Self-sampling and HPV testing or ordinary Pap-smear in women not regularly attending screening: a randomised study

Br J Cancer. 2011 Jul 26;105(3):337-9. doi: 10.1038/bjc.2011.236. Epub 2011 Jul 5.

Abstract

Background: Most women with cervical cancer have not participated in Pap-smear screening. Self-sampling of vaginal fluid in combination with high-risk HPV testing may be a method to increase the attendance rate.

Methods: A total of 4060 women, 39-60 years old, who had not attended the organised Pap-smear screening for 6 years or more were randomised into two equal groups. A study group was offered to self-sample vaginal fluid (Qvintip) at home and/or recommended to attend the Pap-smear screening. The collected fluid after self-sampling was examined for the presence of high-risk HPV (Hybrid Capture 2 method). Controls were only recommended to attend the Pap-smear screening. The end point was a histological identification of CIN2-3.

Results: The participation rate was 39% (771 out of 2000) in the self-sampling group and 9% (188 out of 2060) in the conventional cytology (P<0.001). The number of histological CIN2-3 alterations detected was 0.4% (8 out of 2000) among women offered self-sampling of vaginal fluid and 0.07% (3 out of 4060) in women offered Pap-smears. The odds ratio (OR) for offering self-sampling and HPV testing instead of Pap-smear screening for detection of CIN2-3 was OR=5.42 (95% CI: 1.30-31.8).

Conclusion: Offering self-sampling of vaginal fluid followed by a high-risk HPV test was considerably more effective for detection of histological CIN2-3 lesions in comparison with offering Pap-test in a midwife reception in women not regularly attending organised screening.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cervical Intraepithelial Neoplasia / diagnosis*
  • Early Detection of Cancer
  • Female
  • Humans
  • Mass Screening
  • Middle Aged
  • Papanicolaou Test*
  • Papillomaviridae / isolation & purification*
  • Papillomavirus Infections / diagnosis*
  • Specimen Handling / methods*
  • Vaginal Smears* / methods