NEW YORK (GenomeWeb) – The US Food and Drug Administration has granted a CLIA waiver to Alere's respiratory syncytial virus infection panel, the firm announced today. The Alere i RSV test will be available in physicians' offices, hospital emergency rooms, and walk-in clinics throughout the US.
Alere said that it is the first molecular test that can be used at the point of care to detect RSV in 13 minutes or less, and that it is "significantly faster than conventional PCR tests."
The FDA granted 510(k) clearance to the test in August 2016.
The Alere I RSV test uses isothermal nucleic acid amplification technology to detect RSV, a respiratory virus that infects the lungs and breathing passages, in nasopharyngeal swab samples.
Arming healthcare personnel with a simple-to-use, point-of-care RSV test that offers speed and molecular accuracy facilitates early and appropriate supportive care, Alere said. It enables rapid initiation of infection control measures to help restrict the spread of RSV, and it enables avoiding unnecessary antibiotic treatment, the firm added.
Alere noted that in the US each year, RSV leads to 177,000 hospitalizations and 14,000 deaths among adults older than 65 years, and almost 58,000 children under the age of five with RSV infection are hospitalized. No treatment exists for RSV, so clinicians focus infection control strategies on reducing transmission, the firm added.
Alere Global President of Infectious Disease Avi Pelossof said in a statement that the "Alere i platform now offers the key trio of respiratory assays for rapid molecular detection of RSV, Influenza A & B, and Strep A in a broad range of healthcare settings."
“Healthcare providers can now deploy the power of rapid molecular testing to quickly and accurately differentiate these potentially serious infections, and link patients to the appropriate treatment,” he added.