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

التفاصيل البيبلوغرافية
العنوان: Quality control and performance of HIV rapid tests in a microbicide clinical trial in rural KwaZulu-Natal.
المؤلفون: Nina von Knorring, Mitzy Gafos, Motsei Ramokonupi, Ute Jentsch, MDP Team
المصدر: PLoS ONE, Vol 7, Iss 1, p e30728 (2012)
بيانات النشر: Public Library of Science (PLoS), 2012.
سنة النشر: 2012
المجموعة: LCC:Medicine
LCC:Science
مصطلحات موضوعية: Medicine, Science
الوصف: 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.
نوع الوثيقة: article
وصف الملف: electronic resource
اللغة: English
تدمد: 1932-6203
Relation: http://europepmc.org/articles/PMC3268764?pdf=render; https://doaj.org/toc/1932-6203
DOI: 10.1371/journal.pone.0030728
URL الوصول: https://doaj.org/article/9c96c3169be647eabc6f29d5993a60bb
رقم الأكسشن: edsdoj.9c96c3169be647eabc6f29d5993a60bb
قاعدة البيانات: Directory of Open Access Journals
الوصف
تدمد:19326203
DOI:10.1371/journal.pone.0030728