title: Screening for cervical cancer with the human papillomavirus test in an area of central Italy with no previous active cytological screening programme.
abstract: OBJECTIVE
  We report performance indicators and costs of the first round of a cervical cancer screening programme based on the human papillomavirus (HPV)-DNA test.
  
  
  METHODS
  We implemented a demonstration study using HPV as the primary test in Guidonia, Italy (90,000 inhabitants). All women aged 25-64 were invited to undergo a Hybrid Capture II high-risk HPV test. Two cervical samplings, smear and liquid, were taken. The smear was dyed and interpreted only for HPV-positive (HPV+) women. Women with a non-negative Pap smear were referred for colposcopy, women HPV+/cytology negative were referred to one-year follow-up with HPV. A cost-analysis indicated the price at which the HPV-based and cytological screening would cost the same per screened woman and per lesion found.
  
  
  RESULTS
  Of 24,000 women invited, 7639 accepted and 427 (5.6%) were HPV+; 141 (34%) of these had a non-negative Pap test, and 20 cervical intraepithelial neoplasia (CIN) 2 or higher were found (positive predictive value 15%). Compliance to one-year follow-up was 58% (166/286); 90 (54%) were HPV-positive and five additional lesions were found (positive predictive value 9%; overall detection rate 3.4/1000). The cost analysis showed that at a price of 8.3 euros per HPV-DNA test, the strategy using HPV as primary test followed by cytological triage would cost the same per screened woman, while at a price of 12.7 euros it would have the same cost per CIN2+ found.
  
  
  CONCLUSIONS
  The workload for management of positive women was similar to cytological screening. Low compliance to one-year follow-up was the main barrier to effectiveness. The price of HPV test should be about 9 euros to maintain the same screening budget, and can go as high as 13 euros per lesion found.
authors.affiliation: Department, Analytical and Biomolecular Cytology Unit, Cancer Prevention and Research Institute, ISPO, Florence, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Confortini
authors.forename: Paolo
authors.initials: P
authors.lastname: Giorgi Rossi
authors.forename: Paolo
authors.initials: P
authors.lastname: Barbarino
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Passarelli
authors.forename: Letizia
authors.initials: L
authors.lastname: Orzella
authors.forename: Maria Concetta
authors.initials: MC
authors.lastname: Tufi
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D007558:Italy; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000302:isolation & purification*; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D014626:Vaginal Smears / Q000379:methods*; D055815:Young Adult