1. INTENDED USE

The Veterinary TSH Rapid Test is a fluorescence-based immunoassay designed for the quantitative measurement of Thyroid-Stimulating Hormone (TSH) in canine serum or plasma. This test provides veterinarians with a reliable diagnostic tool to:

• Differentiate primary vs. secondary hypothyroidism (elevated TSH with low T4 indicates primary hypothyroidism in dogs)
• Monitor thyroid function in patients receiving thyroid hormone replacement therapy
• Assess pituitary-thyroid axis in cases of suspected thyroid dysfunction
• Aid in breed-specific thyroid disorder screening (e.g., Golden Retrievers, Dobermans)

Note: For veterinary diagnostic use only. Not validated for feline samples due to species-specific TSH differences.

2. TEST PRINCIPLE

The test utilizes a sandwich fluorescence immunoassay methodology:

1. Capture Phase: Mouse anti-canine TSH monoclonal antibodies are immobilized on the test strip to specifically capture TSH from the sample
2. Detection Phase: A second anti-canine TSH antibody conjugated with europium fluorescent nanoparticles binds to the captured TSH, forming a sandwich complex
3. Signal Measurement: Time-resolved fluorescence is quantified by a portable reader, with signal intensity directly proportional to TSH concentration
4. Rapid Results: Provides quantitative TSH levels in 10-15 minutes with a detection range of 0.03-1.5 ng/mL

Key Features:

• Canine-specific: Antibodies specifically target canine TSH with <0.1% cross-reactivity to other pituitary hormones
• High Sensitivity: Detects subclinical hypothyroidism (LLOQ: 0.03 ng/mL)
• Stable Performance: Fluorescent nanoparticles provide stable signals with CV <8%
• Correlation: Results show >95% correlation with reference laboratory methods

*For optimal results, use fresh serum samples and avoid repeated freeze-thaw cycles. Include T4 testing for comprehensive thyroid evaluation.*