Clinical performance of Onclarity HPV assay and Cobas HPV test in detection of cervical precancer and cancer in Chinese women
Clinical performance of Onclarity HPV assay and Cobas HPV test in detection of cervical precancer and cancer in Chinese women
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DOI：
10.1016/j.ygyno.2020.01.011
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发表时间：
2020-04-01
影响因子：
4.7
通讯作者：
Chen, Wen
中科院分区：
文献类型：
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作者：
Li, Tingyuan;Wu, Zeni;Chen, Wen
客观的。罗氏 Cobas (Cobas) 和 BD Onclarity (Onclarity) 人乳头瘤病毒 (HPV) 检测是方便的、基于 PCR 的 HPV DNA 检测；目前，有关Onclarity在中国女性中的表现的数据有限。我们的目的是评估 Onclarity 在检测中国女性宫颈病变方面的临床表现。方法。总共有 1122 名女性参加了这项研究。将脱落的宫颈细胞收集在 PreservCyt 培养基中，并使用 Cobas 和 Onclarity 进行测试。细胞学和组织学分别由中国医学科学院肿瘤医院资深细胞学家和病理学家小组解读。结果。检测显示 HPV16（kappa = 0.91，95% CI：0.85-0.97）和其他 12 种高危类型（HPV31/33/35/39/45/51/52/56/58/59/66/68，kappa = 0.84，95% CI： 0.78-0.90），与 HPV18 具有非常好的一致性（kappa = 0.75，95% CI：0.69-0.81）。 Onclarity 和 Cobas 之间没有观察到 >= CIN2 敏感性的差异（均为 90.5%）； Onclarity 和 Cobas 的 = CIN2 敏感性为 75.0%（95% CI：53.1-88.8）。结论。在中国女性宫颈病变检测方面，Onclarity 与 Cobas 表现出相当的筛查性能和分诊效率。 (C) 2020 由爱思唯尔公司出版
Objective. The Roche Cobas (Cobas) and BD Onclarity (Onclarity) human papillomavirus (HPV) assays are convenient, PCR-based, HPV DNA tests; currently, data on performance of Onclarity in Chinese women is limited. We aimed to evaluate the clinical performance of Onclarity for detecting cervical lesions in Chinese women.Methods. In total, 1122 women were enrolled into this study. Exfoliated cervical cells were collected in PreservCyt medium and were tested using Cobas and Onclarity. Cytology and histology were interpreted by senior cytologists and a panel of pathologists, respectively, at Cancer Hospital, Chinese Academy of Medical Sciences.Results. The assays showed excellent concordance for HPV16 (kappa = 0.91, 95% CI: 0.85-0.97) and for 12 other high-risk types (HPV31/33/35/39/45/51/52/56/58/59/66/68, kappa = 0.84, 95% CI: 0.78-0.90), and very good concordance for HPV18 (kappa = 0.75, 95% CI: 0.69-0.81). No difference for >= CIN2 sensitivity was observed between Onclarity and Cobas (both 90.5%); and the = CIN2 sensitivity of 75.0% (95% CI: 53.1-88.8) for Onclarity and Cobas.Conclusions. Onclarity exhibited comparable screening performance and triage efficiency compared to Cobas in detection of cervical lesions in Chinese women. (C) 2020 Published by Elsevier Inc.