Kufa Tendesayi, Lane Tim, Manyuchi Albert, Singh Beverley, Isdahl Zachary, Osmand Thomas, Grasso Mike, Struthers Helen, McIntyre James, Chipeta Zawadi, Puren Adrian
Centre for HIV and STIs, National Institute for Communicable Diseases School of Public Health, University of the Witwatersrand, Johannesburg, South Africa Center for AIDS Prevention Studies, University of California, San Francisco, CA Anova Health Institute, Johannesburg, South Africa Global Health Sciences, University of California, San Francisco, CA Division of Infectious Diseases & HIV Medicine, Department of Medicine, University of Cape Town, Cape Town School of Public Health & Family Medicine, University of Cape Town, Cape Town Centres for Disease Control and Prevention (CDC), Pretoria Division of Virology, School of Pathology, University of the Witwatersrand, Johannesburg, South Africa.
Medicine (Baltimore). 2017 Jul;96(28):e7391. doi: 10.1097/MD.0000000000007391.
We describe the accuracy of serial rapid HIV testing among men who have sex with men (MSM) in South Africa and discuss the implications for HIV testing and prevention.This was a cross-sectional survey conducted at five stand-alone facilities from five provinces.Demographic, behavioral, and clinical data were collected. Dried blood spots were obtained for HIV-related testing. Participants were offered rapid HIV testing using 2 rapid diagnostic tests (RDTs) in series. In the laboratory, reference HIV testing was conducted using a third-generation enzyme immunoassay (EIA) and a fourth-generation EIA as confirmatory. Accuracy, sensitivity, specificity, positive predictive value, negative predictive value, false-positive, and false-negative rates were determined.Between August 2015 and July 2016, 2503 participants were enrolled. Of these, 2343 were tested by RDT on site with a further 2137 (91.2%) having definitive results on both RDT and EIA. Sensitivity, specificity, positive predictive value, negative predictive value, false-positive rates, and false-negative rates were 92.6% [95% confidence interval (95% CI) 89.6-94.8], 99.4% (95% CI 98.9-99.7), 97.4% (95% CI 95.2-98.6), 98.3% (95% CI 97.6-98.8), 0.6% (95% CI 0.3-1.1), and 7.4% (95% CI 5.2-10.4), respectively. False negatives were similar to true positives with respect to virological profiles.Overall accuracy of the RDT algorithm was high, but sensitivity was lower than expected. Post-HIV test counseling should include discussions of possible false-negative results and the need for retesting among HIV negatives.
我们描述了南非男男性行为者（MSM）中连续快速HIV检测的准确性，并讨论了其对HIV检测和预防的意义。这是一项在来自五个省份的五个独立机构进行的横断面调查。收集了人口统计学、行为学和临床数据。采集干血斑进行HIV相关检测。为参与者提供了串联使用2种快速诊断检测（RDT）的快速HIV检测。在实验室中，使用第三代酶免疫测定（EIA）和第四代EIA作为确证进行参考HIV检测。确定了准确性、敏感性、特异性、阳性预测值、阴性预测值、假阳性率和假阴性率。2015年8月至2016年7月期间，招募了2503名参与者。其中，2343人在现场接受了RDT检测，另外2137人（91.2%）在RDT和EIA检测中都有明确结果。敏感性、特异性、阳性预测值、阴性预测值、假阳性率和假阴性率分别为92.6%[95%置信区间（95%CI）89.6 - 94.8]、99.4%（95%CI 98.9 - 99.7）、97.4%（95%CI 95.2 - 98.6）、98.3%（95%CI 97.6 - 98.8）、0.6%（95%CI 0.3 - 1.1）和7.4%（95%CI 5.2 - 10.4）。假阴性在病毒学特征方面与真阳性相似。RDT算法的总体准确性较高，但敏感性低于预期。HIV检测后咨询应包括讨论可能的假阴性结果以及HIV阴性者再次检测的必要性。
