Abstract
BackgroundThe United States FDA approved an over-the-counter HIV self-test, to facilitate increased HIV testing and earlier linkage to care. We assessed the accuracy of self-testing by untrained participants compared to healthcare worker (HCW) testing, participants’ ability to interpret sample results and user-acceptability of self-tests in Singapore.Methodology/Principal FindingsA cross-sectional study, involving 200 known HIV-positive patients and 794 unknown HIV status at-risk participants was conducted. Participants (all without prior self-test experience) performed self-testing guided solely by visual instructions, followed by HCW testing, both using the OraQuick ADVANCE Rapid HIV 1/2 Antibody Test, with both results interpreted by the HCW. To assess ability to interpret results, participants were provided 3 sample results (positive, negative, and invalid) to interpret. Of 192 participants who tested positive on HCW testing, self-testing was positive in 186 (96.9%), negative in 5 (2.6%), and invalid in 1 (0.5%). Of 794 participants who tested negative on HCW testing, self-testing was negative in 791 (99.6%), positive in 1 (0.1%), and invalid in 2 (0.3%). Excluding invalid tests, self-testing had sensitivity of 97.4% (95% CI 95.1% to 99.7%) and specificity of 99.9% (95% CI: 99.6% to 100%). When interpreting results, 96%, 93.1% and 95.2% correctly read the positive, negative and invalid respectively. There were no significant demographic predictors for false negative self-testing or wrongly interpreting positive or invalid sample results as negative. Eighty-seven percent would purchase the kit over-the-counter; 89% preferred to take HIV tests in private. 72.5% and 74.9% felt the need for pre- and post-test counseling respectively. Only 28% would pay at least USD15 for the test.Conclusions/SignificanceSelf-testing was associated with high specificity, and a small but significant number of false negatives. Incorrectly identifying model results as invalid was a major reason for incorrect result interpretation. Survey responses were supportive of making self-testing available.
Highlights
Awareness of HIV status is crucial to prevent onward transmission and achieve favorable treatment outcomes [1,2]
87.4% of participants would purchase an overthe-counter rapid test kit, with the highest proportion being among private clinic at-risk participants (92.4%). 89% wanted to conduct HIV testing in private and only 36.4% would agree to have their names recorded when undergoing a HIV test. 72.5% felt that pretest counseling was necessary
Negative Positive Invalid aThree invalid self-tests were excluded from analysis, of which 1 was paired with a positive healthcare worker test and another 2 paired with a negative healthcare worker test
Summary
Awareness of HIV status is crucial to prevent onward transmission and achieve favorable treatment outcomes [1,2]. A recent randomized trial demonstrating a 96% reduction in onward transmission associated with antiretroviral therapy further highlights the importance of early diagnosis, a prerequisite for treatment initiation [3]. In the first year of home testing availability, 174,316 home-tests were ordered in the United States [9]. This was despite the inconvenience and discomfort of finger-prick to obtain dried-blood spots and having to mail these samples to a commercial company before receiving results via phone-call after a few days. We assessed the accuracy of self-testing by untrained participants compared to healthcare worker (HCW) testing, participants’ ability to interpret sample results and user-acceptability of self-tests in Singapore
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
