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.
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.
For more information call (800) 323-3199 or visit Alere-i.com.