Alert Inc’s new Alere i Influenza A & B Test is now approved for use in physician offices, according to the FDA. The new point-of-care influenza test was approved in June but not available for use outside regulated laboratories. The test yields highly accurate molecular results in less than 15 minutes.
Today, the FDA issued a Clinical Laboratory Improvement Amendments (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.
The decision was based 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.
“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.”