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Between 2013 and 2015 over 6,000 women aged 18 or older were recruited in Hungary. Liquid\u2010based cytology (LBC), high\u2010risk HPV (hrHPV) DNA detection and single target host gene methylation test of the promoter sequence of the POU4F3 gene by quantitative methylation\u2010specific polymerase chain reaction (PCR) were performed from the same liquid\u2010based cytology sample. The current analysis is focused on the baseline cross\u2010sectional clinical results of 5,384 LBC samples collected from subjects aged 25 years or older. The performance of the CONFIDENCE HPV\u2122 test was found to be comparable to the cobas\u00ae HPV test with good agreement. When applying the CONFIDENCE Marker\u2122 test alone in hrHPV positives, it showed significantly higher sensitivity with matching specificity compared to LBC\u2010based triage. For CIN3+ histological endpoint in the age group of 25\u201365 and 30\u201365, the methylation test of POU4F3 achieved relative sensitivities of 1.74 (95% CI: 1.25\u20132.33) and 1.64 (95% CI: 1.08\u20132.27), respectively, after verification bias adjustment. On the basis of our findings, POU4F3 methylation as a triage test of hrHPV positives appears to be a noteworthy method. We can reasonably assume that its quantitative nature offers the potential for a more objective and discriminative risk assessment tool in the prevention and diagnostics of high\u2010grade cervical intraepithelial neoplasia (CIN) lesions and cervical cancer.<\/jats:p>","DOI":"10.1002\/ijc.30534","type":"journal-article","created":{"date-parts":[[2016,11,22]],"date-time":"2016-11-22T12:37:13Z","timestamp":1479818233000},"page":"1119-1133","source":"Crossref","is-referenced-by-count":48,"title":["Performance of a new HPV and biomarker assay in the management of hrHPV positive women: Subanalysis of the ongoing multicenter TRACE clinical trial (<i>n<\/i>\u2009&gt;\u20096,000) to evaluate POU4F3 methylation as a potential biomarker of cervical precancer and cancer"],"prefix":"10.1002","volume":"140","author":[{"given":"Adrienn","family":"Kocsis","sequence":"first","affiliation":[{"name":"NEUMANN Diagnostics Ltd. Budapest Hungary"},{"name":"Cellcall Ltd. 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