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Related Experiment Video

Updated: Jun 26, 2025

Development and Validation of an Ultrasensitive Single Molecule Array Digital Enzyme-linked Immunosorbent Assay for Human Interferon-α
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Using Bland-Altman plot-based harmonization algorithm to optimize the harmonization for immunoassays.

Huiling Fang1, Ruifeng Yang2,3, Jiayue Guo1

  • 1Department of Clinical Chemistry and Immunology, Shanghai Center for Clinical Laboratory, Shanghai, P.R. China.

Clinical Chemistry and Laboratory Medicine
|May 14, 2024
PubMed
Summary
This summary is machine-generated.

A new Bland-Altman plot-based harmonization algorithm (BA-BHA) shows improved accuracy for in vitro diagnostic measurement devices (IVD-MDs) compared to the weighted Deming regression-based harmonization algorithm (WD-BHA). BA-BHA offers a viable alternative for optimizing immunoassay harmonization.

Keywords:
Bland-Altman plotharmonizationharmonization reference materialweighted Deming regression

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Area of Science:

  • Clinical Chemistry
  • Biomedical Engineering
  • Medical Diagnostics

Background:

  • Harmonization of in vitro diagnostic measurement devices (IVD-MDs) is crucial for equivalent results, as recommended by the International Organization for Standardization (ISO).
  • Existing methods like weighted Deming regression-based harmonization algorithm (WD-BHA) may obscure analytical differences.

Purpose of the Study:

  • To evaluate the effectiveness of a novel Bland-Altman plot-based harmonization algorithm (BA-BHA).
  • To compare BA-BHA with the ISO 21151:2020 recommended WD-BHA for IVD-MD harmonization.

Main Methods:

  • Developed IVD-MD-specific harmonization algorithms using 80 patient sera as harmonization reference material (HRM).
  • Validated algorithms with a separate panel of 40 patient sera.
  • Compared regression slopes, intercepts, Bland-Altman plot layouts, percent differences, limits of agreement (LoAs), and between-method coefficients of variation (CV) before and after harmonization.

Main Results:

  • WD-BHA harmonization resulted in acceptable slopes/intercepts but showed large mean differences (-33.9 to 23.9%) and wide LoAs (-64.6 to 74.6%), with high between-method CV (22.9%).
  • BA-BHA harmonization yielded harmonized results in both weighted Deming and Passing-Bablok regressions, with significantly smaller mean differences (-1.1 to 1.6%), narrower LoAs (-23.3 to 23.2%), and lower between-method CV (8.4%).
  • Bland-Altman plots after BA-BHA showed even data distribution around the mean.

Conclusions:

  • WD-BHA may hide unacceptable analytical differences despite acceptable slope and intercept values.
  • The new BA-BHA protocol demonstrates potential as a viable alternative for optimizing harmonization in immunoassays.
  • BA-BHA provides a more accurate and reliable method for harmonizing IVD-MD results.