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WALTHAM, MA – Emergency departments now can employ a nucleic acid-based influenza test that promises to provide highly accurate results in as little as 15 minutes.
The FDA recently granted a Clinical Laboratory Improvement Amendments (CLIA) waiver to allow the Alere i Influenza A & B test to be used in a greater variety of healthcare settings, including EDs. The test was previously only available for use in certain laboratories.
“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. “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 healthcare 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 patients presenting with signs and symptoms of flu infection. The simple test, which may be performed in the presence of the patient, analyzes DNA and RNA strains to determine the causes of infections.
The Alere product is one of more than 15 rapid influenza detection tests (RIDTs) on the market and one of several producing results in about 15 minutes. The CDC says other RIDTs use enzyme immunoassay technology, however, and have sensitivities ranging from 50% to 70%, which is lower than the typical accuracy for molecular testing.
The FDA granted the 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,” according to the FDA, which cautioned that negative results do not rule out influenza virus infection The FDA also said the test is intended to aid in diagnosis along with the evaluation of other risk factors.
Clinical study data was collected 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. 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, according to the agency.
"This milestone greatly expands the availability of molecular testing to a wide range of healthcare settings during this influenza season," explained Avi Pelossof, global president of infectious disease at Alere. "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."
Molecular testing involves the extraction and analysis of DNA or RNA strands to detect sequences associated with viral and bacterial causes of infections.
“Unlike polymerase chain reaction (PCR) testing, Alere's proprietary Molecular. In Minutes™ (MIM) isothermal nucleic acid amplification technology (iNAT) does not require lengthy and complex thermo cycling or DNA purification, and can therefore deliver PCR-caliber results more quickly – and in a broad range of settings,” the manufacturer said in a press release..
Alere said it recently filed an application maintaining that a Strep A test is substantially equivalent to a legally marketed device and is planning to initiate clinical trials for a respiratory syncytial virus test during the current respiratory season.