Attention: Clinical Laboratories

Please share this announcement with:

  • Medical Director, Laboratory Services
  • Administrative Director and Managers, Laboratory Services

Key points:

  1. The U.S. Food and Drug Administration (FDA) recently updated its website to provide increased functionality. The new link leads directly to FDA-authorized tests for the SARS-CoV-2 virus and viral antibodies. As of June 19, 2020, FDA has authorized 144 tests under Emergency Use Authorizations (EUAs), including 122 molecular tests, 21 antibody tests, and 1 antigen test.
  2. FDA issued warning letters to three companies: Medakit, Ltd., of Sheung Wan, Hong Kong; Antibodiescheck.com; and Dr. Jason Korkus, DDS, and Sonrisa Family Dental d/b/a My COVID19 Club of Chicago, Illinois. These warning letters were issued for marketing adulterated and misbranded COVID-19 antibody tests.
  3. FDA has also issued a letter to clinical laboratory staff and healthcare providers to stop using tests on FDA’s removed list. The letter provides details about why certain tests were added to the list, recommendations for how healthcare providers and clinical laboratories should handle unused tests, information about how to evaluate whether patients should be retested using an FDA-authorized test, and instructions for reporting problems with COVID-19 tests.
  4. On June 16, 2020, FDA revoked the EUA of the Chembio Diagnostic System, Inc.’s DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, because of performance concerns with the accuracy of the test.

Additional information is available at the following links:

Direct Link to FDA-authorized tests for SARS-CoV 2 virus and viral antibodies

Warning Letters

FDA Removed Test List

Revoked EUA for Chembio Diagnostic System, Inc.’s DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test

Questions? Reach out to info@hfap.org.