Interpretation

Results will be reported as Positive or Negative with the following notes:

• This assay has been approved for use by the FDA under the Emergency Use Authorization for Medical Devices. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covidinvitrodev

• 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. 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.

• Not for the screening of donated blood.

• This test may be useful for its negative predictive value in patients whom symptoms began at least 14 days ago.

This testing is only advised to be performed on individuals at least 10 days after initial symptom onset or at least 10 days after initial known exposure. This is because IgG antibodies to SARS-CoV-2 develop approximately 8 to 11 days post-symptom onset (seroconversion) for the majority of patients. The presence of IgG antibodies indicates that the patient has been exposed to COVID-19.