{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T09:56:46Z","timestamp":1753869406136,"version":"3.41.2"},"reference-count":23,"publisher":"Wiley","issue":"S1","license":[{"start":{"date-parts":[[2019,3,25]],"date-time":"2019-03-25T00:00:00Z","timestamp":1553472000000},"content-version":"vor","delay-in-days":24,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Intern AIDS Soc"],"published-print":{"date-parts":[[2019,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Scale\u2010up of <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content> self\u2010testing (<jats:styled-content style=\"fixed-case\">HIVST<\/jats:styled-content>) will play a key role in meeting the United Nation's 90\u201090\u201090 targets. Delayed re\u2010reading of used <jats:styled-content style=\"fixed-case\">HIVST<\/jats:styled-content> devices has been used by early implementation studies to validate the performance of self\u2010test kits and to estimate <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content> positivity among self\u2010testers. We investigated the stability of results on used devices under controlled conditions to assess its potential as a quality assurance approach for <jats:styled-content style=\"fixed-case\">HIVST<\/jats:styled-content> scale\u2010up.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>444 OraQuick<jats:sup>\u00ae<\/jats:sup> <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u20101\/2 rapid antibody tests were conducted using commercial plasma from two <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u2010positive donors and <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u2010negative plasma (high\u2010reactive n\u00a0=\u00a0148, weak\u2010reactive n\u00a0=\u00a0148 and non\u2010reactive n\u00a0=\u00a0148) and incubated them for six months under four conditions (combinations of high and low temperatures and humidity). Devices were re\u2010read 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results and discussion<\/jats:title><jats:p>There was a high incidence of device instability. Forty\u2010three (29%) of 148 initially non\u2010reactive results became false weak\u2010reactive results. These changes were observed across all incubation conditions, the earliest on Day 4 (n\u00a0=\u00a09 kits). No initially <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u2010reactive results changed to a non\u2010reactive result. There were no significant associations between storage conditions and hazard of results transition. We observed substantial statistical agreement between independent re\u2010readers over time (agreement range: 0.74 to 0.96).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Delayed re\u2010reading of used OraQuick<jats:sup>\u00ae<\/jats:sup> <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>\u20101\/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\u2010reactive tests changing to false weak\u2010reactive and therefore its use may overestimate true <jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content> positivity.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jia2.25234","type":"journal-article","created":{"date-parts":[[2019,3,25]],"date-time":"2019-03-25T09:40:15Z","timestamp":1553506815000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Re\u2010reading of OraQuick <scp>HIV<\/scp>\u20101\/2 rapid antibody test results: quality assurance implications for <scp>HIV<\/scp> self\u2010testing programmes"],"prefix":"10.1002","volume":"22","author":[{"given":"Victoria","family":"Watson","sequence":"first","affiliation":[{"name":"Department of International Public Health Liverpool School of Tropical Medicine Liverpool United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Russell J","family":"Dacombe","sequence":"additional","affiliation":[{"name":"Department of International Public Health Liverpool School of Tropical Medicine Liverpool United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher","family":"Williams","sequence":"additional","affiliation":[{"name":"Research Centre for Drugs and Diagnostics Liverpool School of Tropical Medicine Liverpool United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Edwards","sequence":"additional","affiliation":[{"name":"Research Centre for Drugs and Diagnostics Liverpool School of Tropical Medicine Liverpool United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emily R","family":"Adams","sequence":"additional","affiliation":[{"name":"Research Centre for Drugs and Diagnostics Liverpool School of Tropical Medicine Liverpool United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheryl C","family":"Johnson","sequence":"additional","affiliation":[{"name":"HIV Department World Health Organisation Geneva Switzerland"},{"name":"Department of Clinical Research London School of Hygiene &amp; Tropical Medicine London United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miriam N","family":"Mutseta","sequence":"additional","affiliation":[{"name":"Population Services International Harare Zimbabwe"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth L","family":"Corbett","sequence":"additional","affiliation":[{"name":"Department of Clinical Research London School of Hygiene &amp; Tropical Medicine London United Kingdom"},{"name":"Malawi Liverpool Welcome Trust Clinical Research Programme Blantyre Malawi"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frances M","family":"Cowan","sequence":"additional","affiliation":[{"name":"Department of International Public Health Liverpool School of Tropical Medicine Liverpool United Kingdom"},{"name":"Centre for Sexual Health HIV and AIDS Research Harare Zimbabwe"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helen","family":"Ayles","sequence":"additional","affiliation":[{"name":"Department of Clinical Research London School of Hygiene &amp; Tropical Medicine London United Kingdom"},{"name":"Zambart Lusaka Zambia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karin","family":"Hatzold","sequence":"additional","affiliation":[{"name":"Population Services International Harare Zimbabwe"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"MacPherson","sequence":"additional","affiliation":[{"name":"Malawi Liverpool Welcome Trust Clinical Research Programme Blantyre Malawi"},{"name":"Department of Clinical Sciences Liverpool School of Tropical Medicine Liverpool United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miriam","family":"Taegtmeyer","sequence":"additional","affiliation":[{"name":"Department of International Public Health Liverpool School of Tropical Medicine Liverpool United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,3,25]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(16)00041-2"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2458-14-1226"},{"key":"e_1_2_8_4_1","unstructured":"GreenK ThuH.In the hands of the community: accelerating key population\u2010led HIV lay and self\u2010testing in Viet Nam. [Abstract THSA1804] 21st International AIDS Conference 18\u201022 July2016."},{"key":"e_1_2_8_5_1","unstructured":"BradyM.Self\u2010testing for HIV: initial experience of the UK's first kit. [Abstract 19] 22nd\u00a0Annual Conference of the British HIV Association 21 April2016."},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0122783"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.7448\/IAS.18.1.19445"},{"key":"e_1_2_8_8_1","unstructured":"DacombeRJ WatsonV SibandaE NyirendaL SimwingaM CowenE et\u00a0al.A Baseline Assessment of the Policy and Regulatory Environment for HIV Self\u2010testing in Malawi Zimbabwe and Zambia. [Oral poster] African Society for Laboratory Medicine 3rd International Conference 3\u20108 December2016."},{"key":"e_1_2_8_9_1","unstructured":"JohnsonC FigueroaC CambianoV PhillipsA SandsA MeurantR et\u00a0al.A clinical utility risk\u2010benefit analysis for HIV self\u2010testing. [Abstract TUPEC0834]. 9th IAS Conference on HIV Science 23\u201026 July2017."},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(18)30044-4"},{"key":"e_1_2_8_11_1","unstructured":"GotscheCI SimwingaM MuzumaraA KapakuKN SigandeL NeumanM et\u00a0al.HIV self\u2010testing in Zambia: User ability to follow the manufacturer's instructions for use. [Abstract MOPED1167]. 9th IAS Conference on HIV Science 23\u201026 July2017."},{"key":"e_1_2_8_12_1","unstructured":"MwauM AchiengL BwanaP.Performance and usability of INSTI a blood\u2010based rapid HIV self test for qualitative detection of HIV antibodies in intended use populations in Kenya. [Abstract MOAX0106LB] 9th IAS Conference on HIV Science 23\u201026 July2017."},{"issue":"11","key":"e_1_2_8_13_1","first-page":"e1002458","article-title":"Direct provision versus facility collection of HIV self\u2010tests among female sex workers in Uganda: a cluster\u2010randomized controlled health systems trial","volume":"14","author":"Ortblad K","year":"2017","journal-title":"PLoS One"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2014.6493"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-017-2093-2"},{"key":"e_1_2_8_16_1","unstructured":"Unitaid PSI HIV STAR Consortium.Zambia clinical performance study protocol.2016; Available from:http:\/\/hivstar.lshtm.ac.uk\/files\/2016\/11\/STAR-Protocol-for-Zambia-Clinical-Performance-Study-web.pdf"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0158107"},{"key":"e_1_2_8_18_1","unstructured":"WHO Prequalification ofIn VitroDiagnostics.Public Report. Product: OraQuick HIV Self\u2010Test WHO reference number: PQDx 0159\u2010055\u201001.2017[cited 2018 Aug 08]. Available from:http:\/\/www.who.int\/diagnostics_laboratory\/evaluations\/pq-list\/170720_final_amended_pqdx_0159_055_01_oraquick_hiv_self_test_v2.pdf"},{"key":"e_1_2_8_19_1","unstructured":"Zeptometrix.HIV Seroconversion Panel Donor No. 73695. Zeptometrix.2019; URL:https:\/\/www.zeptometrix.com\/media\/documents\/PIHIV12007.pdf. Accessed: 2019\u201001\u201004.http:\/\/www.webcitation.org\/75Ajt4f0y(Archived by WebCite\u00aeathttp:\/\/www.webcitation.org\/75Ajt4f0y)"},{"key":"e_1_2_8_20_1","unstructured":"Zeptometrix.HIV Seroconversion Panel Donor No. 75018. Zeptometrix.2019; URL:https:\/\/www.zeptometrix.com\/media\/documents\/PIHIV9077.pdf. Accessed: 2019\u201001\u201004.http:\/\/www.webcitation.org\/75AjSCRd9. (Archived by WebCite\u00aeathttp:\/\/www.webcitation.org\/75AjSCRd9)"},{"volume-title":"Validity and Inter\u2010Rater Reliability Testing of Quality Assessment Instruments","year":"2012","author":"Hartling L","key":"e_1_2_8_21_1"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1586\/14787210.2014.866516"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.7448\/IAS.20.7.21755"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000001421"}],"container-title":["Journal of the International AIDS Society"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jia2.25234","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jia2.25234","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jia2.25234","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,11]],"date-time":"2023-09-11T00:42:56Z","timestamp":1694392976000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jia2.25234"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,3]]},"references-count":23,"journal-issue":{"issue":"S1","published-print":{"date-parts":[[2019,3]]}},"alternative-id":["10.1002\/jia2.25234"],"URL":"https:\/\/doi.org\/10.1002\/jia2.25234","archive":["Portico"],"relation":{},"ISSN":["1758-2652","1758-2652"],"issn-type":[{"type":"print","value":"1758-2652"},{"type":"electronic","value":"1758-2652"}],"subject":[],"published":{"date-parts":[[2019,3]]},"assertion":[{"value":"2018-05-07","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-12-19","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-03-25","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e25234"}}