FDA grants waiver for 15-minute flu test
from Becker's Infection Control & Clinical Quality
The U.S. Food and Drug Administration has granted a Clinical Laboratory Improvement Amendments waiver to allow a nucleic acid-based influenza test to be used in physician offices, emergency departments, health department clinics and other healthcare facilities. The Alere i Influenza A & B test — which can be performed in the presence of the patient — uses a nasal swab sample and can provide results in as little as 15 minutes. Although negative results do not completely rule out an influenza virus infection, the test can aid physicians and healthcare professionals in their diagnosis and evaluation processes.
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