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

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

USDA-APPROVED ENFER TEST Automation 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 Plastic Punch Blade replaced by No sharps Standard cuts Easy disposal Rapid Inexpensive

Tube Bag replaced by EASIER SAMPLE HANDLING

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

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

Streamlined Sample Processing with Tecan 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 PERFORMANCE Specificity Testing - LGC

HIGH PERFORMANCE Sensitivity/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 PERFORMANCE Sensitivity/Autolyzed Samples 100 % Sensitivity 100% Specificity in this sample population

Questions?