{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,5]],"date-time":"2025-11-05T06:50:21Z","timestamp":1762325421486,"version":"3.40.5"},"reference-count":23,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2022,9,6]],"date-time":"2022-09-06T00:00:00Z","timestamp":1662422400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Influenza Resp Viruses"],"published-print":{"date-parts":[[2022,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The rapid diagnostics tests for SARS\u2010CoV\u20102 antigen vary in their sensitivities, and moreover, genomic mutations may further affect the performance of the assays. We aimed to evaluate the analytical performance of an automated antigen assay and compare its sensitivity in Delta\u2010 and Omicron\u2010variant positive clinical samples.<\/jats:p><\/jats:sec><jats:sec><jats:title>Material and methods<\/jats:title><jats:p>The analytical performance of an automated mariPOC SARS\u2010CoV\u20102 antigen test was evaluated on a population of community\u2010dwelling subjects with mild respiratory symptoms or being asymptomatic investigated by the RT\u2010qPCR Allplex\u2122 SARS\u2010CoV\u20102 assay. The sensitivity and specificity of the antigen test were evaluated on prospective 621 nasopharyngeal swabs along with oropharyngeal swabs. The sensitivity regarding variants determined by the Allplex\u2122 SARS\u2010CoV\u20102 Variant assays was analysed in additional, retrospective 158 Delta and 59 Omicron samples.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The overall sensitivity of the antigen test in prospective samples was 77.9% (113\/145; 95% confidence interval [CI] 70.3\u201384.4) with the specificity of 99.8% (95% CI 98.8\u2013100). Regarding the variant, the sensitivity was higher in Omicron\u2010variant samples, 93.2% (55\/59; 95% CI 83.5\u201398.1), compared to Delta\u2010variant samples, 71.5% (113\/158; 95% CI 63.8\u201378.4; p\u2009=\u2009.001).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In community\u2010dwelling subjects with mild respiratory symptoms or being asymptomatic, the automated mariPOC SARS\u2010CoV\u20102 antigen test showed high sensitivity over 98.0% in subgroup samples with cycle threshold (Ct) values\u00a0&lt;\u00a025. Regarding the variant, the antigen test sensitivity was higher in the Omicron\u2010variant samples compared to the Delta\u2010variant samples. The analytical performance of the antigen test can differ between the SARS\u2010CoV\u20102 variants, and a re\u2010evaluation should be performed for new circulating lineages.<\/jats:p><\/jats:sec>","DOI":"10.1111\/irv.13048","type":"journal-article","created":{"date-parts":[[2022,9,6]],"date-time":"2022-09-06T08:42:11Z","timestamp":1662453731000},"page":"1033-1039","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["The evaluation of an automated <scp>mariPOC SARS\u2010CoV\u20102<\/scp> antigen test compared to <scp>RT\u2010qPCR SARS\u2010CoV\u20102<\/scp> assay and comparison of its sensitivity in Delta\u2010 and Omicron\u2010variant samples"],"prefix":"10.1111","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4511-9430","authenticated-orcid":false,"given":"Marcela","family":"Krutova","sequence":"first","affiliation":[{"name":"Department of Medical Microbiology, 2nd Faculty of Medicine Charles University and Motol University Hospital  Prague Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marie","family":"Brajerova","sequence":"additional","affiliation":[{"name":"Department of Medical Microbiology, 2nd Faculty of Medicine Charles University and Motol University Hospital  Prague Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zdenek","family":"Kepka","sequence":"additional","affiliation":[{"name":"Department of Medical Microbiology, 2nd Faculty of Medicine Charles University and Motol University Hospital  Prague Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ales","family":"Briksi","sequence":"additional","affiliation":[{"name":"Department of Medical Microbiology, 2nd Faculty of Medicine Charles University and Motol University Hospital  Prague Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Petr","family":"Hubacek","sequence":"additional","affiliation":[{"name":"Department of Medical Microbiology, 2nd Faculty of Medicine Charles University and Motol University Hospital  Prague Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pavel","family":"Drevinek","sequence":"additional","affiliation":[{"name":"Department of Medical Microbiology, 2nd Faculty of Medicine Charles University and Motol University Hospital  Prague Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,9,6]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"Centre for Health Protection of the Hong Kong Special Administrative Region Government CHP closely monitors cluster of pneumonia cases on Mainland. Dec 31 2019.https:\/\/www.info.gov.hk\/gia\/general\/201912\/31\/P2019123100667.htm"},{"key":"e_1_2_11_3_1","unstructured":"CohenJ. American Association for the Advancement of Science; Washington DC: Jan 11 2020.Chinese researchers reveal draft genome of virus implicated in Wuhan pneumonia outbreak.https:\/\/www.sciencemag.org\/news\/2020\/01\/chinese-researchers-reveal-draft-genome-virus-implicated-wuhan-pneumonia-outbreak"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(22)00172\u20106"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.2807\/1560\u20107917.ES.2021.26.44.2100441"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD013705.pub2"},{"key":"e_1_2_11_7_1","unstructured":"EU health preparedness: a common list of COVID\u201019 rapid antigen tests; a common standardised set of data to be included in COVID\u201019 test result certificates; and a common list of COVID\u201019 laboratory based antigenic assays. Available at:https:\/\/ec.europa.eu\/health\/system\/files\/2022-03\/covid-19_rat_common-list_en_0.pdf"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.27124"},{"volume-title":"Tracking SARS\u2010CoV\u20102 Variants","author":"World Health Organization","key":"e_1_2_11_9_1"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.gpb.2022.01.001"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1101\/2021.12.18.21268018"},{"issue":"3","key":"e_1_2_11_12_1","first-page":"156","article-title":"The sensitivity of SARS\u2010CoV\u20102 antigen tests in the view of large\u2010scale testing","volume":"70","author":"D\u0159ev\u00ednek P","year":"2021","journal-title":"Epidemiol Mikrobiol Imunol"},{"key":"e_1_2_11_13_1","unstructured":"CDC.Interim guidelines for collecting handling and testing clinical specimens for COVID\u201019 2020. 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