Cervical screening with self-sampling for postmenopausal women with molecular triage using extended genotyping and methylation.

Objective: With the transition from cytology to human papilloma virus (HPV) testing in cervical cancer screening, it is possible to use self-sampling instead of professionally collected samples. Most studies have included women between 20 and 60 years age. Here we aimed to study postmenopausal women and investigate whether vaginal self-sampling is equally effective as professional sampling for detection of HSIL and the possibility to use a method for molecular triage directly on the screening sample.

Methods: Postmenopausal women in Örebro county, Sweden, were invited (n = 7835) during 2018-2020 to participate in the study including both professional and self-sampling. In total 2258 women returned both sample types, that were analyzed for HPV followed by triage for cytology, HPV genotyping and methylation and clinical follow-up according to national guidelines.

Results: The prevalence of HPV was 3.4 % in the professionally collected samples and 12.6 % in the self-collected. All women with high-grade squamous intraepithelial lesion (HSIL) were HPV-positive in both professionally and self-collected samples. For self-collected samples, we compared different triage strategies. Cytology was the most efficient strategy. Among the molecular triage methods, the combination of methylation and genotyping was most efficient but resulted in twice as many colposcopy referrals as cytology.

Conclusions: In conclusion, HPV self-sampling with molecular triage detects HSIL to the same extent as professional screening with cytological triage. The specificity of molecular triage is, however, unacceptably low, and to avoid overtreatment other triage methods following primary self-sampling need to be developed.