Partial analytical validation of the VetScan cPL rapid test

Area of Science:

• Veterinary Diagnostics
• Clinical Pathology
• Canine Medicine

Background:

• Serum canine pancreatic lipase immunoreactivity (cPLI) is the standard for diagnosing canine pancreatitis.
• A new point-of-care assay, VetScan cPL, is available, but lacks validation data.

Purpose of the Study:

• To conduct a partial analytical validation of the VetScan cPL rapid test.
• Evaluate the performance of the VetScan cPL against established diagnostic standards.

Main Methods:

• Utilized leftover serum samples from a diagnostic laboratory.
• Assessed adherence to manufacturer guidelines, linearity, repeatability, and reproducibility.
• Correlated VetScan cPL results with Spec cPL assay results.

Main Results:

• Dilutional parallelism ranged from 77.4% to 162.9% (mean 119.3%).
• Intra-assay and inter-assay variability ranged from 16.9% to 36.7% (mean 25.1%) and 14.1% to 51.2% (mean 31.8%), respectively.
• Only 39% of measurements met manufacturer specifications; correlation with Spec cPL was r=.758.

Conclusions:

• The VetScan cPL demonstrated suboptimal linearity and imprecision.
• The test failed to meet manufacturer specifications for most measurements.
• The VetScan cPL did not pass basic analytical validation in this study.