Reference : Provisional standardization of hepcidin assays: Creating a traceability chain with a ...
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/258830
Provisional standardization of hepcidin assays: Creating a traceability chain with a primary reference material, candidate reference method and a commutable secondary reference material
English
Diepeveen, L. E. [Department of Laboratory Medicine, Radboud University Medical Center, Translational Metabolic Laboratory (830), P.O. Box 9101, Nijmegen, 6500 HB, Netherlands, Hepcidinanalysis.com, Nijmegen, Netherlands]
Laarakkers, C. M. M. [Department of Laboratory Medicine, Radboud University Medical Center, Translational Metabolic Laboratory (830), P.O. Box 9101, Nijmegen, 6500 HB, Netherlands, Hepcidinanalysis.com, Nijmegen, Netherlands]
Martos, G. [Laboratoire National de Métrologie et d'Essais (LNE), Paris, France, Departement de Chimie, Bureau International des Poids et Mesures (BIPM), Sèvres, France]
Pawlak, M. E. [Department of Laboratory Medicine, Radboud University Medical Center, Translational Metabolic Laboratory (830), P.O. Box 9101, Nijmegen, 6500 HB, Netherlands]
Uǧuz, F. F. [Department of Laboratory Medicine, Radboud University Medical Center, Translational Metabolic Laboratory (830), P.O. Box 9101, Nijmegen, 6500 HB, Netherlands]
Verberne, K. E. S. A. [Department of Laboratory Medicine, Radboud University Medical Center, Translational Metabolic Laboratory (830), P.O. Box 9101, Nijmegen, 6500 HB, Netherlands]
Van Swelm, R. P. L. [Department of Laboratory Medicine, Radboud University Medical Center, Translational Metabolic Laboratory (830), P.O. Box 9101, Nijmegen, 6500 HB, Netherlands, Hepcidinanalysis.com, Nijmegen, Netherlands]
Klaver, S. [Department of Laboratory Medicine, Radboud University Medical Center, Translational Metabolic Laboratory (830), P.O. Box 9101, Nijmegen, 6500 HB, Netherlands, Hepcidinanalysis.com, Nijmegen, Netherlands]
De Haan, A. F. J. [Department for Health Evidence, Radboud University Medical Center, Nijmegen, Netherlands]
Pitts, K. R. [Corgenix Medical Corporation, Broomfield, CO, United States]
Bansal, S. S. [Institute of Pharmaceutical Sciences, King's College London, London, United Kingdom]
Abbas, I. M. [Division 1.5 Protein Analysis, Federal Institute for Materials Research and Testing (BAM), Berlin, Germany]
Fillet, Marianne mailto [Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments >]
Lefebvre, T. [French Center of Porphyria, INSERM U1149, Sorbonne Paris Cité University, Labex GR-Ex, Louis Mourier Hospital APHP, Colombes, France]
Geurts-Moespot, A. J. [Department of Laboratory Medicine, Radboud University Medical Center, Translational Metabolic Laboratory (830), P.O. Box 9101, Nijmegen, 6500 HB, Netherlands]
Girelli, D. [Department of Medicine, University of Verona, Verona, Italy]
Castagna, A. [Department of Medicine, University of Verona, Verona, Italy]
Herkert, M. [DRG Instruments, Marburg, Germany]
Itkonen, O. [Laboratory Division HUSLAB, Helsinki University Central Hospital, Helsinki, Finland]
Olbina, G. [Intrinsic Life Sciences, San Diego, CA, United States]
Tomosugi, N. [Division of Advanced Medicine, Kanazawa Medical University, Ishikawa, Japan]
Westerman, M. E. [Intrinsic Life Sciences, San Diego, CA, United States]
Delatour, V. [Laboratoire National de Métrologie et d'Essais (LNE), Paris, France]
Weykamp, C. W. [Department of Clinical Chemistry, Queen Beatrix Hospital, Winterswijk, Netherlands]
Swinkels, D. W. [Department of Laboratory Medicine, Radboud University Medical Center, Translational Metabolic Laboratory (830), P.O. Box 9101, Nijmegen, 6500 HB, Netherlands, Hepcidinanalysis.com, Nijmegen, Netherlands]
2018
Clinical Chemistry and Laboratory Medicine
De Gruyter
Yes (verified by ORBi)
International
1434-6621
1437-4331
[en] inter labo ; hepcidin ; standardization
[en] Hepcidin concentrations measured by various methods differ considerably, complicating interpretation. Here, a previously identified plasma-based candidate secondary reference material (csRM) was modified into a serum-based two-leveled sRM. We validated its functionality to increase the equivalence between methods for international standardization. We applied technical procedures developed by the International Consortium for Harmonization of Clinical Laboratory Results. The sRM, consisting of lyophilized serum with cryolyoprotectant, appeared commutable among nine different measurement procedures using 16 native human serum samples in a first round robin (RR1). Harmonization potential of the sRM was simulated in RR1 and evaluated in practice in RR2 among 11 measurement procedures using three native human plasma samples. Comprehensive purity analysis of a candidate primary RM (cpRM) was performed by state of the art procedures. The sRM was value assigned with an isotope dilution mass spectrometry-based candidate reference method calibrated using the certified pRM. The inter-assay CV without harmonization was 42.1% and 52.8% in RR1 and RR2, respectively. In RR1, simulation of harmonization with sRM resulted in an inter-assay CV of 11.0%, whereas in RR2 calibration with the material resulted in an inter-assay CV of 19.1%. Both the sRM and pRM passed international homogeneity criteria and showed long-term stability. We assigned values to the low (0.95±0.11 nmol/L) and middle concentration (3.75±0.17 nmol/L) calibrators of the sRM. Standardization of hepcidin is possible with our sRM, which value is assigned by a pRM. We propose the implementation of this material as an international calibrator for hepcidin. © 2018 Walter de Gruyter GmbH, Berlin/Boston.
Centre Interdisciplinaire de Recherche sur le Médicament - CIRM
http://hdl.handle.net/2268/258830
10.1515/cclm-2018-0783

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