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Optimizing hepcidin measurement with a proficiency test framework and standardization improvement.

Ellis T Aune1,2, Laura E Diepeveen1,2, Coby M Laarakkers1,2

  • 1Department of Laboratory Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.

Clinical Chemistry and Laboratory Medicine
|October 1, 2020
PubMed
Summary
This summary is machine-generated.

A new proficiency testing (PT) scheme and high-level calibrator improve hepcidin measurement standardization. This enhances external quality assurance (EQA) for iron disorder diagnosis and treatment.

Keywords:
external quality assurancehepcidiniron metabolismproficiency testingsecondary reference materialstandardization

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Area of Science:

  • Clinical Chemistry
  • Biomarker Measurement
  • Laboratory Quality Assurance

Background:

  • Accurate hepcidin measurement is crucial for understanding and managing iron disorders.
  • Existing secondary reference materials (sRM) allow for standardization but lack a high calibrator, limiting external quality assurance (EQA).
  • Standardized measurement procedures (MPs) are needed for reliable hepcidin assays.

Purpose of the Study:

  • To develop and evaluate a pilot proficiency testing (PT) scheme for hepcidin measurement.
  • To introduce and validate a high-level calibrator to improve hepcidin assay standardization.
  • To establish a framework for future EQA and laboratory accreditation in hepcidin testing.

Main Methods:

  • A pilot PT scheme was developed with 16 international hepcidin MPs using 12 human serum samples.
  • A high-level calibrator was manufactured, value-assigned, and validated.
  • Assay accuracy, linearity, and precision were evaluated, alongside the impact of the new calibrator on standardization.

Main Results:

  • The pilot PT confirmed the logistical feasibility of an annual scheme.
  • While most MPs showed good linearity and precision, significant accuracy variability highlighted the need for EQA.
  • The high-level calibrator effectively reduced inter-assay coefficient of variation (CV) from 42.0% to 14.0%, outperforming the existing two-level sRM set.

Conclusions:

  • A framework for future PT was established, supporting laboratory accreditation for quality hepcidin measurement.
  • Extending the current sRM with a high calibrator optimizes standardization for hepcidin assays.
  • International implementation of the standardized sRM is key for successful global standardization of hepcidin measurements.