SCE Nordic α-amylase study II: Assessment of proposed calibration procedure. A report by the Scandinavian Committee on Enzymes (SCE)

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Abstract
Eighty-seven Nordic Hospital laboratories participated in a joint SCE-NORDKEM follow-up study of the long-term stability of the previously established calibration factors for a number of α-amylase routine methods based on six different substrates. Human control materials with 90% pancreatic, 90% salivary, and pure pancreatic α-amylases were measured by the participants. The data were plotted before and after calibration of each method using a human pancreatic calibrator with an assigned catalytic concentration of 390 U/l (Phadebas® blue starch method, 37 °C). As in the previous study, carried out 9 months earlier, the pre-calibration values varied over a six-fold range. The post-calibration values of all methods except those based on a tetraose substrate showed an acceptable inter-laboratory comparability. As a temporary measure, SCE recommends that the Nordic laboratories calibrate the accepted routine methods by their individual calibration factor. Detailed suggestions for calibration procedures and a discussion of the principles of transferability will shortly be published by the SCE in this journal.

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