{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T12:14:22Z","timestamp":1785413662425,"version":"3.56.0"},"reference-count":43,"publisher":"MDPI AG","issue":"14","license":[{"start":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T00:00:00Z","timestamp":1784505600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Abbott Rapid Diagnostics","award":["ASD-05-002"],"award-info":[{"award-number":["ASD-05-002"]}]},{"award":["ASD-05-002"],"award-info":[{"award-number":["ASD-05-002"]}],"id":[{"id":"https:\/\/ror.org\/04kqnth20","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background: Rapid antigen tests were widely utilised during the COVID-19 pandemic to expand diagnostic access in resource-limited settings. However, prospective evaluations under intended-use conditions remained essential to define their role in decentralised testing strategies. Methods: We conducted a prospective multi-provincial clinical evaluation of the Panbio\u2122 COVID-19 Antigen Rapid Test Device in South Africa between July 2021 and January 2022. Paired nasal and nasopharyngeal swabs were collected from 609 participants across three geographically diverse South African provinces. Antigen test results were compared with standard-of-care TaqPath RT-PCR, with BD MAX\u2122 RT-PCR included as a secondary molecular comparator. Performance was assessed by viral load, symptom status, and variant predominance periods. Results: Standard-of-care RT-PCR identified 136 positive cases (22.3% prevalence). The Panbio\u2122 test demonstrated overall sensitivity of 80.1% (95% CI: 72\u201387) and specificity of 98.5% (95% CI: 97\u201399). Sensitivity reached 90.1% in specimens with Ct values \u226425 and 85.2% among symptomatic participants tested within seven days of onset but declined at Ct values \u226530 and in asymptomatic individuals. Performance remained consistent during Delta- and Omicron-predominant periods. Discussion: The Panbio\u2122 RDT demonstrates high diagnostic accuracy for detecting SARS-CoV-2 in individuals with high viral load, supporting its use for rapid identification of infectious cases during transmission surges. Molecular testing remains necessary for low viral load infections and asymptomatic screening.<\/jats:p>","DOI":"10.3390\/diagnostics16142263","type":"journal-article","created":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T10:44:02Z","timestamp":1784544242000},"page":"2263","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Multi-Provincial Clinical Evaluation of the PANBIO\u2122 COVID-19 Antigen Rapid Test Device in South Africa"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7785-5280","authenticated-orcid":false,"given":"Vidya","family":"Keshav","sequence":"first","affiliation":[{"name":"Wits Diagnostic Innovation Hub, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2050, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6573-9525","authenticated-orcid":false,"given":"Lesley","family":"Scott","sequence":"additional","affiliation":[{"name":"Wits Diagnostic Innovation Hub, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2050, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1590-198X","authenticated-orcid":false,"given":"Anura","family":"David","sequence":"additional","affiliation":[{"name":"Wits Diagnostic Innovation Hub, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2050, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carey","family":"Pike","sequence":"additional","affiliation":[{"name":"Desmond Tutu HIV Centre, University of Cape Town, Cape Town 7925, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda-Gail","family":"Bekker","sequence":"additional","affiliation":[{"name":"Desmond Tutu HIV Centre, University of Cape Town, Cape Town 7925, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wendy","family":"Stevens","sequence":"additional","affiliation":[{"name":"Wits Diagnostic Innovation Hub, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2050, South Africa"},{"name":"National Priority Program, National Health Laboratory Service, Johannesburg 2131, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,7,20]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"e060838","DOI":"10.1136\/bmjopen-2022-060838","article-title":"A systematic review of strategies adopted to scale up COVID-19 testing in low-, middle-and high-income countries","volume":"12","author":"Muttamba","year":"2022","journal-title":"BMJ Open"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"593","DOI":"10.1038\/s41563-020-00906-z","article-title":"Diagnostics for SARS-CoV-2 infections","volume":"20","author":"Kevadiya","year":"2021","journal-title":"Nat. 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