CLIA Waiver for QuickVue® RSV Test
Quidel Corporation has announced that the U.S. Food and Drug Administration (FDA) granted CLIA waiver for the QuickVue® RSV test for the qualitative detection of respiratory syncytial virus (RSV). The waiver makes the QuickVue RSV test more widely available for use, especially in physician offices and clinics where waived tests are used most frequently. The QuickVue RSV test is simple and accurate, with high sensitivity and specificity. Respiratory syncytial virus is recognized by the American Academy of Pediatrics as the leading cause of pneumonia and bronchiolitis among children two years of age and younger. RSV is a common virus with symptoms that often resemble the common cold. The QuickVue RSV test is intended for use as an aid in the diagnosis of acute RSV viral infections for symptomatic pediatric patients. |
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Source : Quidel Corporation View Company Information
Posted on March 7, 2008