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

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.... Mehr ...

Verfasser: Federica Inturrisi
Clare A. Aitken
Willem J.G. Melchers
Adriaan J.C. van den Brule
Anco Molijn
John W.J. Hinrichs
Hubert G.M. Niesters
Albert G. Siebers
Rob Schuurman
Daniëlle A.M. Heideman
Inge M.C.M. de Kok
Ruud L.M. Bekkers
Folkert J. van Kemenade
Johannes Berkhof
Dokumenttyp: Artikel
Erscheinungsdatum: 2021
Reihe/Periodikum: The Lancet Regional Health. Europe, Vol 11, Iss , Pp 100235- (2021)
Verlag/Hrsg.: Elsevier
Schlagwörter: Human papillomavirus (HPV) / Cervical intraepithelial neoplasia / CIN3 / Self-sampling / Cervical screening / Clinical accuracy / Public aspects of medicine / RA1-1270
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-27190160
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://doi.org/10.1016/j.lanepe.2021.100235

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.