To assess the diagnostic accuracy of self-collected urine and vaginal samples for the identification of precancerous cervical lesions in the referral population using high-risk human papillomavirus (hrHPV) assays based on polymerase chain reaction (PCR). It was a prospective study carried out in China from June 2021 to March 2022. The vaginal and urine samples were collected and analyzed by using a newly developed specific hrHPV PCR test, and matched cervical samples were analyzed by using an approved hrHPV DNA test. The primary outcomes were sensitivity for cervical intraepithelial neoplasia 2 or greater (CIN2 +). The secondary outcome was the accuracy of hrHPV findings in urine and vaginal samples compared to cervical samples. A total of 1,701 women were recruited with 113 women excluded. Among 1,588 qualified participants, a total of 203 cases of the CIN2 + group were enrolled in the two centers. The sensitivity and specificity of HPV detection for CIN2 + in urine, vaginal and cervical samples were 86.70% and 36.46%, 90.64% and 30.54%, 93.60% and 26.14%, respectively. The urine sample performed lower sensitivity (p = 0.003) and higher specificity (p < 0.001) than the cervical sample. There was no difference in sensitivity between vaginal and cervical samples (p = 0.146), and the specificity of vaginal samples was higher than that in cervical samples (p < 0.001). The agreement was 78.15% of urine and cervical samples and 85.71% of vaginal and cervical samples. HPV testing on self-collected urine and vaginal samples has acceptable consistency compared with traditional cervical samples. It may be an alternative option for cervical cancer screening. Additional studies are still required to substantiate this issue.
Keywords: Cervical intraepithelial neoplasia; Diagnostic test accuracy; HPV testing; Human papillomavirus; Self-sampling; Urine.
© 2025. The Author(s).