IFCC primary reference procedure for the measurement of catalytic activity concentrations of enzymes at 37 °C. Part 10: Reference procedure for the measurement of catalytic concentration of pancreatic α-amylase

This paper is the tenth in a series of publications dealing with reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 °C and the certification of reference materials. In the former publications the general concept for reference procedures for enzymes (Part 1), the measurement of the catalytic activity concentrations of creatine kinase (Part 2), lactate dehydrogenase (Part 3), alanine aminotransferase (Part 4), aspartate aminotransferase (Part 5), γ-glutamyltransferase (Part 6), total α-amylase (Part 8), and alkaline phosphatase (Part 9) are described. Part 8 describes the measurement of the catalytic activity concentration of total amylase, comprising the isoenzymes salivary derived α-amylase and pancreas derived α-amylase. The catalytic activity concentrations of the pancreatic isoenzyme provides more diagnostic selectivity in cases of differential diagnosis of pancreatitis and its monitoring. The current article describes the IFCC primary reference measurement procedure for pancreatic α-amylase enabling metrological traceability to SI.