FDA clears Alere i rapid influenza test
Alere Inc. announced today that is has received marketing clearance from the FDA for its rapid influenza A and B test, which the company said can produce results in under 5 minutes.
The Alere i Influenza A and B 2 test is a second-generation rapid molecular assay that is cleared for use in adults and children, according to a company press release.
The clinical performance of the test was established during a multicenter trial conducted at 10 sites in the United States during the 2016-2017 influenza season. Researchers used the Alere i Influenza A and B 2 device to evaluate 1,074 nasal or nasopharyngeal swab specimens collected from patients with influenza-like symptoms and compared its accuracy with an FDA-cleared real-time PCR test.
“In acute care settings, every minute counts when assessing symptomatic patients,” Avi Pelossof, global president of infectious diseases at Alere, said in a press release. “Alere i delivers clinically meaningful and actionable results to clinicians — enabling them to treat patients more quickly and appropriately.”
The original Alere i A and B molecular influenza test was cleared by the FDA in June 2014 as a prescription-only device for use in certain laboratories. In January 2015, the FDA granted a Clinical Laboratory Improvement Amendments (CLIA) waiver that allowed the test to be used at the point of care. The company plans on submitting another CLIA waiver for the Alere i A and B 2 test, which has additional features, including bidirectional connectivity and a quality control lockout option that prevents the testing of samples if quality control requirements are not met, the release said. In addition to the Alere i influenza test, the FDA also granted CLIA waivers for Alere i Strep A and RSV tests.
“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,” Pelossof said in the release. “With this latest enhancement, we now can offer ‘early call out’ of positive results on all three available applications, Alere i Influenza A and B 2, Alere i Strep A and Alere i RSV.”
Disclosure: Pelossof is an employee of Alere.