1. INTENDED USE

The Veterinary D-dimer Rapid Test is a fluorescence-based immunoassay designed for the quantitative detection of D-dimer in canine and feline plasma. This test provides veterinarians with a reliable tool to:

• Diagnose thrombotic disorders (e.g., disseminated intravascular coagulation (DIC), pulmonary thromboembolism, deep vein thrombosis)
• Monitor fibrinolytic activity in patients with suspected coagulation abnormalities
• Assess treatment efficacy of anticoagulant therapy
• Differentiate between inflammatory and thrombotic conditions

Note: For veterinary diagnostic use only. EDTA plasma is the recommended sample type.

2. TEST PRINCIPLE

The test utilizes a sandwich fluorescence immunoassay methodology:

1. Capture Phase: Mouse monoclonal anti-D-dimer antibodies are immobilized on the test membrane to specifically capture D-dimer fragments in the plasma sample.
2. Detection Phase: Fluorescent nanoparticle-conjugated anti-D-dimer antibodies bind to the captured D-dimer, forming a “sandwich” complex.
3. Signal Measurement: The fluorescence intensity is quantitatively measured by a portable analyzer, with results available in 10-15 minutes. The signal intensity is directly proportional to the D-dimer concentration in the sample.

Key Features:

• High Sensitivity: Detection limit as low as 50 ng/mL
• Excellent Specificity: Minimal cross-reactivity with fibrinogen or other fibrin degradation products
• Broad Measuring Range: 50-5000 ng/mL, covering clinically relevant concentrations
• Stable Results: Fluorescent signal remains stable for post-test verification

For optimal performance, use fresh EDTA plasma and follow the manufacturer’s recommended procedures. The test should be interpreted in conjunction with other clinical findings and coagulation tests.