Evaluation of the reliability of 6 current anti-HIV-1/HIV-2 enzyme immunoassays.

The sensitivity for early detection of HIV antibodies and specificity of 6 anti-HIV-1/HIV-2 screening enzyme immunoassays (ELISAs) currently on the market were investigated by testing a panel of 249 well-characterized serum samples. The panel included sera from AIDS patients or children with congenital HIV infection, high-risk individuals and patients with conditions unrelated to AIDS. 'Tricky' sera (repeatedly positive results by ELISA and negative or indeterminate results by Western blot; n = 69) were also used in this evaluation along with 6 seroconversion panels. One second-generation assay (Biotest) and two third-generation assays (Abbott and Murex) showed the highest sensitivity for early detection of HIV-1 antibodies in seroconversion panels. A high specificity was achieved with the Cambridge Biotech (100%) and Ortho ELISA (99.4%). A relatively high rate of false-positive results was obtained with the Biotest (n = 10) and the Pasteur assays (n = 8) by testing 'tricky' sera and samples from high-risk individuals and from patients with other acute viral infections. In conclusion, it remains difficult to combine high specificity with an accurate detection of early seroconversion for anti-HIV-1/HIV-2 screening enzyme immunoassays.