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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

EDTA-Anticoagulated Whole Blood for SARS-CoV-2 Antibody Testing by Electrochemiluminescence Immunoassay (ECLIA) and Enzyme-Linked Immunosorbent Assay (ELISA)

Detection Principle
ImmunoAssay-Antibody
Target
IgG, IgA (Euroimmun); Total Ab vs N (Elecsys)
Testing Method Category
Mixed
Testing Method
kits (Elecsys, Euroimmun)
Testing Method - Additional Info
evaluation of EDTA-anticoagulated whole blood as an alternative sample material for antibody testing against SARS-CoV-2 by electro-CLIA (ECLIA Elecsys Anti-SARS-CoV-2 assay (Roche Diagnostics, Rotkreuz, Switzerland)) and ELISA (IgG and IgA; Euroimmun, Germany)
Reported Performance
Sensitivity: 88% (IgG ELISA serum), 78% (IgA ELISA serum), 97% (ECLIA serum), 93% (IgG ELISA Whole Blood Corrected for Hematocrit), 84% (IgA ELISA Whole Blood Corrected for Hematocrit), 96% (ECLIA Whole Blood Corrected for Hematocrit); Specificity: 99% (IgG ELISA serum), 93% (IgA ELISA serum), 100% (ECLIA serum), 97% (IgG ELISA Whole Blood Corrected for Hematocrit), 89% (IgA ELISA Whole Blood Corrected for Hematocrit), 99% (ECLIA Whole Blood Corrected for Hematocrit); Diagnostic accuracy: : 0.987 (ECLIA serum), 0.973 (ECLIA whole blood), 0.973 (ECLIA whole blood corrected for hematocrit), 0.969 (IgG ELISA serum), 0.971 (IgG ELISA whole blood), 0.971 (IgG ELISA whole blood corrected for hematocrit), 0.939 (IgA ELISA serum), 0.935 (IgA ELISA whole blood), 0.936 (IgA ELISA whole blood corrected for hematocrit)
Sample Size
223 individuals
Peer-reviewed
yes

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