HbA1c (Direct) assay

Description

Intended Use

For the quantitative in vitro determination of HbA1c in whole blood. This product is suitable for automated, semi-automated and manual use.

Clinical Significance

The measurement of HbA1c is used in the long-term monitoring of diabetes mellitus. This assay should not be used in the diagnosis of diabetes mellitus or for day to day glucose monitoring.

Diabetes Mellitus is a disease associated with poor glycaemic control. Numerous clinical studies, including the Diabetes Control and Complications Trial, have shown that diabetes related complications may be reduced by the long term monitoring and tight control of blood glucose levels.

In the diabetic patient where blood glucose levels are abnormally elevated, the level of HbA1c also increases, the reason for this is that HbA1c is formed by the non-enzymatic glycation of the N-terminus of the ?-chain of haemoglobin A0.

The level of HbA1c is proportional to the level of glucose in the blood and has been widely accepted as an indicator of the mean daily blood glucose concentration over the preceding 6 to 8 weeks. It is therefore, a long term indicator of diabetic control, whereas, the measurement of blood glucose is only a short term indicator.