Oct. 9, 2017—Alere announced that its Alere i Influenza A & B 2 test has received 510(k) marketing clearance from the FDA for the detection of influenza A and B infection in children and adults.
Alere i Influenza A & B 2 is a second-generation rapid molecular assay that can report a positive result in as few as five minutes. The test aims to provide greater convenience with the addition of room temperature storage and reduced warm-up time for transport media samples. The test offers sample flexibility with nasopharyngeal swabs validated for direct use as well as in transport media.
Alere plans to submit an application for CLIA waiver of the Alere i Influenza A & B 2 test. Alere i testing applications have been CLIA waived for Influenza A & B, Strep A, and RSV.
The clinical performance of Alere i Influenza A & B 2 was established in a multicenter, prospective clinical study conducted at 10 U.S. trial sites during the 2016–17 respiratory season in which 1,074 prospective nasal or nasopharyngeal swab specimens, collected from patients with influenza-like symptoms, were evaluated with Alere i and compared with an FDA-cleared real-time polymerase chain reaction test.