1. INTENDED USE

The Canine Leptospira Antibody Rapid Test is a fluorescence-based immunoassay designed for qualitative/semi-quantitative detection of Leptospira-specific antibodies in canine serum, plasma, or whole blood. This test assists veterinarians in:

• Early screening of Leptospira infection (including common serovars like Canicola, Icterohaemorrhagiae, Grippotyphosa, and Pomona)
• Monitoring vaccine efficacy by assessing antibody response post-vaccination
• Supporting differential diagnosis of acute febrile illness or renal/liver disease in dogs

Note: For veterinary use only. Results should be interpreted alongside clinical signs and exposure history.

2. TEST PRINCIPLE

The test utilizes an indirect fluorescence immunoassay format:

1. Antigen Coating: Recombinant Leptospira antigens (major outer membrane proteins) are immobilized on the test strip.
2. Antibody Binding: If present in the sample, anti-Leptospira IgG/IgM antibodies bind to the fixed antigens.
3. Signal Generation: A fluorescently labeled anti-canine IgG secondary antibody binds to the captured antibodies.
4. Quantitative Readout: A handheld fluorescence reader measures signal intensity at 525nm emission, providing:
   • Qualitative result (Positive/Negative) with 99% clinical sensitivity
   • Semi-quantitative index (S/CO ratio) for antibody level estimation

Key Features:

• Multi-serovar Coverage: Detects antibodies against 8 prevalent pathogenic serovars
• Rapid Turnaround: Results in 15 minutes vs. 2-3 days for MAT testing
• No Prozone Effect: Fluorescence detection avoids hook effects at high antibody titers

Storage: Maintain test cassettes at 2-30°C. Use fresh samples (hemolyzed samples may affect accuracy).