FDA Issues Emergency Authorizations for Antibody Test and NASA Ventilator
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of April 26, 2020.
New Total COVID-19 Antibody Test Receives FDA Emergency Use Authorization
The FDA has granted Bio-Rad Laboratories Emergency Use Authorization (EUA) for the company’s severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Total Ab test. This test is the first total antibody test that has received an EUA from the FDA.
The blood-based immunoassay test will be able to help clinicians identify whether an individual has antibodies against SARS-CoV-2, the virus associated with coronavirus disease 2019 (COVID-19).
The test will be available for use both manually or on an automated immunoassay platform.
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FDA Authorizes NASA Developed Ventilator for COVID-19
The FDA has added a ventilator developed by the National Aeronautics and Space Administration to the list of authorized ventilators under the FDA’s ventilator emergency use authorization.
The original emergency use authorization was issued out of concern related to an insufficient supply of FDA-approved ventilators for use in health care settings during the coronavirus disease 2019 (COVID-19) pandemic.
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