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Quidel
QuickVue® RSV Antigen Test
QuickVue® RSV Antigen Test
Description
Simple 3-Step Testing Process
Simplified nasal swab sample collection
Single dipstick test
Approximately 30 seconds to 1 minute hands-on time
Requires minimal training
Ready-to-Use Kit
All components included in kit
Positive and negative internal and external controls included
Quick Reference Instructions provided
Fast, Easy to Read Results
Results in 15 minutes or less; allowing to test and treat in the same office visit
Visible, two-color result
Components Included in One Box Kit
20 Individually Packaged Test Strips
20 Extraction Tubes
20 Disposable Droppers
20 Nasopharyngeal Swabs
1 Extraction Reagent Bottle
1 Positive RSV Control Swab
1 Negative Control Swab
1 Package Insert
1 Quick Reference Instructions
Features and Benefits
| Dipstick | Easy to use, approx. 30 seconds to 1 minute hands-on time |
| Results in 15 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 RSV 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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