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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

An evaluation of COVID-19 serological assays informs future diagnostics and exposure assessment

Detection Principle
ImmunoAssay-Antibody
Target
IgA, IgG, IgM, multiple targets
Testing Method Category
 
Testing Method
kits
Testing Method - Additional Info
a) Wantai Ig total ELISA, (b) Wantai IgM ELISA, (c) Euroimmun IgG ELISA, (d) Euroimmun IgA ELISA, (e) DiaSorin Liaison XL IgG chemiluminescence immunoassay, (f) Cellex IgM/IgG, (g) InTec IgM/IgG, (h) Orient gene/Healgen IgM/IgG compared to an in-house plaque-reduction neutralization test (PRNT50) used as a reference
Reported Performance
Specificity: 99% (Wantai Ig tot), 99% (Wantai IgM), 99% (Euroimmun IgG), 94% (Euroimmun IgA), 90% (Liaison), 99% (Cellex), 85% (Intec), 88% (Orient/Healgen); Sensitivity: 99% (Wantai Ig tot), 90% (Wantai IgM), 81% (Euroimmun IgG), 97% (Euroimmun IgA), 81% (Liaison), 89% (Cellex), 90% (Intec), 100% (Orient/Healgen). Remark: Wantai ELISA detecting total Ig has the best overall characteristics to detect functional antibodies in different stages and severity of disease
Sample Size
147 samples (187 samples sensitivity)
Peer-reviewed
yes

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