- A true one-step rapid lateral-flow immunoassay designed for healthcare professionals to qualitatively detect Group A Streptococcal antigen directly from patient throat swabs
Uses
- Direct Throat Antigen Detection:
- Diagnoses Group A Strep right from the patient’s throat swab during an initial examination
- Pharyngitis Evaluation:
- Diagnoses acute upper respiratory tract infections in exam rooms, urgent care centers, school clinics, and pharmacies
- Same-Visit Screening:
- Screens patients experiencing a sudden-onset sore throat to verify if antibiotics are required
Features
- Patented In-Line Extraction Method:
- Features an in-the-device extraction system where the swab sits inside the cassette chamber, requiring no separate mixing tubes
- CLIA Waived Classification:
- Holds historical distinction as the first rapid strep A test to be CLIA-waived for professional use
- Ultra-Fast 5-Minute Results:
- Develops reliable, final diagnostic endpoints within 5 minutes
- Single Reagent Format:
- Employs a single extraction solution bottle mechanism to minimize sequential step errors
- Visual Solution Color Guide:
- The solution changes to a distinct green color when mixed properly to visually guide the user
- Two-Color Readout Indicators:
- Displays high-contrast lines (such as a pink-to-purple test line and a blue control line) for mistake-proof evaluation
- Comprehensive Kit Materials:
- Each kit box contains 25 test cassettes, 25 sterile rayon throat swabs, and external positive/negative control swabs
- Room Temperature Storage:
- Keeps perfectly stable on medical supply shelves between 59°F and 86°F (15°C to 30°C)
Benefits
- Accelerated Clinical Decisions:
- Facilitates a "test-and-treat" workflow, allowing physicians to prescribe targeted antibiotics during a single patient visit
- High Clinical Performance:
- Delivers medical-grade reliability with 92% sensitivity, 99% specificity, and 96% overall accuracy compared to traditional sheep blood agar culture methods
- Fewer Operational Steps:
- The in-line chamber minimizes "hands-on time," lowering the probability of fluid transfer mistakes by clinical staff
- No Warm-Up Lag time:
- Because it skips refrigeration, staff can process emergent or walk-in patient samples instantly without waiting for chemicals to reach room temperature
- Built-In Procedural Controls:
- Verifies liquid flow and strip integrity automatically with every sample via integrated internal lines
