{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T12:57:41Z","timestamp":1782824261237,"version":"3.54.5"},"reference-count":16,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2019,2,13]],"date-time":"2019-02-13T00:00:00Z","timestamp":1550016000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010661","name":"Horizon 2020 Framework Programme","doi-asserted-by":"publisher","award":["666800"],"award-info":[{"award-number":["666800"]}],"id":[{"id":"10.13039\/100010661","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":[[2019,5]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>HPV\u2010based cervical screening detects women at an increased risk of cervical cancer and precancer. To differentiate among HPV\u2010positive women those with (pre)cancer, triage testing is necessary. The detection of cancer\u2010associated host\u2010cell DNA methylation (<jats:italic>FAM19A4<\/jats:italic> and hsa\u2010<jats:italic>mir124\u20102<\/jats:italic>) in cervical samples has shown valuable as triage test. This multicenter study from 6 collaborating European laboratories and one reference laboratory was set out to determine the intra\u2010 and inter\u2010laboratory agreement of <jats:italic>FAM19A4<\/jats:italic>\/<jats:italic>mir124<\/jats:italic>\u20102 DNA methylation analysis utilizing the QIAsure Methylation Test.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Agreement analysis for the QIAsure Methylation Test was assessed on high\u2010risk HPV\u2010positive cervical specimens (n\u00a0=\u00a01680) both at the level of the assay and at the full workflow, including bisulfite conversion.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Intra\u2010 and inter\u2010laboratory assay agreement were 91.4% (534\/584; 95% CI 88.9\u201093.5; <jats:italic>\u03ba<\/jats:italic>\u00a0=\u00a00.82) and 92.5% (369\/399; 95% CI 90.0\u201094.7; <jats:italic>\u03ba<\/jats:italic>\u00a0=\u00a00.83), respectively. The inter\u2010laboratory workflow (bisulfite conversion and assay combined) agreement was 90.0% (627\/697; 95% CI 87.5%\u201092.0%; <jats:italic>\u03ba<\/jats:italic>\u00a0=\u00a00.76).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>These data show that the QIAsure Methylation Test performs robust and reproducible in different laboratory contexts. These results support the use of the QIAsure Methylation Test for full molecular screening for cervical cancer, including primary HPV testing and triage testing by methylation analysis.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.22854","type":"journal-article","created":{"date-parts":[[2019,2,13]],"date-time":"2019-02-13T14:03:51Z","timestamp":1550066631000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":33,"title":["Intra\u2010 and inter\u2010laboratory agreement of the <i>FAM19A4\/mir124\u20102<\/i> methylation test: Results from an international study"],"prefix":"10.1002","volume":"33","author":[{"given":"Arno","family":"Floore","sequence":"first","affiliation":[{"name":"Self\u2010screen B.V Amsterdam the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Albertus","family":"Hesselink","sequence":"additional","affiliation":[{"name":"Self\u2010screen B.V Amsterdam the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anja","family":"O\u0161trbenk","sequence":"additional","affiliation":[{"name":"Institute of Microbiology and immunology University of Ljubljana Ljubljana Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elia","family":"Alcaniz","sequence":"additional","affiliation":[{"name":"HPV Research Group, Division of Pathology University of Edinburgh Edinburgh Scotland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beate","family":"Rothe","sequence":"additional","affiliation":[{"name":"Institute for clinical chemistry, laboratory and transfusion medicine Wolfsburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helle","family":"Pedersen","sequence":"additional","affiliation":[{"name":"Molecular Pathology Laboratory, Department of Pathology Hvidovre Hospital Hvidovre Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Montserrat","family":"Torres Hortal","sequence":"additional","affiliation":[{"name":"Infections and Cancer Laboratory Catalan Institute of Oncology (ICO) Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saskia","family":"Doorn","sequence":"additional","affiliation":[{"name":"Self\u2010screen B.V Amsterdam the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wim","family":"Quint","sequence":"additional","affiliation":[{"name":"DDL Diagnostic Laboratory Rijswijk the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karl Ulrich","family":"Petry","sequence":"additional","affiliation":[{"name":"Institute for clinical chemistry, laboratory and transfusion medicine Wolfsburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario","family":"Poljak","sequence":"additional","affiliation":[{"name":"Institute of Microbiology and immunology University of Ljubljana Ljubljana Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kate","family":"Cuschieri","sequence":"additional","affiliation":[{"name":"HPV Research Group, Division of Pathology University of Edinburgh Edinburgh Scotland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jesper","family":"Bonde","sequence":"additional","affiliation":[{"name":"Molecular Pathology Laboratory, Department of Pathology Hvidovre Hospital Hvidovre Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"de Sanjos\u00e9","sequence":"additional","affiliation":[{"name":"Infections and Cancer Laboratory Catalan Institute of Oncology (ICO) Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maaike","family":"Bleeker","sequence":"additional","affiliation":[{"name":"Amsterdam UMC, Vrije Universiteit Amsterdam, Pathology, Cancer Center Amsterdam Amsterdam the 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