The Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test is intended to qualify the SARS-CoV-2 IgG and IgM antibody in human plasma, serum or whole blood by colloidal gold immunochromatography assay. The test can be used as an aid detection to SARS-CoV-2 infection and thus caused COVID-19 disease.