Cancer Res Treat.  2021 Jul;53(3):829-836. 10.4143/crt.2020.1165.

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

Affiliations
  • 1Department of Obstetrics and Gynecology, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea
  • 2Department of Obstetrics and Gynecology, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, Korea
  • 3Department of Obstetrics and Gynecology, Kangwon National University Hospital, College of Medicine, Kangwon National University, Chuncheon, Korea
  • 4Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, Seoul, Korea
  • 5Sejong Biomed CO., LTD., Paju, Korea

Abstract

Purpose
The study aimed to evaluate the diagnostic accuracy of polymerase chain reaction ‒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 Conclusion
The detection performance for hrHPV and CIN2+ on self-collected vaginal samples was comparable to that of clinician-collected cervical samples. On the other hand, HPV tests using urine were inferior to those using clinician-collected cervical samples in terms of detecting hrHPV and CIN2+.

Keyword

Cervical intraepithelial neoplasia; Human papillomavirus DNA tests; Specimen handling; Urine
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