FDA revokes authorization for antibody test
The Food and Drug Administration last week revoked its emergency use authorization for a SARS-CoV-2 antibody test made by Autobio Diagnostics Co. due to concerns with the accuracy of the test when evaluated at the National Institutes of Health’s Frederick National Laboratory for Cancer Research.
“Specifically, the Agency has concluded that it is unlikely that this test is effective in detecting SARS-COV-2 IgM antibodies and that the known and potential benefits of its use do not outweigh the known and potential risks,” the agency said.
Related News Articles
Blog
The RAND Corporation recently released the fifth iteration of its biannual hospital price report. The AHA has previously highlighted significant flaws with…
Headline
Adults age 65 and older are encouraged to receive an updated dosage of the COVID-19 vaccine, the Centers for Disease Control and Prevention announced April 25…
Headline
The Pfizer and Moderna COVID-19 vaccines can cause myocarditis, but do not appear to cause infertility, Guillain-Barré syndrome, Bell’s palsy, thrombosis with…
Headline
The Food and Drug Administration recently granted emergency use authorization for the first over-the-counter home antigen test to detect both flu and COVID-19…
Headline
Centers for Disease Control and Prevention Director Mandy Cohen, M.D., Feb. 28 endorsed a recommendation by its Advisory Committee on Immunization Practices…
Headline
Paxlovid may no longer be distributed with an emergency use label after March 8, the Food and Drug Administration announced. Providers may dispense unexpired…