Respiratory virus test gets FDA clearance for point of care
A diagnostic test that detects respiratory syncytial virus (RSV)—a common cause of pneumonia and bronchiolitis—is about to see easier and greater use. The Food and Drug Administration (FDA) has issued a laboratory waiver for the i RSV testing system, manufactured by Alere, allowing it to be used outside of a laboratory setting. Physicians will now be able to perform the test at the point of care instead of transporting seniors to a hospital laboratory.
The molecular test, first approved by the FDA in mid-2016, uses nasal swabs to detect the presence of RSV in 13 minutes or less, significantly faster than laboratory-based testing, notes a company announcement. The swift diagnosis can help physicians treat ill residents faster, avoid the unnecessary use of antibiotics, and maintain infectious disease control protocols.
Pamela Tabar was editor-in-chief of I Advance Senior Care from 2013-2018. She has worked as a writer and editor for healthcare business media since 1998, including as News Editor of Healthcare Informatics. She has a master’s degree in journalism from Kent State University and a master’s degree in English from the University of York, England.
Topics: Clinical , Infection control