Food and Drug Administration
September 18, 2003
Briefing Information
Licensed-Approved HIV Tests, Dr. Paul Mied, PhD (HTM) (PDF) (Word)
Current Thinking on Use of Chlorhexidine as an Arm Preparation for Donor Phlebotomy, Dr. Leslie Holness, MD (HTM) (PDF) (Word)
Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma, Elizabeth Callaghan (HTM) (PPT)
Publications (HTM) (PDF) (Word)
Topic I: West Nile Virus (WNV) - Informational
Progress in West Nile virus Testing and Donor Screening, Dr. Hira Nakhasi, PhD (HTM) (PPT)
West Nile Virus and Plasma-Derived Products, Dr. Mahmood Farsid, PhD (HTM) (PPT)
Letter Regarding PPTA's Presentation on West Nile Virus, Mary Gustafson (HTM) (PDF) (Word)
Memorandum Regarding Summary of West Nile Virus Meeting With FDA, Christopher P. Healey, PPTA (HTM) (PDF) (Word)
PPTA – FDA West Nile Virus Working Meeting (HTM) (PPT)
Impact of NAT Screening of Donations on Safety Margin of Plasma Derivatives, Dr. Albrecht Gröner, PhD, Aventis Behring (HTM) (PPT)
Risk assessment: The Safety of Blood Products, Dr. Thomas R. Kreil, Baxter BioScience (HTM) (PPT)
CPMP Position Statement on West Nile Virus and Plasma-Derived Medicinal Products (PDF)
Procleix® WNV Assay: Update, Dr. Jeffrey Linnen, PhD, Gen-Prob, Inc. (HTM) (PPT)
Update on West Nile Virus, Dr. George Dawson, PhD (HTM) (PPT)
Recent Serologic Studies with Potential Impact on WNV Blood Screening, Wayne Hogrefe and Harry Prince, Focus Technologies (HTM) (PPT)
Topic II: Supplemental Testing for HIV and HCV
Supplemental Testing of Donors for HIV and HCV, Dr. Robin Biswas, MD and Dr. Indira Hewlett, PhD (HTM) (PPT)
Guidelines for Laboratory Testing and Result Reporting for Antibody to Hepatitis C Virus, Dr. Miriam Alter, PhD, CDCP (HTM) (PPT)
Clinical Sensitivity of WNV Screening and Supplemental NAT Assays for Detection of Very Low-Level Viremic Donations, Dr. Michael Busch, MD (HTM) (PDF) (Word)
Incorporation of NAT into Supplemental Testing of HCV and HIV Seroreactive Donors, Dr. Michael Busch, MD, University of CA (HTM) (PPT)
Evaluation of an alternate HIV confirmatory testing algorithm, Dr. Susan Stramer, PhD (HTM) (PDF) (Word)
ARC Experience with Indeterminate Blood Donors, Dr. Susan Stramer, PhD, American Red Cross (HTM) (PPT)