1. A prospective pilot evaluation of vaginal and urine self-sampling for the Roche cobas 4800 HPV test for cervical cancer screening
- Author
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Sang-Hyun Hwang, Jae Kwan Jun, Bomyee Lee, Na Young Sung, Dong Ock Lee, Hye Young Shin, and Dohoon Lee
- Subjects
Adult ,medicine.medical_specialty ,lcsh:Medicine ,Uterine Cervical Neoplasms ,Pilot Projects ,Urine ,Malignancy ,Cervical intraepithelial neoplasia ,Sensitivity and Specificity ,03 medical and health sciences ,0302 clinical medicine ,Colposcopic Biopsy ,Republic of Korea ,Humans ,Medicine ,Sampling (medicine) ,Prospective Studies ,030212 general & internal medicine ,lcsh:Science ,Prospective cohort study ,Early Detection of Cancer ,Cervical cancer ,Human papillomavirus 16 ,Multidisciplinary ,Human papillomavirus 18 ,business.industry ,Obstetrics ,lcsh:R ,Papillomavirus Infections ,Chronic Cervicitis ,Reproducibility of Results ,Middle Aged ,medicine.disease ,female genital diseases and pregnancy complications ,030220 oncology & carcinogenesis ,Vagina ,lcsh:Q ,Female ,business ,Papanicolaou Test - Abstract
This pilot study sought to evaluate the feasibility of utilizing vaginal self-swabs and urine samples for HPV-based cervical cancer screening in 700 women who had undergone conventional Pap smear screening via the national cervical cancer program in Korea. The cobas 4800 HPV test was utilized to detect HPV in the self-samples. Pap smear results revealed three cases of atypical squamous cells of undetermined significance, 649 cases of negative for an intraepithelial lesion or malignancy, and 48 non-specific inflammatory findings. High-risk HPV was detected in 6.7% of urine samples and 9.6% of vaginal self-swab samples. The overall agreement for HPV 16/18 between urine and vaginal self-swab samples was 99.1% (95%CI 98.1% to 99.6%). Colposcopic biopsy revealed one cervical intraepithelial neoplasia (CIN) 3 lesion, 12 CIN1 lesions, and 23 normal or chronic cervicitis lesions. In conclusion, urine and vaginal self-swab sampling was feasible and deemed a potential alternative for HPV detection in women who hesitate to participate in cervical cancer screening programs. Meanwhile, due to overall lower rates of abnormal cytology and sexual risk behaviors in Korea, a larger sample size than expected is needed to assess the sensitivity of CIN2+ detection via self-samples.
- Published
- 2018
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