Hepcidin reference material

Secondary reference material for standardization of hepcidin assays

Currently, the absolute measurement of the hepcidin concentrations in the same sample differs between labs and assays. An important step toward the international use of hepcidin in both diagnostics and research is standardization 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, as results are comparable and tracable to SI units.

 

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

 

Recently, a so-called candidate primary RM has been developed by the Laboratoire National de métrologie et d’Essais (LNE RM hepcidin 501a), based in Paris, France. Using this primary RM we assigned a value to our two leveled secondary RM with an isotope dilution mass spectrometry-based candidate reference method. Implementation of this secondary RM will allow standardization of hepcidin assays worldwide with results traceable to SI units.

 

The secondary RM will be used to calibrate analytically reliable hepcidin assays worldwide, including all laboratories and manufacturers of diagnostic kits, as solely this material is commutable. Calibration will benefit the clinical, pharmaceutical and research communities by ensuring comparable and accurate results, uniform reference values and clinical decision limits.

 

For more information or in case of interest in purchasing the material, please send an e-mail to hepcidinanalysis@radboudumc.com.

 

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, et al. Establishment of a traceability chain to SI units for serum hepcidin allows standardization of serum hepcidin. Abstract of oral presentation on February 10th 2018 at European Iron Club meeting in Zurich.
  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.