FDA grants waiver for influenza test

FDA this week granted the first waiver to allow a nucleic acid-based test, the Alere i Influenza A & B test, to be used in a greater variety of healthcare settings. Previously, the test was only available for use in certain laboratories, and now can be distributed to emergency departments, health department clinics, physicians’ offices, and other healthcare facilities.

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Because FDA granted a waiver under the Clinical Laboratory Improvement Amendments (CLIA), the Alere i Influenza A & B test, manufactured by Alere Scarborough, Inc. in Scarborough, Maine, can be distributed to a broad variety of non-traditional laboratory sites.

The test is important since, according to the Centers for Disease Control and Prevention (CDC), more than 200,000 people in the United States are hospitalized from seasonal flu-related complications each year.

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“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 VitroDiagnostics 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.”

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The Alere i Influenza A & B test uses a nasal swab sample from a patient with signs and symptoms of flu 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. Instead, the test is intended to aid in diagnosis, along with the evaluation of other risk factors.

FDA first cleared the Alere i Influenza A & B test in June, 2014, as a prescription-only device to detect influenza A and B viral RNA in nasal swab samples and categorized it under CLIA as moderate complexity.

FDA granted a waiver under CLIA for the Alere i Influenza A & B test after the manufacturer submitted data demonstrating the test’s ease of use and low risk of false results when used by untrained operators. “This is critical if the test is to be allowed for use outside of moderate- and high-complexity laboratories,” FDA said in a statement.

The agency reviewed clinical study data from more than 500 patients with signs and symptoms of respiratory viral infection tested for influenza using both the Alere i Influenza A & B test and an FDA-cleared molecular comparator. Compared to the FDA-cleared comparator method, 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.