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Quidel

QuickVue® RSV Antigen Tests

QuickVue® RSV Antigen Tests

Type: RT-Antigen

CLIA: (CLIA) waived - Requires Companies CLIA Number

Test Count: 20

Box Contents

20 Tests

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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