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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Evaluation of a COVID-19 IgM and IgG rapid test; an efficient tool for assessment of past exposure to SARS-CoV-2

Detection Principle
IgG, IgM
Testing Method Category
Testing Method
Commercially available serological kit
Testing Method - Additional Info
qPCR to confirm positive/negative cases
Reported Performance
Sensitivity: 69% (IgM), 93.1% (IgG) ; specificity: 100% (IgM), 99.2% (IgG) ; remarks: compared to qPCR results
Sample Size
29 PCR-confirmed COVID-19 cases and 124 negative controls

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