1. INTENDED USE

The CIV Ag Rapid Test is a fluorescence-based immunoassay designed for the qualitative detection of Canine Influenza Virus (CIV) antigens (H3N2 and H3N8 subtypes) in canine nasal swabs, oropharyngeal swabs, or bronchoalveolar lavage samples. This test assists veterinarians in:

• Rapid screening of acute canine influenza virus infections
• Early clinical intervention to prevent outbreaks in kennels or multi-dog environments
• Differential diagnosis of canine respiratory diseases (e.g., distinguishing from kennel cough)

Note: For veterinary point-of-care use only. Confirmatory testing may be required for definitive diagnosis.

2. TEST PRINCIPLE

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

1. Sample Application: The specimen is added to the test device, where CIV antigens (if present) bind to fluorescent nanoparticle-conjugated monoclonal antibodies specific to CIV nucleoproteins.
2. Lateral Flow: The antigen-antibody complex migrates via capillary action to the test line containing immobilized anti-CIV antibodies, forming a fluorescent “sandwich” complex.
3. Detection: A handheld fluorescence reader quantifies the signal intensity at 520 nm emission wavelength, providing:
   • Results in 8-10 minutes
   • High sensitivity (98.2%) and specificity (99.1%) compared to PCR
   • Detection limit of 1.2×10³ TCID50/mL

Key Features:

• Dual-subtype detection: Recognizes both H3N2 and H3N8 strains
• No cross-reactivity with other canine respiratory pathogens (CPIV, CAV-2, CDV)
• Stable fluorescent labels resistant to environmental interference

Storage: Maintain test kits at 2-30°C. Bring to room temperature before use.
Sample Integrity: Process fresh samples within 1 hour or store at 4°C for ≤24 hours.