FDA approves first point-of-care antibody test

Sep 24, 2020 - 04:13 PM
FDA product update

The Food and Drug Administration today authorized for emergency use the first serology test to help identify individuals with antibodies to SARS-CoV-2 at the point of care.

The agency previously authorized the test for use by certain labs. 

“Until today, serology test samples were generally only able to be evaluated in a central lab, which can be time consuming and use additional resources to transport samples and run the test,” noted FDA Commissioner Stephen Hahn, M.D.
 

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