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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Validation of a new automated chemiluminescent anti-SARS-CoV-2 IgM and IgG antibody assay system detecting both N and S proteins in Japan

Detection Principle
ImmunoAssay-Antibody
Target
IgM, IgG vs N, S
Testing Method Category
 
Testing Method
CLIA
Testing Method - Additional Info
iFlash3000 CLIA analyzer
Reported Performance
Remark: concordance rates of the antibody test with the PCR test were 98.1% (IgM) and 100% (IgG) among PCR-negative cases and 30.8% (IgM) and 73.1% (IgG) among PCR-positive cases
Sample Size
199 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