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Cancer Research and Treatment > Accepted Articles
doi: https://doi.org/10.4143/crt.2020.1165    [Accepted]
Performance and Diagnostic Accuracy of Human Papillomavirus Testing on Self-Collected Urine and Vaginal Samples in a Referral Population
Hyun-Woong Cho1, Jin Hwa Hong1, Kyung Jin Min2, Yung-Taek Ouh3, Seok Ju Seong4, Jun Hye Moon5, Seong Hwan Cho5, Jae Kwan Lee1
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
Correspondence  Jae Kwan Lee ,Tel: 82-2-2626-3142, Fax: 82-2-838-1560, Email: jklee38@korea.ac.kr
Received: November 9, 2020;  Accepted: December 23, 2020.  Published online: December 24, 2020.
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 <CIN2. Secondary endpoints were the relative accuracy of high-risk HPV (hrHPV) test results in vaginal and urine samples versus cervical samples. Result 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, 83.63 to 94.61) for CIN2+ (n=130); specificity for <CIN2 was 32.69% (95% CI, 25.03 to 38.97) and 33.33% (95% CI, 26.26 to 41.00), respectively. Relative sensitivity of Realtime HR-S and Anyplex HPV tests for the detection of CIN2+ in vaginal versus cervical samples were 0.91 (95% CI, 0.90 to 1.03) and 0.87 (95% CI, 0.75 to 1.02), respectively; urine versus cervical comparisons were 0.79 (95% CI, 0.70 to 0.92) and 0.74 (95% CI, 0.61 to 0.89).
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+.
Key words: Cervical intraepithelial neoplasia, Human papillomavirus DNA tests, Specimen handling, Urine
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