The Food and Drug Administration (FDA) has granted the first CLIA waiver for Alere i Influenza A & B test, a nucleic acid-based test, for use in expanded healthcare settings.

Prior to this clearance, Alere i Influenza A & B test was limited for use in certain laboratories. Now, the test can be distributed to a range of non-traditional laboratory sites, including physicians’ offices, emergency rooms, health department clinics, and other healthcare facilities. This test is intended for use as an aid in diagnosis; a negative result does not rule out influenza virus infection.

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The waiver was granted after review of data showing the test’s usability and low risk of false results when operated by untrained users. Data from >500 patients with respiratory viral infection tested for influenza using both the Alere i Influenza A & B test and an FDA-cleared molecular comparator. The Alere i Influenza A & B test showed high accuracy in detecting patients with or without influenza A and influenza B by untrained users in laboratory procedures.

The Alere i Influenza A & B test uses a patient’s nasal swab sample and results are provided in as fast as 15 minutes.

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