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.
Study Type
OBSERVATIONAL
Enrollment
23,941
AOU Città della Salute e della Scienza di Torino S.S.D. Epidemiologia, Screening- CPO
Torino, Italy
Sensitivity of the index triage test: Pap-test
Sensitivity of the index triage test(s) performed at the time of reflex testing for CIN2+ and CIN3+ detected at the time of reflex triage and relative sensitivity (index vs comparator)
Time frame: Baseline
Sensitivity of the index and comparator triage test: HPV molecular test
Sensitivity of the index and comparator triage test(s) performed at the time of reflex testing for CIN2+ and CIN3+ detected at the time of reflex triage + delayed triage; and relative sensitivity (index vs comparator).
Time frame: Baseline
Specificity of the index and comparator triage test
Specificity of the index and comparator triage test(s) performed at the time of reflex testing for \<CIN2 considered at the time of reflex triage accepting negative colposcopy at the time of reflex testing and double negative index triage testing (reflex and delayed) as an acceptable proxy for \<CIN2 and relative specificity for \<CIN2 (index vs comparator).
Time frame: Month 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.