Comparative performance of novel self‐sampling methods in detecting high‐risk human papillomavirus in 30,130 women not attending cervical screening

Abstract

We determined whether the participation rate for a brush-based cervicovaginal self-sampling device is noninferior to the participation rate for a lavage-based one for testing for hrHPV (high-risk human papillomavirus). Additionally, positivity rates for hrHPV, the detection rates for cervical intraepithelial neoplasia grades 2 and 3 or worse (CIN21/31), and user comfort were compared. A total of 35,477 non-responders of the regular cervical screening program aged 33-63 years were invited to participate. Eligible women (n 5 30,130) were randomly assigned to receive either a brush-based or a lavage-based device, and a questionnaire for reporting user convenience. Self-sampling responders testing hrHPV-positive were invited for a physiciantaken sample for cytology; triage-positive women were referred for colposcopy. A total of 5,218 women participated in the brush-based sampling group (34.6%) and 4809 women in the lavage-based group (31.9%), i.e. an absolute difference of 2.7% (95%CI 1.8-4.2). The hrHPV-positivity rates in the two groups were identical (8.3%, relative risk (RR) 0.99, 95%CI 0.87-1.13). The detection of CIN21 and CIN31 in the brush group (2.0% for CIN21; 1.3% for CIN31) was similar to that in the lavage group (1.9% for CIN21; 1.0% for CIN31) with a cumulative RR of 1.01, 95%CI 0.83-1.24 for CIN21 and 1.25, 95%CI 0.92-1.70 for CIN31. The two self-sampling devices performed similarly in user comfort. In conclusion, offering a brush-based device to non-responders is noninferior to offering a lavage-based device in terms of participation. The two self-sampling methods are equally effective in detecting hrHPV, CIN21/CIN31 and are both well accepted.The introduction of organized programs for cervical cancer screening in developed countries has contributed to a significant decrease in the incidence and mortality rate of cervical cancer.1-5 A major issue concerning the effectiveness of the screening programs is that many women do not attend the cervical screening (i.e., non-responders). Non-participation women are at increased risk of developing cervical cancer; therefore, it is important to reach these women. 5-8 Offering

Self-sampling to improve cervical cancer screening coverage in Switzerland: a randomised controlled trial

“…Another strength is represented by the fact that we used a real-time PCR that allowed distinguishing the HPV-16/18 genotypes, which are associated to a higher risk of developing CC, from other 12 HR-HPV types. In addition, as opposed to other trials using Self-sampling, which registered between 0.5 and 0.7% of unsatisfactory HPV test results, we had no invalid results (Bosgraaf et al , 2015; Giorgi-Rossi et al , 2015). …”

Human papillomavirus self-sampling for screening nonattenders: Opt-in pilot implementation with electronic communication platforms

“…We chose it based on the security consideration of not distributing medical liquids to private homes. Also, among Dutch women this brush was slightly more acceptable than a lavage device 19. By our request, the manufacturer embedded a unique RFID chip into the each brush's handle.…”

The clinical value of HPV genotyping in triage of women with high-risk-HPV-positive self-samples

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