|
Ideally,of course ,all assay systems should produce identical results for any given enzyme assay in a given sample. Accordingly, this would be the ultimate goal for the standardization of clinical laboratory methods. The problem of method-dependent results has been recognized most clearly in the measurement of enzymes in terms of the catalysed rate of reaction. Here, method-dependence derives from the large range of variables-pH and nature of the buffers, temperature, presence of activators or inhibitors, substrate concentration and in some cases its nature-which, together with the amount of active enzyme present, influence the reaction rate. The large number of methods used for the measurement of the activities of enzymes in clinical laboratories and the multitude of different units of activity and reference intervals to which this lack of standardization gives rise form a serious barrier to the interpretation of data obtained in different laboratories, both in the records of individual patients and in reports in the scientific literature. Unification of interlaboratory clinical enzyme data cannot be achieved by method standardization alone, but requires stable and well-caracterized enzyme reference materials carrying a certified reference method value. The time is thus ripe for expansion of the use of enzyme reference materials as intermethod calibrators: an effort that should engage the same levels of collaborative effort and experimental rigour that were deployed in support of the recommended-method approach in the field of clinical enzymology. As soon as possible,organizing committee for clinical laboratory standrdization which comprised by clinical laboratorians, clinical pathologists, health administration authorities and manufacturer should be established in Korea.
|