The US Food and Drug Administration will take “appropriate action against firms making false claims or marketing” coronavirus tests, according to a news release from FDA Commissioner Dr. Stephen Hahn.
As of Tuesday, only one Emergency Use Authorization has been issued by the FDA for a serological test for coronavirus. The test is intended only for clinical laboratory use.
A serology test would be able to identify past coronavirus infections, although it may be less effective at identifying recent ones.
More than 70 test developers have notified the agency that they have serological tests available for use, according to Hahn’s statement.
"However, some firms are falsely claiming that their serological tests are FDA approved or authorized, or falsely claiming that they can diagnose COVID-19."
In March, the FDA issued a new policy which allows companies to market serological tests for coronavirus without FDA review so long as they met certain conditions. The new policy was an effort to identify individuals who have overcome an infection and have developed an immune response to coronavirus, according to Hahn.