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Original Article

Standardization of clinical enzyme analysis using frozen human serum pools with values assigned by the International Federation of Clinical Chemistry and Laboratory Medicine reference measurement procedures

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Pages 74-80 | Received 02 Jun 2017, Accepted 03 Dec 2017, Published online: 09 Dec 2017

References

  • Jansen R, Schumann G, Baadenhuijsen H, et al. Trueness verification and traceability assessment of results from commercial systems for measurement of six enzyme activities in serum: an international study in the EC4 framework of the Calibration 2000 project. Clin Chim Acta. 2006;368:160–167.
  • Xia C, Tong Q, Wang Q, et al. Application of five frozen human-pooled serum samples assigned by the International Federation of Clinical Chemistry Laboratory Medicine and reference procedure in a traceability investigation of gamma-glutamyltransferase catalytic concentration measurements in China. Ann Clin Biochem. 2010;47:189–194.
  • Wang Y, Wang J, Zhao H, et al. Assessment of enzyme measurement procedures in China through a trueness verification program. Clin Chim Acta. 2016;461:98–102.
  • Infusino I, Schumann G, Ceriotti F, et al. Standardization in clinical enzymology: a challenge for the theory of metrological traceability. Clin Chem Lab Med. 2010;48:301–307.
  • Vesper HW, Thienpont LM. Traceability in laboratory medicine. Clin Chem. 2009;55:1067–1075.
  • Panteghini M. Traceability, reference systems and result comparability. Clin Biochem Rev. 2007;28:97–104.
  • International Organization for Standardization (ISO). In vitro diagnostic medical devices -Measurement of quantities in biological samples –Metrological traceability of values assigned to calibrators and control materials. 1st ed. ISO 17511. Geneva (Switzerland): ISO; 2003.
  • International Organization for Standardization (ISO). 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. 1st ed. ISO 18153. Geneva, Switzerland: 2003.
  • Infusino I, Bonora R, Panteghini M. Traceability in clinical enzymology. Clin Biochem Rev. 2007;28:155–161.
  • Panteghini M. Traceability as a unique tool to improve standardization in laboratory medicine. Clin Biochem. 2009;42:236–240.
  • Jones GR. Laboratory analytical quality – the process continues. Clin Chem Lab Med. 2016;54:1275–1276.
  • Ge M, Zhao H, Yan Y, et al. Performance of electrolyte measurements assessed by a trueness verification program. Clin Chem Lab Med. 2016;54:1319–1327.
  • Plebani M. Harmonization of clinical laboratory information – current and future strategies. EJIFCC. 2016;27:15–22.
  • International Organization for Standardization (ISO). Reference materials – General and statistical principles for certification. 3rd ed. ISO Guide 35. Geneva, Switzerland: ISO; 2006.
  • Cattozzo G, Guerra E, Ceriotti F, Enzyme Working Group of the Italian Society of Clinical B, Clinical Molecular B, et al. Commutable calibrator with value assigned by the IFCC reference procedure to harmonize serum lactate dehydrogenase activity results measured by 2 different methods. Clin Chem. 2008;54:1349–1355.
  • Rami L, Roura M, Canalias F. Evaluation of commutability of several materials for harmonization alkaline phosphatase catalytic concentration measurements. Clin Chim Acta. 2012;413:1249–1254.
  • Clinical and Laboratory Standards Institute (CLSI). Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline. 1st ed. CLSI document C37-A. Wayne, PA: CLSI; 1999.
  • Myers GL, Miller WG, Coresh J, National Kidney Disease Education Program Laboratory Working G, et al. Recommendations for improving serum creatinine measurement: a report from the Laboratory Working Group of the National Kidney Disease Education Program. Clin Chem. 2006;52:5–18.
  • Zhang S, Zeng J, Zhang C, et al. Commutability of possible external quality assessment materials for cardiac troponin measurement. PLoS One. 2014;9:e102046.
  • Thienpont LM, Van Uytfanghe K, De Leenheer AP. Reference measurement systems in clinical chemistry. Clin Chim Acta. 2002;323:73–87.
  • Panteghini M. The never-ending search of an acceptable compromise for pancreatic lipase standardisation. Clin Chem Lab Med. 2012;50:419–421.
  • Goossens K, Van Uytfanghe K, Thienpont LM. Trueness and comparability assessment of widely used assays for 5 common enzymes and 3 electrolytes. Clin Chim Acta. 2015;442:44–45.

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