FDA Grants Waiver for Nucleic Acid-Based Flu Diagnostic Test
The FDA has granted the first waiver to allow a nucleic acid-based test, the Alere i Influenza A & B test (Alere Scarborough, Inc.), to be used in a greater variety of health care settings. The test was previously available only for use in certain laboratories.
Influenza is caused by types of flu viruses: type A and type B. Flu infections can range from mild to severe and can sometimes lead to hospitalization and death. According to the Centers for Disease Control and Prevention, more than 200,000 people in the U.S. are hospitalized with seasonal flu-related complications each year.
Because the FDA granted a waiver under the Clinical Laboratory Improvement Amendments (CLIA), the Alere i Influenza A & B test can be distributed to non-traditional laboratory sites, including physicians’ offices, emergency rooms, health department clinics, and other health care facilities.
“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 the 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 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 the diagnosis along with the evaluation of other risk factors.
The type of CLIA certificate a laboratory obtains depends on 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 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 the test under CLIA as moderate complexity.
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 with 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.