Epidemiology | Published:

Randomised study shows that repeated self-sampling and HPV test has more than two-fold higher detection rate of women with CIN2+ histology than Pap smear cytology

British Journal of Cancer volume 118, pages 896904 (20 March 2018) | Download Citation

Abstract

Background:

This randomised study compared the detection rate of cervical intraepithelial neoplasia-positive (CIN2+) based on histology in women performing repeated self-sampling of vaginal fluid (VF) for human papillomavirus (HPV) test with a control group following the ordinary screening by Pap smear cytology.

Methods:

36390 women aged 30–49 years scheduled for invitation to organised screening were randomised in two groups, one to perform self-sampling of VF for HPV test (n=17 997, HPV arm) and the other group to perform screening by PAP smear cytology (n=18 393, control arm). HPV positive women in the HPV arm repeated the self-sampling and the HPV test on average 4.4 months later and those with two consecutive positive HPV tests were referred to colposcopy. Outcome was CIN2+ based on histology during 18-month follow-up.

Results:

Participation rate was 47% in the HPV arm and 39% in the control arm. The HPV prevalence in the first self-sampling was 6.9%, and 71% of these women were HPV positive in their second test. For the per-protocol approach, cumulative prevalence of histological CIN2+ in the HPV arm was 20.2 per 1000 women screened as compared to 10.8 in the control arm. The cumulative prevalence of CIN2+ diagnosed per 1000 years screened was 160.8 in the HPV arm as compared with 25.4 in the control arm.

Conclusions:

Repeated self-sampling of VF and HPV test had more than a two-fold higher discovery rate of CIN2+ per 1000 women screened as compared with PAP smear cytology.

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Change history

  • Corrected online 20 March 2018

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Acknowledgements

This work was supported by the Swedish Cancer Foundation, the Swedish Medical Research Council and the Foundation for Strategic Research. We thank all of the participants and the staff who made this study possible.

Author information

Affiliations

  1. Science for Life Laboratory (SciLifeLab), Department of Immunology, Genetics, and Pathology, Biomedical Center, Uppsala University, Box 815, Uppsala 75108, Sweden

    • Inger Gustavsson
    • , Malin Berggrund
    • , Julia Hedlund-Lindberg
    • , Ann-Sofi Strand
    • , Stefan Enroth
    •  & Ulf Gyllensten
  2. Department of Women’s and Children’s Health, Uppsala University, Uppsala 75185, Sweden

    • Riina Aarnio
    • , Karin Sanner
    • , Ingrid Wikström
    •  & Matts Olovsson

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Competing interests

The funders of the study had no role in the design, data collection, data analysis, data interpretation or writing of the report. All authors had full access to the data in the study and the corresponding author (UG) had final responsibility for the decision to submit for publication. The authors declare no conflict of interest.

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Correspondence to Ulf Gyllensten.

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DOI

https://doi.org/10.1038/bjc.2017.485

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