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Related Experiment Video

Updated: Jul 24, 2025

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Accurate method for value assignment of carcinoembryonic antigen reference materials.

Rui Zhang1, Zhenzhen Xu1, Rui Zhao1

  • 1Department of Clinical Laboratory, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.

Journal of Clinical Laboratory Analysis
|July 3, 2023
PubMed
Summary

Reference materials for carcinoembryonic antigen (CEA) were found to be commutable across immunoassays. Using World Health Organization (WHO) 73/601 diluted in phosphate-buffered saline (PBS) improved CEA measurement comparability and harmonization.

Keywords:
carcinoembryonic antigencommutabilitycomparabilityreference material

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Area of Science:

  • Clinical Chemistry
  • Immunoassay Development
  • Biomarker Standardization

Background:

  • Standardization of carcinoembryonic antigen (CEA) measurements is crucial for clinical decision-making.
  • Variability in CEA immunoassay results necessitates the development of commutable reference materials.
  • International Reference Preparation (IRP) 73/601 from the World Health Organization (WHO) is a key standard for CEA.

Purpose of the Study:

  • To assess the commutability of candidate reference materials (RMs) for CEA.
  • To identify an appropriate diluent matrix for WHO 73/601 for CEA.
  • To enhance the comparability of CEA measurement results across different immunoassay systems.

Main Methods:

  • Preparation of candidate CEA RMs at five concentrations (C1-C5) by the Beijing Clinical Laboratory Center (BCCL).
  • Dilution of WHO 73/601 into nine concentrations using five different diluents.
  • Analysis of samples using five automated CEA immunoassays and evaluation using CLSI and IFCC approaches.

Main Results:

  • Candidate CEA RMs (BCCL C2-C5) demonstrated commutability across all tested immunoassays.
  • WHO 73/601 diluted in phosphate-buffered saline (PBS) showed commutability across all assays (CLSI) and in most pairwise comparisons (IFCC).
  • Calibration with selected RMs reduced median percentage biases among assays, particularly improving consistency at lower concentrations.

Conclusions:

  • BCCL candidate RMs (C2-C5) are suitable for use in CEA immunoassays.
  • WHO 73/601 diluted in PBS is recommended as a common calibrator for harmonizing CEA detection.
  • The developed RMs and selected diluent effectively improve the harmonization of CEA measurements, facilitating accurate clinical interpretation.