BD Diagnostics, Sparks, Md, announced that it received 510(k) clearance from the US Food and Drug Administration 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.
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.
According to the US 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.
[source: BD]
