FDA Expands Access to Nucleic Acid-Based Flu Test

The FDA today granted the first waiver to allow the use of a nucleic acid-based influenza diagnostic test in a greater variety of health care settings.

Prior to receiving the FDA waiver, the Alere i Influenza A & B test was only available for use in moderate- and high-complexity laboratories. Because the waiver was granted under the Clinical Laboratory Improvement Amendments (CLIA), the influenza test can now be distributed to a broad variety of nontraditional laboratory sites, including physicians’ offices, emergency rooms, health department clinics, and other health care facilities, the FDA 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, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “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 i Influenza A & B test uses a nasal swab sample from a patient with signs and symptoms of influenza infection. The test provides results in as little as 15 minutes and may be performed in the presence of the patient.

Negative results do not rule out influenza virus infection; rather, the test is intended to aid in a flu diagnosis, along with the evaluation of other risk factors.

The FDA waiver for the Alere i Influenza A & B test was based on the data submitted by the manufacturer, Alere Scarborough, Inc, which demonstrated the test’s ease of use and low risk of false results when used by untrained operators.

The FDA reviewed clinical study data from more than 500 patients with signs and symptoms of respiratory viral infection who were tested for influenza using both the Alere i Influenza A & B test and an FDA-cleared molecular comparator. Compared to its comparator, the test demonstrated high accuracy in identifying patients with or without influenza A and influenza B by those untrained in laboratory procedures.