Evaluation of the concordance in HPV type between self- and physician-collected samples using a brush-based device and a
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ORIGINAL ARTICLE
Evaluation of the concordance in HPV type between self‑ and physician‑collected samples using a brush‑based device and a PCR‑based HPV DNA test in Japanese referred patients with abnormal cytology or HPV infection Toshimichi Onuma1 · Tetsuji Kurokawa1 · Akiko Shinagawa1 · Yoko Chino1 · Yoshio Yoshida1 Received: 17 December 2019 / Accepted: 11 June 2020 © The Author(s) 2020
Abstract Background To adopt HPV self-sampling in Japan, we assessed the concordance between self- and physician-collected human papillomavirus (HPV) samples from Japanese patients and examined the performance of HPV self-sampling for cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Methods Patients who had previously tested negative for intraepithelial lesions or malignancy/HPV-positive, and patients with atypical squamous cells of undetermined significance or worse (ASCUS+) cytology were eligible for this cross-sectional study. Participants performed HPV self-sampling using an Evalyn brush, which was submitted at the Fukui Prefectural Health Care Association. The Evalyn brush heads were stored in ThinPrep vials. The physician, however, performed HPV and cell sampling using an endocervical brush and immediately stored the brush heads in ThinPrep vials. All participants underwent colposcopy and biopsy. Histopathological diagnoses were made by pathologists at Fukui University Hospital. HPV infection was confirmed using a PCR-based Cobas 4800 HPV DNA test. Cytological analysis was performed at Fukui Prefectural Health Care Association. Results HPV-positive rates for physician-collected samples and self-collected samples were 51 and 50%, respectively. The perfect match rate of HPV type between the groups was 88% (κ = 0.76). HPV16/18 showed higher agreement rates than other HPVs (99%, kappa 0.96 and 89% kappa 0.77, respectively). Both groups showed 100% sensitivity to CIN2+, but specificity was 57.0 and 58.1%, respectively. Conclusion For HPV typing, a good concordance rate was seen between self- and physician-collected samples. Self-sampling showed high sensitivity for CIN2+. Self-sampling using the Evalyn brush and Cobas 4800 may be feasible for screening Japanese individuals. Keywords Cervical cancer · Screening · HPV self-sampling · Brush · PCR-based HPV test
Introduction Japan has a higher incidence of age-adjusted cervical cancer than the United States and Australia, where screenings are organized [1]. The mortality rate of cervical cancer patients aged
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