QuickVue RSV10 Test

quickvue-rsv-10

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QuickVue RSV10 Test

Pediatric

The QuickVue RSV 10 Test is a dipstick immunoassay that detects respiratory syncytial virus (RSV) antigen directly from nasopharyngeal swab or nasopharyngeal aspirate/wash specimens for symptomatic pediatric patients (five years of age and younger). A single sample can be used to run both the QuickVue RSV 10 Test and the QuickVue Influenza A+B Test.

INTENDED USE

The QuickVue RSV 10 test is an immunoassay that allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens for symptomatic pediatric patients (less than six years old). The test is intended for use as an aid in the rapid diagnosis of acute RSV infection. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by cell culture. 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.
PRODUCT SPECIFICATIONS
Sample type Nasopharyngeal swab, nasopharyngeal aspirate/wash
Time to results 10 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* 86% – Nasopharyngeal swab
90% – Nasopharyngeal aspirate/wash
Specificity* 95% – Nasopharyngeal swab
96% – Nasopharyngeal aspirate/wash
PPV* 79% – Nasopharyngeal swab
85% – Nasopharyngeal aspirate/wash
NPV* 97% – Nasopharyngeal swab
97% – Nasopharyngeal aspirate/wash
Shelf life 24 months from date of manufacture
CLIA complexity Moderate
*Refer to Package Insert for additional performance claims.

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