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 CIN2+, 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. Funding: National Institute for Public Health and the Environment (the Netherlands) and the European Commission.
Original language | English |
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Article number | 100235 |
Journal | The Lancet Regional Health - Europe |
Volume | 11 |
DOIs | |
Publication status | Published - Dec 2021 |
Bibliographical note
Funding Information:FI and JB report grants from the European Commission (RISCC, grant number 847845) during the conduct of the study. CA, IdK, and JB report grants from the Dutch National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu, RIVM) during the conduct of the study.
Funding Information:
This study was funded by the Dutch National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu, RIVM) and the European Commission (RISCC, grant number 847845). We acknowledge the five screening laboratories that serve the national cervical screening programme: UMCG Groningen, Radboudumc Nijmegen, JBZ Den Bosch, NMDL Rijswijk, and Symbiant Hoorn.
Funding Information:
This study was funded by the Dutch National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu, RIVM) and the European Commission (RISCC, grant number 847845). We acknowledge the five screening laboratories that serve the national cervical screening programme: UMCG Groningen, Radboudumc Nijmegen, JBZ Den Bosch, NMDL Rijswijk, and Symbiant Hoorn.
Publisher Copyright:
© 2021 The Authors