IFCC working group recommendations for assessing commutability part 1: General experimental design

W. Greg Miller, Heinz Schimmel, Robert Rej, Neil Greenberg, Ferruccio Ceriotti, Chris Burns, Jeffrey R. Budd, Cas Weykamp, Vincent Delatour, Göran Nilsson, Finlay MacKenzie, Mauro Panteghini, Thomas Keller, Johanna E. Camara, Ingrid Zegers, Hubert W. Vesper

Research output: Contribution to journalArticlepeer-review

Abstract

Commutability is a property of a reference material (RM) that relates to the closeness of agreement between results for an RM and results for clinical samples (CSs) when measured by 2 measurement procedures (MPs). Commutability of RMs used in a calibration traceability scheme is an essential property for them to be fit for purpose. Similarly, commutability of trueness controls or external quality assessment samples is essential when those materials are used to assess trueness of results for CSs. This report is part 1 of a 3-part series describing how to assess commutability of RMs. Part 1 defines commutability and addresses critical components of the experimental design for commutability assessment, including selection of individual CSs, use of pooled CSs, qualification of MPs for inclusion, establishing criteria for the determination that an RM is commutable, generalization of commutability conclusions to future measurements made with the MPs included in the assessment, and information regarding commutability to be included in the certificate for an RM. Parts 2 and 3 in the series present 2 different statistical approaches to commutability assessment that use fixed criteria related to the medical decisions that will be made using the laboratory test results.

Original languageEnglish
Pages (from-to)447-454
Number of pages8
JournalClinical Chemistry
Volume64
Issue number3
DOIs
Publication statusPublished - Mar 1 2018

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

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