- A rapid diagnostic tool designed for healthcare professionals to qualitatively detect Group A Streptococcal antigen directly from patient throat swabs
Uses
- Direct Antigen Detection:
- Identifies Group A Strep antigens directly from throat swab specimens during a patient visit
- Culture Confirmation:
- Verifies presumptive beta-hemolytic Group A Streptococcal colonies recovered from standard blood agar plates
- Pharyngitis Assessment:
- Aids in the rapid diagnosis of acute upper respiratory tract infections
Features
- CLIA Waived Classification:
- Certified for straightforward point-of-care professional testing without advanced laboratory oversight
- Dipstick Immunoassay Format:
- Employs an off-line extraction process where the strip is dipped directly into the prepared sample solution
- 5-Minute Diagnostic Window:
- Yields final, definitive results within 5 minutes or less from the start of the test
- Patented Antibody-Labeled Particles:
- Utilizes QuidelOrtho's lateral flow technology to isolate both viable and nonviable organisms
- Two-Color Line Readout:
- Displays a distinct pink-to-purple Test line along with a blue procedural Control line for uncomplicated interpretation
- High-Volume Kit Sizing:
- Arrives as a bulk configuration containing 50 tests per box, including extraction reagents and positive/negative controls
- Room Temperature Storage:
- Stores safely on standard medical shelves, eliminating the need to take up valuable lab refrigeration space
Benefits
- Same-Visit Clinical Workflows:
- Allows physicians to test, diagnose, and prescribe antibiotics within a single, 15-minute office window
- 95% Overall Agreement to Culture:
- Delivers high medical-grade reliability with exceptional sensitivity even at low bacterial colony counts
- Fewer Operational Mistakes:
- Simplifies testing with an easy-to-use pictorial procedure guide that demands minimal staff training
- Integrated Quality Control:
- Confirms strip functional integrity and appropriate fluid migration automatically via the built-in blue control line
- Prevents Downstream Complications:
- Prompt confirmation facilitates early treatment, mitigating severe conditions like rheumatic fever and glomerulonephritis
