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^™.

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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

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%)

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	GP15