Good concordance of HPV detection between cervico-vaginal self-samples and general practitioner-collected samples using the Cobas 4800 HPV DNA test.

ABSTRACT

BACKGROUND: Studies comparing self-samples and clinician-collected samples for high-risk human papillomavirus (HPV) detection using clinically validated PCR-based HPV DNA assays are limited. We measured the concordance of HPV detection between home-based self-sampling and general practitioner (GP) sampling using the Cobas 4800 HPV DNA test and studied women's accept of home-based self-sampling. METHODS: Paired GP-collected samples and cervico-vaginal self-samples were obtained from 213 women aged 30-59 years diagnosed with ASC-US within the cervical cancer screening program. After undergoing cervical cytology at their GP, the women collected a self-sample with the Evalyn Brush at home and completed a questionnaire. Both samples were HPV-tested using the Cobas 4800 test. Histology results were available for those who tested HPV positive in GP-collected samples. RESULTS: We observed good concordance for HPV detection between self-samples and GP-collected samples (κ 0.70, 95% CI 0.58-0.81). No underlying CIN2+ cases were missed by self-sampling. Women evaluated that self-sampling was easy (97.2%, 95% CI 93.9-98.9%) and comfortable (94.8%, 95% CI 90.9-97.4%). CONCLUSIONS: Home-based self-sampling using the Evalyn Brush and the Cobas 4800 test is an applicable and reliable alternative to GP-sampling.