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Toward Worldwide Hepcidin Assay Harmonization: Identification of a Commutable Secondary Reference Material
Lisa N van der Vorm1, Jan C M Hendriks2, Coby M Laarakkers3
1Department of Laboratory Medicine and.
Clinical Chemistry
|May 14, 2016
Summary
Harmonizing hepcidin measurements using a commutable reference material significantly improves assay equivalence. This standardization effort is crucial for reliable hepcidin test results and clinical interpretation.
Area of Science:
- Clinical chemistry
- Biomarker standardization
- Laboratory medicine
Background:
- Hepcidin measurements vary significantly across different assays, hindering accurate interpretation and method-dependent reference intervals.
- Lack of standardization complicates clinical decision-making and research reproducibility.
Purpose of the Study:
- To achieve harmonization of plasma hepcidin measurement procedures.
- To identify a commutable secondary reference material for hepcidin assays.
Main Methods:
- Applied harmonization techniques from the Consortium for Harmonization of Clinical Laboratory Results.
- Evaluated eleven hepcidin measurement procedures (mass spectrometry and immunochemical).
- Assessed eight candidate reference materials for commutability.
Main Results:
- Significant variability in absolute hepcidin values and reproducibility was observed between procedures.
- Harmonization with a common calibrator improved inter-measurement procedure CV from 28.6% to 7.7%.
- A native lyophilized plasma reference material demonstrated commutability across all tested procedures.
Conclusions:
- Identified a commutable secondary reference material with potential to enhance hepcidin assay equivalence.
- This reference material is key for establishing traceability and standardizing hepcidin measurements.
- Improved standardization will lead to more reliable hepcidin test results for clinical use.
