May 26, 2020

FDA Nixes Certain COVID-19 Antibody Tests

With dozens of manufacturers providing various types of diagnostic tests for COVID-19, several companies have created serological (antibody) tests. Many manufacturers have received Emergency Use Authorizations (EUA) for tests they have developed, with the FDA including such tests on a website notification list.

However, the FDA has now published a list of 31 serological tests that have now been removed from their notification list, meaning they will not receive an EUA soon and should not be distributed for COVID-19 testing.

Further information can be found in a related FDA news release.

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