Comparative evaluation of 36 commercial assays for detecting antibodies to HIV.

Summarized are the results of an assessment of the major operational characteristics of 36 commercially available assays for detection of antibodies to human immunodeficiency virus type 1 (HIV-1) and/or type 2 (HIV-2). For this purpose, 20 enzyme-linked immunosorbent assays (ELISAs), 11 simple immunoassays with visual reading, four supplemental assays, and one discriminatory assay were assessed using a panel of 537 sera (65% of which were of African, 26% of European, and 9% of South American origin); the prevalence of HIV-1 was 39.1% and of HIV-2, 15.7%. The following operational parameters of the assays were investigated: ease of performance; suitability for use in small blood collection centres; sensitivity and specificity; positive predictive values at different prevalences; inter-reader variability for simple assays whose results were read visually; the proportion of indeterminate results; and, for some of the ELISA assays, delta-values, as quantitative measures of sensitivity and specificity. The results will be of use to health policy decision-makers, managers of national AIDS prevention and control programmes, directors of blood banks, and laboratory specialists in the selection of appropriate HIV antibody assays.