FDA & Health Canada Emergency Use Authorized

From Senior Experts In The In-Vitro Diagnostic Field

FDA & Health Canada Approved Serological Technology

This COVID-19 IgG/IgM Rapid Antibody Test device is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. This test intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. It is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. An antibody test may not be able to show if you have a current infection, because it can take 1-3 weeks after infection to make antibodies.

The test is approved for laboratory testing and is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC).

With a waiver the test is approved for over-the-counter home self testing in Canada.