Journal of virological methods · 2021
A study of performance evaluation of cobas e 801 infectious diseases panel.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Jiang Fanming, Ji Yangtao, Liu Yusi, Yu Xiaoou, Sun Yu, Jin Guojiang, Pu Cunying, Zhao Min
Аннотация
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.
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.