NEW YORK (GenomeWeb) – Alere said today the US Food and Drug Administration has granted 510(k) clearance of its Alere i Influenza A & B 2 test for the faster detection of influenza A and B infection in children and adults.
Alere said that the test is a second-generation rapid molecular assay that delivers lab-accurate results and has the ability to report a positive result in as little as five minutes.
The test provides "greater convenience with the addition of room-temperature storage and reduced warm-up time for transport media samples," Alere noted. It also offers increased sample flexibility with nasopharyngeal swabs now validated for direct use and in transport media, the firm said.
Alere said it will soon submit an application for a CLIA 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.
Alere Global President of Infectious Disease Avi Pelossof noted that the Alere i platform already has 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," he said.
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 and Alere i RSV received clearance in October 2016.
The clinical performance of Alere i Influenza A & B 2 was established in a multicenter, prospective clinical study conducted at 10 US trial sites during the 2016-2017 respiratory season. During the study, 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 RT-PCR test, the firm said.
The Alere i Influenza A & B 2 test will be available for use in hospitals in time for the 2017-2018 respiratory season, the firm noted.