{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,21]],"date-time":"2026-02-21T11:45:06Z","timestamp":1771674306349,"version":"3.50.1"},"reference-count":26,"publisher":"Public Library of Science (PLoS)","issue":"3","license":[{"start":{"date-parts":[[2023,3,3]],"date-time":"2023-03-03T00:00:00Z","timestamp":1677801600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Foundation for Innovative Diagnostics, FIND"},{"name":"UNITAID","award":["2019-32-FIND MDR"],"award-info":[{"award-number":["2019-32-FIND MDR"]}]},{"name":"The Government of the Netherlands","award":["MINBUZA-2020.961444"],"award-info":[{"award-number":["MINBUZA-2020.961444"]}]},{"name":"UK Department for International Development","award":["300341-102"],"award-info":[{"award-number":["300341-102"]}]},{"DOI":"10.13039\/501100000272","name":"National Institute for Health Research","doi-asserted-by":"crossref","award":["COV0051"],"award-info":[{"award-number":["COV0051"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Objectives<\/jats:title>\n<jats:p>In order to generate independent performance data regarding accuracy of COVID-19 antigen-based rapid diagnostic tests (Ag-RDTs), prospective diagnostic evaluation studies across multiple sites are required to evaluate their performance in different clinical settings. This report describes the clinical evaluation the GENEDIA W COVID-19 Ag Device (Green Cross Medical Science Corp., Chungbuk, Korea) and the ActiveXpress+ COVID-19 Complete Testing Kit (Edinburgh Genetics Ltd, UK), in two testing sites Peru and the United Kingdom.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>Nasopharyngeal swabs collected from 456 symptomatic patients at primary points of care in Lima, Peru and 610 symptomatic participants at a COVID-19 Drive-Through testing site in Liverpool, England were analyzed by Ag-RDT and compared to RT-PCR. Analytical evaluation of both Ag-RDTs was assessed using serial dilutions of direct culture supernatant of a clinical SARS-CoV-2 isolate from the B.1.1.7 lineage.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>For GENEDIA brand, the values of overall sensitivity and specificity were 60.4% [95% CI 52.4\u201367.9%], and 99.2% [95% CI 97.6\u201399.7%] respectively; and for Active Xpress+ the overall values of sensitivity and specificity were 66.2% [95% CI 54.0\u201376.5%], and 99.6% [95% CI 97.9\u201399.9%] respectively. The analytical limit of detection was determined at 5.0 x 10<jats:sup>2<\/jats:sup> pfu\/ml what equals to approximately 1.0 x 10<jats:sup>4<\/jats:sup> gcn\/ml for both Ag-RDTs. The UK cohort had lower median Ct values compared to that of Peru during both evaluations. When split by Ct, both Ag-RDTs had optimum sensitivities at Ct&lt;20 (in Peru; 95% [95% CI 76.4\u201399.1%] and 100.0% [95% CI 74.1\u2013100.0%] and in the UK; 59.2% [95% CI 44.2\u201373.0%] and 100.0% [95% CI 15.8\u2013100.0%], for the GENDIA and the ActiveXpress+, respectively).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusions<\/jats:title>\n<jats:p>Whilst the overall clinical sensitivity of the Genedia did not meet WHO minimum performance requirements for rapid immunoassays in either cohort, the ActiveXpress+ did so for the small UK cohort. This study illustrates comparative performance of Ag-RDTs across two global settings and considers the different approaches in evaluation methods.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0281925","type":"journal-article","created":{"date-parts":[[2023,3,3]],"date-time":"2023-03-03T18:26:10Z","timestamp":1677867970000},"page":"e0281925","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":1,"title":["Diagnostic performance of GENEDIA W and ActiveXpress+ COVID-19 antigens tests among symptomatic individuals in Peru and The United Kingdom"],"prefix":"10.1371","volume":"18","author":[{"given":"Sandra","family":"Palomino-Padilla","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8167-8766","authenticated-orcid":true,"given":"Lorna","family":"Finch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Margaretha","family":"de Vos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2592-9257","authenticated-orcid":true,"given":"Helen","family":"Savage","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luz","family":"Villa-Castillo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gail","family":"Hayward","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elo\u00efse","family":"Cook","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"LSTM diagnostics group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"UTB-IMTAvH group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"CONDOR steering group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Camille","family":"Escadafal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard","family":"Body","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emily R.","family":"Adams","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2833-9087","authenticated-orcid":true,"given":"Cesar","family":"Ugarte-Gil","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana I.","family":"Cubas-Atienzar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2023,3,3]]},"reference":[{"key":"pone.0281925.ref001","volume-title":". Coronavirus disease 2019 (COVID-19): situation report","author":"WHO","year":"2020"},{"issue":"338","key":"pone.0281925.ref002","article-title":"A Comprehensive Review of Viral Characteristics, Transmission, Pathophysiology, Immune Response, and Management of SARS-CoV-2 and COVID-19 as a Basis for Controlling the Pandemic","volume":"12","author":"CR Triggle","year":"2021","journal-title":". Frontiers in Immunology"},{"key":"pone.0281925.ref003","unstructured":"FIND. SARS-CoV-2 Diagnostic Pipeline 2021 [Available from: https:\/\/www.finddx.org\/covid-19\/pipeline\/."},{"key":"pone.0281925.ref004","unstructured":"Statista. Am\u00e9rica Latina y el Caribe: n\u00famero de casos de COVID-19 por pa\u00eds 2021 [Available from: https:\/\/es.statista.com\/estadisticas\/1105121\/numero-casos-covid-19-america-latina-caribe-pais\/."},{"key":"pone.0281925.ref005","author":"PEM Soler","year":"2020"},{"key":"pone.0281925.ref006","unstructured":"Soler PEM. Documento T\u00e9chnico: Lineamientos de validaci\u00f3n de procedimientos diagn\u00f3sticos del SARS CoV-2 Republica Del Peru2020 [Available from: https:\/\/cdn.www.gob.pe\/uploads\/document\/file\/1279285\/Resoluci%C3%B3n%20Ministerial%20N%C2%B0%20687-2020%20%20-%20ANEXO.pdf."},{"key":"pone.0281925.ref007","unstructured":"Gob.pe. Covid 19 en el Per\u00fa\u2014Ministerio del Salud [Internet]. 2021 [Available from: https:\/\/covid19.minsa.gob.pe\/sala_situacional.asp."},{"key":"pone.0281925.ref008","unstructured":"UK-Goverment. Coronavirus (COVID-19) in the UK: Testing. 2021 [updated 19 August 2021. Available from: https:\/\/coronavirus.data.gov.uk\/testing."},{"key":"pone.0281925.ref009","unstructured":"UK-Government. Coronavirus (COVID-19): getting tested 2020 [updated 15 April 2021. Available from: https:\/\/www.gov.uk\/guidance\/coronavirus-covid-19-getting-tested."},{"key":"pone.0281925.ref010","article-title":"COVID-19: Rapid Antigen detection for SARS-CoV-2 by lateral flow assay: a national systematic evaluation for mass-testing","author":"T. Peto","year":"2021","journal-title":"medRxiv"},{"key":"pone.0281925.ref011","unstructured":"The-Guardian. Liverpool to pioneer UK\u2019s first attempt at mass Covid testing 2020 [updated 02\/10\/2020. Available from: https:\/\/www.theguardian.com\/uk-news\/2020\/nov\/02\/liverpool-uk-first-attempt-coronavirus-mass-testing."},{"key":"pone.0281925.ref012","first-page":"2021","article-title":"Limit of detection in different matrices of nineteen commercially available rapid antigen tests for the detection of SARS-CoV-2","author":"AI Cubas-Atienzar","year":"2021","journal-title":"medRxiv"},{"issue":"8","key":"pone.0281925.ref013","doi-asserted-by":"crossref","first-page":"891","DOI":"10.1002\/(SICI)1097-0258(19980430)17:8<891::AID-SIM780>3.0.CO;2-B","article-title":"Equivalence test and confidence interval for the difference in proportions for the paired-sample design","volume":"17","author":"T. Tango","year":"1998","journal-title":"Stat Med"},{"key":"pone.0281925.ref014","unstructured":"WHO. Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays 2021 [Available from: https:\/\/www.who.int\/publications\/i\/item\/9789240017740."},{"issue":"3","key":"pone.0281925.ref015","article-title":"Rapid, point\u2010of\u2010care antigen and molecular\u2010based tests for diagnosis of SARS\u2010CoV\u20102 infection","author":"J Dinnes","year":"2021","journal-title":". Cochrane Database of Systematic Reviews"},{"key":"pone.0281925.ref016","doi-asserted-by":"crossref","first-page":"282","DOI":"10.1016\/j.ijid.2020.10.073","article-title":"Field evaluation of the performance of a SARS-CoV-2 antigen rapid diagnostic test in Uganda using nasopharyngeal samples","volume":"104","author":"A Nalumansi","year":"2021","journal-title":"Int J Infect Dis"},{"issue":"3","key":"pone.0281925.ref017","doi-asserted-by":"crossref","first-page":"472.e7","DOI":"10.1016\/j.cmi.2020.11.004","article-title":"Field evaluation of a rapid antigen test (Panbio\u2122 COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres","volume":"27","author":"E Albert","year":"2021","journal-title":"Clin Microbiol Infect"},{"issue":"4","key":"pone.0281925.ref018","doi-asserted-by":"crossref","first-page":"115514","DOI":"10.1016\/j.diagmicrobio.2021.115514","article-title":"Evaluation of the Abbott Panbio(TM) COVID-19 Ag rapid antigen test for the detection of SARS-CoV-2 in asymptomatic Canadians","volume":"101","author":"JLV Shaw","year":"2021","journal-title":"Diagn Microbiol Infect Dis"},{"issue":"6","key":"pone.0281925.ref019","article-title":"Viral Dynamics and Real-Time RT-PCR Ct Values Correlation with Disease Severity in COVID-19","volume":"11","author":"AA Rabaan","year":"2021","journal-title":"Diagnostics (Basel)"},{"issue":"32","key":"pone.0281925.ref020","doi-asserted-by":"crossref","DOI":"10.2807\/1560-7917.ES.2020.25.32.2001483","article-title":"Duration of infectiousness and correlation with RT-PCR cycle threshold values in cases of COVID-19, England, January to May 2020","volume":"25","author":"A Singanayagam","year":"2020","journal-title":"Euro Surveill"},{"issue":"1","key":"pone.0281925.ref021","doi-asserted-by":"crossref","first-page":"1071","DOI":"10.1186\/s12879-021-06716-1","article-title":"Performance of SARS-CoV-2 antigen testing in symptomatic and asymptomatic adults: a single-center evaluation","volume":"21","author":"SL Mitchell","year":"2021","journal-title":"BMC Infectious Diseases"},{"issue":"4","key":"pone.0281925.ref022","doi-asserted-by":"crossref","first-page":"262","DOI":"10.7326\/M20-1495","article-title":"Variation in False-Negative Rate of Reverse Transcriptase Polymerase Chain Reaction-Based SARS-CoV-2 Tests by Time Since Exposure","volume":"173","author":"LM Kucirka","year":"2020","journal-title":"Ann Intern Med"},{"issue":"3","key":"pone.0281925.ref023","first-page":"100061","article-title":"Laboratory Diagnosis and Monitoring the Viral Shedding of SARS-CoV-2 Infection","volume":"1","author":"Y Yang","year":"2020","journal-title":"Innovation (N Y)"},{"issue":"4","key":"pone.0281925.ref024","doi-asserted-by":"crossref","first-page":"e0249408","DOI":"10.1371\/journal.pone.0249408","article-title":"Comparative analysis of various clinical specimens in detection of SARS-CoV-2 using rRT-PCR in new and follow up cases of COVID-19 infection: Quest for the best choice","volume":"16","author":"K Sharma","year":"2021","journal-title":"PLOS ONE"},{"key":"pone.0281925.ref025","doi-asserted-by":"crossref","first-page":"100150","DOI":"10.1016\/j.lanepe.2021.100150","article-title":"Decreased infectivity following BNT162b2 vaccination: A prospective cohort study in Israel","volume":"7","author":"G Regev-Yochay","year":"2021","journal-title":". Lancet Reg Health Eur"},{"key":"pone.0281925.ref026","doi-asserted-by":"crossref","first-page":"n1442","DOI":"10.1136\/bmj.n1442","article-title":"Covid-19: Peru\u2019s official death toll triples to become world\u2019s highest","volume":"373","author":"O. Dyer","year":"2021","journal-title":"BMJ"}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0281925","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,3,3]],"date-time":"2023-03-03T18:26:33Z","timestamp":1677867993000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0281925"}},"subtitle":[],"editor":[{"given":"Cedric P.","family":"Yansouni","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2023,3,3]]},"references-count":26,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2023,3,3]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0281925","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,3,3]]}}}