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Integrated Solutions — Diagnostic Sample Preparation
Reduce your workload and simplify
validation with the BioRobot® MDx DSP!
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The BioRobot MDx DSP system
One front-end IVD-D compliant solution for all your
viral sample preps
The BioRobot MDx DSP system provides true walkaway purification of viral
nucleic acids in clinical laboratories. The CE-marked system (including
instrument, software, service, purification kits, and protocols) provides
exact performance specifications, assuring highly reliable purification
procedures for in vitro diagnostic purposes.
■ Regulatory compliance — with EU Directive 98/79/EC on in vitro diagnostic medical devices
■ Universal viral nucleic acid purification system from plasma and serum samples — allowing
compatibility with other in vitro diagnostic detection assays
■ Effortless data management — full process documentation and sample tracking
■ Secure user environments — increased protocol protection for regulatory compliance
■ Error-free worktable setup — including a detailed load check
Worry-free viral nucleic acid purification and downstream integration
IVD-D compliance makes validation and quality control fast and easy. The generic nature of the
system enables nucleic acid purification from a wide range of viruses (Figures 1 and 2) and ensures
that the system is compatible with a wide range of upstream sample collection systems (Figures 3
and 4) and downstream assay systems. This streamlines integration into diagnostic workflows.
Linear Range of Yields of RNA from HIV and HCV
B
7
7
6
Result (log IU/ml)
8
6
5
4
y = 0.8838x + 0.3818
R2 = 0.9976
3
5
4
3
y = 0.9054x + 0.3011
R2 = 0.9982
2
1
2
3
4
5
6
Input (log IU/ml)
7
8
2
3
4
5
Input (log IU/ml)
6
7
Linear Range DNA Yields from HBV
5
Result (log IU/ml)
Figure 1 The linear range
of the standard QIAamp®
DSP 96 Virus MDx
protocol was determined
using A the LCx® HIV RNA
Quantitative Assay and
B the COBAS® TaqMan®
HCV Test.
Result (log IU/ml)
A
4
3
2
y = 1.0577x – 0.5599
R2 = 0.9987
1
0
1
2
3
Input (log IU/ml)
4
www.qiagen.com
5
Figure 2 The linear range of the QIAamp DSP 96 Virus
MDx (AW1) protocol, which includes an extra wash step,
was determined using the COBAS AMPLICOR® HBV
MONITOR® Test.
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Result (log IU/ml)
System Robustness Using Different Tubes — HCV
4
Figure 3 Commercially available HCV virus standard
(genotype 1a) from AcroMetrix was used to spike donor
samples to a titer of 500 IU/ml. For detection, the COBAS
TaqMan HCV Test (Roche Diagnostics GmbH) was used as
the downstream diagnostic assay. Sample preparation was
performed using the QIAamp DSP 96 Virus MDx (AW1)
protocol. The tubes used were BD Vacutainer® PPT™ (PPT)
from BD, and Monovette® Coagulation 9 NC (S 9NC) and
Monovette Serum Gel S 9 (S Gel) from Sarstedt.
3
2
1
0
PPT
S 9NC
Tubes
S Gel
Result (log IU/ml)
System Robustness Using Different Tubes — HIV
6
5
4
3
2
1
0
PPT
Vacuette
Tubes
Figure 4 An HIV in-house virus working standard, calibrated
to the WHO International standard 97/656, was used to
spike plasma samples with HIV at a titer of 1.4 x 105 IU/ml.
HIV RNA was purified using the QIAamp DSP 96 Virus
MDx protocol and detected using the COBAS TaqMan
HIV-1 Test (Roche Diagnostics GmbH). The tubes used were
BD Vacutainer PPT (PPT) from BD, Vacuette® EDTA (Vacuette)
from Greiner bio-one, and Primavette S EDTA (Primavette)
from Kabe Labortechnik.
Primavette
High-quality nucleic acids for sensitive detection
The BioRobot MDx DSP system, with the QIAamp DSP 96 Virus MDx Kit, provides efficient purification
of high-quality viral nucleic acids from human plasma or serum for sensitive detection (Figure 5).
Viral nucleic acids are ready to use in a broad range of sensitive diagnostic assays (Figures 1–5),
such as PCR and RT-PCR.
Walkaway automation on a closed, safe system
The BioRobot MDx DSP is a closed system with true walkaway automation. The fully automated
process, including bar code reading, load check, sample tracking, and complete process
documentation, requires a maximum of 2.5 hours to process 96 samples, with no hands-on time.
Manual handling of potentially infectious samples is minimized, ensuring safety for the user and
reliable processing of samples. The detailed load check ensures high process reliability, and
precision pipetting minimizes the risk of cross-contamination.
Further advantages of the system include error-free worktable setup, automated sample tracking,
starting with primary tubes, and ready-to-run protocols with secure user environments for regulatory
compliance.
Sensitive Detection of HBV DNA
100
Hits (%)
75
50
25
0
0
10
20
30
Input titer (IU)
40
50
Figure 5 Sensitivity is quantified by the 95% probit value
(vertical line), at which detection can be expected with a
95% probability. The graph shows the mean proportion of
hits (center line) and the confidence interval. Serial dilutions
from a negative plasma pool spiked with HBV WHO
international virus standard 97/746 were processed in
replicates of 36 each, following the QIAamp DSP 96 Virus
MDx protocol. HBV DNA was analyzed using an in-house,
endpoint PCR method, followed by agarose gel
electrophoresis. Amplicons of the expected size were
counted as hits. The 95% probit value was 37.51 IU/ml.
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1029651_FLY_IAS_MDxDSP_1004.qxd
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Instrument Service and Support
Service and application support
The molecular biology and engineering expertise offered by QIAGEN
Instrument Service guarantees optimal performance from diagnostic
applications. With a broad portfolio of Service Support Agreements,
regulatory support, ISO 9001/ISO 13485 certification, and an
international team of highly qualified and experienced Support Specialists,
QIAGEN Instrument Service delivers the high-quality instrument service
and application support you deserve. Our flexible Service Support
Agreements are designed to provide peace of mind by minimizing
instrument downtime.
IQ/OQ service and documentation
QIAGEN Qualification Services help you to qualify your system for correct
installation (IQ) and operation (OQ) in your laboratory. IQ/OQ
Documentation can be ordered on request after the delivery of the
BioRobot MDx DSP system. We also offer on-site performance of the
IQ/OQ to save time and costs. IQ/OQ packages consist of professional
documentation as well as the performance done by Support Specialists to
ensure compliance with regulatory demands.
Coverage tailored to your needs
With a QIAGEN® Service Support Agreement, you will get priority access
to our expert service ensuring maximum productivity from your investment.
Our Service Support Agreements are designed to make ownership of
laboratory instruments easy, and include:
■ Premium Cover Agreements — for peace-of-mind coverage including
24-hour priority response
■ Full Cover Agreements — for complete, annual coverage including
48-hour priority response
■ Basic Cover Agreements — same as Full Cover Agreement but with a
5-day response
■ Preventive Maintenance — for scheduled maintenance and complete
documentation
■ Warranty Extensions — to increase your warranty period
■ Out of Warranty Special Agreements — for long-term coverage
■ Training Program — tailored to the number of attendees and offering
basic or specialized training
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Ordering Information
Product
Contents
Cat. no.
BioRobot MDx DSP*
For automated purification of nucleic acids for in vitro diagnostic
purposes, conforming to the requirements of IvDD 98/79 EC:
Robotic workstation, computer, QIAsoft MDx DSP Operating system,
laboratory cabinet, accessory cabinet, installation and training,
1-year warranty on parts and labor
QIAamp DSP 96
Virus MDx Kit*
For 12 x 96 preps: 12 QIAamp 96 Plates, RNase-Free Buffers,†
QIAGEN Protease, Elution Microtubes CL, Caps, S-Blocks, Carrier RNA
* Not available in all countries; please inquire.
†
Wash buffers are labeled with bar codes, and expiration date is stated on the Q-Card in the kit.
Visit www.qiagen.com/goto/MDxDSP to discover how IVD-D compliant
walkaway automation can benefit your diagnostic sample preparation!
Trademarks: QIAGEN®, QIAamp®, BioRobot® (QIAGEN Group); AMPLICOR®, COBAS®, MONITOR®, TaqMan® (Roche Group); BD Vacutainer®, BD PPT™ (Becton, Dickinson and
Company); LCx® (Abbott Laboratories); Monovette® (Sarstedt AG & Co.); Vacuette® (C.A. Greiner & Söhne GmbH). The QIAGEN BioRobot MDx DSP workstation and QIAamp
DSP kits comply with EU Directive 98/79/EC on in vitro diagostic medical devices. The PCR process is covered by U.S. Patents 4,683,195 and 4,683,202 and foreign equivalents
owned by Hoffmann-La Roche AG.
1029651 10/2004 © 2004 QIAGEN, all rights reserved.
www.qiagen.com
9000909
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Diagnostic Sample Preparation
Australia ■ QIAGEN Pty Ltd
Orders 03-9840-9800 ■ Fax 03-9840-9888 ■ Technical 1-800-243-066
Belgium ■ QIAGEN Benelux B.V.
Orders 0800-79612 ■ Fax 0800-79611 ■ Technical 0800-79556
Canada ■ QIAGEN Inc.
Orders 800-572-9613 ■ Fax 800-713-5951 ■ Technical 800-DNA-PREP (800-362-7737)
France ■ QIAGEN S.A.
Orders 01-60-920-920 ■ Fax 01-60-920-925 ■ Technical 01-60-920-930
Germany ■ QIAGEN GmbH
Orders 02103-29-12000 ■ Fax 02103-29-22000 ■ Technical 02103-29-12400
Italy ■ QIAGEN S.p.A.
Orders 02-33430411 ■ Fax 02-33430426 ■ Technical 02-33430414
Japan ■ QIAGEN K.K.
Telephone 03-5547-0811 ■ Fax 03-5547-0818 ■ Technical 03-5547-0811
Luxembourg ■ QIAGEN Benelux B.V.
Orders 8002-2076 ■ Fax 8002-2073 ■ Technical 8002-2067
The Netherlands ■ QIAGEN Benelux B.V.
Orders 0800-0229592 ■ Fax 0800-0229593 ■ Technical 0800-0229602
Switzerland ■ QIAGEN AG
Orders 055-254-22-11 ■ Fax 055-254-22-13 ■ Technical 055-254-22-12
UK and Ireland ■ QIAGEN Ltd.
Orders 01293-422-911 ■ Fax 01293-422-922 ■ Technical 01293-422-999
USA ■ QIAGEN Inc.
Orders 800-426-8157 ■ Fax 800-718-2056 ■ Technical 800-DNA-PREP (800-362-7737)
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