- Comprehensive kit designed for rapid and accurate Lyme disease testing at the point of care
Purpose:
- Rapid, qualitative detection of human IgM and IgG antibodies to Borrelia burgdorferi from finger-stick whole blood specimens
Technology:
- utilizes advanced immunofluorescence-based lateral-flow technology and the Sofia 2's Advance Result Technology (ART) to provide automated and objective results
Result Time:
- Results can be obtained in as few as 3 minutes, with a range of 3-15 minutes
Regulatory Status:
- CLIA-waived for finger-stick whole blood, meaning it can be used in a point-of-care setting by medical professionals
Storage:
- Can be stored at room temperature (15°C to 35°C / 59°F to 86°F)
Contents:
- Sofia 2 Analyzer (a benchtop instrument that uses advanced fluorescence detection)
- 15 Individually packaged test cassettes for Lyme disease
- Blood collection and preparation kits (e.g., capillary tubes, reagent tubes, reagent solution)
- Positive and negative controls
- Package insert and quick reference instructions
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