Comparative evaluation and assessment of the diagnostic usefulness of four commercial HIV-l/HIV-2 antibody assays using two well-characterized serum panels from Blood Transfusion Service and the National Health Laboratory services in Zimbabwe

Abstract

Objective: To evaluate four Enzyme Linked Immunosorbent Assay ( ELISA) HIV kits for possible use as a combination at the National Health Laboratory Services (NHLS) in Zimbabwe. Design: Laboratory evaluation, sensitivity, specificity and cost effectiveness of HIV diagnostic kits. Setting: Blood Transfusion Service (BTS) and Parirenyatwa Hospital in Zimbabwe. Subjects: A total of 346 samples from 245 patients referred to Parirenyatwa Hospital and 101 blood donors at BTS. Main outcome: The main goal was to come out with the best combination of ELISA kits in terms of sensitivity, specificity and cost effectiveness for use in diagnosis of HIV infection in Zimbabwe. Results: The best combination kit was the Murex/Innotest with 100% sensitivity and 98.9% specificity, being slightly superior to the Genelavia/Vironostika combination kits in current use at NHLS. In addition, the Murex/Innotest combination has the shortest assay running time and requires fewer internal controls thereby increasing the number of test specimens per run. Conclusion: We recommend the use of the Murex/Innotest kits as a suitable combination for HIV infection diagnosis in Zimbabwe. The combination has a relatively low number of discordant results, drastically reducing the cost of running a third confirmatory test to resolve the discordant results. Most importantly, this combination maximizes HIV infection diagnosis by its ability to detect antibodies to HIV-1 groups M and O as well as HIV--2.