دورية أكاديمية
Re-reading of OraQuick HIV-1/2 rapid antibody test results: quality assurance implications for HIV self-testing programmes.
| العنوان: | Re-reading of OraQuick HIV-1/2 rapid antibody test results: quality assurance implications for HIV self-testing programmes. |
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| المؤلفون: | Watson, Victoria, Dacombe, Russell J, Williams, Christopher, Edwards, Thomas, Adams, Emily R, Johnson, Cheryl C, Mutseta, Miriam N, Corbett, Elizabeth L, Cowan, Frances M, Ayles, Helen, Hatzold, Karin, MacPherson, Peter, Taegtmeyer, Miriam |
| بيانات النشر: | Wiley Open Access |
| سنة النشر: | 2019 |
| المجموعة: | London School of Hygiene & Tropical Medicine: LSHTM Research Online |
| الوصف: | 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. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | text |
| اللغة: | English |
| العلاقة: | https://researchonline.lshtm.ac.uk/id/eprint/4652499/1/Watson_et_al-2019-Journal_of_the_International_AIDS_Society.pdfTest; Watson, Victoria; Dacombe, Russell J; Williams, Christopher; Edwards, Thomas; Adams, Emily R; Johnson, Cheryl C ; Mutseta, Miriam N; Corbett, Elizabeth L ; Cowan, Frances M; Ayles, Helen ; +3 more. Hatzold, Karin; MacPherson, Peter; Taegtmeyer, Miriam; (2019) Re-reading of OraQuick HIV-1/2 rapid antibody test results: quality assurance implications for HIV self-testing programmes. Journal of the International AIDS Society, 22 Sup (S1). e25234-. DOI: https://doi.org/10.1002/jia2.25234Test |
| الإتاحة: | https://doi.org/10.1002/jia2.25234Test https://researchonline.lshtm.ac.uk/id/eprint/4652499Test/ https://researchonline.lshtm.ac.uk/id/eprint/4652499/1/Watson_et_al-2019-Journal_of_the_International_AIDS_Society.pdfTest |
| حقوق: | cc_by_igo |
| رقم الانضمام: | edsbas.3613836E |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |