UNLABELLED: The prevalence of high-risk human papillomavirus (hrHPV) types varies across countries, making it essential to estimate prevalence using nationwide samples. Data on hrHPV prevalence in the Czech Republic are very limited. This study aimed to determine the prevalence of various hrHPV types in an unselected screening population of Czech women aged 30-65 years, using paired clinician-obtained cervical swab (CS) and self-collected cervicovaginal swabs (CVS). A total of 1026 eligible women were recruited into two study arms. In arm A, the digene® HC2 DNA Collection Device was used for both CS and CVS. In arm B, the Evalyn Brush was used for CVS, while the Cervex Brush was used for CS. All samples were tested for hrHPV using the digene® HC2 High-Risk HPV DNA Test and genotyped with the PapilloCheck® HPV-Screening assay. The overall hrHPV prevalence was 14.8%, based on positive results from either CVS or CS samples. hrHPV positivity was detected in 10.8% of clinician-obtained CSs and 11.8% of self-collected CVSs. A combined analysis of CS and CVS samples identified the five most prevalent hrHPV genotypes: HPV16, HPV31, HPV39, HPV56, and HPV68. The comparison of hrHPV detection in paired CS and CVS samples showed an overall concordance of 93%. These findings highlight the importance of detecting hrHPV genotypes alongside conventional Pap testing in national cervical screening programs. Furthermore, the results confirm that self-sampling kits represent a suitable alternative to clinician-collected samples. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier (NCT04133610).

Cancer Research Czech Republic Olomouc The Czech Republic

Institute of Molecular and Translational Medicine Faculty of Medicine and Dentistry Palacky University Olomouc Olomouc The Czech Republic

Institute of Molecular and Translational Medicine University Hospital Olomouc The Czech Republic

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