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

BMC Infect Dis. 2018 Jul 27;18(1):348. doi: 10.1186/s12879-018-3254-y.

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.

MeSH terms

  • Adult
  • DNA, Viral / analysis
  • DNA, Viral / genetics
  • Female
  • Human Papillomavirus DNA Tests* / methods
  • Human Papillomavirus DNA Tests* / standards
  • Humans
  • Middle Aged
  • Papillomaviridae / genetics*
  • Papillomavirus Infections* / diagnosis
  • Papillomavirus Infections* / virology
  • Specimen Handling* / methods
  • Specimen Handling* / standards
  • Vaginal Smears / methods
  • Vaginal Smears / standards

Substances

  • DNA, Viral