Initial Accuracy of HIV Rapid Test Kits Stored in Suboptimal Conditions and Validity of Delayed Reading of Oral Fluid Tests

Choko, Augustine; Taegtmeyer, Miriam; MacPherson, Peter; Cocker, Derek; Khundi, McEwen; Thindwa, Deus; Sambakunsi, Rodrick; Kumwenda, Moses; Chiumya, Kondwani; Malema, Owen; Makombe, Simon D; Webb, Emily L.; Corbett, Elizabeth L.

doi:10.1371/journal.pone.0158107

Cited by 12 publications

(16 citation statements)

References 12 publications

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“…A previous study conducted in Malawi examined the pre‐use stability of OraQuick ® HIV test kits . 371 optimally stored and 375 pre‐incubated used devices were re‐read over a 12‐month period.…”

Section: Resultsmentioning

confidence: 99%

“…Methods that detect incorrect results and misinterpretation are required for individual care as well as for quality assurance. One approach, which has been utilized in early HIVST implementation studies, is for self‐testers to return used devices for delayed re‐reading by trained staff in parallel with self‐reported interpretation of results . However, delays between device use and re‐reading, and environmental storage conditions during this period could impair the validity of this method.…”

Section: Introductionmentioning

confidence: 99%

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Re‐reading of OraQuick HIV‐1/2 rapid antibody test results: quality assurance implications for HIV self‐testing programmes

et al. 2019

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Introduction Scale‐up of HIV self‐testing ( HIVST ) will play a key role in meeting the United Nation's 90‐90‐90 targets. Delayed re‐reading of used HIVST devices has been used by early implementation studies to validate the performance of self‐test kits and to estimate HIV positivity among self‐testers. We investigated the stability of results on used devices under controlled conditions to assess its potential as a quality assurance approach for HIVST scale‐up. Methods 444 OraQuick ® HIV ‐1/2 rapid antibody tests were conducted using commercial plasma from two HIV ‐positive donors and HIV ‐negative plasma (high‐reactive n = 148, weak‐reactive n = 148 and non‐reactive n = 148) and incubated them for six months under four conditions (combinations of high and low temperatures and humidity). Devices were re‐read daily for one week, weekly for one subsequent month and then once a month by independent readers unaware of the previous results. We used multistage transition models to investigate rates of change in device results, and between storage conditions. Results and discussion There was a high incidence of device instability. Forty‐three (29%) of 148 initially non‐reactive results became false weak‐reactive results. These changes were observed across all incubation conditions, the earliest on Day 4 (n = 9 kits). No initially HIV ‐reactive results changed to a non‐reactive result. There were no significant associations between storage conditions and hazard of results transition. We observed substantial statistical agreement between independent re‐readers over time (agreement range: 0.74 to 0.96). Conclusions Delayed re‐reading of used OraQuick ® HIV ‐1/2 rapid antibody tests is not currently a valid methodological approach to quality assurance and monitoring as we observed a high incidence (29%) of true non‐reactive tests changing to false weak‐reactive and therefore its use may overestimate true HIV positivity.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Re‐reading of OraQuick HIV‐1/2 rapid antibody test results: quality assurance implications for HIV self‐testing programmes

et al. 2019

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“…Of these, seven participants did not use HIVST. The median age of the remaining 143 participants was 25 years (interquartile range [IQR], [22][23][24][25][26][27][28] with a median number of eight sexual partners in the prior year (IQR 4-19) ( Table 1). Most (58%) had received primary education, while 18% had no formal education.…”

Section: Population Characteristicsmentioning

confidence: 99%

“…However, few studies have evaluated uptake of HIVST among MSM in sub-Saharan Africa [22,24] Novel, effective strategies are urgently needed to increase coverage of HIV testing services among MSM, and promote linkage to prevention, care and treatment services. Peer distribution of HIVST kits in MSM networks may increase access to HIV testing in Uganda where 33% of MSM had never tested for HIV in 2012 [8,9,12,25]. In a recent pilot intervention at the AIDS Support Organization (TASO) secondary distribution of referral coupons by MSM peers increased uptake of facility-based HIV testing [26].…”

Section: Introductionmentioning

confidence: 99%

Peer distribution of HIV self-test kits to men who have sex with men to identify undiagnosed HIV infection in Uganda: A pilot study

et al. 2020

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Introduction One-in-three men who have sex with men (MSM) in Uganda have never tested for HIV. Peer-driven HIV testing strategies could increase testing coverage among non-testers. We evaluated the yield of peer distributed HIV self-test kits compared with standard-of-care testing approaches in identifying undiagnosed HIV infection. Methods From June to August 2018, we conducted a pilot study of secondary distribution of HIV selftesting (HIVST) through MSM peer networks at The AIDS Support Organization (TASO) centres in Entebbe and Masaka. Peers were trained in HIVST use and basic HIV counselling. Each peer distributed 10 HIVST kits in one wave to MSM who had not tested in the previous six months. Participants who tested positive were linked by peers to HIV care. The primary outcome was the proportion of undiagnosed HIV infections. Data were analysed descriptively. Results A total of 297 participants were included in the analysis, of whom 150 received HIVST (intervention). The median age of HIVST recipients was 25 years (interquartile range [IQR], 22-28) compared to 28 years IQR (25-35) for 147 MSM tested using standard-of-care (SOC) strategies. One hundred forty-three MSM (95%) completed HIVST, of which 32% had never tested for HIV. A total of 12 participants were newly diagnosed with HIV infection: 8 in the peer HIVST group and 4 in the SOC group [5.6% vs 2.7%, respectively; P = 0.02]. All

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“…evaluated the OraQuick HIV‐1/2 antibody test kits for result stability post‐testing. They showed that while strongly reactive HIVST remained stable, 29% of initially non‐reactive kits converting to be weakly reactive false positive when read at least four days later, countering previous work which indicated OraQuick test kits were stable for up to a year . Re‐reading may be problematic and result in artificially inflated positivity rates; this finding led the WHO to recommend against any delayed readings of kits .…”

mentioning

confidence: 93%

To thine own test be true: HIV self‐testing and the global reach for the undiagnosed

et al. 2019

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Initial Accuracy of HIV Rapid Test Kits Stored in Suboptimal Conditions and Validity of Delayed Reading of Oral Fluid Tests

Cited by 12 publications

References 12 publications

Re‐reading of OraQuick HIV‐1/2 rapid antibody test results: quality assurance implications for HIV self‐testing programmes

Re‐reading of OraQuick HIV‐1/2 rapid antibody test results: quality assurance implications for HIV self‐testing programmes

Peer distribution of HIV self-test kits to men who have sex with men to identify undiagnosed HIV infection in Uganda: A pilot study

To thine own test be true: HIV self‐testing and the global reach for the undiagnosed

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