The SARS-CoV-2 IgM-IgG (GICA) is intended to be used by trained professionals to qualitatively determine SARS-CoV-2 IgM and IgG antibodies in serum or plasma or whole blood by the mean of colloidal gold immunochromatography assay (GICA). The test results of SARS-CoV-2 IgM/IgG combined with other clinical manifestations and other laboratory test results are helpful for the diagnosis of suspected SARS-CoV-2 infection.