FDA Expands Approved Use of Rapid Flu Test to Include Physician Offices

A rapid molecular flu test that provides results in as little as 15 minutes using a nasal swab and can be performed in front of the patient is now available to physician offices, emergency rooms, health department clinics, and other health care facilities. The test — the Alere i Influenza A & B test — had previously only been approved for use in specialized laboratories.

This was the first waiver granted by the FDA that allows a nucleic acid-based test to be used in a greater variety of health care settings. It was approved under the Clinical Laboratory Improvement Amendments (CLIA).

“This new test has the potential to expedite the diagnosis and treatment of patients with flu-like illnesses in physician offices as well as emergency departments across the commonwealth,” said Kristen Sandel, MD, an emergency physician at Reading Hospital and a member of the PAMED Board of Trustees. “It also has the potential to improve patient satisfaction, as they will receive their test results in a matter of minutes and begin the course of treatment as soon as possible.”

“As an emergency physician, it would assist me in making a diagnosis of influenza quickly and disposition patients more efficiently in a very busy emergency department,” she said.

“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, in the FDA’s Center for Devices and Radiological Health, in a Jan. 6 press release. “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 FDA release also said that “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.”

The announcement of a new flu test for use in physician offices and other health care facilities comes as many areas across the U.S. are seeing an increase in the flu. As has been widely reported, this flu season is expected to be more severe as the flu vaccine isn’t fully effective against a predominant strain this year (H3N2). However, Pennsylvania physicians say this doesn’t mean patients shouldn’t get the vaccine, and cases are likely to be less severe in a person who has gotten the flu shot.

The state Department of Health (DOH) estimates that 600,000 to 2.4 million Pennsylvanians get the flu each year, and between 120 and 2,000 people die from flu-related complications. To date, according to statistics from DOH, there have been 1,180 cases of the flu and four influenza-associated deaths in the state this season so far.

The Pennsylvania Medical Society (PAMED) hosted a media call-in on Dec. 22, 2014, to address this year’s flu season with Pennsylvania media, providers, and the public. Read more from the call-in.