title: Multisite evaluation of four anti-HIV-1/HIV-2 enzyme immunoassays. Australian HIV Test Evaluation Group.
abstract: The performance of four enzyme immunoassays, manufactured by Abbott, Diagnostics Pasteur, Genetic Systems, and Organon Teknika, for the combined detection of anti-human immunodeficiency virus type 1 (HIV-1) and anti-HIV-2, was examined in a multisite evaluation. The collaborative efforts of 7 Australian Red Cross Blood Transfusion and 12 Australian Public Health Laboratories minimized potential biases in data by providing large numbers of anti-HIV-1-negative and -positive samples. Sensitivity was estimated using samples that were positive for anti-HIV-1 from individuals known to be infected and seroconversion samples. Sensitivity estimates in the four assays were 99.71, 99.94, 99.49, and 99.68%, respectively. Specificity was measured using fresh, sequential blood donations and samples with previous false-positive reactions in other assays. Specificity estimates from blood donations were 99.92, 99.46, 99.67, and 99.85%, respectively. The data were analyzed further using the delta statistic, which distinguishes the performance of assays of similar sensitivity and specificity by providing a measure of how well results in a population of positive or negative samples are removed from the assay's cutoff value.
authors.affiliation: National HIV Reference Laboratory, Fairfield Hospital, Victoria, Australia.
authors.forename: C
authors.initials: C
authors.lastname: Silvester
authors.forename: D S
authors.initials: DS
authors.lastname: Healey
authors.forename: P
authors.initials: P
authors.lastname: Cunningham
authors.forename: E M
authors.initials: EM
authors.lastname: Dax
mesh_terms: D001315:Australia; D005189:False Positive Reactions; D015483:HIV Antibodies / Q000032:analysis*; D015658:HIV Infections / Q000175:diagnosis*; D018023:HIV Seronegativity / Q000276:immunology; D006679:HIV Seropositivity / Q000276:immunology; D015497:HIV-1 / Q000276:immunology*; D015498:HIV-2 / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
chemical_list: D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic