{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,26]],"date-time":"2026-03-26T18:15:41Z","timestamp":1774548941457,"version":"3.50.1"},"reference-count":15,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2021,12,9]],"date-time":"2021-12-09T00:00:00Z","timestamp":1639008000000},"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":[[2022,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Various nucleic acid amplification assays for the diagnosis of SARS\u2010CoV\u20102 infection have been developed, and there is a need to assess their test performance relative to one another. The aim of this study was to compare the performance characteristics of the Biosewoom Real\u2010Q 2019\u2010nCoV assay targeting the E and RdRP genes to DaAn Gene 2019\u2010nCoV kit targeting the N gene and ORF1ab in the diagnosis of SARS\u2010CoV\u20102.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We performed a diagnostic comparison study by testing nasopharyngeal samples for SARS\u2010CoV\u20102 using the two reverse transcription polymerase chain reaction (RT\u2010PCR) assays. Assay agreement was assessed by overall percent agreement, negative percent agreement, positive percent agreement, and Cohen's kappa coefficient.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 48 nasopharyngeal samples were tested using the two assays. One sample was invalid, and three showed inconclusive results with Real\u2010Q; hence, 44 were included for the comparative analysis. Overall, percent agreement between the assays was 93.2% (95% CI 81.3%\u201398.6%), Positive percent agreement (PPA) was 86.4% (95% CI 65.1%\u201397.1%) and negative percent agreement (NPA) was 100% (95% CI 84.6%\u2013100%). The kappa coefficient was 0.86 (95% CI 0.72\u20131.01). Three samples (6.8%) were positive with DaAn gene kit and negative with Real\u2010Q. The fluorescence intensity for Real\u2010Q reporter dyes was low.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The two kits showed high levels of concordance in their detection of SARS\u2010CoV\u20102 despite having different gene targets. The Biosewoom kit can be improved through addressing the fluorescence intensity of the target dyes, and feedback was given to the manufacturer.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.24161","type":"journal-article","created":{"date-parts":[[2021,12,9]],"date-time":"2021-12-09T13:44:28Z","timestamp":1639057468000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Comparison of Real\u2010Q 2019\u2010nCoV and DaAn Gene 2019\u2010nCoV polymerase chain reaction assays for the detection of SARS\u2010CoV\u20102"],"prefix":"10.1002","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0293-4088","authenticated-orcid":false,"given":"Takudzwa","family":"Marembo","sequence":"first","affiliation":[{"name":"Africa Centres for Disease Control and Prevention African Union Commission Addis Ababa Ethiopia"},{"name":"Department of Medical Microbiology Midlands State University Faculty of Medicine Gweru Zimbabwe"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Prosper","family":"Chimbunde","sequence":"additional","affiliation":[{"name":"Department of Medical Microbiology Midlands State University Faculty of Medicine Gweru Zimbabwe"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tendai","family":"Chipendo","sequence":"additional","affiliation":[{"name":"Africa Centres for Disease Control and Prevention African Union Commission Addis Ababa Ethiopia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Clayton","family":"Munemo","sequence":"additional","affiliation":[{"name":"Africa Centres for Disease Control and Prevention African Union Commission Addis Ababa Ethiopia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Portia","family":"Manangazira","sequence":"additional","affiliation":[{"name":"Africa Centres for Disease Control and Prevention African Union Commission Addis Ababa Ethiopia"},{"name":"Ministry of Health and Child Care Epidemiology and Disease Control Directorate Harare Zimbabwe"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Donewell","family":"Bangure","sequence":"additional","affiliation":[{"name":"Africa Centres for Disease Control and Prevention African Union Commission Addis Ababa Ethiopia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,12,9]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00784-020-03248-x"},{"key":"e_1_2_9_3_1","unstructured":"COVID\u201019 public health emergency of international concern (PHEIC) Global research and innovation forum [Internet]. [cited 2020 Jul 22]. Available from:https:\/\/www.who.int\/publications\/m\/item\/covid\u201019\u2010public\u2010health\u2010emergency\u2010of\u2010international\u2010concern\u2010(pheic)\u2010global\u2010research\u2010and\u2010innovation\u2010forum"},{"key":"e_1_2_9_4_1","unstructured":"Coronavirus update (Live): 15 153 194 Cases and 621 153 deaths from COVID\u201019 virus pandemic \u2010 worldometer [Internet]. [cited 2020 Jul 22]. Available from:https:\/\/www.worldometers.info\/coronavirus\/?utm_campaign=homeAdvegas1?"},{"key":"e_1_2_9_5_1","unstructured":"Ministry of health and child care \u2010 latest updates [Internet]. [cited 2020 Jul 22]. Available from:http:\/\/www.mohcc.gov.zw\/"},{"issue":"2","key":"e_1_2_9_6_1","first-page":"174","article-title":"SARS\u2010CoV\u20102, SARS\u2010CoV, and MERS\u2010COV: a comparative overview","volume":"28","author":"Rabaan AA","year":"2020","journal-title":"Infez Med"},{"key":"e_1_2_9_7_1","unstructured":"Transmission of SARS\u2010CoV\u20102: implications for infection prevention precautions [Internet]. [cited 2020 Jul 22]. Available from:https:\/\/www.who.int\/news\u2010room\/commentaries\/detail\/transmission\u2010of\u2010sars\u2010cov\u20102\u2010implications\u2010for\u2010infection\u2010prevention\u2010precautions"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(20)30113-4"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00310-20"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1080\/22221751.2020.1745095"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm9030623"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2020.104510"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.2807\/1560-7917.ES.2020.25.14.2000398"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcla.23643"},{"issue":"7","key":"e_1_2_9_15_1","first-page":"201025","article-title":"Comparative performance of four nucleic acid amplification tests for SARS\u2010CoV\u20102 virus","volume":"67","author":"Zhuang QZ","year":"2021","journal-title":"Clin Lab"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bdq.2019.100082"}],"container-title":["Journal of Clinical Laboratory Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.24161","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcla.24161","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.24161","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,28]],"date-time":"2023-08-28T04:20:26Z","timestamp":1693196426000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jcla.24161"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,12,9]]},"references-count":15,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2022,1]]}},"alternative-id":["10.1002\/jcla.24161"],"URL":"https:\/\/doi.org\/10.1002\/jcla.24161","archive":["Portico"],"relation":{},"ISSN":["0887-8013","1098-2825"],"issn-type":[{"value":"0887-8013","type":"print"},{"value":"1098-2825","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,12,9]]},"assertion":[{"value":"2021-10-09","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-11-20","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-12-09","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e24161"}}