{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T12:33:11Z","timestamp":1792672391899,"version":"4.5.0"},"reference-count":49,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2023,11,15]],"date-time":"2023-11-15T00:00:00Z","timestamp":1700006400000},"content-version":"vor","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Laboratory testing for cytomegalovirus (CMV) in bodily fluids is essential to manage congenital and prenatal CMV infection. The rapid and fully automated cobas\u00ae CMV PCR is approved only for the testing of plasma in transplant patients. To evaluate the performance of the cobas\u00ae CMV to detect and quantify CMV DNA in neonatal and adult female urine, saliva, and vaginal secretion, the limit of detection (LoD), limit of quantification (LoQ), imprecision, linearity, PCR efficiency, bias, analytical specificity, cross\u2010reactivity, and cross\u2010contamination of the cobas\u00ae CMV for urine, saliva, and vaginal secretion was determined. The performance of the assay was evaluated prospectively with two laboratory\u2010developed PCR assays using neonatal and adult urine, saliva swabs, and vaginal swabs. The LoD and LoQ were 31 and 100\u2009IU\/mL, respectively, for urine, and 81 and 100\u2009IU\/mL, respectively, for vaginal secretion. The LoD and LoQ for saliva were the same (200\u2009IU\/mL). The cobas\u00ae CMV was precise (coefficient of variation\u2009\u226410%), linear (<jats:italic>R<\/jats:italic><jats:sup>2<\/jats:sup>\u2009\u2265\u20090.995), and efficient (1.07 and 1.09) between 100 and 250,000\u2009IU\/mL for the sample types. The bias and analytical specificity was &lt;\u00b10.30 log<jats:sub>10<\/jats:sub> IU\/mL and 100%, respectively. Cross\u2010reactivity with non\u2010CMV pathogens was not detected. Cross\u2010contamination rate was 0.28%. The diagnostic accuracy, sensitivity, and specificity of the cobas\u00ae CMV for neonatal urine and saliva were \u226595.0%, \u226593.3%, and \u226590.4%, respectively. The overall percent agreement for adult urine, saliva, and vaginal secretion was 86.6%, 94.5%, and 89.4%, respectively. Taken together, the cobas\u00ae CMV demonstrated acceptable analytical and diagnostic performance, and is suitable for routine diagnostic laboratory investigation of CMV infection in neonates and adults.<\/jats:p>","DOI":"10.1002\/jmv.29223","type":"journal-article","created":{"date-parts":[[2023,11,15]],"date-time":"2023-11-15T21:34:47Z","timestamp":1700084087000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Performance evaluation of fully automated cobas\u00ae 6800 CMV PCR for the detection and quantification of cytomegalovirus DNA in neonatal urine and saliva, and adult urine, saliva, and vaginal secretion"],"prefix":"10.1002","volume":"95","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6522-000X","authenticated-orcid":false,"given":"Ngee Keong","family":"Tan","sequence":"first","affiliation":[{"name":"Department of Medical Microbiology, Infection and Immunity, South West London Pathology St George's University Hospitals NHS Foundation Trust London UK"},{"name":"School of Biological Sciences, Faculty of Biology, Medicine and Health University of Manchester Manchester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cassie F.","family":"Pope","sequence":"additional","affiliation":[{"name":"Infection Care Group St George's University Hospitals NHS Foundation Trust London UK"},{"name":"Institute for Infection and Immunity, St George's University of London London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Carrington","sequence":"additional","affiliation":[{"name":"Infection Care Group St George's University Hospitals NHS Foundation Trust London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,11,15]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2020.104518"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2023.2222583"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.20619"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.24158"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2017.03.004"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciw707"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1086\/586715"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(17)30143-3"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1006561"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiu263"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.lanwpc.2021.100182"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.3389\/fped.2022.988039"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.3389\/fped.2020.00013"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2021.09.013"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciy166"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2022.09.040"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1099\/jmm.0.000838"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1080\/14737159.2017.1275962"},{"key":"e_1_2_10_20_1","unstructured":"Roche Diagnostics GmbH. cobas\u00ae CMV \u2010 Quantitative nucleic acid test for use on the cobas\u00ae 6800\/8800 systems. 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