Metrological traceability of values for catalytic concentration of enzymes assigned to a calibration material
-
Francesca Canalias
Abstract
Background: The metrological traceability of values for the catalytic concentration of several enzymes assigned to a calibration material has been assured by following the recently published International Standard ISO 18153.
Methods: A traceable value with a measurement uncertainty was assigned for the catalytic concentration of alanine aminotransferase, creatine kinase, γ-glutamyltransferase and lactate dehydrogenase in two materials from different sources. These are all measurable quantities, with the primary reference measurement procedure described by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and a primary calibrator giving metrological traceability to the SI unit of measurement. The metrologically traceable calibration was validated by measuring human serum samples using the primary reference measurement procedure and a routine commercial measurement procedure calibrated with the traceable materials.
Results: Results showed that the primary reference procedure, selected manufacturers' procedures and the end-user's routine procedure for each enzyme have the same analytical specificity. Four of eight commercial calibrators tested were commutable, whereas the others had a very small difference in absolute terms, indicating that these materials would be useful for calibration.
Conclusion: The implementation of a reference system for enzyme measurements was demonstrated that assures the traceability of patient results to SI units.
References
1. Directive 98/79/EC of the European Parliament and the Council of 27 October 1998 on in vitro diagnostic medical devices.Suche in Google Scholar
2. International Organization for Standardization. Medical laboratories – particular requirements for quality and competence. ISO 15189. Geneva: ISO, 2003.Suche in Google Scholar
3. International Organization for Standardization. In vitro diagnostic medical devices – measurement of quantities in biological samples – metrological traceability of values assigned to calibrators and control materials. ISO 17511. Geneva: ISO, 2003.Suche in Google Scholar
4. International Organization for Standardization. In vitro diagnostic medical devices – measurement of quantities in biological samples – metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials. ISO 18153. Geneva: ISO, 2003.Suche in Google Scholar
5. Siekmann L, Bonora R, Burtis CA, Ceriotti F, Clerc-Renaud P, Férard G, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C. Part 1. The concept of reference procedures for the measurement of catalytic activity concentrations of enzymes. Clin Chem Lab Med 2002; 40:631–4.10.1515/CCLM.2002.109Suche in Google Scholar PubMed
6. Schumann G, Bonora R, Ceriotti F, Clerc-Renaud P, Ferrero CA, Férard G, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C. Part 2. Reference procedure for the measurement of catalytic concentration of creatine kinase. Clin Chem Lab Med 2002; 40:635–42.10.1515/CCLM.2002.110Suche in Google Scholar PubMed
7. Schumann G, Bonora R, Ceriotti F, Clerc-Renaud P, Ferrero CA, Férard G, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C. Part 3. Reference procedure for the measurement of catalytic concentration of lactate dehydrogenase. Clin Chem Lab Med 2002; 40:643–8.10.1515/CCLM.2002.111Suche in Google Scholar PubMed
8. Schumann G, Bonora R, Ceriotti F, Férard G, Ferrero CA, Franck PF, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C. Part 4. Reference procedure for the measurement of catalytic concentration of alanine aminotransferase. Clin Chem Lab Med 2002; 40:718–24.10.1515/CCLM.2002.124Suche in Google Scholar PubMed
9. Schumann G, Bonora R, Ceriotti F, Férard G, Ferrero CA, Franck PF, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C. Part 5. Reference procedure for the measurement of catalytic concentration of aspartate aminotransferase. Clin Chem Lab Med 2002; 40:725–33.10.1515/CCLM.2002.125Suche in Google Scholar PubMed
10. Schumann G, Bonora R, Ceriotti F, Férard G, Ferrero CA, Franck PF, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C. Part 6. Reference procedure for the measurement of catalytic concentration of γ-glutamyltransferase. Clin Chem Lab Med 2002; 40:734–8.Suche in Google Scholar
11. Siekmann L, Bonora R, Burtis CA, Ceriotti F, Clerc-Renaud P, Férard G, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C. Part 7. Certification of four reference materials for the determination of γ-glutamyltransferase, lactate dehydrogenase, alanine aminotransferase and creatine kinase according to IFCC reference procedures at 37°C. Clin Chem Lab Med 2002; 40:631–4.10.1515/CCLM.2002.127Suche in Google Scholar PubMed
12. Ellison SL, Rosslein M, Williams A, editors. EURACHEM/CITAC guide. Quantifying uncertainty in analytical measurement, 2nd ed. EURACHEM, 2000 (http://www.vtt.fi/ket/eurachem/quam2000-p1.pdf).Suche in Google Scholar
13. Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. J Clin Chem Clin Biochem 1983; 21:709–20.Suche in Google Scholar
©2006 by Walter de Gruyter Berlin New York
Artikel in diesem Heft
- Recent advances in physiological calcium homeostasis
- Associations of apolipoprotein E exon 4 and lipoprotein lipase S447X polymorphisms with acute ischemic stroke and myocardial infarction
- Association of angiotensin II type 1 receptor gene polymorphism with carotid atherosclerosis
- Comparison of the TaqMan and LightCycler systems in pharmacogenetic testing: evaluation of CYP2C9*2/*3 polymorphisms
- Urinary cystatin C as a specific marker of tubular dysfunction
- Time-resolved fluorimetric immunoassay of calprotectin: technical and clinical aspects in diagnosis of inflammatory bowel diseases
- Direct and fast determination of antiretroviral drugs by automated online solid-phase extraction-liquid chromatography-tandem mass spectrometry in human plasma
- Markers of oxidative stress in children with Down syndrome
- Influence of hemolysis on routine clinical chemistry testing
- C-Reactive protein and neopterin levels in healthy non-obese adults
- Comparison of the lipid profile and lipoprotein(a) between sedentary and highly trained subjects
- Clinical outcome estimates based on treatment target limits of laboratory tests: proposal for a plot visualizing effects and differences of medical target setting exemplified by glycemic control in diabetes
- Metrological traceability of values for catalytic concentration of enzymes assigned to a calibration material
- Evaluation of a new Sebia kit for analysis of hemoglobin fractions and variants on the Capillarys® system
- Recommendation for measuring and reporting chloride by ISEs in undiluted serum, plasma or blood: International Federation of Clinical Chemistry and Laboratory Medicine (IFCC): IFCC Scientific Division, Committee on Point of Care Testing and Working Group on Selective Electrodes
- Diluent Multiassay for the MODULAR ANALYTICS E170 does not improve TSH dilutions compared to Diluent Universal
Artikel in diesem Heft
- Recent advances in physiological calcium homeostasis
- Associations of apolipoprotein E exon 4 and lipoprotein lipase S447X polymorphisms with acute ischemic stroke and myocardial infarction
- Association of angiotensin II type 1 receptor gene polymorphism with carotid atherosclerosis
- Comparison of the TaqMan and LightCycler systems in pharmacogenetic testing: evaluation of CYP2C9*2/*3 polymorphisms
- Urinary cystatin C as a specific marker of tubular dysfunction
- Time-resolved fluorimetric immunoassay of calprotectin: technical and clinical aspects in diagnosis of inflammatory bowel diseases
- Direct and fast determination of antiretroviral drugs by automated online solid-phase extraction-liquid chromatography-tandem mass spectrometry in human plasma
- Markers of oxidative stress in children with Down syndrome
- Influence of hemolysis on routine clinical chemistry testing
- C-Reactive protein and neopterin levels in healthy non-obese adults
- Comparison of the lipid profile and lipoprotein(a) between sedentary and highly trained subjects
- Clinical outcome estimates based on treatment target limits of laboratory tests: proposal for a plot visualizing effects and differences of medical target setting exemplified by glycemic control in diabetes
- Metrological traceability of values for catalytic concentration of enzymes assigned to a calibration material
- Evaluation of a new Sebia kit for analysis of hemoglobin fractions and variants on the Capillarys® system
- Recommendation for measuring and reporting chloride by ISEs in undiluted serum, plasma or blood: International Federation of Clinical Chemistry and Laboratory Medicine (IFCC): IFCC Scientific Division, Committee on Point of Care Testing and Working Group on Selective Electrodes
- Diluent Multiassay for the MODULAR ANALYTICS E170 does not improve TSH dilutions compared to Diluent Universal
