Concordance between the BD Onclarity and Roche cobas assays for detection of HPV DNA in a Chinese population
Concordance between the BD Onclarity and Roche cobas assays for detection of HPV DNA in a Chinese population
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BD Onclarity 与罗氏 cobas 检测方法在中国人群中检测 HPV DNA 的一致性
DOI：
10.1002/jmv.28072
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发表时间：
2022
影响因子：
12.7
通讯作者：
Wen Chen
中科院分区：
文献类型：
--
作者：
Yakun Wang;Ting;J. Yin;Yin Liu;Zhifang Li;Yujing Liu;Tingting Chen;Simiao Chen;Yu Dai;J. Cui;Bin Liu;Xiangxian Feng;Shaokai Zhang;Wen Chen
随着宫颈癌筛查从细胞学转向人乳头瘤病毒（HPV）检测，一个主要问题涉及验证更多的HPV检测。近年来，一些HPV检测在中国用于临床性能验证。本研究的目的是探索BD Onclarity（Becton，Dickinson and Company）HPV检测试剂盒与Roche cobas（Roche Molecular Systems）HPV检测试剂盒是否存在差异，使用944份宫颈样本（包括588份测序结果）进行测定。在核酸检测准确度验证中，检测HPV16的一致性极佳（κ = 0.93，95%置信区间[CI]：0.89 - 0.97）和HPV 18（κ = 0.90，95% CI：0.83 - 0.97），其他12种高风险类型的一致性非常好（HPV 31/33/35/39/45/51/52/56/58/59/66/68，κ = 0.79，95%CI：0.75 - 0.83）。Onclarity和cobas之间HPV DNA检测的总体一致性非常好（κ = 0.7755）。Onclarity和cobas对≥ CIN2的敏感性无差异（均为96.5%），而Onclarity检测≥ CIN2的特异性（16.6%，95%CI：13.7 - 19.9）高于cobas（11.5%，95%CI：9.1 - 14.5）。在中国女性宫颈疾病的检测中，Onclarity的筛查性能和分诊效率与cobas相当。
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 are used for clinical performance verification in China. The purpose of this study was to explore whether the BD Onclarity (Becton, Dickinson and Company)HPV assay differs from the Roche cobas (Roche Molecular Systems)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 (κ = 0.93, 95% confidence interval [CI]: 0.89–0.97) and HPV18 (κ = 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, κ = 0.79, 95% CI: 0.75–0.83). The overall agreement for HPV DNA detection between Onclarity and cobas was very good (κ = 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 the detection of cervical disease in Chinese women.