The CareStart™ COVID-19 IgM/IgG is an immunochromatographic lateral flow assay intended for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum, plasma (sodium citrate, sodium heparin, or dipotassium EDTA), and venous whole blood (sodium citrate, sodium heparin, or dipotassium EDTA).
The CareStart™ COVID-19 IgM/IgG is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The CareStart™ COVID-19 IgM/IgG should not be used to diagnose or exclude acute SARS-CoV-2 infection. This testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests.