- A rapid, point-of-care immunochromatographic assay designed for the qualitative detection of Group A Streptococcus antigen, it's utilized in clinical settings to quickly confirm pharyngitis from direct patient specimens
Uses
- Acute Pharyngitis Screening:
- Aids clinicians in the rapid differential diagnosis of Group A Strep infections in patients presenting with sore throats and fever
- Point-of-Care Diagnostics:
- Employed directly in physician offices, urgent care clinics, and pediatric emergency rooms to enable immediate clinical decisions
- Direct Swab Processing:
- Validated exclusively for testing human throat swab specimens, capturing both viable and non-viable organisms
Features
- Dual Labeling Technology (DLT):
- Utilizes antibody-labeled color particles coated at two distinct locations, driving higher analytical sensitivity without degrading specificity
- CLIA Waived Status:
- Certified for immediate point-of-care use, allowing non-laboratory medical staff to safely operate the assay
- High Clinical Sensitivity:
- Delivers a 96.4% sensitivity and 96.3% specificity profile, making it statistically equivalent to traditional single-swab bacterial cultures
- Comprehensive 52-Stick Kit:
- Bundled as a 50-test commercial box that includes 50 test sticks, 50 test tubes, 50 sterile throat swabs, extraction reagents, and liquid workstations
- "QC Inside®" Feature:
- Packaged with 2 additional test sticks specifically set aside for mandatory external quality control testing (totaling 52 sticks per box)
Benefits
- Rapid Turnaround Speed:
- Delivers highly visible, clear diagnostic results in 5 minutes, minimizing patient wait times
- Supports Antibiotic Stewardship:
- Swiftly differentiates bacterial strep from viral sore throats, preventing unnecessary or inappropriate antibiotic prescriptions
- Easy-to-Read Output:
- Uses a highly distinct, two-color visual confirmation line system to minimize reading errors or subjectivity by clinical staff
- Simplified Laboratory Workflow:
- Requires only two minutes of hands-on preparation time, eliminating the 18-to-24-hour incubation lag required by traditional petri dishes
