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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Evaluation of the EDI enzyme linked immunosorbent assays for the detection of SARS-CoV-2 IgM and IgG antibodies in human plasma

Detection Principle
IgG, IgM
Testing Method Category
Testing Method
kit (Epitope)
Testing Method - Additional Info
EDI Novel Coronavirus COVID-19 Enzyme Linked Immunosorbent Assays (ELISAs)
Reported Performance
positivity rate: 5.9% (IgM, ? 5 dpo), 2.9% (IgG, ? 5 dpo), 31.7% (IgM, 5-10 dpo), 37.1% (IgG, 5-10 dpo), 76.4% (IgM, >10-15 dpo), 82.4% (IgG > 10–15 dpo); True positivity rate: 94.4% (IgM, >15-22 dpo), 100% (IgG > 15–22 dpo); false positivity rate: 0.5% (IgM in healthy blood donors), 1.0% (IgG in healthy blood donors), 1.6% (IgM in ICU patients), 1.2% (IgG in ICU patients)
Sample Size
520 samples

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