July 16, 2002 - FDA on its Draft Guidance Document, "Guidance for Industry: Use of Nucleic Acid Tests"

The American Society for Microbiology (ASM) is the largest educational, professional, and scientific society dedicated to the advancement of the microbiological sciences and their application for the common good. The Society represents more than 40,000 microbiologists, including scientists and science administrators in academic, industry and government institutions working in a variety of areas, including biomedical, environmental, and clinical microbiology. In response to the notice announcing the availability of the draft document, "Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components for Transfusion to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV, published in the Federal Register on April 9, 2002, the ASM provides the following comments:

  1. The "window" period between infection and detection of laboratory evidence of infection will be less when using nucleic acid testing (NAT) as compared to p24 antigen testing, but, the risk of HIV-1 and HCV transmission will not be zero. The FDA Guidance Document should acknowledge the limitations of NAT with pooled and individual samples.
  2. ASM is concerned that currently, only one FDA-approved NAT assay is available for laboratories. Manufacturers may inflate the price of NAT assay kits, based on its knowledge that laboratories would be using the only FDA-approved NAT test on the market, regardless of cost. In addition, the FDA Guidance Document does not address the course of action required for laboratories or industry, should there be a shortage or inadequate number of test kits available from the manufacturer, particularly during times of regional, national and/or international emergencies. The ASM recommends that FDA include a provision to address this issue.

We appreciate the opportunity to comment and would be pleased to respond to any questions or requests for additional information.