Standardization of clinical enzyme assays.

During 1969, discussions between the Standards Subcommittee of the Laboratory Equipment and Methods Advisory Group of the Department of Health and Social Security and representatives of professional societies concerned with the assay of enzymes for diagnostic purposes led to the establishment of a working party to consider the current state of accuracy and reliability of diagnostic enzymology and to make recommendations for their improvement. The working party was based on one which was then in process of formation by the Association of Clinical Biochemists and its composition was chosen so that the Association of Clinical Pathologists and the Royal College of Pathologists would also be represented. This first report discusses the general principles of standardization of enzyme assays, and deals in detail with alkaline phosphatase, the commonest serum enzyme assay performed by a fixed time procedure. The second report will deal with aspartate and alanine transaminases, the commonest serum enzyme assays performed by a kinetic procedure.