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Food and Drug Administration

Transmissible Spongiform Encephalopathies Advisory Committee

September 19, 2006

Slides

Potential Screening Assays to Detect Blood and Plasma Donors Infected with TSE Agents: Possible Criteria for Validation, P. Piccardo, MD, FDA (ppt) (htm)

Proposed Algorithm for Approval of Human TSE Tests in Europe, M. Turner, MBChB, PhD, FRCP, FRCPath, University of Edinburgh (ppt) (htm)

Objective: To define a process such that if an assay method successfully completes it, it is justifiable to try it in the Blood Transfusion Service at some scale. (ppt) (htm)

Development of Rapid Blood Screening Tests for vCJD, Alex Raeber, Prionics AG (ppt) (htm)

Use of PMCA for Biochemical Diagnosis of Prion Diseases, Claudio Soto, PhD, University of Texas Medical Branch and Aprion Inc. (ppt) (htm)

The Seprion Separation System: Development of a feasible blood screening protocol for abnormal prion protein, Stuart Wilson, Microsens Biotechnologies (ppt) (htm)

Detection of PrPres in Plasma, H. Perron, Biomerieux (ppt) (htm)

Pronucleon Amplified Misfolded Protein Diagnostic Assay (AMP-D) Kenton Lohman, Ph.D., Adlyfe Inc. (ppt) (htm)

CHIRON Submission, David Peretz, M.Sc., D.Sc. (ppt) (htm)

Open Public Hearing Speakers

Possible Criteria for Approval of Donor Screening Tests for vCJD, M. Allene Carr-Greer, MT, ASCP(SBB), AABB (pdf)

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