Federica Braga1, Alberto Dolci, Andrea Mosca, Mauro Panteghini. 1. Centro Interdipartimentale per la Riferibilità Metrologica in Medicina di Laboratorio (CIRME), Università degli Studi, Milano, Italy. federica.braga@studenti.unimi.it
Abstract
BACKGROUND: The measurement of glycated hemoglobin (HbA(1c)) has a pivotal role in monitoring glycemic state in diabetic patients. Furthermore, the American Diabetes Association has recently recommended the use of HbA(1c) for diabetes diagnosis, but a clear definition of the clinically allowable measurement error is still lacking. Information on biological variability of the analyte can be used to achieve this goal. METHODS: We systematically reviewed the published studies on the biological variation of HbA(1c) to check consistency of available data in order to accurately define analytical goals. RESULTS: The nine recruited studies were limited by choice of analytic methodology, population selection, protocol application and statistical analyses. CONCLUSIONS: There is an urgent need to determine biological variability of HbA(1c) using a specific and traceable assay, appropriate protocol and appropriate statistical evaluation of data. 2010 Elsevier B.V. All rights reserved.
BACKGROUND: The measurement of glycated hemoglobin (HbA(1c)) has a pivotal role in monitoring glycemic state in diabeticpatients. Furthermore, the American Diabetes Association has recently recommended the use of HbA(1c) for diabetes diagnosis, but a clear definition of the clinically allowable measurement error is still lacking. Information on biological variability of the analyte can be used to achieve this goal. METHODS: We systematically reviewed the published studies on the biological variation of HbA(1c) to check consistency of available data in order to accurately define analytical goals. RESULTS: The nine recruited studies were limited by choice of analytic methodology, population selection, protocol application and statistical analyses. CONCLUSIONS: There is an urgent need to determine biological variability of HbA(1c) using a specific and traceable assay, appropriate protocol and appropriate statistical evaluation of data. 2010 Elsevier B.V. All rights reserved.