公开(公告)号：US20140106383A1

公开(公告)日：2014-04-17

申请号：US14136769

申请日：2013-12-20

Applicant: Roche Diagnostics Operations Inc.

Inventor： Liesel Doerge ,  Margarete Galm ,  Carina Horn

IPC: G01N27/26

CPC classification number: G01N27/26 ,  C12Q1/005 ,  C12Q1/56 ,  G01N33/86

Abstract: Methods and devices for determining factor Xa inhibitors, in particular heparins and fractionated or low-molecular-weight heparins, as well as direct factor Xa inhibitors in blood samples. The methods include contacting a blood sample with a detection reagent that contains at least one thrombin substrate having a peptide residue that can be cleaved by thrombin and is amidically bound via the carboxyl end to an electrogenic substance, and with a known amount of factor X reagent and an activator reagent which induces the conversion of factor X into factor Xa. Subsequently, in a second step, the amount or activity of the electrogenic substance that is cleaved from the thrombin substrate by the factor Xa-mediated thrombin activation and/or the time course thereof is determined as the measurement signal using electrochemical methods. In a third step, the amount of the factor Xa inhibitor in the sample of the blood to be analyzed or a measured quantity that correlates therewith, in particular a clotting time that correlates therewith, is determined on the basis of this measurement signal.

Abstract translation: 用于确定因子Xa抑制剂，特别是肝素和分级或低分子量肝素的方法和装置，以及血液样品中的直接因子Xa抑制剂。 所述方法包括使血液样品与含有至少一个凝血酶底物的检测试剂接触，所述凝血酶底物具有可被凝血酶切割的肽残基，并且经由羧基末端与电生物质酰胺结合，并且使用已知量的因子X试剂 和诱导因子X转化成因子Xa的活化剂。 随后，在第二步骤中，通过因子Xa介导的凝血酶活化和/或其时间过程将从凝血酶底物切割的电生物质的量或活性确定为使用电化学方法的测量信号。 在第三步骤中，基于该测量信号确定要分析的血液样品中的因子Xa抑制剂的量或与其相关的测量量，特别是与其相关的凝血时间。

公开(公告)号：US09594042B2

公开(公告)日：2017-03-14

申请号：US14136769

申请日：2013-12-20

Applicant: Roche Diagnostics Operations Inc.

Inventor： Liesel Doerge ,  Margarete Galm ,  Carina Horn

IPC: G01N27/26 ,  C12Q1/00 ,  C12Q1/56 ,  G01N33/86

CPC classification number: G01N27/26 ,  C12Q1/005 ,  C12Q1/56 ,  G01N33/86

Abstract: Methods and devices for determining factor Xa inhibitors, in particular heparins and fractionated or low-molecular-weight heparins, as well as direct factor Xa inhibitors in blood samples. The methods include contacting a blood sample with a detection reagent that contains at least one thrombin substrate having a peptide residue that can be cleaved by thrombin and is amidically bound via the carboxyl end to an electrogenic substance, and with a known amount of factor X reagent and an activator reagent which induces the conversion of factor X into factor Xa. Subsequently, in a second step, the amount or activity of the electrogenic substance that is cleaved from the thrombin substrate by the factor Xa-mediated thrombin activation and/or the time course thereof is determined as the measurement signal using electrochemical methods. In a third step, the amount of the factor Xa inhibitor in the sample of the blood to be analyzed or a measured quantity that correlates therewith, in particular a clotting time that correlates therewith, is determined on the basis of this measurement signal.

Abstract translation: 用于确定因子Xa抑制剂，特别是肝素和分级或低分子量肝素的方法和装置，以及血液样品中的直接因子Xa抑制剂。 所述方法包括使血液样品与含有至少一个凝血酶底物的检测试剂接触，所述凝血酶底物具有可被凝血酶切割的肽残基，并且经由羧基末端与电生物质酰胺结合，并且使用已知量的因子X试剂 和诱导因子X转化成因子Xa的活化剂。 随后，在第二步骤中，通过因子Xa介导的凝血酶活化和/或其时间过程将从凝血酶底物切割的电生物质的量或活性确定为使用电化学方法的测量信号。 在第三步骤中，基于该测量信号确定要分析的血液样品中的因子Xa抑制剂的量或与其相关的测量量，特别是与其相关的凝血时间。