Quality control and performance of HIV rapid tests in a microbicide clinical trial in rural KwaZulu-Natal
Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Mtubatuba, South Africa; Wits Reproductive Health and HIV Institute, Johannesburg, South Africa; Contract Laboratory Services, University of the Witwatersrand Health Consortium, Johannesburg, South Africa
Background: Quality control (QC) and evaluation of HIV rapid test procedures are an important aspect of HIV prevention trials. We describe QC and performance of two rapid tests, Determine™ and Uni-Gold™ used in a microbicide clinical trial in rural KwaZulu-Natal, South Africa. Methods/Results: Internal QC of both HIV rapid tests was conducted at the trial site using a Uni-Gold control kit (Uni-Gold™Recombigen® HIV). Both assays produced the expected results for a total of 4637 QC tests. Study participants were tested for HIV at screening and, if enrolled, at regular time points throughout the study. Positive or discordant results were confirmed by a double HIV immunoassay testing strategy at a local laboratory. Overall, 15292 HIV rapid test were performed. Sensitivity and specificity of Determine was 98.95% (95% CI: 97.72-99.61) and 99.83% (95% CI: 99.70-99.91) respectively [positive predictive value (PPV) 97.91% (95% CI: 96.38-98.92)], for Uni-Gold it was 99.30% (95% CI: 98.21-99.81) and 99.96% (95% CI: 99.88-99.99) respectively [PPV 99.47% (95% CI: 98.46-99.89)]. Conclusions: The results suggest that a Uni-Gold control kit can be used for internal QC of both Uni-Gold and the HIV-1 component of the Determine rapid tests. Both rapid tests performed proficiently in the trial population. © 2012 von Knorring et al.
microbicide; anti human immunodeficiency virus agent; antiinfective agent; adult; article; controlled study; female; HIV test; human; Human immunodeficiency virus infection; immunoassay; major clinical study; male; predictive value; quality control; rural area; sensitivity and specificity; South Africa; analytical equipment; clinical trial (topic); diagnostic procedure; drug effect; Human immunodeficiency virus 1; Human immunodeficiency virus infection; isolation and purification; methodology; microbiological examination; quality control; rural population; standard; virology; Human immunodeficiency virus 1; Adult; Anti-HIV Agents; Anti-Infective Agents; Clinical Trials as Topic; Diagnostic Techniques and Procedures; Female; HIV Infections; HIV-1; Humans; Immunoassay; Microbial Sensitivity Tests; Quality Control; Reagent Kits, Diagnostic; Rural Population; South Africa; Young Adult