{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,2]],"date-time":"2026-02-02T20:34:14Z","timestamp":1770064454561,"version":"3.49.0"},"reference-count":32,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2025,7,29]],"date-time":"2025-07-29T00:00:00Z","timestamp":1753747200000},"content-version":"vor","delay-in-days":28,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Immunity Inflam &amp;amp; Disease"],"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Development of readily available Rapid COVID\u201019 Antigen tests essential for promptly identifying SARS\u2010CoV2 infection and preventing its spread.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This study evaluated the clinical performance of the Healgen Rapid COVID\u201019 antigen test as a point\u2010of\u2010care diagnostic tool with 806 evaluable subjects who were within 6 days post\u2010symptom onset. The results from the Healgen test were compared to the results from Emergency Use Authorization (EUA) approved SARS\u2010CoV\u20102 RT\u2010PCR tests.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Out of the 806 evaluable subjects, 140 tested positive and 640 tested negative for SARS\u2010CoV\u20102 with the Healgen COVID\u201019 test, showing good agreement with the EUA RT\u2010PCR results. There were 26 subjects with discordant results, of which 24 were negative according to the Healgen test but positive according to the RT\u2010PCR test, while 2 were positive by the Healgen test but negative by the EUA\u2010PCR test. The positive percent agreement (PPA) and negative percent agreement (NPA) were 85.4% and 99.7%, respectively. Additionally, the Healgen COVID\u201019 test detected 34 cases (60.7%) out of 56 weak positive cases (based on Ct values of \u2265\u200930 by the EUA PCR test), demonstrating good detection capability of the test.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The Healgen Rapid COVID\u201019 antigen detection test demonstrated good performance in terms of PPA and NPA when compared to the EUA RT\u2010PCR assays and has potential as a diagnostic tool for SARS\u2010CoV\u20102.<\/jats:p><\/jats:sec>","DOI":"10.1002\/iid3.70228","type":"journal-article","created":{"date-parts":[[2025,7,29]],"date-time":"2025-07-29T10:59:49Z","timestamp":1753786789000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Clinical Evaluation of the Healgen Rapid COVID\u201019 Antigen Test as a Point\u2010of\u2010Care Diagnostic Tool"],"prefix":"10.1002","volume":"13","author":[{"given":"Stephen A.","family":"Young","sequence":"first","affiliation":[{"name":"TriCore Reference Laboratories Albuquerque New Mexico USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hua","family":"Zhang","sequence":"additional","affiliation":[{"name":"Zhejiang Orient Gene Biotech Co. 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Zhejiang China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jose","family":"Rodriguez","sequence":"additional","affiliation":[{"name":"Golden Research Miami Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Mishkin","sequence":"additional","affiliation":[{"name":"Proactive Clinical Research Fort Lauderdale Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ward","family":"Paine","sequence":"additional","affiliation":[{"name":"Frontier Clinical Research LLC Morgantown West Virginia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Li","family":"Seyfried","sequence":"additional","affiliation":[{"name":"Healgen Scientific LLC Houston Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"LaTisha","family":"Hargrove","sequence":"additional","affiliation":[{"name":"Healgen Scientific LLC Houston Texas 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