Enzymatic determination of hba1c

Abstract

The present invention relates to a method for determining the amount of glycated haemoglobin (HbA1c), in which -if required -the erythrocytes in a sample are haemolysed, the haemoglobin that is then released -if required -is contacted with a proteolytic agent and the glycated haemoglobin degradation products obtained in this way or otherwise are quantified. In order to provide such a process and reagents employable therein that has / have the property of sufficient stability of the chemical compounds that are essential to the reaction, the provision of the requisite proteolytic agent in the form of an inactivated protease is proposed, which is then only reactivated in situ. In particular embodiments of the invention, for the stabilization of the haemoglobin which is unfolded at a very low pH in the range from 1 to 3, at least one suitable stabilizer should be present in the haemolysis solution, and, in the embodiments of the invention in which a leuco dye is used in connection with the determination of the amount of HbA1c, it is proposed in accordance with the invention that the latter be stabilized with particular phosphine compounds and / or thio compounds.

Description

Enzymatic determination of HbA1c technical field The present invention relates to a method for determining the amount of glycated hemoglobin (HbA1c) in a sample, and a kit useful in the method for determining the amount of glycated hemoglobin (HbA1c) in a sample. Background technique According to the definition of IFCC (International Federation of Clinical Chemistry and Experimental Medicine), glycated hemoglobin (HbA1c) is a stable product of glucose coupled to the N-terminal valine of the beta chain of hemoglobin, and the amount of HbA1c is relative to the amount of total hemoglobin (mmol HbA1c / mol total hemoglobin) represents the average blood glucose level in the last 8 weeks before the blood sample was taken and is therefore called "long-term blood glucose". Therefore, the HbA1c value that should generally be in the range of 20 to 42 mmol / mol is an important index for the diagnosis and treatment of diabetes. Known methods of determining HbA1c are eg immunoassays suc...

AI Technical Summary

Problems solved by technology

However, this method poses difficulties, the autoxidation of the leuco dye leads to a non-specific blank value signal as well as increased spectral background, which leads to difficulties in accurate spectrophotometric measurement of the analytical signal

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