Hepcidin reference material

Secundary reference material for hepcidin assays

An important step toward the international use of hepcidin in both diagnostics and research is  harmonization of hepcidin assays worldwide. Consensus among the hepcidin results for various methods is necessary to facilitate interpretation of clinical studies and  future implementation of assays in the clinic. This will enable the establishment of uniform reference intervals and decision limits, and ultimately standardization.

 

The degree of equivalence between results can be improved by the appliance of a commutable secondary reference material, as recently developed by Hepcidinanalysis.com.1,2 The reference material is based on the principle of two-point calibration, and therefore consists of two lyophilized samples representing two levels in order to increase the accuracy. These samples cover both the lower and middle range of the hepcidin reference range and are produced following technical procedures to achieve efficient harmonization, as recently developed by the International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR).3

 

Currently, hepcidin levels continue to differ between labs. Recently, a so called candidate primary reference has been developed by the Laboratoire National de métrologie et d’Essais (LNE), based in Paris, France. In collaboration with LNE, we are working towards true standardization of worldwide hepcidin assays by assigning a value to our recently produced commutable secondary reference material using their primary reference material.

Usage of this material in reliable hepcidin assays worldwide, including all laboratories and manufacturers of diagnostic kits, will benefit the clinical, pharmaceutical and research communities by ensuring comparable results, uniform reference values and clinical decision limits.

 

As of now, we have assigned two values to our reference material by 1) our own validated WCX-MALDI-TOF assay and by 2) the mean of 9 assays worldwide as described in van der Vorm et al.1,2  This reference material can be used as an “on demand” external proficiency test for hepcidin assays. For more information or in case of interest in purchasing the material, please send an e-mail to hepcidinanalysis@radboudumc.nl.

 

References

  1. van der Vorm LN, Hendriks JC, Laarakkers CM, et al. Toward Worldwide Hepcidin Assay Harmonization: Identification of a Commutable Secondary Reference Material. Clin Chem. 2016; 62(7): 993-1001.
  2. Diepeveen LE, Weykamp C, Swinkels D, and participants in the hepcidin harmonization study 2016. Development of a commutable secondary reference material. 2016, report in preparation.
  3. Myers GL, Miller WG. The International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR) – A Pathway for Harmonization. EJIFCC. 2017; 27(1): 30–36.