Urinary detection of high-risk HPV DNA to enhance cervical cancer screening in developing countries.

To increase cervical cancer screening capacity and participation, we evaluated the performance of the newly developed high-risk human papillomavirus (hrHPV) ReadyMix qPCR Kit for detecting hrHPV in urine samples while genotyping for HPV-16, HPV-18, and HPV-52. A total of 876 samples were used to assess the performance of the hrHPV ReadyMix qPCR Kit in detecting hrHPV in standard cervical swab samples compared with that of the Roche Cobas 6800 HPV system. hrHPV detection in urine was compared with that in corresponding paired cervical swab samples. The sensitivity of the hrHPV ReadyMix qPCR Kit for HPV detection in cervical swab samples was 96.55%, and the specificity was 99.87%. Despite higher cycle threshold (Ct) values, urine samples demonstrated 80.88% sensitivity and 100.00% specificity compared with cervical swab samples. Our method enables population-based hrHPV analysis, with a 6.62% HPV prevalence determined via cervical swab samples and a 6.28% HPV prevalence determined via urine samples. Furthermore, the hrHPV ReadyMix qPCR Kit presented comparable HPV type distributions in urine samples and the ability to genotype HPV-16 and HPV-18 to those obtained via the Roche Cobas 6800 HPV system. Self-collected urine samples tested using the hrHPV ReadyMix qPCR Kit demonstrated a diagnostic accuracy of 98.48% for detecting hrHPV. This study highlights the potential of the hrHPV ReadyMix qPCR Kit to enhance cervical cancer screening, offering valuable insights for future interventions.IMPORTANCEThis study demonstrated that urinary detection of high-risk HPV DNA using the hrHPV ReadyMix qPCR Kit is an effective alternative for hrHPV screening. This non-invasive approach holds significant potential for large-scale screening, particularly in underserved populations. Integrating urine-based hrHPV testing into screening programs could improve early detection efforts, thereby enhancing the prevention and control of cervical cancer in low-resource settings.