{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T17:46:10Z","timestamp":1775065570239,"version":"3.50.1"},"reference-count":6,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2020,5,22]],"date-time":"2020-05-22T00:00:00Z","timestamp":1590105600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2020,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The urgent need to implement and rapidly expand testing for severe acute respiratory syndrome coronavirus\u20102 (SARS\u2010CoV\u20102) infection has led to the development of multiple assays. How these tests perform relative to one another is poorly understood. We evaluated the concordance between the Roche Diagnostics cobas 6800 SARS\u2010CoV\u20102 test and a laboratory\u2010developed test (LDT) real\u2010time reverse transcription\u2010polymerase chain reaction based on a modified Centers for Disease Control and Prevention protocol, for the detection of SARS\u2010CoV\u20102 in samples submitted to the Clinical Laboratories of the Mount Sinai Health System. A total of 1006 nasopharyngeal swabs in universal transport medium from persons under investigation were tested for SARS\u2010CoV\u20102 as part of routine clinical care using the cobas SARS\u2010CoV\u20102 test with subsequent evaluation by the LDT. Cycle threshold values were analyzed and interpreted as either positive (\u201cdetected\u201d or \u201cpresumptive positive\u201d), negative (not detected), inconclusive, or invalid. Statistical analysis was performed using GraphPad Prism 8. The cobas SARS\u2010CoV\u20102 test reported 706 positive and 300 negative results. The LDT reported 640 positive, 323 negative, 34 inconclusive, and 9 invalid results. When excluding inconclusive and invalid results, the overall percent agreement between the two platforms was 95.8%. Cohen's <jats:italic>\u03ba<\/jats:italic> coefficient was 0.904 (95% confidence interval, 0.875\u20100.933), suggesting almost perfect agreement between both platforms. An overall discordance rate of 4.2% between the two systems may reflect differences in primer sequences, assay limit of detection, or other factors, highlighting the importance of comparing the performance of different testing platforms.<\/jats:p>","DOI":"10.1002\/jmv.25988","type":"journal-article","created":{"date-parts":[[2020,5,8]],"date-time":"2020-05-08T08:07:39Z","timestamp":1588925259000},"page":"1695-1698","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":85,"title":["Comparison of SARS\u2010CoV\u20102 detection from nasopharyngeal swab samples by the Roche cobas 6800 SARS\u2010CoV\u20102 test and a laboratory\u2010developed real\u2010time RT\u2010PCR test"],"prefix":"10.1002","volume":"92","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4795-7945","authenticated-orcid":false,"given":"Elisabet","family":"Pujadas","sequence":"first","affiliation":[{"name":"Department of Pathology, Molecular, and Cell\u2010Based Medicine Icahn School of Medicine at Mount Sinai  New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nnaemeka","family":"Ibeh","sequence":"additional","affiliation":[{"name":"Department of Pathology, Molecular, and Cell\u2010Based Medicine Icahn School of Medicine at Mount Sinai  New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew M.","family":"Hernandez","sequence":"additional","affiliation":[{"name":"The Graduate School of Biomedical Sciences Icahn School of Medicine at Mount Sinai  New York New York"},{"name":"Department of Microbiology Icahn School of Medicine at Mount Sinai  New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aneta","family":"Waluszko","sequence":"additional","affiliation":[{"name":"Molecular Pathology Laboratory Mount Sinai Health System  New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tatyana","family":"Sidorenko","sequence":"additional","affiliation":[{"name":"Molecular Pathology Laboratory Mount Sinai Health System  New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vanessa","family":"Flores","sequence":"additional","affiliation":[{"name":"Clinical Microbiology Laboratory Mount Sinai Health System  New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Biana","family":"Shiffrin","sequence":"additional","affiliation":[{"name":"Clinical Microbiology Laboratory Mount Sinai Health System  New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Numthip","family":"Chiu","sequence":"additional","affiliation":[{"name":"Clinical Microbiology Laboratory Mount Sinai Health System  New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alicia","family":"Young\u2010Francois","sequence":"additional","affiliation":[{"name":"Clinical Microbiology Laboratory Mount Sinai Health System  New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael D.","family":"Nowak","sequence":"additional","affiliation":[{"name":"Department of Pathology, Molecular, and Cell\u2010Based Medicine Icahn School of Medicine at Mount Sinai  New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alberto E.","family":"Paniz\u2010Mondolfi","sequence":"additional","affiliation":[{"name":"Department of Pathology, Molecular, and Cell\u2010Based Medicine Icahn School of Medicine at Mount Sinai  New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emilia M.","family":"Sordillo","sequence":"additional","affiliation":[{"name":"Department of Pathology, Molecular, and Cell\u2010Based Medicine Icahn School of Medicine at Mount Sinai  New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlos","family":"Cordon\u2010Cardo","sequence":"additional","affiliation":[{"name":"Department of Pathology, Molecular, and Cell\u2010Based Medicine Icahn School of Medicine at Mount Sinai  New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane","family":"Houldsworth","sequence":"additional","affiliation":[{"name":"Department of Pathology, Molecular, and Cell\u2010Based Medicine Icahn School of Medicine at Mount Sinai  New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6960-0763","authenticated-orcid":false,"given":"Melissa R.","family":"Gitman","sequence":"additional","affiliation":[{"name":"Department of Pathology, Molecular, and Cell\u2010Based Medicine Icahn School of Medicine at Mount Sinai  New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,5,22]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"https:\/\/www.fda.gov\/emergency-preparedness-and-response\/mcm-legal-regulatory-and-policy-framework\/emergency-use-authorization. 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