The Food and Drug Administration cleared the first-ever CLIA-waived molecular flu test, which delivers lab-accurate results at the point of care in less than 15 minutes.
In the molecular testing, called Alere i Influenza A & B, DNA or RNA strands are extracted and analyzed for sequences that are associated with viral and bacterial causes of infections, according to a news release.
Similar tests, such as polymerase chain reaction (PCR) testing, take much longer to complete and are not available in as many health facilities as the new Alere i test.
Before FDA approval, the test was used in a U.S. study where nasal swab specimens were evaluated with Alere i and compared to an FDA cleared Real-Time PCR (RT-PCR) assay, according to the release.
"This milestone greatly expands the availability of molecular testing to a wide range of healthcare settings during this influenza season," Avi Pelossof, Global President of Infectious Disease at Alere, said in the release. "By making lab-accurate, actionable results available at the point of care, Alere i empowers healthcare providers to quickly identify and treat people with influenza - improving patients' clinical outcomes, protecting their communities, and reducing healthcare costs."
In June 2014 the Alere i test was cleared for marketing by the FDA. A few months later, in September, the test to introduce Alere i in health facilities and laboratories licensed to conduct tests of moderate complexity under the CLIA program was completed.
The most recent CLIA waiver will now allow the test to be issued in a much broader range of health care facilities - including hospitals, clinics and physicians offices.
