Diagnostic performances and thresholds: the key to harmonization in serological SARS-CoV-2 assays?
Detection Principle
ImmunoAssay-Antibody
Target
IgM IgG vs S and N (Maglumi); IgG vs S1/S2 (Liaison); IgG, IgM vs NP and S (iFlash); IgG, IgA vs S (Euroimmun); total Ab vs RBD (Wantai)
Testing Method Category
Testing Method
CLIA, ELISA kits
Testing Method - Additional Info
CLIA assays: Maglumi (Snibe), Liaison (Diasorin), iFlash (Yhlo); ELISA kit : Euroimmun (Medizinische Labordiagnostika AG), Wantai (Wantai Biological Pharmacy)
Reported Performance
Sensitivity: 93.8% (Maglumi), 97.1% (Liaison), 97.2% (iFlash); specificity: 93.3% (Maglumi), 88.9% (Liaison), 85.9%% (iFlash); overall agreement:90.3% (CLIA), 98.4% (ELISA)
Sample Size
271 subjects
Peer-reviewed
yes
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