International Journal of Clinical and Experimental Medical Sciences

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Hemoglobin A(1c) Reporting Units and Diagnostic Cut-Offs in Relation to International Recommendations

Received: 29 October 2018    Accepted: 09 January 2019    Published: 20 May 2019
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Abstract

Purpose. In this account were studied the use of units and cut-off limits for hemoglobin A(1c) in worldwide clinical laboratory practice and the quality assurance ranges of hemoglobin A(1c) by calculating the target limits from the values of Labquality Ltd. and ERLGH. Methods. The use of HbA(1c) units and the diagnostic limits for diabetes were examined using e-mail and letter inquiries to 37–51 societies of laboratory medicine (mainly clinical chemistry) sent from 2009 to 2017. The parametric statistical programs of Labquality Ltd., SPSS® 13.0, and MS Excel 2013 (Microsoft® Co., Cambridge, MA, USA) were used. Results. The mean values of the Finnish quality control organization Labquality Ltd. and the corresponding values from the HbA(1c) queries as to the percentage and mmol/mol SI units (IFCC) were used. The IFCC system for hemoglobin A(1c) is slowly but constantly gaining acceptance in Europe, but remains quite rare outside Europe where the percentage results were correspondingly lower. The mean round values of Labquality Ltd. and the corresponding mean values of the European Reference Laboratory for Glycohemoglobin (ERLGH) showed equal ranges for calculation of the target values with ± 6% intervals for the percentage results and ± 8% intervals for the mmol/mol results. Conclusions. To avoid confusion, the overall use of mmol/mol as a single unit for HbA(1c) may be the best option when the IFCC system has been accepted worldwide. The target values can be calculated equally well from the mean values of Labquality Ltd. and the ERLGH values in terms of both per percentage and mmol/mol units.

DOI 10.11648/j.ijcems.20190501.15
Published in International Journal of Clinical and Experimental Medical Sciences (Volume 5, Issue 1, January 2019)
Page(s) 19-25
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

Diabetes, HbA(1c), IFCC Recommendation, Methods Quality Assurance, Target Limits, Units

References
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[2] Penttilä I, Penttilä K, Holm P, Laitinen H, Ranta P, Törrönen J, Rauramaa R. Methods, units and quality requirements for the analysis of haemoglobin A1c in diabetes mellitus. World J Methdol 2016; 6:133-142.
[3] Rabhar S. An abnormal hemoglobin in red cells of diabetes. Clin Chim Acta. 1968; 22:296-298.
[4] Trivelli LA, Ranney HM, Lai H-T. Hemoglobin components in patients with diabetes mellitus. New Engl J Med. 1971; 284:353-357.
[5] Weykamp CW, Penders TJ, Muskiet FAJ, van der Silk W. Effect of calibration on dispersion of glycohemoglobin values determined from 111 laboratories using 21 methods. Clin Chem. 1994; 40:138-144.
[6] The EurA1c Group: The European HbA1c Trial to Investigate the Performance of HbA1c Assays in 2166 Laboratories across 17 Countries and 24 Manufacturers by Use of the IFCC Model for Quality Targets. Clin Chem 2018; 64:1183-1192.
[7] Little RR, Rohlfing CL. Assessing quality from an accuracy-based HbA1c proficiency survey. Clin Chem 2018;64:Issue 12.
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[9] Jeppsson J-O, Kobold U, Barr J, Finke A, Hoelzel W, Hashino T, Miedema K, Mosca A, Mauri P, Paroni R, Thienpont L, Umemoto M, Weykamp C. Approved IFCC reference method for the measurement of HbA1c in human blood. Clin Chem Lab Med. 2002; 40:78-89.
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[14] Manley S, John WG, Marshall S. Introduction of IFCC reference method for calibration of HbA1c: implications for clinical care. Diabetes Med. 2004; 21:673-676.
[15] Labquality Ltd., Finland; www.labquality.fi/2018.
[16] Penttilä I, Penttilä K, Halonen T, Pulkki K, Törrönen J, Rauramaa R. Adaptation of the Diazyme direct enzymatic HbA1c assay for a microplate reader at room temperature. Clin Chem Lab Med. 2011; 49:1221-1223.
[17] Weykamp C, Lenters-Westra E, van der Vuurst H, Slingerland R, Siebelder C, Visser-Dekkers W. Evaluation of the Menarini/ARKRAY ADAMS A1c HA-8180V analyzer for HbA1c. Clin Chem Lab Med. 2011; 49:647-651.
[18] Little RR, Rohlfing CL, Sacks DB for the NGSP Committee. Status of hemoglobin A1c measurement and goals for improvement: from chaos to order for improving diabetes care. Clin Chem. 2011; 57:205-214.
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Author Information
  • The International External Quality Assessment Schemes for, Clinical Laboratories Labquality Ltd., Kumpulankatu, Helsinki, Finland

  • Research Institute of Exercise Medicine, University of Eastern Finland, Haapaniementie, Kuopio, Finland

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  • APA Style

    Penttilä Ilkka, Penttilä Karri, Laitinen Harri, Ranta Päivi, Törrönen Jukka, et al. (2019). Hemoglobin A(1c) Reporting Units and Diagnostic Cut-Offs in Relation to International Recommendations. International Journal of Clinical and Experimental Medical Sciences, 5(1), 19-25. https://doi.org/10.11648/j.ijcems.20190501.15

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    ACS Style

    Penttilä Ilkka; Penttilä Karri; Laitinen Harri; Ranta Päivi; Törrönen Jukka, et al. Hemoglobin A(1c) Reporting Units and Diagnostic Cut-Offs in Relation to International Recommendations. Int. J. Clin. Exp. Med. Sci. 2019, 5(1), 19-25. doi: 10.11648/j.ijcems.20190501.15

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    AMA Style

    Penttilä Ilkka, Penttilä Karri, Laitinen Harri, Ranta Päivi, Törrönen Jukka, et al. Hemoglobin A(1c) Reporting Units and Diagnostic Cut-Offs in Relation to International Recommendations. Int J Clin Exp Med Sci. 2019;5(1):19-25. doi: 10.11648/j.ijcems.20190501.15

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  • @article{10.11648/j.ijcems.20190501.15,
      author = {Penttilä Ilkka and Penttilä Karri and Laitinen Harri and Ranta Päivi and Törrönen Jukka and Rauramaa Rainer},
      title = {Hemoglobin A(1c) Reporting Units and Diagnostic Cut-Offs in Relation to International Recommendations},
      journal = {International Journal of Clinical and Experimental Medical Sciences},
      volume = {5},
      number = {1},
      pages = {19-25},
      doi = {10.11648/j.ijcems.20190501.15},
      url = {https://doi.org/10.11648/j.ijcems.20190501.15},
      eprint = {https://download.sciencepg.com/pdf/10.11648.j.ijcems.20190501.15},
      abstract = {Purpose. In this account were studied the use of units and cut-off limits for hemoglobin A(1c) in worldwide clinical laboratory practice and the quality assurance ranges of hemoglobin A(1c) by calculating the target limits from the values of Labquality Ltd. and ERLGH. Methods. The use of HbA(1c) units and the diagnostic limits for diabetes were examined using e-mail and letter inquiries to 37–51 societies of laboratory medicine (mainly clinical chemistry) sent from 2009 to 2017. The parametric statistical programs of Labquality Ltd., SPSS® 13.0, and MS Excel 2013 (Microsoft® Co., Cambridge, MA, USA) were used. Results. The mean values of the Finnish quality control organization Labquality Ltd. and the corresponding values from the HbA(1c) queries as to the percentage and mmol/mol SI units (IFCC) were used. The IFCC system for hemoglobin A(1c) is slowly but constantly gaining acceptance in Europe, but remains quite rare outside Europe where the percentage results were correspondingly lower. The mean round values of Labquality Ltd. and the corresponding mean values of the European Reference Laboratory for Glycohemoglobin (ERLGH) showed equal ranges for calculation of the target values with ± 6% intervals for the percentage results and ± 8% intervals for the mmol/mol results. Conclusions. To avoid confusion, the overall use of mmol/mol as a single unit for HbA(1c) may be the best option when the IFCC system has been accepted worldwide. The target values can be calculated equally well from the mean values of Labquality Ltd. and the ERLGH values in terms of both per percentage and mmol/mol units.},
     year = {2019}
    }
    

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  • TY  - JOUR
    T1  - Hemoglobin A(1c) Reporting Units and Diagnostic Cut-Offs in Relation to International Recommendations
    AU  - Penttilä Ilkka
    AU  - Penttilä Karri
    AU  - Laitinen Harri
    AU  - Ranta Päivi
    AU  - Törrönen Jukka
    AU  - Rauramaa Rainer
    Y1  - 2019/05/20
    PY  - 2019
    N1  - https://doi.org/10.11648/j.ijcems.20190501.15
    DO  - 10.11648/j.ijcems.20190501.15
    T2  - International Journal of Clinical and Experimental Medical Sciences
    JF  - International Journal of Clinical and Experimental Medical Sciences
    JO  - International Journal of Clinical and Experimental Medical Sciences
    SP  - 19
    EP  - 25
    PB  - Science Publishing Group
    SN  - 2469-8032
    UR  - https://doi.org/10.11648/j.ijcems.20190501.15
    AB  - Purpose. In this account were studied the use of units and cut-off limits for hemoglobin A(1c) in worldwide clinical laboratory practice and the quality assurance ranges of hemoglobin A(1c) by calculating the target limits from the values of Labquality Ltd. and ERLGH. Methods. The use of HbA(1c) units and the diagnostic limits for diabetes were examined using e-mail and letter inquiries to 37–51 societies of laboratory medicine (mainly clinical chemistry) sent from 2009 to 2017. The parametric statistical programs of Labquality Ltd., SPSS® 13.0, and MS Excel 2013 (Microsoft® Co., Cambridge, MA, USA) were used. Results. The mean values of the Finnish quality control organization Labquality Ltd. and the corresponding values from the HbA(1c) queries as to the percentage and mmol/mol SI units (IFCC) were used. The IFCC system for hemoglobin A(1c) is slowly but constantly gaining acceptance in Europe, but remains quite rare outside Europe where the percentage results were correspondingly lower. The mean round values of Labquality Ltd. and the corresponding mean values of the European Reference Laboratory for Glycohemoglobin (ERLGH) showed equal ranges for calculation of the target values with ± 6% intervals for the percentage results and ± 8% intervals for the mmol/mol results. Conclusions. To avoid confusion, the overall use of mmol/mol as a single unit for HbA(1c) may be the best option when the IFCC system has been accepted worldwide. The target values can be calculated equally well from the mean values of Labquality Ltd. and the ERLGH values in terms of both per percentage and mmol/mol units.
    VL  - 5
    IS  - 1
    ER  - 

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