Product Spotlight: HbA1c Quality Controls

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HbA1c Quality Controls


Diabetes is a life-long condition which occurs when the glucose level in the blood is too high because it can’t enter the body’s cells to be used as fuel. There are two types of diabetes: type 1 and type 2. They are distinct conditions and must be treated and managed differently.

Type 1 Diabetes

Type one diabetes is an autoimmune condition in which the body attacks insulin-producing cells, this causes a lack of insulin, leading to an increased blood glucose level. Around 10% of people with diabetes has type 1.

Type 2 Diabetes

A mixture of genetic and environmental factors causes type 2 diabetes. The body doesn’t make enough insulin or the insulin it does create does not work correctly, leading to a glucose build up in the blood. It’s thought that up to 58% of type 2 diabetes can be prevented or delayed through healthy lifestyle choices.


HbA1c is the average blood glucose level for the past two to tthree months. A high HbA1c means there is too much sugar in the bloodstream. This means the patient is more likely to develop complications associated with diabetes, like problems with feet and eyes [1].

HbA1c in Diagnostics

In 2011, the WHO accepted the use of glycated haemoglobin (HbA1c) testing in the diagnosis of diabetes, Diabetes UK also supports this decsion [2].

HbA1c can be used as a diagnostic test for diabetes providing that stringent quality assurance tests are in place and assays are standardised to criteria aligned to the international reference values, and there are no conditions present which preclude its accurate measurement.”
World Health Organisation (2011)

Clinically Significant Levels

A HbA1c level of 6.5% is recomended as the cut off for diabetes diagnosis [3], this can be seen in Fig. 1.

HbA1c Levels

Fig. 1. Clinically relevant levels for Diabetes diagnosis.

Acusera HbA1c Controls

Acusera HbA1c Quality Control

The Randox Acusera HbA1c control is designed for use in the quality control of both HbA1c and Total Haemoglobin assays. Assayed instrument and method specific target values and ranges are provided for all major systems and methods including HPLC. A reconstituted stability of 4 weeks keeps waste to a minimum and helps to reduce costs.

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Acusera Liquid HbA1c Quality Control

Conveniently supplied liquid ready-to-use the Liquid HbA1c control is ideally suited to both clinical laboratories and POCT helping to significantly reduce preparation time. With a stability of 30 days waste and costs are also kept to a minimum.

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  • References

    [1] “What is HbA1c?”, Diabetes UK, 2018. [Online] Availabel:

    [2] Diabetes UK, “Diagnostics criteria for deabetes”, Diabetes UK, 2018. [Online]. Available:

    [3] WHO, “Use of Glycated Haemoglobin (HbA1c) in the Diagnosis of Diabetes Mellitus”, World Health Organisation, 2011.

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