1. This test detects the presence of SARS-CoV-2 IgM/IgG in the specimen and should not be used as the sole criteria for the diagnosis of SARS-CoV-2 infection.
2. Test results must be considered with other clinical data available to the physician.
3. For more accuracy of immune status, additional follow-up testing using other laboratory methods is recommended.
NOTIFICATION FOR COVID-19 ANTIBODY TESTS
1. This test has not been reviewed by the FDA.
2. 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.
3. 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.
4. 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 or past or present infection with SARS virus (no. 6).
5. Not for the screening of donated blood.