Quidel QuickVue RSV Test Kit
(20 Tests)
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Respiratory Syncytial Virus (RSV) Test Kits, the QuickVue RSV test is a dipstick immunoassay which allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) antigen (viral fusion protein) directly from nasopharyngeal swab or nasopharyngeal aspirate 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. It is recommended that negative test results be confirmed by cell culture. Negative results do not preclude RSV infection and it is recommended that they not be used as the sole basis for treatment or other management decisions. FDA Cleared and CLIA Waived. (FDA 510K#: K061008)
Who is at risk for RSV?
-Nearly half of all infants become infected during their first year of life, and virtually all children have been infected by the age of two.6 However, those at greatest risk of severe RSV infections include7:
- Infants born prematurely
- Term infants younger than 6 weeks old
- Children with medical conditions such as:
- Chronic lung disease
- Serious heart conditions
- Problems with their immune system
Product specifications |
|
Sample type |
Nasopharyngeal swab, nasopharyngeal aspirate, nasal/nasopharyngeal wash |
Time to results |
15 minutes or less |
Kit storage conditions |
Room temperature (15°C to 30°C/59°F to 86°F) |
Internal controls |
Positive and negative included |
External controls |
Positive and negative included |
Sensitivity* |
92% - Nasopharyngeal swab; 99% - Nasopharyngeal aspirate; 83% - Nasal/nasopharyngeal wash |
Specificity* |
92% - Nasopharyngeal swab; 92% - Nasopharyngeal aspirate; 90% - Nasal/nasopharyngeal wash |
PPV* |
56% - Nasopharyngeal swab; 84% - Nasopharyngeal aspirate; 86% - Nasal/nasopharyngeal wash |
NPV* |
99% - Nasopharyngeal swab; 99% - Nasopharyngeal aspirate; 88% - Nasal/nasopharyngeal wash |
Overall accuracy * |
92% - Nasopharyngeal swab; 94% - Nasopharyngeal aspirate 87% - Nasal/nasopharyngeal wash |
Shelf life |
12-18 Months |
CLIA complexity |
Waived |