Second-Generation Rapid Influenza Test Clears FDA

Megan Brooks


October 03, 2017

The US Food and Drug Administration (FDA) has cleared for marketing the Alere i Influenza A & B 2 rapid molecular diagnostic test for use in children and adults.

This 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," the company said in a news release.

An earlier version of the company's point-of-care Alere i influenza test, which was cleared by the FDA in 2014, gives results in under 15 minutes. 

"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," Avi Pelossof, Alere's global president of infectious disease, said in the release.

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 season.  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 season.

Alere plans to submit an application for a Clinical Laboratory Improvement Amendments waiver for the influenza test, which would allow it to be used in nontraditional laboratory sites, such as physician offices, hospital emergency departments, and health department clinics.

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