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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

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

Overview

  • Brief Overview of the Enfer TSE Assay

  • Automation of “Front End”

  • Brief Data Review – External Evaluation

    • Specificity

    • Sensitivity

    • Autolyzed Samples


Enfer assay overview

Front End Automation

Enfer Assay Overview


Usda approved enfer test automation of front end

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

SAFER SAMPLE CUTTING

replaced by

Plastic Punch

Blade

  • No sharps

  • Standard cuts

  • Easy disposal

  • Rapid

  • Inexpensive


Fda advisory committee meeting

EASIER SAMPLE HANDLING

replaced by

Tube

Bag


Fda advisory committee meeting

FASTER SAMPLE HOMOGENIZATION

replaced by

ETDS VIII

Stomacher

Time To Process 8 Samples:

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


Fda advisory committee meeting

STREAMLINED SAMPLE PROCESSING

Same Tube Moves Through Process

Final component of

new automation


Streamlined sample processing with tecan genesis rsp

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)


Fda advisory committee meeting

HIGH PERFORMANCESpecificity Testing - LGC


Fda advisory committee meeting

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


Fda advisory committee meeting

HIGH PERFORMANCESensitivity/Autolyzed Samples

100 % Sensitivity

100% Specificity

in this sample

population


Questions

Questions?

[email protected]


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