Quality control and performance of HIV rapid tests in a microbicide clinical trial in rural KwaZulu-Natal.
PLoS One
; 7(1): e30728, 2012.
Article
em En
| MEDLINE
| ID: mdl-22303452
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Kit de Reagentes para Diagnóstico
/
População Rural
/
Testes de Sensibilidade Microbiana
/
HIV-1
/
Fármacos Anti-HIV
/
Técnicas e Procedimentos Diagnósticos
/
Anti-Infecciosos
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
Limite:
Adult
/
Female
/
Humans
País/Região como assunto:
Africa
Idioma:
En
Revista:
PLoS One
Assunto da revista:
CIENCIA
/
MEDICINA
Ano de publicação:
2012
Tipo de documento:
Article
País de afiliação:
África do Sul