{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,14]],"date-time":"2026-07-14T07:24:08Z","timestamp":1784013848550,"version":"3.55.0"},"reference-count":27,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2022,3,21]],"date-time":"2022-03-21T00:00:00Z","timestamp":1647820800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007225","name":"Ministry of Science and Technology","doi-asserted-by":"publisher","award":["\u0110T\u0110L.CN\u201029\/20"],"award-info":[{"award-number":["\u0110T\u0110L.CN\u201029\/20"]}],"id":[{"id":"10.13039\/100007225","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2022,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The COVID\u201019 pandemic caused by SARS\u2010CoV\u20102\u00a0remains public health burdens and many unresolved issues worldwide. Molecular assays based on real\u2010time RT\u2010PCR are critical for the detection of SARS\u2010CoV\u20102 in clinical specimens from patients suspected of COVID\u201019.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>We aimed to establish and validate an in\u2010house real\u2010time RT\u2010PCR for the detection of SARS\u2010CoV\u20102.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methodology<\/jats:title><jats:p>Primers and probes sets in our in\u2010house real\u2010time RT\u2010PCR assay were designed in conserved regions of the <jats:italic>N<\/jats:italic> and <jats:italic>E<\/jats:italic> target genes. Optimized multiplex real\u2010time RT\u2010PCR assay was validated using the first WHO International Standard (NIBSC code: 20\/146) and evaluated clinical performance.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The limit of detection validated using the first WHO International Standard was 159\u00a0IU\/ml for both E and N target genes. The evaluation of clinical performance on 170 clinical samples showed a positive percent agreement of 100% and the negative percent agreement of 99.08% for both target genes. The Kappa value of 0.99 was an excellent agreement, the strong correlation of <jats:italic>C<\/jats:italic><jats:sub>t<\/jats:sub> values observed between two tests with <jats:italic>r<\/jats:italic><jats:sup>2<\/jats:sup>\u00a0=\u00a00.84 for the E gene and 0.87 for the N gene. Notably, we assessed on 60 paired saliva and nasopharyngeal samples. The overall agreement was 91.66%, and Kappa value of 0.74\u00a0showed a high agreement between two types of samples. When using nasopharyngeal swabs as the reference standard, positive percent agreement, and negative percent agreement were 91.83% and 90.90%, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In the present study, we established and validated an in\u2010house real\u2010time RT\u2010PCR for molecular detection of SARS\u2010CoV\u20102 in a resource\u2010limited country.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.24355","type":"journal-article","created":{"date-parts":[[2022,3,21]],"date-time":"2022-03-21T11:37:40Z","timestamp":1647862660000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Establishment of an in\u2010house real\u2010time RT\u2010PCR assay for the detection of severe acute respiratory syndrome coronavirus 2 using the first World Health Organization international standard in a resource\u2010limited 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