RSV Test Receives CLIA Waiver
Quidel Corporation’s QuickVue RSV test was granted a CLIA waiver from the Food and Drug Administration. With this approval, the test can be used in a much broader array of treatment settings, including physician offices. The approval was posted on the Quidel website.
The QuickVue RSV test is easily completed by healthcare providers and results are accurate. Clinical studies validated the test, which has both high sensitivity and specificity. The QuickVue RSV is now the most widely available tool to test patients for this disease. Availability of this test allows confirmation of suspected diagnosis in the doctor’s office for pediatric patients who present with appropriate symptoms.
Respiratory syncytial virus (RSV) is the main cause of bronchiolitis and pneumonia among children under two years of age. The virus is common and the symptoms can often be mistaken for the common cold.
Quidel has a range of tests already available for use, including those for influenza and Strep A. Quidel specializes in the development of rapid diagnostic test solutions.
March 24, 2008 Related topics: Pulmonary, Product Approval & Certification, Diagnostic, Pediatrics