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Clinical performance of Onclarity HPV assay and Cobas HPV test in detection of cervical precancer and cancer in Chinese women

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WOS体系：
Pubmed体系：

收录情况： ◇ SCIE

作者：
Li, Tingyuan[1,2] ; Wu, Zeni[2] ; Jiang, Mingyue[2] ; Zhao, Yuqian[1] ; Yu, Lulu[2,3] ; Qin, Yu[2] ; Liu, Bin[2] ; Cui, Jianfeng[2] ; Li, Li[2,4] ; Pan, Qinjing[2] ; Zhang, Xun[2] ; Liu, Daokuan[2] ; Chen, Feng[2] ; Qiao, Youlin[2,*1] ; Chen, Wen[1,2,*2] ;
机构： [1]Office of Cancer Prevention and Treatment, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu 610041, China [2]Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China [3]RNA Biology Laboratory, Tumor Virus RNA Biology Section, Center for Cancer Research, National Cancer Institute, USA [4]Science and Education Office, The First Affiliated Hospital, Jinan University, 613 West Huangpu Ave, Guangzhou 510632, China
出处：
DOI： 10.1016/j.ygyno.2020.01.011
ISSN：

关键词： Cervical cancer Cervical cancer screening Diagnostic test performance Human papillomavirus

摘要：
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 specificity for detection was similar between Onclarity (84.2%, 95% CI: 81.6-86.4) and Cobas (80.4%, 95% CI: 77.6-82.8). When combined with cytology triage, the colposcopy referral rate point estimate was slightly lower for Onclarity (9.0%) than for Cobas (11.0%), with the same >= 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.

基金：
BD Diagnostics; Roche Molecular Systems, Inc.; National Natural Science FoundationNational Natural Science Foundation of China [81973136]
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2020]版：
大类 | 2 区 医学
小类 | 1 区 妇产科学 2 区 肿瘤学
最新[2023]版：
大类 | 2 区 医学
小类 | 1 区 妇产科学 2 区 肿瘤学
JCR分区：
出版当年[2020]版：
Q1 OBSTETRICS & GYNECOLOGY Q2 ONCOLOGY
最新[2023]版：
Q1 OBSTETRICS & GYNECOLOGY Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

第一作者：
第一作者机构： [1]Office of Cancer Prevention and Treatment, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu 610041, China [2]Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
通讯作者：
通讯机构： [1]Office of Cancer Prevention and Treatment, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu 610041, China [2]Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China [*1]Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, P.O.Box 2258, Beijing 100021, China. [*2]Office of Cancer Prevention and Treatment, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu 610041, China.
推荐引用方式(GB/T 7714)：
Li Tingyuan,Wu Zeni,Jiang Mingyue,et al.Clinical performance of Onclarity HPV assay and Cobas HPV test in detection of cervical precancer and cancer in Chinese women[J].GYNECOLOGIC ONCOLOGY.2020,157(1):202-208.doi:10.1016/j.ygyno.2020.01.011.
APA：
Li, Tingyuan,Wu, Zeni,Jiang, Mingyue,Zhao, Yuqian,Yu, Lulu...&Chen, Wen.(2020).Clinical performance of Onclarity HPV assay and Cobas HPV test in detection of cervical precancer and cancer in Chinese women.GYNECOLOGIC ONCOLOGY,157,(1)
MLA：
Li, Tingyuan,et al."Clinical performance of Onclarity HPV assay and Cobas HPV test in detection of cervical precancer and cancer in Chinese women".GYNECOLOGIC ONCOLOGY 157..1(2020):202-208

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