Hepcidin Harmonization Study: New Paper accepted by Clinical Chemistry
The publication of the Hepcidin Harmonization study from Lisa N. van der Vorm et al, was accepted by Clinical Chemistry. The print version we will show on this pdf.
DRG´s Hepcidin 25 (bioactive) HS ELISA, EIA-5782 was part of this study. You can find it in the paper, please refer to reference number IC-6 (immunochemical measurement procedure 6), Dorine Swinkel´s home-brew ELISA is IC-2, Eli Lilly´s Sandwich Assay is IC-3, Bachem´s assay has IC-4, and Intrinsic LifeSciences is IC-5.
Dr. Matthias Herkert, Director R&D of DRG: "The results of the study are very encouraging for the DRG team and will be motivation for all to keep high quality standards for our products!"
Dr. Herkert summarized this paper as follows:
Hepcidin plasma concentrations differ substantially between various procedures on the market (mass spectrometry or immunoassays). This is due to the lack of certified reference material. The Worldwide Hepcidin Assay Harmonization study intended to establish and test a commutable reference material.
DRG was invited to participate in the study together with other suppliers of Hepcidin-25 immunoassays and mass spectrometry procedures (11 measurement procedures in total). As expected, absolute Hepcidin concentrations differed considerably by a mean factor 7 difference between the extreme procedures. However, DRG`s Hepcidin-25 (bioactive) HS ELISA showed excellent correlation to reference mass spectrometry results. Furthermore, the DRG assay showed good precision (mean intra-CV of 5.7 %) and linearity of dilution (Pearson correlation coefficient r = 0.997).
A commutable candidate reference material with robust stability and compatibility to all procedures was identified and will be further validated in 2016. In conclusion, a harmonization and standardization of all procedures to quantify Hepcidin-25 should be expected in the near future. This will facilitate comparison of various studies using Hepcidin as a biomarker, and support medical research and its translation to the clinic.