IFCC Working Group Recommendations for Correction of Bias Caused by Noncommutability of a Certified Reference Material Used in the Calibration Hierarchy of an End-User Measurement Procedure.

Miller, W Greg and Budd, Jeffrey and Greenberg, Neil and Weykamp, Cas and Althaus, Harald and Schimmel, Heinz and Panteghini, Mauro and Delatour, Vincent and Ceriotti, Ferruccio and Keller, Thomas and Hawkins, Douglas and Burns, Chris and Rej, Robert and Camara, Johanna E and MacKenzie, Finlay and van der Hagen, Eline and Vesper, Hubert (2020) IFCC Working Group Recommendations for Correction of Bias Caused by Noncommutability of a Certified Reference Material Used in the Calibration Hierarchy of an End-User Measurement Procedure. Clinical chemistry. ISSN 1530-8561. This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs

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Abstract

Establishing metrological traceability to an assigned value of a matrix-based certified reference material (CRM) that has been validated to be commutable among available end-user measurement procedures (MPs) is central to producing equivalent results for the measurand in clinical samples (CSs) irrespective of the clinical laboratory MPs used. When a CRM is not commutable with CSs, the bias due to noncommutability will be propagated to the CS results causing incorrect metrological traceability to the CRM and nonequivalent CS results among different MPs. In a commutability assessment, a conclusion that a CRM is commutable or noncommutable for use with a specific MP is made when the difference in bias between the CRM and CSs meets or does not meet a criterion for that specific MP when compared to other MPs. A conclusion regarding commutability or noncommutability requires that the magnitude of the difference in bias observed in the commutability assessment remains unchanged over time. This conclusion requires the CRM to be stable and no substantive changes in the MPs. These conditions should be periodically reverified. If an available CRM is determined to be noncommutable for a specific MP, that CRM can be used in the calibration hierarchy for that MP when an appropriately validated MP-specific correction for the noncommutability bias is included. We describe with examples how a MP-specific correction and its uncertainty can be developed and applied in a calibration hierarchy to achieve metrological traceability of results for CSs to the CRM's assigned value.

Item Type: Article
Additional Information: This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs
Subjects: WA Patients. Primary care. Medical profession. Forensic medicine
Divisions: Clinical Support
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Depositing User: Jamie Edgar
Date Deposited: 01 May 2020 12:40
Last Modified: 01 May 2020 12:40
URI: http://www.repository.uhblibrary.co.uk/id/eprint/3030

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