FDA Disclaimer:

SARS-CoV2 antibody assessments are not FDA approved. However, we have had communications with the FDA and the FDA does not object to the use of our tests. We use the Wondfo and Anhui SARS-CoV-2 Antibody Test's, which are  serology tests. On March 16, 2020 the FDA issued guidelines which stated that they do not intend to object to these tests, so long as the following guidelines have been followed:

  1. the test has been validated;

  2. notification is provided to the FDA; and

  3. information along the lines of the following is included

·      

  • 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 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

Wondfo and Anhui notified the FDA about their intention to distribute their validated tests and also provided the required language in the test instructions for use.

Our tests are administered by credentialed medical professionals. They are imported from an FDA compliant manufacturers and have passed US customs and FDA inspections in the USA.

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