title: Self-sampling and HPV testing or ordinary Pap-smear in women not regularly attending screening: a randomised study.
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).
  
  
  CONCLUSIONS
  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.
authors: Department of Women's and Children's Health, Uppsala University, S751 85 Uppsala Sweden. ingrid.wikstrom@kbh.uu.se
authors: I
authors: I
authors: Wikström
authors: M
authors: M
authors: Lindell
authors: K
authors: K
authors: Sanner
authors: E
authors: E
authors: Wilander
mesh_terms: D055088:Early Detection of Cancer; D005260:Female; D006801:Humans; D008403:Mass Screening; D008875:Middle Aged; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis*; D013048:Specimen Handling / Q000379:methods*; D014626:Vaginal Smears / Q000379:methods; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis*