QuickVue Influenza Test

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QuickVue Influenza Test

Respiratory

The QuickVue Influenza Test detects Influenza type A and B viral antigens in three easy steps from a nasal swab or nasal aspirate/nasal wash specimen. A single sample can be used to run both the QuickVue Influenza Test and QuickVue RSV Test.

INTENDED USE

The QuickVue Influenza Test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid diagnosis of acute influenza virus infection. The test is not intended to detect influenza C antigens. Negative test results should be confirmed by cell culture; they do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. This test is intended for professional and laboratory use.

FEATURES & BENEFITS
Feature Benefit
Dipstick Easy to use, approx. 30 seconds 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
Pictorial Procedure Card Clear and simple illustrations to guide the flu test procedure
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 influenza tests can be run immediately as needed
PRODUCT SPECIFICATIONS
Sample type Nasal swab, nasopharyngeal swab, nasal aspirate/nasal 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* 73% – Nasal swab; 81% – Nasal aspirate/nasal wash
Specificity* 96% – Nasal swab; 99% – Nasal aspirate/nasal wash
PPV* 92% – Nasal swab; 96% – Nasal aspirate/nasal wash
NPV* 85% – Nasal swab; 93% – Nasal aspirate/nasal wash
Overall accuracy * 87% – Nasal swab; 94% – Nasal aspirate/nasal wash
Shelf life 24 months from date of manufacture
CLIA complexity Waived
*Refer to Package Insert for additional performance claims.

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