FDA Grants Waiver for Wider Flu Test Use

The 2014-2015 flu season has been one of the worst on record in recent years and now the US Food and Drug Administration (FDA) has approved a waiver allowing a test to be more widely when confirming a diagnosis of influenza virus infection.

The Alere I Influenza A& B test has already been used at a few select laboratories but will now be able to be put into wider circulation under the FDA’s Clinical Laboratory Improvement Amendments (CLIA). The US Centers for Disease Control and Prevention has reported that in any given year more than 200,000 people in the country are hospitalized due to the virus.

With the CLIA waiver doctors’ offices, emergency rooms and other healthcare locations will be able to conduct the test themselves rather than sending samples to specific labs already equipped with the necessary devices.

“Today’s decision allows the first nucleic acid-based test to be available in clinical settings that previously could not use this technology,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health in an FDA statement. “We expect many other simple and accurate tests using nucleic acid-based technology to be developed in the near future. Once cleared by FDA, such tests can allow health care professionals to receive test results more quickly to inform further diagnostic and treatment decisions.”

The Alere test involves a nasal swab taken from a patient with flu-like symptoms and results can be determined in as little as 15 minutes. While effective, the statement notes, “Negative results do not rule out influenza virus infection; the test is intended to aid in diagnosis along with the evaluation of other risk factors.”

According to the FDA statement the test was first approved in June of 2014 but the waiver was granted after the manufacturer, Alere Scarborough, Inc., “submitted data demonstrating the test’s ease of use and low risk of false results when used by untrained operators.” The data included results from a study involving more than 500 patients who were tested both with the Alere technology and a previously approved molecular comparator.

The results of that study showed “The Alere I Influenza A& B test demonstrated high accuracy when identifying patients with or without influenza A and influenza B by users untrained in laboratory procedures.”