FDA. US: 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.