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

BACKGROUND

Pancreatic lipase assays are commonly utilized in the diagnostic approach to suspected pancreatitis in cats. The Vcheck fPL 2.0 assay is commercially available; however, analytical validation has yet to be reported in the peer-reviewed literature.

OBJECTIVE

To evaluate the analytic validity of a fluorescent immunoassay for the point-of-care quantification of feline pancreatic lipase immunoreactivity (Vcheck fPL 2.0 assay).

METHODS

Linearity was assessed via dilutional parallelism. Intra- and interassay variability was assessed by calculating coefficients of variation (%CV) across replicates on the same day and across multiple days, respectively. Bilirubin, hemoglobin, and intralipid (intralipid 30% IV emulsion, VWR, Radnor, PA, USA) were utilized to evaluate the potential effects of interfering substances on the assay.

RESULTS

Linearity was sub-optimal, with 12/15 diluted runs having an O/E ratio outside of the 80-120% target range. The mean %CV was 10.2% for intra-assay variability and 16.3% for interassay variability. Interfering substances had no significant effect on the results of the Vcheck fPL 2.0 assay (P = 0.888).

CONCLUSIONS

The Vcheck fPL 2.0 appears to have poor linearity and suboptimal precision, limiting the accurate interpretation of results. Additional assay optimization should be considered prior to routine clinical use.