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Clinical Performance of the Standard Q COVID-19 Rapid Antigen Test and Simulation of its Real-World Application in Korea

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dc.contributor.author홍기호-
dc.contributor.author이혁민-
dc.date.accessioned2022-04-07T05:02:24Z-
dc.date.available2022-04-07T05:02:24Z-
dc.date.issued2021-11-
dc.identifier.issn2234-3806-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/188117-
dc.description.abstractThe rapid antigen test (RAT) for coronavirus disease (COVID-19) represents a potent diagnostic method in situations of limited molecular testing resources. However, considerable performance variance has been reported with the RAT. We evaluated the clinical performance of Standard Q COVID-19 RAT (SQ-RAT; SD Biosensor, Suwon, Korea), the first RAT approved by the Korean Ministry of Food and Drug Safety. In total, 680 nasopharyngeal swabs previously tested using real-time reverse-transcription PCR (rRT-PCR) were retested using SQ-RAT. The clinical sensitivity of SQ-RAT relative to that of rRT-PCR was 28.7% for all specimens and was 81.4% for specimens with RNA-dependent RNA polymerase gene (RdRp) threshold cycle (Ct) values ≤23.37, which is the limit of detection of SQ-RAT. The specificity was 100%. The clinical sensitivity of SQ-RAT for COVID-19 diagnosis was assessed based on the Ct distribution at diagnosis of 33,294 COVID-19 cases in Korea extracted from the laboratory surveillance system of Korean Society for Laboratory Medicine. The clinical sensitivity of SQ-RAT for COVID-19 diagnosis in the Korean population was 41.8%. Considering the molecular testing capacity in Korea, use of the RAT for COVID-19 diagnosis appears to be limited.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherKorean Society for Laboratory Medicine-
dc.relation.isPartOfANNALS OF LABORATORY MEDICINE-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHCOVID-19 / diagnosis*-
dc.subject.MESHCOVID-19 / virology-
dc.subject.MESHCOVID-19 Testing / methods-
dc.subject.MESHHumans Nasopharynx / virology-
dc.subject.MESHRNA, Viral / analysis-
dc.subject.MESHRNA, Viral / metabolism-
dc.subject.MESHRNA-Dependent RNA Polymerase / genetics*-
dc.subject.MESHReal-Time Polymerase Chain Reaction-
dc.subject.MESHRepublic of Korea-
dc.subject.MESHSARS-CoV-2 / genetics*-
dc.subject.MESHSARS-CoV-2 / isolation & purification-
dc.titleClinical Performance of the Standard Q COVID-19 Rapid Antigen Test and Simulation of its Real-World Application in Korea-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Laboratory Medicine (진단검사의학교실)-
dc.contributor.googleauthorJaehyeon Lee-
dc.contributor.googleauthorSo Yeon Kim-
dc.contributor.googleauthorHee Jae Huh-
dc.contributor.googleauthorNamsu Kim-
dc.contributor.googleauthorHeungsup Sung-
dc.contributor.googleauthorHyukmin Lee-
dc.contributor.googleauthorKyoung Ho Roh-
dc.contributor.googleauthorTaek Soo Kim-
dc.contributor.googleauthorKi Ho Hong-
dc.identifier.doi10.3343/alm.2021.41.6.588-
dc.contributor.localIdA06207-
dc.contributor.localIdA03286-
dc.relation.journalcodeJ00164-
dc.identifier.eissn2234-3814-
dc.identifier.pmid34108286-
dc.subject.keywordCoronavirus disease-
dc.subject.keywordKorea-
dc.subject.keywordLaboratory surveillance-
dc.subject.keywordRapid antigen test-
dc.subject.keywordReal-time reverse-transcription PCR-
dc.contributor.alternativeNameHong, Ki Ho-
dc.contributor.affiliatedAuthor홍기호-
dc.contributor.affiliatedAuthor이혁민-
dc.citation.volume41-
dc.citation.number6-
dc.citation.startPage588-
dc.citation.endPage592-
dc.identifier.bibliographicCitationANNALS OF LABORATORY MEDICINE, Vol.41(6) : 588-592, 2021-11-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실) > 1. Journal Papers

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