SARS-CoV-2 IgG/IgM

Rapid immunochromatographic test for the qualitative detection of IgG and IgM antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human whole blood, serum and plasma samples as an aid in diagnosis of Coronavirus (Covid-19) infection.

IgG

Test sensitivity: 100% (95% CI*: 86.0% - 100%) 

Test specificity: 98.0% (95% CI*: 89.4% - 99.9%)

Overall Agreement: 98.6% (95% CI*: 92.3% - 99.96%) 

IgM

Test sensitivity: 85.0% (95% CI*: 62.1% - 96.8%) 

Test specificity: 96.0% (95% CI*: 86.3% - 99.5%)

Overall Agreement: 92.9% (95% CI*: 84.1% - 97.6%) 

* Confidence Interval