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NAT Update; Where are We Today?

  • Susan L. Stramer
Chapter
Part of the Developments in Hematology and Immunology book series (DIHI, volume 37)

Abstract

A recent review covered the one-year experience with NAT in North America [1]. In that review, five different programs including testing with two different manufacturers of NAT assays for both HIV-1 and HCV were discussed. When combined, the HCV yield for 16 3 million donations tested was 62 confirmed positives (1:263,000); the HIV-1 yield for 12.6 million donations tested was 6 (1:2,100,000). Two of the six HIV-1 NAT positives were also HIV-1 p24 antigen (Ag) reactive; excluding those donors that were already detected by an FDA licensed screening test for p24 Ag reduced yield to 1:3,150,000. Updating these numbers for two years of screening increases the number of yield samples for HCV to 113 per 29,253,815 donations screened (1:259,000) and for HIV-1, including HIV-1 p24 Ag reactives, to 8 per 26,339,192 donations screened (1:3,292,400). Excluding the two HIV-1 p24 Ag reactives reduces the HIV-1 NAT yield to 6 (1:4,390,000). The updated numbers for the two-year experience are shown in Tables 1 and 2. Variability observed by site for HCV NAT yield is influenced greatly by the HCV antibody-screening test used. For sites using HCV 2.0, their yield is approximately 1:150,000 whereas sites using HCV 3.0 have yields that range from 1:300,000 to 1:500,000 (March 2001, FDA Blood Products Advisory Committee, BPAC, Meeting).

Keywords

Viral Load High Viral Load Residual Risk Window Period Nucleic Acid Testing 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science+Business Media Dordrecht 2002

Authors and Affiliations

  • Susan L. Stramer
    • 1
  1. 1.National Testing and Reference Laboratories and Blood Services American Red CrossGaithersburgUSA

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