“The FDA does not intend to object to the development and distribution of serology tests by commercial manufacturers or laboratories that identify antibodies to SARS-CoV-2 where 1) the test has been validated, 2) notification has been provided to the FDA, and 3) information along the lines of the following is included in the test report:
This test has not been reviewed by the FDA.
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 test 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.
This policy is limited to such testing in laboratories or by healthcare workers at the point-of-care.”
Above can be found within Predictive Labs website Q&A regarding this test not needing to be approved by FDA to be socially accepted.
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