title: Analytical validation of an ELISA for measurement of canine pancreas-specific lipase.
abstract: BACKGROUND
  The diagnosis of canine pancreatitis is challenging. Clinical presentation often includes nonspecific clinical signs, such as vomiting, anorexia, and abdominal discomfort. Increased serum lipase activity can be indicative of pancreatitis; however, it can also be increased with other conditions. An immunoassay for measurement of canine pancreas-specific lipase in canine serum that would be suitable for commercial application and provide rapid results would be beneficial.
  
  
  OBJECTIVE
  The goal of this study was to validate the Spec cPL assay, a commercially available ELISA for the quantitative measurement of canine pancreas-specific lipase.
  
  
  METHODS
  Dynamic range, dilutional linearity, precision, interfering substances, assay stability, and reproducibility were investigated for analytical validation. The method was compared with the reference assay, canine pancreatic lipase immunoreactivity (cPLI), and included evaluation of a sample population of dogs and bias.
  
  
  RESULTS
  Analytical validation showed a dynamic range of 36-954 μg/L; good precision (intra- and interassay coefficient of variation <12%); absence of interference from lipid, hemoglobin, or bilirubin; 12-month kit stability; and good reproducibility. Method comparison showed a positive bias relative to the cPLI reference method; however, the bias can be accommodated by adjustment of decision limits. The upper limit of the reference interval for Spec cPL was determined to be 216 μg/L based on the upper 97.5th percentile of results from 93 clinically healthy, kennel-housed dogs.
  
  
  CONCLUSIONS
  Validation data demonstrated that the Spec cPL assay provides reproducible results for canine pancreas-specific lipase. A readily available assay for measurement of this enzyme allows broader clinical utilization of this analytical tool, generating timely results to aid in the diagnosis of canine pancreatitis.
authors.affiliation: IDEXX Laboratories Inc., One IDEXX Drive, Westbrook, ME 04096, USA. stacey-huth@idexx.com
authors.forename: Stacey P
authors.initials: SP
authors.lastname: Huth
authors.forename: Roberta
authors.initials: R
authors.lastname: Relford
authors.forename: Jörg M
authors.initials: JM
authors.lastname: Steiner
authors.forename: Marilyn I
authors.initials: MI
authors.lastname: Strong-Townsend
authors.forename: David A
authors.initials: DA
authors.lastname: Williams
mesh_terms: D000818:Animals; D004283:Dog Diseases / Q000097:blood / Q000175:diagnosis / Q000201:enzymology; D004285:Dogs / Q000097:blood*; D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards / Q000662:veterinary*; D005260:Female; D008049:Lipase / Q000097:blood*; D008297:Male; D010179:Pancreas / Q000201:enzymology*; D010195:Pancreatitis / Q000097:blood / Q000175:diagnosis / Q000201:enzymology / Q000662:veterinary; D011933:Reagent Kits, Diagnostic / Q000662:veterinary; D012015:Reference Standards; D015203:Reproducibility of Results
chemical_list: D011933:Reagent Kits, Diagnostic; D008049:Lipase