Alere Inc. has announced that its respiratory syncytial virus test has been granted a Clinical Laboratory Improvement Amendments waiver by the Food and Drug Administration, paving the way for the test to be available to doctors, walk-in clinics and emergency rooms.
The Alere i RSV test is the first molecular test that can be used to detect RSV in 13 minutes or less, according to a press release.
Respiratory syncytial virus is a respiratory virus that infects a person’s lungs and breathing passages, and is the most common cause of bronchiolitis, which is the inflammation of the small airways in the lung.
“Our innovative 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,” Avi Pelossof, Alere's global president of infectious disease, said in the press release.
“Health care 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,” Pelossof said.
Respiratory infection test now available to doctors, clinics