FDA Authorizes New COVID Tests
The FDA authorized the following new diagnostic tests:
- Lucira COVID-19 and Flu Test is a single use molecular test intended for detection of both the SARS-CoV-2 and influenza (A or B) viruses. It can be used in a point-of-care setting for persons age two years and older.
- Fastep COVID-19 Antigen Home Test, manufactured by azure Biotech Inc., can be used as a serial test for people with or without symptoms and provides results in 15 minutes.
- CorDx COVID-19 Antigen Test shows results in ten minutes and can be used as a serial test for people with or without symptoms.