Comparison of urine and cervical swab samples for the molecular detection of human papillomavirus (HPV) in gynecology patients

Introduction and Objective: HPV is one of the most important causative agents of cervical cancer, and detection of HPV DNA plays a critical role in diagnosis and screening. This study aimed to compare HPV DNA results obtained from first-void urine samples collected simultaneously with cervical swabs and to evaluate the diagnostic performance of urine samples. The association between HPV DNA positivity and cytological abnormalities was also investigated. Materials and Methods: The study included 300 women aged 18–65 who presented to the Gynecology Outpatient Clinic of MCBU Hafsa Sultan Hospital between September 2024 and March 2025. Both cervical swab and urine samples were tested using the QIAscreen HPV PCR Test kit. Cytological evaluation was performed according to the 2014 Bethesda system. Statistical analyses were conducted using SPSS and MedCalc software. Results: HPV DNA positivity was detected in 19.3% (n=58) of cervical samples, 15.3% (n=46) of urine samples, and 14% (n=42) of both samples simultaneously. Taking cervical samples as the reference, the sensitivity, specificity, and accuracy of urine samples for HPV DNA detection were 72.4%, 98.4%, and 93.3%, respectively. The two sample types showed good agreement (κ = 0.768), and complete concordance was observed between HPV genotypes identified in cervical and urine samples. The mean Ct value in urine samples was significantly higher than in cervical samples (27.43 ± 3.94 vs 23.05 ± 4.39; p<0.0001). A significant positive correlation was also observed between cervical and urine Ct values (r = 0.40, p = 0.0086). ROC analysis revealed high diagnostic performance at optimal Ct cut-off values of ≤ 25.6 for cervical and ≤ 29.59 for urine samples. Cervical cytological abnormalities were found in 10 patients: 8 classified as ASC-US and 2 as LSIL. Five of these patients showed HPV DNA positivity in both sample types, and positivity rates increased with the severity of cytological abnormality (37.5% in ASC-US, 100% in LSIL). Conclusion: Urine samples can reflect cervical HPV DNA positivity with high specificity and strong concordance. Accordingly, integrating urine-based HPV DNA tests into screening programs is considered an effective strategy that may enhance patient participation and contribute to the early detection of cervical cancer. Key words: HPV DNA, urine sample, cervical swab, diagnostic performance, Ct value, sensitivity, specificity.