Title: IFCC Working Group Recommendations for assessing commutability part 2: Using the Difference in Bias Between a Reference Material and Clinical Samples
Authors: NILSSON GORANBUDD JEFFREYGREENBERG NEELDELATOUR VINCENTREJ ROBERTPANTEGHINI M.CERIOTTI FERRUCCIOSCHIMMEL HEINZWEYKAMP CASKELLER THOMASCAMARA JOHANNABURNS CHRISVESPER HUBERTMACKENZIE FINLAYMILLER W. GREG
Citation: CLINICAL CHEMISTRY vol. 64 no. 2
Publisher: AMER ASSOC CLINICAL CHEMISTRY
Publication Year: 2017
JRC N°: JRC106619
ISSN: 0009-9147
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC106619
DOI: 10.1373/clinchem.2017.277541
Type: Articles in periodicals and books
Abstract: A process is described to assess the commutability of a reference material intended for use as a calibrator, trueness control or external quality assessment sample based on the difference in bias between a reference material and clinical samples measured using two different measuring systems. This difference in bias is compared to a criterion based on a medically relevant difference between a reference material and clinical sample results to make a conclusion regarding commutability. When more than two measuring systems are included, the commutability is assessed pair-wise for all combinations of two measuring systems. This approach allows the same criterion to be used for all combinations of measuring systems included in the assessment. The assessment is based on an error model that allows estimation of various random and systematic sources of error including that from sample specific effects of interfering substances. An advantage of this approach is that the difference in bias between a reference material and the average bias of clinical samples at the concentration (i.e. amount of substance present or quantity value) of the reference material is determined and its uncertainty estimated. A reference material is considered fit for purpose for those measuring systems where commutability is demonstrated.
JRC Directorate:Health, Consumers and Reference Materials

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