Control Reagent Monitors the Performance of HbA1c Assays

Good quality control is essential to monitor accurately and efficiently the performance of glycated hemoglobin (HbA1c) tests.

The HbA1c test is used primarily to identify the average plasma-glucose concentration over prolonged periods of time and is a more reliable indicator of long-term diabetic control than blood glucose.

The new HbA1c control from Randox Laboratories (Crumlin, UK) is made from 100% human whole blood and is designed to be consistent over repeated analysis. The HbA1c controls are lyophilized providing enhanced shelf life and stability. An extended shelf life reduces the frequency of lot crossovers and allows the user to sequester and use the same lot of control over a number of years significantly reducing reagent costs. A working stability of 28 days at 2 °C - 8 °C minimizes waste and saves money.

Accurately assigned percentage HbA1c target values and ranges with corresponding total hemoglobin and HbA1c concentration values are provided for all major systems and methods including HPLC. To complement the HbA1c controls, a linearity set is also available designed to verify the linearity of HbA1c assays across the clinically important range. Four clinically significant levels are provided eliminating the requirement for very low and or very high patient samples normally used to assess linearity. The HbA1c controls and the linearity set are suitable for use on all platforms and contain accurately assigned values for the most common analyzers and methods.

The American Diabetes Association, the International Diabetes Federation, and the European Association for the Study of Diabetes all consider HbA1c a more dependable gauge for continuous diabetic management than other assays.

Related Links:
Randox Laboratories
American Diabetes Association
International Diabetes Federation
European Association for the Study of Diabetes