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Evaluation of effects from hemoglobin variants on HbA1c measurements by different methods

  • Yichuan Song , Anping Xu ORCID logo , Mo Wang , Jie Shi , Wenxuan Fu , Ling Ji EMAIL logo and Rui Zhang EMAIL logo
Published/Copyright: April 3, 2024
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 62 Issue 10

Abstract

Objectives

The impact of seven hemoglobin variants (Hb Q-Thailand, Hb G-Honolulu, Hb Ube-2, Hb New York, Hb J-Bangkok, Hb G-Coushatta, and Hb E) on the outcome of HbA1c was investigated for six methods by comparing with liquid chromatography-tandem mass spectrometry (LC/MS/MS) reference method.

Methods

Twenty-nine normal and 112 variant samples were measured by LC/MS/MS, Sebia Capillarys 3 TERA, Intelligene Biosystems QuanTOF, Premier Hb9210, Arkray HA-8190V, Bio-Rad D-100, and Tosoh G11, then evaluated for correlation, consistency, and mean relative bias among six methods. The lowest biological variation bias of ±2.8 % was an acceptable standard.

Results

All methods showed poor correlation and consistency with LC/MS/MS for Hb E. The unacceptable biases were observed for Capillarys 3 TERA (−14.4 to −3.7 % for Hb Q-Thailand, Hb Ube-2, Hb New York, Hb J-Bangkok and Hb E), QuanTOF (−8.3 to −2.9 % for Hb Ube-2, Hb New York and Hb G-Coushatta), Premier Hb9210 (−18.3 to −3.6 % for Hb Q-Thailand, Hb Ube-2, Hb New York, Hb J-Bangkok and Hb E), HA-8190V variant mode (−17.3 to 6.6 % for Hb G-Honolulu, Hb Ube-2, Hb New York, Hb G-Coushatta and Hb E). All variant samples showed larger biases than ±2.8 % comparing HA-8190V fast mode, D-100, and G11 with LC/MS/MS.

Conclusions

The accuracy of different HbA1c methods was influenced by some Hb variants, especially Hb Ube-2 and Hb New York. Thus, laboratories need to choose appropriate methods to measure HbA1c with different Hb variants.

Keywords: HbA1c; hemoglobin variants; method comparison
Corresponding authors: Ling Ji, Department of Laboratory Medicine, Peking University Shenzhen Hospital, 1120 Lianhua Road Futian, Shenzhen, Guangdong, 518036, P.R. China, E-mail: ; and Rui Zhang, Department of Clinical Laboratory, Beijing Chao-Yang Hospital, Capital Medical University, No. 8, Gongtinan Road, Chao-Yang District, Beijing 100020, P.R. China, Phone: +86 1085231660, E-mail:
Yichuan Song and Anping Xu contributed equally to this work.

Funding source: Beijing Chaoyang Hospital Science and Technology Innovation Fund

Award Identifier / Grant number: 22kcjjzd-7

Funding source: Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support

Award Identifier / Grant number: ZYLX202137

  1. Research ethics: The study involved the use of leftover patient whole samples. The leftover patient samples were all de-identified during the collection. The use of patient samples in the present study was reviewed by the Ethics Committee of Peking University Shenzhen Hospital. Detailed patient information was not needed, and the data were analyzed anonymously; therefore, participants did not provide written informed consent.

  2. Informed consent: Not applicable.

  3. Author contributions: Yichuan Song: Conceptualization, Data Curation, Formal analysis, Investigation, Visualization, Writing – Original Draft. Anping Xu: Conceptualization, Resources, Supervision, Writing – review &editing. Mo Wang: Investigation, Methodology. Jie Shi: Investigation, Methodology. Wenxuan Fu: Investigation, Formal analysis. Ling Ji: Resources, Supervision, Writing – review &editing. Rui Zhang: Funding acquisition, Project administration, Supervision, Writing – review &editing.

  4. Competing interests: The authors state no conflict of interest.

  5. Research funding: This study was supported by the Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support (ZYLX202137) and Beijing Chaoyang Hospital Science and Technology Innovation Fund (grant numbers 22kcjjzd-7).

  6. Data availability: The raw data can be obtained on request from the corresponding author.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2024-0186).

Received: 2024-02-14
Accepted: 2024-03-19
Published Online: 2024-04-03
Published in Print: 2024-09-25

© 2024 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2024-0186
Keywords for this article
HbA1c; hemoglobin variants; method comparison

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Six years of progress – highlights from the IFCC Emerging Technologies Division
  4. IFCC Papers
  5. Skin in the game: a review of single-cell and spatial transcriptomics in dermatological research
  6. Bilirubin measurements in neonates: uniform neonatal treatment can only be achieved by improved standardization
  7. Validation and verification framework and data integration of biosensors and in vitro diagnostic devices: a position statement of the IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MBHLM) and the IFCC Scientific Division
  8. Linearity assessment: deviation from linearity and residual of linear regression approaches
  9. HTA model for laboratory medicine technologies: overview of approaches adopted in some international agencies
  10. Considerations for applying emerging technologies in paediatric laboratory medicine
  11. A global perspective on the status of clinical metabolomics in laboratory medicine – a survey by the IFCC metabolomics working group
  12. The LEAP checklist for laboratory evaluation and analytical performance characteristics reporting of clinical measurement procedures
  13. General Clinical Chemistry and Laboratory Medicine
  14. Assessing post-analytical phase harmonization in European laboratories: a survey promoted by the EFLM Working Group on Harmonization
  15. Potential medical impact of unrecognized in vitro hypokalemia due to hemolysis: a case series
  16. Quantification of circulating alpha-1-antitrypsin polymers associated with different SERPINA1 genotypes
  17. Targeted ultra performance liquid chromatography tandem mass spectrometry procedures for the diagnosis of inborn errors of metabolism: validation through ERNDIM external quality assessment schemes
  18. Improving protocols for α-synuclein seed amplification assays: analysis of preanalytical and analytical variables and identification of candidate parameters for seed quantification
  19. Evaluation of analytical performance of AQUIOS CL flow cytometer and method comparison with bead-based flow cytometry methods
  20. IgG and kappa free light chain CSF/serum indices: evaluating intrathecal immunoglobulin production in HIV infection in comparison with multiple sclerosis
  21. Reference Values and Biological Variations
  22. Reference intervals of circulating secretoneurin concentrations determined in a large cohort of community dwellers: the HUNT study
  23. Sharing reference intervals and monitoring patients across laboratories – findings from a likely commutable external quality assurance program
  24. Verification of bile acid determination method and establishing reference intervals for biochemical and haematological parameters in third-trimester pregnant women
  25. Confounding factors of the expression of mTBI biomarkers, S100B, GFAP and UCH-L1 in an aging population
  26. Cancer Diagnostics
  27. Exploring evolutionary trajectories in ovarian cancer patients by longitudinal analysis of ctDNA
  28. Diabetes
  29. Evaluation of effects from hemoglobin variants on HbA1c measurements by different methods
  30. Letters to the Editor
  31. Are there any reasons to use three levels of quality control materials instead of two and if so, what are the arguments?
  32. Issues for standardization of neonatal bilirubinemia: a case of delayed phototherapy initiation
  33. The routine coagulation assays plasma stability – in the wake of the new European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) biological variability database
  34. Improving HCV diagnosis following a false-negative anti-HCV result
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