A rapid chromatographic immunoassay for the qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2 in human venous whole blood, serum or plasma, or fingerstick whole blood. The test is intended for use as an aid in identifying individuals with adaptive immune response to SARS-CoV-2, indicating recent or prior infection. CLIA waived.
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This test has not been FDA cleared or approved.
This test is authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories only.