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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. Brief Overview of the Enfer TSE Assay

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FDA Advisory Committee Meeting

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  1. 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…

  2. Overview • Brief Overview of the Enfer TSE Assay • Automation of “Front End” • Brief Data Review – External Evaluation • Specificity • Sensitivity • Autolyzed Samples

  3. Front End Automation Enfer Assay Overview

  4. 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

  5. SAFER SAMPLE CUTTING replaced by Plastic Punch Blade • No sharps • Standard cuts • Easy disposal • Rapid • Inexpensive

  6. EASIER SAMPLE HANDLING replaced by Tube Bag

  7. FASTER SAMPLE HOMOGENIZATION replaced by ETDS VIII Stomacher Time To Process 8 Samples: 2 Stomachers – 240 seconds (4 minutes) 1 ETDS – 10 seconds

  8. STREAMLINED SAMPLE PROCESSING Same Tube Moves Through Process Final component of new automation

  9. 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)

  10. HIGH PERFORMANCESpecificity Testing - LGC

  11. 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

  12. HIGH PERFORMANCESensitivity/Autolyzed Samples 100 % Sensitivity 100% Specificity in this sample population

  13. Questions? Steve.Figard@Abbott.com

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