SCE Nordic α-amylase method selection and calibration study. A report by the Committee of Enzymes of the Scandinavian Society for Clinical Chemistry (SCE)

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Abstract
Seventy-six Nordic routine laboratories participated in a joint SCE-NORDKEM study comprising evaluation, selection, and temporary calibration of amylase methods. Human control materials with known fractions of salivary and pancreatic amylase were determined by seven routine amylase assays based on substrates with glucosyl (G) chain lengths G4, G5, G5-6, G7, G9, amylopectin and blue starch polymer (Phadebas®). The data were plotted before and after calibration of each method using a human pancreatic calibrator with an assigned value of 390 U/l (37 °C, Phadebas®). The study led to three conclusions: (1) The analytical overestimation of salivary to pancreatic amylase ratio (S:P) increased with decreasing number of glucosyl units in the substrates. Relative to the S:P value of blue starch polymer (set at 1.00), for example, tetraose mean S:P value was 1.55. (2) The hydrolysis rates relative to that with blue starch polymer decreased with the number of glucosyl units in the substrates. The precalibration values of all methods spread over an approximately six-fold range. (3) Post-calibration values of all methods, except tetraose, showed an acceptable inter-laboratory comparability. The CV values for low, medium, and high controls were about 5.5, and 6% respectively. As a temporary solution to the current problem of diverse amylase assays, the SCE suggests calibration of the methods considered acceptable in this study. The long-term effects will be evaluated in a follow-up study within a year.

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