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.
Prior to receiving the CLIA waiver, the Alere i Influenza A & B test, which is manufactured by Alere Scarborough in Scarborough, Maine, was only available for use in certain laboratories.
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.
When compared to the already FDA-cleared comparator method of testing for influenza in laboratory procedures, the Alere i Influenza A & B test demonstrated high accuracy.
In addition to its accuracy, the test's ease of use and low risk of false results when used by untrained operators led the FDA to grant the waiver.
This year's flu season has been severe, as the virus is now widespread in 43 states and has been linked to 21 pediatric deaths as of Dec. 27.
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