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Clin Chem. 2016 Jul;62(7):993-1001. doi: 10.1373/clinchem.2016.256768. Epub 2016 May 12.

Toward Worldwide Hepcidin Assay Harmonization: Identification of a Commutable Secondary Reference Material.

Author information

1
Department of Laboratory Medicine and.
2
Department of Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands;
3
Department of Laboratory Medicine and Hepcidinanalysis.com, Nijmegen, the Netherlands;
4
MRC Human Immunology Unit, Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, UK, and Blood Theme, NIHR Oxford Biomedical Research Centre, Oxford, UK;
5
Corgenix Medical Corporation, Broomfield, CO;
6
Department of Medicine, University of Verona, Verona, Italy;
7
DRG Instruments, Marburg, Germany;
8
Helsinki University Central Hospital, Laboratory Division HUSLAB, Helsinki, Finland;
9
Eli Lilly and Company, Indianapolis, IN;
10
Division of Advanced Medicine, Medical Research Institute, Kanazawa Medical University, Ishikawa, Japan;
11
Intrinsic LifeSciences, La Jolla, CA;
12
Institute of Pharmaceutical Sciences, King's College London, London, UK;
13
Department of Analytical Pharmaceutical Chemistry, Institute of Pharmacy, University of Liège, Liège, Belgium;
14
Department of Diagnostics and Public Health, University of Verona, Italy;
15
Department of Clinical Chemistry, Queen Beatrix Hospital, Winterswijk, the Netherlands.
16
Department of Laboratory Medicine and Hepcidinanalysis.com, Nijmegen, the Netherlands; dorine.swinkels@radboudumc.nl.

Abstract

BACKGROUND:

Absolute plasma hepcidin concentrations measured by various procedures differ substantially, complicating interpretation of results and rendering reference intervals method dependent. We investigated the degree of equivalence achievable by harmonization and the identification of a commutable secondary reference material to accomplish this goal.

METHODS:

We applied technical procedures to achieve harmonization developed by the Consortium for Harmonization of Clinical Laboratory Results. Eleven plasma hepcidin measurement procedures (5 mass spectrometry based and 6 immunochemical based) quantified native individual plasma samples (n = 32) and native plasma pools (n = 8) to assess analytical performance and current and achievable equivalence. In addition, 8 types of candidate reference materials (3 concentrations each, n = 24) were assessed for their suitability, most notably in terms of commutability, to serve as secondary reference material.

RESULTS:

Absolute hepcidin values and reproducibility (intrameasurement procedure CVs 2.9%-8.7%) differed substantially between measurement procedures, but all were linear and correlated well. The current equivalence (intermeasurement procedure CV 28.6%) between the methods was mainly attributable to differences in calibration and could thus be improved by harmonization with a common calibrator. Linear regression analysis and standardized residuals showed that a candidate reference material consisting of native lyophilized plasma with cryolyoprotectant was commutable for all measurement procedures. Mathematically simulated harmonization with this calibrator resulted in a maximum achievable equivalence of 7.7%.

CONCLUSIONS:

The secondary reference material identified in this study has the potential to substantially improve equivalence between hepcidin measurement procedures and contributes to the establishment of a traceability chain that will ultimately allow standardization of hepcidin measurement results.

PMID:
27173010
DOI:
10.1373/clinchem.2016.256768
[Indexed for MEDLINE]
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