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Related Experiment Video

Updated: May 4, 2026

Harmonic Nanoparticles for Regenerative Research

Harmonic Nanoparticles for Regenerative Research

Published on: May 1, 2014

A "Step-Up" approach for harmonization.

Katleen Van Uytfanghe¹, Linde A De Grande¹, Linda M Thienpont¹

¹Laboratory for Analytical Chemistry, Faculty of Pharmaceutical Sciences, Gent University, Harelbekestraat 72, 9000 Gent, Belgium.

Clinica Chimica Acta; International Journal of Clinical Chemistry

|December 24, 2013

Summary

Achieving assay equivalence for complex analytes requires harmonization, not just standardization. The "Step-Up" design, using method comparisons with commutable samples, offers a practical approach to harmonize laboratory assays.

Keywords:

Commutable samples Complex analytes Harmonization Method comparison study Statistical derived target

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Area of Science:

Clinical Chemistry
Measurement Science
Laboratory Medicine

Background:

Assays for complex analytes often lack equivalence due to arbitrary units and lack of SI-traceability.
Standardization to SI-traceable systems is key for assay equivalence, but often not feasible for complex measurands.
Harmonization is proposed to achieve among-assay equivalence when SI-traceability is insufficient.

Purpose of the Study:

To describe the practical aspects of the "Step-Up" design for assay harmonization.
To provide a framework for achieving and sustaining harmonization of laboratory assays.
To outline the requirements for a successful harmonization process.

Main Methods:

The "Step-Up" design involves sequential method comparisons using commutable samples.
Each phase determines readiness for the subsequent step, guiding the harmonization process.
A statistically valid location measure serves as a surrogate reference measurement procedure.

Main Results:

The "Step-Up" design provides a phased approach to assess and achieve assay harmonization.
A protocol for maintaining the established harmonization status is included.
Successful harmonization depends on broad assay participation and demonstrated correlation and consistency.

Conclusions:

The "Step-Up" design offers a practical methodology for harmonizing assays of complex analytes.
Achieving assay equivalence through harmonization is crucial for reliable clinical decision-making.
Sustained harmonization requires ongoing monitoring and adherence to established protocols.