Fogel Jessica M, Piwowar-Manning Estelle, Donohue Kelsey, Cummings Vanessa, Marzinke Mark A, Clarke William, Breaud Autumn, Fiamma Agnès, Donnell Deborah, Kulich Michal, Mbwambo Jessie K K, Richter Linda, Gray Glenda, Sweat Michael, Coates Thomas J, Eshleman Susan H
*Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD; †Program in Global Health, University of California, Los Angeles, Los Angeles, CA; ‡Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA; §Department of Global Health, University of Washington, Seattle, WA; ‖Department of Probability and Statistics, Faculty of Mathematics and Physics, Charles University, Prague, Czech Republic; ¶Muhimbili University of Health and Allied Sciences, Muhimbili University Teaching Hospital, Dar es Salaam, Tanzania; #DST-NRF Centre of Excellence in Human Development, Universities of the Witwatersrand and KwaZulu-Natal, Johannesburg, South Africa; **Human Sciences Research Council, Durban, South Africa; ††Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, University of the Witwatersrand, Johannesburg, South Africa; ‡‡South African Medical Research Council, Cape Town, South Africa; §§Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC; and ‖‖Center for World Health, David Geffen School of Medicine and UCLA Health, Los Angeles, CA.
J Acquir Immune Defic Syndr. 2015 Aug 1;69(4):430-8. doi: 10.1097/QAI.0000000000000610.
In resource-limited settings, HIV infection is often diagnosed using 2 rapid tests. If the results are discordant, a third tie-breaker test is often used to determine HIV status. This study characterized samples with discordant rapid tests and compared different testing strategies for determining HIV status in these cases.
Samples were previously collected from 173 African adults in a population-based survey who had discordant rapid test results. Samples were classified as HIV positive or HIV negative using a rigorous testing algorithm that included two fourth-generation tests, a discriminatory test, and 2 HIV RNA tests. Tie-breaker tests were evaluated, including rapid tests (1 performed in-country), a third-generation enzyme immunoassay, and two fourth-generation tests. Selected samples were further characterized using additional assays.
Twenty-nine samples (16.8%) were classified as HIV positive and 24 of those samples (82.8%) had undetectable HIV RNA. Antiretroviral drugs were detected in 1 sample. Sensitivity was 8.3%-43% for the rapid tests; 24.1% for the third-generation enzyme immunoassay; 95.8% and 96.6% for the fourth-generation tests. Specificity was lower for the fourth-generation tests than the other tests. Accuracy ranged from 79.5% to 91.3%.
In this population-based survey, most HIV-infected adults with discordant rapid tests were virally suppressed without antiretroviral drugs. Use of individual assays as tie-breaker tests was not a reliable method for determining HIV status in these individuals. More extensive testing algorithms that use a fourth-generation screening test with a discriminatory test and HIV RNA test are preferable for determining HIV status in these cases.
在资源有限的环境中，通常使用两种快速检测来诊断HIV感染。如果结果不一致，常使用第三种决胜检测来确定HIV状态。本研究对快速检测结果不一致的样本进行了特征分析，并比较了在这些情况下确定HIV状态的不同检测策略。
样本先前是在一项基于人群的调查中从173名非洲成年人中收集的，这些人的快速检测结果不一致。使用严格的检测算法将样本分类为HIV阳性或HIV阴性，该算法包括两种第四代检测、一种鉴别检测和两种HIV RNA检测。对决胜检测进行了评估，包括快速检测（1种在国内进行）、第三代酶免疫测定和两种第四代检测。使用其他检测方法对选定样本进行进一步特征分析。
29个样本（16.8%）被分类为HIV阳性，其中24个样本（82.8%）的HIV RNA检测不到。在1个样本中检测到了抗逆转录病毒药物。快速检测的灵敏度为8.3%-43%；第三代酶免疫测定为24.1%；第四代检测为95.8%和96.6%。第四代检测的特异性低于其他检测。准确率在79.5%至91.3%之间。
在这项基于人群的调查中，大多数快速检测结果不一致的HIV感染成年人在未使用抗逆转录病毒药物的情况下病毒得到抑制。使用单个检测作为决胜检测不是确定这些个体HIV状态的可靠方法。在这些情况下，使用第四代筛查检测结合鉴别检测和HIV RNA检测的更广泛检测算法更适合确定HIV状态。
