Catalytic concentration of α-amylase determined by IFCC reference method at 37 ºC : IRMM/IFCC-456

The Institute for Reference Materials and Measurements and the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) characterised and certified a reference material under the name and number IRMM/IFCC-456. This report describes the certification of the catalytic concentration of α-amylase in a purified lyophilised material of human origin (pancreas) in a human serum albumin matrix when measured by the IFCC reference method at 37 °C. The catalytic concentration of amylase in reconstituted material is certified to 546 ± 19 U/L or 9.1 ± 0.3 μkat/L. It is the intention that the reference material should be used to control and optimise the performance of enzyme measurements, verify the comparability of results from different laboratories and be used as a reference material for manufacturers of reagents and diagnostic kits.