{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,2]],"date-time":"2026-02-02T21:00:45Z","timestamp":1770066045814,"version":"3.49.0"},"reference-count":16,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2020,10,27]],"date-time":"2020-10-27T00:00:00Z","timestamp":1603756800000},"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":[[2021,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>We aimed to evaluate the analytical performance of five commercial RT\u2010PCR kits (Genekey, Daan, BioGerm, Liferiver, and Yaneng) commonly used in China, since such comparison data are lacking.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A total of 20 COVID\u201019 confirmed patients and 30 negative nasopharyngeal swab specimens were analyzed by five kits. The detection ability of five RT\u2010PCR kits was evaluated with 5 concentration gradients diluted by a single positive sample. The limit of detection was evaluated by N gene fragment solid standard. Two positive clinical specimens were used to evaluate the repeatability and imprecision. Finally, we used six human coronaviruses plasmid and four respiratory pathogens plasmid to check for cross\u2010reactivity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The positive detection rate was 100% for Genekey, Daan, and BioGerm,and 90% for Liferiver and Yaneng in 20 clinical SARS\u2010CoV\u20102 infection. The coincidence rate of five kits in 10 negative samples was 100%. The detection rate of target genes for Daan, BioGerm, Liferiver, and Yaneng was 100% from Level 1 to Level 3. In Level 4, only Daan detection rate was 100%. In Level 5, five kits presented poor positive rate. The limit of detection declared by each manufacturer was verified. The repeatability for target genes was less\u00a0than 5% and so did the total imprecision. There is no cross\u2010reactivity of five kits with six human coronaviruses and four respiratory pathogens for ORF1ab and N gene.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Five RT\u2010PCR kits assessed in this study showed acceptable analytical performance characteristics and are useful tools for the routine diagnosis of SARS\u2010CoV\u20102.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.23643","type":"journal-article","created":{"date-parts":[[2020,10,27]],"date-time":"2020-10-27T08:44:34Z","timestamp":1603788274000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Analytical performance evaluation of five RT\u2010PCR kits for severe acute respiratory syndrome coronavirus 2"],"prefix":"10.1002","volume":"35","author":[{"given":"Mengmeng","family":"Wang","sequence":"first","affiliation":[{"name":"Anhui University of Science and Technology Huainan China"},{"name":"Medical Laboratory of the Third Affiliated Hospital of ShenZhen University Shenzhen China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dayang","family":"Chen","sequence":"additional","affiliation":[{"name":"Medical Laboratory of the Third Affiliated Hospital of ShenZhen University Shenzhen China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei","family":"Wu","sequence":"additional","affiliation":[{"name":"Medical Laboratory of the Third Affiliated Hospital of ShenZhen University Shenzhen China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Huamei","family":"Tang","sequence":"additional","affiliation":[{"name":"Medical Laboratory of the Third Affiliated Hospital of ShenZhen University Shenzhen China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lijuan","family":"Kan","sequence":"additional","affiliation":[{"name":"Medical Laboratory of the Third Affiliated Hospital of ShenZhen University Shenzhen China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2332-4211","authenticated-orcid":false,"given":"Zengyan","family":"Zong","sequence":"additional","affiliation":[{"name":"Anhui University of Science and Technology Huainan China"},{"name":"Medical Laboratory of the Third Affiliated Hospital of ShenZhen University Shenzhen China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaowen","family":"Dou","sequence":"additional","affiliation":[{"name":"Medical Laboratory of the Third Affiliated Hospital of ShenZhen University Shenzhen China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiang","family":"Ji","sequence":"additional","affiliation":[{"name":"Medical Laboratory of the Third Affiliated Hospital of ShenZhen University Shenzhen China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dan","family":"Xiong","sequence":"additional","affiliation":[{"name":"Anhui University of Science and Technology Huainan China"},{"name":"Medical Laboratory of the Third Affiliated Hospital of ShenZhen University Shenzhen China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7971-6444","authenticated-orcid":false,"given":"Xiuming","family":"Zhang","sequence":"additional","affiliation":[{"name":"Anhui University of Science and Technology Huainan China"},{"name":"Medical Laboratory of the Third Affiliated Hospital of ShenZhen University Shenzhen China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,10,27]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.3390\/v12020135"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp2000929"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1261\/rna.076232.120"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.14238"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2020.104397"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2020.104412"},{"key":"e_1_2_9_8_1","doi-asserted-by":"crossref","unstructured":"WangX YaoH XuX ZhangP ZhangM ShaoJ XiaoY WangH.Limits of Detection of Six Approved RT\u2010PCR Kits for the Novel SARS\u2010coronavirus\u20102 (SARS\u2010CoV\u20102). 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(2020). doi: 10.1093\/clinchem\/hvaa099.","DOI":"10.1093\/clinchem\/hvaa099"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijid.2020.04.023"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/hvaa091"},{"key":"e_1_2_9_11_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_9_12_1","doi-asserted-by":"crossref","unstructured":"XiongY et al.Comparative performance of four nucleic acid amplification tests for SARS\u2010CoV\u20102 virus. bioRxiv 2020.03.26.010975; doi: 10.1101\/2020.03.26.010975.","DOI":"10.1101\/2020.03.26.010975"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13054-020-02893-8"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaa345"},{"issue":"1","key":"e_1_2_9_15_1","first-page":"3","article-title":"Properties of Coronavirus and SARS\u2010CoV\u20102","volume":"42","author":"Malik YA","year":"2020","journal-title":"Malaysian J Pathol"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.1248627"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcla.23032"}],"container-title":["Journal of Clinical Laboratory Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.23643","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcla.23643","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.23643","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,10]],"date-time":"2023-10-10T17:41:30Z","timestamp":1696959690000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jcla.23643"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,10,27]]},"references-count":16,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,1]]}},"alternative-id":["10.1002\/jcla.23643"],"URL":"https:\/\/doi.org\/10.1002\/jcla.23643","archive":["Portico"],"relation":{},"ISSN":["0887-8013","1098-2825"],"issn-type":[{"value":"0887-8013","type":"print"},{"value":"1098-2825","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,10,27]]},"assertion":[{"value":"2020-08-24","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-10-09","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-10-27","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e23643"}}