QuickVue RSV Test

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QuickVue RSV Test

Pediatric

The 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
*Refer to Package Insert for additional performance claims.

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