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Traceability of values for catalytic activity concentration of enzymes: a Certified Reference Material for aspartate transaminase

  • Brigitte Toussaint , Hendrik Emons , Heinz G. Schimmel , Steffen Bossert-Reuther , Francesca Canalias , Ferruccio Ceriotti , Georges Férard , Carlo A. Ferrero , Paul F.H. Franck , F. Javier Gella , Joseph Henny , Poul J. Jørgensen , Rainer Klauke , Jean-Marc Lessinger , Daniel Mazziotta , Mauro Panteghini , Shigeru Ueda , Gerhard Schumann and on behalf of the IFCC Committee on Reference Systems for Enzymes
Published/Copyright: May 4, 2010

Abstract

Background: A new reference material for the liver enzyme aspartate transaminase (AST) (L-aspartate: 2-oxoglutarate-aminotransferase, EC 2.6.1.1), also called aspartate aminotransferase (ASAT), has been developed under the code ERM-AD457/IFCC. This certified reference material (CRM) for AST has been produced from a human type recombinant AST expressed in Escherichia coli and a buffer containing bovine serum albumin, and has been lyophilised.

Methods: The homogeneity and the stability of the material have been tested and the catalytic activity concentration has been characterised by 12 laboratories using the reference procedure for AST at 37°C from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).

Results: The certified catalytic activity concentration and certified uncertainty of AST in the reconstituted material are (1.74±0.05) μkat/L or (104.6±2.7) U/L (with a coverage factor k=2; 95% confidence interval).

Conclusions: Both the certified value and uncertainty are traceable to the International System of Units (SI). The material is aiming to control the IFCC reference procedure for AST at 37°C, which will then be used to assign values to calibrants and control materials. The present paper highlights the scientific challenges and innovations which were encountered during the development of this new CRM.

Clin Chem Lab Med 2010;48:795–803.


Corresponding author: Brigitte Toussaint, Institute for Reference Materials and Measurements (IRMM), Joint Research Centre, European Commission, Retieseweg 111, 2440 Geel, Belgium Phone: +32-14-571-339, Fax: +32-14-571-548,

Received: 2009-12-21
Accepted: 2010-2-15
Published Online: 2010-05-4
Published in Print: 2010-06-01

©2010 by Walter de Gruyter Berlin New York

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