cancel> again to close the Set-up Panel dialog box.
‰
Select the Utilities | Options menu item and click on the Plate Layout
Import tab.
‰
Deselect the Enable Plate Layout Import checkbox.
‰
Click <OK>. You can now re-open the Set-up Panel dialog box and
define your worklist as in the basic worklist definition process.
2) No plate layout file is found in the pre-defined import directories
Figure 128: No plate layout file found
If, when you enter/scan the plate ID in the Plate dialog box and click <OK>,
the system, instead of automatically adding the complete plate layout and
test information to the worklist, displays the above error message, this
means that no plate layout corresponding to the plate ID you entered could
be found in the pre-defined import directories.
This can be either:
• because the plate ID you entered is incorrect, or
• because the required plate layout import file is not in the specified
directories (it has not been sent or has been sent to another directory or
the required data is not available so that the EVOLIS system is not able
to interpret it).
The recommended actions in this case are as follows:
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‰
Click <Retry> to go back to the Plate dialog box and try entering the
plate ID or scanning the plate barcode again (if scanning, make sure the
settings of the handheld barcode are adequate for the type of barcode
used on the microplate).
‰
If the error persists and the above message is displayed again, click
<Abort> to go back to the Set-up Panel dialog box (without adding a
plate). Check that the required plate layout import file (sent by the
external dispenser) is in the correct import directory and that it contains
the appropriate data. If not, you will need to either redefine your import
directories (see Section 3.3.3), review the file structure/format of the files
sent by the external dispenser or correct the file transfer process. In
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most cases, this implies that the immediate processing of the plate has
to be aborted.
What you should not do in this case:
‰
‰
Click <Abort>, try and find the plate layout file, correct it manually and/or
paste it manually in the correct import directory and click <Add Plate…>
again.
Click <Ignore>. If you click <Ignore>, the system prompts you to select an
assay file manually and add patients (as in the basic worklist definition
procedure) but then you have no way to retrieve and process your predispensed plate.
3) A plate layout file is found but EVOLIS cannot find the
corresponding assay file
Figure 129: Assay file not found
If, when you enter the plate ID and click <OK>, the system, instead of
automatically adding the complete plate layout and test information to the
worklist, displays the above error message, this means that a plate layout
import file was found but EVOLIS could not find the assay file corresponding
to the test required in the plate layout import file.
This can be either:
• because the required assay file is not saved in the main Apf directory, or
• because the assay link for that test has not been correctly defined.
What you can do in this case:
‰
194
Click <OK> to close the error message.
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Figure 130: Select assay file for the imported plate layout
‰
The Open dialog box is automatically displayed and you can browse and
select the assay file to use to process the pre-dispensed plate.
‰
Click Open. The Set-up Panel dialog box is displayed again and the
selected assay has been assigned to the imported plate layout (including
the sample data!).
This should remain a "last minute" solution only! Selecting the assay
manually obviously involves a risk of error.
The recommended procedure is to define your assay links carefully,
make sure the required assay files are in the Apf directory and validate
all this beforehand.
4) The plate loaded is not the expected plate
Figure 131: Wrong plate loaded message
The above message is displayed when the Plate ID you entered in the Load
Plate dialog box does not correspond to the Plate ID expected by the
system from the plate layout import file.
Remove the plate from its carrier and load the correct plate instead: the
expected Plate ID is displayed in the Load Plate dialog box just beneath the
Plate ID entry field (see Figure 125).
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3.4 Using the Reagent Database
The EVOLIS software includes a reagent database. This database is used to
store the information on all reagents, controls and buffers used on the
system.
This information includes:
• The properties of the reagents themselves (stability, preparation time...).
• The properties of the bottles in which each reagent is used (diameter,
dead volume...).
• The pipetting profiles to be used with each reagent.
3.4.1 Viewing the Contents of the Database
To view the list of reagents included in the reagent database:
‰
Select the File | New menu item.
‰
In the New dialog box, scroll down and select Reagent Parameters
Report.
‰
Click <OK>.
Figure 132: Contents of the reagent database
The Reagent Parameters Report provides a list of all reagents included in
the reagent database. The various columns [Name, ID, Volume, Dead
(dead volume), Size (diameter x height), Profiles (aspiration/dispense),
Times (life time / preparation time), ID (Reagent ID for Unity Real Time, if
any)] correspond to the parameters entered, for each reagent, in the Edit
Reagent Details dialog box (see Section 3.4.3.1).
This list can be printed (use File | Print in the menu bar or the <Print>
button).
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3.4.2 Selecting Reagents for an Assay
When you load pre-defined assay files from Bio-Rad (Apf), the data
corresponding to the reagents (and controls) required for those assays
is automatically included in the reagent database. In this case, you do
not have to individually select or create the reagents.
To select the reagents required for a specific assay:
‰
Open the assay file for which you want to select a reagent (select the
File | Open menu item, select an (*.asy) file and click <Open>). It can
be a new assay file if you are in the process of creating an assay, or an
existing (non-protected) assay file if you want to change some of the
reagents associated to this assay.
‰
Access either:
the Aspirate dialog box (in the assay file, double-click on a Pipette step,
click the <Edit Operations> button, in the Edit Operations dialog box,
click the <Aspirate> button)
or
the Dispense dialog box (in the assay file, double-click on a Dispense
step)
‰
In any of these dialog boxes, click on the <Reagents> button. This
opens the Select Reagents dialog box.
‰
In the Available Reagents list, highlight the first required reagent you
want to select for that assay and click on the arrow (>) button to transfer
it to the Selected Reagents list.
‰
Repeat this step for all other reagents you want to select for that assay.
‰
Confirm with <OK>.
Figure 133: Select Reagents dialog box
Available Reagents
Shows all the reagents included in the reagent database.
Selected Reagents
Lists all the reagents selected for that particular assay. If you are creating a
new assay, this box is empty when you open the dialog box.
>
Transfers the reagents highlighted in the Available Reagents list to the
Selected Reagents list.
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<
Removes the reagents highlighted in the Selected Reagents list and
moves it to the Available Reagents list.
<<
Removes all reagents available in the Selected Reagents list to the
Available Reagents list.
<New...>
Opens the Edit Reagent Details dialog box with default values to allow
you to create a new reagent (see below)
<Edit...>
Opens the Edit Reagent Details dialog box with the details of the reagent
selected in the Available Reagents list. If it is a non-protected reagent, you
can edit these details (see below)
<Delete>
Deletes a selected reagent from the reagent database. The Bio-Rad
reagents are protected and cannot be deleted.
<OK>
The selected reagents are accepted. The program returns to the previous
dialog box.
<Cancel>
The program returns to the previous dialog box without saving the changes
made (be aware, however, that if you have changed some reagent details
(see Section 3.4.3.1) and confirmed them by clicking <OK> in the Edit
Reagent Details dialog box, these changes will be retained even if you exit
the Select Reagents dialog box by clicking <Cancel>).
If the reagents you require for your assay are not included in the Available
Reagents list, you have to create them as described in the following
Sections.
3.4.3 Creating and Editing Reagents
3.4.3.1 The Edit Reagent Details Dialog Box
This dialog box is displayed if you click the <New...> or <Edit...> button in
the Select Reagents dialog box.
Figure 134: Edit Reagent Details dialog box
Name
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Name of reagent.
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ID
Bottle Properties
Volume
Dead Vol
Width
String of alphanumeric characters used as barcode identification. If using
barcoded reagents, this string (generally a number) is on the barcode label
of the respective reagent bottle. This field can be left blank if you use nonbarcoded bottles.
Bottle parameters.
Volume in ml. Enter here the volume of reagent actually available in a bottle
e.g. bottle theoretical volume (60.0ml) – dead volume (3.0ml) = available
volume (57.0ml).
Dead volume of container in ml (see below).
Width/diameter of container in mm. This data is very important to ensure
correct pipetting! If the manufacturer's specifications are not available or
reliable, make sure to measure precisely the width/diameter of the inside of
the bottle.
Height
Height of the shoulder level of the reagent bottle in mm (see below).
Shape
Select shape of reagent container (round or square).
Reagent Properties
Reagent parameters:
Preparation time
Enter a preparation time for the reagent in minutes. When the reagent is
needed, the system prompts you with an acoustic signal and a message on
the screen to load the reagents (see Section 2.5.3.3).
Lasts for the
duration of a
worklist
If this item is checked, the reagent remains stable and can be used for the
entire duration of the worklist. If this item is not checked, you have to enter
below the lifetime of the reagent (in minutes).
Lifetime
(for unstable reagents) Maximum length of time (in minutes) during which
this reagent may be used. Do not use the reagent any more once this time
period is over! If all the samples have not yet been processed you have to
prepare and load a new quantity of the same reagent into the system.
Allow changing of
bottles during a
dispense
If this item is checked and if you load and allocate two bottles of the same
reagent, the system is able to switch to the second bottle automatically
when the first one is empty without interrupting the dispense process. On
how to load these bottles on the racks, see Section 2.5.3.4.2.
If this item is not checked, the system limits the number of samples it can
process according to the quantity of reagent available in just one bottle.
Reagent Dynamics
Define the desired aspirate and dispense profiles for each reagent or control
(on pipetting profiles in general, see Section 3.10.4.2).
Aspirate profile
Select the aspirate profile. The name of the selected profile is displayed.
Dispense profile
Select the dispense profile. The name of the selected profile is displayed.
Lot Tracking
Enable lot tracking
Specify if you want the system to verify reagent lots for this reagent.
If this item is checked, it is possible to use the lot tracking function on this
type of reagent, provided the general kit lot tracking function is enabled (see
Section 3.5.1).
Uncheck this item for reagents that you want to exclude from the lot tracking
function even when this function is generally enabled (e.g. for reagents that
have no lot number or for which the lot number is irrelevant).
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Reagent ID
Enter here the Reagent ID you want the system to use for kit lot tracking
purposes. This Reagent ID may be identical to the general reagent ID
entered above in the ID field. If you intend to use the kit lot tracking function
on controls in conjunction with QC On Call, see also Section 3.5.5.
Dead volume determination.
To determine the dead volume of a bottle, create an assay in which the
pipettor will aspirate 100 µl from the reagent bottle, dispense it to a test plate
and repeat this action until it cannot aspirate any more (an error message
"Insufficient volume..." will be displayed). Fill the bottle with tap water and
perform the assay. The dead volume is what is left in the bottle when the
pipettor cannot aspirate any more.
Height parameter
The height parameter should be set in reference to the shoulder level of the
bottle.
Figure 135: Height parameter
This is important because the system determines precisely the aspirate
position for each aspirate volume, based on the diameter of the bottle. If the
pipettor aspirates reagent in the neck of the bottle (where the diameter is
smaller), these calculations are wrong and this in turn induces pipetting
errors (and false results!).
To prevent aspirating from the bottle neck, as long as the actual level of
reagent in the bottle (detected by the pipettor through its Liquid Level
Detection system) is higher than the Height parameter defined here
(shoulder level), the pipettor moves to this Height position and starts to
aspirate there only. Also, as long as the actual level of reagent in the bottle
is higher than the Height parameter, the Aspirate Check function (see
Section 3.12.3.3.4) is automatically disabled.
3.4.3.2 Creating Reagents
The EVOLIS system allows the user to define new assays (see Section 3.12
on Programming Assays). If you define a new assay, you must enter the
details of all the reagents and controls used for this assay in the reagent
database.
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To do this:
‰
Open the Select Reagents dialog box (as described in Section 3.4.1).
‰
Click on the <New> button. This opens the Edit Reagent Details dialog
box. Some fields are blank, some contain standard values.
‰
Enter the appropriate data (or edit the standard values as appropriate)
for the first reagent required for your assay.
‰
Confirm with <OK>. This takes you back to the Select Reagents dialog
box.
‰
Repeat this procedure for all the reagents and controls required for your
assay (for buffers, see Section 3.4.5).
‰
When you have defined all your reagents and controls, these should be
listed in the Available Reagents list of the Select Reagents dialog box.
Highlight them (one by one) and click on the arrow (>) button to transfer
them to the Selected Reagents list.
‰
When the Selected Reagents list includes all the reagents and controls
required for your assay, confirm with <OK>.
3.4.3.3 Editing User-Defined Reagents
If you have created new reagents as described in the previous section, you
can freely edit them later (e.g. if you want to change the pipetting profiles,
the bottle properties...). Unlike Bio-Rad reagents, user-defined reagents
cannot be protected against editing.
To edit user-defined reagents:
‰
Open the Select Reagents dialog box (as described in Section 3.4.1).
‰
Click on the <Edit> button. This opens the Edit Reagent Details dialog
box with the data you previously specified for your reagent.
‰
Edit the data you want to change.
‰
Confirm with <OK>. This takes you back to the Select Reagents dialog
box.
If you have changed the name of the reagent, you will need to reinclude it in the Selected Reagents list (in the Selected Reagents
dialog box, highlight it in the Available Reagents list and transfer it
using the arrow (>) button).
3.4.3.4 Editing Bio-Rad Reagents
Normally, the data included in the database for each Bio-Rad reagent
corresponds exactly to what is found in the Bio-Rad kit for each particular
assay so there should be not need to edit it.
This is why the data for Bio-Rad reagents is protected (read-only). When
you open the Edit Reagent Details dialog box for a Bio-Rad reagent, you
can view the characteristics of that reagent but not edit them.
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However, there may be a few rare cases in which you may need to edit a
Bio-Rad reagent. One of these is if you need to transfer the Bio-Rad
reagent into a bottle which is different from the one included in the kit (this is
not recommended but it may happen).
In this case:
‰
Open the Select Reagents dialog box (as described in Section 3.4.1).
‰
In the Available Reagents field, highlight the reagent which you want to
edit.
‰
Click <Edit>. This opens the protected data for this reagent.
‰
Write down this data (or copy and print the dialog box).
‰
Click <Cancel>. This takes you back to the Select Reagents dialog box.
‰
Click <New>. In this new Edit Reagent Details dialog box, enter those
data of the Bio-Rad reagent which you want to retain (e.g. Reagent
Properties, Aspirate and Dispense profiles) and enter also the new
data (for those characteristics that you want to change, e. g. new Bottle
Properties).
‰
Enter a new name for the reagent.
‰
Click <OK>.
As you have changed the name of the reagent, you will need:
1) To include the reagent under its new name in the Selected Reagents
list (in the Selected Reagents dialog box, highlight it in the Available
Reagents list and transfer it using the arrow (>) button).
AND
2) To edit the assay accordingly (see Section 3.12.2 on editing assays).
3.4.4 Updating the Reagent Database
The reagent database is automatically updated when you install a new BioRad APF version (see Section 3.11.1). If the APF installation was successful
a reagent update report is displayed.
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Figure 136: Reagent database update report
It is recommended that you print and archive this report.
1) The automatic update is actually a merge operation. This means that
only Bio-Rad reagents are updated (and new ones added). If you
created your own reagents, these are retained unchanged.
2) The reagent database file is called "Reagents.db" and is found in the
BioRad\System directory.
3.4.5 Buffer Database
The wash buffer properties are also included in the reagent database but in
a separate section.
To access the list of available wash buffers:
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‰
Open an assay file.
‰
Double-click on a Wash step. This displays the Wash dialog box.
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Figure 137: Wash dialog box
‰
Click on the <Buffers> button.
This displays the Select Reagents dialog box but the Available Reagents
list does not display the list of reagents and controls but the list of wash
buffers and clean fluids.
To select, create, edit or delete wash buffers, refer to what is described in
the previous Sections for reagents.
3.4.6 Troubleshooting
1) Undefined reagent error
When you try to start a worklist and the following message is displayed, this
means that the system is unable to find, in the reagent database, the data
corresponding to a reagent needed for one of the assays you intend to
process.
Figure 138: Undefined reagent error message
If the assay is a pre-defined Bio-Rad assay, make sure that you are using
the most recent version of that assay (as reagents are sometimes redefined
or renamed from one version to the other). If this still does not solve the
problem, contact your Bio-Rad Technical Support.
If the assay is one that you created, open that assay and open the Select
Reagents dialog box as described in Section 3.4.1. If the required reagent is
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listed in the Available Reagents list, just select it and click the arrow button
to transfer it to the Selected Reagents list. If the required reagent is not in
the Available Reagents list, you have to click the <New> button and define
the reagent properties as described in Section 3.4.3.
If you were intending to process several assays and you do not know for
which assay this reagent was required, check the Reagents requirements list
(to display it, click on the Reagents requirements section in the Worklist
Tree). In this list, reagents are ordered per assay. If one reagent is
undefined, all the reagents required for that assay are missing from the list.
From this, you should be able to determine which is the assay that you need
to check.
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3.5 Kit Lot Tracking
The EVOLIS software includes a kit database. This database is used for kit
lot and reagent lot tracking.
If the lot tracking function is enabled, when you load reagents on EVOLIS for
a run, the system checks that they correspond to the kit lot data stored in the
database.
3.5.1 Enabling / Disabling Kit Lot Tracking
The lot tracking system can be disabled altogether or individually for each
assay or each reagent.
3.5.1.1 General Enable / Disable Option
To disable the kit lot tracking system completely:
‰
Select the Utilities | Kit Database menu item. The Kit Database dialog
box is displayed.
Figure 139: Disable kit lot tracking
‰
Deselect the Enabled checkbox located in the bottom left-hand corner of
the dialog box.
‰
Click <Close> to confirm and close the dialog box.
This disables the kit lot tracking function completely, i.e. for all kits and for
reagents as well as microplates.
If you later want to re-enable the lot tracking function, open this dialog box
again and reselect the Enabled checkbox.
If you want to be sure that the lot tracking function is enabled, you
have to open this dialog box and make sure the "Enabled" checkbox is
selected before starting the run. If the function has been disabled (for
example, by a previous operator), no specific message is displayed
during the worklist verification to warn you that the lot tracking
function has been disabled.
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3.5.1.2 Individual Enable / Disable Option
Assays
To enable / disable the kit lot tracking function individually for a specific
assay:
‰
Select the File | Open menu item and open the assay file (*.asy). If it is
a password protected assay file (e.g. an official Bio-Rad assay file), you
will have to click the <Don't Know Password> button before the file is
actually displayed. If it is an unprotected assay file, it will open directly.
‰
Double-click on the Assay Header (top section of the assay description).
‰
If the assay is password protected, this opens the following "restricted"
Assay Protocol Header dialog box.
Figure 140: Enable /disable lot tracking (protected assay)
‰
If it is an unprotected assay file, this opens the general Assay Protocol
Header dialog box (see Section 3.12.3.1).
‰
In both cases, select or deselect the Enable Lot Tracking item to
enable or disable the lot tracking function for that assay (default setting
is disabled), then click <OK> to save the setting.
If lot tracking is disabled:
• The kit database shall not be used to update the lot specific values.
• The software shall not report if an incorrect reagent is being used for the
assay or if a reagent has expired.
• No results shall be sent to URT (Unity Real Time).
Reagents
If you want to disable the kit lot tracking function individually for a specific
type of reagent, you can do this in the reagent database (Edit Reagent
Details dialog box, see Section 3.4.3.1). In that case, this reagent is always
disregarded for lot tracking purposes even if the general lot tracking function
above is Enabled. Note that enabling/disabling kit lot tracking individually is
not possible for Bio-Rad reagents as these are protected against editing.
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3.5.2 Entering a New Kit Lot
3.5.2.1 Handheld Barcode Scanner Configuration
For the basic kit lot entry procedure described below, the use of a handheld
barcode scanner to read the barcodes on the kit boxes is strongly
recommended.
Any type of barcode wand (handheld scanner), connected to the EVOLIS
computer, can be used.
It is essential, however, that the scanner's reading parameters be set
to:
• Postambule – None.
• QWERTY keyboard.
3.5.2.2 Basic Procedure (for Bio-Rad Kits Only)
The basic procedure consists in declaring the new kit lot data "as you go",
i.e. while preparing the run in which you intend to use the new kit.
To do this:
‰
Define your worklist as you usually do.
‰
When you reach the Lot Specific Values dialog box, click on the Batch
Number drop-down list to make sure the LOT number of the kit box
you intend to use is not already listed.
Figure 141: Search batch numbers
‰
208
If this number is not available in the list, click <Add Kit…>. This opens
the Kit Information dialog box.
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Figure 142: Enter kit lot data
‰
With the hand scanner, scan the main kit barcode on your kit box.
Product Code
Assay Name
Main Kit Barcode
Batch Number
Expiry Date
Figure 143: Kit information on kit package
‰
All general kit information (except the kit expiry date) is automatically
entered.
Figure 144: Enter kit lot data
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‰
If you do not have a handheld scanner, the same result may be obtained
by entering the kit's product code and batch number via the keyboard
and then clicking the <FIND> button.
‰
Enter the Expiry Date manually via the keyboard.
‰
Click <Scan kit Bottles…>. This opens the following dialog box. The Kit
drop-down list shows the batch number of the kit package you have just
entered.
Figure 145: Scan kit bottles
‰
Take the individual reagent bottles (and control vials) out of the kit
package and place them on reagent racks with the barcode labels facing
right.
‰
Load the reagent rack on the EVOLIS instrument. The individual reagent
barcodes are read and the corresponding data is displayed in the Scan
Kit Bottles dialog box (Column 1 = Reagent ID, Column 2 = Lot number
of individual reagent, Column 3 = Individual reagent expiry date [Date
format = DDMMYY]).
Figure 146: Scanned data
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Some generic reagents (e.g. stop solution) are overlooked in this
process. This is normal. They do not need to be tracked.
‰
Click <Close> to close the Scan Kit Bottles dialog box. In the Kit
Information dialog box, the complete kit lot data is now entered.
Figure 147: Kit information dialog box with complete data
‰
Click <OK> to save and close the Kit Information dialog box.
‰
If you had started the process by clicking <Add Kit…> in the Lot
Specific Values dialog box, this takes you back to the Lot Specific
Values dialog box and you can now select the appropriate kit lot from
the Batch Number dialog box (see Section 2.4.6.1) and proceed with
the run preparation.
3.5.2.3 Specific Procedures
3.5.2.3.1 Enter Kit Lots in Advance
If you prefer to enter all your new kit lots in advance (e.g. each time you
receive new kits) rather than just before starting a run:
‰
Select the Utilities | Add Kit… menu item. This opens directly the Kit
Information dialog box.
‰
Enter the kit lot data exactly as described in the "basic procedure"
above.
‰
Once you have finished the procedure for the first kit lot, click <OK> and
repeat the same steps for the next kit lot.
Make sure to unload and store the reagents from the first kit before
dealing with the next kit to avoid any mix –up!
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3.5.2.3.2 Multi-Assay Kits
Some kits can be used with several assays (e.g. a qualitative assay and a
quantitative assay).
In that case:
‰
When you are in the Kit Information dialog box and you scan the kit's
main barcode with the hand scanner, another dialog box is displayed to
let you select the type of test you intend to run.
Figure 148: Select assay type
‰
Select an item in the list and click <OK>.
3.5.2.3.3 Non-Barcoded Kit Packages
If you use non-barcoded kit packages, you can enter all data in the top part
of the Kit Information dialog box manually (use the <Browse…> button to
enter the Assay Name in order to avoid mistakes).
3.5.2.3.4 Non-Barcoded Kit Bottles / Unreadable Barcodes
If the bottles included in the kits are not already barcoded, it is
recommended that you barcode them yourself.
• For Bio-Rad kits in which reagent bottles are non-barcoded, assayspecific barcode labels can be ordered separately (see Appendix A 3).
• For other kits, if you create your own barcode labels, you will need to
define the barcode format first (see Section 3.5.3).
Manual lot data entry procedure
It is possible to enter lot data for individual reagents/controls manually. This
procedure is not recommended however as a standard procedure for nonbarcoded bottles but only as an exceptional solution when the EVOLIS
integrated scanner fails to read a specific barcode (e.g. the barcode label is
damaged, too small…) or for isolated non-barcoded containers (e.g. external
controls).
If you have scanned the kit bottles but one of them was not read:
‰
212
Click <Close> in the Scan Kit Bottles dialog box, check that all barcode
labels are correctly oriented (facing right) and try inserting the rack
again.
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‰
If the failure persists, click <Close> again to go back to the Kit
Information dialog box.
Figure 149: Kit information dialog box with incomplete data
‰
Click the <Add…> button to enter the missing individual reagent data
manually. This opens the Reagent Information dialog box.
Figure 150: Individual reagent lot parameters
‰
Remove the unread reagent bottle from the rack.
‰
Enter the required information as stated on the label.
LOT
4J0101
Reagent Batch Number
(last 3 digits)
2008-05-22
Reagent Expiry Date
Exp:
Reagent ID
(fourth and fifth digits)
11704101220508
Figure 151: Reagent label information
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Reagent ID
Required field. For Bio-Rad assay-specific reagents, enter the fourth and
fifth digits (or letters) of the individual reagent number (under the barcode).
If you have doubts about the reagent ID you should enter here, open the
reagent database list (see Section 3.4.1) and enter the ID included in this
list for the same reagent.
Expiry Date
Required field. Note that the reagent expiry date entry format is the
reverse of what is printed on the label. For example, for a printed expiry
date of 2008-05-22, you must enter "220508" (DDMMYY).
The system allows you to enter expired reagents in the kit database but a
warning will be displayed when you actually use these reagents in a run
(see Section 3.5.4) and the results will be flagged (see Section 2.8.2).
Batch Number
Required field. For Bio-Rad assay-specific reagents, the batch number
you need to enter here includes only the last 3 digits. In the above
example, the Batch Number is "101". Note that each reagent has an
individual batch number which is generally different from the general kit
batch number.
QA - Mean
Default value is "0". Do not edit.
QA - SD
Default value is "0". Do not edit.
QC On Call Interface
Use this field if you want the control values to be tracked by the URT
(Unity Real Time) software.
For controls included in Bio-Rad kits, select the Use Barcode option.
For external controls, see Section 3.5.5).
‰
Click <OK> to close the Reagent Information dialog box and come
back to the Kit Information dialog box. The missing reagent has now
been added.
Figure 152: Kit information dialog box with complete data
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3.5.2.3.5 External Controls
The manual lot data entry procedure described above can also be used for
external controls (i.e. controls not included in the kits). For more information,
see Section 3.5.5.
3.5.2.3.6 Non-Bio-Rad Kits
If you intend to use the kit lot tracking function on EVOLIS with non-Bio-Rad
kits, you need first to define the barcode format used by other suppliers on
the reagent bottles, as described in Section 3.5.3.
Then declare the kit lot as follows:
‰
Select the Utilities | Add Kit… menu item. This opens the Kit
Information dialog box.
‰
Enter the data required in the top part of the Kit Information dialog box
manually. You cannot scan the kit barcode and you cannot use the
<FIND> button (error messages will be displayed). The Assay Name,
however, can be entered with the <Browse…> button (recommended in
order to avoid mistakes).
‰
In the Barcode Format drop-down list, select the barcode format you
have defined for this supplier.
Figure 153: Kit lot entry for non-Bio-Rad kits
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‰
Click <Scan kit Bottles…> to open the Scan Kit Bottles dialog box.
Load the kit reagents on the reagents racks and load them on EVOLIS
as described in the "basic procedure" (see Section 3.5.2.2).
‰
When the reagents have been identified, click <Close> to close the
Scan Kit Bottles dialog box, then click <OK> to close the Kit
Information dialog box.
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3.5.3 Barcode Format Definition
The barcode format used on reagent bottles needs to be predefined so that
when bottles of a specific kit lot are scanned by the barcode scanner, the
system can interpret all information included in the barcode.
For example, the barcode format used on Bio-Rad assay-specific reagents
(and controls) is as follows.
Assay ID
Reagent ID
Reagent Batch Number
Reagent Expiry Date
First 3 digits
Following 2 digits
Following 3 digits
Last 6 digits – DDMMYY
Total = 14 digits
This means that when a reagent bottle is scanned, the system "knows"
automatically not only which type of reagent this is but what assay it is for,
which kit lot it came from and whether or not it is expired.
1) Barcode formats used in Bio-Rad kits
All relevant barcode formats used on the reagents in Bio-Rad kits are
predefined and pre-entered in the system.
As a consequence, if you use only reagents from Bio-Rad kits, you do not
need to define any barcode format.
2) Barcode formats for kits from other suppliers
To enter barcode formats for kits from other suppliers you first have to know
what each digit stands for in the barcode IDs used in those kits. Then you
need to enter the barcode format into the database as described below.
This step does not have to be repeated for each new kit lot. You generally
have to do it only once, when you start using a kit from a new supplier (or
when a supplier changes the barcode formats used on its kits).
Barcode format entry procedure
Once you have determined that the barcode format used on reagents from
Supplier "XYZ" is, for example, organized as follows:
Assay ID
Reagent ID
Reagent Batch Number
Reagent Expiry Date
First 2 digits
Following 2 digits
Following 4 digits
Last 6 digits – YYMMDD
Total = 14 digits
‰
216
Select the Utilities | Kit Database menu item. This opens the Kit
Database dialog box.
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Figure 154: Kit Database dialog box
‰
Click the <Add…> button located to the right of the Barcodes list. This
opens the Barcode Label dialog box.
Figure 155: Barcode Label dialog box
‰
In the Description field, enter a name for the new kit barcode format
you want to enter. For example, enter "XYZ" if you are entering barcode
information for kits from Supplier "XYZ".
‰
You then need to specify how many digits are included in the barcode
format and what each digit (or series of digits) stands for (see table
above).
‰
Click the <Add…> button to insert the first digit. This opens the Barcode
Digit dialog box.
Figure 156: Specifying barcode digits
‰
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In the Usage drop-down list, select what the first barcode digit stands
for. Referring to the example above, select "Assay ID" form the dropdown list.
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‰
Click <OK>. This closes the Barcode Digit dialog box and goes back to
the Barcode Label dialog box where you can see that the value entered
for the first digit has been entered in the Digits field.
‰
Click the <Add…> button again to insert the value for the second digit
(in this case "Assay ID" again) and click <OK>.
‰
Repeat these steps until you have added all the digits included in the
barcode format.
Figure 157: New barcode definition
‰
When done, click <OK> to close the Barcode Digit dialog box, then
<OK> again to close the Barcode Label dialog box. This brings you
back to the Kit Database dialog box where the new barcode format is
now included in the Barcodes list.
Figure 158: Kit Database dialog box
3.5.4 Kit Tracking Errors
The purpose of the lot tracking system is to increase the test results
reliability by making sure all kit components are used as intended by the kit
manufacturer.
Therefore, any inconsistent use of kit components (e.g. exchanging reagent
bottles between different kit lots, using expired reagents…) is signaled to the
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user. In some cases, you can decide to override the warning and start the
run as is. This is then traced in the log / result files.
Message
Reagent
Cause
Lot
Action
Tracking The reagent you loaded is referenced Click <OK> to close the message.
Error For Reagent '…'
in the kit database but with another Pull out the reagent rack and check
Expected barcode(s): '(list ID.
of
all
reagent
barcodes The message tells you the expected message.
expected for that assay)…'
Scanned
the reagent(s) mentioned in the
•
ID and the scanned ID.
barcode: A new message is displayed for each
reagent(s)
correspond
to
the
the
expected
only expected reagents.
which the scanned barcode ID does
not
with
barcode ID, reload the rack with
'(barcode of first unexpected "unexpected" reagent (i.e. reagent for
reagent)…'
If you can find the correct
expected •
If you are unable to load the
reagent bottles with the expected
barcode ID).
barcodes, turn the incorrectly
labeled
bottles
so
that
the
unexpected barcodes cannot be
scanned, reload the rack and
assign these reagents manually
in the Load window. The system
then assumes that the expected
reagent has been loaded but
reports the manual assignment in
the Result Report.
Reagent '…', barcode '…', The reagent you loaded is not Click <OK> to close the message.
was not found in the kit referenced at all in the kit database.
You should not use reagents that are
database.
reported
not
found
in
the
kit
database. If you cannot use another
reagent, you need to either reference
that reagent in the kit database
before reloading that bottle or disable
reagent lot tracking altogether.
Warning! Reagent '…' has The expiry date of the reagent you Click <OK> to close the message.
expired! (Expiry date '…'.)
loaded is exceeded. The message You can then either:
tells you when the expiry date was.
−
start the run as is. The expired
reagent is traced in the log files
and the corresponding sample
results
are
flagged
("REAG
EXP", see Section 2.8.2).
−
unload the reagent and replace
it with a unexpired reagent. In
this case, you have to reference
the new reagent in the kit
database.
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Warnings and flags
Manually assigned reagents are reported in the Title Block section of the
Result Report. Individual results are not flagged.
Reagents not found in the kit database are also reported in the Title Block
section of the Result Report. Individual results are not flagged.
Still in the Result Report, the Lot Specific Values section includes a list of
"Expected Kit Components".
This list shows the reagent information entered in the Lot Specific Values
dialog box, either manually or by recalling the kit lot number (batch number)
from the kit database (see Section 2.4.6.1).
This list does NOT show the lot information about the reagents
actually loaded, only about the expected reagents!
Expired reagents are signaled by a "Reagent Expired" mention in the Lot
Specific Values section of the Result Report. Individual results are flagged
"REAG EXP" but the results are calculated.
3.5.5 Lot Tracking and Unity Real Time (URT)
Unity Real Time (hereafter "URT") is a Bio-Rad software developed to
manage and analyze quality control data from various sources, including
data transferred from the EVOLIS software. For general information on the
URT software, please ask your Service Engineer or refer to the URT user
documentation.
1) The explanations below apply only if URT has been correctly
installed and configured by your Bio-Rad Service Engineer (including
data transfer settings). If you encounter any problem, please call your
Bio-Rad Service Engineer for assistance.
2) URT replaces the former QC On Call software. Any remaining
reference to QC On Call in this manual or in the EVOLIS software can
be understood as a reference to URT.
The purpose of this Section is only to describe how to set-up EVOLIS lot
tracking parameters so that the control data sent can be received and
processed by URT.
Controls included in Bio-Rad kits
For controls included in Bio-Rad kits, you only need to make sure the kit lot
data for each control is entered in the kit database as described above in
Section 3.5.2.2.
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External controls
For external (user-specific) controls, you need to:
‰
Enter the control in the reagent database. Refer to the description of the
Edit Reagent Details dialog box in Section 3.4.3.1 and to the general
reagent creation procedure in Section 3.4.3.2.
‰
In the Lot Tracking field of the Edit Reagent Details dialog box, check
the Enable lot tracking item and enter the Reagent ID for your control.
The ID you enter here has to be identical to the Reagent ID that will be
included in the barcode label you attach to the tube/bottle in which your
control will be loaded.
Figure 159: Enable lot tracking for user-defined controls
‰
When done, close the Edit Reagent Details dialog box and enter the kit
lot data for that control in the kit database.
‰
To do this, use the manual lot data entry procedure described in Section
3.5.2.3.4 and enter the control-specific lot data as follows.
Figure 160: QC On Call (URT) Interface
‰
In the Reagent Information dialog box, in the Reagent ID field, enter
the same Reagent ID you entered in the Edit Reagent Details dialog
box.
‰
In the QC On Call Interface field make sure to select Other and enter
the same reagent ID again. You can also enter an expiry date and a
batch number (optional).
‰
Click <OK> to save the entries.
URT warnings in the Result Report
When you run a worklist including these controls, the control values are
automatically sent to and processed by URT.
The URT status will be returned to EVOLIS and included in the Result
Report, next to the respective controls in the Expected Kit Components list.
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For example:
Expected Kit Components:
HCV Ultra Ag-Ab 1P BR V12
049
2006-02-28
HCVU R3 Neg Ctrl Anti-HCV Ultra
099
300306
OK
HCVU R4 1P Ab Pos Ctrl Anti-HCV Ultra
099
300306
1-2S[W]
HCVU R5 Ag Pos Ctrl Anti-HCV Ultra
199
150406
1-4S[R]
HCVU R6 1P Conj. 1 Anti-HCV Ultra
099
300306
HCVU R7 1P Conj. 2 Anti-HCV Ultra
099
300306
BR Substrate TMB#7 N60 (1:11) R8+R9
BR Stop Sol. #1 N30 H2SO4 1N R10
External Control
301206
OK
Bio-Rad WB R2
The URT status is indicated in the last column on the right-hand side.
OK
[W]
[R]
1-2S,
1-4S,
…
222
Æ
Æ
Æ
Æ
Control value is conform
Warning
Reject
Rule for which the warning [W] or the reject [R]
status was calculated. For more information on
URT rules, please refer to the URT User Manual.
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3.6 Archiving Samples
The EVOLIS system includes a sample archiving function.
The purpose of the sample archiving process is to set aside a small volume
of each sample to be later frozen and saved (as reference or in case retesting is needed). This can be done either:
• as an independent process i.e. a run defined only for sample archiving
• in conjunction with a normal run.
The EVOLIS system also allows you to perform runs directly from previously
archived samples and even to process samples archived on another system
(external archives).
3.6.1 Independent Sample Archiving
1) Display an Archive "plate" in the Set-up panel dialog box:
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‰
Click the <New Worklist> button to open the Set-up Panel dialog box.
‰
In the Set-up Panel dialog box, click the <Add Plate> button. A first
plate is displayed.
‰
Click the <Add Assay…> button. The Open dialog box is displayed.
‰
In this dialog box, select any assay file (*.asy) and click <Open>. The
selected assay is displayed in the Set-up Panel dialog box.
‰
Do not click the <Add Patient…> button (as you would if you were
creating a normal worklist). Click directly the <OK> button. The Lot
Specific Values dialog box is displayed.
‰
Click <OK> to close the Lot Specific Values dialog box and display the
Worklist window.
‰
When the Worklist window is displayed, select the Edit | Panel Options
menu item. This opens the Worklist Options dialog box.
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Figure 161: Worklist Options dialog box
‰
In this dialog box, check the Archive patient samples during the run item.
‰
Then click on the <Archiving Parameters> button to open the
Archiving Parameters dialog box.
‰
In the Archiving Parameters dialog box, deselect the Automatically
archive loaded patient samples and the Archive at end of worklist
items (or make sure they are deselected), then define the other
parameters as explained in Section 3.6.3.
‰
Click <OK> to close the Archiving Parameters dialog box.
‰
Click <OK> again to close the Worklist Options dialog box and return
to the Worklist window.
‰
Click File | Close to close the Worklist window. A message is displayed
asking you if you want to save this worklist.
‰
Click <No> to close the message without saving the worklist.
‰
Click the <New Worklist> button again. The Set-up Panel dialog box is
displayed and, this time, an Archive "plate" is automatically displayed in
the Plate Tree (see below).
This complete procedure needs only to be performed once. Thereafter,
as long as the items "Automatically archive loaded patient samples"
and "Archive at end of run" remain unchecked in the Archiving
Parameters dialog box, the Set-up Panel will always display an Archive
"plate" when you open it.
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Figure 162: Archive plate in the Set-up Panel dialog box
2) Load the samples you want to archive
‰
Load the samples you want to archive on the instrument as described in
Section 2.2.1.
‰
Wait until the column format Patient Editor is displayed (see Figure 33)
with the sample IDs in the first column.
‰
Check that all barcodes have been correctly read (otherwise, refer to
Section 2.3.2.1) and click the <Close> button. The Patient Editor dialog
box is closed and you return to the Set-up Panel dialog box.
If the samples you want to archive are not barcoded, you can either operate
as said and then enter the sample IDs manually in the first column of the
Patient Editor (column format) or click the <Patient Details…> button in the
Set-up Panel dialog box and enter the patient samples there as described in
Section 2.3.2.3.
3) Define the sample archiving run
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‰
Back in the Set-up Panel dialog box, select the Archive "plate" in the
Plate Tree.
‰
Click the <Add Patient…> button. This opens the Select Patients
dialog box (see Figure 49).
‰
Select the patient samples you want to archive and click <OK>. The
selected samples are now displayed in the Set-up Panel.
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Figure 163: Archive plate with patients
‰
For multiple archiving (i.e. if you want a primary sample to be archived in
two or more secondary tubes or plate wells), you can click <Add
Patient…> again. In the Select Patient(s) dialog box, check the Allow
multiple determinations item and select some Patient IDs again. When
you click <OK> and go back to the Set-up Panel, a "(x2)" tag has been
added to each twice selected Patient ID. Note: This can also be done
automatically via the No. of replicates field of the Archiving
Parameters dialog box (see Section 3.6.4), but only if multiple archiving
is intended for all Patient IDs.
‰
Click <OK> to close the Set-up Panel and open the Worklist window.
4) Load other resources and start the run
‰
In the Worklist window, click the <Start> button to open the Load dialog
box.
Figure 164: Load archive plate
‰
226
Load the required resources (tips, archive plate or secondary tubes) as
shown in the Load dialog box. On loading and identifying the archive
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plate, see Section 3.6.5. On loading and identifying secondary tubes,
see Section 3.6.6.
‰
Click <OK> to start the sample archiving run.
3.6.2 Archiving Samples within a Normal Run
The way to add a sample archiving process to a normal (assay testing) run
depends on whether you want to automatically archive all the samples
tested or to archive only some of the samples tested.
To automatically archive all the samples tested:
‰
Create your worklist as usual (see Section 2.4.2).
‰
When you have finished defining your worklist and the Worklist window
is displayed, select the Edit | Panel Options menu item.
‰
This opens the Worklist Options dialog box (see Figure 161).
‰
In this dialog box, check the Archive patient samples during the run item.
‰
Then click on the <Archiving Parameters> button to open the
Archiving Parameters dialog box.
‰
In this dialog box, check the Automatically archive loaded patient
samples item.
‰
After setting the other archiving parameters (see below), click <OK> to
go back to the Worklist window and perform your test run as usual.
To archive only some of the samples tested:
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‰
Create your worklist as usual (see Section 2.4.2).
‰
Make sure the Archive "plate" is displayed in the Plate Tree of the Setup Panel. If not, display it using the procedure described in Section
3.6.1 under 1).
‰
Click the <Add Patient…> button to open the Select Patient dialog box
(see Figure 49) and select the sample IDs you want to archive.
‰
Click <OK> to close this dialog box. The selected samples are now
displayed in the Set-up Panel.
‰
For multiple archiving (i.e. if you want a primary sample to be archived in
two or more secondary tubes or plate wells), you can click <Add
Patient…> again. In the Select Patient(s) dialog box, check the Allow
multiple determinations item and select some Patient IDs again. When
you click <OK> and go back to the Set-up Panel, a "(x2)" tag has been
added to each twice selected Patient ID. Note: This can also be done
automatically via the No. of replicates field of the Archiving
Parameters dialog box (see Section 3.6.4), but only if multiple archiving
is intended for all Patient IDs.
‰
Perform your test run as usual
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3.6.3 Imported Worklists with Sample Archiving Orders
It is possible to include sample archiving orders in imported worklists.
This feature is available only with ASCII file imports, not ASTM.
The basic structure of imported ASCII (*.txt) worklist files is described in
Section 3.13.1.3. It generally includes at least a "Patient ID" field and one or
more "Test name" fields.
For each "Patient ID", if one "Test name" is "Archive", the respective sample
will be archived.
The imported worklist file may also include an optional "Secondary Tube"
field used to specify the barcode ID of the secondary tube when archiving is
to be done in tubes.
The Secondary Tube ID is only used for identifying the tube(s) the
sample is archived to. The secondary tube ID is neither reported in the
archive information nor available in the dialog box for selection of
archived samples.
If the Archive to setting of the Archiving Parameters dialog box is set
to "dilution plate", the samples will be archived into plates even if the
import file includes a Secondary tube value.
When a file in which an "Archive" test name is included (for some or all
Patient IDs) has been imported and you load the corresponding samples on
the instrument, the system automatically generates the corresponding
worklist, including an Archive "plate".
After clicking <OK> to confirm the worklist and close the Set-up Panel
dialog box, you can review and, if you want, edit the other archiving
parameters as explained below (select Edit | Panel Options, then click the
<Archiving Parameters…> button to open the Archiving Parameters
dialog box).
When the worklist is processed, the samples for which an "Archive" test
name has been included will be archived.
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3.6.4 Archiving Parameters
Figure 165: Archiving Parameters dialog box
Options
Automatically
archive loaded
patient samples
Archive at end of
worklist
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Check this item only if you want to automatically archive all the samples
tested in a worklist.
Uncheck it if you want:
•
to archive samples independently (not within a worklist), or
•
to archive samples within a worklist but only selected samples.
This item is relevant only when the sample archiving process is added to a
normal worklist. If this item is checked, the archiving is done only when the
samples have already been pipetted into all the test plates. If this item is
not checked, the archiving is done at any time during the run when the
pipettor is not already busy.
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No. of Replicates
You can use this item for multiple archiving (i.e. if you want each primary
sample to be archived in two or more secondary tubes or plate wells). For
example, if this item has been set to "2", when you add the Patient IDs in
the Set-up Panel dialog box, they will be automatically selected twice
(signaled by the "(x2)" tag). Note however that this means that ALL Patient
IDs will be archived twice. If you want multiple archiving only on some
specific samples (and single archiving on the rest), set this item to "1" and
use instead the multiple determination option in the Select Patient(s)
dialog box (as described in Section 3.6.1 under 3)).
Minimum number of replicates = 1, maximum = 96.
Archiving Area
Specify where the samples should be archived.
Archive to
The choice here is between dilution plates and test tubes (i.e. secondary
sample tubes). For details, see Sections 3.6.5 and 3.6.6 below.
Plate type
Use the drop-down list to select a plate type (e.g. deepwell plate).
<Plate Types...>
If the desired plate type is not available in the drop-down list, click this
button to open the Plate Type Editor dialog box (see Section 3.12.3.1.1)
to add a new plate type.
Sample Aspirate
Aspirate parameters:
Volume
Specify the aspirate volume. Default is 800 ul (=µl). For multi-pipetting and
large volume archiving (see Section 3.6.9).
Profile
Specify the aspirate profile to be used. Default is profile 0 (on pipetting
profiles, see Section 3.10.4.2).
Sample Dispense
Dispense parameters:
Volume
Specify the dispense volume. Default is 800 ul (=µl). Enter a smaller
volume if using ordinary flat-bottom or round bottom plates (see Section
3.6.9). The Sample Dispense / Volume cannot be greater than the
Sample Aspirate / Volume.
Profile
Specify the dispense profile to be used. Default is profile 0 (on pipetting
profiles, see Section 3.10.4.2).
In liquid dispense
If this item is checked, the system starts by dispensing the Z-max volume
at the Z-max position (deepest position) and dispenses the remaining
volume with reverse tracking of the pipettor.
This option is useful as it prevents splashing and reduces significantly the
risk of contamination.
Z-max volume
Define the volume to be dispensed at the Z-max position.
Example: Z-max volume = 50
The pipettor moves to the Z-max position (LLD not active), dispenses 50
µl and starts dispensing the remaining volume with reverse tracking.
Example: Z-max volume = 0
The pipettor moves to the liquid surface (LLD active) and starts dispensing
the dispense volume with reverse tracking.
Wash (Needle)
230
Do not specify anything in this field. This field was included in case the
pipetting would be done through aspirating and dispensing needles. It is
inapplicable in the case of instruments operating with a pipettor and
disposable tips.
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Active wash
--- Not applicable ---
Pump time
at waste position
--- Not applicable ---
Pump time
at wash position
--- Not applicable ---
Syringe volume
--- Not applicable ---
<OK>
Saves the parameters and returns to the Worklist Options dialog box.
<Cancel>
Discards the changes and returns to the Worklist Options dialog box.
3.6.5 Archiving in Archive Plates
The samples will be archived into archive plates if you have selected
Dilution plate in the Archive to field of the Archiving Parameters dialog
box. The archive plates have to be loaded on the instrument in the dilution
plate tray.
In the Load dialog box, you can see in which position(s) the archive plate(s)
should be placed. Note that if you intend to archive the samples within a test
run which also includes an assay with a pre-dilution step, two types of plates
will be shown in the dilution area of the Load dialog box.
Figure 166: Archive plate in the Load dialog box
Different colors let you identify which plates are pre-dilution plates and which
plates are archive plates.
Green
Blue-green
Pre-dilution plate
Archive plate
Moving your mouse over each plate also lets you know what type of plate it
is.
Double-clicking on an archive plate opens the Object ID dialog box.
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Figure 167: Object ID dialog box
In this box, you can enter a specific ID for your archive plate (max. = 20
characters).
3.6.6 Archiving in Secondary Tubes
The samples will be archived into secondary tubes if you have selected Test
tubes in the Archive to field of the Archive Parameters dialog box.
To be able to archive samples into secondary archive tubes, you need
to have Z racks (20-position archiving racks) or S racks (22-position
archiving racks) Both Z and S racks are specially adapted sample
racks (see Section 1.1.1.2). If you do not have any Z (or S) sample
racks, call you Bio-Rad Service Engineer.
In the explanations below, only Z (20-position) archive racks and T (20position) sample racks are mentioned but the same would apply with S (22position) archive racks and B (22-position) sample racks. Note that it is
possible to use in the same run T racks for primary sample tubes and S
racks for secondary tubes, for example if the tubes you intend to use for
archiving are smaller than the primary tubes.
Rack preparation / Tube barcodes
Prepare your T racks with the primary samples and your Z racks with the
(empty) secondary tubes.
If possible, label the secondary tubes in the Z racks with the same barcodes
as the samples. For example, if your samples are barcoded "00001" to
"00080", your secondary tubes should also be labeled "00001" to "00080". If
you want to be able to differentiate sample tubes from archive tubes visually
to avoid any mix-up after the run, see Section 3.6.9.
Run preparation
Load the T sample racks on the instrument and define your archiving
worklist as described above in Section 3.6.1 for independent sample
archiving or in Section 3.6.2 for archiving within a normal run.
Continue until you get to the Load dialog box.
Secondary tubes - Loading and identification
In the Load dialog box, you should see the loaded T sample racks in the
sample and reagent unit and the yet unloaded secondary tubes in the
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Unallocated Resources area, as well as reagents if the sample archiving is
done within a normal run.
Figure 168: Unloaded secondary tubes
Primary and secondary tubes are identified by different colors (these colors
can be changed on the Pipette tab of the System Set-Up dialog box, see
Section 3.10.4.1).
‰
Now load the Z racks (secondary tubes) on the instrument next to the
sample racks.
‰
If the secondary tubes have the same barcodes as the primary tubes,
the primary tubes are automatically matched to the corresponding
secondary tubes and the Load dialog box is updated. This also applies if
the IDs of the secondary tubes have been included in the imported
worklist file (see Section 3.6.3). If the secondary tubes have either no
barcode labels (not recommended!) or barcodes that are different from
the barcodes of the primary samples (and for which no secondary IDs
have been imported), the association between primary tubes and
secondary tubes has to be entered manually as explained below.
Figure 169: Loaded secondary tubes
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When all tubes and resources have been loaded and allocated, click
<OK> to close the Load dialog box and start the run as usual.
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Non-barcoded secondary tubes (or non-matching barcodes)
It is generally not recommended to use non-barcoded secondary tubes or
secondary tubes with non-matching barcodes for sample archiving.
However, if you cannot avoid this (and cannot import the secondary tubes ID
from the LIS either), it is possible to enter the associations between primary
tubes and secondary tubes as follows.
Before defining the worklist:
‰
Open the door of the samples and reagent unit.
‰
Insert the first T rack with primary samples on the track indicated by a
red LED.
‰
Wait until the column format Patient Editor is displayed.
Figure 170: Primary tubes identification
234
‰
If your primary tubes were barcoded, check that the barcodes have been
correctly read. If your primary tubes were not barcoded, enter the IDs
manually in the Patient IDs column.
‰
Click <Close>.
‰
Insert the first Z rack with empty secondary tubes on the next track. Wait
until the Secondary Tubes dialog box is displayed.
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Primary tubes loaded
on track 12
Figure 171: Secondary Tubes dialog box
‰
If the secondary tubes were not barcoded, all entry fields are blank. The
IDs of the primary samples you previously loaded are shown on gray
background under the Track field. The digits in the Track field show on
which track these samples are loaded. You now need to enter manually
the IDs of the primary samples and of the secondary tube associated to
each sample.
‰
If the secondary tubes were barcoded, the barcodes read on the Z rack
by the barcode scanner are listed in the Secondary IDs column and in
the Primary IDs column (by default, the system assumes that primary
and secondary tubes have the same barcodes). If you use non-matching
barcodes, delete the entries in the Primary IDs column and enter
manually the barcodes of the primary samples.
‰
When all primary samples Æ secondary tubes associations are done,
click <Close> to close the dialog box. Repeat for each T rack / Z rack
pair.
‰
When done, define your worklist (including the archiving parameters)
and start the run as usual.
3.6.7 Archiving Information and Archiving Report
Figure 172: Archiving information
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In the Worklist window, clicking on the Archiving section in the Worklist Tree
will display the Patient Archiving Information for the current worklist. This
information includes, for each archived sample:
• Patient ID,
• Patient name
• Patient birthdate,
• Archive location, i.e. tube location or archive plate ID and well location,
• Volume archived in µl (if a pipetting error was detected, a "<" sign is
displayed before the volume archived indication),
• Pipetting flags (if any).
To print this information, click the <Print> button on the toolbar or select the
File | Print menu item.
To save and/or export a (*.txt) file archiving report:
‰
When your worklist is fully processed, select the Edit | Export Archive
menu item. This will open the following dialog box.
Figure 173: Saving or exporting the archive report
‰
Select the directory in which you want to save (or to which you want to
export) the file.
‰
If you want, change the file name (the default file name has the following
format "A+year+month+day.txt").
‰
Click the <Save> button.
The (*.txt) archiving report includes the same items listed above, separated
by a comma.
Use any text editor to open and print this report (but not the EVOLIS
software).
No Patient Archiving Information is displayed if the EVOLIS system is
in Demo Mode. The (*.txt) Archive report file will be generated but it will
be empty.
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3.6.8 Testing Archived Samples
The special procedures described below apply only to samples
archived into archive plates. When samples have been archived into
secondary tubes, you can process them normally (as if they were
primary samples).
3.6.8.1 Samples Archived on the EVOLIS System
When you need to test or retest samples that have been archived on an
archive plate at an earlier date and the archiving process has been done on
the same EVOLIS system:
‰
Click the <New Worklist> button to open the Set-up Panel dialog box
and start creating your worklist normally (<Add Plate…>, <Add
Assay…>..).
Figure 174: Testing archived patients
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But instead of the <Add Patient…> button, click on the <Archived
patient…> button. This opens the following dialog box.
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Figure 175: Selecting archived patients
Patient ID
Archive Plate ID
Archived sample IDs.
ID of the archive plate(s).
Well Location
Location of each sample on each archive plate.
Date Archived
Date on which the archive plate was created (for external archives – see
below – this is the date on which the External Archive Information file was
imported into the EVOLIS system).
Allow multiple
determinations
If a sample is already assigned to the worklist (e.g. has already been
selected on another plate), it no longer appears on the list. To test the
same samples with the same assay twice in the same run, check this item.
Already assigned samples are displayed again in the list and can be
reselected.
Filter
All Archived Plates
Includes in the list samples from all plates archived on the EVOLIS system.
Archive Plate ID
Allows you to look only for samples archived on one specific archive plate
(check the item and enter the plate ID in the respective field).
All Sample IDs
Depending on the item selected before, includes in the list all the samples
archived on all plates or on a specific plate.
Sample IDs between
(…) and (…)
Allows you to look only for specific samples (check the item and enter the
sample IDs in the respective fields).
<Apply Filter>
When you have checked the desired sort criteria, click this button to view
the results.
‰
238
If necessary, use the Filter options to reorganize the sample list and find
the samples you want to (re)test and click <Apply Filter>.
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‰
Then, in the displayed list, select the samples you want to (re)test (use
the CTRL key to select non-consecutive samples) and click <OK>.
‰
The system returns to the Set-up Panel in which the selected archived
samples are now displayed. Finish the rest of the worklist creation
process as usual.
When loading the required resources, the system prompts you (through the
Load dialog box) to load the archive plate (containing the archived samples
to be tested) in the dilution area. During the run, the pipettor will pipette each
archived sample directly from the archive plate into the test plate.
1) The Result Report does not include any indication that the samples
used were pipetted from an archive plate.
2) If flags (e.g. clot, insufficient liquid) were returned during the
archiving process, they are saved in the original archive report (see
Section 3.6.7) but not mentioned again in the new Result Report.
3.6.8.2 Samples Archived on Another System
If the archive plate has been prepared manually or on another system
(including another EVOLIS system), you can still use the archive plate
directly, i.e. without having to transfer the archived samples into tubes.
But first you need to import an External Archive Information file so that the
EVOLIS system can identify the exact location of each sample on the
archive plate.
External Archive Information files are fixed format ASCII files with an (*.aim)
extension. They include the following data (separated by a comma and a
space):
Sample ID, Plate ID, Well Location, Sample Volume, Flag(s) (if any)
(example)
1750, 030930-002, A1, 200, ManID, , , , , , ,
1753, 030930-002, B1, 200, ManID, , , , , , ,
1752, 030930-002, C1, 200, ManID, , , , , , ,
1759, 030930-002, D1, 200, NoLiq, ManID, , , , , ,
1751, 030930-002, E1, 200, ManID, , , , , , ,
If you prepared your archive plate manually, you can create a corresponding
External Archive Information file on any text editor. Create a (*.txt) text file
then change its extension into (*.aim). Make sure the commas and spaces
are correct.
If you prepared your archive plate on another EVOLIS system, copy the
(*.txt) archiving report (see Section 3.6.7) and change the copy's extension
into (*.aim).
If you prepared your archive plate on a different instrument, adapt and
rename the archiving report file created by the instrument so that it
corresponds to the above import format.
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To import an External Archive Information file:
‰
Select the File | Open menu item.
‰
In the Open dialog box, select the desired (*.aim) file and click <Open>.
Figure 176: Importing an external archive
‰
Click <OK> to close this message and create your worklist as described
in the previous section.
‰
When you click the <Archived Patient…> button in the Set-up Panel
dialog box, the archived information you imported is now included in the
list displayed in the Select Archived Patient(s) dialog box.
Figure 177: Imported archived patients
‰
Finish your worklist creation process and start your run as described in
the previous section.
3.6.9 Tips and Troubleshooting
Pipetting errors during the archiving process
The Archiving Parameters dialog box does not include a field allowing
users to specify an "action on error" option (as exists in the Pipette step
dialog box, see Section 3.12.3.3.1). If a pipetting error occurs during a
sample archiving operation the system automatically uses the "log and
continue" mode. For example, if a clot is detected in a sample, the pipettor
moves on to the assigned archiving tube or archiving plate and dispenses
whatever quantity of liquid is present in the tip (i.e. the quantity it has been
able to aspirate before the clot).
The respective sample is flagged with "Clot" in the Archiving Report and the
pipetting error is traced in the log file.
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Sample Aspirate and Sample Dispense volumes
In the Archiving Parameters dialog box, the default Sample Dispense /
Volume is 800 µl. If you intend to archive your samples in standard flatbottom or round-bottom plates, do not forget to enter a smaller dispense
volume (recommended is 300 µl for flat-bottom and 200 µl for round-bottom
plates). Otherwise, when you confirm your archiving parameters by clicking
<OK>, the system will display an error message stating:
"All of the dilution resources have been used."
Another option is to select deepwell plates as archive plates in the Plate
type drop-down list.
Multiple archiving
If multiple archiving has been programmed, during the archiving process, the
pipettor will dispense each sample in consecutive wells of the archive plate
(e.g. Sample 1 Æ A1 and B1, Sample 2 Æ B3 and B4, etc.) or in two or more
secondary tubes.
If you want the pipettor to make a multishot dispense (e.g. aspirate once
then dispense the two wells in succession), make sure to enter the
appropriate values in the Sample Aspirate / Volume and Sample
Dispense / Volume fields of the Archive Parameters dialog box. For
example 220 µl as sample aspirate volume (allowing for oversoak) and
100 µl as dispense volume.
Volume offset error
The following volume offset error message is displayed if the aspirate
volume and dispense volume values you defined are incompatible with the
volume offset values stored in the system.
Figure 178: Volume offset error
If this happens, click <OK> to close the error message. A second error
message is displayed ("Scheduling error"). Click <OK> again to close this
second message. Then go back to the Archiving Parameters dialog box
and edit Sample Aspirate / Volume and Sample Dispense / Volume
values until this error message is no longer displayed.
Archiving large volumes
If you select an archiving volume higher than 1000 µl (maximum capacity for
large tips), the system will automatically perform several pipetting operations
in order to archive the selected volume. For example, if, in the Archive
Parameters dialog box, you have set the Sample Aspirate / Volume to
2500 µl and the Sample Dispense / Volume also to 2500 µl, the pipettor will
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execute three successive pipetting operations from the primary to the
secondary tube (with the same tip).
Microtube trays
Because the EVOLIS pipettor uses disposable tips and not pipetting
needles, it is recommended not to use trays with individually removable
microtubes for sample archiving as these can be responsible for various
pipetting errors: collisions because of misplaced tubes, tubes sucked out of
the tray when the tip moves out…
If you need to archive large volumes, use deepwell plates with fixed wells or,
for even larger volumes, secondary tubes.
Barcode labels for primary and secondary tubes
If, as recommended, you have used the same barcode IDs for your primary
and secondary tubes (e.g. primary sample tube "00001" corresponds to a
secondary tube also labeled "00001") you may want to add on or two digits /
characters to be able to visually differentiate sample tubes from archive
tubes. For example you may decide to label the primary tubes with an
additional "S" for "sample" (e.g. "S00001") and the secondary tubes with an
"A" for "Archive" ("A00001"). If you want this prefix to be for visual
determination only and to be overlooked by the barcode reader, edit the
scanner settings so that this prefix is omitted when the tubes are scanned
(see Section 3.10.6.2).
Secondary tubes loaded on ordinary sample racks
If the following error message is displayed, this generally means that the
system has detected two identically barcoded tubes although no multiple
determination has been defined in the worklist. Check that you have not
inadvertently loaded some secondary archiving tubes (with identical barcode
labels) on a standard T sample rack instead of on a Z archiving rack.
Figure 179: Duplicate patient ID error
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3.7 Retesting Samples
In most cases, if a sample is found to be reactive in a first test, at least one
re-testing is required to confirm (or infirm) the result obtained in the first test
and the patient's status as positive (or negative).
The re-testing of reactive samples can be ordered manually, on a case-bycase basis, after examining the results of the first test.
For a more systematic approach, it is possible to define precise retesting
criteria at assay level. If this has been done, any sample found to comply
with these criteria is automatically retested.
3.7.1 Case-by-Case Retest Orders
If, after examining the results, you decide that some patient samples need to
be re-tested:
‰
Select the Edit | Retest menu item (available if a Result Report window
is active). This opens the following dialog box.
Figure 180: Retest patients
‰
Select the patients to be re-tested. Use the CTRL and Shift keys for
multiple selection.
‰
Click <OK>.
These patients, with the corresponding assay, will be transferred back to the
Patient Editor dialog box, so that they can be re-tested next time a worklist
is created for that assay.
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Figure 181: Patient Editor with patients to be re-tested
3.7.2 Automatic Retest Procedure
A Retest tab is included both in the Qualitative Settings dialog box (see
Section 3.12.3.4.4) and in the Quantitative Settings dialog box (see Section
3.12.3.4.5).
Figure 182: Retest tab
On this tab you define the conditions for automatic retesting in reference to
the result calculations defined on the other tabs of the Qualitative or
Quantitative Settings dialog box.
Defining retest conditions is very complex (see example below) and
requires specific training. It is beyond the scope of this general
reference manual. If you require more information on this function (e.g.
to evaluate if it could be useful for you), please call your local Bio-Rad
representative.
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Example of qualitative settings with retest conditions
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3.8 Using External Controls
External controls may be used to monitor consistent system/assay
performance and/or assist in complying with accreditation and regulatory
requirements.
The EVOLIS software allows you to define your external controls and include
them directly in your worklist without having to edit or redefine the
corresponding assay files.
3.8.1 Defining the External Controls
When you define external controls, these are defined in reference to a
particular assay file. Once defined, they can be processed directly in the
current worklist or the definition can be saved and recalled each time you
intend to process the same assay.
To define external controls:
‰
Click the <New Worklist> button and start defining your worklist as
described in the basic worklist definition procedure (see Section 2.4.2).
‰
Once you have assigned the selected assay to your plate, select the
Use External Controls checkbox. The <External Controls…> button is
now enabled.
Figure 183: Define external controls – Step 1
‰
246
Click the <External Controls…> button. This opens the External
Controls dialog box.
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Figure 184: Define external controls – Step 2
‰
The name of the test for which you are defining an external control is
displayed automatically in the Assay field. Click <New…> to define a
new external control for that assay. This opens the External Control
dialog box.
Figure 185: Define external controls – Step 3
Name
Enter a name for your control.
ID
Enter the barcode identifier to be used on the control container / tube you
will load on EVOLIS. If you use non-barcoded containers / tubes for your
external controls, you can leave this field blank but you will have to allocate
the external controls manually in the Load dialog box.
QC On Call
If you use QC On Call or Unity Real Time (URT) as quality assurance
systems (see Section 3.8.4), enter the QC On Call / URT specific ID for this
control. If you do not track your controls with QC On Call / URT, you can
leave this field blank.
Position
Define the position of the external control on the plate.
First - The external control will be dispensed in the well located directly
after the last assay-specific control and before the first sample.
Random - The external control will be dispensed in any well between the
first and last samples on the plate.
Last - The external control will be dispensed in the well located directly
after the last sample.
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‰
Click <OK> to save and close the External Control dialog box.
‰
Repeat this step to define other external controls for this assay. When
done, click <OK> twice to go back to the Set-up Panel dialog box.
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Figure 186: External controls defined
‰
You can see that your external controls are now visible on the plate
layout, with an "EC" label. Note that because there are no samples
assigned yet, all controls are shown one after the other irrespective of
the positions you defined in the External Control dialog box.
‰
You can now either click <Add Patient…> to add patient samples now
and finish defining your worklist,
or,
‰
Click <OK> to save the external controls you have just defined for future
use. You will need to click <OK> again in the Lot Specific Values
dialog box and then close the worklist without processing it (select File |
Close).
3.8.2 Including External Controls in a Worklist
To test samples while including external controls on the plate:
248
‰
Click the <New Worklist> button to open the Set-up Panel dialog box.
‰
Define your worklist as usual, i.e. click <Add assay…>, <Add
Patient…> if you usually define your worklists manually, or review the
automatically generated worklist if you generally work with imported test
orders.
‰
Once you have defined your worklist, select the assay for which you
want to include external controls.
‰
Select the Use External Controls checkbox. If external controls had
been pre-defined, these are automatically added to the plate layout. If no
external controls had been pre-defined for that assay, you need to define
them now as described in Section 3.8.1.
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Figure 187: Plate layout with external controls
‰
Complete your worklist definition as usual.
3.8.3 Loading External Controls
Barcoded external controls
If your external controls are in barcoded containers/tubes and you have
entered the barcode ID in the ID field of the External Control dialog box
(see Figure 185), you can load them on any sample rack and in any position.
The system will identify them and pipette them accordingly.
Non-barcoded external controls
If your external controls are non-barcoded, you will need to allocate them
manually, in the Load dialog box, to the rack position in which you loaded
them (as for non-barcoded samples, see Section 2.5.2.2).
3.8.4 Tracking External Controls with Unity Real Time (URT)
External controls can be tracked using the EVOLIS lot tracking function and
the resulting data can be further interpreted with external QA software such
as Unity Real Time (for more information, see Section 3.5.5).
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3.9 Pressure Monitoring (APM)
3.9.1 Pressure Monitoring Device
New generation EVOLIS instruments are equipped with a pressure
monitoring device. Older systems can be upgraded if required (information
can be obtained from your Bio-Rad Service Engineer).
The explanations included in the following Sections apply only to
instruments equipped with a pressure monitoring device.
If you examine closely the top part of the EVOLIS pipettor, you can
determine if your EVOLIS system is equipped with a pressure monitoring
device.
When the system is equipped with a pressure monitoring device, a small
plastic clip is fixed at the top of the pipettor. This clip is connected to the
pressure monitoring electronic card by a specific wire (so that there are two
visible wires connecting the pipettor to the system instead of one for
instruments without pressure monitoring).
Pipettor with pressure monitoring
Pipettor without pressure
monitoring
Figure 188: Pipettor with / without pressure monitoring device
The tip-holding end of the pipettor is also different.
3.9.2 Purpose
If pressure monitoring is installed and enabled, when a worklist is processed,
the system monitors the pressure changes in the pipettor during each
aspirate step and compares it to predefined pressure thresholds.
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p max
PRESSURE
p min
p mean
p stop
p max static
p min static
TIME
Figure 189: Pressure thresholds
If at any time the aspirate pressure detected exceeds or falls below the
relevant threshold values, the system treats it as a pipetting error (for more
information, see Section 3.9.4).
To display (and print) a complete list of the predefined air pressure
monitoring thresholds, select File | New Æ APM Report (see Section
1.2.4.4).
3.9.3 Enable / Disable Pressure Monitoring Function
In the software, the pressure monitoring can be enabled / disabled at three
different levels:
• At system level, in the System Set-Up dialog box (Pipette tab, see
Section 3.10.4.1).
• At assay level, in the Assay Header dialog box (see Section 3.12.3.1).
• For each individual aspirate sub-step (see Section 3.12.3.3.1, paragraph
4), if the aspirate sub-step is part of a Pipette step and Section
3.12.3.3.4 if the aspirate sub-step is part of a Dispense step).
For a given aspirate step, the pressure monitoring is enabled only if
pressure monitoring is enabled at all three levels (system, assay and
individual step).
Under default settings, when using Bio-Rad predefined assays, pressure
monitoring is enabled at assay level and individual aspirate step level but
disabled at system level.
System
Assay
Asp.
Pressure Monitoring Status
Step
Æ Pressure monitoring is disabled
To enable pressure monitoring for all assays and all steps, you only need to
go to the System Set-Up dialog box, Pipette tab and enable pressure
monitoring at system level.
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System
Assay
Asp.
Pressure Monitoring Status
Step
Æ Pressure Monitoring is enabled for all assays and all
aspirate steps.
If you want to enable the pressure monitoring system generally but disable it
on a particular assay, open the Assay Header dialog box for that assay and
deselect the Pressure Monitoring item.
System
Assay
Asp.
Pressure Monitoring Status
Step
Æ Pressure Monitoring is generally enabled but
disabled on that specific assay.
This can even be done for Bio-Rad password-protected assays as the
Pressure Monitoring item is also available in the restricted Assay Header
dialog box (see Section 3.12.2.2).
As a user, you cannot disable pressure monitoring on individual assay steps
in predefined Bio-Rad assays, you can only do it for the assay as a whole.
3.9.4 Pressure Monitoring Errors
If at any time the aspirate pressure detected exceeds or falls below the
relevant threshold values, the system treats it as a pipetting error (see
Section 2.7.5.3) and.
• Flags the respective result / well with the appropriate pressure
monitoring flag.
• Signals the pipetting error in the event log.
• Triggers the "action on error" predefined for pipetting errors on that
aspirate step (see Section 3.12.3.3.1).
If the predefined "action on error" is "Raise alarm and stop", the processing
will be paused and an error message will be displayed indicating:
"APM error in […]"
"Possible causes: [clot / air / foam]"
The operator then has the following options:
<Retry>
252
The system retries the same aspirate operation.
<Abort Plate>
The system aborts the processing of the whole plate, i.e. even the wells
dispensed before the interruption are not further processed.
<Continue>
The system dispenses whatever volume it was able to aspirate in spite of
the pressure monitoring error and attempts to continue the processing.
Affected wells are flagged and it is the biologist's responsibility to evaluate
whether the wells can be validated or not.
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If the predefined "action on error" is "Log and continue", the processing
continues as planned but the APM error is traced in the Event Log and the
corresponding results are flagged as follows.
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Flag
Description
(included in the Event Log)
P_delay
P_max_high
P_min_low
P_stop_high
P_static_high
P_static_low
P_mean_low
Pressure rise delayed
Aspiration pressure too high
Aspiration pressure too low
Pressure at pump stop too high
Static pressure too high
Static pressure too low
Mean pressure too low
Hint in error message
(if error message is
displayed)
Foam or air
Clot
Foam or air
Clot
Clot
Foam or air
Foam or air
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3.10 Customizing the System
The Utilities | System Setup menu item opens the System Set-Up dialog
box, which includes nine tabs. Access to this menu item may be restricted
(see note at the end of this Section).
Figure 190: System Set-Up dialog box
The Utilities | Options menu item opens the Options dialog box which
includes nine tabs.
Figure 191: Options dialog box
These two dialog boxes allow you to adapt the EVOLIS system to your
specific circumstances and needs. The Options dialog box lets you specify
software options while the System Set-Up dialog box allows you to adapt
the parameters of each instrument module (incubators, pipetting system,
wash unit, etc.).
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Most parameter settings accessed through these two menu items are
described in this Section. However, some settings are addressed in other
Sections (e. g. Maintenance tab in the Maintenance chapter). Use the
following Reference Table to find the appropriate Section.
System Set-Up dialog box (Utilities | System Setup menu item)
Tabs
System
Section 3.10.1
Incubators
Section 3.10.2
Colorimeter
Section 3.10.3
Luminometer
Section 3.10.3.2
Pipette
Section 3.10.4
Sample Rack
Section 3.10.6.1
Washer
Section 3.10.5
Plate Transport
Section 3.10.6.3
Section 4.3.5
Maintenance
Options dialog box (Utilities | Options menu item)
Tabs
User Groups
Section 1.2.7.2
Users
Section 1.2.7.1
Password
Sections 1.2.2.1.3 and 1.2.7.4
Preferences
Sections 3.10.4.3 (Well
orientation), 1.2.4.1 (Left margin)
and 3.13.1.4 (File export)
File Polling
Section 3.13.1.3.1
Plate Layout Import
Section 3.3
ASTM
Section 3.13.2.1
Laboratory
Section 1.2.6.1
Directories
Section 1.2.6.2
The buttons at the bottom of these dialog boxes apply to all tabs.
<Apply>
<OK>
<Cancel>
This button is always disabled.
Saves the entries on all tabs and returns to the main menu.
Returns to the main menu without saving any entries.
If:
• the System Setup item in the Utilities menu is disabled, or
• the Options dialog box, when it is displayed, is different from the
one displayed in Figure 191 above,
this means that you belong to a user group with restricted access
rights. For more information on access rights and user groups, see
Section 1.2.7.2).
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3.10.1 System
Figure 192: System tab
Communications
Link
Defines the PC’s communication link to EVOLIS instrument.
COM port
Select the COM port for the computer-to-instrument link. Default is COM
port 1 (see Figure 30).
Simulate system
This item is automatically checked when you check the Demo Mode item
in the Log-On dialog box (see Section 1.2.2.1).
Generate a COM
port log
Select this item to document communication via the selected COM port in a
log file.
Command Processor
Information
Serial Number
Information on the EVOLIS COP.
Shows the COP serial number
Firmware Version
Shows the COP firmware version.
Recovery mode
Used for COP firmware upgrades.
<Upgrade Firmware>
Function for performing a firmware upgrade (see Section 3.11.2).
Self-diagnostics
See Section 1.2.3.
Perform self-diagnostics before a run
See Section 1.2.3.
Auto print selfdiagnostics report
See Section 1.2.3.
256
System Serial
Number
Information on the instrument serial number.
Serial number
Serial number of the EVOLIS instrument. This number will be needed if
you call your Bio-Rad representative for support or service.
System Cover
Status of the cover hood of the EVOLIS instrument.
Lockable flap
If this item is checked, the instrument cover remains locked during a run
(see Section 2.7.1). If it is unchecked, the cover may be opened but this
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will pause the worklist (see Section 2.4.8).
3.10.2 Incubators
The EVOLIS instrument includes four independent heated incubators and up
to four darkened room-temperature incubators (to check the location of these
incubators, see Section 1.1.1.10).
Room-temperature incubation can also be done in the upper level work area
(test plate "parking" positions next to the pipetting position) if darkness is not
required. This allows the system to optimize the number of plates being
incubated at the same time.
The four heated incubators can reach a temperature of 50° C. They are
independent so that different test plates can be incubated at different
temperatures at the same time. On defining assay incubation steps, see
Section 3.12.3.3.3.
No cooling system is available on the EVOLIS instrument.
To change the parameter settings for the incubators:
‰
Select System Setup in the Utilities menu.
‰
Click on the Incubators tab.
Figure 193: Incubator parameter setting
Darkened Ambient
Incubators
Setting of the room-temperature incubators.
Number of Positions
Specify how many room-temperature incubators are to be used. This item
is set to 4 and protected against editing.
Prefer use …
If you check this item, the system will use the darkened room-temperature
incubators (and not the upper level "parking" positions) for roomtemperature incubation, even if darkness is not required (This item is
checked and cannot be edited.)
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Options
Setting for the heatable incubators.
Incubators support
shaking
Enable the shaking function of the incubators. (This item is checked and
cannot be edited.)
Pre-heat
Setting for the incubators preheat function on power-up. The incubators
take some time to reach high temperatures. The system will not start a run
if the temperatures required for the assays to be processed are not
reached. If you intend to process assays with high incubation
temperatures, it is a good idea to select a pre-heating on power-up option.
Disable
Last used
temperature
Incubators are preheated to the last used temperature on power-up
(default setting).
Prompt for
temperature
Incubators are preheated to the temperature selected in the window
coming up on power-up.
User-defined
Incubators are preheated to the temperature defined in the fields for
incubator #1 to #4 on power-up (values between 21 and 55 can be
entered).
Information
Serial number
Firmware version
<Upgrade Firmware>
258
Incubators are not preheated on power-up.
System information
Shows the serial number of the incubators.
Shows the firmware version number for the incubators.
Function for performing a firmware upgrade (see Section 3.11.2).
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3.10.3 Photometer
The photometer is used to read the microplate results. Both endpoint and
kinetic reading are possible. On defining the reading parameters for each
assay, see Section 3.12.3.4.1.
On photometer maintenance, see Section 4.4.8. On technical data, see
Appendix A 1.
In the software and in this manual, the words “photometer” and “colorimeter”
are synonymous.
For “luminometer”, see Section 3.10.3.2.
3.10.3.1 Photometer Settings
By default, the photometer on the EVOLIS instrument is equipped with six
filters. Two more filters can be added to suit the user-specific needs. To add
filters, contact your Bio-Rad Service Engineer. To clean the filters, see
Section 4.4.8.
The system is not able to check automatically in which position each
filter is installed. When the system is installed, the appropriate data is
entered in the software by your Service Engineer using the Colorimeter
tab below.
If you ever add or change filters, always make sure the parameters
specified in the software (number of filters, order, wavelengths) strictly
correspond to the filters that are on the instrument.
To check/edit the photometer settings:
‰
Select System Setup in the Utilities menu.
‰
Click on the Colorimeter tab.
Figure 194: Photometer settings
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Filters
Number of filters
Filter 1 ... 8
Number of filters used in the instrument (default is 6).
The number of boxes that are enabled depends on the number that has
been specified above. Shows the wavelength of each filter in nm. The
numbering of the filter in the instrument must match the numbering on this
tab!
Out of Range Values
OVER limit
Enter the upper limit value (OD) for the photometer (e.g. 2.5). The
maximum value that can be set is 3.5. The lower limit value is equal to the
negative value of the upper limit value. The photometer is linear up to
2.000. For other specifications, see Appendix A 1.
Enabled
When the value read by the photometer is OVER the upper limit (or
UNDER the lower limit), you can choose to replace, in the results, the
actual value by another character string, e.g. a wildcard (*), a digit or a
comment.
OVER replacement
value
UNDR replacement
value
Information
Serial number
Firmware version
<Upgrade Firmware>
<Verification Plate>
260
In this case, check the item and enter the replacement string in the
respective field (default is a wildcard sign).
By default, these items are checked and cannot be edited ("grayed").
System information:
Shows the serial number of the photometer.
Shows the firmware version number.
Function for performing a firmware upgrade (see Section 3.11.2).
Click this button to open the Verification Plate dialog box (see Section
4.5.4.2).
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3.10.3.2 Luminometer
The System Set-Up dialog box (accessed via the Utilities | System Setup
menu item) includes a Luminometer tab. A luminometer tool is not part of
the standard equipment of the EVOLIS instrument.
This tab is provided for users who have installed a luminometer so that they
may enter the parameters for this tool.
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3.10.4 Pipette Parameters
3.10.4.1 The Pipette Tab
The Pipette tab is used to define the Pipetting parameters at system
level, i.e. to define how the pipettor works. Do not confuse it with the
Pipette dialog box (see Section 3.12.3.3.1) or the Dispense dialog box
(see Section 3.12.3.3.4) which are used to define, at assay level, which
aspirate/dispense steps the pipettor should execute.
To open the Pipette tab:
‰
Select System Setup in the Utilities menu.
‰
Click on the Pipette tab.
Figure 195: Pipette tab
Options
262
These options are protected against editing.
Syringe volume
Shows the syringe volume of the pipettor pump in microliters (1000 µl).
Disposable tips
This item is always checked (it ensures that a warning message is
displayed if a problem occurs when the pipettor picks up or ejects a tip).
Enable clot
detection
This item is always checked. It ensures that a warning message is
displayed if a clot is detected.
Enable liquid level
detection
This item is always checked. The liquid level detection process enables
the system to monitor the height at the surface of the respective liquid. It
then calculates how the pipettor should move during aspiration/dispense
in relation to the surface of the liquid and the volume to be
aspirated/dispensed.
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Enable pressure
monitoring
Dilution Plates
Coordinates
Select/deselect this checkbox to enable/disable the pressure monitoring
function. For more information on the pressure monitoring function, see
Section 3.9.
See also Section 2.5.4.
The parameters offered here are based on a (*.mpc) file.
Here you select the dilution plates used. The respective file must be in the
EVOLIS program directory.
Maximum Volume
Enter the maximum volume of a well of the dilution plate.
Minimum Volume
Enter the minimum detectable volume of a well of the dilution plate. This
value can be overridden if an alternative minimum volume has been
defined at assay level (see Section 3.12.3.3.1, Aspirate sub-step).
Dilution Tubes
Information about the dilution tubes. Dilution tubes may be used for
sample archiving (see Section 3.6.3). They may also be used for predilution steps (for assays for which such a step is necessary); however,
pre-defined Bio-Rad assays always make use of dilution plates and not
tubes for pre-dilution steps.
Max. Volume
Enter the maximum volume of a dilution tube.
Min. Volume
Enter the minimum detectable volume of a dilution tube.
Colour
Information
Firmware version
Select the colour in which dilution tubes are displayed in the Load dialog
box.
System information:
Shows the current firmware version of the pipetting system.
Bridge version
Shows the current firmware version of the pipetting guide rail (back-front
horizontal movement).
X-Axis version
Shows the current firmware version of the pipetting X-movement (left-right
horizontal) controller.
Z-Axis version
Shows the current firmware version of the pipetting Z-movement (vertical)
controller.
<Upgrade Firmware>
Aspirate Profile
Enable
Function for performing a firmware upgrade (see Section 3.11.2).
See also Section 3.10.4.2 below on Pipetting profiles.
The corresponding profile (selected in the Profile number field) can only
be used by the system if this item is checked. When this item is not
checked, assays using the corresponding pipetting parameters cannot be
processed.
To edit a profile, you need to check this item and then edit the profile
parameters (profiles 5-9).
If this item is disabled ("grayed"), the corresponding profile is protected
and cannot be edited (profiles 0-4).
Profile number
Description
Start velocity
Select the profile which you want to view or edit.
Name of the aspirate profile.
Velocity at the start of aspiration (in Hz).
Top velocity
Maximum aspirate velocity (in Hz).
Acceleration
Enter the acceleration of the aspirate velocity in kHz/s.
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Airgap
This airgap is aspirated before a reagent and blown out after the reagent
to ensure the full dispense of the reagent.
Dive out velocity
Velocity in percent of the maximum velocity used to move the tip out of the
liquid.
Dive out
Distance the tip has to travel up when being moved out of the liquid in
steps of the stepper motor.
Submerge steps
Number of steps the tip is to submerge into the liquid following liquid
detection.
LLD Velocity
Velocity of liquid detection in percent of the maximum velocity.
Transportation
airgap
This airgap is aspirated after a reagent.
Aspirate delay
Delay time after aspiration to allow the liquid to settle.
Dispense profiles
See also Section 3.10.4.2 below on Pipetting profiles.
Enable
The corresponding profile (selected in the Profile number field) can only
be used by the system if this item is checked. When this item is not
checked, assays using the corresponding pipetting parameters cannot be
processed.
To edit a profile, you need to check this item and then edit the profile
parameters (profiles 5-9).
If this item is disabled ("grayed"), the corresponding profile is protected
and cannot be edited (profiles 0-4).
Profile number
Description
Start velocity
Name of the dispense profile.
Velocity at the start of dispensing (in Hz).
Top velocity
Maximum dispense velocity (in Hz).
Acceleration
Enter the acceleration of the dispense velocity in kHz/s.
Cutoff velocity
Dive out velocity
Dive out
Resoak
Cutoff velocity in Hz (stop velocity).
Velocity in Hz with which the tip is moved out of the liquid.
Distance the tip to travel when being moved out of the liquid (in steps of
the stepper motor).
Define how much liquid in µl is resoaked again after dispensing.
Dispense delay
Delay time before dispensing (the pipettor moves from the reagent bottle
to the test plate and waits) to allow the liquid to settle.
Active washing
Pipette parameters for washing:
Dive out velocity
Velocity in Hz with which the tip is moved up out of the liquid. This should
be set slower than the normal velocity.
Dive out
Distance the tip has to travel when being pulled out of the liquid (in steps
of the stepper motor).
Sample Tubes
Colour
LLD Parameters
264
Select the profile which you want to view or edit.
See also Section 2.5.2.2.
Select the color in which sample tubes are displayed in the Load dialog
box.
Liquid Level Detection parameters.
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Verifies
Do not change the default settings.
Retries
Do not change the default settings.
Bubble Kill
Do not change the default settings.
Pressure Monitoring
Use pressure monitoring in calibration mode (without reference to
predefined APM thresholds).
Calibration Mode
Use of this item is reserved for Bio-Rad personnel only. Do not check
this item!
3.10.4.2 Pipetting Profiles
Purpose
The purpose of pipetting profiles is to optimize the pipetting process (e.g.
increase accuracy and precision, avoid dripping, air bubbles, splashing,
hanging drops, etc.) by adjusting the pipetting parameters to the type of
liquid (samples, controls, reagents) which is aspirated/dispensed and to
other specific circumstances (e.g. multishots, low volumes, large volumes,
etc.).
Defining pipetting profiles
Defining pipetting profiles is done at system level, using the Aspirate Profile
and the Dispense Profile fields in the Pipette tab (see above). However,
defining pipetting profiles is a fairly complex process which requires a good
knowledge of how the pipettor operates and adequate testing.
This is why the software includes some pre-defined profiles.
Profile Number
0 to 4 (included)
Pre-defined profiles.
These profiles are protected (read-only). They cannot be edited
but the profile parameters can be viewed in the Pipette tab.
5 to 9
(included)
User-definable profiles.
To define a new profile, select one of these profiles (e.g.
Aspirate6), rename it and enter the desired parameters.
10 to 19
(included)
Pre-defined Bio-Rad profiles.
These pre-defined profiles are included in the software but they
are "hidden". This means that you can use them (see below)
but you cannot view them in the Pipette tab (this is why the
Profile number field only scrolls up to 9). They are proprietary
Bio-Rad profiles created for Bio-Rad pre-defined assays.
This adds up to a total of 20 possible aspirate profiles and 20 possible
dispense profiles.
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Using a pipetting profile
If you are using pre-defined assays, the profiles to be used for each aspirate
or dispense operation are already specified in the assay.
If you are creating your own assays, you have to specify the profiles you
want to use:
• when you define your Pipetting steps (see Section 3.12.3.3.1 under 4)
and under 5)),
• and when you enter your reagent data in the reagent database (see
Section 3.4.3.1).
Bio-Rad's Aspirate Profile 18 is a default profile. This means that if you
create your own assays and do not specify an aspirate profile, you will be
using this profile.
Troubleshooting
Defining profiles or even selecting the right profile to use can be difficult in
some cases. If in doubt, contact your Bio-Rad Application Engineer.
3.10.4.3 Pipetting Direction
This option is a software option. It does not change the way the pipettor
operates. It changes the way the results are displayed. Default is columns.
(To change the direction in which the pipettor operates, you have to change
the Fill Orientation field in the Assay Layout dialog box, see Section
3.12.3.2.)
To set/edit the pipetting direction preferences:
‰
Select the Options item in the Utilities menu.
‰
Click on the Preferences tab.
Figure 196: Preferences tab
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‰
In the Well Orientation field, select Columns or Rows.
‰
Confirm with <OK>.
(For information on the Left Margin item, see Section 1.2.4.1 and for the
Automatically create exported result files and Export results if VC fail
items, refer to Section 3.13.1.4.)
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3.10.5 Washer
The parameters of the wash unit are entered by your Bio-Rad Service
Engineer when the EVOLIS system is first installed and almost all of them
are protected against editing. You can view them via the Washer tab of the
System Set-Up dialog box but if you want to change them you need the
assistance of your Bio-Rad Service Engineer.
If you find that the wash unit is not operating correctly, please refer to the
procedures described in Sections 4.3.2.1, 4.3.3.1 (washer quality control
assays) and in Section 4.4.4 (cleaning the manifold needles).
On defining wash steps in an assay, see Section 3.12.3.3.2.
3.10.5.1 The Washer Tab
To open the Washer tab:
‰
Select System Setup in the Utilities menu.
‰
Click on the Washer tab.
Figure 197: Washer tab
Reagent Bottles
Number of
reagent bottles
Dead volume
per bottle
Red/Blue/Yellow
Black/White/Green
268
Parameters for the wash buffer and clean fluid containers.
Number of wash buffer/clean fluid containers used (default is 4).
Dead volume of each wash buffer/clean fluid container in ml.
Capacity
Use these items if you want to use a 1-liter bottle where you
were previously using a 2-liter bottle (or vice-versa). The
change will be reflected in the Load dialog box display of
the wash buffer/clean fluid bottles (see Section 2.5.6). In
any case, always make sure what is specified in the
software corresponds to the actual wash buffer/clean fluid
bottles loaded on the instrument.
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Default
reagent
By default, the clean fluid is always in the red-capped
container while the other containers are used for other wash
buffers, as assigned by the system depending on the
assays selected in a given run.
With these drop-down lists, you can change these default
settings so that a given wash buffer should always be
assigned to a specific bottle, e.g. wash buffer Bio-Rad WB
R2 should always be in the blue-capped bottle. The change
will be reflected in the Load dialog box display of the wash
buffer/clean fluid bottles (see Section 2.5.6).
Check reagent
Purging
Volume (µl/tip)
Cleaning
Volume (µl/tip)
Fluid
<Reagents...>
Clean after every
wash step
Default Heights
The wash buffer volume sensor (float switch) is checked at the beginning
of each wash cycle.
Purge parameters (= cleaning before the first wash step of the worklist).
Purge volume in µl per tip.
Cleaning parameters.
Cleaning volume (µl per tip).
Is defaulted to clean fluid and cannot be edited.
Disabled.
Default is checked and cannot be edited.
Set the height of the dispensing needle during washing. 0 means: highest
position of dispensing needle. You can check the exact height setting as
follows: enter a height and click the <Show> button. The dispensing needle
is then moved to the defined height. If the setting is not yet adequate,
correct the height and click <Show> again.
Should be done only by your Bio-Rad Service Engineer.
Top Wash Height
Aspiration needle on the level of the upper edge of the plate.
Bottom Wash Height
Aspiration needle on a level slightly above the well bottom. On this level,
the dispense tip is also in the liquid for intense washing of the wells
(simultaneous aspiration during dispensing).
Aspirate Height
Aspiration needle on the same level as the well bottom. Set the height
such that the aspiration needles. Notches in the aspiration needles
prevent that the washer heads get stuck.
<Show>
Information
Serial number
Firmware version
<Upgrade Firmware>
<Calibrate>
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See above under Default Heights.
System information
Shows the firmware version number.
Firmware upgrade function.
Function for performing a firmware upgrade (see Section 3.11.2).
Click this button to perform an internal calibration of the 4 dosing units of
the wash system (see Section 4.4.5).
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3.10.6 Barcode Settings
The EVOLIS system is equipped with two barcode scanners.
The first one, located on the right-hand side of the sample and reagent unit
is used to identify:
• Rack types and racks positions.
• Sample tubes.
• Reagent containers and control tubes.
This barcode scanner is a fixed feature of the instrument and it cannot be
turned off even if operating with non-barcoded racks, samples or reagents.
The second barcode scanner is located in the plate loading compartment
and is used to identify
• Test plates.
This barcode scanner can be turned off when operating with non barcoded
test plates.
3.10.6.1 Rack Barcodes
All EVOLIS sample and reagent racks are barcoded. The barcode labels are
located on the right-hand side of each rack. They serve to identify both the
rack type and individual positions on each rack. The largest reagent rack
(rack type –0) is the only rack type that includes a number of "blind" (nonbarcoded) positions (see Section 2.5.3.2 c)).
The system is preconfigured to be able to read the rack barcodes. It is
recommended not to use racks with missing or damaged barcodes.
Replacement barcode labels for EVOLIS racks can be ordered from BioRad (see Appendix A 3). However, if you need to use non-barcoded racks
(or racks with damaged labels), follow the instructions in Section 2.5.2.2 c)
and allocate the on-board samples or reagents manually.
Rack barcodes are used by the system to identify different rack types
but not individual racks. For example, the system can differentiate a
reagent rack from a sample rack or a "T" sample rack from a "Z"
archiving rack but it cannot differentiate one "T" sample rack from
another "T" sample rack.
3.10.6.2 Sample Barcodes
Barcode types
The following barcode types can be used for samples to be processed on
the EVOLIS system.
• 2/5 Interleaved,
• Code 39,
• 2/5 IATA,
• 2/5 Industrial,
• UPCA, UPCE,
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•
•
•
•
•
EAN 8 or 13 digits,
Code 128, EAN 128,
Pharmacode,
EAN Addendum, 2or 5 digits,
Codabar.
Typically, when the system is installed, your Bio-Rad Service Engineer
configures the barcode scanner to accept the barcode types you generally
use on the samples you process. If you later need to change the
preconfigured barcode settings, operate as follows.
To select (or change) the barcode types to be used:
‰
Select the Utilities | System Setup menu item.
‰
Click on the Sample Rack tab.
Figure 198: Setting barcode types to be read
Scanner firmware
version
Barcode Type
Lengths: Min. Max.
Reference of the scanner firmware installed on the system.
List of all barcode types that can be read by the integrated barcode
scanner. If a checkbox is selected, the scanner is able to read the
respective barcode type. It is possible to select several checkboxes but
the more checkboxes are selected, the slower and less accurate the
reading will be. Some barcodes types are always selected and cannot be
unchecked (barcode types used on EVOLIS racks and Bio-Rad
reagents).
Minimum and maximum character length of each barcode type.
Note: Generally, if you do not know these values, you can leave the
default values. However, if you also use the Prefix and Suffix options to
exclude some digits (see below), you should enter in the Min. and Max.
fields exactly the number of significant digits (including the prefix and
suffix) in the respective barcode type. For example, if you use a barcode
format with 14 digits altogether and exclude the date suffix (6 digits), enter
"14" in both the Min. and Max. fields.
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Checksum
Some barcode formats include a checksum digit placed either at the end
or at the beginning or the actual barcode number. In some cases, this
checksum digit is included in the barcode labels attached to the samples
but not in the sample IDs of the test order requests sent by the LIS. In this
case, the EVOLIS system cannot match the imported sample IDs with the
barcode IDs scanned during the sample loading process. To avoid this,
the Checksum column can be used to tell the system to "drop" the
checksum digit scanned by the barcode reader.
If item is checked, EVOLIS excludes the checksum digit (if any) from the
scanned barcode ID. The checksum is excluded whatever its position
(last, first…) in the barcode. If there is no checksum in the barcode label,
no other digit is excluded.
If item is unchecked, EVOLIS includes the checksum digit (if any) in the
scanned barcode ID.
Grayed items show barcode formats that normally require a checksum
digit and for which the EVOLIS system always disregards the checksum.
Auto Load
See Section 2.2.2 under 6).
Options
If the barcode labels include digits which are not relevant to the sample
IDs as used on EVOLIS, you can tell the scanner to skip them by entering
the appropriate number of digits in the Options fields.
Prefix
If the digits to be disregarded are at the beginning of the barcode ID, enter
them under Prefix. For example, if the sample barcodes include 10 digits
altogether but you want the barcode scanner to read only the last 8 digits,
enter two digits in the Prefix field (any digits; the actual digits you type in
are irrelevant, two "wildcards" appear in the field).
Suffix
If the digits to be disregarded are at the end of the barcode ID, enter them
under Suffix. For example, to omit a six digit date format at the end of a
barcode, enter six digits (six "wildcards").
You can also combine the Prefix and Suffix fields. For example, if you
want to disregard one digit at the beginning and one at the end, enter one
digit in each field.
Rack Types
See Section 2.5.2.2 under c).
1) For better reading accuracy, select only those barcode types which
you actually use. Never select all barcode types.
2) To edit the barcode settings just before a run (e. g. to select a
barcode type which you specifically need for this run) you can access
this dialog box by clicking the <Scanner Setup> button in the Load
dialog box (see Section 2.5.1.2).
3) Never use the "Prefix / Suffix" fields to exclude a Checksum (use the
“Checksum” checkbox).
If you intend to make use of the "Checksum" and/or the "Prefix /
Suffix" options, it is essential that you label empty tubes and validate
your settings on these before running actual sample tubes. Check in
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particular that the Sample IDs read by the barcode scanner and the
Sample IDs in the result report correspond to what you expected.
Using several barcode types
You will frequently have to select several barcode types, e.g. when a
laboratory uses one set of barcodes for racks and patient sample tubes differ
from one customer to the other.
In this case, click the corresponding checkboxes. The scanner will work
faster and more precisely if you choose fewer barcode types. Choose only
those you will use. Never check all the barcode types.
If you don’t know the type of barcode used
In most cases, the types of barcodes used are specified by the suppliers of
the various accessories or products. However, it can happen that the user
does not know the type of barcode used. For example, if a laboratory
receives barcoded patient samples or reagent containers but is not sure of
the type of barcode used.
What you can do to identify the barcode type:
‰
Fit the barcoded samples in a rack.
‰
Select the Utilities | System Setup menu item and click on the Sample
Rack tab.
‰
Select three barcode types and click <OK>.
‰
Insert the rack in its track.
‰
When the Patient Editor dialog box opens (see Section 2.3.2.1), check
the first column.
‰
If the system has been able to read the barcodes, the Patient IDs are
already displayed in this first column. In this case, go back to the
Sample Rack tab, select each of these three barcode types one at a
time and, for each type, pull out the rack and then reinsert it until you
determine which of the three barcode types is correct.
‰
If the system has not been able to read the barcodes, the first column is
blank. In this case, click the <Close> button in the Patient Editor dialog
box and open the Sample Rack tab again.
‰
Deselect the three selected Barcode Type checkboxes, select the
following three and click <OK>.
‰
Pull out your rack and insert it again.
‰
Check the display in the Patient Editor dialog box again.
‰
Continue this “trial and error” procedure until you find the appropriate
barcode types.
3.10.6.3 Reagent Barcodes
Most reagents included in Bio-Rad kits are barcoded. In some cases,
barcode labels are provided in the kits and need to be attached to the
respective vials before use. In some cases, barcode labels can be ordered
separately. For more information, refer to the "EVOLIS APF User Manual".
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The barcode settings of the EVOLIS system are preconfigured so that the
system can read all barcode types used on Bio-Rad reagent bottles.
For reagents from other suppliers, select the appropriate barcode types
selected on the Sample Rack tab of the System Set-Up dialog box as
described above. Note however that the Prefix / Suffix options apply to
sample barcodes only, not reagent barcodes.
The barcode type settings selected on the Sample Rack tab enable the
barcode scanner to read the respective reagent barcodes. They do not
enable the system to actually interpret the barcode IDs for reagent lot
tracking purposes. If you intend to use the reagent lot tracking
function, the specific barcode format used (i.e. the meaning of each
digit in a barcode ID) has to be entered in the kit database (see Section
3.5.3).
3.10.6.4 Test Plate Barcodes
The barcode scanner for test plates is located in the test plate compartment.
Under default settings, the test plate scanner is enabled and cannot be
disabled by the user.
This does not prevent you to use the EVOLIS system with non-barcoded test
plates (see Section 2.6.3 on how to load barcoded and non-barcoded test
plates).
If, however, you need to unlock or disable this function, please ask your BioRad Service Engineer.
The Barcode Scanner Fitted item that allows to enable/ disable the test
plate scanner barcode is included on the Plate Transport tab of the System
Set-Up dialog box. To open it, select the Utilities | System Setup menu
item.
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Figure 199: Plate Transport tab
Verify check
characters
Some barcode formats include a checksum digit placed either at the end
or at the beginning of the actual barcode number.
If item is checked, the plate barcode scanner expects a checksum digit (if
any) in the scanned barcode ID and verifies it.
If this item is not checked, the plate barcode scanner reads all digits as
part the barcode ID (no checksum).
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3.11 Upgrading the System
3.11.1 Software and APF upgrades
The EVOLIS software is regularly upgraded. These upgrades introduce
technical improvements as well as new features.
New APF versions are also regularly released. These include new Bio-Rad
pre-defined assays but also new versions of existing assays, validated for
the most recent software version.
The best way to avoid problems is to integrate new software and APF
versions into your system as soon as possible. Using old software versions
with newly released APF files or vice-versa is either impossible or may lead
to errors and/or loss of guarantee.
You can check precisely which software version is currently installed on your
computer by selecting the Help | About EVOLIS menu item.
If you want to upgrade your system or inquire about the latest available
versions, call your Bio-Rad Service Engineer.
In most cases, updating the main EVOLIS software also requires that you
upgrade the instrument firmwares.
3.11.2 Instrument and Firmware Upgrades
Instrument and firmware upgrades must be performed by your Bio-Rad
Service Engineer. To know whether an upgrade is needed or possible, you
will generally have to check the serial number of your instrument and/or the
serial number and firmware version of the instrument modules.
System serial number
To check the main serial number of your EVOLIS system, select the Utilities
| System Setup menu item. The system serial number is displayed in the
bottom left-hand corner of the System tab.
Serial number and firmware version of the various instrument modules
In addition to the main system serial number, each instrument module/tool
has its own serial number and firmware version.
To check them, you need to open the appropriate dialog box:
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Instrument module
Dialog box
Command processor
Utilities | System Setup menu item, System tab.
Incubators
Utilities | System Setup menu item, Incubators
tab.
Photometer
Utilities | System Setup menu item, Colorimeter
tab.
Pipettor
Utilities | System Setup menu item, Pipette tab.
Wash unit
Utilities | System Setup menu item, Washer tab.
Barcode Scanner
Utilities | System Setup menu item, Plate
Transport tab.
Each of these dialog boxes includes an Information field showing the serial
number and firmware version.
Figure 200: Information field
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3.12 Programming Assays
3.12.1 Introduction
The EVOLIS system is an open system. It allows users to process predefined assays but also to edit existing assays or to create their own assays.
Defining assays with the EVOLIS software is facilitated by visual dialog
boxes (no actual programming is needed) but because the system is very
flexible and because it allows users to define not only the processing steps
but also the result evaluation steps, defining assays remains a process that
must be done with adequate care and reference to the procedures described
in this manual.
This introduction covers the basic concepts of assay files (layout, structure,
protection). The second part (Section 3.12.2) explains how to edit predefined Bio-Rad assays (within certain strict limits) while the third part (from
Section 3.12.3) is a step-by-step description of how to create completely new
assays.
3.12.1.1 The Assay window
Figure 201: Assay window
The Assay window is displayed whenever you open an existing assay file
(see Section 3.12.1.2) or whenever you create a new assay file (see Section
3.12.3).
On the left-hand side of the screen, the Assay Tree lets you have a global
view of the assay layout and of the various steps (Pipette, Wash, Incubate,
Dispense, Read...) of that particular assay. Use the plus (+) and minus (-)
signs to unfold or close the Assay Tree.
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a)
b)
Figure 202: Assay Trees – a) Default -- b) Fully defined
In the Assay Display Area, on the right-hand side of the screen, you can
read the description of each step (pipetting profiles used, incubation
temperature, wavelengths used for reading, report parameters, etc.).
Summary or detailed assay description
Two versions of this description are available: a short version and a detailed
version.
To select (or change) the version to be displayed:
‰
Choose the View menu in the menu bar.
‰
Select Summary or Detailed.
To move from one step to the other use the scroll bar on the side. You can
also click on the desired step in the Assay Tree. This will display a step-bystep view in the Display Area.
The separating bar between the Assay Tree and the Assay Display Area can
be shifted (click and drag with the mouse). The left margin of the Display
Area can be adjusted (see Section 1.2.4.1).
3.12.1.2 Opening and Printing Assay Files
To open an assay file:
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‰
In the menu bar, select File | Open.
‰
In the Open dialog box, select the assay file which you want to open.
Assays files have an (*.asy) extension and they are saved, under default
settings, in the BioRad\Resources\Apf directory.
‰
Click <Open>.
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If the assay file is not password protected it is opened and displayed in
the Assay window.
If the assay file is password protected, the Enter Password dialog box
is displayed.
Figure 203: Assay password dialog box
‰
Click the <Don't Know Password> button. The assay file is opened and
displayed in the Assay window. You can review it and print it but not edit
it (if you want to edit a protected assay file, you have to either know the
password or edit its "Open" copy, see Section 3.12.2.3).
To print the assay file:
‰
Select the top folder in the Assay Tree to display the complete assay
description.
‰
Select Print in the File menu or click the <Print> button.
The version printed (Summary or Detailed) will be the one displayed on the
screen.
If you want to print the description of one assay step only, click on this
particular step in the Assay Tree before selecting File | Print.
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3.12.1.3 Basic Structure of Assay Files
All assay files (*.asy) have the same basic structure, consisting of some
defaulted assay steps (marked with a * in the table below) and a list of freely
selectable assay steps which can be arranged and defined according to the
requirements of each test.
Assay Header *
The assay header includes general information such as: assay name, comments
(if any), password protection, written by, creation date, last edited, plate type used,
maximum ambient temperature.
Assay Layout *
Table representation of a test plate showing the respective positions of the
samples, standards and controls for that assay.
Assay steps before Read (Processing steps)
Pipette
Inserts a pipetting step (for samples, controls
and standards).
Wash
Inserts a washing step.
Incubate
Inserts an incubation step.
Dispense
Inserts a dispense step (for reagents).
Verify dispense
Inserts the verify dispense step (colorimetric
verification for colored reagents).
Background read
Inserts a background reading. The baseline is
stored and later subtracted from the measured
plate.
Conditional delay
Inserts an incubation time; the length can be
set relative to an event on the plate.
Shake
Shake on the plate transport unit.
Incubate Verification
Incubator performance verification.
Clean Washer
Washer manifold maintenance.
Read/Evaluation Settings
Reader settings *
Definition of the colorimeter settings.
Background subtraction *
Definition
method.
Validation criteria
Definition of validation criteria.
Qualitative settings
Qualitative evaluation.
Quantitative settings
Quantitative evaluation.
Spreadsheet
Spreadsheet
operations.
of
the
for
background
user-defined
calculation
calculation
Report Settings *
Definition of the contents of the result printout, of the combined report and of the
format and contents of the result export file.
End of Protocol *
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3.12.1.4 Basic Rules on Inserting and Editing Assay Steps
Inserting new assay steps
To insert a new assay step:
‰
In the Assay Tree, always select the assay step immediately below the
one you want to insert (e.g. to insert a processing step, select Read; to
insert an evaluation step, select Report Settings).
‰
Select the Edit | Insert Step menu item or click on the selected assay
step with the right mouse button to display the following context menu
and select Insert Step.
Figure 204: Insert Step context menu
This will open one the two following Insert Step dialog boxes
a)
b)
Figure 205: Insert Step – a) Processing steps -- b) Evaluation Steps
‰
Select the step you want to insert and click <OK>.
This will display the dialog box corresponding to the step you inserted so that
you can enter the appropriate parameters for this step.
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Editing assay steps
To edit an assay step you need to open the dialog box corresponding to that
step and edit the step parameters.
To open the corresponding dialog box you can either:
‰
Double-click on a step in the Assay Display Area
or
‰
Double-click on a step in the Assay Tree.
If this does not work (if no dialog box is displayed when you doubleclick), this means that the assay is password protected (see next
page).
To know which parameters to enter or to edit, refer to the part on Creating
new assays (Section 3.12.3 and after) which includes extensive descriptions
of all dialog boxes and parameters.
Copying/pasting assay steps
The context menu (see Figure 204) which is displayed when you click on a
step with the right mouse button and the Edit menu in the menu bar both
include Copy and Paste items which you can use to copy and paste assay
steps.
Note, however, that assay steps can be copied and pasted only within the
same assay! It is not possible to copy a step in one assay and paste it in
another.
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3.12.1.5 Assay Password Protection
The Assay Protocol Header dialog box (see Section 3.12.3.1) includes a
Password field which allows the person who programs the assay to protect
it against editing.
The assay password is completely independent from the general EVOLIS
password and user rights system. If an assay is protected, it cannot be
edited even by users who are generally authorized to "Edit assays" (see
Section 1.2.7.2).
The assay password protection is strictly against editing, i.e. changing any of
the assay steps or parameters defined by the person who wrote the assay.
The password is not required to use the protected assay in a test run. It
is not required either if you just want to open and print the assay (click the
<Don't know password> button, see Section 3.12.1.2).
A password protected assay may be copied and renamed but the copy will
also be protected against editing (on editing Bio-Rad assays, see Section
3.12.2).
For users who create their own assays, it is strongly recommended
that they use this assay password protection (once they have finished
defining an assay). This will ensure that no accidental change can be
made by operators who use the assays for test runs.
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3.12.2 Editing Pre-Defined Bio-Rad Assays
3.12.2.1 General Rule on Editing Bio-Rad Assays
All Bio-Rad assay parameters have been carefully defined and checked.
They should not be changed!
This is why the assay files distributed by Bio-Rad are protected by a special
password (see Section 3.12.1.5). Any changes made to official Bio-Rad
assay files can be traced and result in a loss of guarantee (unless covered
by the authorized editing exception below).
3.12.2.2 Authorized Editing
As an exception to the general rule described above, the following changes
in Bio-Rad assay files are allowed without loss of guarantee (the purpose of
these minor changes is generally to enable valid data transfer to / from a
host computer or to adapt documents to the language of the user):
• Changing the name of the assay protocol so that it matches the name
expected by the LIS (host computer). This can be done either by
defining a LIS Assay Name as described in Section 3.13.2.2
(recommended procedure) or by actually editing the assay Description
field. To do this, open the assay and double-click on the Assay Header
item. If the assay is password protected, this does not open the general
Assay Protocol Header dialog box (see Section 3.12.3.1) but only the
following restricted dialog box.
Figure 206: Editing the assay name
•
•
•
•
Edit the assay name and click <OK>. When you then close the assay
file, you will be asked to confirm that you want to save the changes.
Enabling /disabling kit lot tracking (see Section 3.5.1.2).
Enabling /disabling pressure monitoring (see Section 3.9.3).
Changing all Report and Export Settings (see Section 3.12.3.5).
Changing a reagent ID i.e. editing the ID field in the Edit Reagent
Details dialog box (see Section 3.4.3.1).
Only changes falling in one of these five categories can be done on normal
(password protected) Bio-Rad assay files. All other changes can only be
done on "Open" assay files.
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3.12.2.3 "Open" Assay Files
On a practical basis, because the official Bio-Rad assay files are protected
against editing, each Bio-Rad assay file is distributed together with an
unprotected version of the same file. The file names are identical except that
the unprotected file begins with "Open".
Example:
HIV Ag-Ab 1P BR V12.asy
Open_HIV Ag-Ab 1P BR V12.asy
The contents of the official file and of the "Open" file are also identical.
To edit an "Open" assay file:
‰
Select File | Open.
‰
In the Open dialog box, select the desired "Open" assay file (*.asy) and
click <Open>.
‰
Double-click on the section of the Assay Tree or of Assay Display Area
that you want to edit (e.g. Incubate or Reader Settings) to open the
corresponding dialog box.
‰
Edit the parameters as desired.
‰
Repeat for other steps (you can also add or delete steps as described in
Section 3.12.1.4).
‰
Back in the Assay window, double-click on Assay Header in the Assay
Tree or in the Assay Display Area to open the Assay Protocol Header
dialog box. Edit the Description, Written by, Comments and
Password fields (for more information, see Section 3.12.3.1) and
confirm with <OK>.
‰
Select File | Save as to save the assay under a new name.
"Open" assay files edited by users (e.g. as a basis to create their own
assay files) are never guaranteed by Bio-Rad.
"Open" assay files edited for a user by a Bio-Rad Application Engineer
(e.g. to suit user-specific needs like introducing an internal control)
may be guaranteed on a case-by-case basis. Official approval of the
change is required.
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3.12.3 Creating New Assays
To create new assays, you first create a new assay file and then you define
all the necessary steps and parameters: layout parameters, processing
steps, reading parameters, result evaluation criteria and methods, report and
export settings.
To create a new assay file:
‰
Select the File | New menu item. This displays the New dialog box.
Figure 207: New dialog box
‰
Select Assay and click <OK>. This opens the Select Assay Protocol
Type dialog box.
Figure 208: Select Assay Protocol Type dialog box
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‰
Select the appropriate type for your assay (Colorimeter - Endpoint or
Colorimeter – Kinetic; standard EVOLIS instruments do not include a
Luminometer) and click <OK>.
‰
The default Assay window is displayed.
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Figure 209: New Assay window (default settings)
The assay definition process described in the following sections will follow
the basic assay structure described in Section 3.12.1.3.
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3.12.3.1 Assay Header
Double-click on Header in the Assay Tree to open the Assay Protocol
Header dialog box. The information in this window is printed out with the
report.
If the assay is password-protected, only a limited Assay Protocol
Header is displayed (see Section 3.12.2.2).
Figure 210: Assay Protocol Header dialog box
Description
Written by
Combination group
Comments
Plate type
Name of assay.
Name of the person/company who created the assay protocol.
Assays belonging to the same combination group can be combined on the
same plate (provided the assay parameters are compatible). Assays
belonging to different combination groups cannot be combined on the same
plate (even if they have compatible parameters). The default combination
group for all assays is "0". To assign an assay to a new group, enter a group
number. For more information on combination groups see Section 3.1.2.
Additional explanations.
Select a plate type from the drop-down list.
<Plate Types...>
Click this button to open the Plate Type Editor and create new plate types
(see below).
Password
Enter a password (and retype it) if you want to protect your assay against
editing (see Section 3.12.1.5).
Maximum ambient
temp.
Enter the maximum permissible room-temperature. If this temperature is
exceeded, this will be indicated in the result file.
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Plate ID check
If you use barcoded test plates, enter here the alphanumeric string used for
barcode identification. A (?) sign replaces any character, a (*) sign replaces
any number of consecutive characters.
If you use non-barcoded test plates, enter a (*) sign.
Enable Lot
Tracking
Enable / disable kit lot tracking for that assay.
If lot tracking is disabled:
• The kit database shall not be used to update the lot specific values.
• The software shall not report if an incorrect reagent is being used for the
assay or if a reagent has expired.
• No results shall be sent to Unity Real Time
For more information on kit lot tracking, see Section 3.5.
Pressure
Monitoring
Enable / disable pressure monitoring for that assay (only applies to EVOLIS
instruments equipped with a pressure monitoring system, see Section 3.9).
Variables
Shows the variables used in the assay which can be deleted by clicking on
the <Delete> button.
Labels
Shows the labels used in the assay which can be deleted by clicking on the
<Delete> button.
Input of labels or variables is not possible here, but is automatically carried
out by the system when they are defined in later process steps.
3.12.3.1.1 Creating Plate Types
Click on the <Plate Types...> button to open the Plate Type Editor dialog
box, showing the plate types available on the system and allowing you to
generate new ones. Plate type coordinate files are saved as (*.mpc) files in
the C:\BioRad\System directory. The Plate Type Editor dialog box allows
you to create new plate types from existing (*.mpc) files available on the
system. It does not allow you to create new (*.mpc) files. If you need to
create new (*.mpc) files, please contact your Bio-Rad Service Engineer.
Figure 211: Plate Type Editor dialog box
List of plate types
290
Selection box listing the plate types pre-defined for the system.
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Name
The name of plate type highlighted in the list box is displayed. Click on
<Add> to define a new plate type and enter a new name. This will create a
new plate type which has to be combined with an (*.mpc) file, i.e. you have
to choose an (*.mpc) file in the Coordinates drop-down list box.
Coordinates
Drop-down list box showing the available (*.mpc) files. These files contain
the plate coordinates and are created using the teacher software.
Select the number of rows and columns of the plate type.
Rows / Columns
X Offset
This field can be used to adapt the horizontal (centering) position of the
wash needles relatively to the plate wells if your assay requires a plate that
is slightly different from the existing plate types. If you enter a negative
value, the wash needles will be closer to the left side of the wells; if you enter
a positive value, the needles will be closer to the right side of the wells.
<Add>
Click this button to create a new plate type. The previous entry in the Name
box is deleted. The next running number is entered as default name, which
can be overwritten. The generated plate type is entered in the list box to the
left and it has to be combined with an (*.mpc) file.
<Delete>
Deletes the plate type highlighted in the selection box.
<Close>
Closes the Plate Type Editor dialog box. Changes are saved. The program
returns to the Assay Protocol Header dialog box.
To add a new plate type:
‰
Click on <Add>. The previous entry in the Name box is deleted and the
next running number is entered as default name.
‰
Enter the desired name.
‰
In the Coordinates list box, select a suitable microplate parameter file.
‰
Specify the number of Rows and Columns.
‰
Click on <Close> to accept the generated plate type and to return to the
Assay Protocol Header dialog box.
3.12.3.2 Assay Layout
Double-click on Assay Layout in the Assay Tree or on the Layout table in
the Assay Display Area to open the Assay Layout dialog box.
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3.12.3.2.1 The Assay Layout Dialog Box
Figure 212: Assay Layout dialog box
Plate Layout
<Remove>
Deletes the label highlighted in the Label list.
<Add>
Adds a new label in the Label list. The new label has to be renamed in the
Label box.
Label list
Shows the existing label types for pre-selection. Pre-select (delete) to clear
a well.
Label
Displays the name of the label type pre-selected in the Label list. This
name can be edited here.
Labelling
Type of numbering (digits or letters) to be used when filling the plate wells
(e.g. T1, T2, etc. or TA, TB, etc.).
Colour
To better distinguish different label types, you can assign colors to these
labels.
Replicates
Lets you specify the number of replicates you want for a pre-selected label
type.
Orientation
Fill Orientation
<Randomise>
<Renumber>
<Fill>
Fill orientation of the replicates: Columns, Rows or Random.
General fill orientation of the labels: Columns or Rows. The consecutive
numbering will be done accordingly.
The selected labels are randomly distributed over the plate.
Updates the consecutive numbering. This may be necessary, for example,
if you have deleted a sample within a consecutively numbered area,
creating a gap.
Fills all blank wells of the plate with the selected label.
<Clear>
Deletes all labels from the plate wells (in the Plate Layout).
<Undo>
Revokes the last action. This command can be repeated several times, so
that up to 10 steps can be undone.
<Redo>
Revokes an Undo command again. Can also be repeated several times
(max. 10 times).
<OK>
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Table presentation of the test plate.
Saves the assay layout. Returns to the assay window.
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<Cancel>
Returns to the assay window without saving any changes.
3.12.3.2.2 Creation of Assay Layout
Figure 213: Assay Layout creation
A Plate Layout with 96 positions corresponding to the layout of a microplate
is displayed, numbered consecutively (default setting T1 to T96, with T = test
(sample)).
Here you define how to distribute the controls, standards and patient
samples on the test plate, by providing the individual wells with a coded
Label.
To clear previously labeled wells:
Either clear all previous labels by clicking the <Clear> button or delete
individual wells by selecting the (delete) function in the Label list and then
selecting the well(s) which you want to clear (as shown above).
The Label list
The Label list is located in the bottom left-hand corner of the dialog box. The
letters in that list correspond to the individual sample or control types (label
types).
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B
Blank value (Blank)
S
Standard
T
Test (sample)
NC
Negative control
PC
Positive control
PC Ab
Positive control (antibody)
PC Ag
Positive control (antigen)
CO
Cut-off
EC
External control (see Section 3.8)
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You may define further labels (see next page).
The label type highlighted in the Label list is active. If you select a label type
in the Label list and click on an empty well in the Plate Layout, the respective
label is entered. If you select several empty wells in the Plate Layout, the
respective label is entered in all selected wells with consecutive numbering
(see below).
If (delete) is pre-selected, the contents of all selected wells is cleared.
Only standards can be taken into account in the quantitative analysis.
But in some kit inserts, standard O is deemed to be a "negative
control". In this case, users should redefine this "control" as a
standard in order to maximize the number of data used to build the
signal / concentration curve.
Consecutive numbering
If the same label has been assigned to several wells, the consecutive
numbering is done according to the following rules:
‰
If you select a well area, this area is numbered consecutively columnwise or row-wise, depending on the setting in the Fill Orientation field.
‰
If you select another well area for the same label type, the consecutive
numbering is continued accordingly.
‰
If you select several wells one by one (instead of clicking and dragging
the mouse to select a well area), the wells are numbered in the order of
their selection (i.e. not column- or row-wise).
‰
If you have pre-selected 2 or more in the Replicates field, the
consecutive numbering is automatically repeated corresponding to the
number of replicates.
Defining/editing the label type parameters
If you want to edit the parameters (name, type of numbering, color, number
of replicates) of an existing label type, you have to do so before you include
this label type in the Plate Layout:
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‰
Edit the label name in the Label field.
The label selected in the Label list is displayed in the Label field and can
be edited/renamed there. Any changes are immediately reflected in the
Label list.
‰
Select the numbering type in the Labelling selection box.
The choice is between digits (e.g. T1, T2, etc.) or letters (e.g. TA, TB,
etc.).
‰
Select the label color in the Colour selection box
You can select the color for the active label to distinguish the different
label types (e.g. green for NC, red for PC, etc). Default is black.
‰
Define the number of replicates in the Replicates field.
Enter the number of replicates for the label type selected in the Label
list. Each number is repeated automatically, when this label type is
entered in the Plate Layout (e.g. T1, T1, T2, T2, etc.). If you want to
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include replicates, choose also the fill orientation for the replicates below
in the Orientation drop-down list: column-wise, row-wise or random.
‰
Select the general numbering direction in the Fill Orientation drop-down
list: column-wise or row-wise.
Filling the Plate Layout
A well has to be empty before you can fill it. The actions described below do
not allow you to directly "replace" one label type by another. If the wells you
want to fill are not empty, you first need to clear them (as described on the
previous page).
a) Filling individual wells
‰
Select the desired label type in the Label list and check/edit the
respective parameters.
Click consecutively on the wells to be filled with this label type. The label
is entered with consecutive numbering.
b) Filling well areas
‰
‰
Select the desired label type in the Label list and check/edit the
respective parameters.
With the mouse pointer, select the desired area: select a row from left to
right or a column from top to bottom or a rectangular area from the top
left corner to the bottom right corner.
c) Filling all empty wells
‰
‰
Select the desired label type in the Label list and check/edit the
respective parameters.
‰
Click the <Fill> button. All empty wells are filled with the selected label
type.
Creating a new label type
‰
Select any label in the Label list.
‰
Click on the <Add> button next to the Label list.
‰
A new label type named C appears in the Label list and in the Label
field.
‰
Rename it in the Label field to suit your needs.
‰
Define the other parameters (color, numbering, replicates) as described
above.
‰
Insert it in the Plate Layout as described above.
3.12.3.3 Assay Steps before Read (Processing Steps)
An assay is programmed by adding individual processing steps.
Click with the right mouse button on Read in the Assay Tree and then select
Insert Step in the context menu. The Insert Step dialog box is displayed,
showing the assay steps you can select.
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Figure 214: Insert Step dialog box
Pipette
Aspirate/Dispense samples and controls.
Wash
Wash the test plate in the wash unit.
Incubate
Incubate the test plate.
Dispense
Aspirate/Dispense reagents.
Verify dispense
Check (photometer) if a dispense step was correctly
carried out.
Background read
Background reading.
Conditional delay
Variable incubation time.
Shake
Shake the test plate on the plate transport unit.
Incubate Verification
Used for performance verification purposes only.
Clean Washer
Used for maintenance purposes only.
After selection of a step the respective dialog box is displayed for parameter
entry. Once you have entered your parameters and saved your entries, the
new step is inserted in the Assay Tree.
Order of processing steps
When you insert a new assay step it is always inserted in the Assay Tree
just above the step you selected to open the Insert Step dialog box.
But when defining your steps, you can freely add them in any order to start
with (some are easier to define than others) and then rearrange them in the
correct order of the assay with the Move Up / Move Down items of the Edit
menu (or of the context menu).
Replicate steps
If your assay includes steps that are repeated twice identically or almost
identically (this is often the case for Wash steps or Incubation steps), you
can speed up the definition process by using the Copy / Paste function of
the Edit menu (or of the context menu). Edit the parameters if necessary.
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3.12.3.3.1 Pipetting Steps
The Pipette dialog box lets you define how the samples and controls will be
aspirated from one location and dispensed into another (e.g. for samples,
from test tubes to test plate). When dispensing to a test plate you also define
the well(s) to pipette into.
The Pipette dialog box is also used to define Predilution steps. In this
case, it is used not only to define the aspiration and dispense of
samples and controls but also of reagents (e.g. diluents) into the
dilution plates (or tubes).
One pipetting step generally includes several sub-steps
aspirate/dispense samples, aspirate/dispense positive control...).
(e.g.
Figure 215: Pipette dialog box
Select Pipette in the Insert Step dialog box and click <OK> (or double-click
on a Pipette step in the Assay Tree) to open this dialog box:
Plate Layout
The Plate Layout defined in assay layout definition (Section 3.12.3.2.2) is
displayed. Default setting is that all wells have a checkmark. A checkmark
in the Plate Layout means that pipetting is performed into the respective
well. Click on a well to remove the respective checkmark (= deselect the
pipetting function); click again to add the checkmark again.
Steps
List box displaying the pipetting steps that have been defined. Default
setting if no step has yet been defined is Step1. You can edit the step
name in the Edit Operations dialog box.
<New Step>
Adds a new pipetting step to the Steps list box (default is Step1, Step2...).
<Delete Step>
Deletes the highlighted pipetting step in the Steps list box. The button is
not available when only one step exists because this step cannot be
deleted.
<Edit Operations>
Opens the Edit Operations dialog box and you can define individual
pipetting functions such as aspirate and dispense.
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Eliminate assay drift
caused by this
operation
If this item is checked, the system calculates the time needed to pipette all
the samples and delays the first wash cycle of the following wash step
accordingly. For more information, see below under 7).
Action On Error
Here you can define how the system should respond to a pipetting error:
Raise alarm and stop, Log and continue or Manually pipette at end of
step (see Section 2.7.5.3). It is possible to select a different response for
each pipetting substep (e.g. Log and continue when the pipetting error
affects samples but Manually pipette at end of step when the pipetting error
is on a control).
Each pipetting error is documented in the Event log. In the results, affected
wells are flagged (NoLiq, InsLiq, Clot, PipErr, ManPip - see Section
2.8.2).
If pressure monitoring, the "action on error" defined here will also apply in
case a pressure monitoring error is detected (see Section 3.9.4).
<Layout>
<OK>
<Cancel>
Opens the Assay Layout dialog box, and you can make corrections, if
necessary (see Section 3.12.3.2).
Saves the information and closes the dialog box.
Closes the dialog box without saving any changes.
1) Defining pipetting steps
Now you can define the various pipetting steps in accordance with your
assay:
‰
With the mouse, deselect wells for Step1 which should not be pipetted
into.
‰
Click on <Edit Operations...> and define the individual pipette functions
(aspirate, dispense) and the respective parameters for Step 1 in the Edit
Operations dialog box (see next page). You can change the name
Step1 as you wish.
‰
Click <OK> to confirm the entries in the Edit Operations dialog box.
The program returns to the Pipette dialog box.
‰
Click on <New Step> to define a second pipetting step. In the Steps list
box, Step2 is displayed and highlighted. In the Plate Layout, all wells
have a checkmark. Define the wells for this step to which the pipetting
functions shall apply; then click again on <Edit Operations...> to define
the individual pipetting functions for Step2. You can change the name
Step2 as you wish.
‰
Further steps can be defined.
‰
For each step, do not forget to select the appropriate response in the
Action On Error list box.
‰
When you have defined all your pipetting steps, click on <OK> to save
your entries and insert the Pipette step in the Assay Tree.
If you highlight a step in the Steps list box, the respective Plate Layout (the
wells with defined pipetting functions and in the Edit Operations dialog box
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the defined pipetting functions) is displayed automatically. You can view the
respective parameters in the respective dialog boxes and edit them, if
necessary.
2) The Edit Operations Dialog Box
Figure 216: Edit Operations dialog box
The Edit Operations dialog box is displayed when you click the <Edit
Operations...> button in the Pipette dialog box.
In the Description field, you can edit the name of the step (default is Step 1,
Step 2...).
Click on one of the icon buttons to open the respective dialog box and enter
the respective parameters. If you confirm the parameters with <OK>, the
step is entered in the Operations list box before the highlighted position.
The steps Wash/Tip eject and End are always defaulted.
Description
Description of the pipetting step. This name can be edited. It is displayed
in the Steps list in the Pipette dialog box.
Defines the aspiration of samples and controls.
Defines the dispense function for samples and controls. This button is
enabled only when the aspirate function has been defined.
Opens the Wash/Tip eject sub-step dialog box. Do not edit these
parameters and do not remove the Wash/Tip eject sub-step.
Edits the operations highlighted in the Operations list box. Editing is also
possible by double-clicking on the respective step.
Removes the highlighted steps from the Operations list box.
Operations
Lists all operations that are combined in the step displayed in the
Description field.
<Move Up>
Moves the highlighted step in the Operations list box up one row.
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<Move down>
Moves the highlighted step in the Operations list box down one row.
<OK>
Confirms the entries in this window and takes you back to the Pipette
dialog box. The selected pipetting functions are assigned to the
highlighted step.
<Cancel>
Closes the dialog box and discards all changes The program returns to
the Pipette dialog box.
3) Example of pipetting step
Figure 217: Example: Edit Operations dialog box with Aspirate, Dispense
and Wash/Tip eject operations.
The Pipette dialog box may look as follows, if several steps have been
defined. The program shows which wells are being processed for the
highlighted step:
Figure 218: Pipette dialog box. The wells that will be pipetted during the
highlighted step (here “Dispense Negative Control) are signaled by a
checkmark.
4) Aspirate sub-step (for samples and controls).
Click this button in the Edit Operations dialog box to open the Aspirate
dialog box.
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Figure 219: Aspirate dialog box
Volume
Enter the aspirate volume. To ensure precise pipetting, the aspirate volume
can be set larger than the dispense volume.
Note: In that case, please make sure that no mix cycle is later defined!
Volume Offset
Select the volume offset parameters: <None>, Multi 10-300 or Single 10350. The actual volume offset values are predefined and cannot be edited
by users. To review them, open the Volume Offset Report as described in
Section 1.2.4.4. For a Pipette step, generally select either Single 10-350 or
<None> (volume offset disabled).
Note: If you select Single 10-350 for the Aspirate sub-step, you have
to select it also for the corresponding Dispense sub-step (see below).
From
Define from where the reagent or sample is to be aspirated. Microplate
refers to the test plate, Patient sample refers to the sample tubes in the
sample racks, Dilution plate refers to a plate placed in the dilution area,
Test Tube refers to dilution tubes (placed in the sample racks if pre-dilution
is done in tubes), Reagent refers to all available reagents (including
controls and standards).
Note: Microplate refers to a test plate. However, samples can only be
aspirated from sample tubes or from a dilution plate. Aspiration from
a test plate is not possible.
Label
Applies to dilution plates or tubes only. If you use more than one dilution
plate or tube, you have to affect a label to each plate (or tube) so that the
pipettor knows from which plate (or tube) it should aspirate.
Reagent
The Reagent drop-down list is enabled if you have selected Reagent in
the From list. You have to select the reagent (control, standard or diluent)
to be aspirated. If the desired reagent is not included in the list, you can
enter it by clicking on the <Reagents...> button (see below).
Use default predilution minimum
volume
If this item is checked (default setting), the minimum pre-dilution volume is
the minimum volume defined in the Pipette tab of the System Set-Up
dialog box (see Section 3.10.4.1).
To enter an assay-specific pre-dilution minimum volume, deselect the
checkbox and enter a value in the next field.
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Alternative minimum
volume
Enter an alternative pre-dilution minimum volume (0-10000 µl). If an
alternative minimum volume is specified then the software shall use this
volume when determining if pre-dilution wells/tubes can be re-used by the
assay.
Aspirate profile
Select the desired aspirate profile. The aspirate profile you define here will
apply to both samples and reagents (controls, standards or diluents). Note
that, for reagents, it will override the aspirate profile defined in the Edit
Reagent Details dialog box (see Section 3.4.3.1).
On pipetting profiles in general, see Section 3.10.4.2.
Aspirate Check
If this item is checked, the system verifies if a dive out position is detected
when retracting the tip after the aspirate operation and if the difference
between dive in and dive out position is in accordance with the calculated
drop of the liquid surface. This function securizes the pipetting and
dramatically reduces the risk of false pipetting.
Pressure Monitoring
If this item is checked, pressure monitoring is enabled during the aspirate
sub-step (but only if it is also generally enabled at system level and at
assay level). For more information on the pressure monitoring function, see
Section 3.9.
Liquid Type
If you have enabled pressure monitoring, use this drop-down list to select a
liquid-specific threshold set. If you do not know which liquid-specific
threshold set to select, you can review and print the APM Report with the
details of all predefined threshold sets (see Section 1.2.4.4) and/or review
which threshold sets are selected for similar liquids in Bio-Rad assay files.
If in doubt, ask your Bio-Rad Application Specialist for assistance.
<Reagents...>
Click this button if the reagent (control, standard or diluent) you want is not
listed in the Reagent drop-down list. This gives access to the reagent
database where you can select or create the reagents and controls you
need for your assay (see Section 3.3).
<OK>
Confirms the entries and returns to the Edit Operations dialog box. The
Operations list box shows the Aspirate step.
<Cancel>
Returns to the Edit Operations dialog box without saving the changes.
This means: if you call an already created step by double-clicking on it, and
you exit the window by clicking <Cancel>, the changes are not saved, the
original step is retained.
5) Dispense sub-step (for samples and controls)
Do not confuse this Dispense sub-step, which is defined (within the
Pipette step) for samples and controls (or reagents/diluents when they
are dispensed into a dilution plate), with the actual Dispense step
which is used for reagents dispensed into test plates (see Section
3.12.3.3.4).
Click this button in the Edit Operations dialog box to open the Dispense
dialog box. This button is enabled only if the aspirate sub-step has already
been defined.
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Figure 220: Dispense dialog box
Volume
Define the dispense volume in µl. If you specify a dispense volume which is
larger than the aspirate volume, an error message stating "Insufficient
aspirate volume for the required dispenses" is displayed.
Volume Offset
Select the volume offset parameters (see explanations above in the
Aspirate sub-step description).
In liquid dispense
If this item is checked, the system starts by dispensing the Z-max volume
at the Z-max position (deepest position) and dispenses the remaining
volume with reverse tracking of the pipettor.
This option is useful as it prevents splashing and reduces significantly the
risk of contamination when dispensing controls and samples.
Z-max volume
Define the volume to be dispensed at the Z-max position.
Example: Z-max volume = 50
The pipettor moves to the Z-max position (LLD not active), dispenses 50 µl
and starts dispensing the remaining volume with reverse tracking.
Example: Z-max volume = 0
The pipettor moves to the liquid surface (LLD active) and starts dispensing
the dispense volume with reverse tracking.
To
Select the target for the dispense operation from the drop-down list.
Microplate refers to the test plate, Dilution plate refers to a plate placed
in the dilution area, Test Tube refers to dilution tubes (placed in the
sample racks if pre-dilution is done in tubes).
Label
Applies to dilution plates or tubes only. If you use more than one dilution
plate or tube, you have to affect a label to each plate (or tube) so that the
pipettor knows into which plate (or tube) it should dispense.
Multishots
Several dispensing steps can be performed. Prerequisite is that a multiple of
the dispense volume has been aspirated using the aspirate function, so that
the contents can be dispensed (e.g. aspirate 300 µl and dispense 3 x 100
µl).
Dispense profile
Select the desired dispense profile. The dispense profile you define here
will apply to both samples and reagents (controls, standards, diluents…).
Note that, for reagents, it will override the dispense profile defined in the
Edit Reagent Details dialog box (see Section 3.4.3.1).
On pipetting profiles in general, see Section 3.10.4.2.
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Back to source
If oversoak volume is defined (i.e. the volume aspirated is larger than the
volume being dispensed), you may move the excess volume back to its
source container or discard it. The volume entered here in µl indicates the
volume that is to be moved back to the container. This function is rarely
used for samples and controls because of the potential contamination risk.
No. of mix cycles
Number of mix cycles for optimum mixing. A mix cycle consists of
aspiration and dispensing of the liquid within a well.
Note: when a worklist includes several assays with a predilution step using
the same diluent and the same dilution rate, the system normally makes a
single predilution for each sample. However, when the mix settings are
different, the system makes separate predilutions for each assay.
Volume to mix with
Define the volume to be used for mixing.
Use alternative
coordinate file
Enable and select an alternative plate coordinate file (*.mpc) for that step.
In this case a different Z dispense height can be used instead of the default
height of the plate type selected in the Assay Header dialog box (see
Section 3.12.3.1).
<OK>
Saves the dispense parameters, the program returns to the Edit
Operations dialog box.
<Cancel>
The program returns to the Edit Operations dialog box without saving the
entries.
6) Wash / Tip Eject sub-step
Click this button in the Edit Operations dialog box to open the Wash
dialog box.
The Wash step in this dialog box is not related to the Wash step that is
defined in the Wash dialog box (see Section 3.12.3.3.2). In the Wash
dialog box, you define how the test plate will be washed in the wash
unit. The Wash step here was designed to specify how the pipettor
needles should be washed. As the pipettor on existing EVOLIS
instruments works only with disposables tips (not needles), this Wash
step ensures only that the disposable tips are ejected at the end of
each sample pipetting operation.
This Wash step should be left as is. Do not delete it.
Figure 221: Wash (Pipette step) dialog box
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Leave as shown above. Do not edit or delete.
7) Eliminate assay drift
Because pipetting samples (or dispensing reagents) into a whole plate can
be fairly long, the time span between the moment when the first strip and the
last strip of a plate is pipetted (dispensed) can be significant. But then, when
these strips get washed, they get washed almost simultaneously (as the
washer operates much faster than the pipettor). In other words, the waiting
time between pipetting (dispensing) and washing is much longer for the wells
of the first strip than for those on the last strip.
In some assays, this can create problems (inconsistent results from one strip
to the other).
The purpose of the Eliminate assay drift caused by this operation item
available in the Pipette and in the Dispense dialog box is to correct this.
If you check this item in the Pipette dialog box, the system delays the first
wash cycle of each strip in such a way that the time span between pipetting
(dispensing) and washing is the same for each strip (Time needed to pipette
all the samples / controls = Time used to perform the first wash cycle of the
following wash step).
If you check this item in the Dispense dialog box, the system monitors the
time needed to dispense the reagent into the whole plate and delays the first
wash cycle accordingly (Time needed to dispense the reagent = Time used
to perform the first wash cycle of the following wash step).
Because the Eliminate assay drift caused by this operation function
results in an increase (for all strips except the first one) of the waiting time
span between pipetting (dispensing) and washing, you should normally have
to reduce accordingly the duration of the plate's room-temperature
incubation in between the Pipette (Dispense) and the Wash steps. Because
this reduction would be different for each strip, it would be difficult to define.
Instead, you just need to check the Time incubation from start of previous
assay step item in the Incubate dialog box (see Section 3.12.3.3.3). The
system then calculates the incubation time from the start of the pipetting
(dispensing) step. That way, all strips will have an identical incubation time.
This feature works only for room-temperature incubation.
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Example
0
10
20
30
40
50
60
Time (minutes)
Pipetting (24 mn)
1
Incubation (30 mn)
1st wash cycle (24 mn)
Pipetting (24 mn)
2
Incubation (30 mn)
1st wash cycle (+/- 2 mn)
In case 1, with drift elimination, you can see that each strip gets a precise
30 min. waiting time (room-temperature incubation) between pipetting and its
first wash cycle. In case 2, without drift elimination, only the last strip gets an
adequate waiting time of 30 min., all the other strips get an extended waiting
time.
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3.12.3.3.2 Wash Step
Here you define the parameters used when test plates are washed in the
wash unit.
Normally, a wash step includes several wash cycles. The Wash dialog box
lets you define different parameters for the first wash cycles and for the last
wash cycle. The first wash cycles include dispense and aspirate functions,
the last wash cycle is aspirate only.
When a wash step is being performed, you can check it through the window
in the front panel of the instrument (to the left of the waste container).
Figure 222: Definition of a wash step
To open the Wash dialog box, select the Wash item in the Insert Step
dialog box and click <OK> (or double-click on an existing Wash step in the
Assay Tree).
Wash buffer
Select the wash buffer in the drop-down list.
<Buffers>
If the desired buffer is not available in the drop-down list, you may define or
load another wash buffer by clicking the <Buffers> button (this opens the
Buffer section of the Reagent Database and lets you select or create the
desired buffer, see Section 3.4.5).
Strips
Select the strips to be washed. Each box corresponds to a strip. The strips
marked by a checkmark are washed. To remove/add a checkmark, click on
the respective strip number.
Under default settings, all strips are checked. If, for example, you use
plates with removable strips without including the 12 strips, make sure that
you uncheck the boxes corresponding to the strips not included.
On defining different wash parameters on the same plate or on defining a
strip-wise washing mode, see below.
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Heights
Automatic or freely definable height settings for the washer head.
Automatic setting is enabled when a checkbox is checked. In this case, the
respective edit box is disabled. To freely define the height setting, uncheck
the box and use the edit box on the right to specify a value. You can
visualize the respective height setting through the window on the front
panel of the instrument.
Top wash height
The wash head is on the level of the upper edge of the well, i.e. higher than
during dispensing. 0 = highest position of dispensing needle.
Bottom wash height
The wash head is directly above the well bottom = height for executing the
bottom wash function, i.e. intense washing of the wells.
Aspirate height
Wash Mode
Height of the wash head during aspiration.
Use the drop-down list to select the wash mode:
Plate wash mode
In a plate-wise washing mode, the washer performs the first wash cycle on
the whole plate, then the second wash cycle on the whole plate, etc. until
the complete wash step is finished.
Strip wash mode
In a strip-wise washing mode, the washer performs all the wash cycles
included in the wash step on the first strip, then all the wash cycles on the
second strip, etc.
Note: Default setting is Plate wash mode. Strip wash mode can induce
assay drift and/or well dehydration. It is recommended to select Strip wash
mode only if it is absolutely required for a specific test and with proper
validation (see explanations below).
Reset assay drift
This item applies only if Strip wash mode has been selected in the dropdown list above (see explanations below).
Purge
The washer's Purge and Clean sequences are normally defined at system
level (see Section 3.10.5.1) and are identical for all assays. The Purge and
Clean fields in this dialog box allow you to define assay-specific Purge and
Clean settings, for example for assays using special reagents that require
a more thorough Purge or Clean function or a different clean fluid.
Use system defaults
Check this item if you want to use the default washer purge settings as
defined in the Utilities | System Setup (Washer tab) dialog box. Uncheck
this item to define assay-specific Volume settings.
Volume (ul/tip)
Enter the volume to use per manifold needle for the Purge function. The
liquid used is the wash buffer selected in the Wash buffer drop-down list
(see above).
Clean
Use system defaults
Volume (ul/tips)
Fluid
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See above under Purge.
Check this item if you want to use the default washer clean settings as
defined in the Utilities | System Setup (Washer tab) dialog box. Uncheck
this item to define assay-specific Volume and Fluid settings.
Enter the volume to use per manifold needle for the Clean function.
Select the liquid (wash buffer, clean fluid, etc.) you want ot use for the
Clean function.
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3.12. Programming Assays
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Dispense
Parameters of all the wash cycles before last. These parameters include
aspirate and dispense parameters.
Top wash volume
(µl)
Wash volume per well (normal washing) in µl. During dispensing a
permanent vacuum is applied to the aspiration needles to rule out any
overflow of wash buffer.
No. of cycles
Number of wash cycles using those parameters.
Dispense rate
The dispense rate defines the pressure or the speed, respectively, with
which the wash buffer is dispensed into the wells in percent of the pumping
capacity.
Dispense as head
rises
If this item is selected, the wash head dispenses the wash buffer while
moving upward.
Bottom wash
volume (µl)
Volume at bottom wash function in µl. Enter the volume per well for tests
requiring bottom wash.
No. of cycles
Number of wash cycles including bottom wash (e. g.: "1" indicates that
each normal wash cycle will include a bottom wash function).
Aspirate mode
See Aspirate mode entry below.
Min. cycle time
(secs)
Specify the time for one cycle. Enter the minimum action time of the wash
buffer.
Partial plate mode
Defines the speed of processing a partially loaded plate.
As Quick As Possible.
In this mode, only those strips checked in the Strips field are washed. After
washing the last strip, the system immediately starts the next wash step or
cycle.
Maintain Full Plate time.
In this mode, the washer keeps the same cycle time for a partially filled
plate as for a full plate, so that the minimum dwell-time of the wash buffer
is ensured even for partially loaded plates.
Aspirate
No. of cycles
Aspirate mode
Aspiration step after the last wash step:
Number of cycles using these parameters.
Specify the aspiration mode depending on the type of test plate used.
Centre.
The needle position when aspirating is in the center of the well. This mode
is adequate for plates with round-bottom wells.
Sweep.
When aspirating the needle position moves from one side of the well to the
other. This is recommended for flat bottom test plates. However, as it
makes the aspiration process last longer, it is recommended mostly for the
final aspiration.
Partial plate mode
Final aspirate
minimum cycle time
<OK>
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See the Partial plate mode entry above.
The value entered here imposes a waiting time (in seconds) before the
final aspiration (to ensure an extended wash buffer dwell-time if
necessary).
Saves the entries and returns to the Assay Tree.
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<Cancel>
Closes the dialog box without saving any entries.
Defining different wash parameters on one plate
You can only define one set of wash parameters for each wash step. The
only option you have is to specify (in the Strips field) that some strips are not
washed but you cannot specify different wash parameters (e.g. different
wash buffers) for different strips on the same plate in the same wash step.
If you want to do so, you have to create several consecutive wash steps and
select/deselect the respective strips (e.g. wash step 1 will use wash buffer X
on strips 1 to 6, wash step 2 will use wash buffer Y on strips 7 to 12). The
system will then be able to adjust and apply the different wash parameters to
different strips on the same plate.
Strip wash mode - Assay drift
If you select Strip wash mode, this means that each strip is washed at a
slightly different time than the others. This "waiting time", for example
between the moment the wash step is completed on the first strip and the
moment the wash step is completed on the last strip is equivalent to a longer
room-temperature incubation (for the first strip). In some assays, this "drift"
effect can have adverse consequences on the results.
If the Reset assay drift item is checked, the system compensates this drift
effect by rescheduling the following pipette, dispense or wash steps so that
the "room-temperature incubation time" for each strip is identical.
Strip wash mode - Well dehydration
Generally, a wash step includes one or more wash cycles followed by a final
aspiration of the liquid from the plate wells.
In Plate wash mode, the final aspiration is performed almost simultaneously
on all strips at the end of the complete wash step.
In Strip wash mode, the complete wash step, including the final aspiration, is
performed individually on each strip. This means that the first strip will be
aspirated a relatively long time before the last strips on the plate (the exact
time difference depending on the duration of the wash step and the number
of strips used). The result of this is a risk of dehydration of the wells of the
first strips. To avoid this, you can, if the assay absolutely requires a Strip
wash mode, program two consecutive wash steps instead of one: the first
one in Strip mode without aspiration and the second one in Plate mode with
only the final aspiration.
1) If you have any doubt about when and how to use the Strip wash
mode option, please call your Bio-Rad Application Engineer for
assistance.
2) Avoid combining assays with Plate wash mode and assays with
Strip wash mode on the same plate! This could result in a delayed final
aspiration including on the Plate wash mode assay.
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3.12.3.3.3 Incubation Step
1) Definition
Select the Incubate item in the Insert Step dialog box and click <OK> (or
double-click on an existing Incubate step in the Assay Tree) to open the
Incubate dialog box.
Figure 223: Definition of an incubation step
Temperature
Select the incubation temperature.
Room temperature
Room temperature (RT). Because of the heating due to the instrument
itself, it is generally estimated that the "room-temperature" inside the
instrument can be up to 5°C higher than the actual "room temperature" in
the rest of the room.
Elevated
temperature
Enter the temperature required (from RT +5°C up to 50°C) and the
acceptable temperature limits (e.g. +/- 1°C).
Duration
Incubate for
Tolerance
Time incubation
from start of
previous assay step
Define the incubation time.
Select the minutes by clicking on the respective arrow buttons.
Always enter tolerances for the incubation duration (e.g. +/- 2 minutes).
This feature applies only to room-temperature incubation.
If this item is checked, the incubation duration you have specified above is
timed from the start of the previous (Pipette or Dispense) assay step. You
should check this item only if you have checked the Eliminate assay drift
caused by this operation item in the Pipette or in the Dispense dialog
box. For more information on this feature, see Section 3.12.3.3.1 under 7).
Required Lighting
Level
Select the required lighting level. This applies only for room-temperature
incubation since heated incubators are always dark.
Ambient light levels
Ambient light levels. If you select this option, the plate will be stored for
room temperature incubation on one of the locations of the pipetting area.
Dark
Darkness. If you select this option, room-temperature incubation is always
carried out in the room-temperature incubators.
Don’t care
Brightness/darkness is irrelevant. If you select this option, the system will
decide where to store the plate for room-temperature incubation either in a
dark incubator or on one of the pipetting area positions on a case-by-case
basis (taking into account the number of plates that are currently being
processed and the system settings – see Section 3.10.2).
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Shaking
Enter the shaking parameters for one incubation step. This applies only to
heated incubators. For plates which need shaking but do not need heated
incubation, you can define an independent Shake step (see Section
3.12.3.3.8) or enable shaking prior to reading (see Section 3.12.3.4.1).
Enable shaking
When this item is checked, shaking is performed over the entire incubation
time. If you want to specify a shaking time shorter than the incubation time,
you have to create two successive incubation steps (for the same total
incubation duration), one with shaking and one without.
Frequency
Shaking frequency in Hz (this parameter is preset and cannot be changed).
<OK>
Saves the incubation parameters and the program returns to the Assay
window.
<Cancel>
The program returns to the Assay window without saving any entries.
2) Incubation errors
For elevated temperature incubation, if the incubation temperature monitored
during the run does not correspond to the incubation temperature defined in
the assay:
• A general warning will be included in the Title Block section of the Result
Report ("Warning! Incubator tolerance of xx°C was exceeded." – see
Section 2.8.1).
• In the Combined Report, all affected samples will be flagged (IncKo –
Incubation overrun, see Section 2.8.2) and the results for these samples
will not be calculated.
Example
If the temperature defined in the assay is 37°C +/- 1°C, there is a flag and no
result calculation when:
• the mean incubation temperature is < 36°C or > 38°C or
• the maximum incubation temperature is > 38°C.
If the temperature defined in the assay is 37°C +/- 1°C, there is no flag and
the results are calculated when:
• the minimum incubation temperature is < 36°C and
• the mean incubation temperature is > 36°C and < 38°C.
Min
36.3
35.5
36.3
34.3
Temperature
Mean
Max
37
37.5
36.5
37.5
37.5
38.2
35.8
37.5
No Flag, Result calculated
No Flag, Result calculated
Flagged, Result not calculated
Flagged, Result not calculated
The same warning and flags apply if there is a discrepancy between the
actual duration of an incubation step during a run and the incubation duration
defined in the assay. Incubation duration errors apply both to roomtemperature and elevated-temperature incubations.
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Using the Outliers dialog box, it is possible to calculate results for samples
invalidated because of incubation errors (see Section 2.8.3.1). This,
however, should only be done for reference purposes and under the
laboratory supervisor's sole responsibility.
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3.12.3.3.4 Dispense Step
The Dispense dialog box lets you define how the required reagents will be
aspirated and then dispensed into the various wells of the test plate (you
have to specify which wells should receive a shot).
This Dispense step is not to be used for dispensing samples and
controls. For these, refer to the Pipetting step (see Section 3.12.3.3.1).
Refer also to the Pipetting step concerning the dispensing of reagents
(e. g.: diluents) into dilution plates.
Figure 224: Definition of a reagent Dispense step
Select Dispense in the Insert Step dialog box and click <OK> (or doubleclick on a Dispense step in the Assay Tree) to open the Dispense dialog
box.
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Plate Layout
The Plate Layout defined in assay layout definition (Section 3.12.3.2.2) is
displayed on the left-hand side. Default setting is that all wells have a
checkmark. This means that all wells will receive a shot of the respective
reagent. Click on a well to remove the checkmark (= deselect the dispense
function); click again to add the checkmark again.
Reagent
Select the reagent to be aspirated and dispensed. If the desired reagent is
not yet included in the drop-down list, click on the <Reagents...> button
(see below).
Volume Offset
Select the volume offset parameters: <None>, Multi 10-300 or Single 10350. The actual volume offset values are predefined and cannot be edited
by users. To review them, open the Volume Offset Report as described in
Section 1.2.4.4. For a Dispense step, generally select either Multi 10-300
or <None> (volume offset disabled).
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3.12. Programming Assays
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Aspirate Check
If this item is checked, the system verifies if a dive out position is detected
when retracting the tip after the aspirate operation and if the difference
between dive in and dive out position is in accordance with the expected
drop of the liquid surface (corresponding to the aspirated volume).
Pressure Monitoring
If this item is checked, pressure monitoring is enabled during the aspirate
step (but only if it is also generally enabled at system level and at assay
level). For more information on the pressure monitoring function, see
Section 3.9.
Liquid Type
If you have enabled pressure monitoring, use this drop-down list to select a
liquid-specific threshold set.
Intra-well delay
Define delay between individual well dispense steps in milliseconds. This
option can be used to avoid air bubbles in the wells. However, it lengthens
the dispense time.
Volume
Define the dispense volume per well in µl. The aspirate volume will be
calculated by the system:
Asp. vol.= (No. of multishots x Disp. vol.) + Oversoak vol.
Oversoak
Define how much oversoak volume (µl) is to be aspirated (see below).
No. of Multishots
For multiple shots (fill one time, dispense several times): number of
dispense steps (see below).
Back to source
Volume in µl which is to be moved back into the reagent container (see
below).
Eliminate assay drift
caused ...
Eject tip/wash tip
between shots
Agitation
See Section 3.12.3.3.1 under 7).
If you select this item, the pipette tip is ejected between each dispense.
The wash tip option is not available since EVOLIS instruments operate with
disposable tips only.
Agitation time for mixing after dispensing in seconds.
<Wash
parameters…>
This button is enabled if you check the Eject/wash tips between shots
option. However, no entries are required since EVOLIS instruments
operate with disposable tips only, which cannot be washed but only ejected
to the waste container. These "wash parameters" are for tips only, they are
not related to the test plate Wash step (see Section 3.12.3.3.2).
<Reagents...>
Opens the Select Reagents dialog box and you can select or enter the
reagents to be dispensed.
<OK>
Saves the information in this window (dispense parameters and well
selection). The program returns to the assay window.
<Cancel>
Changes are not saved. The program returns to the assay window.
Multishots and oversoak
The multi-dispense function ("multishots") is commonly used for reagents
because it shortens the dispense time and saves tips.
Oversoak defines an excess volume that will be aspirated to ensure correct
dispensing even in the last wells of a multi-dispense series. The oversoak
volume is usually defined as 10% of the total dispense volume.
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Example:
If you want to dispense 50 µl of reagent per well, you can define the
following parameters:
Dispense volume = 50 µl
No. of multishots = 16
Oversoak = 80 µl (10% of 16 x 50 µl).
The pipettor will aspirate 880 µl of reagent, dispense 50 µl in the first
selected 16 wells of the plate, discard the tip with the excess volume and
repeat this procedure until all the defined wells have been dispensed.
Make sure also that the total aspirate volume [(No. of multishots x Disp. vol.)
+ Oversoak] does not exceed 990 µl otherwise this would exceed the syringe
capacity.
However, if because of the volume offset corrections, the total volume of a
multishot step exceeds the syringe capacity, the system automatically
reduces the number of shots as required (e.g. from 16 to 14). This means
that the dispense step will take a little longer but all required wells will still be
dispensed.
If an Oversoak volume has been defined, the Back to source option lets
you select to transfer any reagent left in the pipettor after the end of a
dispense operation back to its original container. Otherwise, any excess
volume left after dispensing is discarded in the pipettor wash station before
the tip is ejected. The Back to source option is rarely used because of
contamination risks.
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3.12.3.3.5 Dispense Verification Step
If this step is inserted, the system verifies if the dispense process was
carried out properly by using the OD-value of colored reagents. You have to
define the wells to be verified and the test parameters.
A Dispense Verification step can be included after a Pipette step (for
samples and controls) or after a Dispense step (for reagents).
If you are running a worklist on the EVOLIS software in Demo Mode
(see Section 1.2.2.2), the system will return an error message
(Dispense Verification Failure dialog box) with an acoustic signal each
time a Dispense Verification step is performed. This is normal. Just
click the <Continue> button to continue.
In the Result Report, wells for which a dispense failure has been noted are
shown at the top of the Result Report and the corresponding samples are
individually flagged (VDFail) in the Combined report (see Section 2.8.2).
Figure 225: Colorimetric Dispense Verification dialog box
Select Dispense Verification in the Insert Step dialog box and click <OK>
(or double-click on Verify Dispense in the Assay Tree) to open the
Colorimetric Dispense Verification dialog box .
Plate Layout
The Plate Layout defined in assay layout definition (Section 3.12.3.2.2) is
displayed on this dialog box. Default setting is that all wells have a
checkmark. This means that all wells will be verified. Click on a well to
remove the checkmark (= deselect the verify function); click again to add
the checkmark again.
<= Well Value <=
Define the OD-value range within which the OD value of each well should
lie. An error message is displayed if the value determined is outside the
defined range. Here you can enter logical functions (see Section
3.12.3.4.7).
Test wavelength
Define the wavelength of the filter used to perform the reading.
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Ref. wavelength
Enter the wavelength of a possibly required reference filter.
Relative to last
verification
If this item is enabled, the last value measured with dispense verification
and the current value are compared. The value must lie within the range
defined above.
Store mean value in
QA database
If you select this item, the mean value of the checked well is saved in the
QA (Qualitative Analysis) database under the name of the reagent name
selected here. To view the database, select the menu item File | New and
then in the New dialog box the item Q.A. Report (see Section 2.4.6.1). The
Q.A. Report dialog box is displayed any you can select the respective
reagent. Then the measured mean value is displayed in a diagram.
Reagent
Select the reagent used. The mean values are saved in the QA database
under this name.
Action on failure
Take action if ... or
more control wells
fail
You have to define a limit, the exceeding of which triggers the desired
action (error message or abort assay):
Take action if ... or
more patient wells
fail
You have to define a limit, the exceeding of which triggers the desired
action (error message or abort assay):
Action to take
Select the action to take when one of the limits defined above has been
exceeded. You may choose: Alert User (error message) or Abort assay.
<Insert Function>
Opens the Insert function dialog box (see Section 3.12.3.4.7) and you can
select the logical functions for definition of the value range (see query <=
Well Value <=).
<Select All>
All wells are selected for verification (i.e. all wells of the plate that have a
checkmark). Click on the respective well again to deselect individual wells.
<Clear All>
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Action to take if an error occurs:
Clears all checkmarks on the Plate Layout.
<OK
Saves the verification data and closes the dialog box. The program returns
to the Assay window.
<Cancel>
Any changes you may have made are not saved. The program returns to
the Assay window.
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3.12. Programming Assays
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3.12.3.3.6 Background Read Step
Here you define the wavelengths to be used to measure blank plates/wells.
The value determined is then subtracted (well by well) from the reading
result in the Background subtraction step (see Section 3.12.3.4.2).
Figure 226: Background Read dialog box
Select the item Background Read in the Insert Step dialog box and click
<OK> to open the Background Read dialog box.
Test wavelength
Reference
Wavelength
<OK>
<Cancel>
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Define the filter to be used for reading.
Select a reference wavelength. If this item is checked, you can set the
wavelength via the arrow buttons.
Saves the information. The program returns to the Assay window.
The program returns to the Assay window without saving the changes.
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3.12.3.3.7 Conditional Delay Step
In most assays, incubation steps, defined in the Incubate dialog box (see
Section 3.12.3.3.3) have a fixed duration (notwithstanding acceptable
tolerances).
The Conditional Delay dialog box allows you to define instead an
incubation step with a variable incubation time depending on specific
measured values. In that case, the incubation time is over only when the
specified measured value at the reference well has been reached and the
next step can be started.
The variable incubation time define in the Conditional Delay dialog box
applies only to room-temperature incubation! This incubation takes
place in the photometer.
Figure 227: Conditional Delay dialog box
Select the item Conditional Delay in the Insert Step dialog box and click
<OK> to open the Conditional Delay dialog box.
Read Parameters
Shake
Shake mode
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Define the shake time in seconds.
Select the shake mode.
Test wavelength
Define the wavelength to be verified = specify which filter is to be used for
reading.
Ref. Wavelength
Define the reference wavelength.
Read interval
Define the read intervals in seconds (e.g. 180 = the plate will be read every
3 minutes until the set end-of-incubation condition is reached).
Timeout
End of incubation time, even if the desired measured value has not been
reached (see explanation below on Wait until).
Condition
Define the end-of-incubation condition. This condition can be set either in
reference to a set OD-value or in reference to a variation of the OD-value
over time (OD/minute rate). When the set value (or rate) is reached, the
incubation time is over.
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Value calculation
mode
If this item is checked the incubation time is over when the OD-value
entered in the Wait until edit box is reached.
Rate calculation
mode
If this item is checked the incubation time is over when the rate entered in
the Wait until edit box (ratio of current to previous measurement in
OD/Minute) is reached.
Wait until
The incubation is set to last until the OD-value or the rate specified here
has been reached (e.g. T1>=1). The entry is considered as an OD-value
when the item Value calculation mode is enabled, or as a rate, when the
item Rate calculation mode is enabled. When the cursor is in this field,
the <Insert Function...> button is enabled (see below). In this edit box you
may enter mathematical operators and brackets.
<Insert Function...>
Opens the Insert Function dialog box (see Section 3.12.3.4.7) so that you
can use logical functions to define the conditional OD-value or rate.
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3.12.3.3.8 Shake Step
Shaking is used to homogenize the contents of the wells after various
dispenses or before reading. On the EVOLIS system, a shaking function can
be defined at different stages of the process: during incubation (see Section
3.12.3.3.3), before reading (see Section 3.12.3.4.1).
It is also possible to define an independent Shake step which can be
inserted wherever you require in the Assay Tree. To open the Shake dialog
box, select Shake in the Insert Step dialog box and click <OK>.
Figure 228: Shake dialog box
Duration
Here you can define the duration (between 1 and 59 seconds) for shaking
the test plate. This shaking is performed on the plate transport unit at room
temperature.
If the assay requires a longer shaking time, several shake steps can be
defined one after the other.
This Shake step lets you define only the duration parameter, not the
Frequency as in the incubation shaking function.
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3.12.3.4 Read/Evaluation Settings
Steps defined in the Read folder of the Assay Tree
Double-click on Read to open the Read folder. The defaulted steps are
displayed:
Figure 229: Assay Tree – Default Read folder
Definition of photometer parameters
Subtraction of blank value
Definition of result output
Reader settings
Background subtraction
Report settings
You can do the following:
1) Define parameters
‰
Double-click on a folder to open the respective parameter window.
2) Insert evaluations steps
‰
Click with the right mouse button on the step immediately below the
space where you want to insert the new step; then select Insert Step
from the context menu. The Insert Step dialog box appears showing the
following items.
Figure 230: Insert Step dialog box with evaluation steps
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Validation criteria
Enter the test validation criteria.
Qualitative Settings
Define parameters for qualitative analysis
(reactive, negative, equivocal).
Quantitative Settings
Define parameters for quantitative analysis
(e.g. standard curve evaluation, correction of
reading value).
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Spreadsheet
‰
Spreadsheets allow you to apply various
calculation or evaluation methods to your
results or to specific values.
Select the evaluation step which you want to insert and click <OK>. This
opens the respective dialog box and you can define the parameters for
that evaluation step.
Order of evaluation steps
Each evaluation step uses the output data of the previously programmed
evaluation step. The Quantitative Settings and Spreadsheet steps can be
inserted twice, all others only once.
Each new step is inserted above the one you selected before opening the
Insert Step dialog box. You can use the Move Up / Move Down items in the
Edit menu (context menu) to re-arrange the order of evaluation steps.
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3.12.3.4.1 Reader Settings
Double-click with the left mouse button on the Reader settings folder in the
Assay Tree to open the Colorimeter Settings dialog box.
Endpoint or Kinetic reading
The choice between Endpoint reading and Kinetic reading is made when the
assay file is created (see Section 3.12.3). In Endpoint reading, the
photometer measures the absorbance at the end of the process only. In
Kinetic reading, the photometer measures absorbance changes at specific
intervals. Bio-Rad assays use Endpoint reading.
If Colorimeter - Endpoint had been selected when creating the assay, the
Colorimeter Settings dialog box includes two tabs: Endpoint and Layout.
If Colorimeter - Kinetic had been selected when creating the assay, the
Colorimeter Settings dialog box includes four tabs: Kinetic, Calculations,
Reports and Layout.
1) Endpoint Reading
a) Endpoint Tab
Figure 231: Colorimeter Settings dialog box - Endpoint tab
Wavelengths
Define the wavelengths:
Test wavelength
Define the test wavelength.
Ref. wavelength
Select a reference wavelength. If this item is checked you can set the
wavelength via the arrow buttons.
Shake
Mode
Duration
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Shake parameters prior to reading:
Select the shake mode.
Define the shake duration in seconds.
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Multi-Wavelength
Reading
Parameters for a second reading using a different wavelength, when the
results of the first reading were outside the reading range.
Enabled
If this item is checked you can define the wavelength used for the second
reading. A second reading takes place only when the results of the first
reading were outside the reading range.
Secondary reference
wavelength
Select a reference wavelength for the second reading. If this item is
checked you can set the wavelength via the arrow buttons.
Data Conversion
Mode
Select the data conversion mode for both readings:
Linear Regression
Linear regression to recalculate to the original filter.
Formula
Specify a factor to be used for multiplication of the result in order to get to
the result of the reading with the first filter pair. The formula may include:
labels, digits, mathematical operators, brackets and the functions that can
be called via the item <Insert Function>.
<Insert Function...>
Opens the Insert Function dialog box (see Section 3.12.3.4.7) and you
can select the logical functions for conversion of the reading results (see
query Formula).
Out of Range Values
Use reader defaults
If this item is checked, out-of range values will be replaced by the general
replacement values defined in the Colorimeter tab of the System Setup
dialog box (see Section 3.10.3.1).
If this item is not checked, you can set assay-specific replacement values
in the fields below.
OVER limit
Enter the upper limit value (OD) for the assay (e.g. 2.5). The maximum
value that can be set is 3.5. The lower limit value is equal to the negative
value of the upper limit value.
Enabled
When the value read by the photometer is OVER the upper limit (or
UNDER the lower limit), you can choose to replace, in the results, the
actual value by another character string, e.g. a wildcard (*), a digit or a
comment.
OVER replacement
value
UNDR replacement
value
<OK>
<Apply>
<Cancel>
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In this case, check the item and enter the replacement string in the
respective field.
Saves the information. The program returns to the Assay window.
This button is always disabled.
The program returns to the Assay window without saving any entries.
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b) Layout Tab (Endpoint Reading)
Figure 232: Colorimeter Settings dialog box – Layout tab
Layout
Display Header
Body: Matrix
Body: Table
Display Legends
Matrix
Available Fields
Definition of the result output.
If checked, any "header" information is displayed.
Result display as matrix (see information in the Matrix box).
Result display as table (see information in the Table box).
If checked, any legends are displayed, e.g. user-defined annotations.
Select which results are to be output in the form of a matrix:
Available fields:
Patient ID
Sample Location
Well Location
Layout Label
Input data
Values that go into the processing option. e.g. OD.
Input Mean
Mean Values that go into the processing option e.g. OD.
Input SD
Standard deviation of input
Input CV
Coefficient of variation of input
Input SE
Standard error of input.
Output Data
Values that come out of the processing option.
Output Mean
Mean of values that come out of the processing option
Output SD
Standard deviation of output
Output CV
Coefficient of variation of output
Output SE
Standard error of output.
Flag
Copy the respective parameters with the arrow buttons > or >> to the
Selected Fields list. You can change the order via the <Move Up> and
<Move Down> buttons according to your needs.
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Selected Fields
List of selected parameters which are output after reading in the form of a
matrix (see also Available Fields).
>
Copies the highlighted parameters from the Available Fields list to the
Selected Fields list.
>>
Copies all parameters from of the Available Fields list to the Selected
Fields list.
<
<<
<Move Up>
<Move Down>
Deletes the highlighted parameters from the Selected Fields list.
Deletes all parameters from the Selected Fields list.
Moves the highlighted parameter up one row.
Moves the highlighted parameter down one row.
<Font...>
Opens the Font dialog box and you can define font, size and type for data
output. The default font is Arial, 10pt, standard. The selected font is valid
for matrix as well as for table presentation.
Gridlines
Select this item to show gridlines.
Calculations
Use Averaged Inputs
Average Mode
Table
Column Title
Column Width
Calculation parameters:
Select this item to use averaged input values.
Select the average mode: Arithmetic mean, geometric mean or median.
Select which results you want to output in a table: this is the same
parameter selection as in the Matrix field. Proceed in the same manner:
Using the arrow buttons, copy the desired parameters to the Selected
Fields list. Click <Font...> in the Matrix field to select another font and
change the defaulted font parameters.
Enter a column title.
Define the column width. The default value is 2.5 cm.
Type Order
Define the order of the well types for data output. Click on the desired well
type and move it up or down with mouse button held down; then release
the mouse button.
Scientific Format
Controls when numbers are displayed in scientific format and when they
aren't. Three options are available:
Auto
Autoformat. You can select the number size (small, intermediate, large).
If Small Numbers is checked then any values less than 1.0 are displayed
in scientific format.
If Intermediate Numbers is checked then values between 1.0 and
10000.0 are displayed in scientific format.
If Large Numbers is checked then any values above 10000.0 are
displayed in scientific format.
Fixed Exponent
Presentation with fixed exponent. Set the value by clicking on the arrow
buttons. For example: 3 means x 103.
Exponent Multiple
Presentation with multiple exponents. Set the value by clicking on the
arrow buttons. For example: 3 means x 103, 106, 109....
Decimal Place
<OK>
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Define the decimal place.
Save the entries on the Endpoint and Layout tabs. The program returns
to the Assay window.
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<Apply>
<Cancel>
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This button is always disabled.
The program returns to the Assay window without saving any entries.
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2) Kinetic Reading
a) Kinetic Tab
Figure 233: Colorimeter Settings dialog box - Kinetic tab
Wavelengths
Define the wavelengths:
Test wavelength
Define the test wavelength.
Ref. wavelength
Select a reference wavelength. If this item is checked you can set the
wavelength via the arrow buttons.
Shake
Mode
Initial Duration
Shake parameters prior to reading:
Select the shake mode. Only Standard is available.
Define the shake initial duration in seconds.
Repeat Duration
Define the shake repeat duration in seconds.
Fill-in time interval
If this item is checked shaking is continuous.
Stopping Condition
Stop after ... readings
Stop after ... minutes
Define the reading time as:
The period of time needed to perform a set number of readings. Stop after
n readings. Define n.
A fixed period of time. Stop after n minutes. Define n.
Stop when rule is true
(Value)
The period of time needed to reach a defined Absorbance. Check this item
and define the A (Absorbance units) in the Stop rule field.
Stop when rule is true
(Rate)
The period of time needed to reach a defined Rate. Check this item and
define the Absorbance per minute (A/min) in the Stop rule field.
Stop rule
See above.
Time-out
Define a time-out limit (if the above stopping conditions are never reached).
Reading Schedule
Fixed interval
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Define the schedule for successive readings.
Check this item if you want successive readings to be performed at fixed
intervals and define this interval in seconds.
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Variable interval
This item is enabled only if you have selected Stop after ... readings as
Stopping Condition. Check this item if you want successive readings to be
performed at variable intervals and define these intervals in the following
field (#1, #2,...).
#1
#1 is always 00:00.00. Define the time of the second interval. Click on it in
the interval list below. #2 is then displayed instead of #1. Enter the length
of the desired interval (format is hours, minutes and seconds, e.g. 00:01.30
indicates 1 minutes and 30 seconds after the first reading).
Interval List
Displays the variable time intervals you have defined for successive
readings. The number of readings displayed corresponds to the number of
readings defined in the Stop after ... readings field.
Out of Range Values
Use reader defaults
If this item is checked, out-of range values will be replaced by the general
replacement values defined in the Colorimeter tab of the System Setup
dialog box (see Section 3.10.3.1).
If this item is not checked, you can set assay-specific replacement values
in the fields below.
OVER limit
Enter the upper limit value (OD) for the assay (e.g. 2.5). The maximum
value that can be set is 3.5. The lower limit value is equal to the negative
value of the upper limit value.
Enabled
When the value read by the photometer is OVER the upper limit (or
UNDER the lower limit), you can choose to replace, in the results, the
actual value by another character string, e.g. a wildcard (*), a digit or a
comment.
OVER replacement
value
UNDR replacement
value
<OK>
<Apply>
<Cancel>
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In this case, check the item and enter the replacement string in the
respective field.
Saves the information. The program returns to the Assay window.
This button is always disabled.
The program returns to the Assay window without saving any entries.
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b) Calculations Tab (Kinetic Reading)
Figure 234: Colorimeter Settings dialog box - Calculations tab
In kinetic reading, the result calculated is either a Rate (Absorbance/time) if
what is sought is to measure the absorbance change over time or a Time, if
measuring the time needed to reach the desired value or rate.
Calculation mode
Select a calculation mode:
Last reading
If selected, the result reported is the rate over
the last reading.
Total rate
If selected, the result reported is the mean value
of all rates.
Maximum rate
If selected, the result reported is the highest
rate.
Linear regression
If selected, the Absorbance variation over time is
approximated to a linear curve and the rate of
this curve is reported.
Time to: value
If selected, the result reported is the time
needed to reach a defined value (see below).
Time to: rate
If selected, the result reported is the time
needed to reach a defined rate (see below).
Time to: relative value If selected, the result reported is the time
needed to reach a relative value (e.g. peak value
divided by x...).
Time to: peak value
If selected, the result reported is the time
needed to reach the highest OD value.
Time to: peak rate
If selected, the result reported is the time
needed to reach the highest rate.
Calculation
Parameters
Time to
Average data
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Enter the value to which the calculation shall be performed.
Enter the number of readings that should be taken into account for rate
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point(s)
Values
Calculation Cut-Off
calculations.
Select whether OD values will Increase over time or Decrease over
time.
Define an absolute value or a relative value as Cut-Off for the calculation.
Results
Scaling factor
Units
Use Readings
Auto
Reading numbers
<OK>
<Apply>
<Cancel>
A scaling factor can be introduced.
Enter a unit for the calculated values.
Define which readings to use.
If this item is checked all readings are used for the calculation.
If you uncheck Auto, you can use these boxes to specify which
successive readings should be used for the calculation.
Saves the information. The program returns to the Assay window.
This button is always disabled.
The program returns to the Assay window without saving any entries.
c) Reports Tab (Kinetic Reading)
Figure 235: Colorimeter Settings dialog box - Reports tab
Plate Layout
In the Plate Layout, check the wells for which you want to create a specific
report.
>, <, <<
When you click on the > button, the selected wells are transfered to the
Graphs list. When you click on > again, a second graph with the same
wells is added to the Graphs list. You can then select (or deselect) wells
in the Plate Layout to add them to (or exclude them from) the highlighted
graph. Clicking on the < button will delete the selected Graph. Clicking on
the << button will delete all graphs.
Graphs
The system creates a graph plot (OD values/time) for the selected wells.
Miniature Graph Plot
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If this item is checked, the system creates a miniature graph plot (OD
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values/time) for all wells.
Individual Readings
Report
<OK>
<Apply>
<Cancel>
None
No individual readings report.
Matrices
Individual readings report in matrix format.
Tables
Individual readings report in table format.
Saves the information. The program returns to the Assay window.
This button is always disabled.
The program returns to the Assay window without saving any entries.
d) Layout Tab (Kinetic reading)
The Layout tab in the Kinetic Colorimeter Settings dialog box is identical to
the Layout tab for Endpoint reading (see Section 3.12.3.4.1, under 1) b))
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3.12.3.4.2 Background Subtraction
In the Assay Tree, double-click with left mouse button on the Background
Subtraction folder to open the Background Subtraction dialog box.
Figure 236: Background Subtraction dialog box
Background subtraction is used to allow better interpretation of the results by
subtracting a background/blank value.
The Background Subtraction dialog box allows the user to enable/disable
background subtraction and to define the calculation method of the
blank/subtracted value.
To disable background calculation, select None in the Background
Subtraction Mode drop-down list box. Note that even if it is disabled, the
Background subtraction item is still displayed in the Assay Tree. It is a
default item and cannot be deleted.
B-wells are the wells which are subtracted as blank value from the other
wells.
Background
Subtraction Mode
Select the calculation method for the blank value:
None
No background subtraction. This step is disabled.
Average
The average of the B-wells is subtracted from each individual well
identified by a checkmark. If only one B-well was set, the corresponding
OD value is used instead of the average value.
Row
The B-well in a certain row is subtracted as background from the wells in
that row.
Column
The B-well in a column is subtracted as background from the wells in that
column.
Paired
Paired subtraction of the background (B) from the other wells. The reverse
order of the categories on the plate is used. This means: B1 is subtracted
from the first sample of the last category (e.g. T), B2 from the 2nd sample
of the last category, etc. If all samples of the last category have been
calculated in this manner, the next B-value is subtracted from the first
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samples of the second to last category. The last B-value is then
subtracted from the last sample of the first category.
Example:
Samples are arranged on a plate as follows:
CO1
B1
CO2
B2
PC1
B3
PC2
B4
T1
B5
T2
B6
In this case, B1 is subtracted from T1, B2 from T2, B3 from PC1, B4 from PC2, B5
from CO1 and B6 from CO2 (see also result file *.res).
Plate
A Background value which has been saved to a file can be subtracted for
the entire plate. The file is called via the Plate ID browser.
Previous Value
The average of the B-wells of the previously measured plate is used for
background subtraction.
Custom
In this mode you can assign B-wells to the T-wells. If you select this mode,
the B-wells are automatically listed in the list box next to the well matrix.
First select a B-well in the list box and then the other well in the matrix
from which the B-well is to be subtracted. Proceed in the same manner
with all B-wells.
Plate Subtraction
Mode
Plate ID
<Browse>
This item is enabled only if you have selected Plate in the previous query.
Define the file name of the plate ID.
Opens the Open dialog box for selection of a file.
Multi-Reading Mode
Options for the kinetics mode.
Subtract From Final
Result
Background subtraction only from final result.
Subtract From
Individual Readings
Background subtraction from each individual well reading.
Paired/Custom
Subtraction Mode
<OK>
<Cancel>
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The Plate Layout is displayed and in Custom Mode those wells from
which the background is to be subtracted are identified by a checkmark.
Saves the entries. The program returns to the Assay window.
The program returns to the Assay window without saving any entries.
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3.12.3.4.3 Validation Criteria
Here you can introduce conditions for quality control using equations. These
equations allow you to specify criteria for the test. If these criteria are not met
you may choose to abort the evaluation of the results.
To open the Validation Criteria Check dialog box, select Validation criteria
in the Insert Step dialog box and click <OK>.
Figure 237: Validation Criteria dialog box
V.C. Check
<Insert Function...>
<New>
<Delete>
<Clear All>
In this field, you enter the equation defining the validation criteria. Use the
keyboard to enter mathematical signs or use the Insert Function dialog
box to enter logical functions. On the syntax used, see Section 3.12.3.4.7
Click this button to open the Insert Function dialog box.
Click this button to enable a new row and to enter another equation.
Deletes the row highlighted in the list box.
Clears all characters available in the list box.
<Undo>
Revokes the previous action.
<Redo>
Revokes the undo function.
Report Format
Don't evaluate
results if Validation
Criteria fail
<OK>
<Cancel>
<Apply>
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Select the information the report should contain.
Detailed (All):
All QC data (equations, values, etc.)
are included in the results report.
Detailed (Failures Only):
Only the QC equations that fail are
reported.
Descriptive (Failures Only):
Only a error message without further
explanation is displayed.
None:
An error will not be reported.
If this item is checked no results are calculated for wells that do not meet
the validation criteria.
Saves all entries and returns to the Assay window.
Returns to the Assay window without saving the entries.
This button is always disabled.
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3.12.3.4.4 Qualitative Evaluation
Here you can define the parameters for qualitative evaluation of the results.
Select Qualitative Settings in the Insert Step dialog box to open the
Qualitative Settings dialog box and click <OK>. This dialog box includes
five tabs: Typing, Validation Criteria, Layout, Annotation, and Retest.
The Validation Criteria, Layout, Annotation, and Retest tabs of the
Qualitative Settings dialog box are identical to the corresponding tabs of
the Quantitative Settings dialog box (see Section 3.12.3.4.5). The Retest
tab is described in Section 3.7.1. Only the Typing tab is described below.
The buttons that apply to all tabs are located at the bottom of the dialog box:
<Apply>
<OK>
<Cancel>
This button is always disabled.
Saves all entries and returns to the Assay window.
Returns to the Assay window without saving the entries.
Typing Tab (Qualitative Settings)
Figure 238: Qualitative settings – Typing tab
Use Stored Control
Value File
Conditions
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If this item is checked, the typing of the results (i.e. defining when a given
result is reactive/positive, equivocal or negative) is done by reference to
control values formerly saved in a specific file. In this case, you must also
enter the name and full path of the file in the field on the right (if you do not
know the full path, use the <Browse> button). If this item is checked, all
other items on this tab are disabled ("grayed") and do not have to be
defined.
Define the conditions for evaluation.
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If
In this field you enter the condition, e.g. ‘Sample<0.9*PC/5 ‘. It is
automatically entered in the first row (or in case several rows exist in the
highlighted row) of the list below.
Input terms: This formula has to include one term refering to the sample
which can be either 'Y', 'Sample' or 'Sample.n' (n = individual value of
well). Moreover, this edit box may contain: well labels, digits, mathematical
operators and brackets, as well as the functions offered via <Insert
Function..> (see below).
Then Result =
Select a code, an abbreviation or a character (e. g. +, -, ?) to be used to
characterize the result when the corresponding condition is fulfilled.
Items available in the selection list are those that have been entered
before in the Result types field below.
List of conditions
List of all already defined conditions.
<Insert Function>
Opens the Insert Function dialog box (see Section 3.12.3.4.7) and you
can select a logical link for the description of your conditions.
<Add>
To define a new condition, click this button then enter the condition in the
If field and the typing code in the Then Result field.
<Remove>
<Clear>
<Move Up>
Removes the highlighted condition from the list of conditions.
Clears the entire list of conditions.
Moves the highlighted row in the list of conditions up one row.
<Move Down>
Moves the highlighted row in the list of conditions down one row.
Default Result
Typing code or sign to be used by the system for results that do not match
any of the defined conditions.
Grey zones
Define grey zones, i.e. reading ranges which are not assigned to any
result type.
Zones
Number of zones.
Low expression
Low expression of grey zone. You can enter well labels, digits,
mathematical operators, brackets and logical functions.
High expression
High expression of grey zone. Input options as for Low expression.
<Font...>
Select fonts.
Result types
Describe the result types, i.e. enter the explanation for the characters +, and ?.
Result
Enter the codes (abbreviations or characters) to be used to characterize
result types. The result type is automatically entered in the first row of the
legend list or if several legend rows exist in the highlighted row.
Use this field to enter new codes.
Legend
Here you enter the description for the result code. This description is also
automatically entered in the list below.
List of legends
Shows the defined result types with the corresponding description
(separated by a tab) entered in the above edit boxes.
<Add>
<Remove>
<Clear>
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Adds a new row for result and legend.
Removes the highlighted row from the legend list.
Clears the legend list.
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<Move Up>
Moves the highlighted row in the legend list up one row.
<Move Down>
Moves the highlighted row in the legend list down a row.
Histogram of
Results
Notes
340
If this item is checked, a histogram showing the repartition of plate wells
by result type is displayed.
See below under Quantitative Evaluation.
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3.12.3.4.5 Quantitative Evaluation
Select Quantitative Settings in the Insert Step dialog box to open the
Quantitative Settings dialog box and click <OK>. This dialog box includes
nine tabs: Data Model, Model V.C., Dilutions, Graph, I.U., Validation
Criteria, Annotation, Layout, and Retest.
Buttons that apply to all tabs are located at the bottom of the dialog box:
<Apply>
<OK>
<Cancel>
This button is always disabled.
Saves all entries and returns to the Assay window.
Returns to the Assay window without saving the entries.
1) Data Model Tab (Quantitative Settings)
Figure 239: Definition of data model for quantitative evaluation
Data Model
Select the data model. You may choose:
Linear Regression
y = a + bx. Fits a straight line model through the data points using the
“least-squares” method.
Quadratic
Regression
y = a + bx + cx2. Fits a quadratic curve model through the data points using
the “least-squares” method.
Cubic Regression
y = a + bx + cx2 + dx3. Fits a cubic curve model through the data points
using the “least-squares” method.
Quartic Regression
y = a + bx + cx2 + dx3 + ex4
Fits a quartic curve through the data points using the “least-squares”
method.
Robust Linear
Regression
y = a + bx
Fits a straight line through the data points by minimizing the absolute
deviation of the points from the line.
Cubic Spline
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y = a0 + a1x + Σ bjΦj(x)
Fits a series of smooth cubic curves through the data points.
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Akima
Point-Point
Joins adjacent data points using a straight line.
4-Parameter
y = (A-D)/(1+(x/C)B)+D
Fits an S-shaped curve through the data points. Also known as Rodbard’s
equation.
Michaelis-Menten
y = Vmax x / (x + Km)
This model simulates the catalytic activity of an enzyme. This equation is
solved using the Lineweaver-Burk transformation.
User-Defined
If you select this item the User-Defined Model field is enabled. Here you
can enter calculation formulae. A weighted SD calculation is not possible
here.
Stored Model
If you select this item the Stored Model FileName field is enabled. Enter
the name of the file containing the curve you want to use for calculation of
the current plate results. No weighted SD calculation is possible.
Result Units
Define the result units, e.g. Titer, IU/ml.
SD weighted data
model
Some data models have the option of weighting the importance of the data
model by using the standard deviation of the replicates that were averaged
to produce that data point (e.g. Linear Regression, 4-parameter). The
model will fit its line/curve closer to points with a lower SD.
Display ANOVA
table
ANOVA stands for ANalysis Of VAriance. This is a table which describes
various sources of errors relating to the data model. This produces t-values
(and probabilities) for each coefficient and a F-value for the fit as a whole.
These can be used to determine just how good the fit is to the data.
Display predicted
standard values
For the standards, the actual concentration corresponding to their
measured OD values is displayed. These are calculated based on the
curve equation which is determined using the curve fit.
Data Transformation
Percentage Mode
342
Fits a series of piecewise cubic curves through the data points.
You can choose between logarithmic presentation of the X or Y axis.
Define percentage mode:
Percentage Y
Scaling in percent by defining a 0% and a 100% value. Click on the check
box if you want to use this mode. This enables the next 3 edit boxes.
0% Value
Enter the 0% value. Enter it as minimum value of one of the measured
samples in the following notation: MIN(sample type). Here you may enter:
well labels, digits, mathematical operators and brackets.
100% Value
Enter the 100% value. Enter it as maximum value of one of the measured
samples in the following notation: MAX(sample type). Here you may enter:
well labels, digits, mathematical operators and brackets.
Report LC/LD
Enter the percentage of the lethal dose. This is drawn into the diagram as a
line, allowing visual control of the reading results.
Standards
In this range you have to define the standard values. In the standard list all
standards defined in the assay are displayed. If the standards are always
equal, enter the respective value for each standard. Select the standard
you want from the list and then enter the value in the entry box above. If
the standard values are variable, do not enter any values here, but select
the item Variable Std. Values. In this case you are prompted to enter the
standard values prior to each run.
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Variable Std. Values
Variable Std.
Multiplier
The standard concentrations are variable. If you select this item, you are
prompted to enter the standard concentrations prior to each run.
Check this item to use a multiplier for the entered standard concentrations.
Average Std. Reps.
Select this item to use the average value of the specified standard
concentrations.
Model Parameters
The fields in this group box are enabled only if you select the item 4Parameter in the Data Model list box. With this data model you have to
define 4 parameters that define the curve.
Auto
In this column you can define for each of the 4 parameters – by clicking on
the respective check box – if it is to be defined automatically (Auto) or if a
Fixed value is to be entered. A checkmark in the check box means
automatic definition of the parameters. Deselect the checkmark to enable
the respective edit box for entry.
Max. no. of
iterations
Enter the number of iterations for curve calculation to be performed by the
program to fit the curve.
Stored Model
FileName
This field and the <Browse> button are enabled if you select Stored
Model in the Data Model list box. Click <Browse> to select the file that
includes the desired evaluation curve (*.mod).
User-Defined Model
Here you can enter a user-defined evaluation curve as formula. To enable
this field you have to select User-Defined in the Data Model list box. Enter
the curve equation next to X =, and use for this the mathematical character
offered in the Insert Function dialog box.
Input terms: This formula has to include 'Y', 'Sample' or 'Sample.n' once (n
= individual value of cavity). Moreover, this edit box may contain: well
labels, digits, mathematical operators and brackets, as well as the
functions offered via <Insert Function..>.
<Insert Function...>
Notes
Opens the Insert Function dialog box showing the available logical steps
(see Section 3.12.3.4.7).
Enter comments explaining the abbreviations.
Note
The additional information entered here appears on the printout of the
result report. The input is automatically entered in the list box below with an
equal sign.
Expression
Enter the expression (abbreviation) you want to explain. This information is
automatically entered in the list box behind the equal sign.
<Add>
<Remove>
<Clear>
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Click on <Add> to insert an additional row with explanation.
Removes the highlighted row.
Clears all notes in the Notes group box.
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2) Model V.C. Tab (Quantitative Settings)
Figure 240: Validation criteria for the defined curve
You can subject the curve defined on the Data Model tab to certain
validation criteria. To this end, you have to enter one or several control
equations. An error message appears if these are not fulfilled.
The r-squared value must be greater than 0.9: r2>0.9.
The slope value of a linear regression must be between 0.9 and 1.1:
0.9<=a(1)<=1.1.
The F-value of the data model must be significant at the 5% confidence
level: P(F)<0.05.
V.C. Check
Enter the desired equation. Use the character offered in the Insert
Function dialog box. The equation is automatically entered in the list box
below. Click on <New> to enter an additional equation. Then the row V.C.
Check is cleared for a new entry. In the list box, the second row is
enabled. You may enter: labels, digits, brackets, mathematical operators,
not equal operators and the functions offered via the item <Insert
Function> (see Section 3.12.3.4.7).
<Insert Function...>
Opens the Insert Function dialog box and you can view and select the
available logical operations.
<New>
<Delete>
<Clear All>
Click this button to enable a new row and to enter another equation.
Deletes the row highlighted in the list box.
Clears all characters available in the list box.
<Undo>
Revokes the previous action.
<Redo>
Revokes the undo function.
Report Format
Select the information the report should contain.
Detailed (All): All QC data (equations, values, etc.) are included in the
results report.
Detailed (Failures Only):
reported.
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Only the QC equations that fail are
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Descriptive (Failures Only):
explanation is displayed.
Only a error message without further
None: An error will not be reported.
Don’t evaluate result
if V. C. fails
If you select this item, the result is not output if the validation criteria are
not fulfilled.
3) Dilutions Tab (Quantitative Settings)
Figure 241: Entry of the dilution factors
On this tab you define the dilution factor for each sample.
T[x]
Shows tests T1 ... T10 selected in the test list below. In the entry box you
can edit the value (dilution factor) of the sample selected from the list box.
This entry is saved if you select another test from the list.
<Auto Fill...>
Opens the Auto Fill Settings dialog box and you can enter information for
automatic filling of the dilution table. Automatic filling starts with the
highlighted row. Enter a value for this dilution. For all following cavities you
can then define a multiple.
Auto Fill Settings dialog box
Figure 242: Options for calculation the dilution factors
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In this dialog box you define automatic filling on the Dilution tab (see
previous page).
‰
Select the dilution with which you want to start filling the table
automatically.
‰
Enter the desired value for this dilution. Based on this value you can
define in the Auto Fill Settings dialog box a mathematical calculation
(addition/subtraction/division/multiplication) for all following dilutions.
You can select the following mutually exclusive items:
Same as previous
The following dilutions will have the same value as the highlighted one.
Add to previous
Add to each previous dilution the value defined in the Factor field.
Example: The highlighted value is 10, the factor 2, this results in the series
of numbers 10, 12,14, 16....
Subtract from
previous
Subtract from each of the previous dilutions the value defined in the Factor
field. Example: The highlighted value is 100, the factor is 1, this results in
the series of numbers 100, 99,98, 97....
Multiply by previous
Multiply each of the previous dilutions by the value defined in the Factor
field. Example: The highlighted value is 10, the factor is 2, this results in
the series of numbers 10, 20, 40, 80....
Divide by previous
Divide each of the previous dilutions by the value defined in the Factor
field. Example: The highlighted value is 10, the factor is 2, this results in
the series of numbers 10, 5, 2.5, 1.25....
Factor
Enter the desired factor for the calculations. Default value is 1.
<OK>
Applies the selected mathematical operations and shows the Dilution tab
with the new dilution values.
<Cancel>
Returns to the Dilution tab without performing any mathematical operation.
4) Graph Tab (Quantitative Settings)
Figure 243: Parameters for graphical presentation
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On this tab you define the parameters for graphical presentation of the
results.
Enabled
A graph is created in the result printout only if this item has been selected
and the graphics functions are available on this tab.
Show all Results
Show all results.
Show Errors Bars
Show error bars.
Auto
Automatic title.
Title
Enter a title.
X Axis/Y Axis
Label
Information on X or Y axis. If an item is checked in the Auto column, the
respective parameters are set automatically. Otherwise that value is used
which has been entered in the respective edit box.
The label is taken from the assay definition or entered manually.
Minimum
Minimum value: automatic or manual setting.
Maximum
Maximum value: automatic or manual setting.
Major Unit
Automatic or manual setting.
Gridlines
Logarithmic Scale
Show gridlines.
Logarithmic scale of the respective axis.
5) I.U. Tab (Quantitative Settings)
Figure 244: Conversion formula for international units
On this tab you define the formula for conversion of the concentration
calculation in I.U. (international units) into another unit.
X=
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Enter the formula. Input terms: This formula has to include 'Y', 'Sample' or
'Sample.n' once (n = individual value of cavity). Moreover, this edit box may
contain: well labels, digits, mathematical operators and brackets, as well as
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the functions offered via <Insert Function..>.
Result Units
<Insert Function...>
Designation of the result unit.
Opens the Insert Function dialog box and you can view and select the
available logical operations (see Section 3.12.3.4.7).
6) Validation Criteria Tab (Quantitative / Qualitative Settings)
Figure 245: Validation criteria for OD single values
Here you define validation criteria for the OD single values. Enter one or
several control equations (e.g. S1>0.5). An error message appears if these
are not fulfilled.
V.C. Check
Enter the desired equation. Use the character that is offered in the Insert
Function dialog box. The equation is automatically entered in the list box
below. Click on <New> to enter an additional equation. Then the row V.C.
Check is cleared for a new entry. The second row in the list box is
enabled. Moreover, you can enter digits, brackets and mathematical
operators.
<Insert Function...>
Opens the Insert Function dialog box and you can view and select the
available logical operations (see Section 3.12.3.4.7).
<New>
<Delete>
<Clear All>
Deletes the row highlighted in the list box.
Clears all characters available in the list box.
<Undo>
Revokes the previous action.
<Redo>
Revokes the undo function.
Report Format
348
Click this button to enable a new row and you can enter another equation.
Select the information the report should contain.
Detailed (All):
All QC data (equations, values, etc.) are
included in the results report.
Detailed (Failures Only):
Only the QC equations that fail are
reported.
Descriptive (Failures Only): Only a error message without further
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None:
Don’t evaluate result
if Validation Criteria
fails
explanation is displayed.
An error will not be reported.
If you select this item, the result is not output if the validation criteria are
not fulfilled.
7) Annotation Tab (Quantitative Settings)
Figure 246: Annotation tab
On this tab you define that text is to be output instead of certain results.
Enter the conditions here.
Conditions
Condition
In this field you enter the condition.
The condition is automatically entered in the first row (or if several rows
exist, in the highlighted row) of the list of conditions. Each row starts with
„If“. The entry you make is automatically saved to this list and continues
the „If“ condition.
You can make the entry via keyboard or by clicking the <Insert
Function...> button; on the syntax used, see Section 3.12.3.4.7. Click on
<New Condition> to define a new condition.
Result Replacement
Here you enter what should appear instead of the result if the above given
condition is fulfilled: letters, digits, other characters (e.g. ****) or a
combination of those. The entries made here are automatically inserted in
the highlighted row of the list of conditions.
Result Annotation
Here you can define a flag to annotate the result which fulfills the above
condition. The entries you make here are automatically inserted in the
highlighted row of the list of the conditions.
Do not process
result any further
If this item is checked, the results which do not fulfill the criteria are not
processed any further.
List of conditions
Here the conditions are listed which are created via the <New Condition>
button.
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<Insert Function>
Opens the Insert Function dialog box and you can select a logical link for
the description of your conditions (see Section 3.12.3.4.7).
<New Condition>
Click on this button to create a new condition in the list. The new row starts
with „IF...“ You can define a condition via keyboard or by clicking the
<Insert Function...> button.
<Delete>
<Clear All>
Clears the entire list of conditions.
<Move Up>
Moves the highlighted row in the list of conditions up one row.
<Move Down>
Moves the highlighted row in the list of conditions down one row.
<Undo>
Revokes the last action.
<Redo>
Revokes the undo function.
Legends
Here you can create a legend and provide explanations on the results and
abbreviations, etc.
Result
Enter the term or the result you want to explain in the legend. It is
automatically entered in the first row of the legend list or in case several
legend rows exist in the highlighted row.
Legend
Enter a description. Separated by a tab mark, this text is written in the
same row as the result.
List of legends
Result and legend, which were entered in the two edit boxes above, are
displayed separated by a tab stop.
<New Legend>
<Delete>
Creates a new row for result and legend.
Deletes the selected row from the legend list.
<Clear All>
Clears the legend list.
<Move Up>
Moves the highlighted row in the legend list up one row.
<Move Down>
Reference Range
350
Deletes the selected condition from the list of conditions.
Moves the highlighted row in the legend list down one row.
You can type text or a formula (using the format function) into this field.
The value of this field will then be displayed in the results, stored in the
patient
results
database
and
transmitted
to
the
LIMS.
This field would normally be used to indicate what range a normal result
might be expected to lie within.
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8) Layout Tab (Quantitative / Qualitative Settings)
Figure 247: Layout for data and result output
On this tab you define the layout for the data and result output.
Layout
In this group box you select the data output elements. Multiple choice is
possible.
Display Header
If checked, any "header" information is displayed, e.g. data model
formulae.
Body: Matrix
Body: Table
Display Legends
Matrix
<Move Up>
<Move Down>
Result display as matrix (see information in the Matrix box).
Result display as table (see information in the Table box).
If checked, any legends are displayed, e.g. user-defined annotations.
Here you define which fields the matrix should contain. Select the desired
fields from the Available Fields list box and copy this to the Selected
Fields list box with the arrow buttons > or >>.
Moves the row highlighted in the Selected Fields list box up one row.
Moves the row highlighted in the Selected Fields list box down one row.
<Font...>
Click this button to define the font for the result output.
Gridlines
Show or hide gridlines.
Calculations
Select the calculations to be performed.
Use Average Inputs
If this item is checked, averaged input values are used for calculation,
otherwise single values.
Average Mode
Select the average mode. You can choose arithmetical and geometrical
averaging.
Table
Here you define the fields to be included in the table. Select the desired
information from the Available Fields list box and copy them to the
Selected Fields list box with the arrow buttons > or >>.
<Move Up>
Moves the row highlighted in the Selected Fields or Type Order list box
up one row.
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<Move Down>
Column Title
Column Width
Type Order
Scientific Format
Auto
Moves the row highlighted in the Selected Fields or Type Order list box
down one row.
Enter a column title.
Define the column width of the table in cm. Default value is 2.5 cm.
Define the order of the sample types for data output.
Controls when numbers are displayed in scientific format and when they
aren't. Three options are available:
Autoformat. You can select the number size (small, intermediate, large).
If Small Numbers is checked then any values less than 1.0 are displayed
in scientific format.
If Intermediate Numbers is checked then values between 1.0 and
10000.0 are displayed in scientific format.
If Large Numbers is checked then any values above 10000.0 are
displayed in scientific format.
Fixed Exponent
Presentation with fixed exponent. Set the value by clicking on the arrow
buttons. For example: 3 means x 103.
Exponent Multiple
Presentation with multiple exponents. Set the value by clicking on the
arrow buttons. For example: 3 means x 103, 106, 109....
Decimal Place
Define the decimal place.
9) Retest Tab (Quantitative / Qualitative Settings)
Figure 248: Retest tab
On this tab you define the criteria and conditions for retesting (see Section
3.7.2).
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3.12.3.4.6 Spreadsheet Parameters
Using a spreadsheet is required when the result calculation involves several
wells which are not just replicates. The value of each well is identified by a
letter and a digit referring respectively to rows and columns: from A1 to H12.
Selecting Spreadsheet Settings in the Insert Step dialog box opens the
Spreadsheet Settings dialog box. This dialog box includes two tabs:
Formulae and Layout. The Layout tab is identical to the corresponding
Layout tab in the Colorimeter Settings dialog box (see Section 3.12.3.4.1).
Only the Formulae tab is described below.
The buttons which apply to both tabs are located at the bottom of the dialog
box:
<Apply>
<OK>
<Cancel>
This button is always disabled.
Saves all entries and returns to the Assay window.
Returns to the Assay window without saving the entries.
Formulae Tab (Spreadsheet Settings)
Figure 249: Formulae tab
Here you define the calculation formulae for each individual well. The
calculation formulae are displayed on the Plate Layout in the respective
fields.
A1 ... H12
In front of this row you see the identification of the well highlighted in the
Plate Layout. Enter the desired calculation formulae, (e.g. A1*100, when
the result of well A1 is multiplied with 100). The entries are automatically
transferred to the highlighted field of the plate matrix.
<Insert Function>
Opens the Insert Function dialog box and you can view and select the
available logical links (see Section 3.12.3.4.7).
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Plate layout
Shows the entered formulae for calculation of the reading results of the
respective cavity.
Result Units
Define the unit of calculated results.
The mathematical syntax used to define the calculation formulae is
described in Section 3.12.3.4.7.
Using spreadsheet settings to test result evaluation
If you insert a Spreadsheet step in your assay (before the other evaluation
steps), enter values in the matrix of the Formulae tab and then process this
assay (in Demo Mode), the system will calculate the results for these values
as if these values had been read by the photometer instead of entered
manually.
To calculate these results, the system applies the evaluation methods and
criteria that you have defined (Validation criteria, Qualitative / Quantitative
parameters).
By entering specific values (e.g. values which you know should be positive
or negative), you can therefore check that the results calculated according to
the parameters that you have defined are correct or not. If they are not, you
can go back to your assay file, change the evaluation criteria and methods
and try again until you are satisfied with the results generated on the basis of
the Spreadsheet values.
To do this:
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‰
Make sure you are in Demo Mode (see Section 1.2.2.2).
‰
In your assay file, insert a Spreadsheet step before the other evaluation
steps and before the validation criteria step.
‰
In the Spreadsheet Settings dialog box, enter pertinent values (refer to
the assay literature if necessary).
‰
Save your assay file.
‰
Create a worklist with one plate for your assay (using dummy patients).
‰
Perform the test run in Demo Mode. At the end of the run a result file is
generated.
‰
Check the results calculated on the basis of your spreadsheet values.
‰
If they do not correspond to what you expected, go back to the assay file
(via the Window menu).
‰
Back in the Assay window, edit the evaluation parameters or the
validation criteria (click on the desired step with the right mouse button,
select Edit in the context menu and change some of the parameters in
the respective dialog box, then click <OK>).
‰
Save the assay file again.
‰
Go back to the results file (via the Window menu).
‰
In the View menu, select Recalculate. The results are calculated again
using the edited evaluation parameters.
‰
Check if these results are better than the first time.
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‰
If so, you can finish you assay definition process.
‰
If you are still not satisfied with the way the results are calculated, you
can edit the evaluation parameters and recalculate the results as many
times as you want until you obtain results which you find are correct,
given the spreadsheet values you entered. Do not forget to save the
assay file each time you edit it, otherwise the recalculation will be done
with the previously saved parameters and not the edited parameters.
Do not forget to delete the Spreadsheet step before processing your
assay in a real run. Otherwise, the input data will replace the measured
values.
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3.12.3.4.7 Entry of Logical Functions and Mathematical Signs
During various stages of the assay definition process (e. g. validation criteria,
qualitative evaluation, etc.), you have to define conditions, equations or
criterias in which you may need to enter logical functions and mathematical
signs.
1) Mathematical signs
Use the keyboard to enter the mathematical signs.
+
*
/
=
>
>=
<
<=
^
Addition
Subtraction
Multiplication
Division
Equal
Greater than
Greater than or equal to
Smaller than
Smaller than or equal to
Exponent (e.g. 103 is entered as 10^3)
Also use the keyboard to enter digits.
2) Logical functions
The logical functions are listed in the Insert Function dialog box, which
appears when you click the <Insert Function...> button in any dialog box.
The actual list of available functions depends on the screen on which you
clicked on the <Insert Function…> button.
The logical functions must be selected through the Insert Function
dialog box! Otherwise, the program does not recognize the character
sequence as a logical function.
Figure 250: Selection of logical functions
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
IF
AND
If the condition is true the „then“ expression is evaluated, otherwise the
„else“ expression.
Logical AND link.
OR
Logical OR link.
SD
Calculates the standard deviation of the respective well type or the plate, if
no well types have been defined.
CV
Calculates the coefficient of variation of the respective well type or the
plate, if no well types have been defined.
SE
Calculates the standard error of the respective well type or the plate, if no
well types have been defined.
Median
Calculates the median of the respective well type or the plate, if no well
types have been defined.
Min
Indicates the minimum value of the respective well type or the plate, if no
well types have been defined.
Max
Indicates the maximum value of the respective well type or the plate, if no
well types have been defined.
Abs
Absolute value.
Sample
Current average well value.
Sample.n
nth replicate of current well.
Y
Current replicate value.
This is used in user-defined data model formulae. As the formula is
evaluated for each well, there has to be some way of getting the current
OD value into the equation to calculate a concentration and this is it. For
example, if you wanted to model a specific straight line, y=2x+3 then you
would create a data model formula like "(Y-3)/2".
X(Y)
Calculates the Y-value corresponding to the X-value.
Y(X)
Calculates the X-value corresponding to the Y-value.
Valid (well type)
Number of valid wells of the selected well type.
Result (expr)
Y'(X)
Gradient at X.
Chi2
Chi-squared value.
This is a statistical term which is calculated as the sum of the squares of
errors between the data points Y values and their predicted Y values.
Row
Column
Int
ROUND
F
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Current row number.
Current column number.
Returns the integer part of the value (e.g. "4.8 Æ 4").
Returns the nearest integer value (e.g. "4.8 Æ 5").
F-value.
This is a statistical term used in hypothesis testing. A large F value
indicates that the data model fits the data well, a low value that it doesn't.
See P(F) too.
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T(n)
Coefficient t-value
This is the student's t-value, another statistical term used in hypothesis
testing. Each coefficient of the data model has its own t-value and this
indicates how well it is modelling the data in a similar manner to the Fvalue. A low t-value indicates that the parameter isn't doing much good
(and could probably be removed), a high t-value indicates that it is doing
useful work in modelling the data. See P(T(n)) too.
R2
A(n)
R² value.
Coefficient value.
This accesses the actual data model coefficient values. If you wanted to
use the slope of a linear regression in a validation formula you would use
A(1), if you wanted to use the D parameter of a 4-parameter fit you would
use A(3).
P(F)
F-value probability.
This would be used in a hypothesis test as it tells you the probability of
achieving this F-value by chance alone. So if you wanted to be 95%
confident that you had a good fit to the data points (i.e. only a 5%
probability that this is pure chance) you would write an equation like
"P(F)<=0.05".
P(T(n))
T-value probability.
This is similar to above. If you wanted to be 95% confident that your slope
parameter in a linear regression was modeling the data well you would
write an equation like "P(T(1))<=0.05". Note that in all cases n is 0 based,
so 0 is the first parameter, 1 the second, etc.
log
alog
ln
exp
History(
Uses the 10x logarithm of the indicated value
Uses the 10x anti-logarithm of the indicated value
Uses the natural logarithm of the indicated value
Uses the natural anti-logarithm of the indicated value
If this function is selected, the software remembers the original qualitative
result when a sample is retested. This function can be accessed from the
Qualitative Settings dialog box (Typing tab and Retest tab) (see also
Section 3.7.2).
The History function takes a qualitative result as an argument, e.g.
History(POS). If the original result was a POS result, the History function
returns a value 1; i the original result was not a POS result (or there was
no original result for example is this is the first test for that sample), the
History function returns a value 0. If the History function is selected
without an argument, it returns simply the value 1 if the current sample is a
retest and the value 0 if it is not.
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3.12. Programming Assays
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Variable 1
If this function is selected, you may introduce a variable (e.g. for a
formula). The term "Variable 1" can be overwritten by a test-specific term.
If Variable 1 is occupied, Variable 2 is created automatically; it can be
treated in the same manner. If Variable 2 is occupied, Variable 3 is
created, etc.
To delete unwanted variables, open the Assay Header dialog box (see
Section 3.12.3.1). In the Variables field, select the variable you want to
delete, then click on the <Delete> button.
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
3.12.3.5 Report and Export Settings
In the Assay Tree, double-click with the left mouse button on the Report
Settings folder. The Report Settings dialog box is displayed.
This dialog box includes three tabs: Report, Combined Report and Export.
Buttons that apply to all tabs are located at the bottom of the dialog box:
<Apply>
<OK>
<Cancel>
This button is always disabled.
Saves the entries on the Report, Combined Report and Export tabs as
well as the data in the Text File Settings dialog box. The program returns
to the Assay window.
Returns to the Assay window without saving the entries.
3.12.3.5.1 Report Tab
Figure 251: Report Settings – Report tab
On the Report tab you select the data fields which you want to include in the
result printout. The layout of the individual components is defined in the
respective dialog boxes (e.g. Quantitative Settings – Layout tab in Section
3.12.3.4.5 under 8)).
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3.12. Programming Assays
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
To help you define these parameters, you can print a result file
obtained after processing a Bio-Rad assay and check the Report
Settings dialog box of the corresponding assay ("Open" version). This
allows you to view the actual output for each parameter.
Page Header
The header is output on each page of the result printout. Here you define
the contents and layout of this page header. A code character corresponds
to each type of information to be included in the page header.
I = laboratory name; D = printout date; Q = quality control (validation criteria)
results ("VC passed" or "VC failed"); F = name of result file; P = page
number; A = number of pages; S = serial number of the instrument; V =
software version.
Using the keyboard, enter the respective code character in one of the three
boxes according to where you want the respective information to appear
(left, center or right) in the actual page header. You must type in the
placeholder & before each code character.
Appart from the coded information, you can also enter (just type it in using
the keyboard) any other information which you think should be included in
the page header.
Left, Centre, Right
This fields allow you to define the layout of the page header by entering the
codes characters or additional text in the field corresponding to the desired
alignment.
Report Structure
The structure of the report is defined by the individual data fields and their
order. Copy the desired data fields from the Available Fields list to the
Selected Fields list and change their order as needed.
Available Fields
Shows all the information fields that can be included in the printout of the
result report.
Laboratory name, address, etc.
Laboratory Details
Name and path of assay file used,
Assay Header
wavelengths used, date/time read, operator.
Lot specific data.
Lot Specific Values
Incubation errors. Selecting this entry is
Incubation Results
mandatory in certain countries.
Error messages and messages about user
Events
interactions taken from the event log.
Data specified in the Reader Settings –
Reader Results
Layout tab.
Data specified in the Validation Criteria
Validation Criteria
step.
Data specified in the Spreadsheet - Layout
Spreadsheet Results 1
tab.
Spreadsheet Results 2 (3 Same as above for the second, third or
fourth spreadsheet (if more than one
or 4)
spreadsheet has been included in the
assay).
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Qualitative Results
Quantitative Results 1
Quantitative Results 2
Combined Report
<Page Break>
Selected Fields
Shows the data fields of the reports selected via the arrow buttons. By
default, only Assay Header and Reader Results are selected.
>
Copies the data fields highlighted in the Available Fields list to the
Selected Fields list.
>>
<
<<
Move Up
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Data specified in the Qualitative Settings Layout tab.
Data specified in the Quantitative
Settings 1 - Layout tab.
Same as above for the second quantitative
evaluation step (if two quantitative
evaluation steps are included in the assay).
Data specified in the Combined Report tab
(see below).
In the printout, the item after a <Page
Break> will start at the top of a new page.
This is useful for example before graphs or
tables so that they are not split over two
pages.
Copies all data fields to the Selected Fields list.
Deletes the data fields highlighted in the Selected Fields list.
Deletes all data fields in the Selected Fields list.
Moves the data field highlighted in the list up one row.
Move Down
Moves the data field highlighted in the list down one row.
Page Footer
Defining the contents and layout of the page footer is done in exactly the
same way as for the page header; see above under Page Header.
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3.12. Programming Assays
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
3.12.3.5.2 Combined Report Tab
The Combined Report is a presentation of the results ordered per Patient
ID. In the Combined Report dialog box, you can select the format used
(Table or Matrix) and which data fields you want to include for each Patient
ID.
Data fields which are most frequently selected are: Patient ID, Layout Label
(#), Well Location (Well), Flag, Reader Value (O.D. Value), Quantitative
Value (Ratio) and/or Qualitative Value (Result) (see below for a complete
description of all available fields).
The Available Fields list in the Combined Report tab allows you to
include the patient names in the Combined Report. This, however, may
be prohibited or restricted under regulations protecting patient identity
and confidentiality. Please check if such restrictions apply in your
country (or laboratory) before including the patient name information
in the Combined Report.
Example of Table format Combined Report
Combined Report
Bio-Rad MONOLISA™ anti HBc PLUS
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Patient ID
NC1
NC2
#
NC1
NC2
Well
A1
B1
Flag
Patient ID
PC1
PC2
PC3
#
PC1
PC2
PC3
Well
C1
D1
E1
Flag
Patient ID
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
#
T1
T2
T3
T4
T5
T6
T7
T8
T9
T10
T11
T12
T13
T14
T15
T16
T17
T18
T19
T20
T21
Well
F1
G1
H1
A2
B2
C2
D2
E2
F2
G2
H2
A3
B3
C3
D3
E3
F3
G3
H3
A4
B4
Flag
O.D.
Value
0.0570
0.0510
Ratio
0.1254
0.1122
Result
NC1
NC2
O.D.
Value
2.2630
2.2740
2.2800
Ratio
4.9795
5.0037
5.0169
Result
PC1
PC2
PC3
O.D.
Value
0.1500
0.1420
0.1600
0.1740
0.1650
0.1660
0.1560
0.1540
0.1590
0.1530
0.1670
0.1760
0.1860
0.1660
0.1650
0.1620
0.1600
0.1720
0.1640
0.1780
0.1510
Ratio
0.3301
0.3125
0.3521
0.3829
0.3631
0.3653
0.3433
0.3389
0.3499
0.3367
0.3675
0.3873
0.4093
0.3653
0.3631
0.3565
0.3521
0.3785
0.3609
0.3917
0.3323
Result
NEG
NEG
NEG
NEG
NEG
NEG
NEG
NEG
NEG
NEG
NEG
NEG
NEG
NEG
NEG
NEG
NEG
NEG
NEG
NEG
NEG
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122
T22
C4
0.1520
0.3345
NEG
The Combined Report is included in the Result Report if it is selected in the
Selected Fields of the Result Report tab (see Section 3.12.3.5.1).
The Combined Report is not an independent document. It can only be
saved within in the (*.res) format Result file in which it is included. To be
exported, it has to be included in the (*.txt) format result export file (see next
Section).
The Combined Report tab
Figure 252: Combined Report definition
Layout
Display Header
Body: Matrix
Combined Report in Matrix format. If this item is checked the Matrix field
is enabled.
Body: Table
Combined Report in Table format. If this item is checked the Table field
is enabled.
Display Legends
Matrix
Available Fields
364
Not available.
Not available.
Select which results are to be included in the Report matrix:
Available fields:
Patient ID
Patient name
Well Location
Layout Label
Flag
e.g.Clot detected
Raw value
OD value (before blank subtraction)
Raw mean
average OD value (before blank subtraction) of every
single measurement
Raw SD
Standard deviation of raw value
Raw CV
Coefficient of variation of raw value
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EVOLIS
3.12. Programming Assays
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Raw SE
Reader value
Reader mean
Reader SD
Reader CV
Reader SE
Spread. 1 value
Standard error of raw value
OD value (after blank subtraction)
Average OD value of replicates
Standard deviation of reader value
Coefficient of variation of reader value
Standard error of reader value
Result of spreadsheet calculation for the first
spreadsheet (up to four can be included)
Spread. 1 mean Average of the replicates after spreadsheet calculation
for the first spreadsheet (up to four)
Spread. 1 SD
Standard deviation of spreadsheet result for the first
spreadsheet (up to four)
Spread. 1 CV
Coefficient of variation of spreadsheet result for the first
spreadsheet (up to four)
Spread. 1 SE
Standard error of spreadsheet result for the first
spreadsheet (up to four)
Quant. 1 value Result of first quantification step
Quant. 1 mean Averaged value for the replicates after quantification
step one
Quant. 1 SD
Standard deviation of result for result of quantification 1
Quant. 1 CV
Coefficient of variation for result of quantification 1
Quant. 1 SE
Standard error of result for quantification 1
Qual. value
Qualitative result for every replicate
Qual. mean
Qualitative result for the averaged value of the replicates
Quant. 2 value Result of quantification 2
Quant. 2 mean Averaged value for the replicates after quantification
step two
Quant. 2 SD
Standard deviation of result for quantification 2
Quant. 2 CV
Coefficient of variation of result for quantification 2
Quant. 2 SE
Standard error of result for quantification 2
Copy the respective parameters with the arrow buttons > or >> to the
Selected Fields list. You can change the order via the <Move Up> and
<Move Down> buttons according to your needs.
Selected Fields
List of selected parameters which are output after reading in the form of a
matrix (see also Available Fields).
>
Copies the highlighted parameters from the Available Fields list to the
Selected Fields list.
>>
<
<<
<Move Up>
<Move Down>
<Font...>
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Copies all parameters
Selected Fields list.
from
the
Available
Fields
list
to
the
Deletes the highlighted parameters from the Selected Fields list.
Deletes all parameters from the Selected Fields list.
Moves the highlighted parameter up one a row.
Moves the highlighted parameter down one row.
Opens the Font dialog box and you can define font, size and type for data
output. The default font is Arial, 10pt, standard.
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Gridlines
Calculations
Use Averaged Inputs
Average Mode
Table
Select this item to show gridlines.
Calculation parameters:
Select this item to use averaged input values.
Select the average mode: Arithmetic mean, geometric mean or median.
Select which results you want to include in the Report table.
The Available Fields are the same as described for the Matrix format.
Using the arrow buttons, copy the desired parameters to the Selected
Fields list.
Column Title
Column Width
Enter a column title. By default, the column title will be identical to the
name of the selected field. You may want to change for a shorter or more
explicit title (e.g. Well instead of Well Location, Ratio instead of Quant.
value). By default, "O.D." is included in the column title before "Reader
value"; you can omit "Reader value" but not omit "O.D.".
Define the column width. The default value is 2.5 cm.
Type Order
Define the order of the sample types for data output. Set the mouse
pointer on the sample type you want to move. Click the left mouse button
and move the sample type up or down with mouse button held down. The
sample type is positioned in the list at the point where you release the
mouse button.
Scientific Format
Controls when numbers are displayed in scientific format and when they
are not. Three options are available:
Auto
Autoformat. You can select the number size (small, intermediate, large).
If Small Numbers is checked then any values less than 1.0 are displayed
in scientific format.
If Intermediate Numbers is checked then values between 1.0 and
10000.0 are displayed in scientific format.
If Large Numbers is checked then any values above 10000.0 are
displayed in scientific format.
Fixed Exponent
Presentation with fixed exponent. Set the value by clicking on the arrow
buttons. For example: 3 means x 103.
Exponent Multiple
Presentation with multiple exponents. Set the value by clicking on the
arrow buttons. For example: 3 means x 103, 106, 109....
Decimal Place
366
Define the decimal place.
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3.12. Programming Assays
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
3.12.3.5.3 Export Tab
The EVOLIS system allows the user to export results either as ASCII (*.txt)
files or via an ASTM connection (this is explained in Section 3.13).
The decision to export results can be made on a case by case basis (by
selecting the Utilities | Export Results menu item) each time a (*.res) result
file is generated or the system can be configured to automatically export
results. To configure the system to create a result export file each time a
result file is created, see Section 3.13.1.4.
At assay level, the user defines:
• what type of export system should be enabled for that assay: ASCII,
ASTM or both.
• for ASCII files, their structure and contents.
• for ASTM exports, specific settings.
This is done on the Export tab of the Report Settings dialog box.
1) Enabling ASCII and/or ASTM exports of test results
Figure 253: Report Settings – Export tab
To enable ASCII and/or ASTM result exports:
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‰
In the Assay Tree, double-click on Report Settings (if you do not see
Report Settings, click on the plus (+) sign next to the Read folder).
‰
Select the Export tab. This opens the above dialog box.
‰
If you want to export the result report as a (*.txt) file, select Text File in
the Available Data Formats list and click the arrow (>) button. Text File
is copied into the Selected Data Formats list.
‰
If you want to export test results via an ASTM connection, select ASTM
E 1394 in the Available Data Formats list and click the arrow (>) button.
ASTM E 1394 is copied into the Selected Data Formats list.
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It is possible to select both formats.
Now you have to define the settings for the format(s) you have selected.
To do this:
‰
In the Selected Data Formats list, select the appropriate format.
‰
Click on the <Settings> button.
2) Text file settings
If you had selected Text File in the Selected Formats list, clicking on the
<Settings> button opens the Text File Settings dialog box. Here you can
define the structure and contents of (*.txt) export files for this assay.
Figure 254: Text File Settings dialog box
Define the desired headers and data fields as well as the separator between
the individual data and select the format (table/matrix). For examples of
ASCII export files with or without header, see Section 3.13.1.4.3.
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Available Header
Fields
Shows the available header fields of a report:
Assay Header
Assay name, Processing time and date, Operator,
Wavelengths used.
Kinetic Readings
Data specified in the Reader Settings - Layout
dialog box (kinetic assay protocol type)
Validation Criteria
Data specified in the Validation Criteria dialog box
Qualitative
Data specified in the Qualitative Settings - Layout
dialog box
Quantitative
Data specified in the Quantitative Settings Layout dialog box.
Lot Specific Values Reagent lot data entered and checked using the
reagent lot tracking function.
LIS Assay Name
Short assay name or code used for file transfer
between the EVOLIS system and the LIS as defined
in the Assay Link dialog box (see Section 3.13.2.2).
Selected Header
Fields
Shows the selected header fields.
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3.12. Programming Assays
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
> , >>, < , <<
<Move Up>/
<Move Down>
Available Fields
Buttons to copy the desired data format to the Selected Header Fields list
(>) or to remove fields from that list (< and <<).
Moves the highlighted field in the list up or down one row.
Shows the available data fields of the export file:
Patient ID
Well Location
Layout Label
Flag
Reader value
OD value
Reader mean
average OD value of replicates
Reader SD
Standard deviation of reader value
Reader CV
Coefficient of variation of reader value
Reader SE
Standard error of reader value
Spread. 1 value
Result of spreadsheet calculation for the first
spreadsheet (up to four can be included)
Spread. 1 mean
Average of the replicates after spreadsheet
calculation for the first spreadsheet (up to four)
Spread. 1 SD
Standard deviation of spreadsheet result for the first
spreadsheet (up to four)
Spread. 1 CV
Coefficient of variation of spreadsheet result for the
first spreadsheet (up to four)
Spread. 1 SE
Standard error of spreadsheet result for the first
spreadsheet (up to four)
Quant. 1 value
Result of first quantification step
Quant. 1 mean
Averaged value for the replicates after quantification
step one
Quant. 1 SD
Standard deviation of result for result of
quantification 1
Quant. 1 CV
Coefficient of variation for result of quantification 1
Quant. 1 SE
Standard error of result for quantification 1
Qual. value
Result of qualitative controls for every replicate
Qual. mean
Result of qualitative controls for the averaged value
of the replicates
Quant. 2 value
Result of quantification 2
Quant. 2 mean
Averaged value for the replicates after quantification
step two
Quant. 2 SD
Standard deviation of result for quantification 2
Quant. 2 CV
Coefficient of variation of result for quantification 2
Quant. 2 SE
Standard error of result for quantification 2
Date
Date of the run
Copy the respective parameters with the arrow buttons > or >> to the
Selected Fields list. You can change the order via the <Move Up> and
<Move Down> buttons according to your needs.
Selected Data Fields
> , >>, < , <<
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Shows the selected data fields for the report.
Buttons to copy the desired data format to the Selected Data Fields (>
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and >>) or to remove fields from that list (< and <<).
<Move Up>/
<Move Down>
Moves the highlighted field in the list up or down one row.
Separator
Enter the desired delimiter separating the individual data from each other,
e.g. colon (;).
Format
Define the formats in which the data shall be output: you may choose table
or matrix. The respective column and row titles are indicated.
Title
Here you may enter another title for the field names displayed in the
Selected Data Fields list. The new title is used in the export file.
To do this: In the Selected Data Fields list, highlight the field name you
want to edit for the report file. This name is then displayed in the Title edit
box. Overwrite the displayed name. The new name is then automatically
used for the export file.
When you have defined your parameters, click <OK> in the Text File
Settings dialog box, then click <OK> in the Export tab dialog box.
3) ASTM E 1394 settings
If you had selected ASTM E 1394 in the Selected Formats list, clicking on
the <Settings> button opens the ASTM E 1394 Export dialog box. In this
dialog box you define the desired Identifier and Result data fields.
Figure 255: ASTM E 1394 Export dialog box
370
Identifier
Use this field to enter, for each result, a word or abbreviation that will be
appended to the universal test ID of the result record and will help identify
that element.
Result
Shows the available data fields to be included in the ASTM export. Select
an item in the drop-down list and click <Add> to display it in the Results
list:
Reader mean
Average OD value of replicates
Qual. mean
Result of qualitative controls for every replicate
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3.12. Programming Assays
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Mean / Replicate
Quant. 1 mean
Averaged value for the replicates after quantification
step one
Spread. 1 mean
Average of
calculation
Quant. 2 mean
Averaged value for the replicates after quantification
step one
Spread. 2 mean
Average of
calculation.
the
the
replicates
replicates
after
after
spreadsheet
spreadsheet
These options apply to replicate wells of the same sample.
If you select Mean, the values exported are the mean values as selected in
the Result drop-down list. If you select Replicate, although mean values
are selected in the Result drop-down list, the values exported will be the
individual values for each replicate.
For example, if you want the ASTM export data to include the Reader
value of each 6 replicates of a sample (and NOT the mean value):
In the Result drop-down list, select "Reader mean".
Select the Replicate option and enter/select "1" in the entry field to indicate
the first replicate.
Click <Add>. In the Results list on the left, you can now see "Reader
value" (and NOT "Reader mean").
Now select "2" in the entry field next to the Replicate option and click
<Add> again.
Repeat this last step for replicates 3, 4, 5 and 6.
Click <OK> twice to close the dialog boxes and go back to the assay.
The selected mean and/or replicate values are listed at the end of the
Report settings section of the assay.
<Move Up>/
<Move Down>
<Add>
<Delete>
<Clear>
Export Control Well
Values
Moves the highlighted field in the list up or down one row.
Moves the information entered in the Identifier and Result fields to the
Results list.
Deletes the selected information from the Results.
Clears the entire Results list.
If this item is checked, the values of the control wells are also included in
the export file.
4) Editing export settings
Whereas file import parameters can be adjusted at system level, file export
settings are defined only at assay level.
This may cause some problems when pre-defined assays are distributed to
various users whose computer systems, networks and communication
protocols are not identical.
In this case, the only solution is to edit the assay file to adapt the export
settings to the computer system on which the export files will be transferred.
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To do this:
‰
Select the File | Open menu item to open the assay file (if it is a
protected Bio-Rad assay file, refer to what is said in Section 3.12.2).
‰
In the Assay Display Area, scroll down first to the end of the file to check
the file export parameters (under Text File).
‰
Double-click on that zone in the Assay Display Area to open the Report
Settings dialog box.
‰
Click on the Export tab.
‰
In the Export tab dialog box, click on the <Settings> button.
‰
In the Text File Settings dialog box, edit the parameters (refer to what is
said above in the 2) Text file settings sub-section).
‰
When done, click on <OK> in the Text File Settings dialog box, then
click <OK> in the Export tab dialog box.
‰
Save the assay file (for more information on saving assay files, see
Section 3.12.4).
5) Export failure
See Section 3.13.1.4.6.
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3.12.4 Verifying and Saving Assay Files
Defining and even editing an assay file can be a long process. Make sure,
therefore, to save your assay file regularly while defining or editing it (do not
wait until the end).
To save your assay file:
Select the File | Save as menu item.
In the Save as dialog box, enter a filename for your assay (see below) and
click the <Save> button.
If your assay file has already been saved under a specific name, just select
the File | Save menu item or click the <Save> button in the tool bar.
Assay file name, extension and directory
By default, assay files as saved as Assay1, Assay 2...
All assay files have a (*.asy) extension.
By default, assay files are saved in the C:\BioRad\Resources\Apf directory.
If you create your own assay files, make sure to choose explicit file names.
If you edit Bio-Rad assay files on the basis of the "Open" version (see
Section 3.12.2.3), make sure to save the edited version under a different
name so as to always keep an "Open" version that is completely identical to
the protected version.
Verifying your assay file
After you have finished defining your assay file, you can verify it.
To do this:
‰
While the assay file is open, select Verify Assay in the Utilities menu.
The system will check that no required parameter is missing or
incorrectly defined and display a corresponding message if it finds any
error.
‰
Correct the respective parameter and repeat the Verify Assay function
until the following message is displayed.
Figure 256: Assay verification
‰
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Save your assay again.
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After this first verification, what you can also do before using your assay for a
real test run is to run it in Demo Mode. This will allow you to follow the
processing and check the evaluation parameters and adjust them again if
necessary (see Section 3.12.3.4.6).
Protecting your assay file
Once you are completely satisfied with your assay, it is a good idea to
protect it so that nobody can change it (on purpose or by mistake).
To do this:
‰
Open your assay file.
‰
In the Assay Tree, double-click on Assay Header.
‰
In the Assay Protocol Header dialog box (see Section 3.12.3.1), enter
a password in the Type password field and re-type it below.
‰
Click <OK> to close this dialog box and save your assay again.
‰
Store your password.
If you are worried that you may forget your password and not be able to edit
your assay later, create an "Open" copy of your assay file, just like for BioRad pre-defined assay (see Section 3.12.2.2). Note that this "Open" version
has to be created before you protect the original file as described above.
To create an "Open" copy of your assay file:
374
‰
Close your assay file.
‰
Open the Windows Explorer. Find the directory where your assay file is
saved.
‰
Click on the file with the right mouse button and select Copy in the
context menu.
‰
Then click on the directory with the right mouse button and select Paste
in the context menu. At the bottom of the directory, a copy of the assay
file is included (Copy of assayname.asy).
‰
Rename this file as you
"Copy_assayname.asy"...).
want
(e.g.
"Open_assayname.asy",
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3.13 Connection to a Host Computer
The EVOLIS system has been designed to easily integrate into a laboratory
environment (see Figure 30).
To that effect, two different methods of exchanging data between the
EVOLIS system and a host computer are supported:
• Transfer of ASCII files (import of patient data or worklists into the
EVOLIS and export of patient test results to the host computer).
• Transfer through an ASTM link (download of test orders to the EVOLIS
system and upload of patient results to the host computer).
These two methods are described in the following Sections.
Note that it is not possible to import absorbance data, pipette data or
other file types from other systems or readers.
3.13.1 ASCII File Transfer
The EVOLIS has the possibility to import (*.txt) worklist or patient data files
and export (*.txt) result files from and to a network server.
The import of worklist files can be performed manually by the user or
automatically with a polling sequence. Export files are generated and
transmitted automatically if this has been defined in the respective assay.
3.13.1.1 Hardware Configurations
The communication between the EVOLIS computer and the host system is
established using an Ethernet card.
In case the EVOLIS computer should be connected to another host system,
please install the necessary protocol or client and configure it according to
the specifications for this host.
1) For all types of servers, note the following restrictions:
• File names should not include more than 20 characters.
• File
names
should
not
include
special
characters
except “-“ and “_”.
2) Characters allowed in file names are:
• Numbers from 0 to 9.
• Letters from A to Z (small and big capitals).
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3.13.1.2 Importing Patient Data and Worklist Files
3.13.1.2.1 Types of Import Files
Import files are (*.txt) files generated by a host computer, which include
information about patients and test orders for these patients. The EVOLIS
system will be able to import and process these files only if their structure
and contents are arranged in a certain order.
Standard Data fields
The standard data fields that can be expected by the EVOLIS system in an
import file are: the Patient ID, the Patient Name, the patient's Birthdate, the
patient's Sex, the Test Name(s) and the Collection Date.
Not all these fields have to be included in the imported files. For instance,
you can import worklist files that include only the Patient IDs and the Test
Name for each Patient ID (see examples below).
For certain fields, a specific format has to be obeyed (e.g. birth dates must
have a YYYYMMDD format, collection dates a YYYYMMDDHHMMSS
format, see Section 3.13.1.3).
Header/No header
The EVOLIS system is able to analyze import files with or without header. A
file has a header if the first line of the file lists the various data fields included
in the file.
Examples of import files with header:
a)
Patient ID,Test name,Test name,Test name,Test name
Header Row
001,HBc+ Ab,HBs+ Ag,HIV Ag-Ab,HCV Ab
Data Fields
002,HBc+ Ab,HBs+ Ag,HIV Ag-Ab,HCV Ab
003,HBc+ Ab,HBs+ Ag,HIV Ag-Ab,HCV Ab
004,HBc+ Ab,HBs+ Ag,HIV Ag-Ab,HCV Ab
005,HBc+ Ab,HBs+ Ag,HIV Ag-Ab,HCV Ab
1001,HBs+ Ag,HSV-IgM
1002,HBs+ Ag,HSV-IgM
1003,HBs+ Ag,HSV-IgM
b)
Patient ID,Patient name,Test name,Birthdate,Sex,Collection Date
Header Row
001,David,HBc+ Ab,19690330,,20020330102944
Data Fields
324,Marco,HBs+ Ag,19770119,M,20020330103344
BF221,Dupont Jean,HIV Ag-Ab,19661101,M,20020330112121
33SD321,Durand Sophie,HIV Ag-Ab,19770202,F,20020324120229
Using headers makes it easier if several Test Names are included for each
patient. Otherwise, a new line has to be included for each Test Name.
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Without a header row, file a) above would have to be structured as follows:
001,HBc+ Ab
001,HBs+ Ag
001,HIV Ag-Ab
001,HCV Ab
002,HBc+ Ab
002,HBs+ Ag
002,HIV Ag-Ab
002,HCV Ab
003,...etc.
For file b), things would be easier since only one Test Name is included per
Patient ID:
001,David,HBc+ Ab,,M,20020330102944
324,Marco,HBs+ Ag,19770119,M,20020330103344
BF221,Dupont Jean,HIV Ag-Ab,19661101,M,20020330112121
33SD321,Durand Sophie,HIV Ag-Ab,19770202,F,20020324120229
Separator
The header fields and the data fields are separated by a special character. In
the examples above it is a comma (,) but the system lets you specify which
character you intend to use as a separator: colon (:), semi-colon (;), vertical
bar (|)...
No space should be included between the separator and the data.
Note that if for a given patient all data fields are not filled (e.g. in example b)
the birthdate of Patient 001 is not known), the data field remains empty but
there must still be the same number of separators.
This is true except for the fields at the end of a line (e.g. in example a) for
patients 1001, 1002 and 1003 for which only two test are assigned).
3.13.1.3 Defining Import Parameters
The ASCII Patient Information Import dialog box allows the user to "tell"
the EVOLIS system what type of import file it is faced with or should expect.
This dialog box is displayed each time you import files or when you define
your file polling (automatic import) parameters.
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Figure 257: ASCII Patient Information Import dialog box
Has Header Row
Select this item if the import file has a header. In this case, the next item is
enabled.
Use Header Row to
Determine Mappings
If you check this item, the system will automatically use the header row to
interpret the data fields. In this case, you do not have to specify which data
fields are included; the Available Fields list and the Selected Fields list
are disabled.
If you do not check this item, you are telling the system to disregard the
header row and to interpret the data fields according to what you select in
the Selected Fields list.
Separator
Available Fields
Enter the character used as separator (see above).
Shows the available fields. Select the fields that the patient ASCII file
includes from this list. If you need additional fields, you can load them from
a file by clicking on <Open Settings...>. This file must include the fields
row-wise in the ASCII format. If necessary, you have to create a file with
the field names and copy it to the respective subdirectory.
Patient ID
Alphanumeric strings accepted.
Patient name
No limits on patient name
Birthdate
YYYYMMDD (year, month, day)
Sex
ASTM states M, F, or U but no actual restrictions
Test name
If you have defined LIS assay names (see
Section 3.13.2.2), the software can use these as
test names (both in case of manual import and in
case of import by file polling).
Otherwise, the imported test name must
correspond exactly to the name of the assay file
stored in the C:\BioRad\Resources\Apf directory
but without the (*.asy) extension.
Example: HBc+ Ab 1P BR VXX
When "Archive" is used as test name, the
respective samples shall be archived (see
Section 3.6.3).
Collection Date
378
YYYYMMDDHHMMSS (year, month, day, hour,
minutes, seconds)
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Secondary Tube
Barcode ID of tube used for sample archiving
when sample archiving order is included in the
worklist.
>, >>, <, <<
Use these buttons to transfer data fields from the Available Fields list to
the Selected Fields list (or back). You can also transfer fields from one list
to the other by double-clicking on them.
Selected Fields
Shows the data fields which the system should expect to find in the import
file.
Make sure that the order of the data fields in the Selected Fields list is in
accordance with the order of the data fields in the import file! You can
move a field in the list by selecting it with the mouse and dragging it
upwards or downwards without releasing the mouse button.
<Open Settings> /
<Save Settings>
If the files you import from the host computer always have the same
structure and include the same data fields, you do not have to redefine the
import parameters each time.
Once you have defined the parameters (header row or not, separator,
selected data fields), you click <Save Settings>. This creates a (*.apm)
ASCII Patient Information Mappings file which you can re-use for later
imports by clicking the <Open Settings> button. However, this is useful
mainly if your import files do not have header rows that can be used for
mappings.
3.13.1.3.1 Automatic Import (File Polling)
The EVOLIS software allows the user to define specific locations that the
software will poll on a regular basis to look for ASCII patient information files.
When a valid file is found, it is automatically imported into the software,
interpreted and the patient database is updated with the new patient details.
To specify the file polling intervals and the structure of the files to be
imported:
‰
‰
Select the Utilities | Options menu item.
Click on the File Polling tab.
Figure 258: File Polling tab
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Enable polling for
files of type
Check this item if the EVOLIS computer is connected to a host computer. If
you select this item, the other boxes on this tab are enabled.
Drop-down list box
In the drop-down selection list you can select the file type for the patient
information. Currently, the only available format is the ASCII format.
Every ... minutes
Enter the intervals (in minutes) information is to be polled from the host
computer.
in directory /
<...>
Specify the location (directory in the host computer) to be polled. Enter the
full path (including a filename).
To browse, click on the <...> button, find the desired directory and select a
file name in that directory.
<File Options>
Opens the ASCII Patient Information Import dialog box and you can
enter the structure of the ASCII files to be imported (see Section 3.13.1.3).
The system time of the server and the system time of the EVOLIS
computer must be synchronized!
If the system time of the server is ahead of the system time of the
EVOLIS computer and they deviate more than the defined polling time
the patient information files will never be imported!
3.13.1.3.2 Manual Import of a Worklist
There are two ways of importing worklists / test orders manually.
1) Manual import from the "File polling" directory
If you have enabled the automatic "File polling" function (see above) but you
want to manually "force" the system to retrieve pending files immediately,
just click the <Import> (Scan now) button in the toolbar.
Figure 259: <Import> button
In this case, the system retrieves file(s) only from the source directory and
with the import parameters defined for the "File polling" function.
2) Purely manual procedure
Use this procedure:
• If the automatic "File polling" function is not enabled, or
• If it is enabled but you want to import files from a source directory or with
import parameters that are different from the ones specified for the
automatic "File polling" function.
380
‰
Select the File | Open menu item.
‰
In the Open dialog box, find the directory, on the host computer, where
the worklist or patient data file has been saved (make sure that “ASCII
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Patient Information (*.txt)” is selected in the File Type drop-down list at
the bottom of the Open dialog box).
‰
Select the desired (*.txt) worklist file and click <Open>.
‰
This opens the ASCII Patient Information Import dialog box. Define
your import parameters as described in Section 3.13.1.3.
‰
Click <OK>. The following message is displayed.
Figure 260: Successful import message
This message just confirms that the file has been imported. It does not
confirm the correct import of all the data fields!
This message is only displayed if you use the purely manual
procedure (paragraph 2) above). It is not displayed in case of
automatic import (see Section 3.13.1.3.1) or manually forced file
polling (paragraph 1) above).
3.13.1.3.3 Import Failure
To make sure that all the data included in the file have been successfully
and correctly imported into the EVOLIS system, you have to check the
Patient Editor dialog box.
To do this:
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‰
Select the Utilities | Patient Details menu item. This opens the Patient
Editor dialog box. If the file was correctly imported and interpreted by
the system, each Patient ID included in your import file should have a
corresponding folder in the Patient Editor dialog box.
‰
If the file you imported included one or more Test Name data fields,
there should be a plus (+) sign next to each patient folder. Click on that
plus (+) sign to check that the corresponding test orders have correctly
been imported.
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Figure 261: Patient Editor with manually imported patient data
If the imported data included Patient Details such as Name, Sex and
Birthdate, you can check that they have been correctly imported by selecting
a patient folder in the Patient Editor and clicking the <Edit> button. This
opens the Patient Details dialog box.
Figure 262: Patient Details dialog box
If the imported data included test order information such as Test Name and
Collection Date, you can check that it has been correctly imported by
selecting a test name in the Patient Editor dialog box and clicking the
<Edit> button. This opens the Test Orders dialog box.
Figure 263: Test Orders dialog box
The same method can be used to check if an automatic file polling and
import process has been successfully carried out.
If the patient data that you imported (whether manually or
automatically) correspond to patient samples that you are loading or
have loaded on the EVOLIS instrument, the system will automatically
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display the imported data in the column format Patient Editor dialog
box (see Section 2.3.2.2).
Import Failure
If the patient data was not correctly imported:
‰
Check that the import parameters that you defined in the ASCII Patient
Information Import dialog box correspond to the actual structure and
contents of the file you tried to import.
‰
Check that the file polling path you specified in the File Polling dialog
box is correct.
‰
Check that network communication is not down.
‰
Check that the system times of the EVOLIS computer and of the host
computer are synchronized.
3.13.1.3.4 Deletion of Imported *.txt Files
To prevent imported worklists from remaining for ever in the Import directory,
imported *.txt files are automatically deleted by the system after importing,
(whether by manual import or file polling). Before the file is deleted a copy is
made in the Backup folder (see Section 1.2.6.2). The filename of the copy is
the same as the filename of the original import file but with a prefix “Copy of“,
e.g. if the import file is named "worklist4.txt", then the backup copy will be
named “copy of worklist4.txt”. If the import file always uses the same
filename, then the name of the backup copy will be incremented, e.g. “Copy
(2) of worklist4.txt“, “Copy (3) of worklist4.txt“, etc.
3.13.1.3.5 Importing of Multiple Test Order Requests for the Same Patient
The software uses a specific setting to control what happens when a
duplicate test order request is received for the same patient. This setting
either allows or ignores the duplicate test order request. The default setting
is that the duplicate test order request is ignored (and processed as an
individual test order). If the duplicate test order request is allowed then, after
a successful import, multiple test order requests are shown for the respective
patient in the Patient Editor dialog box.
Then, when a worklist is created for this patient a number of wells equal to
the number of test order requests shall be allocated to the patient sample.
These shall be combined by the software and given the same layout label ID
(e.g. in the picture below, two T1 labels for patient 000001 (x2)).
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Figure 264: Multiple test order requests for the same patient
This only applies when importing from text files. Duplicate ASTM test
order requests shall always be ignored.
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3.13.1.4 Export of Test Results
3.13.1.4.1 Individual Export Requests
Each time a (*.res) result report is calculated and displayed on the screen,
you can decide to export it.
To do so:
‰
Select the Utilities | Export Results menu item.
If you belong to a user group not authorized to "Post Results to LIMS", the
Log-On dialog box will be displayed and you will need the assistance of a
supervisor to export the results (see Section 1.2.7.3).
Each time you close a (*.res) Result Report displayed on the screen, a
message box is displayed with the following prompt.
Figure 265: Export prompt
‰
Click <Yes> to export the results before closing the Result Report.
This applies both to ASCII and ASTM exports. Prerequisites for these
exports are, however, that the appropriate settings have been defined
at assay level (see Section 3.12.3.5.3) and, for ASTM exports, that the
connection has been enabled as described in Section 3.13.2.1.
3.13.1.4.2 Export Options
Other export options are found on the Preferences tab.
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‰
Select the Utilities | Options menu item.
‰
Click on the Preferences tab.
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Figure 266: Preferences tab
‰
In the Export Options zone, the Automatically create exported result
files item is always disabled and cannot be enabled by end-users. No
automatic export function is available;
‰
The Export results if VC fail item allows you to block the result file
export if the validation criteria for the test have not been met.
Check this item if you want to be able to export results even if the test's
validation criteria are failed.
Uncheck this item if you want the EVOLIS system to block the result
export if the test's validation criteria are failed (Note: the system allows
you to request the export and even tells you that the results have been
exported but no export file is actually generated and exported).
‰
Confirm with <OK>.
3.13.1.4.3 Contents of ASCII Export Files
The structure and contents of the ASCII export files depend on what has
been defined for each assay (see Section 3.12.3.5.3 under 2)).
In Bio-Rad assays, (*.txt) export files include the following data fields:
Patient ID, Assay, Well Location, Flag (not in all assays), Reader value,
Quant. value, Qual. value.
Examples of ASCII export files
Export file without header field
[HBsAg]
No header information
[Results]
Patient ID|Assay|Reader value|Qual. value
Data field header
""|"HBsAg"|"0.009"|"NC1"
Separator is a vertical bar (|)
""|" HBsAg"|"0.011"|"NC2"
""|" HBsAg"|"0.093"|"NC3"
""|" HBsAg"|"1.455"|"PC1"
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""|" HBsAg"|"1.465"|"PC2
"001"|" HBsAg"|"0.004"|"neg"
"002"|" HBsAg"|"0.011"|"neg"
"003"|" HBsAg"|"0.011"|"neg"
"004"|" HBsAg"|"0.002"|"neg"
"005"|" HBsAg"|"0.987"|"pos"
"006|" HBsAg"|"0.009"|"neg"
"007 HBsAg"|"0.075"|"equ"
"008 HBsAg"|"0.011"|"neg"
[End of Results]
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Export files with header field
[HBsAg]
Time:;11:15:00
Date:;27/09/00
OVER limit:;3.000
Assay Header Field
Operator:;User
Wavelengths:;450nm/620nm
-0.01<=NCi<=0.50;-0.01<=0.010<=0.50
;-0.01<=0.009<=0.50
;-0.01<=0.011<=0.50
;-0.01<=0.093<=0.50;Removed
Valid(NC)>=2;2>=2
Validation Criteria Header Field
PCi>=0.550;1.460>=0.55
;1.455>=0.55
;1.465>=0.55
valid(PC)=2;2=2
If 'Sample<(NC+0.05)*0.9' Then
Result:='neg'
If 'Sample>=(NC+0.05)*1.1' Then
Qualitative Header Field
Result:='pos'
Default result := equ
[Results]
Patient ID,Assay,Reader value,Qual. value
Data field header
"","HBsAg","0.009","NC1"
Separator is a comma (,)
""," HBsAg","0.011","NC2"
""," HBsAg","0.093","NC3"
""," HBsAg","1.455","PC1"
""," HBsAg","1.465","PC2
"001"," HBsAg","0.004","neg"
"002"," HBsAg","0.011","neg"
"003"," HBsAg","0.011","neg"
"004"," HBsAg","0.002","neg"
"005"," HBsAg","0.987","pos"
"006," HBsAg","0.009","neg"
"007 HBsAg","0.075","equ"
"008 HBsAg","0.011","neg"
[End of Results]
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3.13.1.4.4 Target Directory for Export Files
Under default settings:
• Result files (*.res) are saved in the C:\Biorad\Resources\Results
directory.
• Result Export files (*.txt) are saved in the C:\BioRad\Export directory.
To change the directory where export files are to be saved (for example if
you want them to be saved on a host computer and not on the EVOLIS PC):
‰
Select the Utilities | Options menu item. This opens the Options dialog
box.
‰
Click on the Directories tab.
‰
Select Export Files and click on the <Browse> button.
‰
In the Browse dialog box, find and double-click on the computer and
then on the directory to which you want to redirect your export files.
‰
In that directory, select any file and click <Open> (if the desired directory
contains no file yet, see Note below).
‰
This takes you back to the Directories tab of the Options dialog box.
Check that Export Files are now directed to the correct directory and
click <OK>.
To change the target directory for export files, the new target
directory to which you want to redirect your files has to include at
least one file (any file) to enable you to select it before clicking
<Open> (otherwise the directory change will not be retained).
If this new target directory is empty just copy or create any file into it
for that purpose (you can later delete it).
3.13.1.4.5 Opening ASCII Result Export Files
Result export files are ordinary (*.txt) files which can be opened with any
standard word processor or spreadsheet software.
They cannot be opened with the EVOLIS software! If you try to open a (*.txt)
result export file with the EVOLIS software, the system will assume that it is
a (*.txt) worklist import file and will automatically display the ASCII Patient
Information Import dialog box as if you had to define import parameters
(see Section 3.13.1.3). Just click <Cancel> in this dialog box and use the
correct software to open the export file.
3.13.1.4.6 Export Failure
1) Automatically generated export files
If you perform a test run and if, when the plate results are calculated and
displayed, the system also displays the following error message:
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Figure 267: Export failure (automatic procedure)
This means that the system has correctly generated the result export file as
specified in the Preferences dialog box but that it cannot find the target
directory where the file should be exported to.
This can happen, for example, when the network is down. Click <Close> in
the error message box and close the (*.res) result file. Then, as soon as the
network communication is reset, open the (*.res) result file again (look in the
C:\BioRad\Resources\Result\ directory). The system will automatically
generate the (*.txt) result export file again and export it to the target
directory.
If this happened for another reason (e.g. because the target directory had
been accidentally moved or deleted), check the defined target directory and
change it if necessary (see the Target directory for export files subsection
above). Then re-open the corresponding (*.res) result file. The system will
then automatically generate the (*.txt) result export file again and export it to
the corrected target directory.
2) Individually ordered export
If the automatic export function in the Preferences dialog box is deselected
and you want to individually export results by selecting the Utilities | Export
Results menu item and if you obtain the following error message:
Figure 268: Export failure (individual exports)
This also means that the system could not find the correct target directory for
the export file.
Once the reason for this (network down or directory moved/deleted) is
identified and corrected as explained above, go back to your result file and
select the Utilities | Export Results menu item again.
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3.13.2 Communication through an ASTM Link
Communication between the EVOLIS and an external host computer is then
accomplished via an RS232 connection and follows the ASTM 1394 (high
level) and 1381 (low level) standards for communication.
ASTM stands for American Society for Testing and Materials. The
ASTM has developed standards on data transfer to/from host
computer in the medical field. For more information on ASTM
standards, see http://www.astm.org.
The EVOLIS host interface consists of:
• ASTM 1381 low-level transfer protocol used to transmit or receive
messages
• Interpretation of received data from the intermediate files and entering it
into the EVOLIS database
The ASTM 1394 defines how the data to be transmitted is represented as a
structured message consisting of several records. These messages are then
translated into one or more frames that will actually be transmitted according
to ASTM 1381.
3.13.2.1 ASTM Link Set-Up
It is possible to configure the ASTM connection settings if the software
is in Demo Mode but not to use the ASTM connection.
To set-up the connection parameters according to ASTM specification for
connection to a host computer:
‰
Select the Utilities | Options menu item.
‰
Click on the ASTM tab.
‰
Click the Enable ASTM E 1381/1394 link checkbox. Then all boxes on
this tab are enabled. The connection setting of the delimiter and the
interface are defined in accordance with the ASTME standard.
‰
‰
Select the correct COM port.
Confirm with <OK>.
Please make sure that you do not select the COM Port used to connect
he PC to the EVOLIS instrument.
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Figure 269: ASTM Interface configuration
Enable ASTM E
1381 / 1394 Link
Select this item if communication with a host computer exists.
ASTM E1394
Delimiters
Query Host For Test
Order Requests
Compact Mode
These fields specify the set of delimiters used for transmissions.
If this item is checked, the Query to Host mode is enabled (see below).
If this item is checked, each patient result information is sent in a separate
package.
ASTM E 1381
COM Port
Baud Rate
Parity
This field specifies the serial port used for host transmissions.
Specifies the baud rate used for transmissions between the EVOLIS and
the host; any values from 110 to 56,000 can be chosen. Default is 9600.
None, odd, even, mark, space. Default is None.
Data Bits
7 or 8, default is 7.
Stop Bits
1, 1.5 or 2, default is 1.
Create Log File
If this item is checked, a log file (yyyymmdd.txt) of the ASTM
communication is created in the BioRad\Resources\Event_log directory.
<Assay links…>
Click this button to review existing LIS assay names or create new ones
(see below).
3.13.2.2 Definition of LIS Assay Names
Because the actual assay file names are often relatively long, it is sometimes
not convenient or not technically possible to use them for file transfer
purposes (for file transfers between the EVOLIS software and the host
computer/LIS).
In this case, shorter code names or "LIS assay names" can be defined.
Once defined, these LIS assay names can be used either for ASTM file
transfers (see Section 3.13.2.3) or for ASCII file transfers (see Sections
3.13.1.3.1 [import] and 3.12.3.5.3 [export]).
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To define LIS assay names:
‰
Select the Utilities | Options menu item.
‰
Click on the ASTM tab.
‰
On this tab, click on the <Assay Links…> button. This opens the
following dialog box showing the list of already defined LIS assay names
and the corresponding assay file names. If you have not yet defined any
LIS names, the list is empty.
Figure 270: List of LIS assay names
‰
To define a new LIS assay name, click <Add…>. This opens the
following dialog box.
Figure 271: Defining / editing a LIS assay name
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‰
Click <Browse…> to open the assay file directory and select the assay
file for which you want to define a LIS assay name.
‰
Click <Open> to close the assay file directory and insert the selected file
in the Assay Protocol Filename field. . It is recommended to always use
the <Browse…> button instead of entering the assay file name via the
keyboard to avoid typing errors.
‰
In the LIS Assay Name field, enter the short name you want to use as
LIS assay name for this assay.
‰
When done, click <OK>. This takes you back to the Assay Links dialog
box and you can check that the newly defined LIS name is now in the
list.
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‰
Click <OK> again to close this dialog box and go back to the ASTM tab
of the Options dialog box.
‰
Click <OK> to close this dialog box.
LIS assay names can include letters, digits and blank spaces. Capitals
and lower case letters are visually different but are treated by the
system as the same character. For example, if "HIV1" is an existing LIS
assay name, you cannot define another LIS assay name as "Hiv1". If
you try, a message is displayed saying: "A link already exists for this
assay name. Do you want to overwrite the existing link?"
To edit an existing LIS assay name, select it in the Assay Links dialog box
and click <Edit…>.
To delete an existing LIS assay name, select it in the Assay Links dialog
box and click <Delete>. If you click <Delete All>, you will be prompted to
confirm that you really want to delete all existing LIS assay names.
3.13.2.3 Communication Procedure
Communication sessions between the EVOLIS and a host computer can be
initiated upon request by the EVOLIS operator or automatically.
Import of test order requests
When patient samples are loaded on the instrument, all tests previously
ordered for these samples at host computer level and downloaded to the
EVOLIS computer will appear on the column format Patient Editor dialog
box (see Section 2.3.2.2).
If you have checked the Query Host For Test Order Requests item in the
ASTM dialog box, each time you load new samples on the system, the
software will automatically interrogate the host computer to know if test order
requests are available for these samples.
When a test order request is received from the LIS, a search is first made
within the list of LIS assay names/assay protocol filename pairings. If a
matching LIS assay name is found, then the software uses the linked assay
protocol filename when the test request is effected. If no match is found, the
software assumes that the assay name received from the LIS is the exact
assay protocol filename.
Export of test results
It is possible to export test results manually (via the Utilities | Export
Results menu item, available when a result report is displayed on the
screen) or to configure the EVOLIS software to create and export test results
automatically. This is done as described for ASCII files in Section 3.13.1.4.
The ASTM format and the data included in the transmission are defined as
described in Sections 3.13.2.1 and 3.13.2.6.2. Additional assay-specific data
fields may be included at assay level.
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3.13.2.4 Low-Level Protocol
3.13.2.4.1 Physical Layer
(refer to the ASTM 1381 Standard, section 5)
EVOLIS
1
PC
Frame
Transmitted
1
Received
2
2
3
3
7
Host
Signal
7
Figure 272 - RS232 Connection to Host
3.13.2.4.2 Data Link Layer
Establishment Phase
(refer to the ASTM 1381 Standard, section 6.2)
Transfer Phase
(refer to the ASTM 1381 Standard, section 6.3)
The checksum is encoded as two characters sent after the <ETB> or <ETX>
character. The checksum includes the first character after <STX> (the frame
number) up to and including <ETB> or <ETX>. It is computed by adding the
binary values of the characters, keeping the least significant eight bits of the
result.
During the transfer phase, if the LIS responds to a frame with an <EOT> the
EVOLIS does NOT stop transmitting and chooses to ignore the interrupt
request.
Termination Phase
(refer to the ASTM 1381 Standard, section 6.4)
After the EVOLIS transmits or receives the <EOT>, indicating that all
messages have been sent, the line is considered to be in the neutral state.
Error Recovery
(refer to the ASTM 1381 Standard, section 6.5)
The EVOLIS checks every frame it receives to guarantee its validity and
sends an <ACK> for a valid frame, or a <NAK> for an invalid frame. Frames
are invalidated when:
• Any character errors are detected (i. e. parity error, framing error).
• The frame checksum does not match the checksum computed on the
received frame.
• The frame number is not the same as the last accepted frame or one
number higher.
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When the EVOLIS receives a <NAK> for a frame rejected by a host it
resends the frame. If a single frame is sent and rejected six times, the
EVOLIS proceeds to the termination phase.
During the establishment phase, the EVOLIS expects to receive a reply
within 15 seconds after sending <ENQ>. During the transfer phase, the
EVOLIS expects to receive a reply within 15 seconds after transmitting the
last character of a frame. If a timeout occurs, the EVOLIS proceeds to the
termination phase.
During the transfer phase, the EVOLIS expects to receive a frame or <EOT>
within 30 seconds after first entering the transfer phase or replying to a
frame. After a timeout, the last incomplete message is discarded and the line
is considered to be in the neutral state. The EVOLIS will also timeout if a
reply to a frame is not received within 15 seconds.
3.13.2.5 Logical Structure of the Message Level Protocol
The blocked stream of data sent between a host computer and the EVOLIS
at a given time is called a message.
Messages consist of a hierarchy of records of various types:
Level
Segment Name
Identifier
Comments
(Record Type ID)
0
Message Header Record
‘H’
0
Message Terminator Record
‘L’
1
Patient Information Record
‘P’
1
Request Information Segment
‘Q’
1
Scientific Record
‘S’
2
Test Order Record
‘O’
3
Result Record
common Comment Record
1
Manufacturer Information Record
not allowed for EVOLIS
‘R’
‘C’
‘M’
not allowed for EVOLIS
A record is identified by the first field of a record, the RecordTypeID.
Most of the various record types are related to each other in a definite
hierarchy:
A lower level record may never appear without the preceding higher level
record (i.e. order records must be preceded by a patient record, result
records must be preceded by an order record... ).
A sequence of records at one level is terminated by the appearance of a
record of the same or higher level.
In some other descriptions a record might also be called segment.
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3.13.2.6 Incoming and Outgoing Transmission Examples
3.13.2.6.1 Host to EVOLIS (test orders)
The host response includes patient demographics, Patient ID, sample ID,
and test orders according to the following record hierarchy.
The response to requests for test orders is expected to be received within
<Timeout> seconds after the request has been sent. <Timeout> is to be
specified in the LISSetupDialog.
Structure defined by ASTM 1394
Structure defined by ASTM 1381
(multiple records comprise a single message)
(each record is sent as one or more frames)
Message Header Record
Patient Information Record 1
Test Order Record 1
:
Test Order Record n
→
:
Frame 1
:
Patient Information Record n
Frame n
Test Order Record 1
:
Test Order Record n
Message Terminator Record
In case there are no test orders available the LIS should respond with an
empty message containing header and terminator records only. The
terminator record should contain an ‘I’ (no information available) flag in the
Termination Code Field.
Example:
H|\^&|||EDVLab||||||||1|19941115202738
P|1||PatID01||Anderson^Anna||19741001|F|||||MARTINEZ
O|1|SampleID01||^^^AFP^1:10||19980506|||||||||S||||||||||X
P|1||PatID02||Newman^Tony||19741001|F|||||MARTINEZ
O|1|SampleID02||^^^AFP||19980506|||||||||S||||||||||X
O|1|SampleID02||^^^TSH||19980506|||||||||S||||||||||X
O|1|SampleID02||^^^T3||19980506|||||||||S||||||||||X
O|1|SampleID02||^^^T4||19980506|||||||||S||||||||||X
P|1||Barcode0815||Palmer^John||19741001|F|||||MARTINEZ
O|1| Barcode0815||^^^AFP^1:10||19980506|||||||||S||||||||||X
P|1||12345|||||F|||||MARTINEZ
O|1|12345||^^^AFP^1:10||19980506|||||||||S||||||||||X
L|1|N
After the EVOLIS receives all test orders from the host, the records are
interpreted. Valid test orders are entered into the loadlist database, while
invalid test orders are not.
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3.13.2.6.2 EVOLIS to host (test results)
Only the final calculated result (Abs, concentration or interpretation) is
transferred per test. For multiple replicate results the mean is transmitted
only.
EVOLIS to Host: (transmit sample information with corresponding tests and
results)
Structure defined by ASTM 1394
Structure defined by ASTM 1381
(multiple records comprise a single message)
(each record is sent as one or more frames)
Message Header Record
Patient Information Record 1
Test Order Record 1
Result Record 1
Comment 1
:
Result Record n
Comment 1
:
Test Order Record n
Result Record 1
Comment 1
:
Result Record n
Comment 1
:
Frame 1
Patient Information Record n
Test Order Record 1
Result Record 1
→
:
Frame n
Comment 1
:
Result Record n
Comment 1
:
Test Order Record n
Result Record 1
Comment 1
:
Result Record n
Comment 1
Message Terminator Record
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3.13. Connection to a Host Computer
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Example:
H|\^&|||EDVLab||||||||1|19941115202738
P|1||PATID01||ANDERSON^ANNA||19741001|F|||||MARTINEZ
O|1|SampleID01||^^^AFP||19980506|||||||||S||||||||||F
R|1|^^^AFP|13.1|IU/ml||H||F||||19980506123145|
L|1|N
Data Record Usage
(refer to the ASTM Standard 1394, particularly sections 6 through 13)
Each record sent by the EVOLIS will contain up to the last field used by the
EVOLIS, which may or may not be all fields possible for the record. An ‘O’ in
Required or Sent field indicates optional. The first <MaxLength> characters
are significant only. Any more characters transmitted for a specific field are
ignored.
3.13.2.6.3 Message Header Record
Field
ASTM Field
Description
No.
1
Record Type ID
Character identifying the
record
as
a
message
received
delimiter
Valid
Max
Required
Contents
Length
‘H’
1
Y
4
Y
header
2
Delimiter Definition
Any
set is accepted.
The delimiters defined in
ASTMSetupDialog
are
sent.
3
Message Control ID
N
4
Access Password
N
5
Sender Name / ID
6
Sender Street Address
20
N
7
Reserved Field
N
8
Sender Telephone No.
N
9
Characteristics
N
of
N
Sender
10
Receiver ID
11
Comment
N
12
Processing ID
N
13
Version No.
14
Date
and
Message
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‘1’
Time
of
Format
is
YYYYMMDD
1
N
14
N
HHMMSS
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3.13.2.6.4 Patient Information Record
Field
ASTM Field
Description
No.
1
Valid
Contents
Record Type ID
Character
identifying
‘P’
Max
Required
Length
1
Y
the record as a patient
information record
2
3
Sequence Number
Y
Practice Assigned Patient
N
ID
4
Laboratory
Assigned
Becomes our PatientID
Y
Patient ID
5
6^1
6^2
Patient ID No. 3
N
Patient Name
O
Patient First Name
O
7
Mother's Maiden Name
N
8
Birthdate
9
Patient Sex
10
Patient
Race
-
Ethnic
8
O
1
O
N
Origin
11
Patient Address
N
12
Reserved Field
N
13
Patient
Telephone
N
Number
14
Attending Physician ID
Becomes our SenderID
N
15
Special Field 1
N
16
Special Field 2
N
17
Patient Height
N
18
Patient Weight
N
19
Diagnosis
N
20
Active Medications
N
21
Diet
N
22
Practice Field No. 1
N
23
Practice Field No. 2
N
24
Admission and Discharge
N
Dates
25
Admission Status
N
26
Location
N
27
Nature
of
Diagnostic
Alternative
Code
N
and
Classifiers
28
Alternative
Diagnostic
N
Code and Classification
400
29
Religion
N
30
Marital Status
N
31
Isolation Status
N
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32
Language
N
33
Hospital Service
N
34
Hospital Institution
N
35
Dosage Category
N
3.13.2.6.5 Test Order Record
Field
ASTM Field
Description
No.
1
Record Type ID
Character identifying the
Valid
Max
Contents
Length
‘O’
1
Required
Y
record as a test order
record
2
Sequence Number
Y
3
Specimen ID
N
4
Patient ID
Y
5^4
Universal Test ID
5^5
Dilution
N
6
Priority
N
Requested/Ordered
N
7
Test Abbreviation
Y
Date and Time
8
Specimen
Collection
‘YYYYMMDDHHMMSS’
14
Y
Date and Time
9
Collection End Time
N
10
Collection Volume
N
11
Collector ID
N
12
Action Code
N
13
Danger Code
14
Relevant
N
Clinical
N
Specimen
N
Information
15
Date/Time
Received
16
Specimen Descriptor
N
(Type)
17
18
Ordering Physician
N
Physician’s
N
Telephone
Number
19
User Field No. 1
N
20
User Field No. 2
N
21
Laboratory Field No. 1
N
22
Laboratory Field No. 2
N
Date/Time
N
23
Reported
Results
or
Last
Modified
24
Instrument
Charge
to
N
Computer System
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25
Instrument Section ID
N
26
Report Types
N
27
Reserved Field
N
28
Location
of
Ward
of
N
Infection
N
Specimen Collection
29
Nosocomial
Flag
30
Specimen Service
N
31
Specimen Institution
N
3.13.2.6.6 Result Record
Field
ASTM Field
Description
No.
1
Record Type ID
Character identifying the
Valid
Max
Contents
Length
R
1
Required
Y
record as a result record
2
Sequence Number
3
Test ID
4
Data
Y
N
or
Measurement
Value
depends
Y
on value
5
Units
Y
6
Reference Ranges
Y
7
Result Abnormal Flags
N
Nature
N
8
of
Abnormality
Testing
9
10
Result Status
Date
of
N
Change
Instrument
in
N
Normative
Values or Units
11
Operator Identification
N
12
Date/Time Test Started
N
Date/Time
N
13
Test
Completed
14
402
Instrument ID
N
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3.13.2.6.7 Comment Record
Comment Records are used either to describe reasons for rejected test
orders or to supply additional result information.
One comment record is used for the kit/reagent/control batch number.
Another comment record is used for the relevant flags.
Comment records begin with a C character.
3.13.2.6.8 Request Information Record
Not applicable.
3.13.2.6.9 Message Terminator Record
Field No.
1
2
ASTM Field
Description
Record Type
Character identifying the record as
ID
the last record in the message
Sequence
Valid Contents
Required
Sent
‘L’
Y
Y
Y
Y
N
N
Number
3
Termination
Code
3.13.2.6.10
Scientific Record
Must not be sent.
3.13.2.6.11
Manufacturer Information Record
Must not be sent.
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EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
4 System Maintenance and Cleaning
In order for it to operate correctly, it is essential that the EVOLIS system be
maintained in accordance with the maintenance plan and procedures
described below.
For all maintenance tasks, comply strictly with the safety precautions listed in
Section 4.1.
Section 4.2 gives, in table form, a general overview of all maintenance
procedures per module. Chronological maintenance checklists (daily,
weekly...), which should be copied and used to document the maintenance
tasks as they are performed by the operator, are provided in Appendix A 7.
Section 4.3 describes in detail all daily, weekly and monthly maintenance
tasks to be performed by the user.
Section 4.4 covers all the special procedures which must be performed when
certain incidents or emergencies affect the system.
Finally, there are a number of automatic maintenance procedures which can
be controlled and/or performed by the system itself. These are dealt with in
Section 4.5.
The operator may only perform the maintenance work described in this
manual. Other servicing and repairs should be done by Bio-Rad
Service personnel only.
4.1 Important Safety Precautions
Always turn off the instrument before cleaning!
Always wear adequate personal protective equipment: laboratory coat,
gloves and eye protection (safety glasses, splash goggles or face
shield).
Always follow Good Laboratory Practices.
Dispose of all waste in accordance with legal regulations for biological
hazardous waste.
When the instrument is turned off, mobile modules such as the pipettor guide
rail or the plate transport unit may be moved manually so as to get better
access to certain parts of the instrument. This is to be done as gently as
possible so as not to damage or unalign the modules.
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4.2. Maintenance Overview
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4.2 Maintenance Overview
Instrument Modules
& Accessories
Maintenance tasks to be done ...
Daily
Weekly
Monthly
Other frequency/Comments
Instrument surfaces and work areas
Outer surfaces
X
Dilution area
X
Including cover hood, flap and handle.
Inspect daily, disinfect weekly.
Inspect daily, disinfect weekly.
Tip rack area
X
Inspect daily, disinfect weekly.
Sample and reagent
unit
Test plate pipetting
area
Bottom drawer
X
Inspect daily, disinfect weekly.
X
Inspect daily, disinfect weekly.
X
Inspect daily, disinfect weekly.
X
Do not spray disinfectant on instrument.
Use moist cloth.
Do not spray disinfectant on bearings and
guides!
Test plate compartment
Plate transport unit
Inside of compartment
X
Pipettor
Guide rail
X
Pipettor wash station
X
Outer surface only. Do not spray
disinfectant on bearings and guides!
Check daily for residue or fragments;
decontaminate weekly.
Pipettor head
X
Tubing
---
---
---
Syringe
---
---
---
System
container
Washer
liquid
WasherClean assay
WasherManifoldDisinfect assay
(table continues on the following page)
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User manual code : 89891 - EN
Replaced by the Bio-Rad Service
Engineer during the regular six-month visit.
Check daily for air bubbles as these can
cause pipetting errors.
Replaced once a year by the Bio-Rad
Service Engineer during the regular
preventive maintenance visit.
X
X
X
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4. System Maintenance and Cleaning
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Instrument Modules
& Accessories
Maintenance tasks to be done ...
Daily
Weekly
Monthly
Other frequency/Comments
---
---
---
---
---
---
When clogged (washer floods or does not
operate correctly).
Replaced by the Bio-Rad Service
Engineer during the regular six-month visit.
Rinse daily, decontaminate monthly.
Washer (continued)
Manifold
needles
(manual cleaning)
Tubing and filters
Wash buffer / clean
fluid bottles
Incubators
X
Room-temperature
incubators
Heated incubators
X
---
---
---
NEVER clean the heated incubators as
this may damage them!
Bulb
---
---
---
Replace bulb if blown.
Filters
---
---
---
Performance
verification
---
---
---
Filters are normally checked and cleaned
by the Bio-Rad Service Engineer during
the regular six-month visit.
Normally performed by the Bio-Rad
Service Engineer during the regular sixmonth visit.
Photometer
Accessories
Sample and reagent
racks
Test plate carrier
frames
Reagent bottles
---
---
---
Vacuum/trap flasks
---
---
---
X
X
Normally, reagent bottles should not be
cleaned and re-used but disposed of in
accordance with legal regulations on
biological hazardous waste. Cleaning and
re-using reagent bottles is allowed only in
certain cases, see Section 4.4.7.
If not draining correctly or overflowing.
Waste
Tip ejection waste
container
Waste slide (ramp)
X
Liquid waste
container
X
406
Check daily; replace when full (2-3 days if
normal use).
X
Check daily; decontaminate when full or
almost full.
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4.3. Regular Maintenance
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
4.3 Regular Maintenance
4.3.1 Daily Maintenance
4.3.1.1 Start-Up Maintenance
‰
Check the level of system liquid in the system liquid container. If low,
refill as described in Section 1.1.4.
4.3.1.2 After Each Run
‰
Remove reagent and patient sample racks as described in Section 2.9.2.
‰
Unload used test and dilution plates, as described in Sections 2.9.1 and
2.9.3.
‰
Dispose of test plates, dilution plates and sample tubes in accordance
with legal regulations for biological hazardous waste.
‰
Check the bag of the tip ejection waste container. If full or nearly full,
replace as described in Section 4.3.1.3.7.
‰
Check the liquid waste level in the liquid waste container. If full or nearly
full, decontaminate and empty as described in Section 4.3.1.3.5.
4.3.1.3 Shut Down Maintenance
4.3.1.3.1 Close the Finished Worklist(s)
Select the File | Close menu item. Close also all other files which may still
be open (assay files, result files...).
4.3.1.3.2 Remove all Remaining Resources
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User manual code : 89891 - EN
‰
Unload the resources which are still in the instrument: test plates,
dilution plates, empty tip racks, sample and reagent racks. Partially used
tip racks may remain on the instrument overnight (particularly if you are
using the "Re-use partially used racks" option - see Section 2.5.5).
‰
Dispose of test plates, dilution plates and sample tubes in accordance
with legal regulations for biological hazardous waste.
‰
If they are not empty and can be re-used, remove the reagent and
control bottles from the racks, close them (be careful not to mix the
caps!) and store them in a refrigerator. Otherwise, dispose of them in
accordance with legal regulations for biological hazardous waste.
‰
In some specific cases, reagent bottles may be emptied and re-used. If
you are in one of these cases, follow strictly the special cleaning
procedure described in Section 4.4.7.
‰
Store the metal test plate carrier frames and the sample and reagent
racks at room-temperature. Never store the reagent racks in the
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4. System Maintenance and Cleaning
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
refrigerator! Inspect the frames and the racks before storing. In case of
stains or spills, decontaminate them as described in Sections 4.3.2.3
and 4.3.2.4.
4.3.1.3.3 Turn Off the System
‰
Close the EVOLIS software (select the File | Exit menu item).
‰
Exit Windows.
‰
Turn off the instrument.
Always turn off the system in that order!
4.3.1.3.4 Inspect the Instrument for Stains or Spills
Every evening after shut down, inspect the instrument for stains or spills.
Make sure to inspect all individual surfaces, compartments and work areas:
‰
Inspect outer surfaces, particularly around the handle of the cover flap
and the top part of drawers and doors.
‰
Open the cover flap to check the upper work areas: dilution area, test
plate pipetting area.
‰
Check the pipettor wash station for residue or fragments.
‰
Open the dilution plates and tip rack drawer.
‰
Open the door of the sample and reagent unit.
‰
Make sure no tips have remained blocked in the waste slide (ramp). If
necessary, pull out the slide to do so.
‰
Open the test plate compartment. Check the plate transport unit and the
inside of the compartment.
‰
Open the bottom drawer. Do not forget to check for liquid underneath the
wash buffer bottles.
If you detect stains, small spills or areas that are generally dirty, disinfect
them as described in Sections 4.3.2.1 and 4.4.1.
If you find a more substantial liquid overflow, refer to Section 4.4.2.
4.3.1.3.5 Wipe the Tip Adapter (Pipettor Head)
408
‰
Normally, if the instrument has been correctly stopped and switched off,
the tip adapter at the bottom end of the pipettor should be at its prime
position i.e. on the front side of the instrument, next to the tip ejection
station. If not, you can (after making sure the instrument is really
switched off) pull the pipettor guide rail manually towards the front of the
instrument so as to access the pipettor more easily.
‰
Use a soft lint-free cloth, moistened with 70% ethanol, to gently clean
the tip adapter part of the pipettor.
‰
Allow to dry.
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EVOLIS
4.3. Regular Maintenance
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
4.3.1.3.6 Check the Liquid Waste Container
The liquid waste container can contain up to 10 liters of liquid waste. In
normal use, it can take from 2-3 days to one week until it is full.
The container is fitted with a sensor which is activated only when the
container is full. The software then pauses the system and warns the
operator. The run can be resumed only when the container has been
emptied. Therefore, if you want to avoid pausing a run, it is recommended to
check the liquid waste level every evening after shut down and empty/clean
the container if it is almost full. You can also order a spare liquid waste
container from Bio-Rad.
Chemicals that may be found in the liquid waste when running Bio-Rad
assays include:
• Sulphuric acid.
• TMB.
• OPD.
• Tris NaCl.
• Citric acid and sodium acetate.
• Hydrogen peroxyde (H2O2).
• DMSO.
• Thimerosal.
• Sodium azide.
• Pro Clin 300.
For other assays, check the corresponding reagent kit inserts.
To decontaminate and empty the liquid waste container:
‰
Open the screw cap.
‰
Pour bleach into the container (without emptying the container first).
With ordinary domestic-use bleach (12° chlorine), the volume of bleach
should equal 10% of the volume of liquid waste in the container. Bleach
tablets may also be used.
‰
Leave it for 30 minutes or overnight.
‰
The next day, empty the container and rinse it thoroughly with tap water.
‰
Put the screw cap back on and check the seat of level sensors and
connections.
When adding the bleach, it is recommended that you operate under a
fume hood as chlorine fumes may occur.
After adding the bleach, do not place the waste container screw cap
back on as this may damage the sensor. Spare waste containers with
ordinary caps may be ordered from Bio-Rad.
If bleach is not allowed in your country, use the decontaminating agent
you normally use instead of bleach.
The screw cap and sensor part may be wiped with a cloth moistened with
RIVASCOP® (diluted in water at 0.4% - 4 ml per liter).
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
4.3.1.3.7 Check the Tip Waste Container
Disposable tips are automatically ejected at the tip ejection station. Via a
slide, they go directly into the plastic waste container fixed on the instrument
front panel. No sensor mechanism is attached (visual check only).
To replace the waste bag:
‰
Pull out the transparent plastic cover horizontally from the front.
‰
If necessary, unclip and remove the front protection panel.
‰
Lift waste bag off the retaining ring and close it using the supplied lid.
‰
Place new waste bag with plastic reinforcing onto the retaining ring and
push it down, making sure it is correctly clipped on.
‰
Attach cover plate (and front protection panel) again.
‰
Dispose of the closed waste bag in accordance with the legal regulations
for biological hazardous waste.
The biohazard label reminds users that the contents of the waste bag
is contaminated and should be dealt with as biological hazardous
waste.
410
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4.3. Regular Maintenance
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
4.3.2 Weekly Maintenance
4.3.2.1 Run the WasherClean Assay
‰
Open the bottom drawer.
‰
Disconnect the wash buffer bottles.
‰
Transfer the wash buffer into other (labeled) containers. Store in
accordance with instructions included in kit inserts for each assay
regarding wash buffer.
‰
Rinse the emptied wash buffer bottles and fill them with about 1000 ml of
deionized water.
‰
Put the bottles back on the instrument and connect them to the system
again.
‰
Start the WasherClean assay (create a worklist for one plate using the
WasherClean.asy assay file and run it).
‰
After being prompted by the system, insert an empty test plate.
‰
When the run is finished, remove and discard the test plate. The wash
buffer bottles filled with deionized water may remain on the instrument
overnight.
This procedure takes approximately 20 minutes.
Spare wash buffer bottles (with normal caps) can be ordered from Bio-Rad.
Having spare bottles allows you to remove your partially full bottles from the
instrument and to store them directly while performing the cleaning
procedure with the spare bottles (instead of having to transfer the buffer into
storage containers at night and re-transfer it back into the bottles later).
After the WasherClean assay is over and you have unloaded the
resources needed for that assay, make sure you turn off the system
(shut down the computer and then the instrument) before performing
the next maintenance tasks.
4.3.2.2 Clean the Instrument Surfaces and Work Areas
Any bactericide, virucide and fungicide hospital-grade disinfectant can be
used to clean the instrument outer and inner surfaces.
To prepare and apply the disinfectant (dilution, spray, wait, wipe...) refer to
the instructions prescribed by the product manufacturer.
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Do not use bleach and do not use any disinfectant which may damage
metal parts.
Do not use any disinfectants containing alcohol or acetone for
Plexiglas surfaces (e.g. cover hood or washer window) and for the
manifold.
Disinfectants must not come into contact with bearings and guides, as
otherwise the lubricant may dissolve.
‰
Disinfect all outer surfaces including the cover and handle, the pipettor
guide rail and the washer window.
‰
Disinfect also the dilution and tip rack area, the sample and reagent unit
and the test plate pipetting area. All resources should have been
previously removed, including partially used tip racks. If you are using
the "Re-use partially used racks" option (see Section 2.5.5), you should
note the respective position of each partially used rack so as to load
them back accordingly after cleaning.
‰
Pull out the tip ejection slide (ramp), disinfect it and put it back.
‰
In the bottom drawer, wipe the bottom of the wash buffer and clean fluid
unit with a wet cloth (water only, no disinfectant) and allow to dry (or
wipe with absorbent paper).
In case of accidental spill or flood, refer to the special procedures described
in Sections 4.4.1 and 4.4.2.
4.3.2.3 Decontaminate the Sample and Reagent Racks
‰
Prepare a decontamination solution consisting of 0.4 % (4 ml per liter)
RIVASCOP® and water in a container/sink large enough so that you can
immerse the racks completely.
‰
Place the racks in the solution.
‰
Let them soak for a minimum of 15 minutes, longer in case of spills or
stains. Overnight if possible.
‰
Take out the racks and rinse them thoroughly under tap water.
‰
Allow to dry.
Alternatively, the racks can be decontaminated in an autoclave. Sterilize at
121°C (250°F) for a minimum of 30 minutes (steam cycle).
4.3.2.4 Decontaminate the Test Plates Carrier Frames
The decontamination procedure for the metal frames used as test plate
carriers is identical to the one described above for the sample and reagent
racks. Provided your container/sink is large enough, the frames can be
soaked with the racks. Make sure however that all the elements are
completely immersed in the decontamination solution.
412
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EVOLIS
4.3. Regular Maintenance
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
4.3.2.5 Decontaminate the Tip Ejection Slide (Ramp)
The tip ejection slide (ramp) can be pulled out completely using its handle.
The decontamination procedure is identical to the one described above for
the sample and reagent racks. Provided your container/sink is large enough,
the slide can be soaked with the racks. Make sure however that all the
elements are completely immersed in the decontamination solution.
DO NOT autoclave!
4.3.2.6 Decontaminate the Pipettor Wash Station
‰
Prepare a decontamination solution consisting of 0.4 % (4 ml per liter)
RIVASCOP® and water. If you have prepared such a solution for
decontaminating your racks and frames (see above) you may put aside
a small volume of this solution (before immersing the racks and frames).
‰
Dispense manually approximately 5 ml of this solution into the pipettor
wash station.
‰
Let it soak for a minimum of 15 minutes (overnight if possible).
‰
Do not empty. The liquid will drain automatically when the system is next
reinitialized.
4.3.2.7 Clean the Plate Transport Unit
‰
Pull out the drawer of the test plate compartment (right-hand side of the
instrument).
‰
If necessary, move the plate transport unit gently (manually) towards the
front.
‰
Clean the plate transport unit with the same disinfectant used to clean
the instrument surfaces and work areas (see Section 4.3.2.2).
‰
Follow the instructions (dilution, spray, wait, wipe...) prescribed by the
product manufacturer. However, if spraying is required, make sure not to
spray on the bearings and guides, otherwise this may damage the
lubricant. If possible, spray or moisten the cloth instead of the instrument
surfaces.
4.3.3 Monthly Maintenance
4.3.3.1 Decontaminate the Washer Manifold
The purpose of this procedure is to decontaminate the washer manifold by
soaking the needles in diluted decontamination solution during 15 minutes.
The procedure is performed by running the WasherManifoldDisinfect.asy
predefined assay.
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4. System Maintenance and Cleaning
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Material required
Deionized water.
RIVASCOP® decontamination solution (for ordering information, see
Appendix A 3).
1 clean (empty) 60 ml-bottle.
1 "RIVASCOP diluted sol. 0.4%" label to stick on the 60 ml-bottle.
1 flat-bottom microplate.
Before you start, prepare 50 ml of diluted decontamination solution
consisting of 0.4% of RIVASCOP® and water in the 60 ml-bottle. Attach the
"RIVASCOP diluted sol. 0.4%" label to the bottle.
Procedure
The instructions below assume familiarity with how to create and process a
worklist on the EVOLIS system. If you are not familiar with this, please refer
Sections 2.4 to 2.8 of this manual before performing this procedure.
The procedure lasts approximately 45 minutes.
Perform the following steps:
414
‰
Create a new worklist with just one plate.
‰
Select the "WasherManifoldDisinfect.asy" assay file and add it to the
plate.
‰
Do not add any patients.
‰
Click <OK> to confirm.
‰
Continue until the Load dialog box is displayed.
‰
Place the 60 ml-bottle with the diluted decontamination solution in a
reagent rack and load the rack on the instrument.
‰
In the Load dialog box, allocate the bottle to the corresponding rack
position.
‰
Make sure the other resources (tips, clean fluid) requested in the Load
dialog box are also loaded.
‰
When done, click <OK>.
‰
When the system prompts you, load the microplate and start the run.
The pipettor dispenses 300 µl of diluted decontamination solution into all
wells. The microplate is then moved into the washer and the washer
manifold is lowered into the wells filled with the diluted decontamination
solution.
‰
A message on the screen then prompts you to open the instrument
drawer, unscrew "waste bottle 1" and close the drawer.
‰
Open the instrument bottom drawer. "Waste bottle 1" is one of the
smaller flasks located at the back of the drawer behind the wash buffer
containers. Normally, bottle 1 is the bottle on the right-hand side when
facing the instrument (it should be labeled "1").
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EVOLIS
4.3. Regular Maintenance
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
"Waste bottle 1"
Figure 273: Waste bottle 1 in the bottom drawer
‰
Unscrew the cap. To do this, you may need to unlock the bottom drawer
as described in Section 1.1.1.7. Be careful not to lean on the drawer
when open. It is not necessary to remove the cap. Just unscrewing it is
sufficient (unscrewing the cap stops the vacuum and allows the
decontamination solution to reach inside the manifold needles).
‰
When done, close the drawer (make sure to reset the lock if you had
unlocked it) and click <OK>. The manifold needles remain soaked in the
decontamination solution for 15 minutes.
‰
After these 15 minutes have elapsed, another message prompts you to
open the drawer, rescrew "waste bottle 1" and close the drawer.
‰
Do as requested and click <OK> when done. Make sure to rescrew the
cap tightly as leaks in the vacuum system could cause washer aspirate
problems.
‰
The liquid in the plate is completely re-aspirated and the washer is then
purged with clean fluid.
‰
When the run is completed, unload the microplate and the reagent rack.
After the washer decontamination procedure has been completed and
you have unloaded the resources needed for that procedure, make
sure you turn off the system (shut down the computer and then the
instrument) before performing the next maintenance tasks.
4.3.3.2 Decontaminate the System Liquid Container
Last modification : 01 – 2008
User manual code : 89891 - EN
‰
Empty the system liquid container.
‰
Inspect the filter (attached to the cap). If damaged or particularly dirty,
replacements can be ordered from Bio-Rad (see ordering information in
415
4. System Maintenance and Cleaning
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Appendix A 3). In normal circumstances, the filter will be replaced every
six months during the regular maintenance visit of the Bio-Rad Service
Engineer.
‰
In the container, prepare a decontamination solution consisting of 0.4%
(40 ml for 10 liters) RIVASCOP ®, without putting the cap back on.
‰
Let it stand for a minimum of 15 minutes (overnight if possible).
‰
Empty the container and rinse it thoroughly twice with tap water and
once with deionized water.
‰
Re-fill the system liquid container with 10 liters of deionized water and 2
ml of Tween 20.
4.3.3.3 Clean the Wash Buffer/Clean Fluid Bottles
The wash buffer/clean fluid bottles are to be either soaked and washed by
hand according to the procedure used for laboratory glassware or cleaned in
a laboratory dishwasher. Use the same cleaning agents as for laboratory
glassware.
Do not autoclave.
Clean the bottles only, NOT the caps and sensor devices.
4.3.3.4 Clean the Test Plate Compartment
‰
Pull out the drawer of the test plate compartment (right-hand side of the
instrument).
‰
If necessary, move the plate transport unit gently (manually) towards the
front.
‰
Clean the test plate compartment with the same disinfectant used to
clean the instrument surfaces and work areas (see Section 4.3.2.2).
‰
DO NOT spray disinfectant onto the bearings and guides (on both sides
of the test plate compartment), otherwise this may affect the lubricant. If
possible, spray or moisten the cloth instead and wipe the main parts of
the test plate compartment, strictly avoiding the bearings and guides.
4.3.3.5 Clean the Room-Temperature Incubators
416
‰
Pull out the drawer of the test plate compartment (right-hand side of the
instrument).
‰
If necessary, move the plate transport unit gently (manually) towards the
front.
‰
Spray disinfectant on a paper wipe. Use the same disinfectant as for
instrument surfaces and work areas (see Section 4.3.2.2). Use high
quality paper wipes so as not to leave shreds and fibers in the
incubators.
‰
Insert your (gloved!) hand with the paper wipe in the room-temperature
incubator and wipe gently on all sides.
‰
Repeat for the other three room-temperature incubators.
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4.3. Regular Maintenance
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
‰
Allow to dry.
‰
Dispose of the paper wipes in accordance with legal regulations for
biological hazardous waste.
NEVER clean the heated incubators as this may damage them!
If you think they may be contaminated, call your Bio-Rad Service
Engineer.
4.3.3.6 Backup System Files
‰
Click the <Backup> toolbar button to open the System Backup dialog
box.
Figure 274: System Backup
<Backup System
Files>
Click this button to start a backup of all current files that are not part of the
standard installation (see details in table below). The process creates
backup copies of these files and stores them, under default settings, in an
individual directory created in the C:\BioRad\Backup directory. To change
the target directory, see Section 1.2.6.2.
The name of the individual system backup directory is formed as follows:
"SYSyyyymmddnn" (y = year, m = month, d = day, n = number of backups
done on that day). A new individual directory is created each time you
launch a new backup process (the previous backup is not overwritten).
Note: Create a complete system backup every month. Do not delete
previous system backup directories manually. Save them as a way to
trace back your system history. If necessary, archive them on CD or
in a different network location.
<Restore System
Files…>
Click this button to replace all current system files by system files from a
previous backup (e.g after a system crash). When you click this button, the
Open dialog box is displayed.
Browse to the directory you want to restore the files from (under default
settings, "C:\BioRad\Backup\SYSyyyymmddnn"). Select any file in this
directory and click <OK>. A message on the screen tells you when the
restore process is completed. Click <OK> to close this message.
Note: The right to restore system files may be restricted to a certain
category of users (see Section 1.2.7.2).
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Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
<Backup Error Files>
Click this button to start a backup of all error files. The process creates
backup copies of all files required for error diagnosis and troubleshooting
(see details in table below) and stores them, under default settings, in an
individual directory created in the C:\BioRad\Backup directory. To change
the target directory, see Section 1.2.6.2.
The name of the individual error backup directory is formed as follows:
"ERRyyyymmddnn" (y = year, m = month, d = day, n = number of backups
done on that day). A new individual directory is created each time you
launch a new backup process (the previous backup is not overwritten).
The error files backup is meant as a troubleshooting procedure. If you
encounter operating problems, backup the error files and send the resulting
directory to you Bio-Rad Service Engineer who will then be able to identify
precisely the cause of the problems you are facing.
Error files do not need to be backed-up on a regular basis but only as
requested by your Bio-Rad Service Engineer. You can also delete former
error files backup directories once the respective operating problems have
been solved.
<Close>
Close the System Backup dialog box.
Details of files included in the backup operations
Backup
Backup
System Files Error Files
418
modified within
Result files (*.res).
Yes
Event log files (*.log, *.txt).
Yes
Assay files (*.asy)
Yes
No
Worklist debug files (*.dbg).
No
Yes
the last 140 days
modified within
the last 140 days
Worklist trace log files (*.trw).
No
Yes
Worklist pipetting log files (*.txt).
Yes
Yes
System coordinate files (*.dat, *.rac, *.mpc).
Yes
Yes
System settings (*.bin).
No
Yes
System databases (*.mdb,*.db)
Yes
Yes
Reader verification files (*.ver)
Yes
Yes
Lot specific value files (*.lsv)
Yes
No
Stored control value files (*.con)
Yes
No
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4.3. Regular Maintenance
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
4.3.4 Six-Month Maintenance
The six-month maintenance will normally be carried out by your Bio-Rad
Service Engineer during the regular half-yearly visit (preventive
maintenance). Please make sure that these visits are correctly documented
in the table provided in Appendix A 9.
The only thing that should be done by the user every six months is to create
backup files for all result, export and event log files.
During the six-month maintenance visit, the Bio-Rad Service Engineer will
do the following:
‰
Replace the filters of the four washer lines.
‰
Replace the syringe of the pipetting system (once a year only, i.e. on
every second six-month visit).
‰
Replace all tubing.
‰
Replace the peristaltic waste pump cassette.
‰
Run the Quality Control assays.
‰
Clean the needles of the washer manifold.
‰
Clean the photometer filters.
‰
Replace the photometer lamp bulb.
Under normal circumstances, the user should not have to carry out any of
these maintenance tasks. However, some of these tasks may be undertaken
by the user if a problem is detected (e.g. clogged manifold needle) which
prevents the system from operating correctly. On these special cases, refer
to the following sections (Section 4.4 on Special Maintenance Procedures
and Section 4.5 on Performance Evaluation Procedures).
Unless this is impossible for technical reasons (severe malfunction of
the system), make sure the regular daily, weekly and monthly
maintenance tasks have been performed before any intervention of the
Bio-Rad Service Engineer (whether it is the regular six-month visit or
in response to a call for assistance on a specific problem).
4.3.5 Automated Maintenance Tasks and Reminders
As part of its normal operating routine, the EVOLIS system performs a
number of maintenance jobs automatically. For example:
• During each selftest (see Section 1.2.3), the system checks the status of
all instrument modules.
• During each run, the pipettor is primed with system liquid.
• Following each wash step, the washer is purged with clean fluid
(deionized water).
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•
These maintenance jobs are controlled automatically without any user
intervention.
But the EVOLIS system also includes a feature allowing users to predefine
some maintenance tasks and maintenance reminders.
1) Example 1: Defining a conditional maintenance reminder
In this example you want to define a maintenance message that will remind
the operator, every morning when starting-up the system, to check the
system liquid level (full), liquid waste and tip waste levels (empty).
To do this:
‰
Select the Utilities | System Setup menu item.
‰
Click on the Maintenance tab to open the following dialog box.
Figure 275: Maintenance tab
420
‰
Click <Add Job> to define a new maintenance job.
‰
In the is true then run job field enter the general name of the
maintenance reminder you want to define, e.g. "General level checking
prompt". This text is automatically entered in the Maintenance Jobs list.
‰
Click <Add Task…> to define the task(s) included in this maintenance
job. This opens the Add Maintenance Task dialog box.
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Figure 276: Add maintenance task
‰
Select Display message and click <OK>. This opens the Display
Message Task dialog box.
Figure 277: Add message text
‰
In the blank space, enter the text of the message prompt. For example,
enter: "Please check that the system liquid container is full, that the
liquid waste container is empty and that the tip waste container is
empty."
‰
Click <OK> to close this dialog box and go back to the main
Maintenance tab.
‰
Now you have to specify when this message prompt should be
displayed. To do this, click <Insert Function…>. This opens the Insert
Function dialog box.
Figure 278: Insert Function dialog box
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‰
In the current example, you want to specify that the message prompt
should be displayed every day upon start-up. Define the condition
("Days>=1") in the If edit box by using the Insert Function dialog box
(e.g. "Days") and the keyboard (for ">" and "=").
‰
When done, click <OK> to confirm and close the Maintenance tab.
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Now every morning when you start-up your EVOLIS instrument, the
following prompt is displayed.
Figure 279: Maintenance reminder
2) Example 2: Defining an automated maintenance task
In this example you want to predefine an additional "Purge washer routine"
that can be launched easily when needed (e.g. after using specific wash
buffers…).
To do this:
‰
Start as described in the previous example. In the is true then run job
field enter "Purge washer routine".
‰
When you get to the Add Maintenance Task dialog box, select Purge
washer and click <OK>.
‰
You are then prompted to specify from which container and with how
much liquid you want to purge the washer (e.g. "Red" container for
Clean fluid and "10 ml/tip").
‰
When done, click <OK> to confirm and close the Maintenance tab.
In this case, you have defined the task but you have not defined a condition
upon which the system would automatically perform the maintenance
routine.
If you want to start this predefined routine:
‰
Click the <Maintenance> toolbar button (or select the Utilities |
Maintenance menu item) to open the System Maintenance dialog box.
Figure 280: Execute automated maintenance routine
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‰
Select the maintenance routine you want to start and click <Execute>.
The system asks you to confirm that you want to perform this
maintenance.
‰
Click <Yes>.
3) More elaborate maintenance routines
From these two relatively simple examples, you can program all sorts of
more complex maintenance checklists or conditional routines such as:
• Start-up checklist: add several consecutive "Display message" tasks and
a "Days>=1" condition.
• Weekly maintenance routine reminder: condition "Days>=7".
• Prime / Purge routine if the system has not been used for over 2 weeks:
condition "Days>=15 AND Worklists=0".
• Empty tip waste reminder if 900 or more tips have been used: condition
"Tips>=900".
• Rinse all four washer lines: combine messages to prompt user to fill all
four wash containers with rinse fluid and 4 purge washer tasks, one for
each container/washer line.
• Etc.
Note however that the maintenance status and conditions are checked
only each time the instrument is initialized. So, if, for example, you
define a message to remind you to empty the tip waste container when
you have used more than "n" tips, the message will not be displayed
as soon as tip "n + 1" is used but only the next time the instrument is
initialized (i.e. upon start-up or when a selftest is performed).
4) Logged maintenance jobs / skipped maintenance jobs
Each time you perform (or allow the system to execute) a predefined
maintenance routine, this is recorded in the log file.
The log file also keeps track of all cases where the operator was prompted to
execute a conditional routine but decided to skip it.
In the log file, performed routines are displayed in black, skipped routines in
red.
A required maintenance routine can only be skipped by the operator if the
person who defined it selected the User can skip job checkbox in the
Maintenance tab.
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4.4 Special Maintenance Procedures / Emergencies
This Section describes maintenance procedures that are not to be performed
on a regular basis but as needed depending on events/incidents affecting
the instrument or its environment.
On emergency stop (canceling a run) and emergency test plate removal, see
Sections 2.7.6 and 2.7.7.
4.4.1 Stains and Small Spills
If stains or small spills are noticed in the instrument work areas, wipe and
disinfect the instrument as described in Section 4.3.2.2. For difficult stains,
use a cloth moistened with RIVASCOP® (diluted in water at 0.4% - 4 ml per
liter).
If stains or small spills are noticed in the room-temperature incubators or in
the test plate compartment, perform the regular maintenance tasks as
described in Section 4.3.3.5 and 4.3.3.4.
If stains or small spills are noticed in the sample or reagent racks or on the
test plate carrier frames, decontaminate them immediately as described in
Section 4.3.2.2.
4.4.2 Heavy Liquid Overflow
In case liquid overflows into the drawers or instrument modules while the
system is running:
‰
Switch off the EVOLIS instrument immediately.
‰
Disconnect the power cord.
‰
Using absorbent paper, clean-up all excess liquid.
‰
Make sure to check all areas that may have been affected. Open the top
and bottom drawers, unload the racks from the sample and reagent
units, check the various modules (including incubators, photometer).
‰
Dispose of used absorbent paper in accordance with legal regulations
for biological hazardous waste.
‰
Disinfect the affected areas as described in Section 4.3.2.1.
‰
Allow to dry.
‰
Before turning the system on again, identify the source of the problem
(damaged tubing, faulty washer...) and take appropriate actions. If in
doubt, call your Bio-Rad Service Engineer.
The procedure is identical if the liquid overflow is noticed only some time
after the incident has occurred (e.g. if the liquid in the bottom drawer is
noticed when performing the daily shutdown maintenance). Even if the
instrument is already turned off, do not forget to disconnect the power cord.
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4.4.3 Pipettor Decontamination
The following procedures should be performed if liquid was aspirated by the
pipettor beyond the disposable tip (e.g. if a 300 µl has been used by the
system instead of a 1100 µl tip to aspirate a large volume of liquid).
To decontaminate the inside of the pipettor:
‰
Select the Utilities | System Setup menu item.
‰
Click on the Maintenance tab (see Figure 275).
‰
On this tab, click on the <Add Task> button. This opens the Add
Maintenance Task dialog box.
‰
In this dialog box, select Prime Pipettor and click <OK>. This opens the
Prime Pipettor Task dialog box.
‰
In the Volume field, enter 100 (ml) and click <OK>.
‰
Click <OK> at the bottom of the Maintenance tab.
To decontaminate the outside of the pipettor, wipe the pipettor head as
described in Section 4.3.1.3.5.
4.4.4 Washer Malfunction
Visual check
If you find that the wash function is no longer adequate, you can first perform
a visual check of how the washer operates.
To do this:
‰
Run the WasherClean assay.
‰
Through the window in the front side of the bottom drawer (next to the
waste container), check how the dispensing and aspirating cycles are
performed.
Aspirate problem (liquid overflow)
If the problem is a problem of liquid overflowing, this generally means that
the aspirate function is not being performed adequately because one or
more manifold aspirate needles (long needles) are clogged.
In this case:
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‰
If the liquid overflow is abundant and if the WasherClean assay is not yet
finished, stop and cancel it as described in Section 2.7.6. Otherwise you
may wait until it finishes.
‰
Clean-up the excess liquid as described in Section 4.4.2.
‰
Clean the manifold needles as described below.
‰
Run the CTRL Washer Aspirate Check assay as described in Section
4.5.3.3.
‰
Run the WasherClean assay again.
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Dispense problem
A dispense problem is generally indicated not by a liquid overflow but either
by the fact that some parts of the test plate are not adequately washed or by
actually observing, during the visual check, that some of the dispense
needles (short needles) are not dispensing correctly.
In this case:
‰
Run the washer decontamination procedure as described in Section
4.3.3.1.
‰
Clean the manifold needles as described below.
‰
Run the CTRL Washer Dispense Check assay as described in Section
4.5.4.4.
‰
Run the WasherClean assay again.
Cleaning a clogged manifold
‰
Open the bottom drawer.
‰
Lift the metal plate holding the manifold.
‰
Unscrew (by hand) the two thumbscrews on top of the manifold.
‰
Pull the manifold gently from side to side to extract it.
‰
Unplug (gently) the tubing leading to the manifold.
‰
Using the supplied cleaning needles, clean the manifold needles. Two
different sizes of cleaning needles are supplied, one for aspirate
needles, one for dispense needles.
Figure 281: Cleaning the manifold needles
‰
Plug in the tubing to the manifold again.
‰
Screw the manifold back onto its holder.
‰
Close the bottom drawer.
Other problems
If you have performed all the above actions but the washer still does not
operate correctly, other parts such as filters or pumps may be involved. Call
your Bio-Rad Service Engineer for assistance.
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4.4.5 Washer Calibration
The washer calibration procedure is normally performed by your Bio-Rad
Service Engineer when the system is first installed or if specific maintenance
jobs have been conducted on that module.
As a user, you should rarely need to perform this procedure yourself. If
in doubt, call your Bio-Rad Service Engineer before performing it.
To calibrate the washer:
‰
Select the Utilities | System Setup menu item. This opens the System
Set-Up dialog box.
‰
In this dialog box, click on the Washer tab.
‰
In the Washer tab, click the <Calibrate> button. You will be asked if you
want to verify the dosing unit 1 (red channel).
‰
Click <Yes>. Please follow the explanations in the next window.
‰
Take a blank microplate and weigh it on a precision scale.
‰
Connect a wash fluid container with water to the red tubing.
‰
Confirm the message window with <OK>.
‰
Place the weighted blank microplate into the system and confirm the
respective message window. Then the injections into all microplate wells
are carried out.
‰
Take the microplate out and confirm the respective message window.
The Weight window is displayed.
‰
Weigh the microplate and subtract the tare weight.
‰
Enter the calculated liquid weight into the Weight window.
‰
Confirm the Weight window with <OK>.
‰
Take a new microplate, weigh it and place it into the instrument.
‰
Confirm the respective message window. Then more injections into the
microplate are performed.
‰
Take the microplate out of the system and confirm the respective
message window. The Weight window is displayed.
‰
Weigh the microplate and subtract the tare weight
‰
Enter the calculated liquid weight into the Weight window.
‰
Confirm the Weight window with <OK>. Then an internal calibration for
dosing unit 1 (red channel) takes place.
To calibrate the other wash buffer pumps, repeat these steps upon request
by the software.
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4.4.6 Vacuum and Trap Flask Maintenance
The vacuum flask and the trap flask are located at the back of the bottom
drawer, behind the wash buffer bottles. Normally, these flasks are checked
by the Bio-Rad Service Engineer during the preventive maintenance visit.
The following procedure is described only in case a problem occurs in the
mean time; it does not need to be performed by the user on a regular basis.
Two main problems can occur: the liquid waste may not be aspirated
correctly into the flasks, or it may remain in the flasks instead of being
evacuated to the main liquid waste container, and cause the flasks to
overflow.
The source of these problems may be either that the peristaltic waste pump
is not functioning correctly or that there is a leak in the vacuum flask or in the
tubing.
Emptying the trap flask
‰
Make sure you are wearing the proper personal protective equipment
(laboratory coat, gloves and eye protection) as the liquid contained in the
flask comes directly out of the washer and may be strongly
contaminated.
‰
Open the bottom drawer up to its first stop.
‰
Unlock the safety catch (see Figure 282) and open the bottom drawer
completely.
When the bottom drawer is fully open, avoid leaning on it. The drawer
and/or the instrument may tip over!
‰
Prepare absorbent paper moistened with RIVASCOP ® (diluted in water
at 0.4% - 4 ml per liter).
‰
Unscrew the cap of the trap flask and remove the flask.
‰
Place the cap on the absorbent paper.
‰
Empty the trap flask into a container for biological hazardous liquid
waste (or into the EVOLIS main liquid waste container).
‰
Put the flask back into the instrument.
‰
Dispose of used absorbent paper in accordance with legal regulations
for biological hazardous waste.
‰
Return the safety catch to its original position and close the bottom
drawer.
If liquid from the flasks has overflowed, refer to the clean-up procedure
described in Section 4.4.2.
If the problem persists, call your Bio-Rad Service Engineer for assistance.
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4.4.7 Reagent Bottles
In most cases, kit reagent bottles have to be discarded after use. Dispose of
them in accordance with legal regulations for biological hazardous waste.
For some bottles, however, a limited re-use is allowed. In those cases, follow
strictly the maintenance instructions described below.
WARNING! Reusing bottles (even if thoroughly cleaned) may affect the
stability of the reagent. If possible, always prefer a new bottle.
Enzyme development solution (TMB and OPD)
‰
Empty remaining TMB or OPD solution.
‰
Fill the bottle with deionized water, then empty it.
‰
Repeat three times.
‰
Fill the bottle with Bio-Rad Wash Buffer R2.
‰
Let it soak for a overnight.
‰
Empty it.
‰
Fill the bottle with deionized water, then empty it.
‰
Repeat three times.
‰
Turn the bottle upside down on absorbent paper and allow to dry.
You can clean and re-use the bottle as many times as needed to finish one
kit. When starting a new kit, use also a new bottle for TMB or OPD.
Working conjugate solution
‰
Empty remaining conjugate solution.
‰
Fill the bottle with deionized water, then empty it.
‰
Repeat three times.
‰
Turn the bottle upside down on absorbent paper and let it dry.
You can clean and re-use the bottle as many times as needed to finish one
kit. When starting a new kit, use also a new bottle for the Working conjugate
solution.
Sample diluent solution
A bottle used for sample diluent does not need to be emptied or cleaned
after each use. It can be refilled as many times as needed to finish one kit.
When starting a new kit, use also a new bottle for the sample diluent.
Even if you clean your bottles thoroughly, never use the same bottle
for different kinds of reagents! Even traces of reagents are sufficient to
cause unwanted chemical reactions.
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4.4.8 Photometer Maintenance and Servicing
Normally, the maintenance of the photometer is done by the Bio-Rad
Service Engineer during the regular six-month maintenance visit and
not by the user. The following procedures are described in case the
photometer lamp is blown or a filter urgently needs cleaning. After the
lamp or a filter has been changed, it is necessary to recalibrate the
photometer (see Section 4.5.4.2).
Accessing the photometer
The photometer is located completely at the rear of the bottom drawer. To
gain access to the photometer for maintenance or servicing, you need open
the drawer to its first stop and then unlock the safety catch (on the left, inside
the drawer).
Figure 282: Accessing the photometer (unlocking the safety catch)
When the bottom drawer is fully open strictly avoid leaning on it. The
drawer and/or the instrument may tip over!
Opening the photometer
To open the photometer:
430
‰
Unscrew the two screws on the side of the photometer. On earlier
versions of the EVOLIS instrument, the screws are ordinary screws for
which a screwdriver is needed; on newer versions, the wing screws can
be undone by hand.
‰
Pull back the photometer drawer.
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Figure 283: Opening the photometer
If the photometer has been used recently, its components may still be
hot. Allow time for them to cool before performing the following
procedures.
Replacing the photometer bulb
If the bulb of the photometer is faulty, a "Bulb blown!" message is
displayed next to "Colorimeter" in the selftest report (see Section 1.2.3). A
spare photometer bulb is supplied with the EVOLIS instrument.
To replace the bulb:
‰
Pull bulb upward and take it out of its holder. (Hot! Be careful!)
Figure 284: Bulb replacement
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‰
Pull the bulb out of the connection socket and replace it with a new bulb.
(Do not touch the reflecting surface of the new bulb!)
‰
Insert the bulb back into its into holder.
‰
Close the photometer drawer and put the screws back in.
‰
Shut the bottom drawer (make sure to return the safety catch to its
original position).
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Cleaning/changing the photometer filters
The filter wheel is located in the photometer drawer behind the bulb. It
includes eight slots numbered from 1 to 8.
‰
Turn the wheel gently to access the filter that needs to be cleaned or
replaced.
‰
Clean the filter using filter wipes (paper wipes used for lenses and
optical instruments) without adding any cleaning agent. Make sure not to
touch the glass part of the filter directly with your fingers.
‰
Insert the new or cleaned filter into the slot again. While doing so make
sure not to touch directly the glass part of the filter.
‰
If necessary, repeat this procedure for other filters.
‰
Close the photometer drawer and put the screws back in.
‰
Shut the bottom drawer (make sure to return the safety catch to its
original position).
When putting the filters back on, make sure not to exchange their
positions. The same applies when adding filters. Always make sure
that the order you have on the instrument corresponds to the order of
the filters in the software (see Section 3.10.3.1)! As a general rule,
filters are placed in ascending order (smaller wavelength in slot No 1).
Photometer verification
The performance of the photometer can be checked using special
verification plates. The procedure is described in Section 4.5.4.2. This
verification is normally carried out by the Bio-Rad Service Engineer during
the preventive maintenance visit.
4.4.9 Damaged Parts
In most cases, repairing and/or replacing damaged parts will require the
assistance of your Bio-Rad Service Engineer. If in doubt, please call before
trying to repair/change the part yourself.
However, two specific cases need to be mentioned.
Parts damaged during shipment
If you have ordered parts that are shipped directly to you, examine them
carefully when unpacking. Although they are packed to provide maximum
protection, damage can occur. In this case, report the damage in the first
place to the carrier/shipping company and then to the supplier.
Decontamination
If you want to return damaged parts to Bio-Rad or to your local supplier (e.g.
if under guarantee), please note that the parts must be decontaminated first.
Follow the decontamination procedure described for sample and reagent
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racks (see Section 4.3.2.3) and fill out the return tag provided in Appendix A
4.
4.4.10 Power Supply Problems
Always use grounded connectors to connect the instrument and
peripherals to electrical outlets.
Checking and replacing fuses
The EVOLIS instrument operates with (two) fuses that are located in a fuse
holder at the back of the instrument, just above the power supply cord.
If the instrument does not power on when you press the ON/OFF switch, the
power fuses may be blown. Spare fuses are supplied with the instrument.
To replace a blown fuse:
‰
Disconnect the power cord.
‰
With a small flat-blade screwdriver, lift the plastic tappet to open the fuse
drawer.
‰
Remove the damaged fuse from the fuse holder and insert a new fuse.
‰
Close the fuse drawer. Make sure the plastic tappet snaps in place.
‰
Reconnect the power cord.
‰
Press the ON/OFF switch to check if the instrument turns on.
1) Although spare fuses are provided with the instrument and the
replacement procedure is described above, you should be aware that
blown fuses are very often indicators of other malfunctions that may
be affecting instrument modules, components or wires.
If in doubt or if the fuse blows again shortly after you have replaced it,
please call you Bio-Rad Service Engineer for assistance.
2) Spare fuses must match the values specified by the system
manufacturer (see Ordering Information in Appendix A 3).
Power cuts / outages
If a power cut occurs during a run, the system can rely on a recovery file to
resume the run automatically when the power cut is over.
When the power supply is reset, the EVOLIS system will normally prompt
you to continue the run from where it was interrupted (your decision to
continue the run will depend on the duration of the power cut). Note however
that if only a part of a plate has been processed, the system does not keep
track of the sample locations and you may have to reselect the patient
samples to be tested (see Section 2.7.8 on Partial processing).
If the power cut occurs outside a run, turn off the instrument.
When the power supply is reset, turn on the instrument, then turn on the
EVOLIS computer and restart the EVOLIS software.
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If you frequently experience power supply fluctuations, it is recommended
that you install a UPS (Uninterruptible Power Source) device to protect your
EVOLIS system.
4.4.11 Disposal of the Instrument
1) European Union Member States + Switzerland and Norway
This product contains electrical or electronic materials. Presence of
this label on the product means it should not be disposed of as
unsorted waste and must be collected separately.
(European Union Directive 2002/96/EC on waste electrical and
electronic equipment - "WEEE Directive")
As a consumer, you are responsible for ensuring that this product is
disposed of properly.
To find out how to properly dispose of this product:
‰
Follow the country-specific instructions provided on the Bio-Rad website:
www.bio-rad.com > Corporate tab > technical support tab > EU
Recycle program link.
or,
‰
Contact your
instructions.
local
Bio-Rad
representative
for
country-specific
2) Other countries
Please contact your local Bio-Rad representative.
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4.5. Performance Evaluation Procedures
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4.5 Performance Evaluation Procedures
The performance evaluation procedures described in this Section have been
developed by Bio-Rad to allow users to monitor, periodically, the level of
operating performance of their EVOLIS instruments.
To make it easy for users to carry out these procedures by themselves, BioRad provides:
• A set of pre-defined performance evaluation assays.
• A ready-to-use performance evaluation Kit (Pipettor – Washer PE Kit hereafter "PE Kit").
• A calibrated check plate for the evaluation of the photometer.
• A calibrated tool to control the performance of the heated incubators
(Incubator Verification Tool – hereafter "IVT").
The last three items in this list have to be ordered separately from Bio-Rad
(for ordering information, see Appendix A 3).
4.5.1 Performance Evaluation Timetable
Module
Protocols used (1)
Monthly PE procedures
Pipettor
CTRL CV Pipettor Low Vol BR V12.asy
Tools / materials required
PE Kit
CTRL CV Pipettor High Vol BR V12.asy
CTRL Pipettor Dilution BR V12.asy
Washer
CTRL Washer Aspirate BR V12.asy
Twice-a-year PE procedures
Plate Transport
CTRL Plate transport BR V12.asy
Photometer
No protocol needed – Verification process
PE Kit
4 flat-bottom microplates
Reader Check Plate
is predefined in the software
Pipettor
CTRL Pipettor Low Vol BR V12.asy
PE Kit
CTRL Pipettor High Vol BR V12.asy
CTRL Pipettor Dilution BR V12.asy
Washer
CTRL Washer Aspirate BR V12.asy
PE Kit
CTRL Washer Dispense BR V12.asy
Yearly PE procedure
Incubators
CTRL Incubators BR V12.asy
IVT (Incubator Verification Tool)
(1) File names listed here correspond to the files included in the latest APF
version available at the time this manual was updated. Always use the latest
version available.
4.5.2 General Performance Evaluation Guidelines
The following guidelines are important for the reliability of the performance
evaluation procedures as well as for the operator's safety:
• Do not use expired reagents.
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•
•
•
•
Make sure all tools and accessories (e.g. Reader Check Plate,
handpipettes) are calibrated.
Wear disposable gloves when handling reagents and thoroughly wash
your hands after handling them.
Do not pipette by mouth.
Pipettor – washer evaluation: verify the pipettor and the washer modules
on the same instrument on the same day and with materials from the
same PE Kit Pipettor – Washer.
Archiving verification reports
A record of all PE procedures should be kept for future reference and to aid
any possible error tracing (see follow-up table provided in Appendix A 8).
4.5.3 Monthly PE Procedure
4.5.3.1 Pipettor – Washer PE Kit
In the monthly PE procedure, only the pipettor's and the washer's
performance is evaluated. Therefore, all you need to have to execute these
procedures is a valid Pipettor – Washer PE Kit ("PE kit").
This kit has been specially developed by Bio-Rad to make it easy for users
to perform these PE procedures. All reagents are ready-to-use. The kit also
includes all other required materials: microplates, empty bottles.
Never use materials not included in the PE Kit.
Always use reagents from the same kit to test the pipettor and the
washer of the same instrument on the same day.
Do not use an expired PE Kit.
Wear disposable gloves when handling the reagents and thoroughly
wash your hands after handling them.
For further details (storage conditions, etc.), refer to the kit insert. For
ordering information, see Appendix A 3.
4.5.3.2 Pipettor Precision Evaluation
What is verified
In the monthly procedure, only the pipettor's precision is verified (the
pipettor's accuracy is verified in the twice-a-year PE procedure, see Section
4.5.4.3). The pipettor's precision is assessed for low volume dispenses
(20 µl), for high volume dispenses (100 µl) and for dispenses after a
predilution step.
For more information on the actual pipetting steps and volumes dispensed,
open and review the respective assay files.
"CTRL CV Pipettor Low Vol.asy"
"CTRL CV Pipettor High Vol.asy"
"CTRL Pipettor Dilution.asy"
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For more information on the verification principles and result validation
criteria used, please call your Bio-Rad Service Engineer.
Materials required
These materials are all included in the Bio-Rad PE Kit. Do not use materials
from any other source.
Color Solution C0 (14 ml bottle)
Color Solution C1 (2 ml vial)
Color Solution C2 (2 ml vial)
Color Solution C3 (10 ml bottle)
Color Solution C4 (10 ml bottle)
2 empty 15 ml bottles
1 flat-bottom microplate.
Procedure
The instructions below assume familiarity with how to create and process a
worklist on the EVOLIS system. If you are not familiar with this, please refer
to Sections 2.4 to 2.8 of this manual before performing this procedure. You
should also have referenced the PE kit you intend to use in the kit database
as described in Section 3.5.2.1.
The procedure lasts approximately 25minutes.
Perform the following steps:
‰
Create a new worklist with one plate.
‰
Select the three following assays successively (and in this order) and
add all three of them to this plate.
"CTRL CV Pipettor Low Vol.asy"
"CTRL CV Pipettor High Vol.asy"
"CTRL Pipettor Dilution.asy"
Figure 285: Monthly Pipettor Evaluation
‰
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Do not add any patients.
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‰
Click <OK> to confirm. In the Lot Specific Values dialog box, select the
Batch Number corresponding to the one printed on the kit package you
are using.
‰
Continue until the Load dialog box is displayed.
‰
Fill the two empty 15 ml-bottles with clean tap water.
‰
Place these water-filled bottles as well as Color Solutions C0, C3 and C4
on a -1 reagent rack. Place Color Solutions C1 and C2 on a -2 reagent
rack.
‰
Load the resources as requested in the Load dialog box: dilution plate,
tips and the reagent racks with the color solutions and water bottles.
‰
When done, click <OK>.
‰
When the system prompts you, insert an empty test plate and start the
run.
‰
When the procedure is completed, unload the test plate when prompted
to do so.
‰
Unload the dilution plate and the reagent racks. Store the reagents as
instructed in the kit insert.
‰
Review the run results displayed on the screen.
Result interpretation
For the first two assays ("CTRL CV Pipettor Low Vol" and "CTRL CV Pipettor
High Vol") the coefficient of variation (%CV) is calculated for the strips
pipetted. The acceptance criteria the %CV must meet are predefined in the
assay protocols. Review the Validation criteria sections of the result report to
see if these are "Passed" or "FAILED".
For the third assay ("CTRL Pipettor Dilution") the mean absorbance and the
coefficient of variation (%CV) are calculated for the strips pipetted. The
acceptance criteria are predefined in the assay protocol. Review the
Validation criteria section of the result report to see if these are "Passed" or
"FAILED".
If some of the results do not meet the acceptance criteria, repeat the
respective assay.
If the procedure fails a second time, please call Bio-Rad Technical Support.
4.5.3.3 Washer Aspirate Evaluation
What is verified
In the monthly procedure, the washer's aspirate function only is assessed,
i.e. the residual volume in the microplate wells after aspiration.
For more information on the actual assay steps and volumes used, open and
review the "CTRL Washer Aspirate" assay file.
For more information on the verification principles and result validation
criteria used, please call your Bio-Rad Service Engineer.
Materials required
These materials are all included in the Bio-Rad PE Kit. Do not use materials
from any other source.
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Color Solution C0 (14 ml bottle)
1 empty 15 ml bottle
1 flat-bottom microplate.
Procedure
The instructions below assume familiarity with how to create and process a
worklist on the EVOLIS system. If you are not familiar with this, please refer
to Sections 2.4 to 2.8 of this manual before performing this procedure. You
should also have referenced the PE kit you intend to use in the kit database
as described in Section 3.5.2.1.
The procedure lasts approximately 15 minutes.
Perform the following steps:
‰
Create a new worklist with one plate and select the "CTRL Washer
Aspirate" assay file.
‰
Do not add any patients.
‰
Click <OK> to confirm. In the Lot Specific Values dialog box, select the
Batch Number corresponding to the one printed on the kit package you
are using.
‰
Continue until the Load dialog box is displayed.
‰
Fill the empty 15 ml-bottle with clean tap water.
‰
Place this water-filled bottles as well as Color Solution C0 on a -1
reagent rack.
‰
Load the resources as requested in the Load dialog box: tips, clean fluid
and the reagent rack with the color solution and water bottle.
‰
When done, click <OK>.
‰
When the system prompts you, insert an empty test plate and start the
run.
‰
When the procedure is completed, unload the test plate when prompted
to do so.
‰
Unload the reagent rack and store the reagent as instructed in the kit
insert.
‰
Review the run results displayed on the screen.
Result Interpretation
The residual volume mean for the plate and for each needle is calculated.
The maximum residual volume of the plate is reported. The mean residual
volume of each row and the maximum individual residual volume must meet
the acceptance criteria defined in the assay protocol. Review the Validation
criteria section of the result report to see if these are "Passed" or "FAILED".
If some of the results do not meet the acceptance criteria, repeat the assay.
If the procedure fails a second time, please call Bio-Rad Technical Support.
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4.5.3.4 Combined Pipettor - Washer Monthly Procedure
If you are confident in your use of the system and of the above procedures,
you can combine the pipettor procedures and the washer procedure in the
same run. Make sure to use two plates (one for the pipettor and one for the
washer) and set-up your worklist as shown below.
Figure 286: Combined pipettor- washer evaluation procedure
The combined procedure lasts approximately 40 minutes.
4.5.4 Twice-a-year PE Procedure
The complete ("twice-a-year") PE procedure is normally carried out every six
months by the Bio-Rad Service Engineer during the preventive maintenance
visit (see Section 4.3.4).
It can also be performed by authorized users having received specific
training from Bio-Rad to perform these procedures.
Other users are not generally allowed to perform them.
Order of verification
Always verify individual modules in the following order:
1) Plate transport module Æ 2) Photometer Æ 3) Pipettor Æ 4) Washer.
The pipettor and the washer must be verified on the same day, using
solutions from the same Pipettor – Washer PE Kit (see Section 4.5.3.1).
4.5.4.1 PE Plate Transport Check
What is verified
In this procedure the system checks that the plate transport unit can
correctly move test plates to and from the various instrument modules
(pipetting station, incubators, washer, photometer).
Materials required
Any 4 flat bottom microplates.
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Procedure
The instructions below assume familiarity with how to create and process
worklists on the EVOLIS system. If you are not familiar with this, please refer
to Sections 2.4 to 2.8 of this manual before performing this procedure.
The procedure lasts approximately 15 minutes.
Perform the following steps:
‰
Create a new worklist with four plates.
‰
Assign the "CTRL Plate Transport" assay file to each plate.
Figure 287: Plate transport check
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‰
Do not add any patients.
‰
Click <OK> to confirm and continue until the Worklist window is
displayed (you do not need to enter anything in the Lot Specific Values
dialog box).
‰
Make sure the quantity of clean fluid available on the instrument
matches the quantity requested in the Reagent requirements list of the
Worklist window (restock if necessary).
‰
Continue until the Load window is displayed.
‰
Click <OK>.
‰
When the system prompts you, insert the first microplate and click
<OK>. The plate is moved into the instrument and the system prompts
you to load another plate.
‰
Load all four plates successively as requested. When the last plate has
been loaded, the actual test procedure begins.
‰
When the procedure is completed, remove the plates as prompted. A
result report is displayed for each plate but no actual results are
calculated.
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Result Interpretation
You know that the plate transport PE procedure has been successfully
performed if no movement error has been detected during the run, i.e no
error message was displayed. You can also review the worklist's active
event log to make sure no movement error occurred.
If any errors were detected, please call Bio-Rad Technical Support.
Do not perform any of the other PE procedures if the Plate Transport
procedure failed.
4.5.4.2 Photometer Verification
What is verified
In this procedure, measurements are made for each well position on the
Reader Check Plate, using each photometer filter. The mean measurement
values are then used to determine the photometer performance as regards
the following parameter.
Alignment Checks if the measurements are taken at the optimum position within the
microplate well.
Accuracy Checks if measurements are within the stated accuracy of the absorbance
reader specification and checks the accuracy of the reference standard of
the value in the certificate file. The software calculates the OD equivalent
based on the certificate value for each filter.
Linearity Checks if measurements are within the stated linearity of the absorbance
reader specification.
Uniformity Checks if every optic channel measures the same value, within the stated
accuracy of the reader specification.
Dynamic Range Checks if the measurements can span the dynamic range as stated within
the absorbance reader specification.
Cross Talk Checks if cross talk is below limits that maintain the stated specifications.
Filter Checks if the correct filter is installed and has no major defects.
Long Term Drift Checks if the measurements remain constant within the accuracy limits
over time.
Precision Checks if the measurements remain constant within repeated readings of
the same sample.
Materials required
A calibrated Reader Check Plate available from Bio-Rad. For ordering
information, see Appendix A 3.
The Reader Check Plate is fragile. Please handle with care.
Avoid touching the underside of the Reader Check Plate and ensure
that it is completely clean, dry and free from particles.
The Reader Check Plate has to be sent back to Bio-Rad every three
years for recalibration. Please make sure it is decontaminated before
sending it back
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1) Enter the Reader Check Plate reference values
Due to variations in the glass, each Reader Check Plate has its own set of
reference values which must be entered into the EVOLIS software before
the plate is used for the first time. If this is not the first time you are using a
plate, move on directly to step 2.
Each Reader Check Plate is supplied with a floppy disk on which the plate's
reference values are saved and a data sheet. To transfer these values to the
EVOLIS software, operate as follows:
‰
Make sure the serial number of the Reader Check Plate is identical to
the number on the floppy disk.
‰
Insert the disk into the computer's floppy disk drive.
‰
Start Windows Explorer to review the files included on the disk.
‰
Find the certification file and copy it from the disk to the
C:\BioRad\System directory. The file's original name corresponds to the
Reader Check Plate's serial number with a (*.cer) extension.
‰
In the C:\BioRad\System directory, rename the file as Verify.cer (if there
is already a file under this name in the directory, delete it before
renaming the new file). Depending on your Windows Explorer options, it
is possible that the file name is displayed without its (*.cer) extension. In
this case, rename the file as Verify (without any space before or after).
‰
Start the EVOLIS software.
‰
Select System Setup in the Utilities menu.
‰
Click on the Colorimeter tab.
‰
Click the <Verification Plate> button. When the Verification Plate
dialog box opens the plate's reference values should already be included
in the various fields (you can check this by comparing the values
displayed with the values on the data sheet supplied with the plate).
Figure 288: Verification Plate dialog box
This dialog box also allows you to enter these values manually (except the
Expiry Date) but you should avoid using a Reader Check Plate when you do
not have the corresponding floppy disk.
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2) Run the photometer check
‰
Select the Verify Photometer item in the Utilities menu. This opens the
Verify Colorimeter dialog box.
Figure 289: Verify Colorimeter dialog box
‰
Select the filter(s) which should be verified with the verification plate.
Use the CTRL key to select more than one filter. When the plate is first
read the values obtained are stored and later readings are compared
against these to check that the reader has not "drifted". If the Reset long
term drift values option is enabled, the system deletes the previously
recorded values and saves the current verification values as original drift
values.
‰
Confirm with <OK>. The system prompts you to load the verification
plate onto the instrument.
‰
Place the Reader Check Plate in the plate carrier frame as shown below
and load it onto the plate transport unit.
1
A
Figure 290: Loading the Reader Check Plate
‰
Click <OK>. All installed filters which have been selected are checked.
‰
When all the criteria have been checked, the system prompts you to
remove the plate from the instrument and the verification report is
displayed.
Result Interpretation
The test is successful if all the criteria are passed.
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Figure 291: Photometer verification report
Select File | Save Report As to save the verification report. By default,
photometer verification reports are saved with a (*.ver) extension in the
C\BioRad\System directory.
If some criteria are failed, you can use the View | Detailed menu item to
display more information.
If a problem was detected on an individual filter only, you may try to solve it
by cleaning or changing this filter as described in Section 4.4.8 and running
the verification procedure again.
If this does not solve the problem, please contact your Bio-Rad Service
Engineer and e-mail him the respective verification report file(s).
4.5.4.3 Pipettor Accuracy Evaluation
What is verified
The principle of this verification is to compare the accuracy of the EVOLIS
pipettor with a range of wells manually pipetted by an authorized laboratory
technician. The comparison is performed on a variety of dispenses.
• 20 µl dispense, one well at a time
• 20 µl dispense, multi-pipetting (16-fold)
• 100 µl dispense, one well at a time
• 100 µl dispense, multi-pipetting (8-fold)
• 1 to 25 dilution in two steps using a dilution plate (1 to 10 dilution in the
dilution plate followed by a 1 to 2.5 dilution in the test plate).
For more information on the actual pipetting steps and volumes dispensed,
open and review the respective assay files.
"CTRL Pipettor Low Vol.asy"
"CTRL Pipettor High Vol.asy"
"CTRL Pipettor Dilution.asy"
For more information on the verification principles and result validation
criteria used, please call your Bio-Rad Service Engineer.
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Materials required
The following materials are included in the Bio-Rad PE Kit (see Section
4.5.3.1). Do not use materials from any other source.
• Color Solution C0 (14 ml bottle)
• Color Solution C1 (2 ml vial)
• Color Solution C2 (2 ml vial)
• Color Solution C3 (10 ml bottle)
• Color Solution C4 (10 ml bottle)
• 2 empty 15 ml bottles
• 1 flat-bottom microplate.
Other materials:
• 1 flat-bottom dilution plate.
• 1 calibrated manual pipette.
Procedure
The instructions below assume familiarity with how to create and process a
worklist on the EVOLIS system. If you are not familiar with this, please refer
to Sections 2.4 to 2.8 of this manual before performing this procedure. You
should also have referenced the PE Kit you intend to use in the kit database
as described in Section 3.5.2.1.
The procedure lasts approximately 40 minutes.
Perform the following steps:
‰
Take a new microplate from the PE Kit.
‰
Using the calibrated manual pipette, dispense the following volumes of
color solution in the following microplate wells.
Wells
A1 and B1
C1 and D1
E1 and F1
G1 and H1
A6 and B6
C6 and D6
E6 and F6
G6 and H6
446
Æ
Æ
Æ
Æ
Æ
Æ
Æ
Æ
Color Solution
14 µl of Color Solution C1 or C2
16 µl of Color Solution C1 or C2
18 µl of Color Solution C1 or C2
20 µl of Color Solution C1 or C2
70 µl of Color Solution C3 or C4
80 µl of Color Solution C3 or C4
90 µl of Color Solution C3 or C4
100 µl of Color Solution C3 or C4
‰
Create a new worklist with one plate.
‰
Select the three following assays successively (and in this order) and
add all three of them to this plate.
"CTRL Pipettor Low Vol.asy"
"CTRL Pipettor High Vol.asy"
"CTRL Pipettor Dilution.asy"
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Figure 292: Twice-a-year pipettor evaluation
‰
Do not add any patients.
‰
Click <OK> to confirm. In the Lot Specific Values dialog box, select, for
each assay, the Batch Number corresponding to the one printed on the
kit package you are using.
‰
Enter the following QA labels for each color solution.
CTRL Color Solution C0
CTRL Color Solution C1
CTRL Color Solution C2
CTRL Color Solution C3
CTRL Color Solution C4
CTRL Water
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Æ
Æ
Æ
Æ
Æ
Æ
QA Label
(none)
X
Y
X
Y
(none)
‰
Continue until the Load dialog box is displayed.
‰
Fill the two empty 15 ml-bottles with clean tap water.
‰
Place these water-filled bottles as well as Color Solutions C0, C3 and C4
on a -1 reagent rack. Place Color Solutions C1 and C2 on a -2 reagent
rack.
‰
Load the resources as requested in the Load dialog box: dilution plate,
tips and the reagent racks with the color solutions and water bottles.
‰
When done, click <OK>.
‰
When the system prompts you, insert the previously prepared microplate
(with strips 1 and 6 manually pipetted) and start the run.
‰
When the procedure is completed, unload the test plate when prompted
to do so.
‰
Unload the dilution plate and the reagent racks. Store the reagents as
instructed in the kit insert.
‰
Review the run results displayed on the screen.
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Result interpretation
For the first two assays ("CTRL Pipettor Low Vol" and "CTRL Pipettor High
Vol") the values for the wells pipetted by the EVOLIS pipettor (strips 2 to 5
for 20 µl and strips 7 to 12 for 100 µl) are compared to the manually pipetted
wells (strip 1 for 20 µl and strip 6 for 100 µl). The acceptance criteria are
predefined in the assay protocols. Review the Validation criteria sections of
the result report to see if these are "Passed" or "FAILED".
For the third assay ("CTRL Pipettor Dilution") the mean absorbance and the
coefficient of variation (%CV) are calculated for strips 11 and 12. The
acceptance criteria are predefined in the assay protocol. Review the
Validation criteria section of the result report to see if these are "Passed" or
"FAILED".
If some of the results do not meet the acceptance criteria, repeat the
respective assay.
If the procedure fails a second time, please call Bio-Rad Technical Support.
4.5.4.4 Washer Aspirate / Dispense Evaluation
What is verified
In the twice-a-year procedure, both the aspirate and the dispense functions
of the washer are assessed. For the aspirate function, the residual volume
left in the wells after aspiration is measured and compared to acceptable
levels. For the dispense function, deionized water volumes are dispensed
through the four washer line to be compared with a range dispensed by the
EVOLIS pipettor.
Strips / Wells
1-3 / A1 to H3
4-6 / A4 to H6
7-9 / A7 to H9
10-11 / A10 to H11
12 / A12 to H12
Æ
Æ
Æ
Æ
Æ
Dispensed by
Red washer line
Blue washer line
Yellow washer line
Black washer line
Pipettor
For more information on the actual assay steps and volumes used, open and
review the "CTRL Washer Aspirate" and "CTRL Washer Dispense" assay
files.
For more information on the verification principles and result validation
criteria used, please call your Bio-Rad Service Engineer.
Materials required
These materials are all included in the Bio-Rad PE Kit. Do not use materials
from any other source.
Color Solution C0 (14 ml bottle)
2 empty 15 ml bottle
2 flat-bottom microplates.
Procedure
The instructions below assume familiarity with how to create and process a
worklist on the EVOLIS system. If you are not familiar with this, please refer
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to Sections 2.4 to 2.8 of this manual before performing this procedure. You
should also have referenced the PE kit you intend to use in the kit database
as described in Section 3.5.2.1.
The procedure lasts approximately 20 minutes.
Perform the following steps:
‰
Create a new worklist with two plates.
‰
Assign assay file "CTRL Washer Aspirate" to the first plate and assay file
"CTRL Washer Dispense" to the second plate.
Figure 293: Twice-a-year washer evaluation
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‰
Do not add any patients.
‰
Click <OK> to confirm. In the Lot Specific Values dialog box, select the
Batch Number corresponding to the one printed on the kit package you
are using.
‰
Continue until the Load dialog box is displayed.
‰
Fill the two empty 15 ml-bottles with clean tap water.
‰
Place these water-filled bottles as well as Color Solution C0 on a -1
reagent rack.
‰
Load the resources as requested in the Load dialog box: tips, the
reagent rack with the color solution and water bottles and, in the bottom
drawer, fill all wash buffer/clean fluid containers with the required
quantity of deionized water.
‰
When done, click <OK>.
‰
When the system prompts you, insert the test plates and start the run.
‰
When the procedure is completed, unload the test plates when prompted
to do so.
‰
Unload the reagent rack and store the reagent as instructed in the kit
insert.
‰
Review the run results displayed on the screen.
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Result Interpretation
"CTRL Washer Aspirate" - The mean residual volume for the plate and for
each needle is calculated. The maximum residual volume of the plate is
reported. The mean residual volume of each row and the maximum
individual residual volume must meet the acceptance criteria defined in the
assay protocol.
Review the Validation criteria section of the result report to see if these are
"Passed" or "FAILED".
"CTRL Washer Dispense" – No results are calculated. Check the dispensed
microplate visually.
There should be liquid in all wells.
Compare the liquid levels in strips 1-11 to the liquid level in strip 12. If
significant deviations can be observed between any of the wells in strips 111 and the wells in strip 12, repeat the assay.
If significant deviations are still observed after the second attempt, call your
Bio-Rad Service Engineer.
The result assessment criteria integrated in the pipettor and washer
performance control assays have been voluntarily set at a very high
level of sensitivity in order to detect and signal any variation – even
slight – from the optimum standards of operating performance
required by Bio-Rad.
Failure to meet these criteria is intended only as a warning to users to
contact their Bio-Rad Service Engineer who will then examine closely
the detailed results of each procedure and issue specific
recommendations or determine the proper corrective actions.
Failure to meet these criteria should not be interpreted as invalidating
existing test results nor as preventing the continued use of the
respective EVOLIS instruments.
4.5.5 Yearly PE Procedure (Incubators)
The performance of the heated incubators on the EVOLIS system needs to
be checked only once a year. This evaluation procedure can either be
performed in conjunction with the twice-a-year evaluation routine (e.g. after
evaluating the washer as described above) or separately from any other
performance evaluation routine.
In any case, this procedure is performed once a year by your Bio-Rad
Service Engineer during the preventive maintenance visit.
As a user, it is also recommended that you perform this procedure if you
suspect an incubator malfunction (e.g. if warning messages are included in
the Title Block section of result reports, see Section 2.8.1).
What is verified
In this procedure, a microplate fitted with a temperature monitoring device
(Incubator Verification Tool – see below) is successively placed in all four
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heated incubators to control the conformity and stability of the programmed
temperature, once reached.
The following parameters are used:
• Incubation temperature: 37 °C (+/- 1.0 °C).
• Incubation time: 30 minutes in the first incubator, then 20 minutes (+/- 2
min.) in each of the other three incubators.
Materials required
An Incubator Verification Tool (hereafter "IVT") available from Bio-Rad. For
ordering information, see Appendix A 3.
The microplate supplied with the IVT (or any 96-well microplate with
removable strips, after removal of strips 8-12).
Procedure
The instructions below assume familiarity with how to create and process a
worklist on the EVOLIS system. If you are not familiar with this, please refer
to Sections 2.4 to 2.8 of this manual before performing this procedure.
The instructions below also assume familiarity with how to use the IVT as
described in the IVT's User Manual.
The procedure lasts approximately 100 minutes (including preparation time
and incubator preheating).
Perform the following steps:
‰
Connect, synchronize and program the IVT's logger as described in the
IVT's User Manual.
‰
When you get to the Launch dialog box, enter the following parameters:
Description
Æ
Interval (duration)
Æ
Serial number of the EVOLIS instrument
you intend to verify.
1 minute
Figure 294: The Launch dialog box (IVT's BoxCar software)
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4. System Maintenance and Cleaning
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
‰
Click <Start> and disconnect the logger following instructions on the
screen.
‰
Take the microplate supplied with the IVT and fit the logger carefully in
the empty space (strips 8 – 12) of the microplate.
‰
On the EVOLIS computer, create a new worklist with one plate and
select the "CTRL Incubators" assay file.
‰
Do not add any patients.
‰
Click <OK> to confirm and continue until the Load Plate dialog box is
displayed (you do not need to enter or change anything in the Lot
Specific Values dialog box and in the Load dialog box).
‰
Make sure the logger's red LED is still blinking.
‰
Load the microplate with the logger as shown in the plate carrier frame
and on the EVOLIS plate transport unit.
1
A
Figure 295: Loading the IVT microplate
‰
When done, click <OK> to start the run.
‰
When the procedure is completed, unload the plate when prompted to
do so.
‰
Remove the logger from the plate.
‰
Reconnect it to the computer on which you programmed it in order to
review the temperature monitoring results. If you do not know how to
reconnect the logger and display the results with the IVT's BoxCar
software, refer to the IVT's own User Manual.
Result Interpretation
Review the data graph and the data list in the BoxCar software. Make sure
the programmed temperature of 37 °C was reached and remained stable
(after stabilization) during the programmed incubation time in each of the
four incubators.
The data graph should be similar to the one below.
452
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4.5. Performance Evaluation Procedures
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Figure 296: Incubator data graph
In the data list, no recorded temperature (after stabilization) should be lower
than 36.0 °C or greater than 38.0 °C.
Figure 297: Incubator data list
Make sure also that the incubation temperature and incubation time data
recorded through the IVT correspond to the incubation temperature and
incubation time data displayed in the EVOLIS result report for that run.
If any of the above conditions are not met, please call your Bio-Rad Service
Engineer.
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EVOLIS
5. Error Messages
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
5 Error Messages
This Section describes system error messages and gives instructions on
error recovery.
Error Messages
1. ABORT button pressed.
2. Aborting plate ... .
3. Barcode IC error.
4. Clot detected in reagent ... .
5. Colorimeter ... not homed.
6. Colorimeter A/D error.
7. Colorimeter A/D over range error.
8. Colorimeter A/D under range error.
9. Colorimeter background light level error.
10. Colorimeter EEPROM error.
11. Colorimeter filter ... error.
12. Colorimeter filter motor home error.
13. Colorimeter filter motor movement error.
14. Colorimeter lamp error.
15. Colorimeter optic channel ... error.
16. Colorimeter plate motor home error.
17. Colorimeter plate motor movement error.
18. Colorimeter voltage reference error.
19. COMGEN error ... .
20. COMGEN error 0x0A - Target overflow error.
21. COP serial port test error.
22. Disposable tip dropped.
23. ERROR: Argument error in ... .
24. Error scheduling plate ... .
25. Incubator heater ... error.
26. Incubator sensor ... error.
27. No disposable tips left.
28. No fluid detected for ... .
29. No respond to command ... .
30. Plate ID verification error.
31. Plate transport ... motor home error.
32. Plate transport ... motor movement error.
33. Plate transport ... motor not homed.
34. Plate transport carrier error.
35. Plate transport EEPROM error.
36. Plate transport error.
37. Plate transport sensor error.
38. Rack scanner focusing error.
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5. Error Messages
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
39.
40.
41.
42.
43.
44.
45.
46.
47.
48.
49.
50.
51.
52.
53.
54.
55.
56.
57.
58.
59.
60.
61.
62.
63.
64.
65.
66.
456
Rack scanner motor error.
Rack scanner not detected.
Reagent ... is undefined.
Resuming after a crash.
RS232 write error – command: ... .
Some required resources have not been allocated to a position.
Suspect tip pickup.
System cover opened.
System fluid low.
The plate transport cannot find a route from its current position to its
next destination.
Tip eject failure.
Unknown colorimeter error code: ... .
Unknown incubator error code: ... .
Unknown plate transport error code: ... .
Unknown washer error code: ... .
Verification failed: ... .
Washer ... motor not homed.
Washer aspirate pump error.
Washer dispense pump error.
Washer EEPROM error.
Washer head home movement error.
Washer head motor movement error.
Washer plate home movement error.
Washer plate motor movement error.
Washer reagent level low error.
Washer valve test error.
Washer waste full.
Washer waste pump error.
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EVOLIS
5. Error Messages
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
1. ABORT button pressed
Cause:
The <Stop> button has been clicked during a run.
Action:
The run has been interrupted and may be continued or aborted completely
(see Section 2.7.6).
2. Aborting plate ... .
Cause:
The operator clicked the <Stop> button during a run and then, in the Pause
dialog box, requested that the processing of one or more plates be aborted
(see Section 2.7.6).
Action:
You can decide to resume the run for the remaining plates or abort it
completely
3. Barcode IC error
Cause:
The barcode cannot be read.
Action:
Verify the readability of the barcodes. Select the Utilities | System Setup
menu item, click on the Sample Rack tab and check the barcode
parameters (see Section 3.10.6.1).
Try reading the barcodes once more (withdraw and insert your rack again). If
this attempts fail, call your Bio-Rad Service Engineer.
4. Clot detected in reagent ... .'
Cause:
A clot was detected in the respective reagent (Note: Clot detection errors in
samples are managed automatically by the system.).
Action:
Pause the run (see Section 2.7.6) and replace reagent.
5. Colorimeter ... not homed
Cause:
The X-motor of the colorimeter is not in the home position.
Action:
Select the Selftest item in the Utilities menu to initialize the EVOLIS again.
If the problem persists, call your Bio-Rad Service Engineer. If this error
message comes up during a run, this run has to be aborted (see Section
2.7.6).
6. Colorimeter A/D error
Cause:
Error of the analog/digital converter of the colorimeter.
Action:
Call your Bio-Rad Service Engineer.
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5. Error Messages
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
7. Colorimeter A/D over range error
Cause:
Upper limit of colorimeter A/D has been exceeded due to the signal height of
the preselected resolution.
Action:
The filter has not been installed properly.
Call your Bio-Rad Service Engineer.
8. Colorimeter A/D under range error
Cause:
Signal detection too low. Defect of power supply unit of colorimeter, or
something similar.
Action:
The halogen lamp of the colorimeter is faulty and has to be replaced (see
Section 4.4.8). If the error persists, the optical components in the photometer
(filter, upper or lower optic block) may be dirty.
Call your Bio-Rad Service Engineer.
9. Colorimeter background light level error
Cause:
Typically occurs when light entered the measurement chamber.
Action:
Avoid direct exposure to sunlight, close all housing doors and covers.
Select the Selftest item in the Utilities menu to initialize the EVOLIS again.
If the error persists, call your Bio-Rad Service Engineer.
10. Colorimeter EEPROM error
Cause:
Error during EEPROM reading or writing.
Action:
Call your Bio-Rad Service Engineer.
11. Colorimeter filter ... error
Cause:
Error at filter no. ... . The gain factor for the respective filter cannot be
identified. Filter is faulty or wrong filter has been installed.
Action:
Call your Bio-Rad Service Engineer to check the installed filter and to
replace it, if necessary.
12. Colorimeter filter motor home error
Cause:
The system does not recognize the current position of the filter motor. Move
to the home position.
Action:
Select the Selftest item in the Utilities menu to initialize the EVOLIS again.
If the error persists, call your Bio-Rad Service Engineer.
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5. Error Messages
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
13. Colorimeter filter motor movement error
Cause:
The system does not recognize the current position of the filter motor. Move
to the home position.
Action:
Select the Utilities | Selftest menu item to initialize the EVOLIS again. If the
error persists, call your Bio-Rad Service Engineer.
If this error message comes up during a run, this run has to be aborted (see
Section 2.7.6).
14. Colorimeter lamp error
Cause:
The halogen lamp of the colorimeter is faulty.
Action:
Replace the lamp (see Section 4.4.8).
15. Colorimeter optic channel ... error
Cause:
Error in one of the optical channels. Upper or lower optic block is dirty or
faulty.
Action:
The optical blocks have to be cleaned by your Bio-Rad Service Engineer.
Call your Bio-Rad Service Engineer.
16. Colorimeter plate motor home error
Cause:
The system does not recognize the current position of the plate motor in the
measuring area. The plate motor has to be moved to the home position.
Action:
Select the Selftest item in the Utilities menu to initialize the EVOLIS again.
If the error persists, call your Bio-Rad Service Engineer.
If this error message comes up during a run, this run has to be aborted (see
Section 2.7.6).
17. Colorimeter plate motor movement error
Cause:
Error of motor when moving the plate to the measurement area.
Action:
Select the Selftest item in the Utilities menu to initialize the EVOLIS again.
If the error persists, call your Bio-Rad Service Engineer.
If this error message comes up during a run, this run has to be aborted (see
Section 2.7.6).
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5. Error Messages
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
18. Colorimeter voltage reference error
Cause:
Error in reference voltage of the colorimeter.
Action:
Call your Bio-Rad Service Engineer.
19. COMGEN error ... .
Cause:
RS232 connection faulty.
Action:
Check that the connection between the EVOLIS computer and the
instrument is satisfactory. Switch on the EVOLIS instrument again and
restart the computer.
20. COMGEN error 0x0A - Target overflow error
Call your Bio-Rad Service Engineer.
21. COP serial port test error
Cause:
The components are connected via serial interfaces to the control board.
Error in serial interfaces.
Action:
Call your Bio-Rad Service Engineer.
22. Disposable tip dropped
Cause:
This error message is displayed if the pipettor accidentally looses the tip
during a pipette or dispense step.
Action:
See Section 2.5.5.2 under 6).
23. ERROR: Argument error in ... .'
Cause:
Component cannot be activated. Error in component ... .
Action:
Call your Bio-Rad Service Engineer.
24. Error scheduling plate '...'
Cause:
Error in assay or missing resources. This error message is displayed in the
worklist for the respective plate, after the active worklist has been verified.
Action:
The worklist or the assay has to be changed accordingly (e.g. remove one
plate or try to change the order of the plates).
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5. Error Messages
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
25. Incubator heater ... error
Cause:
Defect in heater foil no. ... .
Action:
Call your Bio-Rad Service Engineer.
26. Incubator sensor ... error
Cause:
Defect of incubator sensor no. ... .
Action:
Call your Bio-Rad Service Engineer.
27. No disposable tips left
Cause:
Pipettor tips used up or not found.
Action:
Reload required tips at the position indicated in the Load dialog box (see
Section 2.7.4 under 1)).
28. No liquid detected for ... .
Cause:
Insufficient volume for sample ... or reagent ... .
Action:
If this happens for a reagent (Dispense step), see Section 2.7.4.
If this happens on a sample or control, the error message is displayed only if
the predefined "action on error" is "Raise alarm and stop" (see Section
2.7.5.3).
Click <Retry>. If the error persists, click <Abort> to abort the processing of
the plate. If you click <Continue> the processing will resume and the error
and operator intervention are traced in the log file (as if the predefined
"action on error" was "Log and continue"). This may be acceptable in some
cases but it is the biologist's / lab supervisor's responsibility to review the
results and check whether the affected samples may be validated or not.
29. No response to command ... .
Cause:
General software error. Communication between the EVOLIS computer and
the instrument is interrupted.
Action:
Click <Retry>. If the same message is displayed again, switch off the
computer and restart it. Switch off and restart by pressing directly the
ON/OFF switch (cold boot), do not perform a proper Windows shutdown.
When the computer restarts, answer the prompts ”....worklist ...?" and ”is the
analyzer still running?” accordingly. The system starts again and continues
with the worklist in progress.
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5. Error Messages
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
30. Plate ID verification error
Cause:
Plate barcode cannot be read.
Action:
Missing or faulty barcode, incorrectly selected barcode type. Enter the Plate
ID manually in the Load Plate dialog box (see Section 2.6.3).
31. Plate transport ... motor home error
Cause:
Plate transport motor cannot find home position.
Action:
Select the Selftest item in the Utilities menu to initialize the EVOLIS again.
If the error persists, call your Bio-Rad Service Engineer.
If this error message comes up during a run, this run has to be aborted (see
Section 2.7.6).
32. Plate transport ... motor movement error
Cause:
Error in plate transport motor no. ... .
Action:
Click the <Retry> button. If the error persists, call your Bio-Rad Service
Engineer.
33. Plate transport ... motor not homed
Cause:
Plate transport motor cannot find home position.
Action:
Select the Selftest item in the Utilities menu to initialize the EVOLIS again.
If the error persists, call your Bio-Rad Service Engineer.
If this error message comes up during a run, this run has to be aborted (see
Section 2.7.6).
34. Plate transport carrier error
Cause:
Plate holder does not move far enough into the instrument, so that the
sensor barrier is not triggered.
Action:
Click the <Retry> button. If the error persists, the plate transport has to be
adjusted new. Call your Bio-Rad Service Engineer.
35. Plate transport EEPROM error
Cause:
EEPROM error in plate transport.
Action:
Call your Bio-Rad Service Engineer.
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5. Error Messages
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
36. Plate transport error
Cause:
Error in plate transport in case of increased resistance.
Action:
Click the <Retry> button. If the error persists, try to locate the cause of the
resistance (blocking) and eliminate it. If you cannot detect any obvious
mechanical obstacle, call your Bio-Rad Service Engineer.
37. Plate transport sensor error
Cause:
Error in plate transport sensor.
Action:
Call your Bio-Rad Service Engineer.
38. Rack scanner focusing error
Cause:
The barcode scanner of the reagent and sample racks cannot be focused.
Action:
Manual allocation is possible.
Call your Bio-Rad Service Engineer.
39. Rack scanner motor error
Cause:
Motor error in reagent and sample rack scanner. Scanner firmware does not
work correctly. Electrical or mechanical scanner problems.
Action:
Manual allocation is possible.
Call your Bio-Rad Service Engineer.
40. Rack scanner not detected
Cause:
Scanner of reagent and sample racks is not connected.
Action:
Manual allocation of racks or samples and reagents is possible.
Call your Bio-Rad Service Engineer.
41. Reagent ... is undefined
Cause:
The reagent has not been defined.
Action:
Reagent has to be defined in the reagent database. Enter the parameters of
the reagent in the reagent database (see Section 3.4.3).
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5. Error Messages
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
42. Resuming after a crash
Cause:
The EVOLIS computer does not respond while processing the worklist and
has to be restarted.
Action:
Following restart of the computer, you may be able to save the worklist and
the results. Connection to the instrument is established and the results
stored there are transferred to the computer.
43. RS232 write error - command: '%1'
Cause:
Error in interface between the EVOLIS computer and the EVOLIS
instrument.
Action:
Check the connections between the EVOLIS instrument and the EVOLIS
computer. Check that the COM Port selected in the software (see Section
3.10.1) corresponds to the COM Port that is actually used to link the
instrument to the computer (see Section 1.2.8).
44. Some required resources have not been allocated to system
positions
Cause:
Not all required reagents have been allocated to a position.
Action:
All reagents requested in the Load dialog box have to be allocated to a
position or have to be loaded (see Section 2.5.3).
45. Suspect tip pick-up
Cause:
Pipettor cannot pick up a tip correctly (pipettor does not move deep enough
into the tip).
Action:
No user intervention required. Problem is traced in the event log. If this error
occurs repeatedly, a new teaching of the pipettor by your Bio-Rad Service
Engineer is required.
46. System cover opened
Cause:
Instrument cover is opened.
Action:
Close the cover; otherwise the EVOLIS cannot start processing the worklist.
47. System fluid low
Cause:
The system fluid level is too low for the pipettor to operate correctly.
Action:
Refill the system liquid container (see Section 1.1.4).
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5. Error Messages
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
48. The plate transport cannot find a route from its current position to
its next destination
Cause:
Plate transport has no information about its present position.
Action:
Call your Bio-Rad Service Engineer.
49. Tip eject failure
Cause:
Error in the tip eject station.
Action:
Remove tip manually from pipettor or trigger eject mechanism manually,
then click <OK>.
If this error persists, call your Bio-Rad Service Engineer.
50. Unknown colorimeter error code ... .
Cause:
Unknown colorimeter error.
Action:
Call your Bio-Rad Service Engineer.
51. Unknown incubator error code: ... .
Cause:
Unknown incubator error.
Action:
Call your Bio-Rad Service Engineer.
52. Unknown plate transport error code: ... .
Cause:
Unknown plate transport error.
Action:
Call your Bio-Rad Service Engineer.
53. Unknown washer error code ... .
Cause:
Unknown washer error.
Action:
Call your Bio-Rad Service Engineer.
54. Verification failed: ... .
Cause:
The reader has failed the validation criteria.
Action:
Replace the photometer lamp (see Section 4.4.8). Repeat validation.
If the error persists, call your Bio-Rad Service Engineer.
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5. Error Messages
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
55. Washer ... motor not homed
Cause:
Error in washer motor.
Action:
Select the Selftest item in on the Utilities menu to initialize the EVOLIS
again.
If the error persists, call your Bio-Rad Service Engineer.
56. Washer aspirate pump error
Cause:
Error in washer aspirate pump.
Action:
Select the Selftest item in the Utilities menu to initialize the EVOLIS again.
If the error persists, call your Bio-Rad Service Engineer.
If this error message comes up during a run, this run has to be aborted (see
Section 2.7.6).
57. Washer dispense pump error
Cause:
Error in washer dispense pump.
Action:
Select the Selftest item in the Utilities menu to initialize the EVOLIS again.
If the error persists, call your Bio-Rad Service Engineer.
If this error message comes up during a run, this run has to be aborted (see
Section 2.7.6).
58. Washer EEPROM error
Cause:
Error in EEPROM of the washer module.
Action:
Call your Bio-Rad Service Engineer.
59. Washer head home movement error
Cause:
Error when moving washer head to home position.
Action:
Select the Selftest item in the Utilities menu.
If the error persists, call your Bio-Rad Service Engineer.
60. Washer head motor movement error
Cause:
Error in movement motor of the washer head.
Action:
Select the Selftest item in the Utilities menu.
If the error persists, call your Bio-Rad Service Engineer.
466
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5. Error Messages
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
61. Washer plate home movement error
Cause:
Error when moving to the home position.
Action:
Select the Selftest item in the Utilities menu.
If the error persists, call your Bio-Rad Service Engineer.
62. Washer plate motor movement error
Cause:
Plate transport motor of washer blocked.
Action:
Select the Selftest item in the Utilities menu. If necessary, take out plate
that may still be in the washer.
If error persists, call your Bio-Rad Service Engineer.
63. Washer reagent level low error
Cause:
Not enough wash buffer left.
Action:
Refill the wash buffer (see Section 2.5.6). When done, click the <Retry>
button. Then you may continue.
64. Washer valve test error
Cause:
Error in testing the pump valve. Valve does not switch.
Action:
Call your Bio-Rad Service Engineer.
65. Washer waste full
Cause:
Container for washer waste full.
Action:
Decontaminate and empty container (see Section 4.3.1.3.5).
66. Washer waste pump error
Cause:
Error in washer waste pump.
Action:
Check connections and vacuum flask cap for leaks (see Section 4.4.6). If the
error persists, call your Bio-Rad Service Engineer.
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467
A. Appendices
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
A. Appendices
A 1 Technical Data
A 2 Data Label
A 3 Accessories and Consumables (Ordering Information)
A 4 Return Tag
A 5 Do’s and Don’ts
A 6 Rack Layout
A 7 Flags
A 8 Maintenance Checklists
A 9 Service Information
A 10 Index
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A 1. Technical Data
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
A 1. Technical Data
Specifications are subject to change without prior notice
Sample Pipetting
Primary sample capacity
Dilution capacity
Sample tube diameter
Sample tube height
Sample dilution
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Carry-over
Up to 180 samples
90 tubes or 3 dilution plates
9 - 16 mm
Up to 100 mm
Serial dilution possible via tubes or
plates
N.A. (disposable tips)
Reagent Pipetting
Reagent containers
Reagent vials volume
Last min. reagent preparation
Reagent identification
Lot & expiration management
Bio-Rad original reagent bottles
3, 8, 15, 30, 60, 125 ml
Yes
Internal Barcode Scanner
Yes
Disposable Tips
On-board capacity (walk-away)
In-process reload
Reuse partial tip racks option
Tip waste capacity
Tip detection (mechanical)
480 tips of 300 and/or 1 000 µl
Yes
Yes
> 1 000 tips
Yes
Pipetting Features
Patient samples (100 µl/ well)
Reagent (100 µl/ well)
Dilution (1:10)
Dilution (1:100)
Precision (at 20 µl)
Precision (at 100 µl)
Accuracy (at 20 µl)
Accuracy (at 100 µl)
System liquid
< 18 min./ plate
< 4 min./ plate
< 23 min./ plate
< 45 min./ plate
< 6 % CV
< 3 % CV
< 10 %
<5%
1 x 10 L
Pipetting Detection
Colorimetric
Capacitive
Pressure Monitoring (barometric)
Yes (Verify Dispense)
Yes (Aspirate Check)
Yes (Aspirate only)
469
A. Appendices
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Internal Bar Code Scanner
Pos. Ident. of samples and reagents
Microplate Ident.
Reads
External Bar Code Scanner
Shaking
On the plate transport unit
In the incubators
In the photometer
Incubation
Room-temperature incubators
Heated incubators
Precision
Accuracy
Incubation time
Heating-up (room-temperature -> 37°)
Temp. display & tracing
470
Yes
Yes
Interleaved 2 of 5, Code 3 of 9, IATA
2 of 5, Industrial 2 of 5, UPC A & E,
EAN 8 or 13, Code 128,
Pharmacode, Codabar,
EAN Addendum 2 or 5
Optional
Yes (linear, variable time, fixed
frequency)
Yes (linear, variable time, fixed
frequency)
Yes (linear, variable time, fixed
frequency)
4
4 (independent, heatable from roomtemperature + 5°C up to 50° C)
+/- 1.4° C
+/- 1.0° C
Programmable
< 30 min.
Yes
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EVOLIS
A 1. Technical Data
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Washer
Capacity
Manifold
Plate type (bottom shape)
Wash mode
Cycles
Soak time (plate mode)
Dispense volume
Residual volume
Features
3 Wash Buffer bottles, auto-switch
Level sensors (on wash buffer)
Alarm (insufficient liquid)
Liquid waste capacity
Level sensor (on liquid waste container)
Alarm (waste full)
Washer rinse liquid container
Auto-rinse function
Reader (photometer)
Read modes
Capacity
Reading head
Read time (full plate)
Light source
Dynamic range
8 filter wheel
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1 plate, up to 3 wash buffers
8 channels (16 needles)
Flat, u- or v-shaped
Plate & strip
1-9
0 - 999 sec.
200 - 1000 µl/well
< 6 µl in F bottom
top wash and bottom wash, sweep,
soak, variable pump speeds
3x2L
Yes
Yes
1 x 10 L
Yes
Yes
1x1L
Yes
Reading method (beam)
Filter of over-range values
Linearity (0 – 2.0 O.D.)
Accuracy (0 – 2.0 O.D.)
OD and Kinetic
1 plate
8 channels
< 15 sec.
Halogen
0 – 3.0 O.D.
(equipped 405, 450, 492, 550, 620,
690 nm)
Single / double
Yes
1%
+/- 0.005 or 2.5 %
Data Processing
Computer
User Interface
Monitor & Printer
(supplied)
Software under Windows® 2000
(supplied)
Communication
RS-232 Serial Port
On-line (bi-directional)
Yes
ASTM or ASCII format
471
A. Appendices
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
472
Dimensions & Weight
Instrument Size (HxWxD)
Instrument Weight
Table (optional) Size (HxWxD)
950 x 1130 x 760 mm
90 kg
550 x 1200 x 800 mm
Electrical
Line voltage, auto-switch
Frequency
Input Power
Fuse Rating
90 - 260 V
47 - 62 Hz.
max. 0.5 kVA
4 A / 250 V
Operating conditions
Operating ambient temperature
Relative humidity level
Heat emission
Noise level
15° C - 25° C
max. 90 % R.H. - non condensing
1440 BTU/h
65 dB(A) at 1 m
Last modification : 01 – 2008
User manual code : 89891 - EN
EVOLIS
A 2. Data Label
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
A 2. Data Label
Figure 298: Back panel label
Symbols
CE Marking (European Directive 98/79 CE on in vitro diagnostic
medical devices).
Type
Type of instrument
Fuse rating
Reference / Catalog number
Serial number
In vitro diagnostic medical device
Caution, consult accompanying documents.
Product certified for both the U.S. and Canadian markets, to the
applicable American and Canadian standards.
Manufacturer
Date of manufacture
See Section 4.4.11
Last modification : 01 – 2008
User manual code : 89891 - EN
473
A. Appendices
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
A 3. Accessories and Consumables (Ordering Information)
Description, Part No and availability are subject to change without
prior notice. Refer to the Bio-Rad Catalog.
For parts not listed here, refer to the Bio-Rad catalog or call your BioRad Service Engineer.
Ordering Reference
Description
Part No
GENERAL CONSUMABLES
EVOLIS Tips 300 UL (X17280)
Small tips
89611
EVOLIS Tips 1100 UL (X9600)
Large tips
89612
ST Waste Bag (X1)
Tip waste bag + cap (x1)
89586
ST Waste Bag (BoxX10), W/ Label
Biohazard
Tip waste bags + caps (x10)
89799
ST Setup and Cleaning Conc
Decontamination solution (RIVASCOP ®)
Tween 20 (100 ml)
Tween 20
PE Kit Pipettor - Washer
Reagent kit for performance evaluation
procedures on the pipettor and washer
89894
ST Fuse, 4.0A/250V, 5X20 mm (Box/10)
10 EVOLIS Standard fuses
89608
Small reagent rack / control rack
89780
89645
1706531
RACKS / PLATE CARRIER
ST Reagent Rack 2, Ctrl
ST Reagent Rack 1, 7-15 ml
Medium reagent rack
89781
ST Reagent Rack 0, 30-60 ml
Large reagent rack
89782
ST Sample Rack with Numbering 1-20
Standard sample rack for 20 tubes
90433
Rack Alu 22 positions (for tube 12/13 mm)
Sample rack for 22 tubes
97240
EVOLIS Insert (X6)
Rack position adaptors for medium
reagent rack
91488
ST ASSY, Plate Carrier "A1"
Carrier frame for microplate
89679
EVOLIS SAMPLE RACK TRAY
Workbench tray for sample racks
90328
ST Bottle 1L, Wash Buf, Red W/O Filter
1 liter wash buffer bottle with red cap,
without filter
89657
ST Bottle 1L, Wash Buf, Black W/O Filter
1 liter wash buffer bottle with black cap,
without filter
89658
ST Bottle 2L, Wash Buf, Blue W/O Filter
2 liter wash buffer bottle with blue cap,
without filter
89661
ST Bottle 2L, Wash Buf, Yellow W/O Filter
2 liter wash buffer bottle with yellow cap,
without filter
89662
ST Bottle Square PVC 1000 ML, W/Cap
Spare 1 liter wash buffer bottle with
ordinary cap
89934
ST Bottle Square PVC 2000 ML, W/O Cap
Spare 2 liter wash buffer bottle without
cap
89935
EVOLIS cap, Wash Bottle 2L
Ordinary cap for 2 liter wash buffer bottle
90282
ST Bottle, Aspirate, 1
Vacuum flask
89659
ST Bottle, Aspirate, 2
Trap flask
89660
ST Container, System Liquid, 10L
System liquid container
89984
ST Assy Waste Container
Liquid waste container with cap and
tubing
89650
ST Container, Waste, 10L
Spare liquid waste container with ordinary
cap
89985
BOTTLES / CONTAINERS
474
Last modification : 01 – 2008
User manual code : 89891 - EN
EVOLIS
A 3. Accessories and Consumables (Ordering Information)
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Ordering Reference
Description
Part No
EVOLIS Reagent Bottle 15ml X72
15 ml reagent bottle with cap
89776
EVOLIS Reagent Bottle 30ml X72
30 ml reagent bottle with cap
89777
EVOLIS Reagent Bottle 60ml X72
60 ml reagent bottle with cap
89778
EVOLIS Reagent Bottle 125ml X72
125 ml reagent bottle with cap
89779
V-Vial Polyp. Reagent Containers (23ml)
X500
23 ml reagent containers with V shaped
bottom, without cap
402-5900
Reagent Vial Push Caps X500
Caps for 23 ml reagent containers
402-5820
PHOTOMETER
ST 405nm Optical Filter
Photometer filter
89689
ST 450nm Optical Filter
Photometer filter
89688
ST 492nm Optical Filter
Photometer filter
89687
ST 532 nm Optical Filter
Photometer filter
90397
ST 550 nm Optical Filter
Photometer filter
89962
ST 570 nm Optical Filter
Photometer filter
90349
ST 620nm Optical Filter
Photometer filter
89686
ST 650nm Optical Filter
Photometer filter
89684
ST 690nm Optical Filter
Photometer filter
89685
ST Lamp, 13.8V, 30W
Photometer lamp
89604
READER VERIF PLATE
Photometer verification plate
89690
INCUBATOR VERIFICATION TOOL
IVT - Incubator verification tool
91052
UPS Nitram US 9602 2KVA
Uninterruptible Power Source Device
90065
ST SET, BC Labels Sample Rack
Barcodes for standard sample racks (T)
91730
LABELSET, Sample Rack Alternativ
Barcodes for other sample racks
90353
ST Set, Barcode Labels Reagent Rack
(CTRL)
Barcodes for small reagent rack (control
rack)
90290
ST Set, Barcode Labels Reagent Rack (715 ml)
Barcodes for medium reagent rack
90289
ST Set, Barcode Labels Reagent Rack (3060 ml)
Barcodes for large reagent racks
91731
MISCELLANEOUS ACCESSORIES
BARCODE LABELS FOR RACKS
BARCODE LABELS FOR REAGENT BOTTLES (see Note at the end of the Table)
EVOLIS BC Labels ANA Screen
ANA Screen Test
88432
EVOLIS BC Lab Anti-Centromere
Anti-Centromere Test
88433
EVOLIS BC Lab Anti-dsDNA
Anti-dsDNA
88434
EVOLIS BC Labels Anti-Jo-1
Anti-Jo-1 Test
88435
EVOLIS BC Labels Anti-Scl-70
Anti-Scl-70 Test
88436
EVOLIS BC Labels Anti-Sm
Anti-Sm Test
88437
EVOLIS BC Labels Anti-SmRNP
Anti-SmRNP Test
88438
EVOLIS BC Labels Anti-SS-A
Anti-SS-A Test
88439
EVOLIS BC Labels Anti-SS-B
Anti-SS-B Test
88440
EVOLIS BC Labels KS Anti-TPO
KALLESTAD Anti-TPO
EVOLIS BC Labels KS Anti-GBM
97218
™
97219
™
KALLESTAD Anti-GBM
EVOLIS BC Labels KS Anti-dsDNA
KALLESTAD Anti-dsDNA
97220
EVOLIS BC Lab KS Anti-Centrom
KALLESTAD Anti-Centromere
™
97221
™
97222
™
97223
EVOLIS BC Lab KS Anti-Mitochon
EVOLIS BC Labels KS Anti-PR3
Last modification : 01 – 2008
User manual code : 89891 - EN
™
KALLESTAD Anti-Mitochondrial
KALLESTAD Anti-PR3
475
A. Appendices
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Ordering Reference
476
Description
Part No
™
97224
™
EVOLIS BC Labels KS Anti-MPO
KALLESTAD Anti-MPO
EVOLIS BC Labels KS Anti-Tg
KALLESTAD Anti-Tg
97225
EVOLIS BC Labels ENA(+) Screen
ENA(+) Screen Test
88441
™
EVOLIS BC Labels Colored TMB
Genetic Systems HIV-1 Ag EIA
EVOLIS BC Labels Colored TMB
GENSCREEN HIV1/2 version 2
EVOLIS BC Labels Colored TMB
GENSCREEN PLUS HIV Ag-Ab
88452
®
88452
®
88452
®
EVOLIS BC Labels Colored TMB
GENSCREEN ULTRA HIV Ag-Ab
88452
EVOLIS BC Labels HAV IgM
HAV IgM PLUS Assay (ETI-HA-IGMK
PLUS)
88449
EVOLIS BC Labels HAV Ab
HAV PLUS Total Assay (ETI-AB-HAVK
PLUS)
88450
EVOLIS BC Labels Colored TMB
MONOLISA™ Ag HBs PLUS
88452
EVOLIS BC Labels Colored TMB
MONOLISA™ anti-HBc PLUS
88452
EVOLIS BC Labels Colored TMB
MONOLISA™ ANTI-HBS 3.0
88452
EVOLIS BC Labels Colored TMB
MONOLISA™ anti-HCV PLUS version 2
88452
EVOLIS BC Labels Colored TMB
MONOLISA™ HCV ULTRA Ag-Ab
88452
EVOLIS BC Labels HBc IgM PLUS
MONOLISA™ HBc IgM PLUS
88448
EVOLIS BC Labels Colored TMB
MONOLISA™ HBs Ag ULTRA
88452
EVOLIS BC Labels Toxo-IgG
PLATELIA™ HTLV-I NEW
89986
EVOLIS BC Labels Toxo-IgA
PLATELIA™ TOXO IgA TMB
97200
EVOLIS BC Labels Toxo-IgG
PLATELIA™ TOXO IgG TMB
89987
EVOLIS BC Labels Toxo-IgM
PLATELIA™ TOXO IgM TMB
89988
EVOLIS BC Labels ASPERGILLUS
PLATELIA™ Aspergillus
88444
EVOLIS BC Labels CMV-IgM New
PLATELIA™ CMV IgG New
97204
EVOLIS BC Labels CMV-IgG New
PLATELIA™ CMV IgM New
97205
EVOLIS BC Labels EB-NA-1 IgG
PLATELIA™ EB-NA-1 IgG
90274
EVOLIS BC Labels EBV-EA-D IgG
PLATELIA™ EBV-EA-D IgG
90271
EVOLIS BC Labels EBV-VCA IgG
PLATELIA™ EBV-VCA IgG
90272
EVOLIS BC Labels EBV-VCA IgM
PLATELIA™ EBV-VCA IgM
90273
EVOLIS BC Labels H. pylori
PLATELIA™ Helicobacter pylori
90337
EVOLIS BC Labels HSV-IgG
PLATELIA™ HSV (1 + 2) IgG
97206
EVOLIS BC Labels HSV-IgM
PLATELIA™ HSV (1 + 2) IgM
97207
EVOLIS BC Labels VZV IgG
PLATELIA™ VZV IgG
97208
EVOLIS BC Labels VZV IgM
PLATELIA™ VZV IgM
97209
EVOLIS BC Labels Measles IgG
PLATELIA™ MEASLES IgG
97210
EVOLIS BC Labels Measles IgM
PLATELIA™ MEASLES IgM
97211
EVOLIS BC Labels Mumps IgG
PLATELIA™ MUMPS IgG
97212
EVOLIS BC Labels Mumps IgM
PLATELIA™ MUMPS IgM
97213
EVOLIS BC Lab M pneumo IgG TMB
PLATELIA™ M. PNEUMONIAE IgG TMB
97201
EVOLIS BC Lab M pneumo IgM TMB
PLATELIA™ M. PNEUMONIAE IgM TMB
97202
EVOLIS BC Labels Rub-IgG
PLATELIA™ RUBELLA IgG TMB
89989
EVOLIS BC Labels RUBELLA IgM
PLATELIA™ RUBELLA IgM TMB
88446
EVOLIS BC Labels Rabies II Kit
PLATELIA™ Rabies II
91757
EVOLIS BC Labels Syphilis-TA
SYPHILIS TOTAL ANTIBODY (TA) EIA
89993
EVOLIS BC Labels UsDefin 1-5
Label set for user-defined assays
89770
EVOLIS BC Labels UsDefin 6-10
Label set for user-defined assays
88451
Last modification : 01 – 2008
User manual code : 89891 - EN
EVOLIS
A 3. Accessories and Consumables (Ordering Information)
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Note: These barcode labels can be attached to reagent bottles when using Bio-Rad kits in
which the bottles are not already barcoded or not included in the kit. The central column in the
table indicates the name of the corresponding Bio-Rad kit. Each label set contains all the labels
required to process over 20 kits. Labels for colored TMB include 100 items of the same label.
The last two sets are provided for users who define their own assays and want to label the
reagent bottles accordingly.
Last modification : 01 – 2008
User manual code : 89891 - EN
477
A. Appendices
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
A 4. Return Tag
Please read Section 4.4.9 of this manual and fill out the return tag provided
on the following page before sending back any part of the instrument.
Bio-Rad reserves the right to refuse to service parts that have not been
decontaminated or to charge the decontamination cost to the customer.
478
Last modification : 01 – 2008
User manual code : 89891 - EN
EVOLIS
A 4. Return Tag
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Return to:
Bio-Rad Laboratories
Local Technical Support Department.
Customer Information:
Company:
Contact:
E-Mail:
Telephone:
Instrument Type:
REF (BR Part No.):
SN (Serial No.):
Part Description:
Warranty Status:
ICCR: (for internal use only)
on instrument
on spare part
no warranty
Detailed Error Description:
Occurrence of error:
permanent
occasional
after ___________
Certificate of Decontamination:
This part did not have contact with biological, chemical, infectious or radioactive materials
This part had contact with the following materials:
biological
chemical
infectious
radioactive
This part has been decontaminated by:
spraying/wiping: _________________________ (type of disinfectant used)
immersion: _________________________ (type of disinfectant used)
other : _________________________
Parts returned without this certificate of decontamination
will not be accepted and returned at sender's expense
Date:
Last modification : 01 – 2008
User manual code : 89891 - EN
Name:
Signature:
479
A. Appendices
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
A 5. Do’s and Don’ts
The following list (see next page) is a reminder of the main basic operating
rules and safety precautions. It is provided to be copied and posted in your
laboratory next to the EVOLIS instrument.
480
Last modification : 01 – 2008
User manual code : 89891 - EN
EVOLIS
Do’s and Don’ts
Do
•
•
•
•
•
•
•
Always wear proper personal protective equipment: lab coat and gloves (plus eye protection when
performing maintenance tasks).
Start-Up: always turn on the instrument first and then the computer.
Shut Down: always turn off the computer first and then the instrument.
Always turn off the instrument before cleaning.
If liquid gets inside the instrument, immediately disconnect the power cord and clean the affected
areas as described in the User Manual.
Always dispose of waste and used consumables in compliance with your laboratory guidelines and
federal, state and local regulations.
Check system liquid and liquid waste container before a run.
Do Not
•
•
•
•
•
•
•
Do not interfere with the processing unless absolutely necessary. If you need to do so, pause the
system first (open the door of the sample and reagent unit to stop the pipettor, then click the <Stop>
button in the software).
Do not lean on the bottom drawer when open (drawer or instrument may tip over).
Do not use any disinfectant containing alcohol for plexiglas surfaces (e.g. instrument cover) or for the
manifold.
Do not bring disinfectant into contact with bearings and guides (lubricant may dissolve).
Do not use disinfectant in the vicinity of circuit boards and light barriers.
Do not clean heated incubators
Do not refrigerate reagent racks.
A. Appendices
EVOLIS
Bio-Rad EVOLIS Version 1.90, Instrument Code 89601, User manual
A 6. Rack Layout
The following pages provide graphical presentations of the reagent racks.
These can be copied and used as a reminder of the positions in which each
reagent has been or is to be loaded in the instrument (either for a given test
run only or for several runs if you have saved a specific reagent layout – see
Section 2.5.3.5).
482
Last modification : 01 – 2008
User manual code : 89891 - EN
EVOLIS
A 6. Rack Layout
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
EVOLIS - Large reagent rack (-0)
Reagent layout for assay:.........................................................................
Last modification : 01 – 2008
User manual code : 89891 - EN
483
A. Appendices
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
EVOLIS - Medium reagent rack (-1)
Reagent layout for assay:.........................................................................
484
Last modification : 01 – 2008
User manual code : 89891 - EN
EVOLIS
A 6. Rack Layout
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
EVOLIS – Small reagent rack or control rack (-2 / -3)
Reagent layout for assay:.........................................................................
Last modification : 01 – 2008
User manual code : 89891 - EN
485
A. Appendices
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
A 7. Flags
For more information on interpreting and / or recalculating flagged results,
see Section 2.8.2.
486
Flag
Meaning
Result
calculation
SplRem
Sample rack removed.
No
RgtRem
Reagent rack removed.
Yes
CovOp
Cover open.
No
ManID
Manual ID.
Yes
NoLiq
No liquid detected.
No
InsLiq
Insufficient liquid detected.
No
Clot
Clot detected.
No
PipErr
Pipettor hardware error.
No
ManPip
Manually pipetted resource.
Yes
VCFail
Validation criteria failure.
No
VDFail
Verify dispense failure.
No
IncKo
Incubation overrun.
No
REAG EXP
Reagent Expired
Yes
P_max_high,
P_min_low,
P_stop_high,
P_static_high,
P_static_low,
P_mean_low
Pressure monitoring flags (see
Section 3.9.4).
Yes
flagged
(displayed in red) This flag
replaces multiple flags when
results in the Combined Report
are displayed in Matrix format.
NA
Last modification : 01 – 2008
User manual code : 89891 - EN
EVOLIS
A 8. Maintenance Checklists
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
A 8. Maintenance Checklists
The following pages provide maintenance checklists. These should be
copied and used to document the maintenance tasks as they are carried out
by the EVOLIS operators or laboratory workers.
For details on how to perform the various maintenance procedures, see
Section 4.2.
A third checklist is also provided for the Performance Evaluation Procedures
detailed in Section 4.5.
Last modification : 01 – 2008
User manual code : 89891 - EN
487
EVOLIS
Maintenance
Laboratory ............................... Week No .......................................
Weekly Checklist
Instrument No.......................... Month / Year..................................
Initial box upon completion
Daily Maintenance Procedure
Check system liquid level (refill if necessary)
Start Up
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday
After each Remove reagent and patient sample racks
run
Discard used test and dilution plates
Check / Empty the tip waste container
Check / Empty the liquid waste container
Shut
Down
Close the finished worklist(s)
Remove all remaining resources
Close the EVOLIS software, close Windows, turn off PC
Turn off the instrument
Inspect the instrument for stains and spills
Wipe the tip adapter (pipettor head)
Check / Empty the liquid waste container
Check / Empty the tip waste container
Weekly Maintenance Procedure
Run the WasherClean assay
Clean the instrument surfaces and work areas
Decontaminate the sample and reagent racks
Decontaminate the test plate carrier frames
Decontaminate the tip ejection slide (ramp)
Decontaminate the pipettor wash station
Clean the plate transport unit
Operator/Supervisor....................................................
EVOLIS
Maintenance
Laboratory ......................................................................................
Yearly Checklist
Instrument No.......................... Year...............................................
February
May
Date and initial box upon completion
Monthly Maintenance
Run the Washer Manifold
Disinfect assay
January
March
April
June
July
August
September
October
November
December
Decontaminate the system liquid
container
Clean the wash buffer / clean
fluid bottles
Clean the test plate compartment
Clean the room-temperature
incubators
Backup system files
Special procedures
Heavy liquid overflow clean-up
Date
Pipettor decontamination
Washer manifold needles
(unclogging)
Vacuum and trap flask
maintenance
Photometer (bulb replacement, filter
maintenance or replacement)
Fuse replacement
Backup files (for result, export
and event log files)
Other
Operator/Supervisor....................................................
Operator
Comments (circumstances, parts affected, details...)
EVOLIS
PE
Laboratory ......................................................................................
Checklist
Instrument No.......................... Year...............................................
Date and initial box upon completion
Monthly PE Procedures
Pipettor
January
February
March
April
May
June
July
August
September
October
CTRL CV Pipettor Low Vol
CTRL CV Pipettor High Vol
CTRL Pipettor Dilution
Washer
CTRL Washer Aspirate
Twice-a-year PE Procedures
Plate Transport
Date
Operator
Results / Comments
Date
Operator
Results / Comments
CTRL Plate transport
Photometer
Procedure with verification plate
Pipettor
CTRL Pipettor High Vol
CTRL Pipettor Low Vol
CTRL Pipettor Dilution
Washer
CTRL Washer Aspirate
CTRL Washer Dispense
Yearly PE Procedure
Incubators
CTRL Incubators
Operator/Supervisor...........................................
November
December
EVOLIS
A 9. Service Information
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
A 9. Service Information
(to be completed by your Bio-Rad Service Engineer or your local technical
support person).
Contact Information
........................................................................................................................
........................................................................................................................
........................................................................................................................
Instrument Serial number
........................................................................................................................
Maintenance and Servicing Visits
Date
Last modification : 01 – 2008
User manual code : 89891 - EN
Description
Done by
491
A. Appendices
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Date
492
Description
Done by
Last modification : 01 – 2008
User manual code : 89891 - EN
EVOLIS
A 10. Index
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
A 10. Index
A
Abort
a test run 144
plates 142
Access rights 53
Accessories and consumables
general 30
ordering information 474
Action on error
dispense verification failure 317
pipetting steps 297
Active event log
filter 101
general 99
log files 100
Add Patients (dialog box) 70
Add Tests (dialog box) 71
Additional reagent positions 118
Airgap 263
Allocate
patient samples 110
purpose of the allocation process 107
reagents 114
Annotation tab (quantitative settings) 348
ANOVA 341
APF (Assay Protocol File) See Assay(s)
Archive plates
loading archive plates 230
testing samples from archive plates 235
Archiving See Sample archiving
ASCII file transfer 374
Aspirate
delay 263
dialog box 300
profile See Pipetting Profiles
samples and controls 300
sweep 308
Aspirate check
for reagents 314
for samples and controls 301
Assay Layout
definition 292
dialog box 290
Assay Protocol Header (dialog box) 288
Assay(s)
assay display area 278
assay file verification 372
assay steps (evaluation settings) 322
assay steps (processing steps) 294
assay tree 277
assay window 277
assigning assays to patients 64
basic structure of assay files 280
creating new assays 286
Last modification : 01 – 2008
User manual code : 89891 - EN
editing BIO-RAD assays 284
loading new assay files 275
Open assay files 285
opening assay files 278
password protection 283
pre-defined See Pre-defined assays
processing several assays per plate 172
programming (introduction) 277
verification 372
ASTM
interface configuration 391
standards 390
Authorization procedure 54
Auto Fill Settings (dialog box) 344
Auto-arrange samples 111
Autoclave (racks and accessories) 411
B
Background read step 318
Background subtraction 334
Backup files 418
Barcode
settings 269
types 269
unreadable barcode 65
Barcode scanner
location 21
rack scanner 269
test plates 273
Batch number (reagents) 87
Batch-dependent (controls and standards) 91
Blank value (subtraction) 334
Bleach
instrument surfaces 411
liquid waste container 408
Bottles
reagent See Reagent bottles
wash buffer See Wash buffer bottles
Bottom drawer
liquid overflow in drawer 423
maintenance 411
opening positions 22
picture 22
safety catch 23
Bottom wash 308
Breakable wells 133
Buffer See Wash buffer
Buttons
of the Edit Operations dialog box 298
of the Load dialog box 108
of the main EVOLIS toolbar 41
C
Calculations tab (kinetic reading) 331
493
A. Appendices
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Checksum (plate barcodes) 274
Checksum (sample barcodes) 271
Clean fluid
bottle 127
bottle maintenance 415
filling 128
Cleaning agent
decontamination solution 411
for instrument surfaces 410
Clean-up
Patient Editor (dialog box) 74
procedure (stains and spills) 423
Clot detection (enable) 261
Color
dilution/archive plates (in the Load dialog
box) 230
labels and controls 291
LEDs (Light Emitting Diodes) See LED
patient samples (in the Load dialog
box) 110
sample racks (in the Load dialog box) 108
tip racks (in the Load dialog box) 123
Colorimeter See Photometer
Colorimeter tab 258
Colorimetric dispense verification (dialog
box) 316
COM Port
log 255
log (ASTM) 391
selection 255
Combined report
contents definition 362
dialog box 363
interpretation 153
Communication
between EVOLIS and a host computer 374
between the instrument and the PC 255
through an ASTM link 390
Conditional delay 319
Conductivity (tips) 123
Connection to a host computer 374
Consumables See Accessories and
consumables
Continuous loading 179
Control(s)
decanted in hemolysis tubes 119
in the reagent database 196
internal control 285
negative control (label type) 292
pipetting profiles 198
pipetting steps 296
positive control (label type) 292
Copy/paste
assay processing steps 295
assay steps (basic rule) 282
Cover lock 134
Cubic regression 340
Cubic spline 340
Cut-off value 292
494
D
Damaged parts 431
Darkness (incubation) 256
Data Model tab (quantitative settings) 340
Data models 340
Dead volume
reagent bottles 198
wash buffer bottles 267
Decontamination
metal frames for test plates 411
pipettor wash station 412
sample and reagent racks 411
system liquid container 414
washer 412
washer manifold 412
waste ramp 412
Deepwell plates 121
Demo mode
general 34
patient data entry 70
restricted access rights 56
schedule view 96
Detailed assay version 278
Dilution area
location 17
maintenance 411
Dilution plates
coordinates 262
for sample archiving 230
loading 122
types 121
unloading 168
waste disposal 406
Dilution tubes (parameters) 262
Dilutions tab (quantitative settings) 344
Directory
default directory (all file types) 47
default directory (export files) 388
Disinfect See Cleaning agent,
Decontamination, or WasherDisinfect assay
Dispense
dialog box (for reagents) 313
dialog box (for samples and controls) 301
profile See Pipetting profiles
samples and controls 301
step (for reagents) 313
sub-step (for samples and controls) 301
Dispense verification
failure 316
step definition 316
Disposable tips See Tips, Tip racks
Dive out 263
Drift (eliminate drift) 304
E
Edit
assay steps 282
BIO-RAD assays 284
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EVOLIS
A 10. Index
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
export settings 370
worklist definition 109
worklist options 109
Edit Operations (dialog box) 298
Edit Reagent Details (dialog box) 197
Emergency procedures
canceling a run 144
liquid overflow (flood) 423
power supply problems 432
stains and spills 423
test plate removal 144
Endpoint reading
endpoint tab 324
general 324
Enter password (dialog box) 279
Error(s)
correcting worklist definition error 92
incubation errors 311
list of error messages 455
undefined reagent 203
worklist parameters 94
Evaluation steps
general 322
qualitative evaluation 337
quantitative evaluation 340
Event log See Active event log
EVOLIS computer
connection to a host computer 57
link to instrument 255
requirements 31
EVOLIS instrument See Instrument
Execute Current Step (menu item) 146
Execute Remaining Steps (menu item) 146
Expiry date (kits and reagents) 87
Export
(*.txt) result files 384
ASTM exports 393
authorization procedure 54
failure 371,388
file contents 367
file format 366
restrictions 54
sample archiving report 235
tab 366
test results 159
External controls 245
F
File types 47
Filters
of the photometer See Photometer
of the system liquid container
(maintenance) 414
of the washer lines 418
Firmware upgrades 275
Flag
"CovOp" flag (cover open) 142
"ManID" flag 65
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"SplRem" flag (samples removed during
processing) 167
including flags in the Combined report 363
interpreting flagged results 153
Flooding See Overflow
Formulae tab (spreadsheet settings) 352
Four-parameter data model 341
Frames (metal frames for test plates)
loading 131
maintenance 411
Fuses
location 27
replacement 432
G
Graph tab (quantitative settings) 345
H
Heatable incubators See Incubators
Histogram (results) 339
Host computer (connection) 374
I
Icons
EVOLIS program icon 31
of the Edit Operations dialog box 298
of the main EVOLIS toolbar 41
Import
ASTM 393
failure 380
parameters 376
patient data and test orders (new
worklist) 67
patient data and worklist files 375
In liquid dispense
archiving parameters 229
sample and control dispensing 302
Incomplete plates 133
Incubate (dialog box) 310
Incubation step
incubation overrun 311
light level definition 310
parameters 310
Incubation time
check (Schedule view) 95
incubation overrun 311
setting 310
variable incubation time See Conditional
delay
Incubators
location 24
maintenance 415
parameter settings 256
pre-heating options 257
status (worklist window) 99
tab 256
temperature display 99
495
A. Appendices
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Initialization 36
Insert Function (dialog box) 355
Insert Step (context menu) 281
Inserting assay steps (basic rules) 281
Instrument
ON/OFF switch (location) 27
overview 15
technical data 469
Instrument modules
independent use of individual modules 146
location of individual modules 15
Internal control 285
International units 346
Intra-well delay 314
Job list
in the new menu 43
in the worklist window 102
of required reagents 97
LLD See Liquid level detection
Load (dialog box) 108
Load Plate (dialog box) 130
Loading
dilution plates 122
patient samples 60
reagent racks 113
test plates 130
tip racks 123
Log files See Active event log, COM Port log
Logical functions 355
Log-on
as a new user 34
dialog box 32
registered users 32
Lot specific values
dialog box 87
editing the parameters 156
Luminometer 260
K
M
Kinetic reading
general 324
kinetic tab 329
Kit
kit bottles (reagents) 113
specifications 87
Kit database
general 205
Maintenance
checklists 487
daily maintenance 406
general 403
instrument surfaces 410
monthly maintenance 412
of the various modules and
accessories See under each
module/accessory
overview (table) 404
personal protective equipment 403
preventive maintenance 418
reagent bottles 428
safety precautions 403
six-month maintenance 418
special maintenance procedures
(emergencies) 423
weekly maintenance 410
Manifold (clogged needles) 424
Manual allocation
reagents 114
samples 110
Margin See Screen (adjusting margin)
Mathematical operators (function syntax) 355
Menus (description) 41
Michaelis-Menten data model 341
Microplate See Plate, Test plate, Dilution
plate, Archive plate
Mix cycles (sample and control pipetting) 303
Model V.C. tab (quantitative settings) 343
Module schedule 95
Modules See Instrument modules and under
each module (incubators, washer...)
Multi assay processing 172
Multi wavelength reading 324
Multishots
J
L
Label(s)
color 291
replicates 291
types of label 292
Laboratory
details 46
details (in the result report) 151
tab 46
Layout tab
endpoint reading 326
quantitative / qualitative settings 350
LED (Light Emitting Diode)
flashing red LED 167
front panel LEDs 26
red LED (reagent loading) 113
red LED (sample loading) 60
Levey-Jennings plot 91
LIMS See Host computer, Export, Import
Linear regression 340
Liquid level detection (enable) 261
List
of assay processing steps 295
of barcode types 269
of error messages 455
of label/well types 292
of plate types 289
496
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EVOLIS
A 10. Index
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
reagents 314
samples and controls 302
N
Name
laboratory 46
patient 73
Needles (of the washer) See Manifold
New (dialog box) 43
New worklist button
toolbar 41
use 79
Not loaded (worklist parameters) 94
O
OD values
in the result report 151
manual removal (of aberrant values) 155
ON/OFF switch (location) 31
OPD 428
Open assay files 285
Opening
active event log files 100
assay files 278
panel files 84
reagent layout files 120
result export files 388
result files 158
Operator
change 34
registration 50
traceability 150
user name 32
Optimizing
the plate layout 176
the schedule 96
Options (dialog box) 253
Out of range values
assay parameters (endpoint) 325
assay parameters (kinetic) 330
reader settings) 259
Outer surfaces (maintenance) 411
Outliers 155
Overflow (clean-up procedure) 423
Oversoak (reagent dispensing) 314
P
Panel files
default directory 47
saving 84
worklist creation 83
Partial plate mode 308
Parts See Accessories and consumables,
Damaged parts
Password
assay password 283
blank password 56
Last modification : 01 – 2008
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change 32
forgotten password 55
password prompt 32
registration 32
temporary password 56
Patient data entry
import from host computer 67
manual 70
standard procedure 64
Patient details 73
Patient Editor (dialog box)
clean-up 74
column format 64
manual patient data entry 70
Patient ID 73
Patient result report 159
Patient samples See Samples, Sample rack,
Sample tubes
PC See EVOLIS computer
Personal protective equipment 403
Photometer
access 429
bulb replacement 430
cleaning the filters 431
location 24
number of filters 258
settings 258
tab See Colorimeter tab
verification 441
Pipette (dialog box) 296
Pipette tab 261
Pipetting
direction 265
eliminate assay drift 304
errors (action on error) 297
parameters 261
Pipetting profiles
for each reagent and control 198
purpose and definition 264
Pipetting steps
definition 296
Pipettor
emergency stop 144
guide rail 21
head (maintenance) 407
wash station (decontamination) 412
Plate
coordinates 289
definition (in a worklist) 79
dilution plate See Dilution plate
plate type 131
results 152
test plate See Test plate
Plate carrier See Frames
Plate ID 130
Plate layout
as shown in the worklist window 97
general description 290
new strip 175
497
A. Appendices
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
optimizing 176
Plate matrix (in Set-Up Panel dialog box) 77
Plate reader See Photometer
Plate schedule 94
Plate strip
several assays per plate 175
verify strip presence 106
wash step parameters 306
Plate Transport tab 273
Plate transport unit
emergency procedure 144
loading test plates 132
maintenance 412
unloading test plates 165
Plate tree (in Set-Up Panel dialog box) 77
Plate Type Editor (dialog box) 289
Plate washer See Washer
Point-point (curve) 341
Post results to LIMS See Export
Power supply
problems 432
Pre-defined assays 63
processing 59
Pre-dilution plates 121
Preferences tab
adjusting margin 39
well orientation 265
Pre-heating options (incubators) 257
Pressure monitoring 249
Pressure monitoring (Pipette tab) 262
Preventive maintenance 418
Printing
active event log files 100
adjusting margin 39
assay files 278
job lists 102
plate layouts 97
reagent database 195
result reports 158
sample archiving information 235
worklist sections 94
Processing
a worklist 134
assays (overview) 59
optimizing processing time 96
partial processing 146
steps 138
Processing steps
for individual processing steps See under
each step: pipetting step, wash step,
incubation step...
general 294
Profiles See Pipetting profiles
Programming assays
general 277
Protocols See Assay(s)
498
Q
QA Analysis Report dialog box 91
Quadratic regression 340
Qualitative evaluation 337
Quantitative evaluation 340
Quantitative results (graphical
presentation) 346
Quartic regression 340
R
Rack adaptors 119
Racks
"blind" positions (reagent racks) 115
BIO-RAD rack types 19
non-barcoded 112
rack layout forms 482
rack maintenance 411
reagent rack storage 113
reloading sample racks See Continuous
loading
unloading 167
Reader See Photometer
Reader settings 324
Reagent
bottle maintenance 428
details (in the reagent database) 197
editing reagent details 200
entering new reagents in the reagent
database 199
height parameter of reagent bottles 199
list 97
loaded in two separate bottles 119
loading 113
manual allocation 114
preparation time 198
preparing the reagent racks 113
rack layout forms 482
rack maintenance 411
reagent load time (worklist options) 104
reagent rack types 19
save reagent layout 120
select reagents for an assay 196
specifications 87
undefined reagent error 203
unstable reagents 115
volume check 136
Reagent bottles
dead volume 198
large bottles (additional positions) 118
maintenance 428
placing bottles on racks 113
properties (shape, volume...) 198
Reagent database
buffer database 202
general 195
updates 201
view / print the contents of the
database 195
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EVOLIS
A 10. Index
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
Reagent requirements list 97
Recalculate (menu item) 157
Recovery mode 255
Refill partial tip racks 125
Reloading
new samples See Continuous loading
reagents 140
test plates See Continuous loading
time 179
tips 126
wash buffer 140
Removable strips 133
Remove See Unloading
Repairs See Damaged parts
Replicate
assay steps 295
wells/labels (in the plate layout) 291
Report See Combined report, Result(s),
Selftest report
Report tab 359
Reports tab (kinetic reading) 332
Result report
contents definition 359
export See Export
Result(s)
comparing current and former results 159
editing / reclaculating the results 155
exporting the results (ASCII) 384
exporting the results (ASTM) 393
exporting the results (general) 159
interpretation / validation 152
patient result report See Patient result
report
printing the result report 158
result report 150
saving the result report 158
Retest
dialog box 242
patient samples 242
Retest tab
quantitative / qualitative settings 351
Robust linear regression 340
Room-temperature
display 99
incubation parameters 256
incubation step 310
incubators (location) 24
Run See Test run
S
Safety catch (bottom drawer) 23
Safety instructions
do's and don'ts checklist 480
during maintenance 403
general XIII
Sample and reagent unit
cleaning procedure 410
description 17
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opening during a run 134
Sample archiving
archiving during a run 226
archiving in secondary tubes 231
archiving parameters 228
export archive report 235
independent sample archiving 222
loading archive plates 230
patient archiving information 234
testing archived samples 235
Sample rack
color identification 108
for non-standard sample tubes 20
loading process 60
maintenance 411
picture 60
reloading See Continuous loading
unloading 167
Sample Rack tab 270
Sample tubes
barcoded (loading) 60
maximum number 61
non-barcoded (loading) 60
size 61
waste disposal 406
Samples
auto arrange 111
manual allocation 110
pipetting steps 296
select for re-testing 242
volume check 137
Schedule
general 94
optimizing 96
Scheduling gap 103
Screen
adjusting margin 39
assay window 277
description of the main EVOLIS screen 39
dividing line 39
worklist window 93
Select Archived Patients (dialog box) 236
Select Patients (dialog box) 80
Select Reagents
dialog box 196
for an assay 196
Selftest
before each run 37
failure 38
menu item 37
overview 36
print 37
report 36
Serial number
checking the system serial number 275
of the EVOLIS instrument 255
of the various instrument modules 275
Service information 491
Set-Up Panel
499
A. Appendices
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
dialog box 76
go back to the Set-Up Panel (from the Load
dialog box) 109
go back to the Set-Up Panel (from the
worklist window) 92
Shaking
during incubation 311
frequency 311
prior to reading 324
shake dialog box 321
shake step (on plate transport unit) 321
Shut down
maintenance tasks upon shut down 406
the EVOLIS system 407
Simulation mode See Demo mode
Slide (tip ejection slide) See Waste ramp
Software
toolbar 40
updates 275
Spectral response 43
Spills (cleaning procedure) 423
Spreadsheet parameters 352
Stains (cleaning procedure) 423
Standard deviation
insertion of logical functions 356
weighted data model 341
Standard error (logical functions) 356
Standards
label type in plate layout 292
standard values (quantitative settings) 341
Start
start button 107
start processing a test run 134
start the system (sequence order) 31
worklists (authorization procedure) 54
Storage conditions
reagent racks 113
wash buffer 410
Stored model curve 341
Strip See Plate strip
Submerge steps 263
Summary view
assay file 278
patient result report 164
Supervisor(s)
special authorization procedures 54
user group 50
Syntax (logical functions) 355
Syringe
location 21
replacement 418
volume 261
System liquid
container decontamination 414
prepare and fill 29
System lock 134
System Paused (dialog box) 142
System Set-Up (dialog box) 253
System status (worklist window) 98
500
System Utilities (dialog box) 144
T
Technical data 469
Temperature
incorrect incubation temperature 311
inside the instrument 310
maximum temperature (heated
incubators) 256
room-temperature See Room-temperature
select incubation temperature 310
Test plate compartment
loading test plates 132
location 20
maintenance 415
Test plate scan
barcode reader 273
while loading 132
Test plates
coordinates 289
holding frame (loading) 131
holding frame (maintenance) 411
loading 131
types 288
unloading 165
waste disposal 406
Test results See Result(s)
Test run
overview 59
steps of a test run 138
Tip ejection
definition 314
slide See Waste ramp
station 21
Tip rack(s)
display in the Load dialog box (colors) 123
loading 123
refill partial tip racks 125
reloading during a run 126
re-use partially used racks 105,125
tip size verification 137
tray (location) 17
tray (maintenance) 411
unloading 168
Tips
pickup failure 261
reloading 126
tip size (long and short tips) 123
tip size verification 137
Title block (in the result report) 150
TMB
bottle maintenance 428
in liquid waste 408
Toolbar 40
Trap flask (maintenance) 427
Troubleshooting
barcode identification 272
different wash parameters for one plate 309
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EVOLIS
A 10. Index
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
pipetting profiles 265
sample rack loading 61
undefined reagent 203
user and password management 56
worklist definition 85
Tubes See Sample tubes or Dilution tubes
Tubing
maintenance 418
overview 27
Tween 20 29
Typing tab (qualitative settings) 337
U
Unallocated resources 108
Unloading
dilution plates 168
sample racks 167
test plates 165
tip racks 168
Unlocking (the instrument) 134
URT - Unity Real Time (software) 219
User group
assigning a user to a group 50
default user groups 50
defining/deleting user groups 52
User Groups tab 52
User(s)
access rights 50
user name (registered users) 32
user name (registration) 50
Users tab 51
with restricted access rights 54
V
Vacuum flask (maintenance) 427
Validation criteria
data model specific 343
general 336
validation criteria tab 347
Verification plate (photometer) 441
Verify
assay 372
dispense See Dispense verification step
Volume check
patient samples 137
reagents and controls 136
Volume offset 43
values (report) 43
W
Walk-away 139
Wash (dialog box) 306
Wash buffer
database 202
selection for wash step 306
Wash buffer bottles
dead volume 267
Last modification : 01 – 2008
User manual code : 89891 - EN
description 127
display in the Load dialog box 127
filling 128
location in bottom drawer 23
maintenance 415
properties 267
refilling 140
spare bottles 410
Wash heights
wash step parameters 307
washer parameters (default) 268
Wash step
general 306
wash cycle 306
Washer
calibration 426
maintenance (daily/weekly) 410
maintenance (monthly) 412
malfunction 424
manifold (clogged) 424
overview 23
parameters 267
purge 268
washer tab 267
WasherClean assay 410
WasherManifoldDisinfect assay 412
Waste container (liquid waste)
location 27
maintenance 408
Waste container (tips)
location 21
maintenance and replacement 409
Waste disposal
general rules 403
liquid waste 408
used consumables (test plates, sample
tubes...) 406
waste bag (tips) 409
Waste ramp
cleaning 411
decontamination 412
Wavelengths
background read 318
conditional delay 319
endpoint reading 324
kinetic reading 329
of photometer filters 259
spectral response 43
Well(s)
consecutive numbering on plate 293
labels 291
replicates 291
Work area
cleaning procedure 410
graphical presentation (in software) 98
picture 16
Worklist
authorization procedure 54
automatically generated 82
501
A. Appendices
EVOLIS
Bio-Rad EVOLIS Version 1.90 Instrument Code 89601, User manual
definition (basic method) 79
definition (several assays per plate) 174
saving 85
Worklist display area 93
Worklist Options (dialog box) 103
Worklist parameters 94
Worklist tree 93
Worklist window 93
502
Workload planning 97
Z
Z-max volume
archiving parameters 229
sample and control dispensing 302
Last modification : 01 – 2008
User manual code : 89891 - EN