Standardizzazione in enzimologia clinica: Una sfida per la teoria della riferibilità metrologica

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

Ilenia Infusino, Ferruccio Ceriotti, Mauro Panteghini

Research output: Contribution to journalArticlepeer-review

Abstract

The goal of standardization for measurements of catalytic concentrations of enzymes is to achieve comparable results in human samples, independent of the reagent kits, instruments, and laboratory where the assay is carried out. To pursue this objective, the IFCC has established reference measurement systems for the most important clinical enzymes. These systems are based on the following requirements: a) reference methods, well described in procedures that are extensively evaluated; b) suitable reference materials; and c) reference laboratories operating in a highly controlled manner. Using these reference systems appropriately, the diagnostic industry can assign traceable values to commercial calibrators. Clinical laboratories, which use routine procedures with validated calibrators to measure human specimens, can finally obtain values which 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).

Translated title of the contributionStandardization in clinical enzymology: A challenge for the theory of metrological traceability
Original languageItalian
Pages (from-to)96-102
Number of pages7
JournalBiochimica Clinica
Volume34
Issue number2
Publication statusPublished - Apr 2010

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical
  • Medical Laboratory Technology

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