Routine cervical screening with primary HPV testing and cytology triage protocol in a randomised setting

Br J Cancer. 2005 Oct 17;93(8):862-7. doi: 10.1038/sj.bjc.6602799.


The role of high-risk human papillomavirus (hrHPV) testing in primary cervical screening has not been established. We generated a randomised evaluation design ultimately to clarify whether primary hrHPV testing implemented into routine screening can bring increase in the programme effectiveness. The aim of the present report on first-year results was to assess the cross-sectional relative validity parameters for routine hrHPV screening, in comparison with conventional screening. An equal number of women invited to routine screening was randomly allocated to primary hrHPV screening (n=7060) and to cytological screening (n=7089). In the hrHPV screening arm, after a single positive hrHPV test result, the need of colposcopy referral was determined by a cytological triage test. Compared with the conventional arm, more colposcopy referrals were made in the hrHPV screening arm (relative risk 1.51, confidence interval 95% 1.03-2.22). Specificity of the primary screening with sole hrHPV test (91.5-92.1%) was much lower than that with the cytology triage (98.7-99.3%), which was not quite as specific as screening with conventional cytology (99.2-99.6%). Compared with conventional cytology, primary screening with hrHPV test results in increased cross-sectional relative sensitivity at the level of all positive lesions at the cost of substantial loss in specificity. With cytology triage, the specificity improves to the level of conventional cytology.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Adult
  • Colposcopy
  • Cytological Techniques
  • Female
  • Humans
  • Mass Screening
  • Middle Aged
  • Papillomavirus Infections / complications*
  • Papillomavirus Infections / diagnosis*
  • Referral and Consultation
  • Sensitivity and Specificity
  • Triage*
  • Uterine Cervical Neoplasms / diagnosis*
  • Uterine Cervical Neoplasms / virology*
  • Vaginal Smears*