{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T08:55:26Z","timestamp":1782809726583,"version":"3.54.5"},"reference-count":25,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2021,4,29]],"date-time":"2021-04-29T00:00:00Z","timestamp":1619654400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"National Research Foundation of Korea","award":["NRF-2015R1A6A1A03032236"],"award-info":[{"award-number":["NRF-2015R1A6A1A03032236"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Viruses"],"abstract":"<jats:p>Antigen tests for SARS-CoV-2 diagnosis are simpler and faster than their molecular counterparts. Clinical validation of such tests is a prerequisite before their field applications. We developed and clinically evaluated an immunochromatographic immunoassay, GenBody\u2122 COVAG025, for the rapid detection of SARS-CoV-2 nucleocapsid (NP) antigen in two different clinical studies. Retrospectively, 130 residual nasopharyngeal swabs transferred in viral transport medium (VTM), pre-examined for COVID-19 through emergency use authorization (EUA)-approved real-time RT-PCR assay and tested with GenBody\u2122 COVAG025, revealed a sensitivity and specificity of 90.00% (27\/30; 95% CI: 73.47% to 97.89%) and 98.00% (98\/100; 95% CI: 92.96% to 99.76%), respectively, fulfilling WHO guidelines. Subsequently, the prospective examination of 200 symptomatic and asymptomatic nasopharyngeal swabs, collected on site and tested with GenBody\u2122 COVAG025 and EUA-approved real-time RT-PCR assay simultaneously, revealed a significantly higher sensitivity and specificity of 94.00% (94\/100; 95% CI: 87.40% to 97.77%) and 100.00% (100\/100; 95% CI: 96.38% to 100.00%), respectively. Clinical sensitivity and specificity were significantly high for samples with Ct values \u2264 30 as well as within 3 days of symptom onset, justifying its dependency on the viral load. Thus, it is assumed this can help with the accurate diagnosis and timely isolation and treatment of patients with COVID-19, contributing to better control of the global pandemic.<\/jats:p>","DOI":"10.3390\/v13050796","type":"journal-article","created":{"date-parts":[[2021,4,30]],"date-time":"2021-04-30T05:10:55Z","timestamp":1619759455000},"page":"796","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Development and Clinical Evaluation of an Immunochromatography-Based Rapid Antigen Test (GenBody\u2122 COVAG025) for COVID-19 Diagnosis"],"prefix":"10.3390","volume":"13","author":[{"given":"Doyeong","family":"Kim","sequence":"first","affiliation":[{"name":"GenBody Inc., Cheonan 31116, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jihoo","family":"Lee","sequence":"additional","affiliation":[{"name":"GenBody Inc., Cheonan 31116, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5608-6638","authenticated-orcid":false,"given":"Jyotiranjan","family":"Bal","sequence":"additional","affiliation":[{"name":"Zoonosis Research Center, Department of Infection Biology, School of Medicine, Wonkwang University, Iksan 570749, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seul Ki","family":"Seo","sequence":"additional","affiliation":[{"name":"GenBody Inc., Cheonan 31116, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chom-Kyu","family":"Chong","sequence":"additional","affiliation":[{"name":"GenBody Inc., Cheonan 31116, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6837-838X","authenticated-orcid":false,"given":"Jong Ho","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, College of Medicine, Yeungnam University, Daegu 42415, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyun","family":"Park","sequence":"additional","affiliation":[{"name":"Zoonosis Research Center, Department of Infection Biology, School of Medicine, Wonkwang University, Iksan 570749, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2021,4,29]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"275","DOI":"10.1080\/22221751.2020.1723441","article-title":"An emerging coronavirus causing pneumonia outbreak in Wuhan, China: Calling for developing therapeutic and prophylactic strategies","volume":"9","author":"Jiang","year":"2020","journal-title":"Emerg. 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