- Designed for professional medical and laboratory use, it rapidly detects Group A Streptococcal antigens in throat swabs from symptomatic patients
Uses
- Strep A Diagnosis:
- Primarily used as an aid in diagnosing Group A Streptococcal infections (such as strep throat) in patients showing symptoms like a severe sore throat or pharyngitis
- Testing Platforms:
- Designed exclusively to be run on the Sofia or Sofia 2 Fluorescent Immunoassay Analyzers
Features
- Rapid Results:
- Delivers automated, machine-read results in just 5 minutes
- High Accuracy:
- Utilizes advanced immunofluorescence-based lateral-flow technology with 93.7% sensitivity and 94.4% specificity
- CLIA Waived:
- Classified as a CLIA-waived test, meaning it is simple to perform and can be utilized in various point-of-care settings
- Complete Kit:
- Includes 25 individually packaged test cassettes, reagent tubes, sterile rayon throat swabs, a fixed-volume pipette, and positive/negative control swabs
- Storage:
- Features convenient room temperature storage (no refrigeration required)
Benefits
- Objective Readings:
- Eliminates the human subjectivity and guesswork associated with traditional visual dipstick tests
- Workflow Efficiency:
- Requires minimal hands-on time and uses fixed-volume pipettes to ensure the exact correct amount of sample is collected and dispensed
- Immediate Testing:
- Because it stores at room temperature, there is no waiting time for reagents to warm up before running a test
- Data Management:
- When paired with the Sofia analyzer, results can be integrated with Virena (a cloud-based data management system) to track and manage patient data remotely
