Commutability is a property of a reference material (RM) that relates to the closeness of agreement between results for an RM and resultsfor 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.

IFCC Working Group Recommendations for Assessing Commutability Part 1: General Experimental Design / W.G. Miller, H. Schimmel, R. Rej, N. Greenberg, F. Ceriotti, C. Burns, J.R. Budd, C. Weykamp, V. Delatour, G. Nilsson, F. Mackenzie, M. Panteghini, T. Keller, J.E. Camara, I. Zegers, H.W. Vesper. - In: CLINICAL CHEMISTRY. - ISSN 0009-9147. - 64:3(2018 Feb), pp. 447-454.

IFCC Working Group Recommendations for Assessing Commutability Part 1: General Experimental Design

M. Panteghini;
2018

Abstract

Commutability is a property of a reference material (RM) that relates to the closeness of agreement between results for an RM and resultsfor 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.
Settore BIO/12 - Biochimica Clinica e Biologia Molecolare Clinica
feb-2018
Centro per la riferibilità Metrologica in Medicina di Laboratorio (CIRME)
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/558970
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