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QuickVue RSV10 Test
PediatricThe QuickVue RSV 10 Test is a dipstick immunoassay that detects respiratory syncytial virus (RSV) antigen directly from nasopharyngeal swab or nasopharyngeal aspirate/wash specimens for symptomatic pediatric patients (five years of age and younger). A single sample can be used to run both the QuickVue RSV 10 Test and the QuickVue Influenza A+B Test.
INTENDED USE
The QuickVue RSV 10 test is an immunoassay that allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens for symptomatic pediatric patients (less than six years old). The test is intended for use as an aid in the rapid diagnosis of acute RSV infection. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by cell culture. The test is intended for professional and laboratory use.
FEATURES & BENEFITS
| Feature | Benefit |
| Dipstick | Easy to use, approx. 30 seconds to 1 minute hands-on time |
| Results in 10 minutes | Test and treat in the same office visit |
| One reagent | Fewer steps, easy to perform, requires minimal training |
| Two-color result | Easy to read and interpret |
| 3 step procedure | Easy to use, fewer procedural errors |
| Quick Reference Instructions | Clear and simple illustrations to guide the respiratory virus test procedure and interpretation of results |
| All components included in kit | Ready to use, no need for additional equipment |
| Internal controls included | Provides verification of test strip functional integrity, increasing confidence in results |
| External controls included | Facilitates internal laboratory quality control |
| Room temperature storage | No refrigerator space needed. No need to wait for reagents to warm up. |
PRODUCT SPECIFICATIONS
| Sample type | Nasopharyngeal swab, nasopharyngeal aspirate/wash |
| Time to results | 10 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* | 86% – Nasopharyngeal swab 90% – Nasopharyngeal aspirate/wash |
| Specificity* | 95% – Nasopharyngeal swab 96% – Nasopharyngeal aspirate/wash |
| PPV* | 79% – Nasopharyngeal swab 85% – Nasopharyngeal aspirate/wash |
| NPV* | 97% – Nasopharyngeal swab 97% – Nasopharyngeal aspirate/wash |
| Shelf life | 24 months from date of manufacture |
| CLIA complexity | Moderate |
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