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: Inturrisi, Federica
Aitken, Clare A.
Melchers, Willem J.G.
van den Brule, Adriaan J.C.
Molijn, Anco
Hinrichs, John W.J.
Niesters, Hubert G.M.
Siebers, Albert G.
Schuurman, Rob
Heideman, Daniëlle A.M.
de Kok, Inge M.C.M.
Bekkers, Ruud L.M.
van Kemenade, Folkert J.
Berkhof, Johannes
Dokumenttyp: Artikel
Erscheinungsdatum: 2021
Reihe/Periodikum: Inturrisi , F , Aitken , C A , Melchers , W J G , van den Brule , A J C , Molijn , A , Hinrichs , J W J , Niesters , H G M , Siebers , A G , Schuurman , R , Heideman , D A M , de Kok , I M C M , Bekkers , R L M , van Kemenade , F J & Berkhof , J 2021 , ' Clinical performance of high-risk HPV testing on self-samples versus clinician samples in routine primary HPV screening in the Netherlands : An observational study ' , The Lancet Regional Health - Europe , vol. 11 , 100235 . https://doi.org/10.1016/j.lanepe.2021.100235
Schlagwörter: /dk/atira/pure/sustainabledevelopmentgoals/good_health_and_well_being / SDG 3 - Good Health and Well-being
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-29625695
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://pure.eur.nl/en/publications/59d80d9f-fa01-4e4d-8231-052814e38fad

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.