Performance and Diagnostic Accuracy of Human Papillomavirus Testing on Self-Collected Urine and Vaginal Samples in a Referral Population

Abstract

Purpose The study aimed to evaluate the diagnostic accuracy of polymerase chain reaction & ndash;based high-risk human papillomavirus (HPV) assays on self-collected vaginal and urine samples for detection of precancerous cervical lesions in referral population. Materials and Methods Women referred for colposcopy following abnormal cytology, were included this study. A total of 314 matched urine, vaginal, and cervical samples were collected. All samples were tested for HPV DNA using the RealTime HR-S HPV and Anyplex II HPV 28 assays. Primary endpoints were sensitivity for cervical intraepithelial neoplasia (CIN) 2+/CIN3+ and specificity for <CIN2.Secondary endpoints were the relative accuracy of high-risk HPV (hrHPV) test results in vaginal and urine samples versus cervical samples. Results The sensitivity of Realtime HR-s and Anyplex HPV assay was 93.13% (95% confidence interval [CI],87.36 to 96.81) and 90.08% (95% CI,0.70 to 0.92) and 0.74 (95% CI 0.61 to 0.89). Conclusion The detection performance for hrHPV and CIN2+ on self-collected vaginal samples was comperable to that of clinician-collected cervical samples .On the other hand ,HPV tests using urine were inferior to those using clincian-collected cervical samples in terms of detecting hrHPV and CIN2+. & nbsp;