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QuickVue Influenza A+B Test
RespiratoryThe QuickVue Influenza A+B Test detects and differentiates influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasal wash and/or nasal aspirate specimens. A single sample can be used to run both the QuickVue Influenza A+B Test and QuickVue RSV 10 Test.
INTENDED USE
The QuickVue Influenza A+B test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections. The test is not intended to detect influenza C antigens. Negative 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. 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 |
| One-step procedure | Easy to use, fewer procedural errors |
| 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 |
| 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. |
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 |
| External Controls | Positive and negative |
| Sensitivity* | A: 94%, B: 70% – Nasal swab; A: 83%, B: 62% – Nasopharyngeal swab; A: 77%, B: 82% – Nasal aspirate/nasal wash |
| Specificity* | A: 90%, B: 97% – Nasal swab; A: 89%, B: 98% – Nasopharyngeal swab; A: 99%, B: 99% – Nasal aspirate/nasal wash |
| PPV* | A: 62%, B: 82% – Nasal swab; A: 67%, B: 80% – Nasopharyngeal swab; A: 91%, B: 90% – Nasal aspirate/nasal wash |
| NPV* | A: 99%, B: 94% – Nasal swab; A: 95%, B: 95% – Nasopharyngeal swab; A: 96%, B: 97% – Nasal aspirate/nasal wash |
| Overall accuracy * | A: 91%, B: 93% – Nasal swab; A: 88%, B: 94% – Nasopharyngeal swab; A: 95%, B: 96% – Nasal aspirate/nasal wash |
| Shelf life | 24 months from date of manufacture |
| Transport Media Compatibility | BD Universal Viral Transport Media, Bartels Flextrans Media, Copan Universal Transport Media, Hank’s Balanced Salt Solution, M5 Media, Saline |
| CLIA complexity | Waived |
QUICKVUE INFLUENZA TESTS
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