This assay is based on a colloidal gold method for the rapid, qualitative determination of Anti-SARS-CoV-2 (IgG/IgM antibodies of Severe Acute Respiratory Syndrome Coronavirus 2) in human serum, plasma or whole blood. IgM Positive Percent Agreement of Anti-SARS-CoV-2 Rapid Test was 85.43% (346/405), (95%CI: 81.7% - 88.5%), IgM Negative Percent Agreement was 99.68% (311/312), (95%CI: 98.2% - 99.9%). IgG Positive Percent Agreement of Anti-SARS-CoV-2 Rapid Test was 86.17% (349/405), (95%CI: 82.5% - 89.2%), IgG Negative Percent Agreement was 99.36% (310/312), (95%CI: 97.7% - 99.8%).
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements