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The clinical performance of the CONFIDENCE HPV test as a first-line primary cervical cancer screening test from cervical samples collected in ThinPrep® (Hologic, Inc.) and from self-collected vaginal samples taken with the Qvintip® device (Aprovix AB) was assessed in the multicentric prospective TRACE (Triage and Risk Assessment of Cervical Precancer by Epigenetic Biomarker) trial.
The comparison results of the CONFIDENCE HPV test from cervical and vaginal samples showed 89,0% overall agreement for hrHPV detection, 0,89% relative sensitivity and 0,92% relative specificity for CIN2+ cases.