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
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
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DOI：
10.1007/s10147-020-01727-5
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发表时间：
2020-06-24
影响因子：
3.3
通讯作者：
Yoshida, Yoshio
中科院分区：
文献类型：
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作者：
Onuma, Toshimichi;Kurokawa, Tetsuji;Yoshida, Yoshio
背景：为了在日本采用HPV自检，我们评估了自检和内科医生采集的日本人乳头瘤病毒(HPV)标本之间的一致性，并检测了HPV自检在宫颈上皮内瘤变2级或更严重(CIN2+)中的表现。方法对既往上皮内病变或恶性/HPV阳性、细胞学不典型鳞状细胞(ASCUS+)阳性的患者进行横断面研究。参与者使用Evalyn刷子进行HPV自我采样，这是在福井县卫生保健协会提交的。Evalyn刷头被储存在ThinPrep小瓶中。然而，医生使用宫颈内刷子进行了HPV和细胞采样，并立即将刷头存储在ThinPrep小瓶中。所有参与者都接受了阴道镜检查和活检。福井大学医院的病理学家进行了组织病理学诊断。HPV感染通过基于聚合酶链式反应的Cobas 4800人乳头瘤病毒DNA检测得到确认。细胞学分析在福井县保健协会进行。结果医生采集的标本和自身采集的标本HPV阳性率分别为51%和50%。两组间HPV型别完全匹配率为88%(kappa=0.76)。HPV16/18的符合率较高(99%，kappa为0.96，89%kappa为0.77)。两组对CIN2+的敏感性均为100%，但特异性分别为57.0%和58.1%。结论在HPV分型中，自行采集的标本与医生采集的标本具有较好的符合率。自取样法对CIn2+具有较高的灵敏度。使用Evalyn刷子和Cobas 4800进行自我取样对日本人进行筛查可能是可行的。
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% (kappa = 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.