Utilization of non-invasive urine sampling with multiplex PCR to enhance cervical cancer screening in developing countries: a cross-sectional diagnostic accuracy study

ObjectivesTo increase cervical cancer screening capacity and participation, we evaluated the performance of the newly developed hrHPV ReadyMix qPCR Kit for detecting high-risk Human Papillomavirus (HPV) in urine samples while simultaneously genotyping HPV16, HPV18, and HPV52. Methods876 samples were used to assess the performance of hrHPV ReadyMix qPCR Kit in detecting high-risk HPV in standard cervical swab sample compared to the Roche cobas(R) 6800 HPV. The high-risk HPV detection in urine was compared to the corresponding paired cervical swab. ResultsThe sensitivity of HPV detection in cervical swabs using hrHPV ReadyMix qPCR Kit reached 96.55% and the specificity reached 99.87%. Despite higher Ct values, urine samples demonstrated 80.88% sensitivity and 100.00% specificity compared to cervical swabs. Our method enables population-based high-risk HPV analysis with a 6.62% HPV prevalence from cervical swabs and 6.28% from urine samples. Furthermore, urine samples using the hrHPV ReadyMix qPCR Kit showed comparable HPV type distribution and the ability to genotype HPV16 and HPV18, to Roche the cobas(R) 6800 HPV. ConclusionsSelf-collected urine samples offer a 98.48% diagnostic accuracy for detecting high- risk HPV infection. This study highlights the hrHPV ReadyMix qPCR Kits potential in enhancing cervical cancer screening, offering valuable insights for future interventions.