High-Risk Human Papillomavirus Prevalence and Genotypes Distribution: Baseline Findings from Cervical Cancer Screening with Alinity m Among Women in Bulgaria

Background: The infection of the cervical epithelium with high-risk human papillomavirus (HR-HPV) accounts for more than 95% of cervical cancer cases. This study aimed to provide epidemiological data and assess the prevalence and genotype distribution of HR-HPV in Bulgaria. Methods: Cervical samples from 190 women were concurrently tested using routine liquid-based cytology (LBC) for 14 HR-HPV genotypes and cytology. HPV detection and genotyping were performed using the clinically validated Alinity m HR-HPV assay. This test provides detailed information on HPV16, HPV18, and HPV45 and categorizes the remaining 11 HR-HPV genotypes into two groups: other HR-HPV A and other HR-HPV groups. Stained LBC samples were reported using the Bethesda System. Results: HR-HPV infection was detected in 16.8% of the women screened, with mean age 38.2 (± 9.8) years. Infection with HPV16 could be seen in 5.3%, HPV18 positive were 2.2% and genotype HPV45 was found in 1.0%. Abnormalities in LBC cytology were observed in 18.9% of women. HR-HPV positivity in normal cytology samples was 5.2% and 63.9% in abnormal smears. Conclusion: Currently, molecular HPV tests are used for cervical cancer screening adjunctively to LBC as a first-line primary cervical cancer screening test for abnormal cell changes in the cervix.