CLIA Waiver for Alere Rapid Flu Test

Alere Inc., has announced that its Alere™ Influenza Test has received a CLIA waiver from the U.S. Food and Drug Administration (FDA). This will enable the test to be used in physician’s offices, helping healthcare practitioners to manage patients with influenza-like illnesses.

The Alere™ Influenza A&B Test uses highly sensitive antibodies to detect influenza types A and B antigen. When compared to viral culture, the new Alere test showed performance with sensitivity / specificity of 93.8% / 95.8% for flu A and 77.4% / 98% for flu B. Samples are collected via a nasal swab, which is minimally invasive and results are provided in 10 minutes. This makes the product ideal for point-of-care use as it enables the physicians to administer treatment while patients are still in their care.

After multiple studies to validate the test and considerable collaboration with the FDA, the Alere™ Influenza Test has been granted waived status. “We are very pleased to receive the CLIA waiver for the new Alere™ Influenza Test,” said Avi Pelossof, Vice President Infectious Disease at Alere Inc. “By getting this product into the waived segment of the marketplace, we are giving healthcare providers a new tool that will enable them to make better decisions about flu diagnosis and treatment while patients are still in the office.”

The Alere™ Influenza A&B Test adds a dipstick format test to Alere’s existing portfolio of influenza diagnostics, which includes the card format BinaxNOW® Influenza A&B Test. This enables Alere to provide primary care physicians with a full range of easy-to-use, effective tools for identifying influenza A & B at the point of care.

“Alere is dedicated to ensuring that only the highest quality products reach the hands of healthcare providers,” stated Pelossof. “And the Alere™ Influenza A&B Test is one of them.”