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FDA Advisory Committee Meeting. Transmissible Spongiform Encephalopathies October 14, 2004. Performance of the Enfer TSE Test with Front End Automation. Steve Figard, Ph.D. Senior Scientist Abbott Diagnostics And a Host of Others…. Overview. Brief Overview of the Enfer TSE Assay

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FDA Advisory Committee Meeting

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FDA Advisory Committee Meeting

Transmissible Spongiform Encephalopathies

October 14, 2004

Performance of the Enfer TSE Test with Front End Automation

Steve Figard, Ph.D.

Senior Scientist

Abbott Diagnostics

And a Host of Others…


Overview

  • Brief Overview of the Enfer TSE Assay

  • Automation of “Front End”

  • Brief Data Review – External Evaluation

    • Specificity

    • Sensitivity

    • Autolyzed Samples


Front End Automation

Enfer Assay Overview


USDA-APPROVED ENFER TESTAutomation of “Front End”

  • Safer Sample Cutting

    • new plastic tool

  • Faster Sample Homogenization

    • new automated instrument

  • Easier Sample Handling

    • new tube replaces bag

  • Streamlined Sample Processing

    • minimized transfer

  • Same High Performance


SAFER SAMPLE CUTTING

replaced by

Plastic Punch

Blade

  • No sharps

  • Standard cuts

  • Easy disposal

  • Rapid

  • Inexpensive


EASIER SAMPLE HANDLING

replaced by

Tube

Bag


FASTER SAMPLE HOMOGENIZATION

replaced by

ETDS VIII

Stomacher

Time To Process 8 Samples:

2 Stomachers – 240 seconds (4 minutes)1 ETDS – 10 seconds


STREAMLINED SAMPLE PROCESSING

Same Tube Moves Through Process

Final component of

new automation


Streamlined Sample Processing withTecan Genesis RSP

  • Automated sample pipetting

    • ETDS tube to centrifuge plate

    • centrifuge plate to test plate

  • Automated addition of EB2 (PK) to test plate

  • Approximately 5 min for one plate (44 samples)

  • ETDS VIII racks fit directly into Tecan

  • Other “standard” features of automation

    • disposable tips – no cross contamination

    • liquid detection system for tips

    • bar code reader (POSID)


HIGH PERFORMANCESpecificity Testing - LGC


HIGH PERFORMANCESensitivity/Autolyzed Samples

  • 200 positive samples from OTM population

    • collected and frozen at least a year and in good condition

    • confirmed by BioRad/Prionics WB

  • 200 negative samples from fallen stock

    • in state of “severe autolysis” – worst case sample type

    • confirmed by BioRad/Prionics WB

  • Autolyzed samples can have high levels of protease inhibitors which can affect Proteinase K digestion and possibly result in a false positive

  • All samples were supplied as homogenates, not tissue

  • Testing done at Veterinary Laboratories Agency, Newcastle, UK


HIGH PERFORMANCESensitivity/Autolyzed Samples

100 % Sensitivity

100% Specificity

in this sample

population


Questions?

[email protected]


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