Thirteen current anti-HIV-1/HIV-2 enzyme immunoassays: how accurate are they?

The sensitivity and specificity of 13 current anti-HIV-1/HIV-2 screening enzyme immunoassays (EIA) for the detection of anti-HIV in human serum or plasma were investigated by testing against a panel of 454 well-characterised serum or plasma specimens. The panel included specimens confirmed to contain anti-HIV-1 (n = 96), anti-HIV-2 (n = 26), or low levels of anti-HIV (n = 44) as well as specimens collected during HIV-1 seroconversion (n = 73). Specimens from unselected blood donors (n = 80) and samples from patients with a range of pathological conditions (n = 135) were also included. Observed sensitivities ranged from 96.9% (Biochrom, UBI, and Vironostika) to 100% (Biotest, Cambridge Biotech, IAF Biochem, Ortho, and Vidas). For the seroconversion specimens, Biotest, Cambridge Biotech, Ortho, and Vidas were most sensitive. Observed specificities ranged from 89.9% (UBI) to 100% (Biochrom and Ortho). One assay (Ortho HIV 1+2 EIA) achieved maximum sensitivity and specificity, and was one of four assays to detect anti-HIV-1 early in seroconversion. The accuracy of several of the other EIAs was also quite adequate, so additional factors such as convenience and cost can be considered when choosing an assay from the group evaluated.