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. 2012;7(1):e30728.
doi: 10.1371/journal.pone.0030728. Epub 2012 Jan 30.

Quality control and performance of HIV rapid tests in a microbicide clinical trial in rural KwaZulu-Natal

Nina von Knorring  1 , Mitzy Gafos, Motsei Ramokonupi, Ute Jentsch; MDP Team
Affiliations

Quality control and performance of HIV rapid tests in a microbicide clinical trial in rural KwaZulu-Natal

Nina von Knorring et al. PLoS One. 2012.

Abstract

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.

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Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

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