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Alere i Influenza A & B 2 rapid molecular test gets FDA clearance

Published 03 October 2017

Alere announced that its i Influenza A & B 2 test has received 510(k) marketing clearance from the US Food and Drug Administration (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, 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.

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.



Source: Company Press Release