FDA clears test to detect multiple respiratory infections, including COVID-19
The Food and Drug Administration Friday cleared for commercial distribution a test to diagnose multiple respiratory viral and bacterial infections in respiratory specimens from patients with suspected COVID-19 or other respiratory infections. The BioFire SPOTFIRE Respiratory Panel is the first COVID-19 test cleared with a Clinical Laboratory Improvement Amendments waiver, meaning any laboratory with at least a CLIA certificate of waiver can perform the test.
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…