FDA grants first CLIA waiver for nucleic acid-based flu diagnostic test

The U.S. Food and Drug Administration (FDA) has 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. The test was previously only available for use in certain laboratories. Because the FDA granted a waiver under the Clinical Laboratory Improvement Amendments (CLIA), the Alere i Influenza A & B test can be distributed to a broad variety of nontraditional laboratory sites, including physicians’ offices, emergency rooms, health department clinics, and other healthcare facilities.

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; the test is intended to aid in diagnosis along with the evaluation of other risk factors.

The FDA’s waiver is related to CLIA, federal standards that apply to clinical laboratory testing on humans, with certain exceptions. The 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. The type of CLIA certificate a laboratory obtains depends upon the complexity of the tests it performs. CLIA regulations describe three levels of test complexity: waived tests, moderate-complexity tests, and high-complexity tests.

The 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.

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.