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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

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Standardizing plasma protein measurements worldwide: a challenging enterprise

Giampaolo Merlini1 / Søren Blirup-Jensen2 / A. Myron Johnson3 / Joanna Sheldon4 / Ingrid Zegers5 /

1Biotechnology Research Laboratories, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Department of Biochemistry, University of Pavia, Pavia, Italy

2Department of Clinical Chemistry, University Hospital, Lund, Sweden

3Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, USA

4Protein Reference Unit, St. George's Hospital, Blackshaw Road, London, UK

5Institute for Reference Materials and Measurements (IRMM), Joint Research Centre, European Commission, Geel, Belgium

Corresponding author: Giampaolo Merlini, Biotechnology Research Laboratories, Fondazione IRCCS Policlinico San Matteo, Department of Biochemistry, University of Pavia, P.le Golgi, 19, 27100 Pavia, Italy Phone: +39-0382-502995, Fax: +39-0382-502990,

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 48, Issue 11, Pages 1567–1575, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2010.314, October 2010

Publication History

Published Online:


The need for harmonizing laboratory results is particularly intense in the field of quantitative protein assays in consideration of the clinical impact of specific protein measurements and their relevance in monitoring disease. We report the efforts made by the Committee on Plasma Proteins of the IFCC Scientific Division to achieve worldwide comparability in plasma protein results. We focus on the production of reference materials and the methods applied throughout their production process. Particularly, the recent characterization of ERM-DA470k/IFCC and ERM-DA472/IFCC has demonstrated that it is possible to reproduce the earlier established procedures and thereby maintain standardization. Plasma protein reference materials have had a substantial impact in improving the harmonization of patient protein results that should translate into better patient care.

Clin Chem Lab Med 2010;48:1567–75.

Keywords: harmonization; plasma proteins; reference material; traceability

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