Analytical Validation of an Automated Point-of-Care Immunoassay for the Measurement of Canine Pancreatic Lipase Immunoreactivity Concentration (Vcheck cPL 2.0).

Abstract

BACKGROUND: Pancreatic lipase assays are commonly utilized in the diagnostic approach to suspected pancreatitis in dogs. While a previously available point-of-care assay for the quantification of canine pancreatic lipase immunoreactivity (Vcheck cPL 1.0) performed sub-optimally, the updated version (Vcheck cPL 2.0) lacks independent validation. OBJECTIVE: To evaluate the analytic validity of the Vcheck cPL 2.0 assay. METHODS: Linearity was assessed via dilutional parallelism. Intra- and inter-assay variability were assessed by calculating coefficients of variation across replicates on the same day and across consecutive days, respectively. Interference studies were performed to assess the effects of bilirubin, hemoglobin, and lipid presence in test samples on assay performance. RESULTS: Linearity appeared within target parameters at pancreatic lipase concentrations up to ~800 md/dL (mean O/E ratio: 0.968&#x2009;&#xb1;&#x2009;0.104) but was unacceptable at pancreatic lipase concentrations >&#x2009;2000&#x2009;mg/dL (mean O/E ratio: 1.432&#x2009;&#xb1;&#x2009;0.178). Intra-assay precision (median coefficient of variation 7.2%) was acceptable; however, inter-assay precision was sub-optimal (coefficient of variation >&#x2009;10%) in 50% of samples analyzed. Variable precision may result in different diagnostic interpretations. Icterus and lipemia did not impact assay results. However, hemolysis, when severe (375-500&#x2009;mg/dL), may impact test results (p&#x2009;<&#x2009;0.005). CONCLUSIONS: The Vcheck cPL 2.0 shows improved precision compared to previous versions. Linearity was unacceptable at higher pancreatic lipase concentrations and hemolysis may impact Vcheck cPL 2.0 assay results.