{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T14:02:20Z","timestamp":1790517740635,"version":"4.1.0"},"reference-count":27,"publisher":"American Medical Association (AMA)","issue":"8","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n Variants of SARS-CoV-2 have sequence variations in the viral genome that may alter the accuracy of rapid diagnostic tests.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To assess the analytical and clinical accuracy of 2 rapid diagnostic tests for detecting SARS-CoV-2 during 3 phases of variants.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This diagnostic study included participants aged 18 years or older who reported onset of COVID-19\u2013like symptoms within the prior 5 days and were tested at multiple COVID-19 testing locations in King County, Washington, from February 17, 2021, to January 11, 2022, during 3 distinct phases of SARS-CoV-2 infection (pre-Delta, Delta, and Omicron).<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n \n Two anterior nasal swab specimens were collected from each participant\u20141 for onsite testing by the SCoV-2 Ag\n Detect<\/jats:italic>\n Rapid Self-Test and 1 for reverse transcriptase\u2013polymerase chain reaction (RT-PCR) testing.\n <\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n \n The analytical limit of detection of the 2 rapid diagnostic tests (SCoV-2 Ag\n Detect<\/jats:italic>\n Rapid Self-Test and BinaxNOW COVID-19 Ag Card) was assessed using Omicron (B.1.1.529\/BA.1), Delta (B.1.617.2), and a wild-type (USA-WA1\/2020) variant. Diagnostic sensitivity and specificity of clinical testing for the rapid antigen tests were compared with that of RT-PCR testing.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n A total of 802 participants were enrolled (mean [SD] age, 37.3 [13.3] years; 467 [58.2%] female), 424 (52.9%) of whom had not received COVID-19 vaccination and presented a median of 2 days (IQR, 1-3 days) from symptom onset. Overall, no significant differences were found in the analytical limit of detection or clinical diagnostic accuracy of rapid antigen testing across SARS-CoV-2 variants. The estimated limit of detection for both rapid nucleocapsid antigen tests was at or below a 50% tissue culture infectious dose of 62.5, and the positive percent agreement of the SCoV-2 Ag\n Detect<\/jats:italic>\n Rapid Self-Test ranged from 81.2% (95% CI, 69.5%-89.9%) to 90.7% (95% CI, 77.9%-97.4%) across the 3 phases of variants. The diagnostic sensitivity increased for nasal swabs with a lower cycle threshold by RT-PCR, which correlates with a higher viral load.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In this diagnostic study, analytical and clinical performance data demonstrated accuracy of 2 rapid antigen tests among adults with COVID-19 symptoms across 3 phases of SARS-CoV-2 variants. The findings suggest that home-based rapid antigen testing programs may be an important intervention to reduce global SARS-CoV-2 transmission.<\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2022.28143","type":"journal-article","created":{"date-parts":[[2022,8,24]],"date-time":"2022-08-24T11:32:35Z","timestamp":1661340755000},"page":"e2228143","source":"Crossref","is-referenced-by-count":18,"title":["Accuracy of 2 Rapid Antigen Tests During 3 Phases of SARS-CoV-2 Variants"],"prefix":"10.1001","volume":"5","author":[{"given":"Paul K.","family":"Drain","sequence":"first","affiliation":[{"name":"Department of Global Health, University of Washington, Seattle"},{"name":"Department of Medicine, University of Washington, Seattle"},{"name":"Department of Epidemiology, University of Washington, Seattle"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meagan","family":"Bemer","sequence":"additional","affiliation":[{"name":"Department of Global Health, University of Washington, Seattle"},{"name":"Department of Medicine, University of Washington, Seattle"},{"name":"Department of Epidemiology, University of Washington, Seattle"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer F.","family":"Morton","sequence":"additional","affiliation":[{"name":"Department of Global Health, University of Washington, Seattle"},{"name":"Department of Medicine, University of Washington, Seattle"},{"name":"Department of Epidemiology, University of Washington, Seattle"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronit","family":"Dalmat","sequence":"additional","affiliation":[{"name":"Department of Global Health, University of Washington, Seattle"},{"name":"Department of Medicine, University of Washington, Seattle"},{"name":"Department of Epidemiology, University of Washington, Seattle"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hussein","family":"Abdille","sequence":"additional","affiliation":[{"name":"Department of Global Health, University of Washington, Seattle"},{"name":"Department of Medicine, University of Washington, Seattle"},{"name":"Department of Epidemiology, University of Washington, Seattle"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine K.","family":"Thomas","sequence":"additional","affiliation":[{"name":"Department of Global Health, University of Washington, Seattle"},{"name":"Department of Medicine, University of Washington, Seattle"},{"name":"Department of Epidemiology, University of Washington, Seattle"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timsy K.","family":"Uppal","sequence":"additional","affiliation":[{"name":"Department of Microbiology and Immunology, School of Medicine, University of Nevada, Reno"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Derrick","family":"Hau","sequence":"additional","affiliation":[{"name":"Department of Microbiology and Immunology, School of Medicine, University of Nevada, Reno"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather R.","family":"Green","sequence":"additional","affiliation":[{"name":"Department of Microbiology and Immunology, School of Medicine, University of Nevada, Reno"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcellene A.","family":"Gates-Hollingsworth","sequence":"additional","affiliation":[{"name":"Department of Microbiology and Immunology, School of Medicine, University of Nevada, Reno"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David P.","family":"AuCoin","sequence":"additional","affiliation":[{"name":"Department of Microbiology and Immunology, School of Medicine, University of Nevada, Reno"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Subhash C.","family":"Verma","sequence":"additional","affiliation":[{"name":"Department of Microbiology and Immunology, School of Medicine, University of Nevada, Reno"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2022,8,24]]},"reference":[{"issue":"1","key":"zoi220802r2","doi-asserted-by":"publisher","first-page":"4507","DOI":"10.1038\/s41467-020-18272-4","article-title":"Substantial underestimation of SARS-CoV-2 infection in the United States.","volume":"11","author":"Wu","year":"2020","journal-title":"Nat Commun"},{"key":"zoi220802r3","doi-asserted-by":"publisher","author":"COVID-19 Excess Mortality Collaborators","DOI":"10.1016\/S0140-6736(21)02796-3"},{"issue":"3","key":"zoi220802r5","doi-asserted-by":"publisher","first-page":"264","DOI":"10.1056\/NEJMcp2117115","article-title":"Rapid diagnostic testing for 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all.","volume":"371","author":"Mina","year":"2021","journal-title":"Science"},{"issue":"9","key":"zoi220802r18","doi-asserted-by":"publisher","first-page":"e290","DOI":"10.1016\/S1473-3099(21)00048-7","article-title":"Scaling up COVID-19 rapid antigen tests: promises and challenges.","volume":"21","author":"Peeling","year":"2021","journal-title":"Lancet Infect Dis"},{"issue":"6","key":"zoi220802r21","doi-asserted-by":"publisher","first-page":"3114","DOI":"10.1038\/s41596-021-00536-y","article-title":"Quantification of SARS-CoV-2 neutralizing antibody by wild-type plaque reduction neutralization, microneutralization and pseudotyped virus neutralization assays.","volume":"16","author":"Bewley","year":"2021","journal-title":"Nat Protoc"},{"key":"zoi220802r23","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.02479-21","article-title":"Assessment of the analytical sensitivity of 10 lateral flow devices against the SARS-CoV-2 Omicron variant.","author":"Deerain","journal-title":"J Clin 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COVID-19 in vitro diagnostic medical devices: COVID-19 in vitro diagnostic devices and test methods database. Accessed May 5, 2022. https:\/\/covid-19-diagnostics.jrc.ec.europa.eu\/devices?device_id=&manufacturer=&text_name=&marking=Yes&method=&rapid_diag=1&target_type=6&search_method=AND#form_content"},{"key":"zoi220802r14","unstructured":"Hanson? KE, Altayar O, Caliendo AM, . IDSA guidelines on the diagnosis of COVID-19: antigen testing. Infectious Diseases Society of America. May 27, 2021. Accessed May 5, 2022. https:\/\/www.idsociety.org\/COVID19guidelines\/Ag"},{"key":"zoi220802r15","unstructured":"Foundation for Innovative New Diagnostics. Test directory. 2022. Accessed May 5, 2022. https:\/\/www.finddx.org\/test-directory\/"},{"key":"zoi220802r19","unstructured":"World Health Organization. Classification of Omicron (B.1.1.529): SARS-CoV-2 variant of concern. November 26, 2021. 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