The feasibility of the preparation of a purified human pancreatic a-amylase as a reference material standard
The variety of methodologies for amylase determination has led to the current unfortunate situation where there are no reference assays, no standard substrates and no standard activity units. Comparison of results obtained in different laboratories thus becomes very difficult. A reference preparation of human pancreatic alpha amylase could harmonise the results of determinations carried out by different methods, for developing new assay methods (especially a reference method) and for assessing interlaboratory performance. This reference preparation should be commutable, i.e. it should behave with each different method in a way that closely mimics the enzyme activity in human serum. The aim of this project was to develop a stable and well characterised material containing purified human pancreatic alpha amylase. Amylase activity was determined at 30 C with 4,6-benzylidene (G7)-4-nitrophenyl (G1)-alpha-D-maltoheptaoside as substrate, alpha-glucosidase and glucoamylase as auxiliary enzymes, and buffer containing PIPES, calcium chloride and sodium chloride. The methods used to determine amylase for the commutability studies are described.
Bibliographic Reference: EUR 13629 EN (1991) 17 pp., MF, ECU 4, blow-up copy ECU 6
Record Number: 199210032 / Last updated on: 1994-12-02
Original language: en
Available languages: en