- A rapid, point-of-care color immunochromatographic dipstick assay used for the qualitative detection of Group A Streptococcal antigen directly from patient throat swab specimens
Uses
- Acute Pharyngitis Diagnostics:
- Used by healthcare providers to quickly identify or rule out Group A Strep infections in patients suffering from acute sore throat and fever
- On-Site Clinic Screening:
- Deployed directly in high-volume pediatric offices, general family practices, urgent care centers, and school nurse offices
- Bacterial Colony Confirmation:
- Utilized to confirm presumptive Group A Streptococcal colonies recovered from standard laboratory cultures less than 72 hours old
Features
- CLIA Waived Status:
- Certified for point-of-care environments, allowing standard nursing or clinic staff to legally administer the test without advanced laboratory certification
- Proven Performance Characteristics:
- Delivers a 96% clinical sensitivity rating and a 98% specificity rating when measured against traditional backup bacterial cultures
- Viable and Non-Viable Detection:
- Capable of extracting and identifying Streptococcal carbohydrate antigens even if the bacteria are no longer alive
- Comprehensive 50-Test Layout:
- Packaged as a commercial box containing 50 test sticks, 50 sterile throat swabs, extraction reagents, tubes, and a workstation
- "QC Inside®" Allocation:
- Ships with 2 extra test sticks strictly designated for external positive and negative quality control testing, totaling 52 test sticks per box
Benefits
- Rapid Medical Decisions:
- Produces highly visible, clear diagnostic results in just 5 minutes, enabling targeted treatment before the patient leaves the clinic
- Combats Antibiotic Resistance:
- Provides immediate, accurate differentiation between viral sore throats and bacterial strep, preventing unnecessary antibiotic prescriptions
- Stark Two-Color Readout:
- Uses a distinct, two-color line system (typically a blue test line and red control line) to make manual reading simple and minimize user error
- No Capital Equipment Required:
- Operates purely as a manual dipstick test, eliminating the need for expensive analyzers, heating blocks, or digital readers
