[Standardization of measurement of catalytic activity concentration of enzymes--current situation regarding the external quality assessment program provided by the Japan Medical Association].

Measurement of the catalytic activity concentration of enzymes has been standardized using a traceability chain, consisting a reference measurement system for enzyme catalytic activity and reference standard-JSCC enzyme. The Japan Medical Association (JMA) has provided an external quality assessment (EQA) survey program for clinical laboratory testing. More than 3,100 clinical laboratories participated in 2008. The EQA program indicated that standardization of the measurement of the catalytic activity concentration of enzymes has been completed for AST, ALT, LD, ALP, gammaGT, and CK in more than 90% laboratories, and for Amy and ChE in nearly 80% of laboratories. Because such a large survey program must use artificial specimens, a matrix effect cannot be avoided, especially in dry chemistry. However, the bias produced by a matrix effect usually has a predictable tendency: it can be corrected. Next, after standardization of the measurement of the catalytic activity concentration of enzymes, we should develop and use common reference intervals. On completing the standardization, we can make standard medical decisions using reference measurement systems and rules.