quidel
QuickVue RSV Test
PediatricThe QuickVue RSV Test is a dipstick immunoassay that detects 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).
INTENDED USE
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, 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. 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. 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. Rapid RSV tests can be run immediately as needed. |
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 | 24 months from date of manufacture |
| CLIA complexity | Waived |
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