Traceability of values for catalytic activity concentration of enzymes: a Certified Reference Material for aspartate transaminase
-
Brigitte Toussaint
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.
©2010 by Walter de Gruyter Berlin New York
Articles in the same Issue
- Editorials
- The “Obamanomics”: a revolution in laboratory diagnostics
- Skeletal muscle biomarkers: not new but still interesting diagnostic tools
- Necessity for high-quality reference materials in the harmonization of laboratory assays
- Reviews
- Rhabdomyolysis: historical background, clinical, diagnostic and therapeutic features
- Biochemical markers of muscular damage
- Minireview
- Interpretation of serum parathyroid hormone concentrations in dialysis patients: what do the KDIGO guidelines change for the clinical laboratory?
- Guidelines and Recommendations
- 2010 Consensus statement on the worldwide standardization of the hemoglobin A1c measurement
- Genetics and Molecular Diagnostics
- Development of a low-cost real-time reverse transcriptase-polymerase chain reaction technique for the detection and quantification of hepatitis C viral load
- Microsatellite polymorphisms in intron 2 of the toll-like receptor 2 gene and their association with susceptibility to pulmonary tuberculosis in Han Chinese
- Evaluation of a panel of circulating DNA, RNA and protein potential markers for pathologies of pregnancy
- General Clinical Chemistry and Laboratory Medicine
- Traceability of values for catalytic activity concentration of enzymes: a Certified Reference Material for aspartate transaminase
- Development and preparation of a new serum protein reference material: feasibility studies and processing
- A WHO Reference Reagent for the Serum Transferrin Receptor (sTfR): international collaborative study to evaluate a recombinant soluble transferrin receptor preparation
- Hyperhomocysteinemia is not associated with reduced bone quality in humans with hip osteoarthritis
- Diagnostic performance of anti-citrullinated peptide antibodies for the diagnosis of rheumatoid arthritis: the relevance of likelihood ratios
- New quantitative electrochemiluminescence method (ECLIA) for interleukin-6 (IL-6) measurement
- Evaluation of cell counting and leukocyte differentiation in cerebrospinal fluid controls using hematology analyzers by the German Society for Clinical Chemistry and Laboratory Medicine
- Reference Values and Biological Variations
- The relationship of coffee and green tea consumption with high-sensitivity C-reactive protein in Japanese men and women
- Cancer Diagnostics
- Potential biomarkers for esophageal carcinoma detected by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry
- Identification of candidate molecular markers predicting chemotherapy resistance in non-small cell lung cancer
- Factors affecting soluble mesothelin related protein levels in an asbestos-exposed population
- Cardiovascular Diseases
- Dynamic changes in N-terminal pro-brain natriuretic peptide in acute coronary syndromes treated with percutaneous coronary intervention: a marker of ischemic burden, reperfusion and outcome
- Performance characteristics of a microfluidic Lab-on-Chip electrophoresis system for high-density lipoprotein (HDL) subfraction separation and measurement
- Letters to the Editor
- Hemolysis correction factor in the measurement of serum neuron-specific enolase
- Serum paraoxonase-1 activity and genetic polymorphisms: common errors in measurement and interpretation of results
- Neuropharmacology of schizophrenia: is there a role for leptin?
- Relationship between serum concentrations of keratin-18 and apoptosis in chronic hepatitis C
Articles in the same Issue
- Editorials
- The “Obamanomics”: a revolution in laboratory diagnostics
- Skeletal muscle biomarkers: not new but still interesting diagnostic tools
- Necessity for high-quality reference materials in the harmonization of laboratory assays
- Reviews
- Rhabdomyolysis: historical background, clinical, diagnostic and therapeutic features
- Biochemical markers of muscular damage
- Minireview
- Interpretation of serum parathyroid hormone concentrations in dialysis patients: what do the KDIGO guidelines change for the clinical laboratory?
- Guidelines and Recommendations
- 2010 Consensus statement on the worldwide standardization of the hemoglobin A1c measurement
- Genetics and Molecular Diagnostics
- Development of a low-cost real-time reverse transcriptase-polymerase chain reaction technique for the detection and quantification of hepatitis C viral load
- Microsatellite polymorphisms in intron 2 of the toll-like receptor 2 gene and their association with susceptibility to pulmonary tuberculosis in Han Chinese
- Evaluation of a panel of circulating DNA, RNA and protein potential markers for pathologies of pregnancy
- General Clinical Chemistry and Laboratory Medicine
- Traceability of values for catalytic activity concentration of enzymes: a Certified Reference Material for aspartate transaminase
- Development and preparation of a new serum protein reference material: feasibility studies and processing
- A WHO Reference Reagent for the Serum Transferrin Receptor (sTfR): international collaborative study to evaluate a recombinant soluble transferrin receptor preparation
- Hyperhomocysteinemia is not associated with reduced bone quality in humans with hip osteoarthritis
- Diagnostic performance of anti-citrullinated peptide antibodies for the diagnosis of rheumatoid arthritis: the relevance of likelihood ratios
- New quantitative electrochemiluminescence method (ECLIA) for interleukin-6 (IL-6) measurement
- Evaluation of cell counting and leukocyte differentiation in cerebrospinal fluid controls using hematology analyzers by the German Society for Clinical Chemistry and Laboratory Medicine
- Reference Values and Biological Variations
- The relationship of coffee and green tea consumption with high-sensitivity C-reactive protein in Japanese men and women
- Cancer Diagnostics
- Potential biomarkers for esophageal carcinoma detected by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry
- Identification of candidate molecular markers predicting chemotherapy resistance in non-small cell lung cancer
- Factors affecting soluble mesothelin related protein levels in an asbestos-exposed population
- Cardiovascular Diseases
- Dynamic changes in N-terminal pro-brain natriuretic peptide in acute coronary syndromes treated with percutaneous coronary intervention: a marker of ischemic burden, reperfusion and outcome
- Performance characteristics of a microfluidic Lab-on-Chip electrophoresis system for high-density lipoprotein (HDL) subfraction separation and measurement
- Letters to the Editor
- Hemolysis correction factor in the measurement of serum neuron-specific enolase
- Serum paraoxonase-1 activity and genetic polymorphisms: common errors in measurement and interpretation of results
- Neuropharmacology of schizophrenia: is there a role for leptin?
- Relationship between serum concentrations of keratin-18 and apoptosis in chronic hepatitis C