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BinaxNOW™ Influenza A&B Card 2
WITH DIGIVAL™ INTERPRETATION
To learn more about the FDA’s reclassification of Influenza Diagnostics, click here.
BinaxNOW™ Influenza A & B Card 2 is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal swab samples. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. BinaxNOW™ Influenza A & B Card 2 must be read by the DIGIVAL™.
Benefits
Accurate
The first rapid antigen influenza test to achieve 510(k) clearance as a Class II assay under the new FDA Reclassification performance requirements. DIGIVAL provides objective result interpretation.
Convenient
Used with either nasopharyngeal swab or nasal swab samples.
Fast
Results available in just 15 minutes.
Easy
Simple, straightforward testing procedure.
Reliable
Provides accurate results and includes internal controls.
Flexible
Suitable for a wide variety of healthcare settings.
Helpful Documents
PRODUCT DOCUMENTS
SPECIFICATIONS
Method: Lateral Flow
Time to Result: 15 minutes
Storage: 2 - 30°C
Shelf Life: 18 months from date of manufacture
PPA: Flu A 81.0%-91.4%; Flu B 89.7%-97.7%
NPA: Flu A 93.6%-97.1%; Flu B 98.5%-99.8%
Sample Type: Nasal swab, NP swab
Kit Size: 22 tests
Kit Contents:
- Nasal swabs and Elution solution for patient samples
- 22 BinaxNOW Influenza A&B Card 2 tests
- 25 Transfer pipettes
- Positive Control Swab
- Negative Control Swab
- 22 Elution solution vials
- Product Insert and Procedure Card
Influenza A Performance with BinaxNOW™ Influenza A & B Card 2 with the DIGIVAL Against the Comparator Method
| BinaxNOW™ Influenza A & B Card 2– Flu A | Comparator Method | ||
Positive | Negative | Total | |
| Positive | 141 | 23 | 164 |
| Negative | 21 | 508 | 529 |
| Total | 162 | 531 | 693 |
| PPA: 87.0% (141/162), 95%CI: (81.0%-91.4%) | |||
| NPA: 95.7% (508/531), 95%CI: (93.6%-97.1%) | |||
Influenza B Performance with BinaxNOW™ Influenza A & B Card 2 with the DIGIVAL Against the Comparator Method
| BinaxNOW™ Influenza A & B Card 2– Flu B | Comparator Method | ||
Positive | Negative | Total | |
| Positive | 116 | 3 | 119 |
| Negative | 6 | 568 | 574 |
| Total | 122 | 571 | 693 |
| PPA: 95.1% (116/122), 95%CI: (89.7%-97.7%) | |||
| NPA: 99.5% (568/571), 95%CI: (98.5%-99.8%) | |||
PRODUCT CODE
| BinaxNOW™ Influenza A&B Card 2 | Code |
|---|---|
| BinaxNOW™ Influenza A&B Card 2 | 575-000 (US) |
| BinaxNOW™ Influenza A&B Card 2 Control Swab Kit | 575-080 (US) |
| DIGIVAL BinaxNOW™ Complete Kit | LFR-124 (US) |
| Complete Kit Contents | |
| DIGIVAL | LFR-024 |
| Barcode Scanner | L22XWU1-200 |
| BinaxNOW™ Tray Pack | LFR-004 |
| Calibration Check Card Pack | LFR-003 |
| Optional Equipment | |
| Martel Thermal Printer | MCP1810395 |
| Replacement Printer Paper | 20001584 |
