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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 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.
Influenza A Performance with BinaxNOW™ Influenza A & B Card 2 with 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 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 |
BinaxNOW™ Influenza A&B Card 2 Control Swab Kit | 575-080 |
DIGIVAL™ with BinaxNOW™ Tray Pack | LFR-100 |
Accessories |
|
Calibration Check Card Pack | LFR-003 |
Optional Equipment |
|
Martel Thermal Printer | MCP1810395 |
Replacement Printer Paper | 20001584 |
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