Rapid test for influenza A, B now available in Europe

Alere Inc. announced that the first rapid molecular diagnostic test capable of detecting and differentiating influenza A and influenza B within 15 minutes is now commercially available in Europe, according to a press release.

The influenza A and B test (Alere i) is under regulatory review by the FDA and is not yet available in the United States.

“Alere i is a transformational platform that allows health care professionals to make a rapid influenza diagnosis — and effective patient management decisions — in a clinically meaningful timeframe, whether the patient is in the physician office, emergency department or urgent care clinic,” Avi Pelossof, global president of infectious disease at Alere, said in the release. “Alere i also significantly expands screening opportunities by making innovative, rapid molecular testing technology available at the point of care as well as in laboratory settings.”

The influenza test utilizes isothermal nucleic acid amplification technology, and unlike PCR assays, it does not require temperature cycling, which allows for faster results.

The clinical performance of the Alere influenza test was established in multicenter, prospective study conducted in the United States during the 2012-2013 influenza season. A total of 571 nasal swabs collected from adult and pediatric patients presenting with influenza-like symptoms were evaluated using the Alere test. Results were then compared to viral culture. Discrepant samples were resolved using an FDA-approved PCR. For influenza A, the test demonstrated 99.3% sensitivity and 98.1% specificity; and for influenza B, it demonstrated 98.9% sensitivity and 99.6% specificity.