Hyun-Woong Cho1, Yung-Taek Ouh1, Jin Hwa Hong1, Kyung Jin Min2, Kyeong A So3, Tae Jin Kim3, E Sun Paik4, Jeong-Won Lee4, Jun Hye Moon5, Jae Kwan Lee6. 1. Department of Obstetrics and Gynecology, Korea University Guro Hospital, College of Medicine, Korea University, Seoul, Republic of Korea. 2. Department of Obstetrics and Gynecology, Korea University Ansan Hospital, College of Medicine, Korea University, Ansan, Republic of Korea. 3. Department of Obstetrics and Gynecology, Konkuk University School of Medicine, Seoul, Republic of Korea. 4. Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 5. Sejong Medical CO., LTD., Paju-si, Gyeonggi-do, 10880, Republic of Korea. 6. Department of Obstetrics and Gynecology, Korea University Guro Hospital, College of Medicine, Korea University, Seoul, Republic of Korea. Electronic address: jklee38@korea.ac.kr.
Abstract
BACKGROUND: Human papillomavirus (HPV) is well established as the main cause of cervical cancer. Non-invasive self-collected urine and vaginal sampling have the potential advantage of increasing patient compliance with cervical cancer screening. METHODS: Self-collected vaginal and urine samples and clinician-collected cervical samples were collected from 101 patients, including 84 patients with high grade squamous intraepithelial lesion and 17 patients with benign ovarian disease. Each sample was evaluated with RealTime HR-S HPV, Anyplex™ II HPV, and Cobas® HPV assays. The concordance of urine and of self-collected vaginal samples with cervical samples was assessed using the kappa (k) statistic. RESULTS: In any high-risk HPV (hrHPV), the concordance of self-collected vaginal and urine samples compared to cervical samples was moderate (k 0.49-0.58) and fair to moderate (k 0.33-0.51), respectively. In HPV 16/18, the concordance of vaginal and urine samples compared to cervical samples was almost perfect (k 0.81-0.86) and moderate to substantial (k 0.59-0.63), respectively. Among the three methods for HPV detection, RealTime HR-S showed the highest concordance with vaginal (k: any hrHPV 0.58, HPV 16/18 0.86) and urine samples (k: any hrHPV 0.51, HPV 16/18 0.63) compared to cervical samples. CONCLUSION: HPV tests using self-collected vaginal samples and urine showed substantial and moderate agreement compared with cervical samples, respectively, although HPV tests using these samples were still inferior to clinician-collected cervical samples. Further research is needed on the clinical performance of HPV testing using urine and self-collected vaginal samples as the screening method.
BACKGROUND:Human papillomavirus (HPV) is well established as the main cause of cervical cancer. Non-invasive self-collected urine and vaginal sampling have the potential advantage of increasing patient compliance with cervical cancer screening. METHODS: Self-collected vaginal and urine samples and clinician-collected cervical samples were collected from 101 patients, including 84 patients with high grade squamous intraepithelial lesion and 17 patients with benign ovarian disease. Each sample was evaluated with RealTime HR-S HPV, Anyplex™ II HPV, and Cobas® HPV assays. The concordance of urine and of self-collected vaginal samples with cervical samples was assessed using the kappa (k) statistic. RESULTS: In any high-risk HPV (hrHPV), the concordance of self-collected vaginal and urine samples compared to cervical samples was moderate (k 0.49-0.58) and fair to moderate (k 0.33-0.51), respectively. In HPV 16/18, the concordance of vaginal and urine samples compared to cervical samples was almost perfect (k 0.81-0.86) and moderate to substantial (k 0.59-0.63), respectively. Among the three methods for HPV detection, RealTime HR-S showed the highest concordance with vaginal (k: any hrHPV 0.58, HPV 16/18 0.86) and urine samples (k: any hrHPV 0.51, HPV 16/18 0.63) compared to cervical samples. CONCLUSION:HPV tests using self-collected vaginal samples and urine showed substantial and moderate agreement compared with cervical samples, respectively, although HPV tests using these samples were still inferior to clinician-collected cervical samples. Further research is needed on the clinical performance of HPV testing using urine and self-collected vaginal samples as the screening method.
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