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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Specificity and Performance of Nucleocapsid and Spike-based SARS-CoV-2 Serologic Assays

DOI
10.1101/2020.08.05.20168476 
Detection Principle
ImmunoAssay-Antibody
Target
IgA, IgG
Testing Method Category
ELISA
Testing Method
3 in house ELISA; Kits: EDI™ Novel Coronavirus COVID-19 ELISA IgG and IgM, Euroimmun Anti-SARS-CoV-2 ELISA IgG and IgA, lateral flow assay, DPP® COVID-19 IgM/IgG System (Chembio)
Testing Method - Additional Info
comparison of 3 in-house ELISA and 4 commercial ELISA kits
Reported Performance
sensitivity: 90% (in-house trimer spike IgA), 90% (in-house trimer spike IgG), 89% (in-house nucleocapsidIgG), 73.7% (EDI nucleocapsid IgM), 84.5% (EDI nucleocapsid IgG), 95% (Euroimmun S1 IgA), 82.8% (Euroimmun S1 IgG), 82.0% (Chembio nucleocapsid IgM), 92% (Chembio nucleocapsid IgG); specificity: 100% (in-house trimer spike IgA), 99.3% (in-house trimer spike IgG), 98.3% (in-house nucleocapsid IgG), 100% (EDI nucleocapsid IgM), 95.1% (EDI nucleocapsid IgG), 93.7% (Euroimmun S1 IgA), 99.7% (Euroimmun S1 IgG), 91.7% (Chembio nucleocapsid IgM), 93.3% (Chembio nucleocapsid IgG).
Sample Size
400 samples
Assay Type
 
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