F Examination Process
F2 Examination procedures
Printed on : 12/02/2016
Pathology Directorate
Page 1 of 4
Blood Sciences
Section : Point of Care
Urine sample analysis using Clinitek urine analysers
Site/Area of application
Point of Care
Index code
BSF2POC041 v1
Superseded documents
BIMECUA2 v 3 and BSF2POC001 v 1
Implementation date of this version
4th August 2010
Approver of content of SOP
Uche Okeahialam
Reason for change
Review and update to current SOP template
Keywords for search on EQMS
Poct, Urine, Clinitek, Sample.
Author: Rob Coleman
This document is controlled using the Pathology EQMS software.
Controlled printed copies can be identified by the authorisation signature present in the space below. Upon request further authorised
copies can be obtained through the department’s quality system.
Uncontrolled copies may be printed for an individuals use but should not be used after 1 week from the date of printing.
Signature
1.
CLINICAL RELEVANCE/PURPOSE OF PROCEDURE
Semi quantitative analysis of various analytes in urine.
2.
PRINCIPLE OF PROCEDURE
NOTE The Clinitek urine analysers may be used immediately after being turned on and the self-test is
complete. No warm up time is required.
The Clinitek urine analysers are reflectance photometers that analyse the colour and the intensity of the
light reflected from the reagent area and displays the results in meaningful units. The trust utilises two
different models of Clinitek urine analyser, the Clinitek STATUS and the Clinitek 50, both are designed
and programmed to read both Multistix 8SG and Multistix 10SG. The Multistix strip is dipped into a urine
sample, excess urine is drained off the edge of the strip, then placed on the test table after start is
pressed.
3.
PERSONNEL / TRAINING REQUIREMENTS
a)
Training Requirements
A short training course for ward users given by Bayer, Biochemistry Staff or an
authorised trainer nurse.
b)
Maintenance Quality Control and Troubleshooting
Carried out by Biochemistry staff.
4.
SPECIMEN REQUIREMENTS
Multistix 8SG or Multistix 10SG:-
5.
Minimum volume :- 200 L
Stored at :- Room temperature
Means of identification :- Must be labelled with patient ID
Samples are known to be stable for :- Must be less than 4 hours old.
EQUIPMENT
INDEX CODE: BSF2POC041 version 1
TITLE: Urine sample analysis using Clinitek urine analysers
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Paper towels.
Multistix 8SG and Multistix 10SG
6.
HEALTH AND SAFETY/RISK ASSESSMENT
See the COSHH assessment BICOSHH153
7.
REAGENTS
Urine test strips 8SG and 10 SG supplied by Pharmacy
Storage conditions :- Room temperature-Always replace the lid after use.
8.
CALIBRATION
The analyzer performs an automatic calibration each time a test is run. The assay is calibrated to the
World Health Organisation 3rd International Reference Preparation.
9.
QUALITY CONTROL
Kenlor dropper QC Normal and abnormal Quality Control Solutions
UK, Biostat House, Pepper Road, Hazel Grove.
Store at 2-8C
Kit inserts are kept centrally in OMS.
Cat no 210306 Inverness Medical
Internal Quality control is analysed bi-monthly by POCT staff.
All internal QC results and strip lot number used, must be recorded on “Urine IQC results” file
situated in the POCT folder on “G” drive.
Any results not complying with set limits results in troubleshooting procedure being applied.
External Quality Assessment participation :- WEQAS specimens are analysed bi-monthly.
10.
COMPUTER / TELEPATH CODES
N/A
11.
PROCEDURE OR METHODOLOGY
Clinitek STATUS
1. Switch on
If the instrument is switched off switch it on by pressing the ON/OFF button located on the front of the
instrument.
NB Ensure the instrument is plugged into the wall socket and the plug switch is on.
The analyser will run an automatic system diagnostic test.
2. Quality Control Check
NB. Internal Quality Control is analysed bi-monthly by Biochemistry staff.
The Clinitek Status analyser operates via a touch screen.
a) Touch ‘Strip Test’
b) either the Prepare Test screen will appear which contains information on which
Multistix to use (e.g. 10 SG or 8SG).
or
the Patient Information Screen will appear. Touch ‘Enter new patient’ and a keyboard screen appears.
Touch ‘Enter’ which takes you to the Prepare Test screen.
c) Carefully drop the negative control urine. onto a fresh Multistix reagent strip.
d) Touch ‘start’ on the Prepare Test screen.
NB You have 8 seconds to complete the next two steps.
e) With the reagent areas to one side, touch the edge of the strip on a paper towel.
NB Do not draw the strip across the towel, touch the edge only.
f) Place the reagent strip, with reagent areas upwards, in position on the strip test table.
Place the top tip of the reagent strip near the centre of the test table then slide the strip onto the table until
it is touching the end stop.
g) The test table and strip will automatically be pulled into the analyser, and the Analysing screen will
appear with a timer counting down.
INDEX CODE: BSF2POC041 version 1
TITLE: Urine sample analysis using Clinitek urine analysers
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h) The results then print out onto either paper or labels
i) Check printed results with those given as ‘target values’ for the negative control.
j) If results are within target, remove and discard the reagent strip.
k) Save printout of control results. These can be entered in the “Urine IQC results” file
the POCT folder on “G” drive.
situated in
l) Repeat step 2 for the abnormal control.
m) Clean and dry the test table. When all quality checks are complete and successful you may proceed
to measuring patient samples.
Note If any quality checks fail, repeat the process. If there are further failures, contact
POCT Manager.
3. Sample Measurement
a) Touch ‘Strip Test’
b) Either the Prepare Test screen will appear which contains information on which
Multistix to use (e.g. 10 SG or 8SG).
Or
the Patient Information Screen will appear. Either enter the patients name or search for an existing
patient. Touch ‘Enter’ which takes you to the Prepare Test screen.
c) Carefully immerse a fresh Multistix reagent strip into a fresh, well-mixed patient MSU sample.
d) Remove the stick immediately (while removing run the edge of the entire length of the strip against the
side of the tube to remove excess urine).
e) Touch ‘start’ on the Prepare Test screen.
NB You have 8 seconds to complete the next two steps.
f) With the reagent areas to one side, touch the edge of the strip on a paper towel.
NB Do not draw the strip across the towel, touch the edge only.
g) Place the reagent strip, with reagent areas upwards, in position on the strip test table.
Place the top tip of the reagent strip near the centre of the test table then slide the strip onto the table until
it is touching the end stop.
h) The test table and strip will automatically be pulled into the analyser, and the Analysing screen will
appear with a timer counting down.
i) The results then print out onto either paper or labels.
j) Store/record all results.
k) Repeat step 3 for further samples.
l) Clean and dry the test table.
Recording results :- Results should be recorded in the patient’s notes.
Clinitek 50
1. Carefully immerse a fresh Multistix 8SG or 10SG reagent strip (check expiry date before use) into a fresh,
well mixed patient MSU sample- the container holding the urine must contain no preservatives.
Important- the machine must be set up for the correct strip type i.e. 8SG or 10SG.
2. Remove the strip from the urine immediately. Whilst removing the strip, remove excess urine by running
the edge of the entire length of the strip against the side of the container.
3. Press the green ‘Start’ button. NB You now have 10 seconds to complete the next 2 steps.
4. With the reagent areas to one side, touch the edge of the strip on a paper towel to remove remaining
excess urine.
5. Place the reagent strip, with reagent area upwards, in position on the strip feed table.
6. Place the top tip of the reagent strip near the centre of the feed table then slide the strip onto the table
until it is touching the end stop.
7. The feed table will now move into the instrument to allow the strip to be read.
INDEX CODE: BSF2POC041 version 1
TITLE: Urine sample analysis using Clinitek urine analysers
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8. Note Ensure the strip lays flat against the table and is touching the end stop. Repeat the test with a fresh
strip if unsure.
9. When all areas have been read the results will be printed out on the internal printer.
10. Clean the feed table with a damp tissue. Dry with a clean paper towel.
11. Make sure the container holding the urine strips has the cap replaced and is fully tightened after use.
Disposal of waste :- Discard used strips into an infected waste bin.
If you are experiencing problems with the analyser, contact Biochemistry. Bleep 2310, 2311, 1801, 1804,
or 2320. Tel.ext. 22338.
If the machine is not repairable by the laboratory, it must be returned to the manufacturer : Siemens
Medical Solutions Diagnostics, Sir William Siemens Square, Frimley, Camberley, Surrey, GU168QD. Tel
0845 600 1955, have the meter serial number to hand as if the machine is on service contract, then repair
is free. If not on contract an order number must be supplied.
Disinfection procedures for equipment :- Damp tissue moistened with soapy water.
High risk samples – Normal sample precautions
12.
UNCERTAINTY OF MEASUREMENT
1. Urine preservatives may affect results.
2. Bacterial growth from contaminating organisms may affect glucose, pH and blood results.
3. Preservatives will not prevent deterioration of ketones, urobilinogen or bilirubin.
13.
REFERENCE RANGE / ACTION LIMITS
Linearity :- N/A
Analytical range :- N/A
Reportable intervals for patient samples :- N/A
Significant figures to which the assay is assured
Sensitivity (detectable levels)
Glucose
4-7 mmol/L
Bilirubin
7-14 umol/L
Ketones
0.5-1.0mmol/L
Blood
150-620 g/L (Hb)
Protein
0.15-0.30 g/L
Nitrite
13-22 mol/L
Leucocytes 5-15 cells/L
14.
REFERENCES
Training in this procedure is recorded using the generic training record BSF2POC020
Clinitek 50 users manual
Clinitek STATUS users manual
Package insert Bayer Ames Multistix 10 SG or Multistix 8SG
15.
APPENDICES
Lot/batch number records QC materials/reagents are stored :“Urine IQC results” file situated in the POCT folder on “G” drive.
INDEX CODE: BSF2POC041 version 1
TITLE: Urine sample analysis using Clinitek urine analysers
Page
Copies without an Authorised stamp or document manager signature are no longer valid after 7 days of this date 12/02/2016
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