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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
IgG, IgM
Testing Method Category
Testing Method
Colloidal gold immunochromatography assay kit
Testing Method - Additional Info
RT-qPCR to confirm positive and negative cases
Reported Performance
Sensitivity: 71.1% (PCR positive cases), 95.2% (patients with symptoms more than 14 days), 86% (patients with severe clinical condition) ; specificity: 96.2% (positive cases), 100% (negative cases) ; remarks: compared to qPCR results
Sample Size
150 sympthomatic patiens, 26 healthy 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