Analytical evaluation of a newly developed ELISA mass assay for pancreatic amylase

Objective: To evaluate a newly developed ELISA mass assay for Pancreatic Amylase. Methods: The serum levels of pancreatic amylase were measured by an in-house developed ELISA assay on microtitre plate and compared with two activity assays: immunoinhibition and electrophoresis. Results: The proposed method was accurate and precise, as indicated by a recovery of 102% and coefficient of variation of less than 5% for within-run and less than 10% for between-run assay. The proposed assay showed good correlation with the activity assays (r = 0.98). The mass concentrations were three times higher than the activities. The relative values (mass or activity units/upper reference limits), however, were concordant in controls and in pancreatic and non-pancreatic conditions. Conclusion: Our results indicate that the activity measurements and mass concentrations of pancreatic amylase in serum are comparable and interchangeable after adjusting for the reference range.