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. 2021 Nov 9:11:100235.
doi: 10.1016/j.lanepe.2021.100235. eCollection 2021 Dec.

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

Federica Inturrisi  1 , Clare A Aitken  2   3 , Willem J G Melchers  4 , Adriaan J C van den Brule  5 , Anco Molijn  6 , John W J Hinrichs  7 , Hubert G M Niesters  8 , Albert G Siebers  9 , Rob Schuurman  10 , Daniëlle A M Heideman  11 , Inge M C M de Kok  2 , Ruud L M Bekkers  12   13 , Folkert J van Kemenade  3 , Johannes Berkhof  1
Affiliations

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

Federica Inturrisi et al. Lancet Reg Health Eur. .

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.

Keywords: CIN3; Cervical intraepithelial neoplasia; Cervical screening; Clinical accuracy; Human papillomavirus (HPV); Routine screening; Self-sampling.

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Conflict of interest statement

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. DAMH is minority shareholder of Self-screen B.V., a spin-off company of VUmc, which develops, manufactures and licences hrHPV and methylation marker assays for cervical cancer screening and holds patents on these tests. DAMH has been on the speakers’ bureau of Qiagen and serves occasionally on the scientific advisory boards of Pfizer and Bristol-Myers Squibb. All other authors declare no competing interests.

Figures

Fig 1
Figure 1
Flowchart of women attending national HPV primary screening in the Netherlands between 1 January 2017 and 9 March 2018, with histology follow-up until 11 August 2019.
Fig 2
Figure 2
ROC of overall hrHPV Ct values on self-collected (red) and clinician-collected (blue) samples for clinical endpoint CIN3+ (left) and CIN2+ (right).
Fig 3
Figure 3
Risks of CIN3+ against hrHPV Ct value. The risk functions are quadratic I splines with knots at Ct 25, 30, and 35.
See this image and copyright information in PMC

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