Partial analytical validation of the VetScan cPL rapid test.

Abstract

BACKGROUND: Serum canine pancreatic lipase immunoreactivity (cPLI) concentrations have become the standard laboratory test used to diagnose canine pancreatitis. Recently, a new point-of-care assay for cPLI, the VetScan cPL rapid test (VetScan cPL), has become available, but analytical validation data have not yet been published. OBJECTIVE: This study aimed to perform a partial analytical validation of the VetScan cPL. METHODS: Leftover serum samples from a diagnostic laboratory were used. Adherence to the manufacturer's guidelines, linearity, repeatability, and reproducibility were evaluated. Results of the VetScan cPL were correlated with the Spec cPL results. RESULTS: Observed-to-expected ratios for dilutional parallelism ranged from 77.4% to 162.9% (mean 119.3%). Intra-assay and inter-assay variabilities ranged from 16.9% to 36.7% (mean 25.1%) and from 14.1% to 51.2% (mean 31.8%), respectively. Adherence to the manufacturer's specification regarding results within ± 60 µg/L of the Spec cPL result was only achieved for 39% of the measurements. The VetScan cPL and Spec cPL correlation showed a Spearman's r of .758 for 29 data pairs. CONCLUSIONS: Under the conditions of this study, the VetScan cPL did not adhere to the manufacturer's specifications for most measurements. Also, the VetScan cPL showed suboptimal linearity and was not precise. In conclusion, the VetScan cPL failed basic analytical validation.