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* Percentage of specimens that were repeatedly reactive.
† Two of three specimens were also antibody positive. The third specimen was from a donor who subsequently showed no other evidence of HIV infection. The specificity of Manufacturer A’s antigen assay is approximately 99.95% (301,555 per 301,697) based on a) an assumed zero prevalence of HIV-1 p24 antigen in random blood donors who have no other evidence of HIV-1 infection and b) additional testing using the neutralization test and Western blot analysis for HIV-1 antibodies.
§ The repeatedly reactive specimen was confirmed as being HIV-1 p24-antigen positive; the donor subsequently seroconverted to antibodies to HIV-1. When the HIV-1 p24-antigen–positive donor was removed from the calculation, the specificity of Manufacturer B’s test was 99.93% (10,262 per 10,269; 95% confidence interval=99.86%–99.97%).
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