High-risk HPV Prevalence and Distribution in Cervical Cancer Screening: Extended Genotyping in Correlation with Cytology and p16/Ki67 Dual Stain Results

Abstract The prevalence of high-risk human papillomavirus (HR-HPV) in cytology combined with p16/Ki67 status using limited and two types of extended HPV genotyping has not yet been described. A total of 32,724 screening tests results between 2015-2024 were included. The overall HR-HPV-positivity rate was 15.0%. The HR-HPV prevalence in limited genotyping group was 13.9%, in extended genotyping 1 (17.8%), in extended genotyping 2 (17.2%), with statistically significant difference in the proportions of positive/negative cases (p<0.0001). No statistically significant difference was noted between extended genotyping groups (p=0.706). Extended genotyping 1: the highest p16/Ki67-positivity was observed for HR-HPV 33/58 (100.0%) and 31 (58.8%), the lowest for HR-HPV 45 (18.2%), 18 (25.0%) and 59/56/66 (28.9%). Extended genotyping 2: the highest p16/Ki67-positivity was for HR-HPV 16 (66.7%) and 31/33/52/58 (58.8%). A combined approach, implementing new technologies, could help healthcare providers in more informed decisions about patient care, supporting the prevention of cervical precancer and cancer. Statement of Significance The transition to HPV-based cervical cancer screening is progressively advancing. By investigating of HR-HPV prevalence and distribution in limited or extended genotyping, cytology and p16/Ki67 dual-stain, our study aimed to support evidence-based decision-making processes and help guide of medical interventions of public health policies targeted to incorporation of new technologies. Competing Interest Statement M.T. has given lectures sponsored by the Hologic company, received coverage for travel and accommodation costs. R.J. has given a lecture sponsored by the Roche company. No disclosures were reported by the other authors. Funding Statement This study received no external funding. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by the Ethics Committee of Jagiellonian University (opinion ID 118.6120.36.2023). The study was conducted in accordance with the principles of Declaration of Helsinki. Informed consent was not obtained because of the retrospective design of this study. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes Conflicts of Interest M.T. has given lectures sponsored by the Hologic company, received coverage for travel and accommodation costs. R.J. has given a lecture sponsored by the Roche company. No disclosures were reported by the other authors.