임상 효소검사의 표준화

Abstract

The intentional dissimilarity of assay conditions of the many commonly used enzyme methods is the most significant source of interlaboratory variation. Such difference include the wide diversity of substrates that are available for some enzymes ; cofactor or metal- ion supplementation of only a number of methods; and differences in the subtrate concentration; pH, and temperature and other requisite conditions for nearly all methods. For enzyme assays, laboratories should strive for a short-term or intrasurvey CV of less than 5% and a long-term or intrayear Cv of less than 10%. Our limited experience with a reference ondicator material system suggests that interlaboratory standardization based on a calibrator is possible. Certainly, well-charaterized and stable reference materials for enzyme calibration are badly needed by the clinical laboratory community.