Sienna COVID-19 IgG/IgM Rapid Test Cassette is designed to detect the presence of IgM and IgM antibodies to SARS-CoV-2 in blood, serum or plasma samples. This COVID-19 IgG/IgM Rapid Test is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating a prior infection. The COVID-19 IgG/IgM Rapid Test Cassette is not to be used to diagnose acute SARS-CoV-2 infection.