NAT Update; Where are We Today?
A recent review covered the one-year experience with NAT in North America . 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).
KeywordsViral Load High Viral Load Residual Risk Window Period Nucleic Acid Testing
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