A prospective pilot evaluation of vaginal and urine self-sampling for the Roche cobas 4800 HPV test for cervical cancer screening

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 det...

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Bibliographic Details
Published in:Scientific reports 2018-06, Vol.8 (1), p.9015-6, Article 9015
Main Authors: Hwang, Sang-Hyun, Shin, Hye Young, Lee, Dong Ock, Sung, Na Young, Lee, Bomyee, Lee, Do-Hoon, Jun, Jae Kwan
Format: Article
Language:English
Subjects:
38/22
692/4028/67/2322
692/700/459/1748
Biopsy
Cancer screening
Cervical cancer
Cervicitis
Cervix
Cytology
Human papillomavirus
Humanities and Social Sciences
Inflammation
Lesions
Malignancy
Medical screening
multidisciplinary
Risk taking
Sampling
Science
Science (multidisciplinary)
Self
Sexual behavior
Squamous cells
Urine
Vagina
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Summary: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.
ISSN:2045-2322
2045-2322
DOI:10.1038/s41598-018-27390-5