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


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.
Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Mtubatuba, South Africa. nvonknorring@wrhi.ac.za
Nina
N
von Knorring
Mitzy
M
Gafos
Motsei
M
Ramokonupi
Ute
U
Jentsch
D000328:Adult; D019380:Anti-HIV Agents / Q000494:pharmacology*; D000890:Anti-Infective Agents / Q000494:pharmacology*; D002986:Clinical Trials as Topic; D019937:Diagnostic Techniques and Procedures / Q000592:standards*; D005260:Female; D015658:HIV Infections / Q000175:diagnosis / Q000821:virology; D015497:HIV-1 / Q000187:drug effects / Q000302:isolation & purification*; D006801:Humans; D007118:Immunoassay; D008826:Microbial Sensitivity Tests / Q000379:methods*; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012424:Rural Population; D013019:South Africa; D055815:Young Adult
D019380:Anti-HIV Agents; D000890:Anti-Infective Agents; D011933:Reagent Kits, Diagnostic