The US Food and Drug Administration has issued its first emergency use authorization for a coronavirus test that looks for antibodies in the blood.
That type of test, called a serology test, would be able to identify past coronavirus infections, although it may be less effective at identifying recent ones. The authorized test, from a manufacturer called Cellex Inc., requires blood to be collected through a vein, and the test itself can only be performed in a certified lab.Read More Because antibodies can take time to develop, the FDA has previously warned against using antibody tests to definitively diagnose coronavirus.
Multiple news outlets reported on the announcement, but later retracted their articles after the FDA confirmed that no such test had been authorized at the time. On Wednesday, the company acknowledged that the test had not in fact received the authorization. FDA guidance issued last month allows antibody tests to be manufactured and distributed without such authorizations.
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