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
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