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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Clinical validation of an immunochromatographic SARS-Cov-2 IgM/IgG antibody assay with Japanese cohort

Detection Principle
ImmunoAssay-Antibody
Target
IgG, IgM
Testing Method Category
GICA
Testing Method
Kit (INNOVITA)
Testing Method - Additional Info
colloidal gold immunochromatography assay for SARS?Cov?2 IgM/IgG 2019?nCoV Ab Test Cassette (Colloidal Gold) (Innovita)
Reported Performance
sensitivity: 79.7% (IgM, 8 dpo), 86.1% (IgG, 8 dpo);specificity: 100%
Sample Size
151 samples
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