FRANKLIN LAKES, N.J.
Oct. 3, 2012
/PRNewswire/ -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for nasopharyngeal wash, aspirate and swab in transport media specimens on the BD Veritor™ System for Rapid Detection of respiratory syncytial virus (RSV). This new product is cleared for use in clinical settings.
According to the U.S. Centers for Disease Control and Prevention, RSV is the most common cause of pneumonia and bronchiolitis in
the United States
in children under one year of age. Almost all children have been infected with the virus by the time they are two years old, leading to approximately 75,000 to 125,000 hospitalizations annually. Most children hospitalized for RSV infection are under six months of age.
"Early and reliable detection of RSV is critical among high-risk populations to treat and prevent the spread of this contagious virus and hospitalizations," said
, President, BD Diagnostics – Diagnostic Systems. "The BD Veritor System for Rapid Detection of RSV has very high sensitivity and specificity when compared to viral cell culture methods, while providing an objective test result in only 10 minutes."
The BD Veritor System, with proprietary technologies, eliminates the subjective result interpretation of visually read assays and helps deliver an accurate read by providing reliable, objective results on a hand held reader with an easy-to-read digital display. The system utilizes Advanced Particle and Adaptive Read Technologies coupled with a special hand-held analyzer. The Advanced Particle Technology along with improved chemistries helps improve the sensitivity of the test while the Adaptive Read Technology helps reduce false-positive results by examining and compensating for many of the effects of non-specific binding which improves specificity.