ENZYMATIC DETERMINATION OF HBA1C

摘要

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 is disclosed. 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, 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 is present in the haemolysis solution. Where a leuco dye is used in connection with the determination of the amount of HbA1c, it is proposed that the latter be stabilized with particular phosphine compounds and/or thio compounds, and, in particular embodiments, the requisite proteolytic agent is to be provided in the form of an inactivated protease which is then only reactivated in situ.

主权项

1: A method of determining the amount of glycated haemoglobin (HbA1c) in a sample, wherein the following method steps are performed:
a) haemolysis of the erythrocytes in the sample to release the HbA1c contained therein, b) bringing the HbA1c released in method step a) into contact with a proteolytic agent for producing glycated haemoglobin degradation products, and c) determining the amount of HbA1c by quantification of the glycated haemoglobin degradation products produced in method step b), wherein the haemolysis operation in method step a) is effected by adding a haemolysis solution (H), wherein that haemolysis solution has a pH-value in the range of 1 to 3 and contains a haemolytic detergent and at least one stabiliser, and wherein the at least one stabiliser is selected from a phosphatidylcholine, 2-(methacryloxyethyl)-2′-(trimethyl ammoniumethyl)phosphate polymer or copolymer, a zwitterionic detergent or mixtures thereof.