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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 evaluation of a rapid colloidal gold immunochromatography assay for SARS-Cov-2 IgM/IgG

Detection Principle
IgM and IgG
Testing Method Category
Testing Method
colloidal gold immunochromatography antibody detection kit (Shanghai Outdo Biotech Co. Ltd, China, LOT: 20200101
Testing Method - Additional Info
To evaluate the diagnostic performance and clinical utility of the colloidal gold immunochromatography assay for SARS-Cov-2 specific IgM/IgG anti-body detection in suspected COVID-19 cases.
Reported Performance
Sensitivity: 71.1%; specificity: 96.2%
Sample Size
150 patients

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