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Article History

Received: 22 January 2020

Accepted: 22 April 2020

First Online: 6 May 2020

Ethics approval and consent to participate

: The main case population was collected under approval by the Danish regional ethical committee (ethical committee protocol H4–2012-070; ClinicalTrials. Gov, ID NC; 71462). The study was approved by the Danish Data inspection Agency (No. AHH-2017-024, I-Suite: 05356). All collected samples were cross-referenced with the Danish register relating to the collection, storage and use of human biological material in health research projects (Vævsanvendelsesregistret).The Swedish part of the study, i.e. the validation in ThinPrep samples, was approved by the Stockholm regional ethical review board, Dnr 2014/1242–31/4, Dnr 2017/816–32 and 2018/1209–32.The current study is defined as a quality development study. For this, informed consent is not required under Danish nor Swedish law on biomedical research.

: Ditte Møller Ejegod has attended meetings with various HPV device manufacturers.Helle Pedersen has attended meetings with various HPV device manufacturers.Jesper Bonde has attended meetings with various HPV device manufacturers. JB has received honoraria from Hologic and BD Diagnostics for lectures. JBs institution has received research funding and or associated consumable from the following in the last 3 years: Qiagen, Becton-Dickinson, SelfScreen, LifeRiver, GENOMICA, Agena Biotech, BioCartis.Ramya Bhatia has received conference travel monies/ honoraria from Hologic, Abbott and Becton Dickinson. RB and Elia Alcañiz Boada’s institution has previously received research grant monies from Hologic, Becton Dickinson, Cepheid, Genefirst, SelfScreen, EuroImmune, LifeRiver and GENOMICA.Kate Cuschieri: No conflicts of interest to declare, KCs institution has received research funding and or associated consumable from the following in the last 3 years: Hologic, Cepheid, Qiagen, Becton-Dickinson, Euroimmun, SelfScreen, LifeRiver, GENOMICA, Genefirst.Camilla Lagheden Karolinska University Hospital has no conflicts of interest to declare. The Karolinska University hospital has has ongoing contracts with several manufacturers of HPV diagnostics, including Roche and GENOMICA.Karin Sundström has no conflicts of interest to declare. The Karolinska University Hospital has ongoing contracts with several manufacturers of HPV diagnostics, including Roche and GENOMICA.Javier Cortés has received travel and/or research grants and/or fees for conferences and/or consultancies from GENOMICA, GSK, Merck, Procareh, Qiagen and Roche.F. Xavier Bosch Josë: has occasionally received travel and speaking grants from various diagnostic companies. The institutional research program on screening has benefited from lower prices for reagents from qiagen, genomica and hologic and the educational program has received unrestricted grants from various HPV stakeholders including diagnostic and vaccine companies.Joakim Dillner has previously received research grants to his institution for research on HPV vaccines from an HPV vaccine manufacturer (Merck/SPMSD). The Karolinska University Hospital has ongoing contracts with several manufacturers of HPV diagnostics, including Roche and GENOMICA.