COVID-19 Test Statements:
• This test has not been FDA cleared or approved.
• This test has been authorized by FDA under an EUA for use by authorized laboratories.
• This test has been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use
of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1),
unless the authorization is terminated or revoked sooner.
• 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
• 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.