Covid-19 Antibody Test
Terms and Conditions
- The test has not been reviewed by the FDA. The manufacturer of the testing device has notified the FDA that it has validated and is offering this serology test to commercial laboratories in compliance with Section IV.D. of the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019.
- 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.
- This test is not for the screening of donated blood
- 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. The medical and scientific literature around SARS-CoV-2 antibody testing is evolving and a positive result indicates only the prior presence of infection and resulting antigen; to date there is no demonstrative evidence of future resistance.
- The results of SARS-CoV-2 antibody testing is nota substitute for compliance with social distancing and other safety guidance issued by the California Department of Health, the Center for Disease Control or other governing public health and safety organization.
- Alwaysconsult your physician or an authorized health care provider with any questions with respect to COVID-19, the interpretation of this test, and how your behavior may impact your health & safety and that of others.