Standardization and analytical goals for glycated hemoglobin measurement. 2013

Federica Braga, and Mauro Panteghini

Glycated hemoglobin (HbA1c) plays a key role in diagnosing diabetes and monitoring the glycemic state. To guarantee the reliability of its measurement at the global level, the IFCC has defined a reference measurement system, based on the definition of the measurand as hemoglobin molecules having a special hexapeptide in common, which is the stable adduct of glucose to the N-terminal valine of the hemoglobin β-chain. In addition to the traceability of HbA1c results to the reference system, the establishment of analytical goals to make HbA1c measurements clinically reliable becomes crucial. However, allowable goals will depend on the assay specificity (i.e., selectivity) and, consequently, on units in which HbA1c results are expressed [mmol/mol for IFCC-aligned systems or % for National Glycohemoglobin Standardization Program (NGSP) converted numbers]. In this regard, analytical goals derived from biological variability studies in which the determination of HbA1c has been carried out by an assay providing the same selectivity for the measurand as defined by the IFCC are recommended. Only these targets should be used for evaluating the performance of commercial assays traceable to the IFCC system and of clinical laboratories using them through appropriately structured quality assessment schemes. Analytical systems following different calibration hierarchies (e.g., the NGSP-aligned assays) will require different analytical goals, possibly derived from clinical outcome data.

UI MeSH Term Description Entries
D012015 Reference Standards A basis of value established for the measure of quantity, weight, extent or quality, e.g. weight standards, standard solutions, methods, techniques, and procedures used in diagnosis and therapy. Standard Preparations,Standards, Reference,Preparations, Standard,Standardization,Standards,Preparation, Standard,Reference Standard,Standard Preparation,Standard, Reference
D001774 Blood Chemical Analysis An examination of chemicals in the blood. Analysis, Blood Chemical,Chemical Analysis, Blood,Analyses, Blood Chemical,Blood Chemical Analyses,Chemical Analyses, Blood
D002138 Calibration Determination, by measurement or comparison with a standard, of the correct value of each scale reading on a meter or other measuring instrument; or determination of the settings of a control device that correspond to particular values of voltage, current, frequency or other output. Calibrations
D003920 Diabetes Mellitus A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE.
D006442 Glycated Hemoglobin Products of non-enzymatic reactions between GLUCOSE and HEMOGLOBIN (occurring as a minor fraction of the hemoglobin of ERYTHROCYTES.) It generally refers to glycated HEMOGLOBIN A. Hemoglobin A1c (Hb A1c) is hemoglobin A with GLYCATION on a terminal VALINE of the beta chain. Glycated hemoglobin A is used as an index of the average blood sugar level over a lifetime of erythrocytes. Fructated Hemoglobins,Glycohemoglobin,Glycohemoglobin A,Glycohemoglobins,Glycosylated Hemoglobin A,Hb A1c,HbA1,Hemoglobin A(1),Hemoglobin A, Glycosylated,Glycated Hemoglobin A,Glycated Hemoglobin A1c,Glycated Hemoglobins,Glycosylated Hemoglobin A1c,Hb A1,Hb A1a+b,Hb A1a-1,Hb A1a-2,Hb A1b,Hemoglobin, Glycated A1a-2,Hemoglobin, Glycated A1b,Hemoglobin, Glycosylated,Hemoglobin, Glycosylated A1a-1,Hemoglobin, Glycosylated A1b,A1a-1 Hemoglobin, Glycosylated,A1a-2 Hemoglobin, Glycated,A1b Hemoglobin, Glycated,A1b Hemoglobin, Glycosylated,Glycated A1a-2 Hemoglobin,Glycated A1b Hemoglobin,Glycosylated A1a-1 Hemoglobin,Glycosylated A1b Hemoglobin,Glycosylated Hemoglobin,Hemoglobin A, Glycated,Hemoglobin A1c, Glycated,Hemoglobin A1c, Glycosylated,Hemoglobin, Glycated,Hemoglobin, Glycated A1a 2,Hemoglobin, Glycosylated A1a 1,Hemoglobins, Fructated,Hemoglobins, Glycated
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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