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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Quality control and performance of HIV rapid tests in a microbicide clinical trial in rural KwaZulu-Natal
PLoS ONE, Volume 7, No. 1, Article e30728, Year 2012
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Description
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.
Authors & Co-Authors
von Knorring, Nina
South Africa, Durban
University of Kwazulu-natal
South Africa, Johannesburg
University of the Witwatersrand Faculty of Health Sciences
Gafos, Mitzy
South Africa, Durban
University of Kwazulu-natal
Ramokonupi, Motsei
South Africa, Durban
University of Kwazulu-natal
Jentsch, Ute
South Africa, Johannesburg
University of the Witwatersrand
Statistics
Citations: 7
Authors: 4
Affiliations: 3
Identifiers
Doi:
10.1371/journal.pone.0030728
e-ISSN:
19326203
Research Areas
Infectious Diseases
Study Design
Cross Sectional Study
Study Locations
South Africa