Marketing clearance announced for flu tests
Alere Inc. said its Alere i Influenza A & B 2 test has received 510(k) marketing clearance from the U.S. Food and Drug Administration for the detection of influenza A and B infection in children and adults.
The test should provide a result in five minutes, the company said.
“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,” said Avi Pelossof, Alere Global President of Infectious Disease.
The clinical performance of the tests was evaluated through a clinical study at 10 trial sites last flu season, where 1,074 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.
The Alere i molecular platform was initially cleared for marketing by the FDA for the detection and differentiation of influenza A and B virus in June 2014. Alere i Strep A received FDA clearance in March 2015.