title: Comparative evaluation of 36 commercial assays for detecting antibodies to HIV.
abstract: 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.
authors.affiliation: Department of Microbiology, Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: I
authors.initials: I
authors.lastname: Van Kerckhoven
authors.forename: G
authors.initials: G
authors.lastname: Vercauteren
authors.forename: P
authors.initials: P
authors.lastname: Piot
authors.forename: G
authors.initials: G
authors.lastname: van der Groen
mesh_terms: D015492:AIDS Serodiagnosis / Q000592:standards*; D004341:Drug Evaluation; D004797:Enzyme-Linked Immunosorbent Assay; D015497:HIV-1 / Q000276:immunology; D015498:HIV-2 / Q000276:immunology; D006801:Humans; D007118:Immunoassay; D015588:Observer Variation; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity