SARS-CoV-2 antibody tests are designed to detect specific antibodies against this virus. A positive IgG antibody test result suggests past exposure and may indicate a prior infection which may be resolved or is still resolving, and/or protection against re-infection (“protective immunity”).

A diagnosis, in general, is to rule in or to rule out the presence of a medical condition. Again, the SARS-CoV-2 antibody test cannot be used to rule in or rule out active COVID-19 infection.

To date, the United States Food and Drug Administration (FDA) has not required a review of information about any specific antibody test. The FDA is allowing laboratories to perform these tests without extensive review in response to the COVID-19 pandemic emergency.