Clinical Validation of Molecular Triage in HR-HPV Positive Women

VALidation of Tests Usable as a First Step TRIage to Manage Women Positive to High-risk Papillomavirus

Women accessing the HPV-based screening programme for primary screening, will undergo cervical sampling and clinical data recording. Samples from high-risk HPV positive women (around 2000 expected) will be aliquoted for testing with new HPV molecular test, that will allow full genotyping and viral load quantification.

Inclusion Criteria:

• women participating in a cervical cancer screening program using an HPV assay as primary screening test
• positivity to hrHPV;
• written informed consent given.

Exclusion Criteria:

• total hysterectomy;
• diagnosis of CIN2+ in the last two years;
• hrHPV negative or inadequate.