Following the results of Italian NTCC study, several pilot projects were started in Italy aiming to test feasibility and performance of HPV- test as primary screening in cervical cancer. In october 2011 the Local Health Autority of Venice ( ULSS 12 – veneto Region) started a pilot study with HPV-m RNA test as primary screening test for the target population ( women aged 25-64 years ) of the local population screening. The test consists of APTINA HPV ASSAY ( test for detection of HR-HPV E6/E7 m RNA; Hologic S. Diego, CA).
The study was approved by the local ethic-commitee and a clear informed consent was sent to the women together with the invitation to perform the test. The screening algorithm includes samples collection with Thin-Prep transport device; samples were first processed for HPV-mRNA (Aptima); women with negative HPV were referred to a new screening test after three years; women with positive HPV test had a cytological Pap-test triage and invited to colposcopy if PAP >_ASCUS. Women with positive HPV test but negative PAP were referred to repeat HPV-test after one year and colposcopy if persistent positive.
The presentation will present results of the study for women enrolled in the period october 2011-May 2014 end followed until May 2015. Indications which will be discussed are: positivity at HPV-m RNA; referral rate to colposcopy; positive predictive value for CIN 2+ at colposcopy and biopsy; detection rate of CIN 2+.
Conflicts of interests: none
Funding: no funding was obtain for this study.
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