{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T10:41:17Z","timestamp":1780051277470,"version":"3.53.1"},"reference-count":24,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2020,12,15]],"date-time":"2020-12-15T00:00:00Z","timestamp":1607990400000},"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":[[2021,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>We compared the sensitivity and specificity of four commercial coronavirus disease (COVID\u201019) diagnostic kits using real\u2010time reverse transcription\u2013polymerase chain reaction (RT\u2010PCR). Kits I\u2010IV approved by the State Drug Administration of China were selected, and the detection targets were ORF1ab gene and N gene. Specificity was evaluated by detecting other respiratory viruses. The sensitivity and batch effect of each kit were evaluated by testing 10\u2010fold dilutions of RNA. Clinical application was verified by testing nasopharyngeal swab and sputum specimens from COVID\u201019 patients. Among the 78 cases infected by other respiratory viruses, no amplification curve was observed using these four COVID\u201019 RT\u2010PCR kits. The minimum detection limits of kits I\u2010IV were 10<jats:sup>\u22126<\/jats:sup>, 10<jats:sup>\u22125<\/jats:sup>, 10<jats:sup>\u22125<\/jats:sup>, and 10<jats:sup>\u22126<\/jats:sup>dilutions, respectively, and concentrations were 10 copies\/mL (10<jats:sup>\u22125<\/jats:sup>dilution) and 1 copies\/mL (10<jats:sup>\u22126<\/jats:sup>dilution). The sensitivities of kits I\u2010IV detected using 142 nasopharyngeal swab specimens from COVID\u201019 patients were 91.55%, 81.69%, 80.28%, and 90.85%, respectively, while they were 92.68%, 85.37%, 82.93%, and 93.90%, respectively, for the 82 sputum samples. The specificity of each kit was 100.00% (77\/77). The total expected detection rate using sputum samples was 88.59% (691\/780) higher than 86.15% (672\/780) of nasopharyngeal swabs. Comparison of nasopharyngeal swab and sputum samples from the same COVID\u201019 patient led to the detection of ORF1ab and N genes in 16 (100%) sputum samples; only ORF1ab and N genes were detected in 12 (75%) and 14 (87.5%) nasopharyngeal swab specimens, respectively. In conclusion, comparison of commercial COVID\u201019 RT\u2010PCR kits should be performed before using a new batch of such kits in routine diagnostics.<\/jats:p>","DOI":"10.1002\/jcla.23605","type":"journal-article","created":{"date-parts":[[2020,12,20]],"date-time":"2020-12-20T01:34:37Z","timestamp":1608428077000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Comparison of four commercial RT\u2010PCR diagnostic kits for COVID\u201019 in China"],"prefix":"10.1002","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0073-0674","authenticated-orcid":false,"given":"Lingyu","family":"Shen","sequence":"first","affiliation":[{"name":"Institute of Infectious Diseases and Endemic Diseases Prevention and Control, Beijing Municipal Center for Disease Prevention and Control Beijing Municipal Research Center for Preventive Medicine Beijing P. R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shujuan","family":"Cui","sequence":"additional","affiliation":[{"name":"Institute of Infectious Diseases and Endemic Diseases Prevention and Control, Beijing Municipal Center for Disease Prevention and Control Beijing Municipal Research Center for Preventive Medicine Beijing P. R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daitao","family":"Zhang","sequence":"additional","affiliation":[{"name":"Institute of Infectious Diseases and Endemic Diseases Prevention and Control, Beijing Municipal Center for Disease Prevention and Control Beijing Municipal Research Center for Preventive Medicine Beijing P. R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Changying","family":"Lin","sequence":"additional","affiliation":[{"name":"Institute of Infectious Diseases and Endemic Diseases Prevention and Control, Beijing Municipal Center for Disease Prevention and Control Beijing Municipal Research Center for Preventive Medicine Beijing P. R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lijuan","family":"Chen","sequence":"additional","affiliation":[{"name":"Institute of Infectious Diseases and Endemic Diseases Prevention and Control, Beijing Municipal Center for Disease Prevention and Control Beijing Municipal Research Center for Preventive Medicine Beijing P. R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Quanyi","family":"Wang","sequence":"additional","affiliation":[{"name":"Institute of Infectious Diseases and Endemic Diseases Prevention and Control, Beijing Municipal Center for Disease Prevention and Control Beijing Municipal Research Center for Preventive Medicine Beijing P. R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,12,15]]},"reference":[{"key":"e_1_2_5_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2020-320926"},{"key":"e_1_2_5_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaa272"},{"key":"e_1_2_5_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(20)30176-6"},{"key":"e_1_2_5_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2001017"},{"key":"e_1_2_5_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjms.2020.05.006"},{"key":"e_1_2_5_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.antiviral.2020.104873"},{"key":"e_1_2_5_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tim.2016.03.003"},{"key":"e_1_2_5_9_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-micro-020518-115759"},{"key":"e_1_2_5_10_1","doi-asserted-by":"publisher","DOI":"10.2807\/1560-7917.ES.2020.25.3.2000045"},{"key":"e_1_2_5_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30185-9"},{"key":"e_1_2_5_12_1","doi-asserted-by":"publisher","DOI":"10.1128\/JVI.64.3.1050-1056.1990"},{"key":"e_1_2_5_13_1","doi-asserted-by":"publisher","DOI":"10.1128\/JVI.77.18.9790-9798.2003"},{"key":"e_1_2_5_14_1","doi-asserted-by":"publisher","DOI":"10.46234\/ccdcw2020.116"},{"key":"e_1_2_5_15_1","article-title":"Comparison of commercial RT\u2010PCR diagnostic kits for COVID\u201019","author":"Kasteren PB","year":"2020","journal-title":"J Clin Virol"},{"key":"e_1_2_5_16_1","article-title":"Profile of RT\u2010PCR for SARS\u2010CoV\u20102: a preliminary study from 56 COVID\u201019 patients","author":"Tang XA","year":"2020","journal-title":"Clin Infect Dis"},{"key":"e_1_2_5_17_1","doi-asserted-by":"publisher","DOI":"10.1080\/14737159.2020.1757437"},{"key":"e_1_2_5_18_1","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00042-18"},{"key":"e_1_2_5_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11604-020-00967-9"},{"key":"e_1_2_5_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.rmed.2020.105980"},{"issue":"1","key":"e_1_2_5_21_1","first-page":"39","article-title":"A case of highly suspected COVID\u201019 with repeated virus nucleic acid negative","volume":"13","author":"Xin Z","year":"2020","journal-title":"Chinese J Clin Infect Dis"},{"key":"e_1_2_5_22_1","doi-asserted-by":"crossref","first-page":"e23507","DOI":"10.1002\/jcla.23507","article-title":"Laboratory verification of an RT\u2010PCR assay for SARS\u2010CoV\u20102","author":"Wu Y","year":"2020","journal-title":"J Clin Lab Anal"},{"key":"e_1_2_5_23_1","doi-asserted-by":"crossref","first-page":"e23392","DOI":"10.1002\/jcla.23392","article-title":"Clinical features of COVID\u201019 convalescent patients with re\u2010positive nucleic acid detection","author":"Zhu H","year":"2020","journal-title":"J Clin Lab Anal"},{"key":"e_1_2_5_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30184-7"},{"key":"e_1_2_5_25_1","doi-asserted-by":"publisher","DOI":"10.1080\/14737159.2020.1757437"}],"container-title":["Journal of Clinical Laboratory Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.23605","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcla.23605","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.23605","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,15]],"date-time":"2023-10-15T17:43:17Z","timestamp":1697391797000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jcla.23605"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,12,15]]},"references-count":24,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,1]]}},"alternative-id":["10.1002\/jcla.23605"],"URL":"https:\/\/doi.org\/10.1002\/jcla.23605","archive":["Portico"],"relation":{},"ISSN":["0887-8013","1098-2825"],"issn-type":[{"value":"0887-8013","type":"print"},{"value":"1098-2825","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,12,15]]},"assertion":[{"value":"2020-07-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-09-09","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-12-15","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e23605"}}