The Anti-SARS-CoV-2 Rapid Test, which has received an Emergency Use Authorization (EUA) from the U.S Food and Drug Administration (FDA), is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood (Heparin/EDTA/sodium citrate) or serum. The Anti-SARS-CoV-2 Rapid Test 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 Anti-SARS-CoV-2 Rapid Test should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests.