Quidel
Type: RT-Antigen
CLIA: (CLIA) waived - Requires Companies CLIA Number
Test Count: 20
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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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