Standardization of Automated Sample Preparation for Viral Diagnostics
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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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Standardization of Automated Sample Preparation for Viral Diagnostics

Dirk Heckel, PhD

Diagnostic Sample Preparation and Stabilization

QIAGEN GmbH


Standardizing sample preparation in 2004
Standardizing sample preparation in 2004 Diagnostics

  • 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


Benefits of standardization by automation
Benefits of Standardization by Automation Diagnostics

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


Qiagen s solution for required functionality 1

Sample ID tracking Diagnostics

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)


Qiagen s solution for required functionality 2

High Level of Process control Diagnostics

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)


Standardization verification validation

BioRobot MDx DSP system Diagnostics

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


System verification validation
System Verification & Validation Diagnostics

System Verification & Validation

  • Limit of detection

  • Linearity and linear range

  • Accuracy

  • Precision, intermediate precision, reproducibility

  • Robustness, whole system failure rate

  • Cross contamination

  • Clinical specificity


Limit of detection qiaamp dsp 96 virus mdx protocol
Limit of detection DiagnosticsQIAamp 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


Linear range 24 replicates at 7 titer levels
Linear range Diagnostics(24 replicates at 7 titer levels)

COBAS TaqMan HCV

COBAS AMPLICOR HBV MONITOR

LCx HIV RNA Quantitative Assay


Intermediate Precision HIV cont. DiagnosticsQIAamp DSP 96 Virus MDx Protocol


Robustness
Robustness Diagnostics

  • Comparison of different primary tubes

  • 4 Replicates of 13 individual donors

  • 3 tube types per donor

  • Spiked w/ 1*10^5 IU/ml


Standardizing sample preparation in 20041

2005 Diagnostics

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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