Evaluation of diagnostic performance of noninvasive HIV self-testing kit using oral fluid in Addis Ababa, Ethiopia: A facility-based cross-sectional study

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.