학술논문
One in five laboratories using various hemoglobin [A.sub.1c] methods do not meet the criteria for optimal diabetes care management
Document Type
Clinical report
Author
Source
Diabetes Technology & Therapeutics. April 2011, Vol. 13 Issue 4, p429, 5 p.
Subject
Language
English
ISSN
1520-9156
Abstract
Introduction MONITORING GLYCEMIC control by using glycated hemoglobin [A.sub.1c] (Hb[A.sub.1c]) measurements is one of the hallmarks in the management of diabetes mellitus to adjust therapy regimens and to aid in [...]
Background: We assessed the reference change value (RCV) of currently available hemoglobin [A.sub.1c] (Hb[A.sub.1c]) laboratory assays, which is defined as the critical difference between two consecutive Hb[A.sub.1c] measurements representing a significant change in health status. Methods: We examined the individual laboratory coefficients of variation (CVs) in the Dutch/Belgian quality scheme based on 24 lyophilized samples and calculated the RCV per laboratory (n = 220) and per assay method. In addition, two pooled whole blood samples were sent to the participating laboratories. The individual laboratory results were compared to the assigned value [+ or -] an allowable total error ([TE.sub.a]) of 6%. Results: At Hb[A.sub.1c] values of 41.0mmol/mol (5.9%-Diabetes Control and Complications Trial [DCCT]) and 61.8 mmol/mol (7.8%-DCCT), 99% and 98%, respectively, of the laboratories reported a value within a [TE.sub.a] limit of 6%. The analytical CV of the Hb[A.sub.1c] method used in 78% of the laboratories is Conclusions: The analytical performance of the majority of laboratory Hb[A.sub.1c] methods is within the clinical requirements. However, based on the calculated RCV, 21.8% of the laboratories using different Hb[A.sub.1c] methods are not able to distinguish an Hb[A.sub.1c] result of 59 mmol/mol (7.5%-DCCT) from a previous Hb[A.sub.1c] result of 53 mmol/mol (7.0%-DCCT). It can be presumed that differences in Hb[A.sub.1c] results of 5 mmol/mol (0.5%-DCCT) do influence treatment decisions.
Background: We assessed the reference change value (RCV) of currently available hemoglobin [A.sub.1c] (Hb[A.sub.1c]) laboratory assays, which is defined as the critical difference between two consecutive Hb[A.sub.1c] measurements representing a significant change in health status. Methods: We examined the individual laboratory coefficients of variation (CVs) in the Dutch/Belgian quality scheme based on 24 lyophilized samples and calculated the RCV per laboratory (n = 220) and per assay method. In addition, two pooled whole blood samples were sent to the participating laboratories. The individual laboratory results were compared to the assigned value [+ or -] an allowable total error ([TE.sub.a]) of 6%. Results: At Hb[A.sub.1c] values of 41.0mmol/mol (5.9%-Diabetes Control and Complications Trial [DCCT]) and 61.8 mmol/mol (7.8%-DCCT), 99% and 98%, respectively, of the laboratories reported a value within a [TE.sub.a] limit of 6%. The analytical CV of the Hb[A.sub.1c] method used in 78% of the laboratories is Conclusions: The analytical performance of the majority of laboratory Hb[A.sub.1c] methods is within the clinical requirements. However, based on the calculated RCV, 21.8% of the laboratories using different Hb[A.sub.1c] methods are not able to distinguish an Hb[A.sub.1c] result of 59 mmol/mol (7.5%-DCCT) from a previous Hb[A.sub.1c] result of 53 mmol/mol (7.0%-DCCT). It can be presumed that differences in Hb[A.sub.1c] results of 5 mmol/mol (0.5%-DCCT) do influence treatment decisions.