The Alere i Influenza A & B 2 test has received 510(k) marketing clearance from the US FDA for the detection of influenza A and B infection in children and adults, according to Alere Inc.
The Alere i Influenza A & B 2 is a second-generation rapid molecular assay, which delivers lab accurate results in less time, with the ability to report a positive result in as little as 5 minutes.
This test will provide greater convenience with the addition of room temperature storage and reduced warm-up time for transport media samples. Alere i Influenza A & B 2 also offers increased sample flexibility with nasopharyngeal swabs now validated for direct use, as well as, in transport media.
Alere will shortly submit an application for CLIA (Clinical Laboratory Improvement Amendments) waiver of the Alere i Influenza A & B 2 test. Alere i testing applications have previously been CLIA-waived for Influenza A & B, Strep A and RSV.
“Our innovative Alere i platform leads the way in the rapid molecular segment with thousands of placements in hospitals, clinics, physician offices and other point of care settings. With this latest enhancement we now can offer ‘early call out’ of positive results on all three available applications, Alere i Influenza A & B 2, Alere i Strep A and Alere i RSV. In acute care settings, every minute counts when assessing symptomatic patients. Alere i delivers clinically meaningful and actionable results to clinicians – enabling them to treat patients more quickly and appropriately,” said Avi Pelossof, Alere Global President of Infectious Disease.”
The clinical performance of Alere i Influenza A & B 2 was established in a multi-center, prospective clinical study conducted at ten US trial sites during the 2016-2017 respiratory season, in which 1074 prospective nasal or nasopharyngeal swab specimens, collected from patients with influenza-like symptoms, were evaluated with Alere i, and compared to an FDA-cleared real-time Polymerase Chain Reaction (RT-PCR) test.