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

Mette Tranberg, Jørgen Skov Jensen, Bodil Hammer Bech, Jan Blaakær, Hans Svanholm, Berit Andersen, Mette Tranberg, Jørgen Skov Jensen, Bodil Hammer Bech, Jan Blaakær, Hans Svanholm, Berit Andersen

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.

Keywords: Acceptability; Cervical cancer screening; Human papillomavirus testing; Self-sampling.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the local Ethical Committee of the Central Denmark Region (journal no.: 1–16–02-209-15) and by the Danish Data Protection Agency (journal no.: 1–10–72-69-15). Further, all participants provided their written informed consent to participate in the study.

Consent for publication

Not applicable.

Competing interests

Axlab, the Danish manufacturer of the Evalyn® Brush, provided self-sampling devices for the study. In accordance with the contract between the manufacturers and the Department of Public Health Programmes, Randers Regional Hospital, Axlab had no influence on the scientific process and no editorial rights pertaining to this manuscript. The authors retained the right to submit the manuscript. None of the authors were compensated for their work on this study, have any shares in the manufacturers’ companies, or received bonuses from any of the manufacturers. The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The women’s accept of self-sampling

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