Evaluation of five commercial assays for detecting HIV 1 & 2 antibodies, Addis Ababa

Abstract

The major operational characteristics of five commercially available assays for the detection of antibodies to Human Immunodeficiency Virus (HIV1 & 2) were evaluated. Four Enzyme Linked Immuno-sorbent assays (ELISAs) and one simple immuno-dot assay with visual reading, were assessed using a panel of 265 sera (18.8% hospital suspected patients, 18.8% commercial sex-workers (CSW), 31.5% blood donor sample (BDS), and 30.9% of them were scholarship winners (SSW)). Sensitivity, specificity, positive predictive value, test efficiency, delta (δ) values (for the four ELISAs) were determined. All the assays had higher sensitivities (98.7100%), specificities (97.2-99.1%), and test efficiencies (98.1-99.6%). Higher positive and negative delta (δ + ,δ - ) values, +1.17 and –0.99, were observed for ICE*HIV 1-0-2 and Vironostika Uniform II PLUS O, respectively. HIV-SPOT HIV 1 & 2 showed highest value of ease of performance and suitability for small blood bank collection centers. Results of this study showed that the test efficiency, sensitivity, and specificity of the test kits were excellent as compared to the reference test. Further studies on cost-effectiveness and evaluation of newly arrived test kits before use at different levels are recommended.