VALIDATION OF AN ENZYME CALIBRATOR - AN IFCC GUIDELINE

Objectives: The objective of this guideline is to improve standardizat ion in clinical enzymology in order to improve intermethod comparabili ty of patients' results. Design and Methods: The reference system, com bination of the reference method and the reference material, is used t o produce a reference value for a given catalytic activity. Sets of me thods are formed of methods exhibiting the same analytical specificity . Materials intended to be used as enzyme calibrators are experimental ly checked for their commutability. Results: The transfer of accuracy from the reference value to patients' results is dependent on methods (analytical specificity) and on materials (experimentally assessed com mutability). The feasibility of this approach was demonstrated with ma terials of high level for several enzymes and for each of them for sev eral routine methods. Conclusion: Expected advantages of this approach in clinical enzymology are presented. Copyright (C) 1998 The Canadian Society of Clinical Chemists.