The Progress and Future of Human Hemoglobin A1c Certified Reference Materials
LI Jing-jing1,ZHAO Hai-bo2,LIANG Liang1,FAN Pei-lei1,ZHAO Yu-jia1,WU Li-qing2,ZHAI Rui2
1. Beijing Institute of Metrology, Beijing 100029, China
2. Center for Advanced Measurement Science, Technology Innovation Center of
Mass Spectrometry for State Market Regulation, National Institute of Metrology, Beijing 100029, China
Abstract:As the basis of traceability of measurement, Glycated hemoglobin A1c, (HbA1c) reference material is the direct carrier of value traceability and transfer, which plays an essential role in the quality assurance of clinical test results.It is significant to establish a reference measurement system and the satandardization of clinical tests for HbA1c in China. The preparation process, determination method, reporting units and uncertainty of human HbA1c reference materials at domestic and abroad are briefly reviewed, it can provide reference for the promotion of HbA1c standardization in China. We briefly review the preparation process, determination method, reporting units and uncertainty of human HbA1c reference materials at domestic and abroad for the efficient development of the standardization of HbA1c in China. Through a brief review of the preparation process, calibration method, reporting unit and uncertainty of domestic and foreign reference materials for human HbA1c, it provides reference for the promotion of HbA1c standardization in China.
Guo X, Liao Y Q, Shen J L. Advances in laboratory detection techniques and methodology of glycated hemoglobin[J]. Journal of Clinical Transfusion and Laboratory Medicine, 2017, 19(6): 646-650.
Litter R R., Rohlfing C, Sacks D B. The NGSP: Over 20 years of improving HbA1c measurement[J]. Clinical Chemistry, 2019, 65(7): 839-848.
Chen L, Huang Y J, Zhou J Y, et al. Equivalent simulation and reference material of the bacterial colonies[J]. Acta Metrologica Sinica, 2020, 41(1): 121-128.
[5]
Sacks D B,Arnold M,Bakris G L,et al. Position statement executive summary: guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus[J].Diabetes Care, 2011, 34(6): 1419-1423.
Li D, Wang J, Yang J, et al. Experimental design analysis of developing quantitative nucleic acid reference materials[J]. Acta Metrologica Sinica, 2020, 41(11): 1436-1442.
Wu L Q, Yang B, Jin Y X, et al. Development of series of glycated haemoglobin HbA1c certified reference material[J], China Measurement & Test, 2018, 44(1): 1-8.
[4]
The European parliament and the council of the European Union.Directive 98/79/EC of the European Parliament and of the council of 27 October 1998 on in vitro diagnostic medical devices[J]. Official Journal of the European Communities, 1998.
Chen W X, Shen Z Y, Wang S, et al. Measurement traceability in laboratory medicine[J]. Chinese Journal of Laboratory Medicine, 2003, 26(3): 153-159.
[9]
Weykamp C W, Penders T J, Miedema K, et al. Standardization of glycohemoglobin results and reference values in whole blood studied in 103 laboratories using 20methods[J]. Clinical Chemistry, 1995, 41 (1): 82-86.
[10]
Muoz-Pieiro A, Schimmel H, Klein C. Certification of the amount-of-substance fraction of HbA1c versus the sum of all Hb isoforms forming the glycated or non-glycated N-terminal hexapeptide of the β-chain in haemoglobin isolated from whole blood IRMM/IFCC-466[R]. European Commission, Joint Research Centre Institute for Reference Materials and Measurements (IRMM), 2007.
[11]
Jeppsson J O, Kobold U, Barr J, et al. Approved IFCC reference method for the measurement of HbA1c in human blood[J]. Clinical Chemistry and Laboratory Medicine, 2002, 40 (1): 78-89.
[12]
International Committee for Standardization in Haematology (ICSH). ICSH Standard EP 6/3: 1977 Recommendations for reference method for haemoglobinometry in human blood (ICSH Standard EP 6/2 1977) and specifications for international haemoglobincyanide reference preparation[S]. 1978.
[13]
Finke A, Kobold U, Hoelzel W, et al. Preparation of a candidate primary reference material for the international standardisation of HbA1c determinations[J]. Clinical Chemistry and Laboratory Medicine, 1998, 36 (5): 299-308.
[14]
Muoz A, Zegers I, Charoud-Got J, et al. Certification of the amount-of-substance fraction of HbA1c versus the sum of HbA0 and HbA1c in haemoglobin: ERM-AD500/IFCC[R]. European Commission, Joint Research Centre Institute for Reference Materials and Measurements (IRMM), 2016.
[15]
Hoelzel W, Weykamp C, Jeppsson J O, et al. IFCC reference system for measurement of hemoglobin A1c in human blood and the national standardization schemes in the United States, Japan, and Sweden: A method-comparison study[J], Clinical Chemistry, 2004, 50(1): 166-174.
[8]
Weykamp C W, Penders T J, Muskiet F A J, et al. Effect of calibration on dispersion of glycohemoglobin values determined by 111 laboratories using 21 methods[J]. Clinical Chemistry, 1994, 40 (1): 138-144.
[18]
Song Z X, Xie B Y, Ma H A, et al. Modified HPLC-ESI-MS method for glycated hemoglobin quantification based on the IFCC reference measurement procedure and its application for quantitative analyses in clinical laboratories of China[J]. Journal of Clinical Laboratory Analysis, 2016, 30(5): 457-463.
[21]
Bi J M, Wu L Q, Yang B, et al. Development of hemoglobin A1c certified reference material by liquid chromatography isotope dilution mass spectrometry[J]. Analytical and Bioanalytical Chemistry, 2012, 403(2): 549-554.
[22]
Peterson C M, Jovanovic L, Raskin P, et al. A comparative evaluation of glycosylated haemoglobin assays: feasibility of references and standards[J]. Diabetologia, 1984, 26(3): 214-217.
[23]
Nathan D M, Genuth S, Lachin J, et al. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus[J]. New England Journal of Medicine, 1993, 329(14): 977-986.
[24]
Weykamp C, John W G, Mosca A, et al. A review of the challenge in measuring hemoglobin A1c[J]. Journal of Diabetes Science and Technology, 2009, 3(3): 439-445.
[26]
Litter R R,Rohlfing C L. The long and winding road to optimal HbA1c measurement[J]. Clinica Chimica Acta,2013, 418(3): 63-71.
Tang Y X, Yang X D, Zhang X P. Research on conversion factors of the certified reference materials on different chemiluminescence immunity platforms[J]. Acta Metrologica Sinica, 2021, 42(7): 964-969.
[16]
Zwart A, Van Assendelft O W, Bull B S, et al. Recommedations for reference method for haemoglobinometry in human blood (ICSH Stand 1995) and specifications for international haemoglobincyanide standard (4th edition)[J]. Journal of Clinical Pathology, 1996, 49(4): 271-274.
[25]
Rahbar S. An abnormal hemoglobin in red cells of diabetics[J]. Clinica Chimica Acta, 1968,22(2): 296-298.