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A study of performance evaluation of cobas e 801 infectious diseases panel
Fanming Jiang1, Yangtao Ji1, Yusi Liu1
1Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, 110001, China.
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.
