FDA grants CLIA waiver for influenza A, B test

The FDA announced it has granted a waiver to allow a rapid molecular influenza test to be used at the point of care.

The Alere i influenza A and B test (Alere) was cleared by the FDA in June 2014 as a prescription-only device of moderate complexity for use only in certain laboratories. It is now the first molecular assay to receive a Clinical Laboratory Improvement Amendments (CLIA) waiver, permitting its use in hospitals, physician offices and other health care settings.

Alberto Gutierrez

“Today’s decision allows the first nucleic acid-based test to be available in clinical settings that previously could not use this technology,” Alberto Gutierrez, PhD, director of the office of in vitro diagnostics and radiological health at the FDA’s Center for Devices and Radiological Health, said 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 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 test uses nasal swab samples from patients with signs and symptoms of influenza, providing results within 15 minutes. Unlike PCR testing, which requires thermal cycling and DNA purification, the device utilizes isothermal nucleic acid amplification technology, allowing for faster results, according to its manufacturer.

The FDA’s decision was based on a multicenter study conducted in the United States, involving more than 500 patients with signs and symptoms of respiratory viral infection who were tested for influenza using Alere’s influenza A and B test and an FDA-cleared PCR assay. Compared with the PCR method, the Alere i test demonstrated high accuracy identifying patients with influenza A and influenza B by users who were untrained in laboratory procedures, according to the FDA.

Figure 1. The Alere i influenza A and B test is the first molecular assay to receive a CLIA waiver from the FDA.

Source: Alere Inc.

“This milestone greatly expands the availability of molecular testing to a wide range of health care settings during this influenza season,” Avi Pelossof, global president of infectious disease at Alere, said in the company’s press release. “By making lab-accurate, actionable results available at the point of care, Alere i empowers health care providers to quickly identify and treat people with influenza — improving patients’ clinical outcomes, protecting their communities, and reducing health care costs.”

The FDA cautioned that negative test results do not rule out influenza virus infection; the test is designed to aid in the diagnosis of influenza and other clinical factors.