Performance evaluation of a canine C-reactive protein flow-immunosensor measurement system for clinical application

Area of Science:

• Veterinary Diagnostics
• Analytical Chemistry
• Biomedical Engineering

Background:

• Canine C-reactive protein (CRP) is a key biomarker for inflammation and infection in dogs.
• Accurate and rapid CRP measurement is crucial for timely veterinary diagnosis and treatment.
• Existing methods may have limitations in speed or applicability.

Purpose of the Study:

• To evaluate the analytical performance and robustness of a novel flow-type immunosensor (FIS) for canine CRP quantification.
• To optimize the FIS system for reduced measurement time, improving clinical efficiency.
• To assess the agreement of the FIS method with a standard comparative method.

Main Methods:

• Developed and validated a flow-type immunosensor (FIS) for canine CRP measurement.
• Performed statistical analyses including Bland-Altman and Passing-Bablok regression against a particle-enhanced turbidimetric immunoassay.
• Assessed imprecision, linearity, lower limit of quantification, and robustness against common interferents (hemoglobin, lipids, bilirubin).

Main Results:

• The FIS system achieved a measurement time of 9 minutes with good precision (within-run: 6.4-8.2%; between-run: 6.5-9.9%).
• Linearity was confirmed from 4.0 to 300 mg/L, with a lower limit of quantification of 4.0 mg/L.
• The FIS method showed excellent agreement with the comparative method (R² = 0.974) and met veterinary performance standards, though not suitable for K2EDTA plasma.

Conclusions:

• The developed canine FIS CRP measurement system demonstrates robust analytical performance and high accuracy.
• The reduced 9-minute assay time significantly enhances its clinical applicability in veterinary settings.
• This FIS method provides a reliable and efficient tool for canine CRP analysis, meeting established performance goals.