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FDA News Release

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

For Immediate Release

January 6, 2015


The U.S. Food and Drug Administration today 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 health care settings. The test was previously only available for use in certain laboratories.

Influenza, commonly known as the flu, is a contagious respiratory illness caused by two types of influenza 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 United States are hospitalized from 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 a broad variety of 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, Ph.D., 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 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.  

The Alere i Influenza A & B test is manufactured by Alere Scarborough, Inc., located in Scarborough, Maine.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Page Last Updated: 01/06/2015
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