Methods, units and quality requirements for the analysis of haemoglobin A_(1c) in diabetes mellitus  

作　　者：Ilkka Penttil? Karri Penttil? P?ivi Holm Harri Laitinen P?ivi Ranta Jukka T?rr?nen Rainer Rauramaa 

机构地区：[1]Kuopio Research Institute of Exercise Medicine, University of Eastern Finland [2]Finnish Medicines Agency FIMEA [3]Fimlab Laboratories Ltd. [4]Labquality Ltd.

出　　处：《World Journal of Methodology》2016年第2期133-142,共10页世界方法学杂志

摘　　要：The formation of glycohemoglobin, especially the hemoglobin A1c(Hb_(A1c)) fraction, occurs when glucose becomes coupled with the amino acid valine in the β-chain of Hb; this reaction is dependent on the plasma concentration of glucose. Since the early 1970 s it has been known that diabetics display higher values of Hb_(A1c) because they have elevated blood glucose concentrations. Thus Hb_(A1c) has acquired a very important role in the treatment and diagnosis of diabetes mellitus. After the introduction of the first quantitative measurement of Hb_(A1c), numerous methods for glycohemoglobin have been introduced with different assay principles: From a simple minicolumn technique to the very accurate automated highpressure chromatography and lastly to many automated immunochemical or enzymatic assays. In early days, the results of the quality control reports for Hb_(A1c) varied extensively between laboratories, therefore in United States and Canada working groups(WG) of the Diabetes Controls and Complications Trial(DCCT) were set up to standardize the Hb_(A1c) assays against the DCCT/National Glycohemoglobin Standardization Program reference method based on liquid chromatography. In the 1990 s, the International Federation of Clinical Chemistry and Laboratory Medicine(IFCC) appointed a new WG to plan a reference preparation and method for the Hb_(A1c) measurement. When the reference procedureswere established, in 2004 IFCC recommended that all manufacturers for equipment used in Hb_(A1c) assays should calibrate their methods to their proposals. This led to an improvement in the coefficient of variation(CV%) associated with the assay. In this review, we describe the glycation of Hb, methods, standardization of the Hb_(A1c) assays, analytical problems, problems with the units in which Hb_(A1c) values are expressed, reference values, quality control aspects, target requirements for Hb_(A1c), and the relationship of the plasma glucose values to Hb_(A1c) concentrations. We also note that the acceptance of the mmol/mol syThe formation of glycohemoglobin, especially the hemoglobin A1c （HbA1c） fraction, occurs when glucose becomes coupled with the amino acid valine in the β-chain of Hb; this reaction is dependent on the plasma concentration of glucose. Since the early 1970s it has been known that diabetics display higher values of HbA1c because they have elevated blood glucose concentrations. Thus HbA1c has acquired a very important role in the treatment and diagnosis of diabetes mellitus. After the introduction of the first quantitative measurement of HbA1c, numerous methods for glycohemoglobin have been introduced with different assay principles： From a simple mini-column technique to the very accurate automated high-pressure chromatography and lastly to many automated immunochemical or enzymatic assays. In early days, the results of the quality control reports for HbA1c varied extensively between laboratories, therefore in United States and Canada working groups （WG） of the Diabetes Controls and Complications Trial （DCCT） were set up to standardize the HbA1c assays against the DCCT/National Glycohemoglobin Standardization Program reference method based on liquid chromatography. In the 1990s, the International Federation of Clinical Chemistry and Laboratory Medicine （IFCC） appointed a new WG to plan a reference preparation and method for the HbA1c measurement. When the reference procedures were established, in 2004 IFCC recommended that all manufacturers for equipment used in HbA1c assays should calibrate their methods to their proposals. This led to an improvement in the coefficient of variation （CV%） associated with the assay. In this review, we describe the glycation of Hb, methods, standardization of the HbA1c assays, analytical problems, problems with the units in which HbA1c values are expressed, reference values, quality control aspects, target requirements for HbA1c, and the relationship of the plasma glucose values to HbA1c concentrations. We also note that the acceptance of the mmol/mol system fo

关 键 词：Diabetes Hemoglobin A1c GLYCOHEMOGLOBIN Glucose International Federation of Clinical Chemistry and Laboratory Medicine Reference values Quality assurance Recommendation Target limits 

分 类 号：O1[理学—数学]