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Dirk Heckel, PhD Diagnostic Sample Preparation and Stabilization QIAGEN GmbH

Standardization of Automated Sample Preparation for Viral Diagnostics. Dirk Heckel, PhD Diagnostic Sample Preparation and Stabilization QIAGEN GmbH. Standardizing sample preparation in 2004. QIAamp DSP Virus kit: CE certified in April 2004 BioRobot M48 for medium throghput in May 2004

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Dirk Heckel, PhD Diagnostic Sample Preparation and Stabilization QIAGEN GmbH

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  1. Standardization of Automated Sample Preparation for Viral Diagnostics Dirk Heckel, PhD Diagnostic Sample Preparation and Stabilization QIAGEN GmbH

  2. Standardizing sample preparation in 2004 • QIAamp DSP Virus kit: CE certified in April 2004 • BioRobot M48 for medium throghput in May 2004 • BioRobot MDx: CE certification in Q3/04 • BioRobot EZ1: for low throughputin Q3/04

  3. Benefits of Standardization by Automation Automation of generic sample preparation methods can lead to: • Securing of result integrity • Reduction of user errors • Increased process control • Comprehensive process documentation • Medium to High throughput • High level of user convenience

  4. Sample ID tracking Secure system setup Cross contamination free processing Automatic barcode reading of sample ID Tracking of sample ID from sample input area to result documentation Software guidance for system setup Automatic verification of complete and correct system setup (Load Check) Usage of filter tips 8-Channel Pipetting Proprietary design of robotic vacuum chamber (RoboVac) QIAGEN’s solution for required functionality (1)

  5. High Level of Process control Walk away automation Result documentation Clot Check Positive sample dispense verification Liquid detection Constant verification of key process parameters (e.g. temperature/pressure) Load check Robotic arm with lab hand and 8 Channel dispenser head RoboVac Heating/Cooling device Result file including information such assample ID, sample validity, user, instrument, time stamp, maintenance status etc. QIAGEN’s solution for required functionality (2)

  6. BioRobot MDx DSP system IvD Reagents Application process IvD Instrument IvD Hardware IvDSoftware Standardization = Verification / Validation CE-Marking requires performance evaluation of the IvD system System Verification & Validation Chemistry Verification Process Verification / HW/SW integration verification Hardware Module Verification Software Unit Level and Integration Level Verification

  7. System Verification & Validation System Verification & Validation • Limit of detection • Linearity and linear range • Accuracy • Precision, intermediate precision, reproducibility • Robustness, whole system failure rate • Cross contamination • Clinical specificity

  8. Limit of detection QIAamp DSP 96 Virus MDx Protocol LOD HBV = 26 IU/ml  144 c/ml LOD HIV = 123 IU/ml  70 c/ml LOD HCV = 28 IU/ml

  9. Linear range (24 replicates at 7 titer levels) COBAS TaqMan HCV COBAS AMPLICOR HBV MONITOR LCx HIV RNA Quantitative Assay

  10. Intermediate Precision HIV cont.QIAamp DSP 96 Virus MDx Protocol

  11. Robustness • Comparison of different primary tubes • 4 Replicates of 13 individual donors • 3 tube types per donor • Spiked w/ 1*10^5 IU/ml

  12. 2005 Standardizing sample preparation in 2004 BioRobot MDx DSP system • QIAamp DSP Virus kit: CE certified in April 2004 • BioRobot M48 for medium throghput in May 2004 • BioRobot MDx: CE certification in Q4/04 • BioRobot EZ1: for low throughputin Q3/04  BioRobot MDx DSP system  • BioRobot EZ1: CE certification in Q1 2006 • BioRobot EZ1: CE certification of Virus Kit in Q2 2006

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