- A rapid, automated point-of-care immunoassay system designed for the qualitative detection and differentiation of influenza types A and B viral antigens
Uses
- Infection Differentiating:
- Detects and distinguishes between Influenza A and Influenza B viral nucleoprotein antigens from a single patient sample
- Specimen Compatibility:
- Validated for extracting antigens directly from patient nasal swab and nasopharyngeal swab specimens
- Point-of-Care Interventions:
- Intended for rapid deployment inside outpatient clinics, urgent care centers, and physician office laboratories to enable test-and-treat decisions during the same visit
Features
- Innovative Composite Comparator:
- Employs a standardized design that combines molecular and culture methods to deliver best-in-class accuracy and definitive clinical results
- High Clinical Accuracy:
- Boasts an objective sensitivity profile of 96.4% for Influenza A and 82.3% for Influenza B, alongside a specificity profile of 96.0% for Influenza A and 98.1% for Influenza B
- Dual Operational Modes:
- Works exclusively via the digital Acucy Reader (sold separately), offering both a "Walk Away" mode for automated incubation/reading and a "Read Now" mode for fast-paced multi-sample batch processing
- Quality Controls Included:
- Every 25-test pack includes external control swabs to facilitate affordable and straightforward system performance verification
Benefits
- Fast Clinical Turnaround:
- Delivers highly accurate, digitized diagnostic results in just 15 minutes
- Reduced Spread of Infection:
- Facilitates immediate antiviral prescribing and isolation protocols before infected patients re-enter the general public
- Simplified Workflows:
- Holds a CLIA-waived classification, eliminating the need for complex multi-step laboratory processing, dedicated technicians, or manual visual line interpretation
