Impact of reference materials on accuracy in clinical chemistry

Carlo Franzini, Ferruccio Ceriotti

Research output: Contribution to journalArticlepeer-review

Abstract

The analytical accuracy of the results of routine clinical chemistry measurements is contributed by a two-steps mechanism, involving transferring trueness from a higher metrological and monitoring the time-stability of trueness itself. In both operations, different materials are used: however, accuracy in the routine assay of genuine patient samples has to be the end product of this overall process. To such an aim, the materials must show an intermethod behavior similar to that of patient sera, i.e., they have to show commutability. Definitions of commutability and methods for assessing such a property are mentioned. The following aspects of lack of cummutability of materials are then discussed: frequency; effects on the measured interlaboratory variability; and effects on the recalibration of analytical systems. The causes giving rise to lack of commutability are neither clear or easy to be shown. Matrix effect is one of the main causes; also, differences in the characterisics of the component being measured are often responsible for noncommutability of materials for enzyme activity measurements. Examples of these two different situations are given. It is concluded that, for an efficacious overall quality assurance process, either a set of minimally processed patient sera or commutable reference materials are to be used in the operations concerned with the control of trueness. An additional alternative approach is based on the use of materials with system-specific assigned values.

Original languageEnglish
Pages (from-to)449-457
Number of pages9
JournalClinical Biochemistry
Volume31
Issue number6
DOIs
Publication statusPublished - Aug 1998

Keywords

  • Accuracy
  • Commutability
  • Control materials
  • Reference materials

ASJC Scopus subject areas

  • Clinical Biochemistry

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