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Feasibility of improving sLe(a)/CA 19-9 harmonization by recalibration: a simulation study using three EQA programs.

Huub H van Rossum¹, Stefan Holdenrieder², Junghan Song³

¹Department of Laboratory Medicine, Netherlands Cancer Institute, Amsterdam, The Netherlands.

Clinical Chemistry and Laboratory Medicine

|April 14, 2026

Summary

This summary is machine-generated.

Harmonizing the CA 19-9 tumor marker, used for gastrointestinal cancers, showed improved comparability after recalibration. However, significant correlation issues persist, questioning the feasibility of harmonizing current clinical assays.

Keywords:

CA 19-9 EQA gastrointestinal cancharmonization pancreatic cancer tumor marker

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Area of Science:

Clinical Chemistry
Tumor Marker Analysis
Cancer Diagnostics

Background:

The CA 19-9 tumor marker detects the sialylated Lewis a blood group antigen (sLe(a)).
CA 19-9 is crucial for monitoring pancreatic and gastrointestinal cancers.
Existing CA 19-9 assays exhibit significant lack of comparability.

Purpose of the Study:

To simulate and evaluate methods for improving CA 19-9 assay harmonization.
To assess the impact of recalibration on CA 19-9 measurement procedures (MPs).
To determine the feasibility of harmonizing current clinical CA 19-9 assays.

Main Methods:

Utilized data from three External Quality Assessment (EQA) programs.
Employed method comparison studies and mathematical recalibration of MPs.
Harmonization status was assessed pre- and post-recalibration using consensus means.

Main Results:

Recalibration improved mean differences from -50.3-92.0% to -0.48-1.25%.
The range of slopes in method comparisons improved from 0.090-2.56 to 0.93-1.10.
Post-harmonization coefficients of variation (CVs) remained high (22.0-49.2%).

Conclusions:

Recalibration can enhance CA 19-9 harmonization to some extent.
A significant lack of correlation between assays remains post-harmonization.
The overall feasibility of harmonizing current clinical CA 19-9 assays is questionable.