Background: According to the user instructions from the manufacturer of OraQuick HIV self-test (HIVST) kits, individuals whose kits show one red band should be considered to be HIV-negative, no matter how weak the band is. However, recent reports show potential for a second false weak band after storage, thereby creating confusion in the interpretation of results. In this study, we re-tested individuals whose results were initially non-reactive but changed to weak reactive results to determine their true HIV status.
Methods: This study was nested within a large, cluster-randomized HIVST trial implemented among pregnant women attending antenatal care and their male partners in central Uganda between July 2016 and February 2017. Ninety-five initially HIV-negative respondents were enrolled into this study, including 52 whose kits developed a second weak band while in storage and 43 whose kits were interpreted as HIV-positive by interviewers at the next follow-up interview. Respondents were invited to return for repeat HIVST which was performed under the observation of a trained nurse counsellor. After HIVST, respondents underwent blood-based rapid HIV testing as per the national HIV testing algorithm (Determine (Abbot Laboratories), STAT-PAK (Chembio Diagnostic Systems Inc.) and Unigold (Trinity Biotech plc.) and dry blood spots were obtained for DNA/PCR testing. DNA/PCR was considered as the gold-standard HIV testing method.
Results: After repeat HIVST, 90 (94.7%) tested HIV-negative; 2 (2.1%) tested HIV-positive; and 3 (3.2%) had missing HIV test results. When respondents were subjected to blood-based rapid HIV testing, 97.9% (93/95) tested HIV-negative while 2.1% (2/95) tested HIV-positive. Finally, when the respondents were subjected to DNA/PCR, 99% (94/95) tested HIV-negative while 1.1% (1/95) tested HIV-positive.
Conclusions: Nearly all initially HIV-negative individuals whose HIVST kits developed a second weak band while in storage or were interpreted as HIV-positive by interviewers were found to be HIV-negative after confirmatory DNA/PCR HIV testing. These findings suggest a need for HIV-negative individuals whose HIVST results change to false positive while under storage or under other sub-optimal conditions to be provided with an option for repeat testing to determine their true HIV status.
Keywords: Confirmatory HIV testing; HIV self-testing; Uganda; Weak band.