Standardization in clinical enzymology: A challenge for the theory of metrological traceability

Ilenia Infusino, Gerhard Schumann, Ferruccio Ceriotti, Mauro Panteghini

Research output: Contribution to journalArticlepeer-review


The goal of standardization for measurement of the catalytic concentration of enzymes is to achieve comparable results in human samples, independent of the reagent kits, instruments, and laboratory where the assay is performed. To pursue this objective, the IFCC has established reference systems for the most important clinical enzymes. These systems are based on the following requirements: a) reference methods, well described and evaluated extensively; b) suitable reference materials; and c) reference laboratories operating in a highly controlled manner. When these reference systems are used appropriately, the diagnostic industry can assign traceable values to commercial calibrators. Clinical laboratories that use procedures with validated calibrators to measure human specimens can now obtain values that are traceable to higher-order reference procedures. These reference systems constitute the structure of the traceability chain to which the routine methods can be linked via an appropriate calibration process, provided that they have a comparable specificity (i.e., they are measuring the same catalytic quantity).

Original languageEnglish
Pages (from-to)301-307
Number of pages7
JournalClinical Chemistry and Laboratory Medicine
Issue number3
Publication statusPublished - Mar 1 2010


  • Calibration
  • Enzymes
  • IFCC reference methods
  • Reference values
  • Traceability

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical


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