Quidel QuickVue® Respiratory Syncytial Virus (RSV)

The QuickVue RSV Test is a dipstick immunoassay that allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) antigen (viral fusion protein) directly from nasopharyngeal swab, nasopharyngeal aspirate, or nasal/nasopharyngeal wash specimens for symptomatic pediatric patients (eighteen years of age and younger). The test is intended for use as an aid in the diagnosis of acute respiratory syncytial viral infections. The test is intended for professional and laboratory use. Product Specifications Tests/Box 20 Sample type Nasopharyngeal swab, nasopharyngeal aspirate, nasal/nasopharyngeal wash Time to results 15 minutes Accuracy Sensitivity 92% / Specificity 92% Kit contents (20) test devices, (1) Extraction Reagent Bottle, (20) Extraction Tubes, (20) Disposable Droppers, (20) Nasopharyngeal Swabs, (1) Positive RSV Control Swab, (1) Negative Control Swab, Package insert Storage 59°F to 86°F (15°C to 30°C) CLIA complexity Waived Certification FDA