1. INTENDED USE

The Canine ANA Ab Rapid Test is a fluorescence-based immunoassay designed for the qualitative detection of antibodies against Anaplasma spp. (including A. phagocytophilum and A. platys) in canine whole blood, serum, or plasma. This test assists veterinarians in:

• Screening for exposure to Anaplasma infection in dogs
• Supporting clinical diagnosis of canine anaplasmosis (e.g., in cases of fever, lethargy, or thrombocytopenia)
• Differentiating tick-borne diseases when used in combination with other vector-borne disease tests
• Monitoring seroconversion during treatment or recovery

Note: For veterinary in-clinic or laboratory use only. A positive result indicates exposure but does not distinguish between active infection and previous exposure.

2. TEST PRINCIPLE

The test utilizes an indirect fluorescence immunoassay format:

1. Antigen Coating: Recombinant Anaplasma surface proteins are immobilized on the test strip.
2. Antibody Binding: If present in the sample, anti-Anaplasma antibodies bind to the fixed antigens.
3. Signal Generation: Fluorescently labeled anti-canine IgG antibodies then bind to the captured antibodies.
4. Detection: A portable fluorescence reader quantifies the signal intensity, providing:
   • Qualitative results (Positive/Negative) within 10 minutes
   • Semi-quantitative index values (S/CO ratio) when needed

Key Features:

• High Sensitivity (98%) for early antibody detection (7-14 days post-infection)
• No cross-reactivity with antibodies against Ehrlichia, Borrelia, or Dirofilaria
• Stable performance across canine breeds and age groups
• Room temperature storage (no cold chain required)

For optimal results, use fresh samples and follow the recommended testing procedure. Clinical correlation with symptoms and other diagnostic methods is advised.