1. INTENDED USE

The cPL Rapid Test is a fluorescence-based immunoassay designed for the quantitative measurement of canine pancreatic lipase (cPL) in dog serum or plasma. This test provides veterinarians with a critical diagnostic tool to:

• Detect and monitor pancreatitis (acute or chronic) in dogs
• Differentiate pancreatic vs. non-pancreatic causes of vomiting/abdominal pain
• Assess disease severity and guide treatment decisions
• Monitor recovery progress during treatment

Note: For veterinary diagnostic use only. Results should be interpreted in conjunction with clinical signs and other diagnostic tests.

2. TEST PRINCIPLE

The test utilizes a sandwich fluorescence immunoassay methodology:

1. Capture Phase: cPL in the sample binds to anti-cPL monoclonal antibodies immobilized on the test strip
2. Detection Phase: Fluorescent nanoparticle-conjugated antibodies bind to different epitopes of the captured cPL
3. Signal Measurement: A specialized reader quantifies the fluorescence intensity, which is directly proportional to cPL concentration

Key Features:

• High Sensitivity: Detects cPL concentrations as low as 30 μg/L
• Exceptional Specificity: Specifically measures pancreatic lipase without cross-reacting with hepatic or gastric lipase
• Rapid Results: Provides quantitative measurements in 10-15 minutes
• Broad Measuring Range: 30-1000 μg/L covers all clinically relevant concentrations

Sample Requirements: Fresh or refrigerated serum/plasma (EDTA or heparin). Hemolyzed samples may affect results.

This advanced fluorescence technology offers superior performance compared to traditional colorimetric methods, enabling earlier and more accurate detection of pancreatic disorders in canine patients.