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Innovations in HbA1c analysis: finding the balance between speed and accuracy. An investigation of a potential new Secondary Reference Measurement Procedure for the IFCC

  • Erna Lenters-Westra EMAIL logo and Emma English
Published/Copyright: October 24, 2023
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 62 Issue 4

Abstract

Objectives

The escalating prevalence of diabetes worldwide has resulted in a dramatic increase in the number of people who need testing, which in turn necessitates faster HbA1c measurement. The Tosoh GR01 addresses the need for fast turnaround times of whilst offering pragmatic steps to maintain result accuracy in a single instrument by offering two distinct operating modes: Short Mode (SM) and Long Mode (LM). The aim of this study was to evaluate all relevant aspects of the performance of the Tosoh GR01 with a view to accepting the instrument as a future Secondary Reference Measurement Procedure (SRMP) for the IFCC.

Methods

Certified Clinical & Laboratory Standards Institute (CLSI) Evaluation Protocols (EP) were used to evaluate precision (EP-5), accuracy (EP-9), linearity (EP-6), carry-over (EP-10) and the effect of hemoglobin variants and other potential interferences.

Results

Both modes demonstrated CVs <0.6 % in SI units and <0.4 % in NGSP units at 46 mmol/mol (6.4 %) and 75 mmol/mol (9.0 %) and passed both National Glycohemoglobin Standardization Program (NGSP) and International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) certification procedures when compared with 7 IFCC Certified Secondary Reference Measurement Procedures (SRMP). Sigma for both modes was >6 when using the results of EP-5 and EP-9 at an HbA1c concentration of 50 mmol/mol (6.7 %). Neither mode showed any interference with common Hb-variants except for HbAE when HbA1c was >65 mmol/mol. In the SM HbAS, HbAD and HbAC were recognized but no result was reported.

Conclusions

There is a good balance between speed and accuracy for determining HbA1c with the Tosoh GR01 in both analytical modes and the device is suitable for use as an IFCC SRMP.

Keywords: diabetes; HbA1c ; method evaluation; Tosoh GR01
Corresponding author: Erna Lenters-Westra, Department of Clinical Chemistry, Isala, Dr. van Heesweg 2, 8025 AB Zwolle, The Netherlands; and European Reference Laboratory for Glycohemoglobin, Location Isala, Zwolle, The Netherlands, E-mail:

Acknowledgments

The authors would like to thank Tosoh Europe for the contribution of the instruments and reagents for this evaluation.

  1. Research ethics: Not applicable.

  2. Informed consent: Not applicable.

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

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

  5. Research funding: Tosoh Europe financially supported the study.

  6. Data availability: Data are available from the corresponding author upon reasonable request and with permission of Tosoh Europe.

  7. Optional statements: The funding organization played no role in the collection, analysis, and interpretation of data; in the writing of the article; or in the decision to submit the article for publication after the results were known.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2023-1070).

Received: 2023-09-25
Accepted: 2023-10-16
Published Online: 2023-10-24
Published in Print: 2024-03-25

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2023-1070
Keywords for this article
diabetes; HbA1c; method evaluation; Tosoh GR01

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Value-based laboratory medicine: the time is now
  4. Review
  5. Cardiovascular risk evaluation in pregnancy: focus on cardiac specific biomarkers
  6. Opinion Papers
  7. From volume to value: a watershed moment for the clinical laboratory
  8. APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data
  9. Guidelines and Recommendations
  10. Analytical interference of intravascular contrast agents with clinical laboratory tests: a joint guideline by the ESUR Contrast Media Safety Committee and the Preanalytical Phase Working Group of the EFLM Science Committee
  11. Genetics and Molecular Diagnostics
  12. Specifications of qPCR based epigenetic immune cell quantification
  13. General Clinical Chemistry and Laboratory Medicine
  14. An appraisal of the practice of duplicate testing for the detection of irregular analytical errors
  15. Machine learning-based nonlinear regression-adjusted real-time quality control modeling: a multi-center study
  16. The effect of ratios upon improving patient-based real-time quality control (PBRTQC) performance
  17. Diagnostic sample transport via pneumatic tube systems: data logger and their algorithms are sensitive to transport effects
  18. Ambulatory human chorionic gonadotrophin (hCG) testing: a verification of two hCG point of care devices
  19. Monitoring patients with celiac disease on gluten free diet: different outcomes comparing three tissue transglutaminase IgA assays
  20. Verification, implementation and harmonization of automated chemiluminescent immunoassays for MPO- and PR3-ANCA detection
  21. Performance evaluation of a novel platelet count parameter, hybrid platelet count, on the BC-780 automated hematology analyzer
  22. Reference Values and Biological Variations
  23. Pediatric reference intervals for serum neurofilament light and glial fibrillary acidic protein using the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) cohort
  24. Biological variation of serum neopterin concentrations in apparently healthy individuals
  25. Short-term biological variation of serum tryptase
  26. Cancer Diagnostics
  27. Quantification of the lung cancer tumor marker CYFRA 21-1 using protein precipitation, immunoaffinity bottom-up LC-MS/MS
  28. Cardiovascular Diseases
  29. Prognostic significance of chronic myocardial injury diagnosed by three different cardiac troponin assays in patients admitted with suspected acute coronary syndrome
  30. Deep learning-based NT-proBNP prediction from the ECG for risk assessment in the community
  31. Diabetes
  32. Innovations in HbA1c analysis: finding the balance between speed and accuracy. An investigation of a potential new Secondary Reference Measurement Procedure for the IFCC
  33. Precise glucose measurement in sodium fluoride-citrate plasma affects estimates of prevalence in diabetes and prediabetes
  34. Infectious Diseases
  35. Urinary phenotyping of SARS-CoV-2 infection connects clinical diagnostics with metabolomics and uncovers impaired NAD+ pathway and SIRT1 activation
  36. Letters to the Editor
  37. Analytical performance specifications for measurement uncertainty in therapeutic monitoring of immunosuppressive drugs
  38. Capillary blood collection tubes containing serum separator gel result in lower measurements of oestradiol and total testosterone
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  40. A comparison of cannabidiol (CBD) concentrations in venous vs. fingertip-capillary blood
  41. Identification of sulfamethoxazole’s residues in sulfamethoxazole induced kidney stones by mass spectrometry
  42. Impact of different preservation methods on urinary red blood cell counts
  43. Diagnosis of IRAK-4-deficiency by flow cytometric measurement of IκB-α degradation
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