Use of a high-risk human papillomavirus DNA test as the primary test in a cervical cancer screening programme: a population-based cohort study

BJOG. 2013 Sep;120(10):1260-7; discussion 1267-8. doi: 10.1111/1471-0528.12272. Epub 2013 Jun 21.

Abstract

Objective: To present the results of the first 2 years of a human papillomavirus (HPV) test-based screening programme outside the research context.

Design: Population-based cohort study.

Setting: A cervical service screening programme in Italy.

Population: 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.

Main outcome measures: 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.

Keywords: Cervical cancer screening; HPV DNA test; human papillomavirus.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cervix Uteri / virology*
  • Cohort Studies
  • Colposcopy / statistics & numerical data
  • DNA, Viral / analysis*
  • Early Detection of Cancer / methods*
  • Female
  • Humans
  • Italy
  • Middle Aged
  • Papanicolaou Test
  • Papillomaviridae / genetics
  • Papillomaviridae / isolation & purification*
  • Papillomavirus Infections / diagnosis*
  • Papillomavirus Infections / virology
  • Patient Compliance
  • Predictive Value of Tests
  • Referral and Consultation / statistics & numerical data
  • Uterine Cervical Dysplasia / diagnosis*
  • Uterine Cervical Dysplasia / pathology
  • Uterine Cervical Dysplasia / virology
  • Uterine Cervical Neoplasms / diagnosis*
  • Uterine Cervical Neoplasms / pathology
  • Uterine Cervical Neoplasms / virology
  • Vaginal Smears / statistics & numerical data

Substances

  • DNA, Viral