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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

Scientific literature on COVID-19 Test Methods and Devices - detail

Development and Multicenter Performance Evaluation of The First Fully Automated SARS-CoV-2 IgM and IgG Immunoassays

Detection Principle
ImmunoAssay-Antibody
Target
IgM/IgG
Testing Method Category
 
Testing Method
CLIA in-house-method
Reported Performance
Sensitivity: 85.88% (IgM), 96.62% (IgG) ; Specificity: 97.33% (IgM, hospitalized patients), 99.49% (IgM, normal population), 97.42% (IgG, hospitalized patients), 99.15% (IgG, normal population)
Sample Size
1558 patiens
Peer-reviewed
no

The database contains available information from scientific literature that is being updated periodically. Please note that the provided information (as retrieved from analysed papers) is provided only for devices commercially available with CE-IVD mark. Acknowledgements