1. INTENDED USE

The Canine Ehrlichia Antibody Rapid Test is a fluorescence-based immunoassay designed for the qualitative detection of antibodies against Ehrlichia spp. (including E. canis, E. ewingii, and E. chaffeensis) in canine whole blood, serum, or plasma. This test assists veterinarians in:

• Screening for exposure to Ehrlichia infection (acute or chronic phases)
• Supporting clinical diagnosis of canine monocytic ehrlichiosis (CME)
• Differentiating co-infections in tick-borne disease panels
• Monitoring seroconversion post-treatment or during follow-up

Note: For veterinary point-of-care use. A positive result indicates exposure but does not distinguish active infection – clinical correlation required.

2. TEST PRINCIPLE

The test utilizes an indirect fluorescence immunoassay format:

1. Antigen Coating: Recombinant Ehrlichia-specific proteins (P30/P28 antigens) are immobilized on the test membrane.
2. Sample Incubation: Anti-Ehrlichia antibodies (IgG/IgM) in the sample bind to the antigens if present.
3. Signal Development: Fluorescent-labeled anti-canine IgG conjugate binds to captured antibodies, forming an antigen-antibody-fluorophore complex.
4. Optical Reading: A fluorescence reader quantifies the signal intensity at 525nm emission wavelength, with results available in 10 minutes.

Key Features:

• Early Detection: Identifies antibodies as early as 7-10 days post-infection
• High Sensitivity (98.2%) & Specificity (99.4%) against IFA reference
• Minimal Hook Effect: Accurate even with high antibody titers
• Stable at Room Temperature: No cold chain requirement for test strips

Sample Requirements: 50μL of EDTA whole blood, serum, or plasma. For optimal performance, run samples within 24h of collection or store at 2-8°C for up to 72h.