MRC International Statistics and Epidemiology Group and Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
Zambart, University of Zambia School of Public Health, Ridgeway Campus, Off Nationalist Road, Lusaka, Zambia.
BMC Infect Dis. 2022 May 25;22(Suppl 1):494. doi: 10.1186/s12879-022-07457-5.
BACKGROUND: HIV self-testing (HIVST) has the potential to increase coverage of HIV testing, but concerns exist about intended users' ability to correctly perform and interpret tests, especially in poor communities with low literacy rates. We assessed the clinical performance of the 2016 prototype OraQuick® HIV Self-Test in rural and urban communities in Zambia to assess the sensitivity and specificity of the test compared to the national HIV rapid diagnostic test (RDT) algorithm and a laboratory reference standard using 4th generation enzyme immunoassays and HIV RNA detection. METHODS: Participants were recruited from randomly selected rural and urban households and one urban health facility between May 2016 and June 2017. Participants received a brief demonstration of the self-test, and then self-tested without further assistance. The research team re-read the self-test, repeated the self-test, drew blood for the laboratory reference, and conducted RDTs following the national HIV testing algorithm (Determine™ HIV1/2 (Alere) confirmed using Unigold™ HIV1/2 (Trinity Biotech)). Selected participants (N = 85) were videotaped whilst conducting the testing to observe common errors. RESULTS: Initial piloting showed that written instructions alone were inadequate, and a demonstration of self-test use was required. Of 2,566 self-test users, 2,557 (99.6%) were able to interpret their result. Of participants who were videoed 75/84 (89.3%) completed all steps of the procedure correctly. Agreement between the user-read result and the researcher-read result was 99.1%. Compared to the RDT algorithm, user-conducted HIVST was 94.1% sensitive (95%CI: 90.2-96.7) and 99.7% specific (95%CI: 99.3-99.9). Compared to the laboratory reference, both user-conducted HIVST (sensitivity 87.5%, 95%CI: 82.70-91.3; specificity 99.7%, 95%CI: 99.4-99.9) and the national RDT algorithm (sensitivity 93.4%, 95%CI: 89.7-96.1%; specificity 100% (95%CI: 99.8-100%) had considerably lower sensitivity. CONCLUSIONS: Self-testers in Zambia who used OraQuick® HIV Self-Test achieved reasonable clinical performance compared to the national RDT algorithm. However, sensitivity of the self-test was reduced compared to a laboratory reference standard, as was the national RDT algorithm. In-person demonstration, along with the written manufacturer instructions, was needed to obtain accurate results. Programmes introducing self-care diagnostics should pilot and optimise support materials to ensure they are appropriately adapted to context.
背景：HIV 自我检测（HIVST）有可能增加 HIV 检测的覆盖率，但人们对目标使用者正确进行和解释检测的能力存在担忧，尤其是在识字率低的贫困社区。我们评估了 2016 年 OraQuick®HIV 自我检测在赞比亚农村和城市社区的临床性能，以评估该检测与国家 HIV 快速诊断检测（RDT）算法和使用第四代酶免疫测定和 HIV RNA 检测的实验室参考标准相比的敏感性和特异性。
方法：参与者于 2016 年 5 月至 2017 年 6 月期间从随机选择的农村和城市家庭以及一个城市卫生机构中招募。参与者接受了简短的自我检测演示，然后在没有进一步帮助的情况下自行检测。研究团队重新阅读了自我检测结果，重复了自我检测，抽取了血液样本用于实验室参考，并按照国家 HIV 检测算法（使用 Determine™HIV1/2（Alere）和 Unigold™HIV1/2（Trinity Biotech）确认）进行了 RDT。对选定的参与者（N=85）进行了视频拍摄，以观察常见错误。
结果：初步试验表明，仅书面说明是不够的，需要演示自我检测的使用方法。在 2566 名自我检测使用者中，2557 名（99.6%）能够解释他们的结果。在接受视频拍摄的参与者中，75/84（89.3%）人正确完成了所有步骤。使用者读取的结果与研究人员读取的结果之间的一致性为 99.1%。与 RDT 算法相比，使用者进行的 HIVST 的敏感性为 94.1%（95%CI：90.2-96.7），特异性为 99.7%（95%CI：99.3-99.9）。与实验室参考标准相比，使用者进行的 HIVST（敏感性 87.5%，95%CI：82.70-91.3；特异性 99.7%，95%CI：99.4-99.9）和国家 RDT 算法（敏感性 93.4%，95%CI：89.7-96.1%；特异性 100%（95%CI：99.8-100%）的敏感性都明显降低。
结论：在赞比亚，使用 OraQuick®HIV 自我检测的自我检测者与国家 RDT 算法相比，临床性能相当。然而，与实验室参考标准相比，自我检测的敏感性降低，国家 RDT 算法也是如此。需要进行现场演示，同时提供制造商的书面说明，以获得准确的结果。引入自我护理诊断的项目应进行试点并优化支持材料，以确保它们适应当地情况。
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