Global Point of Care
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™.
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.
Used with either nasopharyngeal swab or nasal swab samples.
Results available in just 15 minutes.
Simple, straightforward testing procedure.
Provides accurate results and includes internal controls.
Suitable for a wide variety of healthcare settings.
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:
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%) | |||
| 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 |
Learn how the instrument works by playing our interactive product demonstration.
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