FDA approves first antibody blood test in the U.S. to detect coronavirus, the test might exempt you from social distancing—if you pass and potentially get people back to work
The U.S. Food and Drug Administration has approved the first antibody blood test in the U.S. to detect coronavirus, according to a letter of authorization issued to Research Triangle Park, North Carolina-based Cellex Inc. The antibody test requires blood to be collected through a vein, and the test itself can only be performed in a certified lab.
The test, also called serology test, uses blood drawn from a vein to measure antibodies to the SARS-CoV-2 virus that causes COVID-19. The test will also be able to identify past coronavirus infections but may be less effective at identifying recent ones. Unlike the regular test, the test might exempt you from social distancing—if you pass
To date, all of the coronavirus tests conducted in the U.S. were designed to find fragments of the virus itself. “This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens,” the FDA said in the notice of approval. The test uses a method called PCR to find viral RNA in nasal samples, is useful for detecting people who are currently infected with the coronavirus.
Such tests also will be crucial for vaccine production. To prove a vaccine works, you must show antibody production in someone who hasn’t been exposed to COVID-19. Only an antibody test can do that. The serological test for coronavirus antibodies is much less costly than a PCR test that looks for coronavirus genetic material.