Startseite Medizin Commutability evaluation of glycated albumin candidate EQA materials
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Commutability evaluation of glycated albumin candidate EQA materials

  • Rui Wu , Huijuan Zhou , Xiaerbanu Nizhamnuding , Anqi Pan , Hao Zheng , Jiangtao Zhang , Haijian Zhao , Jing Wang , Tianjiao Zhang EMAIL logo und Chuanbao Zhang ORCID logo EMAIL logo
Veröffentlicht/Copyright: 28. Mai 2025
Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 63 Heft 10

Abstract

Objectives

In clinical practice, glycated albumin (GA), as a key biomarker reflecting the level of blood glucose control in the short and medium term, has been widely used in the diagnosis and efficacy monitoring of diabetes. However, the consistency of GA results between different detection systems remains one of the current challenges in laboratory medicine. we evaluated the commutability of 10 evaluated samples to identify candidate EQA materials for GA measurement.

Methods

According to the Clinical and Laboratory Standards Institute (CLSI) document EP14-A3 and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) commutability evaluation program, we used the established isotope dilution liquid chromatography-tandem mass spectrometry (ID LC-MS/MS) method for serum glycated albumin determination as the comparative method, and six different commercial kits used enzyme assay as the evaluating method. A total of 40 clinical sample serums, 9 pregnancy sample serums, and 10 evaluated samples were analyzed.

Results

For the CLSI approach, pooled serum samples (cRM1-3) at medium concentrations (cRM2) are commutable in 5/6 kits. For the IFCC approach, none of samples commutable.

Conclusions

The commutability evaluation results of the two approaches were different, and the cRM2 has commutability in most enzymatic kits. It can be a commutable material for the EQA project.

Keywords: CLSI; IFCC; commutability; glycated albumin
Corresponding authors: Tianjiao Zhang and Chuanbao Zhang, National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/ National Center of Gerontology, Beijing, P.R. China; and Chinese Academy of Medical Sciences, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P.R. China, E-mail: (T. Zhang), (C. Zhang)
Rui Wu and Huijuan Zhou contributed equally to this work.

Funding source: National Key Research and Development Program of China

Award Identifier / Grant number: 2022YFF0710305

  1. Research ethics: Exempt of ethical declarations.

  2. Informed consent: Not applicable.

  3. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: The authors state no conflict of interest.

  6. Research funding: National Key Research and Development Program of China (2022YFF0710305).

  7. Data availability: Not applicable.

References

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2025-0507).

Received: 2025-01-28
Accepted: 2025-05-12
Published Online: 2025-05-28
Published in Print: 2025-09-25

© 2025 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2025-0507
Schlagwörter für diesen Artikel
CLSI; IFCC; commutability; glycated albumin

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Quality indicators: an evolving target for laboratory medicine
  4. Reviews
  5. Regulating the future of laboratory medicine: European regulatory landscape of AI-driven medical device software in laboratory medicine
  6. The spectrum of nuclear patterns with stained metaphase chromosome plate: morphology nuances, immunological associations, and clinical relevance
  7. Opinion Papers
  8. Comprehensive assessment of medical laboratory performance: a 4D model of quality, economics, velocity, and productivity indicators
  9. Detecting cardiac injury: the next generation of high-sensitivity cardiac troponins improving diagnostic outcomes
  10. Perspectives
  11. Can Theranos resurrect from its ashes?
  12. Guidelines and Recommendations
  13. Australasian guideline for the performance of sweat chloride testing 3rd edition: to support cystic fibrosis screening, diagnosis and monitoring
  14. General Clinical Chemistry and Laboratory Medicine
  15. Recommendations for the integration of standardized quality indicators for glucose point-of-care testing
  16. A cost-effective assessment for the combination of indirect immunofluorescence and solid-phase assay in ANA-screening
  17. Assessment of measurement uncertainty of immunoassays and LC-MS/MS methods for serum 25-hydroxyvitamin D
  18. A novel immunoprecipitation-based targeted liquid chromatography-tandem mass spectrometry analysis for accurate determination for copeptin in human serum
  19. Histamine metabolite to basal serum tryptase ratios in systemic mastocytosis and hereditary alpha tryptasemia using a validated LC-MS/MS approach
  20. Machine learning algorithms with body fluid parameters: an interpretable framework for malignant cell screening in cerebrospinal fluid
  21. Impact of analytical bias on machine learning models for sepsis prediction using laboratory data
  22. Immunochemical measurement of urinary free light chains and Bence Jones proteinuria
  23. Serum biomarkers as early indicators of outcomes in spontaneous subarachnoid hemorrhage
  24. High myoglobin plasma samples risk being reported as falsely low due to antigen excess – follow up after a 2-year period of using a mitigating procedure
  25. Candidate Reference Measurement Procedures and Materials
  26. Commutability evaluation of glycated albumin candidate EQA materials
  27. Reference Values and Biological Variations
  28. Health-related reference intervals for heavy metals in non-exposed young adults
  29. Hematology and Coagulation
  30. Practical handling of hemolytic, icteric and lipemic samples for coagulation testing in European laboratories. A collaborative survey from the European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM)
  31. Cancer Diagnostics
  32. Assessment of atypical cells in detecting bladder cancer in female patients
  33. Cardiovascular Diseases
  34. False-positive cardiac troponin I values due to macrotroponin in healthy athletes after COVID-19
  35. Diabetes
  36. A comparison of current methods to measure antibodies in type 1 diabetes
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  38. The neglected issue of pyridoxal- 5′ phosphate
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  43. Congress Abstracts
  44. 62nd National Congress of the Hungarian Society of Laboratory Medicine Szeged, Hungary, August 28–30, 2025
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