Accuracy of real-time PCR assays for human papillomavirus using urine samples: a systematic review and meta-analysis.

Abstract

This study aims to assess the diagnostic accuracy of real-time PCR assays for detecting human papillomavirus (HPV) in urine samples through a systematic review and meta-analysis. A comprehensive search of PubMed, Embase, and Springer databases (2014-2024) was conducted. Studies comparing urine-based HPV tests with cervical samples as the reference standard were included. Diagnostic accuracy measures such as sensitivity, specificity, diagnostic odds ratio (DOR), likelihood ratios (LR+ and LR-), percent agreement, and Cohen's kappa were calculated. Heterogeneity was assessed using the Higgins' I² index, and subgroup analyses were performed based on HPV test type and urine volume. The study revealed that 15 studies met the inclusion criteria, with pooled sensitivity of urine-based HPV tests at 0.82 (95% CI, 0.78-0.86), specificity at 0.91 (95% CI, 0.87-0.94), positive LR at 9.5 (95% CI, 6.3-14.3), negative LR at 0.19 (95% CI, 0.16-0.24), DOR at 49 (95% CI, 32-75), and the area under the curve at 0.92 (95% CI, 0.90-0.94), with significant heterogeneity observed (I² >50%), particularly in sensitivity and specificity, and subgroup analysis indicating that urine volumes ≤20 mL demonstrated higher sensitivity compared to those >20 mL, despite this finding being based on a limited number of studies. Results suggest that urine-based HPV testing shows strong diagnostic accuracy and could be a viable alternative to cervical swabs, with potential benefits for increasing screening accessibility, especially in areas with limited healthcare resources, despite some variability and limitations in the data.IMPORTANCEThis study is significant as it thoroughly evaluates the diagnostic accuracy of real-time PCR assays for human papillomavirus (HPV) detection in urine samples through a rigorous systematic review and meta-analysis. By integrating data from multiple databases and comparing urine-based HPV tests with the established cervical sample reference standard, the study provides valuable insights into the effectiveness and reliability of non-invasive HPV screening methods. The findings demonstrate that urine-based tests exhibit high sensitivity and specificity, offering a promising alternative to traditional cervical swabs. This advancement has significant implications for increasing accessibility to HPV screening, particularly in under-resourced settings, thereby potentially enhancing cervical cancer prevention efforts on a broader scale. The study not only fills a critical gap in HPV screening methodologies but also supports the development of more inclusive and practical public health strategies for combating cervical cancer.