06/20/2020: Lab Alert: FDA Updates Website, Issues Warning Letters, and Revokes Chembio EUA

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Alert

FDA Updates Website, Issues Warning Letters, and Revokes Chembio EUA

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.

Additionally, 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. At the present time, there are no molecular, antigen, or antibody COVID-19 test kits that are currently authorized, cleared, or approved to be used completely at home. The FDA has authorized several molecular COVID-19 tests for use with at-home collection of samples (e.g., nasal, salivary) that can then be sent to a laboratory for processing and test reporting. However, there are no antibody tests authorized for use with at-home collection of samples.

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.

Lastly, 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.

Online resources:

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)