Abstract
BackgroundInfectious 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. ObjectivesThis 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. MethodsSpecificity 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. ResultsThe 3 investigational assays on cobas e 801 were showed to have excellent sensitivity and specificity which is comparable to existing assays. ConclusionThey are suitable for routine clinical diagnostic use, including pre-operative assessment in China.
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