Recurrent human papillomavirus infection detected with the hybrid capture II assay selects women with normal cervical smears at risk for developing high grade cervical lesions: a longitudinal study of 3,091 women

Int J Cancer. 2002 Dec 10;102(5):519-25. doi: 10.1002/ijc.10735.


To test the reliability of the Hybrid Capture II (HC-II) assay detecting 13 high-risk human papillomavirus (HR-HPV) types for the screening of cervical lesions, we monitored by cytology, HR-HPV testing, colposcopy and biopsy, 3,091 women with normal smears at the first entry. Our primary endpoint was clinical progression defined as the presence of a high-grade lesion (HGSIL) at the biopsy. In our population of 659 HR-HPV-infected women, 241 (36.6%) had a positive HR-HPV test at 2 to 4 examinations with a final histological diagnosis of HGSIL in 51 cases (21.2%) within 4 to 36 months, while women with regressive HPV infection did not develop any lesion during the same period. In the cohort of 2,432 women testing negative for HR-HPV infection, only 2 women (0.08%) developed a HGSIL. Both were HR-HPV positive 18 and 24 months after the first entry, at the time of diagnosis of disease. The RR of incident HGSIL when a HR-HPV was detected at enrollment in women with normal smears was 96.7 (95% CI, 95.8-97.7). The RR increased to 237.3 (95% CI, 222.8-251.8) when the HR-HPV test remained positive at 2 controls, and to 314.3 (95% CI, 260.7-367.9) when the HR-HPV test was positive at 3 controls. The evaluation of the viral load of HR-HPV by the HC-II did not represent a sensitive approach to predict the recurrence of HR-HPV infection and/or the apparition of HGSIL. Nevertheless, a recurrent HR-HPV infection detected with HC-II represents a reliable tool to select populations at risk for the development of HGSIL.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Cohort Studies
  • Colposcopy
  • Female
  • Humans
  • Longitudinal Studies
  • Papillomavirus Infections / diagnosis*
  • Recurrence
  • Reproducibility of Results
  • Risk
  • Uterine Cervical Diseases / etiology*
  • Uterine Cervical Neoplasms / etiology*
  • Vaginal Smears
  • Viral Load