The SARS-CoV-2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma, venous whole blood, or capillary fingertip blood. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.