Skip to main content
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
Shanghai Outdo Biotech Co. Ltd, China, LOT: 20200101
Testing Method - Additional Info
Full article available at:
Reported Performance
sensitivity 71.1% [95% CI 0.609-0.797]; specificity 96.2% [95% CI 0.859-0.993]. In patients with symptoms more than 14 days, sensitivity was higher at 95.2% [95% CI 0.741-0.998] and in patients with severe clinical condition sensitivity was 86.0% [95% CI 0.640-0.970].
Sample Size
150 patients with covid symptoms, 26 healthy blood donors

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