{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T15:38:43Z","timestamp":1787240323849,"version":"build-2736575974"},"reference-count":33,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T00:00:00Z","timestamp":1774569600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Viruses"],"abstract":"<jats:p>Background: This study evaluated the inter-method agreement of an in-house qualitative CMV real-time PCR assay for the detection of cytomegalovirus (CMV) DNA in various non-plasma clinical specimen types, in comparison with a commercially available comparator assay. Methods: In this prospective comparative study, 186 clinical specimens\u2014including bronchoalveolar lavage fluid (BALF), stool, urine, colonoscopic biopsy, amniotic fluid, and intraocular fluid\u2014were analyzed. A total of 166 samples with valid results from both test systems were included in the inter-method comparison. CMV DNA was detected using the in-house qualitative PCR assay in parallel with the comparator assay (artus\u00ae CMV QS-RGQ kit). Agreement was assessed using positive percent agreement (PPA), negative percent agreement (NPA), overall percent agreement (OPA), and Cohen\u2019s kappa coefficient (\u03ba), in accordance with CLSI EP12-A2 recommendations. Results: Substantial overall inter-method agreement was observed when all specimens were evaluated collectively (\u03ba = 0.66). Agreement metrics were highest in stool, urine, and invasive specimens, whereas BALF samples demonstrated comparatively lower agreement, reflecting potential matrix-related analytical variability. Conclusion: The laboratory-developed qualitative CMV PCR assay demonstrated substantial inter-method agreement with the comparator assay across multiple non-plasma specimen types. The findings highlight specimen-specific variability in qualitative CMV DNA detection and represent analytical concordance between two molecular assays rather than definitive clinical diagnostic accuracy or viral load quantification.<\/jats:p>","DOI":"10.3390\/v18040417","type":"journal-article","created":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T12:45:53Z","timestamp":1774615553000},"page":"417","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Inter-Method Agreement of a Laboratory-Developed Qualitative CMV PCR Assay Across Multiple Non-Plasma Clinical Specimens"],"prefix":"10.3390","volume":"18","author":[{"given":"Murat","family":"Aral","sequence":"first","affiliation":[{"name":"Department of Medical Microbiology, Ankara Etlik City Hospital, Ankara 06170, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9006-5267","authenticated-orcid":false,"given":"Ayfer","family":"Bak\u0131r","sequence":"additional","affiliation":[{"name":"Department of Medical Microbiology, Ankara Etlik City Hospital, Ankara 06170, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cemal","family":"\u00c7i\u00e7ek","sequence":"additional","affiliation":[{"name":"Department of Medical Microbiology, Ankara Etlik City Hospital, Ankara 06170, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8832-2201","authenticated-orcid":false,"given":"Elif Tu\u011f\u00e7e","family":"G\u00fcner","sequence":"additional","affiliation":[{"name":"Department of Medical Microbiology, Ankara Etlik City Hospital, Ankara 06170, 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T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yusuf","family":"\u00dcst\u00fcn","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Ankara Etlik City Hospital, Ankara 06170, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harun","family":"Erdal","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Ankara Etlik City Hospital, Ankara 06170, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u015eevki","family":"\u00c7elen","sequence":"additional","affiliation":[{"name":"Department of Perinatology, Ankara Etlik City Hospital, Ankara 06170, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emine Bahar","family":"Kurt","sequence":"additional","affiliation":[{"name":"Department of Chest Diseases, Ankara Etlik City Hospital, Ankara 06170, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Serap Ak\u00e7al\u0131","family":"Duru","sequence":"additional","affiliation":[{"name":"Department of Chest Diseases, Ankara Etlik City Hospital, Ankara 06170, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asuman Nur","family":"Karhan","sequence":"additional","affiliation":[{"name":"Department of Pediatric Gastroenterology and Hepatology, Ankara Etlik City Hospital, Ankara 06170, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ferda","family":"\u00d6zbay Ho\u015fnut","sequence":"additional","affiliation":[{"name":"Department of Pediatric Gastroenterology and Hepatology, Ankara Etlik City Hospital, Ankara 06170, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ay\u015feg\u00fcl","family":"Tok","sequence":"additional","affiliation":[{"name":"Department of Pediatric Gastroenterology and Hepatology, Ankara Etlik City Hospital, Ankara 06170, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9956-4054","authenticated-orcid":false,"given":"Nilg\u00fcn","family":"Ero\u011flu","sequence":"additional","affiliation":[{"name":"Department of Pediatric Hematology and Oncology, Ankara Etlik City Hospital, Ankara 06170, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ferit","family":"Kulal\u0131","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Ankara Etlik City Hospital, Ankara 06170, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nurcan","family":"Hanedan","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Ankara Etlik City Hospital, Ankara 06170, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasemin","family":"Erol","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Ankara Etlik City Hospital, Ankara 06170, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5522-8342","authenticated-orcid":false,"given":"Ahmet K\u00fcr\u015fad","family":"G\u00fcne\u015f","sequence":"additional","affiliation":[{"name":"Department of Hematology, Ankara Etlik City Hospital, Ankara 06170, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G\u00f6knur","family":"Yapar Toros","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Ankara Etlik City Hospital, Ankara 06170, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ebru","family":"Oru\u00e7","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Ankara Etlik City Hospital, Ankara 06170, 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