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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


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Volume 57, Issue 7

Issues

Commutability of reference and control materials: an essential factor for assuring the quality of measurements in Laboratory Medicine

Federica Braga
  • Corresponding author
  • Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), University of Milan, Via G.B. Grassi 74, Milano, Italy, Phone: +39 02 39042766
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Mauro Panteghini
  • Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), University of Milan, Milano, Italy
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2019-03-23 | DOI: https://doi.org/10.1515/cclm-2019-0154

Abstract

Traceability to a common reference ensures equivalence of results obtained by different assays. Traceability is achieved by an unbroken sequence of calibrations, using reference materials (RMs) that must be commutable. Using non-commutable RMs for calibration will introduce a bias in the calibrated method producing incorrect results for clinical samples (CS). Commutability was defined in 1973 as “the ability of an enzyme material to show inter-assay activity changes comparable to those of the same enzyme in human serum” and later extended as a characteristic of all RMs. However, the concept is still poorly understood and appreciated. Commutability assessment has been covered in CLSI guidelines and requires: (a) selection of 20 CS spanning the relevant concentration range; (b) analysis of both RM and CS with the pair of procedures; (c) data elaboration using regression analysis and calculation if RM fall within the 95% prediction interval defined by CS. This approach has been criticized and to improve it The International Federation of Clinical Chemistry and Laboratory Medicine established a working group that recently finalized recommendations. Commutability is also a requirement for the applicability of external quality assessment (EQA) results in the evaluation of the performance of participating laboratories in terms of standardization of their measurements. Unfortunately, EQA materials are usually not validated for commutability.

Keywords: commutability; standardization; uncertainty

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About the article

Received: 2019-02-08

Accepted: 2019-02-25

Published Online: 2019-03-23

Published in Print: 2019-06-26


Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 57, Issue 7, Pages 967–973, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2019-0154.

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