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Concordance between the BD Onclarity and Roche cobas assays for detection of HPV DNA in a Chinese population

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机构: [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, Beijing, China. [2]Center for Cancer Prevention Research, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China [3]Henan Cancer Hospital Department of Cancer Epidemiology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China [4]Department of Public Health and Preventive Medicine, 161East Jiefang Street, Changzhi Medical College, Changzhi, Shanxi, China. [5]Department of Epidemiology and Biostatistics, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, Sichuan, China
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关键词: human papillomavinus cervical intraepithelial neoplasia cervical cancer screening diagnostic test performance

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As cervical cancer screening shifts from cytology to human papillomavirus (HPV) testing, a major issue involves validating more HPV tests. In recent years, some HPV tests have begun to perform for clinical performance verification in China. The purpose of this study was to explore whether the BD Onclarity (Becton, Dickinson and Company, Sparks, MD) HPV assay differs from the Roche cobas (Roche Molecular Systems, Pleasanton, CA) HPV assay, as determined using 944 cervical samples, including 588 with sequencing results. In the nucleic acid assay accuracy verification, the assays showed excellent concordance for detection of HPV16 (kappa = 0.93, 95% CI: 0.89-0.97) and HPV18 (kappa = 0.90, 95% CI: 0.83-0.97), and very good concordance for the 12 other high-risk types (HPV31/33/35/39/45/51/52/56/58/59/66/68, kappa = 0.79, 95% CI: 0.75-0.83). The overall agreement for HPV DNA detection between Onclarity and cobas was very good (Kappa=0.7755). No difference for ≥CIN2 sensitivity was observed between Onclarity and cobas (both 96.5%), whereas the ≥CIN2 specificity for detection of Onclarity (16.6%, 95% CI: 13.7-19.9) was higher than that of cobas (11.5%, 95% CI: 9.1-14.5). Onclarity exhibited comparable screening performance and triage efficiency compared to cobas in detection of cervical disease in Chinese women. This article is protected by copyright. All rights reserved.This article is protected by copyright. All rights reserved.

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出版当年[2022]版:
大类 | 3 区 医学
小类 | 3 区 病毒学
最新[2023]版:
大类 | 3 区 医学
小类 | 3 区 病毒学
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Q1 VIROLOGY
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Q1 VIROLOGY

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第一作者机构: [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, Beijing, China.
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通讯机构: [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, Beijing, 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, Bejjing, Chaoyang District 100021, China.
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