1. INTENDED USE

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

• Screening for Leishmania infantum infection (a major cause of canine leishmaniasis)
• Aiding clinical diagnosis of active infection or carrier status
• Monitoring seroconversion in endemic areas or post-treatment follow-up

Note: For veterinary use only. Results should be interpreted in conjunction with clinical signs and other diagnostic methods.

2. TEST PRINCIPLE

The test utilizes an indirect fluorescence immunoassay format:

1. Antigen Coating: Recombinant Leishmania K39/K26 antigens are immobilized on the test strip.
2. Antibody Binding: Canine anti-Leishmania antibodies (if present) bind to the fixed antigens.
3. Signal Generation: Fluorescent-labeled anti-canine IgG antibodies bind to the captured antibodies, forming a detectable complex.
4. Result Interpretation: A portable fluorescence reader provides:
   • Qualitative result (Positive/Negative) with 99% clinical sensitivity
   • Semi-quantitative value (antibody titer) for monitoring purposes

Key Features:

• Early Detection: Identifies antibodies as early as 2-4 weeks post-infection
• High Specificity: >98% specificity against other parasitic diseases
• Rapid Results: Complete testing within 15 minutes
• Stable Performance: Fluorescent signal remains stable for 30+ days

For optimal results, use fresh samples and follow recommended storage conditions for test components.