Translation: Roadmap for Harmonization of Clinical Laboratory Measurement Procedures*

W. Greg Miller; Gary L. Myers; Mary Lou Gantzer; Stephen E. Kahn; E. Ralf Schönbrunner; Linda M. Thienpont; David M. Bunk; Robert H. Christenson; John H. Eckfeldt; Stanley F. Lo; C. Micha Nübling; Catharine M. Sturgeon

doi:10.3343/lmo.2012.2.1.1

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Miller, Myers, Gantzer, Kahn, Schönbrunner, Thienpont, Bunk, Christenson, Eckfeldt, Lo, Nübling, and Sturgeon: Translation: Roadmap for Harmonization of Clinical Laboratory Measurement Procedures*

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Clinical Chemistry

Laboratory Medicine Online

Laboratory Medicine Online 2012; 2(1): 1-9.

Published online: 1 January 2012

DOI: https://doi.org/10.3343/lmo.2012.2.1.1

Translation: Roadmap for Harmonization of Clinical Laboratory Measurement Procedures^*

W. Greg Miller¹, Gary L. Myers², Mary Lou Gantzer³, Stephen E. Kahn⁴, E. Ralf Schönbrunner⁵, Linda M. Thienpont⁶, David M. Bunk⁷, Robert H. Christenson⁸, John H. Eckfeldt⁹, Stanley F. Lo¹⁰, C. Micha Nübling¹¹, Catharine M. Sturgeon¹²

¹Virginia Commonwealth University, Richmond, VA, USA.

²AACC, Washington, USA.

³Siemens Healthcare Diagnostics, Newark, DE, USA.

⁴Loyola University Health System, Maywood, IL, USA.

⁵Life Technologies, Benicia, CA, USA.

⁶Ghent University, Ghent, Belgium.

⁷National Institute of Standards and Technology, Gaithersburg, MD, USA.

⁸University of Maryland, Baltimore, MD, USA.

⁹University of Minnesota, Minneapolis, MN, USA.

¹⁰Medical College of Wisconsin, Milwaukee, WI, USA.

¹¹Paul-Ehrlich Institut, Langen, Germany.

¹²Royal Infirmary of Edinburgh, Edinburgh, UK.

Translators: Kyung-Hun Lee, Junghan Song. Department of Laboratory Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. (songjhcp@snu.ac.kr). This article is translated from an English language article, originally published in Clinical Chemistry under agreement between the publishers of Laboratory Medicine Online and Clinical Chemistry. Acknowledgement and other information that is not directly related to the content of the article has not been translated, and thus omitted in this article. References are listed as they were in the original work. Original copyright © 2011 American Association for Clinical Chemistry, Inc.

Received 28 October 2011 Revised 28 October 2011 Accepted 28 October 2011

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Results between different clinical laboratory measurement procedures (CLMP) should be equivalent, within clinically meaningful limits, to enable optimal use of clinical guidelines for disease diagnosis and patient management. When laboratory test results are neither standardized nor harmonized, a different numeric result may be obtained for the same clinical sample. Unfortunately, some guidelines are based on test results from a specific laboratory measurement procedure without consideration of the possibility or likelihood of differences between various procedures. When this happens, aggregation of data from different clinical research investigations and development of appropriate clinical practice guidelines will be flawed. A lack of recognition that results are neither standardized nor harmonized may lead to erroneous clinical, financial, regulatory, or technical decisions.

Standardization of CLMPs has been accomplished for several measurands for which primary (pure substance) reference materials exist and/or reference measurement procedures (RMPs) have been developed. However, the harmonization of clinical laboratory procedures for measurands that do not have RMPs has been problematic owing to inadequate definition of the measurand, inadequate analytical specificity for the measurand, inadequate attention to the commutability of reference materials, and lack of a systematic approach for harmonization. To address these problems, an infrastructure must be developed to enable a systematic approach for identification and prioritization of measurands to be harmonized on the basis of clinical importance and technical feasibility, and for management of the technical implementation of a harmonization process for a specific measurand.

Figures and Tables

Fig. 1

Concept of commutability of results for reference materials with results for a panel of individual clinical samples. (A) results for commutable reference materials that have the same numeric relationship between 2 measurement procedures as observed for a panel of patient samples. (B) results for noncommutable reference materials that have a different numeric relationship between 2 measurement procedures than observed for the patient samples.

Fig. 2

Proposed schema for developing method harmonization criteria based on Kenny et al. (31). TE_a derived from allowable bias and imprecision, for the agreement of results among different measurement procedures.

Fig. 3

General process for assessing and achieving harmonization (equivalency) of clinical laboratory measurement results.

Fig. 4

Overview of a general approach to manage harmonization of a measurand.

Table 1

ISO 17511:2003 categories for reference systems

^*More than 1 secondary reference material, with potentially different properties, may be available for the same measurand.

Notes

This article is available from http://www.labmedonline.org

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