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Clinical Chemistry 19: 5-9, 1973;
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Clinical Chemistry, Vol 19, 5-9, Copyright © 1973 by the American Association for Clinical Chemistry

A Discussion of Enzyme Reference Materials: Applications and Specifications

Charles F. Fasce Jr. 1, Robert Rej 1, William H. Copeland 1, and Raymond E. Vanderlinde 1

1 From the Division of Laboratories and Research, New York State Department of Health, New Scotland Ave., Albany, N.Y. 12201

Clinical laboratories estimating enzyme activity in serum are using commercial lyophilized sera for four major purposes. These uses—as a standard and for intermethod, intramethod, and precision control—are segregated, and specifications for each deployment are examined in terms of requirements for the enzyme material: freedom from interfering or indicator enzymes and chromogens; high specific activity; inclusion of optimal cofactor concentrations; commutability, human properties and source; the presence of a single isoenzyme; and stability. The effects of serum matrix and variable assay conditions on the utility of enzyme materials are analyzed. Specifications differ for each enzyme material application. The compatibility of commercial lyophilized sera containing aspartate aminotransferase activity with several cited specifications is assessed


Key Words: commercial lyophilized reference sera • enzyme activity units • aspartate aminotransferase • assessment of interlaboratory accuracy and precision • origin of reference material

Submitted on July 12, 1972




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Copyright © 1973 by the American Association for Clinical Chemistry.