Data di Pubblicazione:
2013
Citazione:
Standardization and analytical goals for glycated hemoglobin measurement / F. Braga, M. Panteghini. - In: CLINICAL CHEMISTRY AND LABORATORY MEDICINE. - ISSN 1434-6621. - 51:9(2013), pp. 1719-1726. [10.1515/cclm-2013-0060]
Abstract:
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.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
Analytical goals; Glycated hemoglobin; Standardization
Elenco autori:
F. Braga, M. Panteghini
Link alla scheda completa: