FDA Approves Alere’s 15-minute Influenza Diagnostic Test
The Alere™ i Influenza A & B test is now all set to revolutionize rapid flu testing by providing highly accurate, molecular results in less than 15 minutes on the user-friendly Alerei platform. A second-generation influenza A and B infection test for children and adults with the ability to report a positive result in as little time as 5 minutes, has received 510(k) marketing clearance from the U.S. Food and Drug Administration .
The clinical performance of the second-generation test was demonstrated in a multicenter, prospective clinical study conducted at 10 centers in the United States during the 2016-2017 respiratory seasons. In the study, 1074 prospective nasal or nasopharyngeal swab specimens collected from patients with influenza-like symptoms were evaluated with the Alere i test and compared to an FDA-cleared real-time polymerase chain reaction test.
The second-generation Alere i influenza test also offers more flexible sampling features and enhanced quality control functions, the company said. The test will be available for use in hospitals in time for the 2017-2018 respiratory seasons.
Alere has also expanded some of the features on the Alere i instrument with the introduction of bi-directional connectivity and an optional QC lockout function, to prevent testing of
patient samples if QC testing requirements are not met, enhancing overall quality assurance.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, with Alere i Strep A receiving FDA clearance in March 2015 and Alere i RSV receiving clearance in October 2016. The Alere i Influenza A & B 2 test will be available for use in hospitals in time for the 2017-2018 respiratory season.
“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.
