May 1, 2002 - Use of Nucleic Acid Tests on Pooled Samples From Source Plasma Donors to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV

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 Samples From Source Plasma Donors to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV," published in the Federal Register on January 31, 2002, the ASM provides the following comments:

Nucleic acid tests (NAT) are sensitive and specific, and theoretically, this would be an improvement over older antibody and antigen assays. However, the tests must include an amplification control for the detection of inhibitors, which was not addressed in the draft Guidance Document. The issue of inhibitors becomes more important as pooled samples are tested. While pooled samples are more convenient and potentially more economical for the laboratories to perform, dilution of a positive sample with negative samples can reduce the overall assay sensitivity. ASM recommends that 1) "amplification control for the detection of inhibitors" be addressed in the final Guidance Document; 2) the FDA advise assay manufacturers, via the final Guidance Document, to demonstrate that test sensitivity is not compromised by testing pooled samples; and 3) FDA define the test parameters that will be required to demonstrate adequate sensitivity, in the final Guidance Document.

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

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