{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,22]],"date-time":"2026-04-22T07:17:35Z","timestamp":1776842255409,"version":"3.51.2"},"reference-count":30,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2022,1,12]],"date-time":"2022-01-12T00:00:00Z","timestamp":1641945600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2022,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Currently, SARS\u2010CoV\u20102 RNA detection using real\u2010time reverse\u2010transcription PCR (rRT\u2010PCR) is the standard diagnostic test for COVID\u201019 infection. Various rRT\u2010PCR assays are currently used worldwide, targeting different genes of the SARS\u2010CoV\u20102. Here, we compared the analytical sensitivity and clinical performance (sensitivity and specificity) of Allplex SARS\u2010CoV\u20102\/FluA\/FluB\/RSV assay (Seegene), Standard M nCoV real\u2010time detection kit (SD Biosensor), and U\u2010TOP COVID\u201019 detection kit (Seasun Biomaterials) for SARS\u2010CoV\u20102 detection.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Two hundred and forty\u2010nine nasopharyngeal swab samples were evaluated to compare the clinical performance of the rRT\u2010PCR assays. For the analytical performance evaluation, two RNA controls with known viral loads\u2014SARS\u2010CoV\u20102 RNA control and SARS\u2010COV\u20102 B.1.351 RNA control\u2014were used to investigate the potential impact of SARS\u2010CoV\u20102 variants, particularly the B.1.351 lineage.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Limits of detection ranged from 650 to 1300 copies\/ml for rRT\u2010PCR assays, and the mean differences in cycle threshold (C<jats:italic><jats:sub>t<\/jats:sub><\/jats:italic>) values of the two RNA controls were within 1.0 for each target in the rRT\u2010PCR assays (0.05\u20130.73), without any prominent C<jats:italic><jats:sub>t<\/jats:sub><\/jats:italic> value shift or dropouts in the SARS\u2010COV\u20102 B.1.351 RNA control. Using the consensus criterion as the reference standard, 89 samples were positive, whereas 160 were negative. The overall clinical performance of rRT\u2010PCR assays was comparable (sensitivity 98.88%\u2013100%; specificity 99.38%\u2013100%), whereas the sensitivities of each target gene were more variable.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The three rRT\u2010PCR assays showed comparable analytical sensitivity and clinical performance. The analytical and clinical sensitivities of each target gene were influenced more by the primer and probe design than the target gene itself.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.24242","type":"journal-article","created":{"date-parts":[[2022,1,12]],"date-time":"2022-01-12T10:41:24Z","timestamp":1641984084000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Comparison of three molecular diagnostic assays for SARS\u2010CoV\u20102 detection: Evaluation of analytical sensitivity and clinical performance"],"prefix":"10.1002","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1928-7411","authenticated-orcid":false,"given":"Ha Nui","family":"Kim","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine Korea University College of Medicine Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Soo\u2010Young","family":"Yoon","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Korea University College of Medicine Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chae Seung","family":"Lim","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Korea University College of Medicine Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9296-5085","authenticated-orcid":false,"given":"Jung","family":"Yoon","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Korea University College of Medicine Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,1,12]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"World Health Organization Coronavirus disease (COVID\u201019) outbreak 2021.https:\/\/www.who.int\/emergencies\/diseases\/novel\u2010coronavirus\u20102019. Accessed September 09 2021."},{"key":"e_1_2_8_3_1","volume-title":"Diagnostic Testing for SARS\u2010CoV\u20102: Interim Guidance","author":"World Health Organization","year":"2020"},{"issue":"2020","key":"e_1_2_8_4_1","first-page":"351","article-title":"Guidelines for laboratory diagnosis of coronavirus disease 2019 (COVID\u201019) in Korea","volume":"40","author":"Hong KH","year":"2019","journal-title":"Ann Lab Med"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41564-020-0761-6"},{"key":"e_1_2_8_6_1","unstructured":"FIND the global alliance for diagnostics 2021.https:\/\/www.finddx.org\/test\u2010directory\/. Accessed September 09 2021."},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ygeno.2020.09.028"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00557-20"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiab082"},{"key":"e_1_2_8_10_1","article-title":"Gene Dropout patterns in SARS\u2010CoV\u20102 tests suggest spread of the H69del\/V70del mutation in the US","author":"Washington NL","year":"2020","journal-title":"medRxiv"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01598-20"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.2807\/1560-7917.ES.2020.25.39.2001650"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41586-021-03402-9"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.2807\/1560-7917.ES.2021.26.23.2100447"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm7008e2"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.2807\/1560-7917.ES.2020.25.3.2000045"},{"key":"e_1_2_8_17_1","volume-title":"Centers for Disease Control and Prevention, novel coronavirus (2019\u2010nCoV) real\u2010time RT\u2010PCR diagnostic panel","author":"CDC","year":"2020"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00743-20"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10096-020-04025-0"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tifs.2014.03.008"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1038\/s12276-020-0452-7"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01535-20"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1097\/JOM.0000000000002138"},{"key":"e_1_2_8_24_1","volume-title":"Impact of false\u2010positives and false\u2010negatives in the UK's COVID\u201019 RT\u2010PCR testing programme","author":"Mayers C","year":"2020"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaa638"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaa1579"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc2027040"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaa398"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-020-0869-5"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaa742"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2021.05.025"}],"container-title":["Journal of Clinical Laboratory Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.24242","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcla.24242","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.24242","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,27]],"date-time":"2023-08-27T05:49:11Z","timestamp":1693115351000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jcla.24242"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,1,12]]},"references-count":30,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2022,2]]}},"alternative-id":["10.1002\/jcla.24242"],"URL":"https:\/\/doi.org\/10.1002\/jcla.24242","archive":["Portico"],"relation":{},"ISSN":["0887-8013","1098-2825"],"issn-type":[{"value":"0887-8013","type":"print"},{"value":"1098-2825","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,1,12]]},"assertion":[{"value":"2021-11-24","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-01-02","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-01-12","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e24242"}}