A new point-of-care influenza test that yields highly accurate molecular results in less than 15 minutes can now be deployed in physician offices, the US Food and Drug Administration (FDA) announced today.
In June, the FDA approved the Alere i Influenza A & B Test(Alere Inc), but limited it to laboratories designated to perform tests of moderate and high complexity under federal regulations called the Clinical Laboratory Improvement Amendments (CLIA). Today, the agency issued a CLIA waiver for the test so it could be used in nontraditional laboratory sites such as physician offices, hospital emergency departments, and health department clinics.
It is the first CLIA waiver granted to a nucleic acid-based test.
The FDA based its decision on clinical study data showing that in comparison with a benchmark molecular test, the Alere i Influenza A & B Test proved highly accurate in identifying patients with or without influenza even though healthcare personnel who lacked lab training were using the device.
The test analyzes nasal swab samples to detect influenza A and B viral RNA. It can distinguish between influenza A and influenza B infections. According to the manufacturer, the test's sensitivity exceeds 90% for both viruses, substantially higher than that of older rapid influenza detection tests (RIDTs) that rely on enzyme immunoassay technology. Such RIDTs are known for a high rate of false negatives.
"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, in a press release. "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 FDA noted that negative results obtained through the Alere i Influenza A & B Test do not rule out an influenza infection.
More information about today's announcement is available on the FDA website.