Lisa N van der Vorm1, Jan C M Hendriks2, Coby M Laarakkers3, Siem Klaver1, Andrew E Armitage4, Alison Bamberg5, Anneke J Geurts-Moespot1, Domenico Girelli6, Matthias Herkert7, Outi Itkonen8, Robert J Konrad9, Naohisa Tomosugi10, Mark Westerman11, Sukhvinder S Bansal12, Natascia Campostrini6, Hal Drakesmith4, Marianne Fillet13, Gordana Olbina11, Sant-Rayn Pasricha4, Kelly R Pitts5, John H Sloan9, Franco Tagliaro14, Cas W Weykamp15, Dorine W Swinkels16. 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.
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.
Authors: Sean Lynch; Christine M Pfeiffer; Michael K Georgieff; Gary Brittenham; Susan Fairweather-Tait; Richard F Hurrell; Harry J McArdle; Daniel J Raiten Journal: J Nutr Date: 2018-06-01 Impact factor: 4.798
Authors: Patrick Gutschow; Huiling Han; Gordana Olbina; Keith Westerman; Elizabeta Nemeth; Tomas Ganz; Karen Copeland; Mark Westerman; Vaughn Ostland Journal: J Appl Lab Med Date: 2020-09-01
Authors: Amat Bah; Sant-Rayn Pasricha; Momodou W Jallow; Ebrima A Sise; Rita Wegmuller; Andrew E Armitage; Hal Drakesmith; Sophie E Moore; Andrew M Prentice Journal: J Nutr Date: 2017-04-19 Impact factor: 4.798
Authors: Katherine Wray; Angela Allen; Emma Evans; Chris Fisher; Anuja Premawardhena; Lakshman Perera; Rexan Rodrigo; Gayan Goonathilaka; Lebbe Ramees; Craig Webster; Andrew E Armitage; Andrew M Prentice; David J Weatherall; Hal Drakesmith; Sant-Rayn Pasricha Journal: Am J Hematol Date: 2017-02 Impact factor: 10.047
Authors: Antonio Martin-Bastida; Bension Shlomo Tilley; Sukhi Bansal; Steve M Gentleman; David T Dexter; Roberta J Ward Journal: J Neural Transm (Vienna) Date: 2020-10-20 Impact factor: 3.575