1. INTENDED USE

The CPV Ag Rapid Test is a fluorescence-based immunoassay designed for the qualitative detection of Canine Parvovirus (CPV) antigen in canine feces or vomitus. This rapid diagnostic tool assists veterinarians in:

• Early and accurate diagnosis of acute CPV infection (especially in puppies and unvaccinated dogs)
• Differentiating parvovirus enteritis from other causes of hemorrhagic gastroenteritis
• Monitoring disease progression and therapeutic efficacy during treatment
• Supporting timely isolation decisions to prevent outbreaks in kennels or shelters

Note: For veterinary use only. Results should be interpreted in conjunction with clinical signs and vaccination history.

2. TEST PRINCIPLE

The test utilizes a sandwich fluorescence immunoassay format with the following mechanism:

1. Sample Application: The diluted fecal sample migrates via capillary action along the test strip.
2. Antigen Capture: CPV antigens bind to anti-CPV monoclonal antibodies conjugated with fluorescent nanoparticles.
3. Complex Formation: The antigen-antibody complex is captured by immobilized anti-CPV antibodies at the test line.
4. Signal Generation: Accumulation of fluorescent nanoparticles produces a measurable signal when excited by the reader.
5. Result Interpretation: The portable fluorescence analyzer provides:
   • Qualitative result (Positive/Negative) within 5-8 minutes
   • Semi-quantitative index (fluorescence intensity ratio) indicating viral load

Key Performance Characteristics:

• High Sensitivity: Detects CPV-2 variants (2a, 2b, 2c) with ≥98% agreement to PCR
• Minimal Hook Effect: Accurate detection even at high antigen concentrations (up to 10⁶ TCID₅₀/mL)
• Reduced Interference: Fluorescence technology minimizes false positives from bloody/hemolyzed samples

For optimal results:

• Use fresh fecal samples (<24h old) or properly stored at 2-8°C
• Follow recommended dilution protocols for formed/vomitus samples
• Confirm negative results in clinically suspicious cases with PCR testing