Partial validation of the Vcheck canine pancreatic lipase assay.

Abstract

Measurement of canine pancreatic lipase immunoreactivity (cPLI) is used for diagnosing pancreatitis in dogs. Because pancreatitis can be a life-threatening disease with severe complications, an in-house cPLI test would be valuable to obtain rapid test results. The aim of this study was to evaluate a point-of-care cPLI test, Vcheck cPL. Precision, determined according to EP15, and linearity under dilution were determined and judged against preset quality goals. Results from the Vcheck cPL were compared with a previously validated cPLI ELISA, Spec cPL. In a retrospective study, cPLI results from dogs with and without acute pancreatitis, as determined by pancreatic ultrasound examination, were investigated to assess the performance of the assay in a clinical setting. Statistical analysis included the Mann-Whitney test, Chi-square test, and Passing-Bablok regression analysis with a significance level of 0.05. Precision of the assay was acceptable, with intra-, inter-, and total coefficients of variation (CV%) less than 12.1%, 6.4%, and 12.1%, respectively. Results from the linearity study indicated that the method was acceptably linear at lower concentrations but not in the high-concentration range. The method comparison study revealed that Vcheck generally measured higher concentrations compared with Spec cPL, and that the methods should not be used interchangeably. Dogs with acute pancreatitis had significantly higher cPLI concentrations compared with dogs without pancreatitis (P < 0.01), but there was a marked overlap in cPL concentrations between the two groups.