• This test has not been reviewed by the FDA but is being offered under the FDA’s Policy for Diagnostic Tests for Coronavirus Disease –2019, Section IV.D
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
• Early infections may not have generated sufficient antibodies to be positive on the test
• Currently it is not known if having any IGG antibodies indicates immunity; however, having IGG antibodies does indicate having had the infection
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.