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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 two commercial and two non-commercial immunoassays for the detection of prior infection to SARS-CoV-2

Detection Principle
ImmunoAssay-Antibody
Target
IgM, IgG, IgA
Testing Method Category
 
Testing Method
Kits & in house
Testing Method - Additional Info
two commercial (Roche Diagnostics and Epitope Diagnostics IgM/IgG) and two non-commercial (Simoa and Ragon/MGH IgG) immunoassays
Reported Performance
Sensitivity: 100% (Epitope IgG, Ragon, Roche, Simoa >21 dpo), 33.3% (Epitope IgM, >21 dpo), 67%-100% (9-14 dpo), 69%-100% (15-21 dpo); Specificity: 99.1% (Epitope IgG), 98.7% (Epitope IgM), 99.6% (Ragon/MGH IgG and Roche), 99.1% (Simoa)
Sample Size
68 positive & 232 negative samples
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