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    ENZYMATISCHE BESTIMMUNG VON HBA1C
    2.
    发明公开
    ENZYMATISCHE BESTIMMUNG VON HBA1C 有权

    公开(公告)号：EP3140660A1

    公开(公告)日：2017-03-15

    申请号：EP15723455.0

    申请日：2015-05-06

    申请人： DiaSys Diagnostic Systems GmbH

    发明人： GORKA, Günther ,  WATAZU, Yoshifumi ,  METZMANN, Erwin ,  LEIN, Alexandra ,  MÜLLER, Holger ,  GRIMMLER, Matthias

    IPC分类号： G01N33/72

    CPC分类号： C12Q1/28 ,  C12N9/6491 ,  C12Q1/26 ,  C12Q1/37 ,  C12Q2326/00 ,  C12Y105/03 ,  C12Y304/24027 ,  G01N33/723 ,  G01N33/725 ,  G01N2333/805 ,  G01N2333/90672 ,  G01N2333/954

    摘要： 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, 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. 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, and in particular embodiments of the invention the requisite proteolytic agent is to be provided in the form of an inactivated protease which is then only reactivated
    in situ .

    摘要翻译： 一种测定糖化血红蛋白（HbA1c）量的方法，其中如果需要的话，将样品中的红细胞溶血，随后释放的血红蛋白（如果需要）与蛋白水解剂接触，并获得糖化血红蛋白降解产物 以这种方式或以其他方式进行量化。 为了提供这样一种方法和其中可用的试剂，其具有反应所必需的化学化合物的足够稳定性的性质，用于稳定在非常低的pH下从1开始的血红蛋白 至3，在溶血溶液中存在至少一种合适的稳定剂。 在测定HbA1c量时使用无色染料的情况下，建议后者用特定的膦化合物和/或硫代化合物稳定化，并且在特定实施方案中，必要的蛋白水解剂应在 然后仅在原位重新活化的失活蛋白酶的形式。

    ENZYMATISCHE BESTIMMUNG VON HBA1C
    6.
    发明公开
    ENZYMATISCHE BESTIMMUNG VON HBA1C 审中-公开

    公开(公告)号：EP3140661A2

    公开(公告)日：2017-03-15

    申请号：EP15771025.2

    申请日：2015-03-31

    申请人： DiaSys Diagnostic Systems GmbH

    发明人： GORKA, Günther ,  WATAZU, Yoshifumi ,  METZMANN, Erwin ,  LEIN, Alexandra ,  MÜLLER, Holger ,  GRIMMLER, Matthias

    IPC分类号： G01N33/72

    CPC分类号： C12Q1/28 ,  C12N9/6491 ,  C12Q1/26 ,  C12Q1/37 ,  C12Q2326/00 ,  C12Y105/03 ,  C12Y304/24027 ,  G01N33/723 ,  G01N33/725 ,  G01N2333/805 ,  G01N2333/90672 ,  G01N2333/954

    摘要： 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.

    摘要翻译： 一种测定糖化血红蛋白（HbA1c）量的方法，其中 - 如果需要的话，样品中的红细胞被溶血，然后释放的血红蛋白（如果需要的话）与蛋白水解剂接触，得到的糖化血红蛋白降解产物 以这种方式或以其他方式被量化是公开的。 为了提供其中可使用的具有/具有对反应必需的化学化合物的足够稳定性的这种方法和试剂，为了稳定在非常低的pH下展开的血红蛋白的范围为1 至3，溶血溶液中存在至少一种合适的稳定剂。 当与确定HbA1c的量相关联使用无色染料时，建议后者用特定的膦化合物和/或硫代化合物稳定，并且在具体实施方案中，所需的蛋白水解剂将被提供在 灭活的蛋白酶的形式然后仅在原位再活化。