cobas e 801 传染病panel 性能评估研究。
A study of performance evaluation of cobas e 801 infectious diseases panel.
机构信息
Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, 110001, China.
Medical Scientific Affairs, Roche Diagnostics (Shanghai) Limited, Shanghai, 200335, China.
出版信息
J Virol Methods. 2021 Jun;292:114112. doi: 10.1016/j.jviromet.2021.114112. Epub 2021 Feb 26.
BACKGROUND
Infectious diseases, such as HCV infection, HBV infection and syphilis, put a huge burden on public health. Accurate and fast testing is required for clinical usage.
OBJECTIVES
This study aimed to evaluate the clinical performance of Elecsys® Anti-HCV II, Elecsys® HBsAg II and Elecsys® Syphilis using samples from routine diagnosis in China.
METHODS
Specificity was tested in approximately 3000 unselected pseudonymized samples from routine clinical patients for each assay. Sensitivity of HCV and HBsAg assays was tested in 2 seroconversion panels, respectively.
RESULTS
The 3 investigational assays on cobas e 801 were showed to have excellent sensitivity and specificity which is comparable to existing assays.
CONCLUSION
They are suitable for routine clinical diagnostic use, including pre-operative assessment in China.
背景
传染病，如丙型肝炎病毒（HCV）感染、乙型肝炎病毒（HBV）感染和梅毒，给公共卫生带来了巨大负担。临床应用需要准确和快速的检测。
目的
本研究旨在评估 Elecsys® Anti-HCV II、Elecsys® HBsAg II 和 Elecsys® Syphilis 在常规诊断样本中的临床性能，这些样本来自中国的常规临床患者。
方法
针对每个检测项目，在大约 3000 份来自常规临床患者的非选择匿名样本中进行特异性测试。丙型肝炎病毒和乙型肝炎病毒检测的敏感性分别在 2 个血清转化面板中进行测试。
结果
cobas e 801 上的 3 种研究检测方法显示出优异的灵敏度和特异性，与现有检测方法相当。
结论
它们适用于常规临床诊断用途，包括中国的术前评估。
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