ANALYTICAL EVALUATION OF A NEWLY DEVELOPED ELISA MASS ASSAY FOR PANCREATIC AMYLASE

Objective: To evaluate a newly developed ELISA mass assay for Pancreat ic Amylase. Methods: The serum levels of pancreatic amylase were measu red by an in-house developed ELISA assay on microtitre plate and compa red with two activity assays: immunoinhibition and electrophoresis. Re sults: The proposed method was accurate and precise, as indicated by a recovery of 102% and coefficient of variation of less than 5% for wit hin-run and less than 10% for between-run assay. The proposed assay sh owed good correlation with the activity assays (r = 0.98). The mass co ncentrations 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 condition s. 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.