title: Use of a high-risk human papillomavirus DNA test as the primary test in a cervical cancer screening programme: a population-based cohort study.
abstract: OBJECTIVE
  To present the results of the first 2 years of a human papillomavirus (HPV) test-based screening programme outside the research context.
  
  
  METHODS
  Population-based cohort study.
  
  
  METHODS
  A cervical service screening programme in Italy.
  
  
  METHODS
  Women aged 25-64 years invited to screening from April 2009 to April 2011.
  
  
  METHODS
  Eligible women were invited to undergo an HPV test: those with a negative HPV test went on to the next screening episode; those with a positive HPV went on to triage with a Pap smear. Women with positive cytology (i.e. positive for atypical squamous cells of undetermined significance or worse, ASC-US+) were referred to colposcopy, whereas those with negative cytology were referred to repeat HPV testing 1 year later.
  
  
  METHODS
  Participation rate, positivity at HPV and at triage, referral rate to colposcopy, positive predictive value for cervical intraepithelial neoplasia grade 2+ (CIN2+) at colposcopy, and detection rate for CIN2+.
  
  
  RESULTS
  Participation increased compared with the previous Pap programme (60.6 versus 43.9%). The HPV positivity rate was 7.0; 39.6% of Pap smears were scored as positive, and therefore 2.8% of the women screened were referred for immediate colposcopy. The compliance of women who scored positive for HPV and negative for Pap for repeat HPV testing at 12 months was 78.6%, and the HPV positivity rate was 56.6%. The overall referral rate to colposcopy was 4.6%. The overall detection rate for CIN2+ was 4.5 versus 1.5% of the Pap programme (25-34 years, 8.2%; 35+ years, 3.6%).
  
  
  CONCLUSIONS
  Compared with the traditional Pap test, the HPV programme recorded a higher response to invitation and an increased DR for CIN2+. The most critical aspects were the reading of cytology in women that were positive for HPV and the increased workload at colposcopy.
authors.affiliation: Veneto Tumour Registry, Istituto Oncologico Veneto IRCCS, Padua, Italy. manuel.zorzi@ioveneto.it
authors.forename: M
authors.initials: M
authors.lastname: Zorzi
authors.forename: A
authors.initials: A
authors.lastname: Del Mistro
authors.forename: A
authors.initials: A
authors.lastname: Farruggio
authors.forename: L
authors.initials: L
authors.lastname: de'Bartolomeis
authors.forename: H
authors.initials: H
authors.lastname: Frayle-Salamanca
authors.forename: L
authors.initials: L
authors.lastname: Baboci
authors.forename: A
authors.initials: A
authors.lastname: Bertazzo
authors.forename: P
authors.initials: P
authors.lastname: Cocco
authors.forename: C
authors.initials: C
authors.lastname: Fedato
authors.forename: M
authors.initials: M
authors.lastname: Gennaro
authors.forename: N
authors.initials: N
authors.lastname: Marchi
authors.forename: M G
authors.initials: MG
authors.lastname: Penon
authors.forename: C
authors.initials: C
authors.lastname: Cogo
authors.forename: A
authors.initials: A
authors.lastname: Ferro
mesh_terms: D000328:Adult; D002584:Cervix Uteri / Q000821:virology*; D015331:Cohort Studies; D003127:Colposcopy / Q000706:statistics & numerical data; D004279:DNA, Viral / Q000032:analysis*; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D007558:Italy; D008875:Middle Aged; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D010349:Patient Compliance; D011237:Predictive Value of Tests; D012017:Referral and Consultation / Q000706:statistics & numerical data; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000821:virology; D014626:Vaginal Smears / Q000706:statistics & numerical data; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000473:pathology / Q000821:virology
chemical_list: D004279:DNA, Viral
keywords: Cervical cancer screening; HPV DNA test; human papillomavirus