Traceability of values for catalytic activity concentration of enzymes: a Certified Reference Material for aspartate transaminase
Autor: | Heinz Schimmel, Poul J. Jørgensen, Francesca Canalias, Georges Férard, F. Javier Gella, Joseph Henny, Shigeru Ueda, Mauro Panteghini, Daniel Mazziotta, Rainer Klauke, Hendrik Emons, Brigitte Toussaint, Jean Marc Lessinger, Steffen Dipl C Bossert-Reuther, Gerhard Schumann, Ferruccio Ceriotti, Carlo A. Ferrero, Paul F H Franck |
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Rok vydání: | 2010 |
Předmět: |
Clinical Biochemistry
Aspartate transaminase Human type Liver enzyme Animals Humans Medicine Aspartate Aminotransferases chemistry.chemical_classification Chromatography biology business.industry Biochemistry (medical) Uncertainty Serum Albumin Bovine General Medicine Clinical Enzyme Tests Reference Standards Recombinant Proteins Enzyme Certified reference materials Biochemistry chemistry biology.protein Cattle Coverage factor business |
Zdroj: | cclm. 48:795-803 |
ISSN: | 1437-4331 1434-6621 |
Popis: | 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. |
Databáze: | OpenAIRE |
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