FDA Clears Rapid RSV Dipstick Test

FDA has granted 510(k) clearance for a dipstick immunoassay as an aid in the diagnosis of respiratory syncytial virus (RSV) in symptomatic pediatric patients younger than 6 years.

October 8, 2010 — The US Food and Drug Administration (FDA) has granted 510(k) clearance for a dipstick immunoassay (QuickVue RSV 10; Quidel Corp) as an aid in the diagnosis of respiratory syncytial virus (RSV) in symptomatic pediatric patients younger than 6 years.

The 10-minute test allows rapid qualitative detection of RSV antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens. The FDA notes that negative results do not preclude infection and should be confirmed by cell culture.

Because the assay is conducted in the same manner as the company's influenza test (QuickVue Influenza A+B), the same specimen may be used to test for RSV and influenza.

"The signs of an RSV infection are often similar to other respiratory infections, and diagnosis by symptoms alone can be difficult. Our new QuickVue RSV 10 product is a reliable, easy-to-use aid in detecting RSV in children. This new product will be available for the upcoming RSV seaso