1. INTENDED USE

The Canine LYME Ab Rapid Test is a fluorescence-based immunoassay designed for the qualitative detection of Borrelia burgdorferi-specific antibodies in canine whole blood, serum, or plasma. This test assists veterinarians in:

• Screening for Lyme disease exposure in dogs from endemic areas or with clinical signs (e.g., lameness, fever, or lethargy).
• Differentiating active infection vs. past exposure when paired with clinical signs and C6 peptide testing.
• Monitoring seroconversion post-tick bite or vaccination (note: may detect vaccine-induced antibodies).

Note: For veterinary use only. A positive result should be interpreted alongside clinical findings and additional diagnostics (e.g., PCR, Western blot).

2. TEST PRINCIPLE

The test utilizes a lateral flow fluorescence immunoassay format:

1. Sample Application: The sample migrates via capillary action, and Borrelia-specific antibodies (if present) bind to recombinant OspC/OspA antigens conjugated with fluorescent nanoparticles.
2. Capture Line Formation: The antibody-antigen complexes are captured by immobilized anti-canine IgG antibodies at the test line, generating a fluorescent signal.
3. Result Interpretation: A portable fluorescence reader quantifies the signal intensity, providing semi-quantitative results (IgG levels) within 10 minutes.

Key Features:

• High Sensitivity: Detects antibodies as early as 3–4 weeks post-infection.
• No Protein A/G Interference: Uses species-specific anti-canine IgG for accurate results.
• Dual-Antigen Design: Combines OspC (early infection) and OspA (chronic/vaccine response) for broad detection.

Store at 2–30°C. Avoid hemolyzed samples. Confirm equivocal results with supplemental testing.