- A rapid, point-of-care infectious disease immunoassay used for the qualitative detection of Group A Streptococcus antigen directly from patient throat swab specimens
Uses
- Acute Pharyngitis Screening:
- Aids physicians in rapidly identifying Group A Strep infections in patients presenting with throat pain, fever, or inflammation
- On-Site Clinic Diagnostics:
- Employed directly in pediatric offices, general family practices, and emergency clinics to expedite clinical decisions
- Viable/Non-Viable Pathogen Capture:
- Extracts and detects Streptococcus antigens directly from human throat swabs, regardless of whether the bacterial organisms are still viable
Features
- Dual Labeling Technology (DLT):
- Uses antibody-labeled color particles coated at two separate locations on the strip, maximizing diagnostic sensitivity without sacrificing specificity
- CLIA Waived Status:
- Certified for straightforward point-of-care use, enabling standard nursing or medical staff to process tests legally without advanced lab certification
- High Clinical Accuracy:
- Features a 96.4% sensitivity and 96.3% specificity profile, yielding results statistically equivalent to a single-swab bacterial culture
- Pre-Filled Extraction Ampules:
- Streamlines setup with pre-measured solution buffers, avoiding manual reagent mixing or fluid measuring
- "QC Inside®" Allocation:
- Packaged with 2 additional test sticks solely dedicated to running external quality control testing, totaling 27 sticks in the box
Benefits
- Accelerated Patient Care:
- Produces clear diagnostic results in 5 minutes, allowing clinicians to prescribe treatments before the patient leaves the office
- Prevents Antibiotic Misuse:
- Minimizes the unnecessary prescription of antibiotics by immediately separating viral sore throats from bacterial strep infections
- Minimal Hands-On Time:
- Requires only two minutes of active preparation time due to the simplified, pre-filled ampule workflow
- Stark Two-Color Results:
- Utilizes contrasting color indicators to provide a distinct visual readout, preventing reading errors and user subjectivity
- Optimized for Lower Volumes:
- The 25-count layout prevents unused product expiration in smaller clinics
