Clinical performance of high-risk HPV testing on self-samples versus clinician samples in routine primary HPV screening in the Netherlands: An observational study

F. Inturrisi*, C.A. Aitken, W.J.G. Melchers, A.J.C. van den Brule, A. Molijn, J.W.J. Hinrichs, H.G.M. Niesters, A.G. Siebers, R. Schuurman, D.A.M. Heideman, I.M.C.M. de Kok, R.L.M. Bekkers, F.J. van Kemenade, J. Berkhof

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

19 Citations (Web of Science)

Abstract

Background: High-risk human papillomavirus (hrHPV) testing on self-collected samples has potential as a primary screening tool in cervical screening, but real-world evidence on its accuracy in hrHPV-based screening programmes is lacking.Methods: In the Netherlands, women aged 30-60 years invited for cervical screening can choose between sampling at the clinician's office (Cervex Brush) or self-sampling at home (Evalyn Brush). HrHPV testing is performed using Roche Cobas 4800. We collected screening test results between January 2017 and March 2018 and histological follow-up until August 2019. The main outcome measures were mean cycle threshold (Ct) value, cervical intraepithelial neoplasia (CIN) grade 3 or cancer (CIN3+) and CIN grade 2 or worse (CIN2+).Findings: 30,808 women had a self-collected and 456,207 had a clinician-collected sample. In hrHPV-positive women with adequate cytology, Ct values were higher for self-collection than clinician-collection with a mean Ct difference of 1.25 (95% CI 0.98-1.52) in women without CIN 2+, 2.73 (1.75-3.72) in CIN2 and 3.59 (3.03-4.15) in CIN3+. The relative sensitivity for detecting CIN3+ was 0.94 (0.90-0.97) for self-collection versus clinician-collection and the relative specificity was 1.02 (1.02-1.02).Interpretation: The clinical accuracy of hrHPV testing on a self-collected sample for detection of CIN3+ is high and supports its use as a primary screening test for all invited women. Because of the slightly lower sensitivity of hrHPV testing on a self-collected compared to a clinician-collected sample, an evaluation of the workflow procedure to optimise clinical performance seems warranted. (C) 2021 The Authors. Published by Elsevier Ltd.
Original languageEnglish
Article number100235
Number of pages8
JournalThe Lancet Regional Health – Europe
Volume11
DOIs
Publication statusPublished - 1 Dec 2021

Keywords

  • Human papillomavirus (HPV)
  • Cervical intraepithelial neoplasia
  • CIN3
  • Self-sampling
  • Cervical screening
  • Clinical accuracy
  • Routine screening
  • HUMAN-PAPILLOMAVIRUS
  • CERVICAL-CANCER
  • CYTOLOGY
  • WOMEN
  • ACCEPTABILITY
  • POPULATION
  • SPECIMENS
  • COVID-19
  • DNA

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