{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,26]],"date-time":"2025-10-26T21:41:30Z","timestamp":1761514890559,"version":"3.41.2"},"reference-count":32,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2022,4,20]],"date-time":"2022-04-20T00:00:00Z","timestamp":1650412800000},"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":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2022,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Surveillance and control of SARS\u2010CoV\u20102 outbreak through gold standard detection, that is, real\u2010time polymerase chain reaction (RT\u2010PCR), become a great obstacle, especially in overwhelming outbreaks. In this study, we aimed to analyze the performance of rapid antigen home test (RAHT) as an alternative detection method compared with RT\u2010PCR.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In total, 79 COVID\u201019\u2010positive and 217 COVID\u201019\u2010negative patients confirmed by RT\u2010PCR were enrolled in this study. A duration from symptom onset to COVID\u201019 confirmation of &lt;5\u00a0days was considered a recruiting criterion for COVID\u201019\u2010positive cases. A nasal cavity specimen was collected for the RAHT, and a nasopharyngeal swab specimen was collected for RT\u2010PCR.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Sensitivity of the STANDARD Q COVID\u201019 Ag Home Test (SD Biosensor, Korea), compared with RT\u2010PCR, was 94.94% (75\/79) (95% [confidence interval] CI, 87.54%\u201398.60%), and specificity was 100%. Sensitivity was significantly higher in symptomatic patients (98.00%) than in asymptomatic (89.66%) patients (<jats:italic>p<\/jats:italic>\u2010value\u00a0=\u00a00.03). There was no difference in sensitivity according to the duration of symptom onset to confirmation (100% for 0\u20132\u00a0days and 96.97% for 3\u20135\u00a0days, respectively) (<jats:italic>p<\/jats:italic>\u2010value\u00a0=\u00a01.00). The RAHT detected all 51 COVID\u201019 patients whose Ct values were \u226425 (100%), whereas sensitivity was 73.33% (11\/15) among patients with Ct values &gt;25 (<jats:italic>p<\/jats:italic>\u2010value\u00a0=\u00a00.01).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The RAHT showed an excellent sensitivity for COVID\u201019\u2010confirmed cases, especially for those with symptoms. There was a decrease in sensitivity when the Ct value is over 25, indicating that RAHT screening may be useful during the early phase of symptom onset, when the viral numbers are higher and it is more transmissible.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.24410","type":"journal-article","created":{"date-parts":[[2022,4,20]],"date-time":"2022-04-20T09:12:00Z","timestamp":1650445920000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Performance evaluation of STANDARD Q COVID\u201019 Ag home test for the diagnosis of COVID\u201019 during early symptom onset"],"prefix":"10.1002","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9737-2393","authenticated-orcid":false,"given":"Hyoshim","family":"Shin","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine Gyeongsang National University Hospital  Jinju Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3377-4833","authenticated-orcid":false,"given":"Seungjun","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Gyeongsang National University Changwon Hospital  Changwon Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1033-734X","authenticated-orcid":false,"given":"Kristin","family":"Widyasari","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Gyeongsang National University Changwon Hospital  Changwon Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9098-3765","authenticated-orcid":false,"given":"Jongyoun","family":"Yi","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Pusan National University School of Medicine  Busan Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5279-467X","authenticated-orcid":false,"given":"Eunsin","family":"Bae","sequence":"additional","affiliation":[{"name":"Seegene Institute of Clinical Research Seegene Inc.  Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8099-8891","authenticated-orcid":false,"given":"Sunjoo","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Gyeongsang National University Changwon Hospital  Changwon Korea"},{"name":"Gyeongsang National University College of Medicine Institute of Health Sciences  Jinju Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,4,20]]},"reference":[{"key":"e_1_2_9_2_1","first-page":"157","article-title":"WHO declares COVID\u201019 a pandemic","volume":"91","author":"Cucinotta D","year":"2020","journal-title":"Acta Bio Medica"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1155\/2021\/5313832"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1155\/2021\/6670798"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcla.24151"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1155\/2021\/5528786"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jare.2020.08.002"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trac.2021.116452"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2021.104785"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.3390\/diagnostics10080594"},{"key":"e_1_2_9_11_1","unstructured":"Center for Disease Control and Prevention.Interim guidance for antigen testing for SARS\u2010CoV\u20102.2020.https:\/\/pesquisa.bvsalud.org\/global\u2010literature\u2010on\u2010novel\u2010coronavirus\u20102019\u2010ncov\/resource\/pt\/grc\u2010742255"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1515\/dx-2020-0131"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1515\/dx\u20102021\u20100078"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.7326\/M20-1301"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.3390\/v12060582"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2020.104654"},{"key":"e_1_2_9_17_1","unstructured":"World Health Organization.Recommendations for national SARS\u2010CoV\u20102 testing strategies and diagnostic capacities: interim guidance.2021.https:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/342002\/WHO\u20102019\u2010nCoV\u2010lab\u2010testing\u20102021.1\u2010eng.pdf?sequence=1&isAllowed=y"},{"key":"e_1_2_9_18_1","first-page":"35","article-title":"When to use Fisher\u2019s exact test","volume":"2","author":"Bower KM","year":"2003","journal-title":"Am Soc Qual Six Sigma Forum Magazine"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.2478\/v10117-011-0021-1"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tjem.2018.08.001"},{"key":"e_1_2_9_21_1","unstructured":"MillensonEJ.Containing Covid\u201019 requires rapid tests that are highly sensitive to infections. 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