Ecole Doctorale Régionale D'Afrique Centrale en Infectiologie Tropicale, Franceville, Gabon.
Department of Internal Medicine, Faculty de Medicine, University of Bunia, Bunia, The Democratic Republic of the Congo.
PLoS One. 2020 Oct 5;15(10):e0239607. doi: 10.1371/journal.pone.0239607. eCollection 2020.
HIV self-testing (HIVST) is an additional approach to increasing uptake of HIV testing services. The practicability and accuracy of and the preference for the capillary blood self-test (Exacto Test HIV) versus the oral fluid self-test (OraQuick HIV self-test) were compared among untrained individuals in the Democratic Republic of the Congo (DRC).
This multicenter cross-sectional study (2019) used face-to-face, tablet-based, structured questionnaires in a facility-based HIVST approach. Volunteers from the general public who were at high risk of HIV infection, who were between 18 and 49 years of age, and who had signed an informed consent form were eligible for the study. The successful performance and correct interpretation of the self-test results were the main outcomes of the practicability evaluation. The successful performance of the HIV self-test was conditioned by the presence of the control band. The sensitivity and specificity of the participant-interpreted results compared to the laboratory results were estimated for accuracy. Preference for either type of self-test was assessed. Logistic regression models were used to examine factors associated with participants' preference.
A total of 528 participants were included in this survey. The rate of successful performance of the HIV self-tests was high, with the blood test (99.6%) and the oral-fluid test (99.4%) yielding an absolute difference of 0.2% (95% CI: -1.8 to 1.1; P = 0.568). The rate of correct interpretation of the HIV self-test results was 84.4% with the blood test versus 83.8% with the oral-fluid test (difference = 0.6; 95% CI: -0.2 to 1.7; P = 0.425). Misinterpretation (25.4% for the blood test and 25.6% for the oral-fluid test) and inability to interpret (20.4% for the blood test and 21.1% for the oral-fluid test) test results were significantly more prevalent with invalid tests. The Exacto Test HIV self-test and the OraQuick HIV self-test showed 100% and 99.2% sensitivity, and 98.9% and 98.1% specificity, respectively. Preference for oral-fluid-based HIVST was greater than that for blood-based HIVST (85.6% versus 78.6%; P = 0.008). Preference for the blood test was greater among participants with a university education (86.1%; aOR = 2.4 [95% CI: 1.1 to 4.9]; P = 0.016), a higher risk of HIV infection (88.1%; aOR = 2.3 [95% CI: 1.0 to 5.3]; P = 0.047), and knowledge about the existence of HIVST (89.3%; aOR = 2.2 [95% CI: 1.0 to 5.0]; P = 0.05).
Our field observations demonstrate that blood-based and oral-fluid-based HIVST are both practicable approaches with a high and comparable rate of accuracy in the study setting. Although preference for the oral-fluid test was generally greater, preference for the blood test was greater among participants with a university education, a high risk of HIV infection, and knowledge about the existence of HIVST. Both approaches seem complementary in the sense that users can choose the type of self-test that best suits them for a similar result. Taken together, our observations support the use of the two HIV self-test kits in the DRC.
HIV 自我检测（HIVST）是增加 HIV 检测服务利用率的另一种方法。在刚果民主共和国（DRC），未经过培训的个体中，比较了毛细血管血自我检测（Exacto Test HIV）与唾液自我检测（OraQuick HIV 自我检测）在实用性、准确性和偏好方面的差异。
这是一项多中心横断面研究（2019 年），采用基于设施的 HIVST 方法，使用面对面、基于平板电脑的结构化问卷。符合以下条件的高危 HIV 感染的公众志愿者有资格参加研究：年龄在 18 至 49 岁之间，签署了知情同意书。自我检测结果的成功表现和正确解释是实用性评估的主要结果。自我检测的成功表现取决于是否存在控制线。参与者解释的结果与实验室结果的敏感性和特异性的比较评估了准确性。评估了对两种自我检测的偏好。使用逻辑回归模型检查与参与者偏好相关的因素。
共有 528 名参与者参加了这项调查。HIV 自我检测的成功率很高，血液检测（99.6%）和唾液检测（99.4%）的成功率绝对差值为 0.2%（95%CI：-1.8 至 1.1；P = 0.568）。血液检测和唾液检测的正确解释 HIV 自我检测结果的比例分别为 84.4%和 83.8%（差异=0.6；95%CI：-0.2 至 1.7；P = 0.425）。错误解释（血液检测 25.4%，唾液检测 25.6%）和无法解释（血液检测 20.4%，唾液检测 21.1%）的检测结果在无效检测中更为常见。Exacto Test HIV 自我检测和 OraQuick HIV 自我检测的灵敏度分别为 100%和 99.2%，特异性分别为 98.9%和 98.1%。与血液检测相比，更倾向于使用基于唾液的 HIVST（85.6%比 78.6%；P = 0.008）。在具有大学教育背景的参与者中，更倾向于使用血液检测（86.1%；aOR = 2.4 [95%CI：1.1 至 4.9]；P = 0.016）、更高的 HIV 感染风险（88.1%；aOR = 2.3 [95%CI：1.0 至 5.3]；P = 0.047）和对 HIVST 存在的了解（89.3%；aOR = 2.2 [95%CI：1.0 至 5.0]；P = 0.05）。
我们的实地观察表明，基于血液和唾液的 HIVST 都是可行的方法，在研究环境中具有相似的高准确性和可比性。尽管一般来说对唾液检测的偏好更大，但在具有大学教育背景、HIV 感染风险高和对 HIVST 存在知识的参与者中，对血液检测的偏好更大。这两种方法似乎是互补的，因为用户可以选择最适合自己的自我检测类型，以获得相似的结果。总的来说，我们的观察结果支持在刚果民主共和国使用这两种 HIV 自我检测试剂盒。
