Abstract
BackgroundAccording 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.MethodsThis 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.ResultsAfter 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.ConclusionsNearly 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.
Highlights
HIV self-testing (HIVST), the process in which a person collects his or her own specimen, performs the test and interprets the results, is recommended by the World Health Organisation (WHO) [1] as one of the strategies that will improve access to HIV testing services
Respondents’ socio‐demographic characteristics Table 1 shows the socio-demographic characteristics of the 95 respondents (43 whose kits were read as HIV-positive by the interviewers and 52 whose kits developed a second weak band while in storage) enrolled in this study
It is important to note that all respondents read their HIV self-test results as HIV-negative immediately after HIV self-testing
Summary
HIV self-testing (HIVST), the process in which a person collects his or her own specimen, performs the test and interprets the results, is recommended by the WHO [1] as one of the strategies that will improve access to HIV testing services. HIVST provides a convenient alternative to tests initiated by a health worker [2], and it reduces the health providers’ workload in areas with a shortage of health resources [3] Despite these benefits, questions have been raised on the performance of HIVST kits under sub-optimal field conditions such as those found in low and middle income countries [4, 5]. Watson et al [7] found that the earliest false weak bands developed after only 4 days of storage These results suggest that individuals whose kits change from non-reactive to false weak-reactive results might not be able to tell what their true HIV status is. We re-tested individuals whose results were initially non-reactive but changed to weak reactive results to determine their true HIV status
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