Ethiopian Public health institute, Addis Ababa, Ethiopia.
Population service International/E, Addis Ababa, Ethiopia.
PLoS One. 2019 Jan 25;14(1):e0210866. doi: 10.1371/journal.pone.0210866. eCollection 2019.
BACKGROUND: Human immunodeficiency virus (HIV) testing is critical for early linkage to treatment and care services. However, there is a substantial gap in HIV testing, particularly in resource limited settings due to low accessibility of HIV testing sites, inconvenient testing hours, and concerns about loss of confidentiality. Thus, adopting new strategies such as HIV self-testing (HIVST) could overcome these barriers and increases HIV testing uptake. OBJECTIVE: The aim of this study was to evaluate the diagnostic performance of non-invasive HIVST kit using oral fluid for HIV diagnosis. This study also aimed to assess the ability of clients in interpretation of OraQuick HIVST results. METHOD: Between December 2017 and February 2018, a total of 400 study participants were enrolled into the study to assess a diagnostic accuracy of Oral fluid-based HIVST kit (OraQuick) in 15 public health facilities in Addis Ababa, Ethiopia. Participants were provided with instructions and visual aids on how to perform HIVST and interpret results. They also underwent a blood-based rapid HIV antibody test as per the current national algorithm. The results of HIVST were interpreted independently by the participants and respective health care workers (HCWs). The sensitivity, specificity, positive predictive value (PPV), Negative predictive value (NPV) and inter-rater agreement of the test were computed. RESULTS: Out of 200 participants who tested positive on the national algorithm testing, oral fluid-based self-testing was positive in 199 (99.5%), false negative in 1 (0.5%). Of 200 participants who tested negative on the national algorithm testing, self-testing was negative in 200 (100%). There were no false positive and invalid tests. The sensitivity and specificity of the OraQuick HIVST were 99.5% (95%CI: 97.26-99.99) and 100% (95%CI: 98.18-100.0), respectively. The overall agreement between the two tests was high (κ value = 0.995). The PPV and NPV of OraQuick test were 100% and 99.5% (95%CI: 96.59-99.93) respectively. CONCLUSION: This study showed a high diagnostic performance of OraQuick HIV self-test and suggests that OraQuick HIVST kit has a potential to be used for HIV testing in Ethiopia along with the national algorithm.
背景：人类免疫缺陷病毒（HIV）检测对于早期与治疗和护理服务建立联系至关重要。然而，由于 HIV 检测点的可及性低、检测时间不方便以及对保密性丧失的担忧，HIV 检测存在很大差距，尤其是在资源有限的环境中。因此，采用 HIV 自我检测（HIVST）等新策略可以克服这些障碍，提高 HIV 检测率。
目的：本研究旨在评估使用口腔液进行非侵入性 HIVST 试剂盒进行 HIV 诊断的诊断性能。本研究还旨在评估客户解读 OraQuick HIVST 结果的能力。
方法：2017 年 12 月至 2018 年 2 月期间，在埃塞俄比亚亚的斯亚贝巴的 15 个公共卫生设施中，共有 400 名研究参与者入组本研究，以评估基于口腔液的 HIVST 试剂盒（OraQuick）的诊断准确性。参与者接受了有关如何进行 HIVST 和解读结果的说明和视觉辅助。他们还按照当前的国家算法接受了基于血液的快速 HIV 抗体检测。参与者和各自的卫生保健工作者（HCWs）独立解读 HIVST 结果。计算了该测试的敏感性、特异性、阳性预测值（PPV）、阴性预测值（NPV）和组内一致性。
结果：在接受国家算法检测呈阳性的 200 名参与者中，有 199 名（99.5%）口腔液自我检测呈阳性，1 名（0.5%）呈假阴性。在接受国家算法检测呈阴性的 200 名参与者中，自我检测均呈阴性。没有假阳性和无效检测。OraQuick HIVST 的敏感性和特异性分别为 99.5%（95%CI：97.26-99.99）和 100%（95%CI：98.18-100.0）。两种检测方法的总体一致性很高（κ 值=0.995）。OraQuick 测试的阳性预测值和阴性预测值分别为 100%和 99.5%（95%CI：96.59-99.93）。
结论：本研究表明 OraQuick HIV 自我检测具有较高的诊断性能，并表明 OraQuick HIVST 试剂盒有可能与国家算法一起在埃塞俄比亚用于 HIV 检测。
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