Quidel Corp, San Diego, a provider of rapid point-of-care diagnostic tests, reports that the FDA has granted CLIA waiver for the QuickVue® RSV test for the qualitative detection of respiratory syncytial virus (RSV).
The waiver makes the test more widely available for use, especially in physician offices and clinics where waived tests are used most frequently. The test features high sensitivity and specificity.
RSV is recognized by the American Academy of Pediatrics as the leading cause of pneumonia and bronchiolitis among children 2 years of age and younger. It is a common virus with symptoms that often resemble the common cold. The test is intended for use as an aid in the diagnosis of acute RSV viral infections for symptomatic pediatric patients.