在夸祖鲁-纳塔尔省农村地区的杀微生物剂临床试验中 HIV 快速检测的质量控制和性能。
Quality control and performance of HIV rapid tests in a microbicide clinical trial in rural KwaZulu-Natal.
机构信息
Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Mtubatuba, South Africa.
出版信息
PLoS One. 2012;7(1):e30728. doi: 10.1371/journal.pone.0030728. Epub 2012 Jan 30.
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.
背景
质量控制（QC）和 HIV 快速检测程序的评估是 HIV 预防试验的一个重要方面。我们描述了在南非夸祖鲁-纳塔尔省农村地区进行的杀微生物剂临床试验中使用的两种快速检测方法 Determine 和 Uni-Gold 的 QC 和性能。
方法/结果：在试验现场使用 Uni-Gold 对照试剂盒（Uni-Gold™ Recombigen® HIV）对两种 HIV 快速检测方法进行内部 QC。两种检测方法共进行了 4637 次 QC 检测，均得到了预期的结果。研究参与者在筛查时接受 HIV 检测，如果入选，在整个研究过程中定期进行检测。阳性或不一致的结果在当地实验室采用双 HIV 免疫测定策略进行确认。总共进行了 15292 次 HIV 快速检测。Determine 的灵敏度和特异性分别为 98.95%（95%CI：97.72-99.61）和 99.83%（95%CI：99.70-99.91）[阳性预测值（PPV）为 97.91%（95%CI：96.38-98.92）]，而 Uni-Gold 的灵敏度和特异性分别为 99.30%（95%CI：98.21-99.81）和 99.96%（95%CI：99.88-99.99）[阳性预测值（PPV）为 99.47%（95%CI：98.46-99.89）]。
结论
结果表明，Uni-Gold 对照试剂盒可用于 Uni-Gold 和 Determine 快速检测的 HIV-1 组件的内部 QC。两种快速检测方法在试验人群中表现良好。
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