- A rapid immunoassay used for the qualitative detection of influenza type A and B nucleoprotein antigens
Uses
- Infection Detection:
- Detects influenza type A and type B nucleoprotein antigens directly from patient specimens
- Specimen Compatibility:
- Uses direct nasal swabs and nasopharyngeal swab specimens
- Patient Population:
- Intended for individuals showing signs and symptoms of a respiratory infection during flu season or routine clinical screening
- Single-Visit Treatment:
- Empowers clinicians to test and treat patients during the same office visit
Features
- Fast Turnaround:
- Provides clear, differentiated results in just 10 minutes
- Simple Workflow:
- Features a CLIA-waived procedure utilizing pre-measured extraction buffer vials for swab samples
- QC Inside®:
- Includes 2 additional test sticks in the kit for external quality control testing
- Regulatory Compliance:
- Meets current FDA influenza reclassification requirements for rapid antigen tests
- High Performance:
- Demonstrates strong sensitivity (approx. 90.3% for Flu A and 88.0% for Flu B) and high specificity (approx. 96.7% for Flu A and 99.2% for Flu B)
Benefits
- Efficiency:
- Reduces wait times and eliminates the need for complex laboratory instrumentation
- Cost-Effective:
- Built-in extra test sticks for quality control provide added value without extra charges for external controls
- Informed Care:
- Allows immediate prescription decisions for antiviral therapies before the patient leaves the clinic