Volume 5, Issue 1, January 2019, Page: 19-25
Hemoglobin A(1c) Reporting Units and Diagnostic Cut-Offs in Relation to International Recommendations
Penttilä Ilkka, Research Institute of Exercise Medicine, University of Eastern Finland, Haapaniementie, Kuopio, Finland
Penttilä Karri, The Finnish Medicines Agency FIMEA, Microkatu, Kuopio, Finland
Laitinen Harri, The International External Quality Assessment Schemes for, Clinical Laboratories Labquality Ltd., Kumpulankatu, Helsinki, Finland
Ranta Päivi, The International External Quality Assessment Schemes for, Clinical Laboratories Labquality Ltd., Kumpulankatu, Helsinki, Finland
Törrönen Jukka, Research Institute of Exercise Medicine, University of Eastern Finland, Haapaniementie, Kuopio, Finland
Rauramaa Rainer, Research Institute of Exercise Medicine, University of Eastern Finland, Haapaniementie, Kuopio, Finland
Received: Oct. 29, 2018;       Accepted: Jan. 9, 2019;       Published: May 20, 2019
DOI: 10.11648/j.ijcems.20190501.15      View  121      Downloads  13
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.
Keywords
Diabetes, HbA(1c), IFCC Recommendation, Methods Quality Assurance, Target Limits, Units
To cite this article
Penttilä Ilkka, Penttilä Karri, Laitinen Harri, Ranta Päivi, Törrönen Jukka, Rauramaa Rainer, Hemoglobin A(1c) Reporting Units and Diagnostic Cut-Offs in Relation to International Recommendations, International Journal of Clinical and Experimental Medical Sciences. Vol. 5, No. 1, 2019, pp. 19-25. doi: 10.11648/j.ijcems.20190501.15
Copyright
Copyright © 2019 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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