{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,12]],"date-time":"2026-05-12T20:00:45Z","timestamp":1778616045047,"version":"3.51.4"},"reference-count":21,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2018,6,12]],"date-time":"2018-06-12T00:00:00Z","timestamp":1528761600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Roche Diagnostics","award":["Investigator Initiated Study (IIS) No. RD002251"],"award-info":[{"award-number":["Investigator Initiated Study (IIS) No. RD002251"]}]},{"name":"University of Maryland Medical Center","award":["Intramural funding"],"award-info":[{"award-number":["Intramural funding"]}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2018,10]]},"abstract":"<jats:p>Cytomegalovirus (CMV) infection is a leading cause of loss of hearing, vision, and mental retardation in congenitally infected children. It is also associated with complications of organ transplant and opportunistic HIV coinfection. The Roche COBAS<jats:sup>\u00ae<\/jats:sup> AmpliPrep\/COBAS<jats:sup>\u00ae<\/jats:sup> TaqMan<jats:sup>\u00ae<\/jats:sup> CMV test is an FDA\u2013approved test that measures CMV DNA viral load in plasma for the diagnosis and management of patients at risk of CMV\u2010associated diseases. Besides plasma, CMV is often found in bronchoalveolar lavage (BAL), cerebrospinal fluid (CSF), and urine. Thus, monitoring of CMV for critical care of patients in these nonplasma samples becomes necessary. The objective of this study was to conduct an analytic and clinical feasibility study of the Roche CMV test in BAL, CSF, and urine. The lower limit of detection, analytic measurement range, assay sensitivity, specificity, and precision were determined. Results of this study showed that the lower limit of detections were 50, 100, and 300\u2009IU\/mL for BAL, CSF, or urine, respectively. The analytic measurement ranges were from log<jats:sub>10<\/jats:sub> 2.48 to log<jats:sub>10<\/jats:sub> 5.48. The assay specificity was 94.4% for BAL and 100% for CSF and urine. The assay precision was all within the acceptable range. The performance of Roche test was further compared with 2 comparators including the RealTime CMV assay (Abbott Molecular) and a CMV Quantitative Polymerase Chain Reaction test (Vela Diagnostics). There was a general positive correlation between the Roche method and the Abbott or the Vela method. Overall, this study suggests that the Roche CMV test is suitable for the quantification of CMV viral load DNA in the described nonplasma samples.<\/jats:p>","DOI":"10.1002\/jmv.25226","type":"journal-article","created":{"date-parts":[[2018,5,24]],"date-time":"2018-05-24T07:41:10Z","timestamp":1527147670000},"page":"1611-1619","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Clinical evaluation of Roche COBAS<sup>\u00ae<\/sup> AmpliPrep\/COBAS<sup>\u00ae<\/sup> TaqMan<sup>\u00ae<\/sup> CMV test using nonplasma samples"],"prefix":"10.1002","volume":"90","author":[{"given":"Cynthia","family":"Hildenbrand","sequence":"first","affiliation":[{"name":"Molecular Diagnostics Laboratory Universtiy of Maryland Medical Center  Baltimore Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Wedekind","sequence":"additional","affiliation":[{"name":"Molecular Diagnostics Laboratory Universtiy of Maryland Medical Center  Baltimore Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ge","family":"Li","sequence":"additional","affiliation":[{"name":"Division of Molecular Pathology, Department of Pathololgy University of Maryland School of Medicine  Baltimore Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeanne E.","family":"vonRentzell","sequence":"additional","affiliation":[{"name":"Department of Pathology Loyola University Medical Center  Chicago Illinois"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Krunal","family":"Shah","sequence":"additional","affiliation":[{"name":"Vela Diagnostics  Fairfield New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Rooney","sequence":"additional","affiliation":[{"name":"Vela Diagnostics  Fairfield New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amanda T.","family":"Harrington","sequence":"additional","affiliation":[{"name":"Department of Pathology Loyola University Medical Center  Chicago Illinois"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3424-2852","authenticated-orcid":false,"given":"Richard Y.","family":"Zhao","sequence":"additional","affiliation":[{"name":"Molecular Diagnostics Laboratory Universtiy of Maryland Medical Center  Baltimore Maryland"},{"name":"Division of Molecular Pathology, Department of Pathololgy University of Maryland School of Medicine  Baltimore Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,6,12]]},"reference":[{"key":"e_1_2_7_1_2_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.40.3.746-752.2002"},{"key":"e_1_2_7_1_3_1","doi-asserted-by":"publisher","DOI":"10.1099\/vir.0.79888-0"},{"key":"e_1_2_7_1_4_1","doi-asserted-by":"publisher","DOI":"10.1099\/vir.0.015891-0"},{"key":"e_1_2_7_1_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/QCO.0b013e32821f6010"},{"key":"e_1_2_7_1_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00430-012-0232-7"},{"key":"e_1_2_7_1_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2458-12-475"},{"key":"e_1_2_7_1_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.cr.7290361"},{"key":"e_1_2_7_1_9_1","first-page":"254","article-title":"From single cell gene\u2010based diagnostics to diagnostic genomics: current applications and future perspectives","volume":"18","author":"Zhao R","year":"2005","journal-title":"Clin Lab Sci"},{"key":"e_1_2_7_1_10_1","unstructured":"Roche Molecular Diagnostics.COBAS\u00aeAmpliPrep\/COBAS\u00aeTaqMan\u00ae CMV Test. 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