Prevalence of human papillomavirus in self-taken samples from screening nonattenders

J. U.H. Lam; M. Rebolj; D. M. Ejegod; H. Pedersen; C. Rygaard; E. Lynge; E. Harder; L. T. Thomsen; S. K. Kjaer; J. Bonde

doi:10.1128/JCM.00550-17

Prevalence of human papillomavirus in self-taken samples from screening nonattenders

J. U.H. Lam
, M. Rebolj
, D. M. Ejegod
, H. Pedersen
, C. Rygaard
, E. Lynge
, E. Harder
, L. T. Thomsen
, S. K. Kjaer
, J. Bonde^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Research › peer-review

Abstract

The Copenhagen Self-Sampling Initiative (CSi) has shown how human papillomavirus (HPV)-based self-sampling can be used to increase screening participation among 23,632 nonattenders in the Capital Region of Denmark. In this study, we describe HPV prevalence and genotype frequency in 4,824 self-samples as determined by three HPV assays (the CLART, Onclarity, and Hybrid Capture 2 [HC2] assays) and compare the results with those for physician-taken follow-up samples. The HPV self-sample findings were also compared to the findings for a reference population of 3,347 routinely screened women from the Horizon study, which had been undertaken in the same screening laboratory. Nonattenders had an HPV prevalence of 11.3% as determined by the CLART assay, which was lower than that for women from the Horizon study (18.5%). One-third of the CSi women who tested HPV positive by self-sampling tested HPV negative on the physician-taken follow-up sample. The CLART and Onclarity assays agreed on 64% (95% confidence interval [CI], 60 to 68%) of the HPV-positive self-taken samples. When the HC2 assay results were added into a three-way comparison, the level of agreement decreased to 27% (95% CI, 24 to 29%). Our findings suggest that further validation of HPV assays on self-taken samples is needed for optimal HPV detection and correct clinical management of HPV-positive women.

Original language	English
Pages (from-to)	2913-2923
Number of pages	11
Journal	Journal of Clinical Microbiology
Volume	55
Issue number	10
DOIs	https://doi.org/10.1128/JCM.00550-17
Publication status	Published - Oct 2017

Funding

J. U. H. Lam, M. Rebolj, D. M. Ejegod, H. Pedersen, and J. Bonde attended meetings with various HPV device manufacturers. M. Rebolj and her former employer received fees from Qiagen for her lectures. D. M. Ejegod received honoraria from BD and Qiagen for lectures. C. Rygaard participated in meetings with Roche, with a fee paid to the University of Copenhagen. E. Lynge participated in meetings with Roche and Astra-Zeneca, with fees paid to the University of Copenhagen, and was an unpaid advisor to GenProbe and NorChip. Roche has provided test kits to Trial23, for which E. Lynge is the principal investigator. E. Harder and L. T. Thomsen declare no conflict of interest. S. K. Kjær has received lecture fees and scientific advisory board fees from Merck, Sanofi Pasteur MSD, and BD, as well as unrestricted research grants from Merck through the Danish Cancer Society. J. Bonde used to serve as a paid advisor to Roche and Genomica and has received honoraria from Hologic/Gen-Probe, Roche, Qiagen, Genomica, and BD Diagnostics for lectures. He is the principal investigator on studies funded by BD Diagnostics. Hvidovre Hospital holds a recompense agreement with Genomica on a KRAS/BRAF diagnostic system.

Keywords

HPV assays
HPV self-sampling
Nonattenders
Primary screening

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10.1128/JCM.00550-17

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title = "Prevalence of human papillomavirus in self-taken samples from screening nonattenders",

abstract = "The Copenhagen Self-Sampling Initiative (CSi) has shown how human papillomavirus (HPV)-based self-sampling can be used to increase screening participation among 23,632 nonattenders in the Capital Region of Denmark. In this study, we describe HPV prevalence and genotype frequency in 4,824 self-samples as determined by three HPV assays (the CLART, Onclarity, and Hybrid Capture 2 [HC2] assays) and compare the results with those for physician-taken follow-up samples. The HPV self-sample findings were also compared to the findings for a reference population of 3,347 routinely screened women from the Horizon study, which had been undertaken in the same screening laboratory. Nonattenders had an HPV prevalence of 11.3\% as determined by the CLART assay, which was lower than that for women from the Horizon study (18.5\%). One-third of the CSi women who tested HPV positive by self-sampling tested HPV negative on the physician-taken follow-up sample. The CLART and Onclarity assays agreed on 64\% (95\% confidence interval [CI], 60 to 68\%) of the HPV-positive self-taken samples. When the HC2 assay results were added into a three-way comparison, the level of agreement decreased to 27\% (95\% CI, 24 to 29\%). Our findings suggest that further validation of HPV assays on self-taken samples is needed for optimal HPV detection and correct clinical management of HPV-positive women.",

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Prevalence of human papillomavirus in self-taken samples from screening nonattenders

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