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

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.

Barriers to Access the Pap Smear Test for Cervical Cancer Screening in Rural Riverside Populations Covered by a Fluvial Primary Healthcare Team in the Amazon

“…The transition to HPV testing as the primary method of screening for cervical cancer has also been recommended, considering the higher level of the test performance and the difficulties faced by low- and middle-income countries in conducting cytology-based programs [ 2 , 52 ]. Self-sampling HPV nucleic acid testing is an additional option that has been shown to be as effective as clinical-collected samples [ 53 ], and with great potential to contribute to increasing cervical cancer screening coverage [ 54 ], and to overcoming barriers to access the health services for early diagnosis in areas with lower availability, such as rural riverside localities [ 52 , 55 ].…”

Shift in harms and benefits of cervical cancer screening in the era of HPV screening and vaccination: a modelling study

“…Lastly, we performed a multivariate sensitivity analysis on the sensitivity of the hrHPV self‐test while adjusting the percentage of self‐tests of all used hrHPV‐tests from 7% to 25%. In this sensitivity analysis, we adjusted the test characteristics of the hrHPV self‐test to those found by Inturissi and colleagues, where the relative sensitivity for all lesion grades was found to be lower 24 …”

“…In this sensitivity analysis, we adjusted the test characteristics of the hrHPV self-test to those found by Inturissi and colleagues, where the relative sensitivity for all lesion grades was found to be lower. 24…”

Comments on: “Meta‐analysis of agreement/concordance statistics in studies comparing self‐ vs clinician‐collected samples for HPV testing in cervical cancer screening”

“…2 Indeed, the latest population-based data from the Netherlands, where selfsampling has been offered to all women in the screening program's target population, suggested a lower sensitivity of self-sampling for detection of CIN2+ compared to clinician sampling, albeit in an unpaired and nonrandomised comparison between the sampling methods. 6…”