MagNA Pure 96 System
Nucleic Acid Purification with Real High Throughput
The MagNA Pure 96 System purifies DNA, RNA, and viral nucleic acids from
a wide range of starting materials using magnetic glass particle technology.
Preprogrammed software protocols are tailored to a diversity of sample requirements. Resulting nucleic acids are suitable for a broad range of downstream applications.
The MagNA Pure 96 System effortlessly processes up to 96 samples in less than one hour using barcoded, prefilled trays with ready-to-use reagents.
Experience seamless data management using intuitive features, such as the link to a laboratory information management system (LIMS).
System Features
3
System Benefits 4
Reagents and Disposables
6
MagNA Pure 96 Software
7
Specifications 8
Kits and Protocols 9
System
Features
System
Benefits
Reagents and
Disposables
MagNA Pure 96
Software
Specifications
Kits and
Protocols
Performance Data
10 /13
Performance
Data
Ordering Information 11
Ordering
Information
2
MagNA Pure 96 System
Discover effortless nucleic acid isolation
Magnetism is used for automated nucleic acid isolation performed by the MagNA Pure 96 System from Roche Applied Science. The high
throughput MagNA Pure 96 Instrument performs automated nucleic acid purification from samples up to 1000 µl, pipetted into
a 96-well processing cartridge.
System
Features
Magnetic glass particles (MGPs) are used to isolate RNA, DNA and total nucleic acids (tNA)
from a variety of different sample materials. The MagNA Pure 96 System permits automated
nucleic acid purification that matches the high speed, accuracy, and reliability of LightCycler® Real-Time PCR Systems.
Key features of the MagNA Pure 96 System are:
Sample number
1 to 96 reactions per run
Sample volumes

5 0 to 500 µl with 96 reactions per run

1000 µl with 48 reactions per run
Max. number of sample types
within one run
10 (whole blood, plasma, serum, urine, swabs, stool, sputum, BAL, CSF,
bacterial cultures)
Run time for 96 reactions

A pprox. 50–60 minutes for 200 µl sample volumes

A pprox. 80–90 minutes for 500 µl sample volumes
Reagent type
Prefilled, ready-to-use
LIMS connectivity
Yes
21CFR part 11 (subsection B)
compatibility
Yes
IVD compliance
Instrument complies with the requirements of IVD directive 98/79/EC
3
MagNA Pure 96 System
Discover real high throughput
The MagNA Pure 96 System performs fast high
throughput processing of a multitude of sample
materials. Robust engineering produces consistent
results, minimizing maintenance and downtime.
System
Benefits
4
Feature
Benefit
Speed and throughput
 A pprox. 1 hour for processing a 96 sample run
 Multiple sample types can be processed in one run
 Q
uick time-to-result for clinicians and
patients
Convenience
 O nly two kits needed to cover various diagnostic applications
 Few reagents and consumables needed
 Connectivity (LIMS and bidirectional file sharing)
 M
inimized error risk
 L ow training effort & hands-on time
Robustness
 Insusceptible against tested substance interferences
 Very stable against cross contamination
 C onfidence & trust in your results
Performance
 Broad range of sample materials
 E xcellent precision, purification efficiency and linear range
 Minimal lot-to-lot variation
 O ne solution for various needs
Service and support
 Globally, approx. 3500 employees at Roche Diagnostics are
dedicated to service and support
 Roche is a leading supplier of IVD products. No other company
has more experience in molecular diagnostics
 M
inimum downtime
 C ost effectiveness
MagNA Pure 96 System
All samples are urgent samples
Process 1 to 96 standard-volume samples in less
than one hour, including the handling time that is
needed for the setup of a run. Larger volumes typically require 80 to 90 minutes for a run. Two
robotic pipetting arms are used to process the up to 96 samples absolutely standardized at the
same time.
The reagent head pipetting arm uses four individually controlled fluid channels to transfer
reagents during purification. The 96-nozzle process head pipetting arm uses CO-RE tip technology to purify nucleic acids in processing
cartridges.
System
Benefits
G Figure 1: Process head
G Figure 2: Reagent head
Using two robotic heads ensures high level process parallelization for high speed nucleic acid
isolation.
5
MagNA Pure 96 System
Convenient setup with reliable reagent
and consumables verification
The few consumables used are barcoded. Prefilled
ready-to-use reagent trays and consumables are easily loaded into racks, ensuring user safety.
The second set of racks permits straightforward
reagent tray exchange, when, for example, purifying cellular RNA from samples, after isolating DNA from a previous batch. In addition,
the onboard magnetic glass particle shaker eliminates the need to manually vortex MGPs
before loading them into the instrument.
Barcode reading is integrated throughout the
purification procedure. This feature minimizes the
risk of user errors during loading and enables full
process documentation.
G Figure 3: A reagent rack in the process of being
loaded with reagent trays
G Figure 4: Example of a reagent tray containing
Reagents and
Disposables
6
a unique barcode identifier
MagNA Pure 96 Software
Easy to learn, easy to use
Users find it easy to learn the MagNA Pure 96 System.
The intuitive graphical user interface provides all instructions to operate the system. The system
guides the user from sample loading to starting
the run.
This advanced software has been designed to
detect loading errors and guide the user to the
appropriate corrective action. For example, when a reagent is loaded in the wrong position,
the system prevents a run from being started until the reagent is repositioned correctly.
MagNA Pure 96
Software
G Figure 5: Overview screen of the MagNA Pure 96 Software
 S ample information can be imported into the
MagNA Pure 96 Software via internal or external
barcode scanner, LIMS, or entered manually.
 Data can be exported in several formats, such as
*.xml.
 P
erform bidirectional file sharing and LIMS connectivity.
 Software-based audit trail, user management, and process monitoring functionalities are
21CFR part 11 (subsection B) compatible.
7
MagNA Pure 96 System
Specifications
General
Type
Benchtop standalone instrument with separate control unit
Sample number
1 to 96 reactions per run
Sample volume
50 to 500 μl with 96 reactions per run
1000 μl with 48 reactions per run
Elution volume
50 to 200 µl
Run time
 Approx. 50 to 60 minutes for 200 μl sample volumes
 Approx. 80 to 90 minutes for 500 μl sample volumes
Setup time:
(Instrument loading, entering run &
sample information into software)
Approx. 5 minutes
Preventive maintenance
Annually or after 1000 runs
IVD compliance
In compliance with requirements of the IVD directive 98/79/EC
Hardware
Specifications
Hardware footprint, dimensions
W x D x H: 136 x 81.5 x 100 cm (53.9 x 31.5 x 39.4 in)
Weight
Approx. 235 kg/518 lbs (instrument)
Liquid handling
Two robotic arms:
1. Reagent head with four individually controlled fluid channels
2. Process head with a 96-nozzle pipette head (CO-RE tip technology)
Power supply
100 to 125 V (–15%, +10%)
200 to 240 V (-15%, +10%)
Power consumption
~450 VA max
Electrical approvals
CE, UL
Emission UV lamp
254 nm
Drop catcher
Yes
Software, Interfaces & Connectivity
8
21CFR part 11 (subsection B)
Compatibility
Yes
Data storage
In database format
Data export
*.xml, LightCycler ® sample input file in csv format (*.txt)
Audit trail
Yes
User management
Yes
LIMS connectivity
Yes (e.g., via HL7 transfer protocol)
Bidirectional file sharing
Yes
MagNA Pure 96 Reagent Kits
Just the number of reagents and consumables you need
The precisely engineered kits are designed profiting from
our more than ten year expertise in magnetic glass particle
technology. We have streamlined the purification process
to a very small number of reagents, consumables and steps.
Optimized preprogrammed purification
protocols ensure routine sample handling and
high quality, reproducible nucleic acid yields.
Reagents & Disposables
MagNA Pure 96 DNA and Viral NA Small Volume Kit
Cat. No. 06 543 588 001
MagNA Pure 96 DNA and Viral NA Large Volume Kit
Cat. No. 06 374 891 001
MagNA Pure 96 Cellular RNA Large Volume Kit
Cat. No. 05 467 535 001
Reagent type
Prefilled, ready-to-use
Automated shaking of magnetic glass particles (MGP)
Yes
Internal control option
Yes
Instrument monitoring of expiry dates
Yes
Unopened kit storage temperature
+15 to +25°C
Dedicated external lysis buffers available
Yes
Kit Name
Pack
Size
Target NA
Sample Material / Volume
Elution
Volume
Up to 5x105 culture cells
Genomic
DNA
DNA and Viral NA
Small Volume Kit
3x192
(Catalog No.
06 543 588 001)
DNA Cells SV
50 or 100
Lysed sample from 100 or 200 µl whole blood
Viral DNA
and RNA
Genomic
DNA
3x48
(Catalog No.
06 374 891 001)
Viral DNA
and RNA
3x48
53
DNA Blood ext lys SV
49
100 or 200
DNA Tissue SV
60
50 or 100
DNA Tissue FFPE SV
60
Viral NA Universal SV OR
Viral NA Plasma SV
55
Viral NA Universal ext lys SV
OR Viral NA Plasma ext lys SV
47
Pathogen Universal 200
58
Up to 1x10 6 culture cells
DNA Cells LV
80
500 µl whole blood
DNA Blood LV 500
72
Lysed sample from 100 or 200 µl plasma, serum or whole blood
Plasma, serum, whole blood, urine, bronchoalveolar lavage (BAL),
sputum, cerebrospinal fluid (CSF), swabs, stool and bacterial
cultures. Sample Volume 200 µl
Lysed sample from 500 µl whole blood
50 or 100
100 or 200
DNA Blood ext lys LV 500
75
DNA Tissue LV
80
1000 µl whole blood (containing up to 1x107 blood cells)
DNA Blood LV 1000
75
500 µl plasma or serum
Viral NA Universal LV 500 OR
Viral NA Plasma LV 500
77
Lysed sample from 500 µl plasma or serum
Viral NA Universal ext lys LV
500 OR Viral NA Plasma ext
lys LV 500
69
Pathogen Universal 500
90
Pathogen Universal 1000
96
3x96
Viral DNA
and RNA,
bacterial and
fungal DNA
55
DNA Blood SV
Up to 5 mg fresh tissue or up to 5 FFPE tissue sections
Up to 25 mg fresh tissue
DNA and Viral NA
Large Volume Kit
Min.
1 FFPE tissue section (5–20 µm thickness)
100 or 200 µl plasma, serum or whole blood
Viral DNA
and RNA,
bacterial and
fungal DNA
3x96
100 or 200 µl whole blood
Protocol Name
Plasma, serum, whole blood, urine, bronchoalveolar lavage (BAL),
sputum, cerebrospinal fluid (CSF), swabs, stool and bacterial
cultures. Sample Volume 500 µl
50 or 100
Plasma, serum, whole blood, urine, bronchoalveolar lavage (BAL),
cerebrospinal fluid (CSF), swabs, and bacterial cultures.
Sample Volume 1000 µl
3x96
Up to 1x10 6 culture cells
50, 100, 200 RNA Cells
80
Cellular RNA
Large Volume Kit
3x48
The complete WBC sediment of one Paxgene tube
(2,5 ml Whole Blood)
100 or 200
RNA PaxGene LV
86
(Catalog No.
05 467 535 001)
3x96
RNA PaxGene Half Tube LV
86
50 or 100
RNA Blood 400
90
3x48
3x96
Half the WBC sediment of one Paxgene tube (2,5 ml Whole Blood)
Total RNA
Lysed sample from 400 µl whole blood
Lysed sample from 800 µl whole blood
RNA Blood 800
92
Up to 25 mg fresh frozen tissue or RNAlater stabilized tissue
50, 100, 200 RNA Tissue FF High LV
91
Up to 20 mg fresh frozen tissue or RNAlater stabilized tissue
50, 100, 200 RNA Tissue FF Standard LV
93
1 FFPE tissue section (5–20 µm thickness)
50 or 100
RNA Tissue FFPE LV
Kits and
Protocols
87
G Table 1: Applications for the MagNA Pure 96 System.
9
MagNA Pure 96 System
Performance data
Representative performance data are shown below.
The data show exemplarily the performance
of the most common sample materials in order to
demonstrate the state of the art performance of
the system. As results obtained may differ depending
on sample and parameter, appropriate performance
characteristics have to be established by the user.
For diagnostic purposes the results shall always be
assessed in conjunction with the relevant application
and other findings.
Precision of purification efficiency
Linear range and limit of detection (LoD)
To determine the precision of the purification
efficiency, genomic DNA was purified from whole
blood. Yield and purity of the isolated nucleic
acids were determined by OD measurement.
Experimental setup and the results are described
below:
The linear range and the limit of detection (LoD),
that can be achieved using the MagNA Pure 96
DNA and Viral Nucleic Acid Kits for automated
nucleic acid purification in combination with the
MagNA Pure 96 Instrument was evaluated, using
virus stock material from Parvo B19 virus and from
Hepatitis A virus (both available in-house only).
Experimental setup to perform analysis of yield and purity:
Performance
Data
10
Experimental setup to determine the linear range and the
limit of detection:
Kit type
MagNA Pure 96 DNA and
Viral NA SV Kit
Kit type
MagNA Pure 96 DNA and
Viral NA LV Kit
Purification protocol
DNA Blood SV
Purification protocol
Viral NA Universal LV
Sample type
Whole blood
(7.6 x 10 6 white blood cells/ml)
Sample type
EDTA plasma
Sample input volume
500 µl
Sample input volume
200 µl
Elution volume
50 µl
Elution volume
100 µl
Replicates per run
24
Dilution series
8 different virus titers:
2 x 10 1 to 5 x 107 (Parvo B19) and
3 x 10 1 to 1 x 10 9 (Hepatitis A)
copies/ml
Overall data
172 (Parvo B19 Virus); 176
(Hepatitis A Virus)
Results (mean values) for DNA yield and purity of
genomic DNA purified from whole blood:
Run 1
Run 2
Run 3
Yield (µg)
5.6
5.6
5.5
CV (%)
3.9
5.5
6.5
OD 260/280
1.9
1.9
1.9
CV (%)
2.5
4.4
1.8
Results determined for linear range and LoD:
Parvo B19 Virus
Hepatitis A Virus
Linear range
(copies/ml)
2 x 10 2 to 5 x 10 6
3 x 10 3 to 1 x 10 9
Limit of detection
(LoD 95)
68 copies/ml
119 copies/ml
Intra-assay, inter-assay, and lot-to-lot precision
CP
Standard deviations (SD) and coefficients
Results for intra-assay, inter-assay, and lot-to-lot
of variations (CVs) were determined for dilution precision:
series within the linear range using Parvo B19
virus and Hepatitis A virus. To determine the intraPrecision – Parvo B19 Virus
30
assay precision, all data were produced in a single
28
run. To determine the inter-assay precision three
26
runs were performed by different operators, on 24
different instruments, in different labs. Lot-to-lot
22
precision was determined using six different lots.
Intra-assay
The experimental setup to perform precision analysis is
shown below:
20
Inter-assay
18
Lot-to-lot
16
Purification protocol
Viral NA Universal SV
32
Sample type
EDTA plasma
30
Sample input volume
200 µl
28
Elution volume
50 µl
26
1 x 10 3 to 1 x 10 6 copies/ml
for both Parvo B19 and
Hepatitis A virus
24
Dilution series
Replicates
8
18
Data points on
LightCycler ® 480
Instrument
Intra-run: 32
Inter-run: 96
Lot-to-lot: 160
CP
Kit type
MagNA Pure 96 DNA and
Viral NA SV Kit
1 x 10 6
1 x 105
1 x 10 4
1 x 103
Precision – Hepatitis A Virus
Intra-assay
22
Inter-assay
20
Lot-to-lot
1 x 10 6
1 x 105
1 x 10 4
1 x 103
G Figure 6: The qPCR results are highly reproducible
(CV <2%) for intra-run, inter-run, and lot-to-lot precision.
Performance
Data
11
13
Ordering Information
MagNA Pure 96 Instrument, Kits,
Consumables and Accessories
1. Instrument
Product Name
Cat. No.
Contents
MagNA Pure 96 Instrument
06 541 089 001
instrument, control unit, software, accessories
Product Name
Cat. No.
Kit Contents
MagNA Pure 96 DNA and Viral NA
Small Volume Kit
06 543 588 001
3 x 192 purifications
MagNA Pure 96 DNA and Viral NA
Large Volume Kit
06 374 891 001
3 x 96 purifications
MagNA Pure 96 Cellular RNA
Large Volume Kit
(The intended use of this kit is
“For life science research only.
Not for use in diagnostic procedures.”)
05 467 535 001
3 x 96 purifications
MagNA Pure 96 System Fluid (Internal)
06 430 112 001
2 containers
MagNA Pure 96 System Fluid (External)
06 640 729 001
1 container
MagNA Pure 96 External Lysis Buffer
06 374 913 001
100 ml
MagNA Pure 96 Bacterial Lysis Buffer
06 374 921 001
20 ml
MagNA Pure 96 DNA Tissue Lysis Buffer
06 640 702 001
200 ml
Product Name
Cat. No.
Kit Contents
MagNA Pure 96 Filter Tips (1000 µl)
06 241 620 001
8 blisters with 5 trays à 96 tips
MagNA Pure 96 Processing Cartridge
06 241 603 001
36
MagNA Pure 96 Output Plate
06 241 611 001
60
MagNA Pure 96 Sealing Foil
06 241 638 001
100
MagNA Pure 96 Internal Control Tube
06 374 905 001
150 (15 x 10)
2. Reagent Kits
3. Consumables
12
11
4. Accessories
Product Name
Cat. No.
Contents
MagNA Pure 96 Drop Catcher
06 541 119 001
10
MagNA Pure 96 Reagent Loop Unit
06 541 127 001
1
MagNA Pure 96 Barcode Scanner
06 541 143 001
1
MagNA Pure 96 Tip Rack
06 541 151 001
1
MagNA Pure 96 Bottle Rack
06 541 178 001
1
MagNA Pure 96 Needle Set of 4
06 541 194 001
4 Needles
MagNA Pure 96 Purification Rack
06 541 208 001
1
MagNA Pure 96 Reagent Rack
06 541 224 001
1
MagNA Pure 96 Waste Rack
06 541 259 001
1
MagNA Pure 96 Internal Waste Container
06 541 267 001
1
MagNA Pure 96 External Waste Container
on request
1
MagNA Pure 96 Waste Cover
06 541 275 001
10
MagNA Pure 96 Plate Holder
06 541 283 001
1
MagNA Pure 96 LightCycler® 480 Adapter
06 638 996 001
1
MagNA Pure 96 Archive Plate Adapter 4S
06 639 003 001
1
Roche Applied Science Service and Support
Roche Applied Science is committed to providing
innovative, high-quality instruments and reagents
combined with excellent customer service. We
provide powerful tools meeting the needs of life
science researchers worldwide.
To explore our products and services
or to find a local representative, please visit
Whether you need expert technical support, online
access to comprehensive product information,
convenient on-site product supply service and online
ordering, or outstanding customer service to
ensure accurate and timely product delivery, we
provide a wealth of resources to help you achieve
your research goals.
Trademarks and disclaimers:
www.roche-applied-science.com.
Products are for in vitro diagnostic use, unless otherwise indicated.
MAGNA PURE and LIGHTCYCLER are trademarks of Roche.
All other product names and trademarks are the property of their
respective owners.
Ordering
Information
This information folder is not intended for use in the USA.
13
12
Published by:
Roche Diagnostics GmbH
Sandhofer Straße 116
68305 Mannheim
Germany
© 2012 Roche Diagnostics.
All rights reserved.
www.roche-applied-science.com
06762069001 1 0612