公开(公告)号：US09285376B2

公开(公告)日：2016-03-15

申请号：US14330179

申请日：2014-07-14

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Jürgen Spinke ,  Marcel Thiele ,  Jürgen Schäffler ,  Andreas Nufer

IPC: G01N33/543 ,  G01N33/74 ,  G01N33/53 ,  G01N33/557

CPC classification number: G01N33/74 ,  G01N33/5306 ,  G01N33/54386 ,  G01N33/557

Abstract: A method for the quantitative determination of an analyte in a sample is provided comprising: (a) providing an analyte-specific substance which is able to undergo a reaction which generates a detectable signal when it is contacted with an analyte; (b) providing at least two calibration graphs which have been generated by reacting in each case the same analyte-specific substance with different amounts of in each case the same test analyte for in each case a predetermined reaction time; (c) contacting the analyte-specific substance with a sample which contains the analyte to be detected; (d) measuring the signal at a first predetermined reaction time for which a first calibration graph according to (b) is provided; (c) checking whether the signal measured according to (d) enables a quantitative determination of the analyte with a desired accuracy; (f) (i) quantitatively determining the analyte on the basis of the signal measured according to (d) if the desired accuracy is reached, or (ii) measuring the signal at a second predetermined reaction time for which a second calibration graph according to (b) is provided; (g) checking whether the signal measured according to (f(ii)) enables a quantitative determination of the analyte with a desired accuracy; and (h) (i) quantitatively determining the analyte on the basis of the signal measured according to f(ii) if the desired accuracy is reached, or (ii) continuing the determination at at least one further predetermined reaction time (corresponding to (f)(ii), (g), (h)(i)).

Abstract translation: 提供了用于定量测定样品中分析物的方法，其包括：（a）提供分析物特异性物质，其能够经历当与分析物接触时产生可检测信号的反应; （b）提供至少两个校准图，其通过在每种情况下使相同的分析物特异性物质与每种情况下具有相同的测试分析物的不同量在每种情况下具有预定的反应时间而反应而产生; （c）使分析物特异性物质与含有待检测分析物的样品接触; （d）在提供根据（b）的第一校准曲线的第一预定反应时间测量信号; （c）检查根据（d）测量的信号是否能够以期望的精度定量分析分析物; （f）（i）如果达到期望的精度，则基于根据（d）测量的信号定量测定分析物，或（ii）在第二预定反应时间测量信号，根据 （b）; （g）检查根据（f（ii））测量的信号是否能够以期望的精度定量分析分析物; 和（h）（i）如果达到期望的准确度，则基于根据f（ii）测量的信号定量测定分析物，或（ii）在至少一个进一步的预定反应时间（对应于 f）（ii），（g），（h）（i））。

公开(公告)号：US20150005605A1

公开(公告)日：2015-01-01

申请号：US14486402

申请日：2014-09-15

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Arnulf Staib ,  Marcel Thiele ,  Karl-Heinz Koelker ,  Ewald Rieger

IPC: G01N27/327 ,  A61B5/145 ,  A61B5/1486

Abstract: An electrode system is disclosed for measuring a concentration or presence of an analyte under in-vivo conditions, where the electrode system includes at least one electrode with immobilized enzyme molecules and an improved diffusion barrier that controls diffusion of the analyte from body fluid surrounding the electrode system to the enzyme molecules. The diffusion barrier includes a hydrophilic polyurethane or a block copolymer having at least one hydrophilic block and at least one hydrophobic block. The electrode system also can include a spacer membrane that includes a hydrophilic copolymer of acrylic and/or methacrylic monomers.

Abstract translation: 公开了用于在体内条件下测量分析物的浓度或存在的电极系统，其中电极系统包括具有固定化酶分子的至少一个电极和改善的扩散阻挡层，其控制分析物从电极周围的体液的扩散 系统对酶分子。 扩散阻挡层包括具有至少一个亲水嵌段和至少一个疏水嵌段的亲水性聚氨酯或嵌段共聚物。 电极系统还可以包括间隔膜，其包括丙烯酸和/或甲基丙烯酸单体的亲水共聚物。

公开(公告)号：US20140018653A1

公开(公告)日：2014-01-16

申请号：US14027493

申请日：2013-09-16

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Arnulf Staib ,  Marcel Thiele ,  Karl-Heinz Koelker ,  Ewald Rieger

IPC: A61B5/1486

Abstract: Electrode systems are disclosed for measuring the concentration of an analyte under in vivo conditions, where the systems includes an electrode with immobilized enzyme molecules and an improved diffusion barrier that controls diffusion of the analyte from body fluid surrounding the electrode system to the enzyme molecules. Methods of making and using the system also are disclosed.

Abstract translation: 公开了用于在体内条件下测量分析物浓度的电极系统，其中系统包括具有固定化酶分子的电极和改进的扩散屏障，其控制分析物从电极系统周围的体液扩散到酶分子。 公开了制造和使用该系统的方法。

公开(公告)号：US20140322703A1

公开(公告)日：2014-10-30

申请号：US14330179

申请日：2014-07-14

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Jürgen Spinke ,  Marcel Thiele ,  Jürgen Schäffler ,  Andreas Nufer

IPC: G01N33/74 ,  G01N33/53 ,  G01N33/557

CPC classification number: G01N33/74 ,  G01N33/5306 ,  G01N33/54386 ,  G01N33/557

Abstract: A method for the quantitative determination of an analyte in a sample is provided comprising: (a) providing an analyte-specific substance which is able to undergo a reaction which generates a detectable signal when it is contacted with an analyte; (b) providing at least two calibration graphs which have been generated by reacting in each case the same analyte-specific substance with different amounts of in each case the same test analyte for in each case a predetermined reaction time; (c) contacting the analyte-specific substance with a sample which contains the analyte to be detected; (d) measuring the signal at a first predetermined reaction time for which a first calibration graph according to (b) is provided; (c) checking whether the signal measured according to (d) enables a quantitative determination of the analyte with a desired accuracy; (f) (i) quantitatively determining the analyte on the basis of the signal measured according to (d) if the desired accuracy is reached, or (ii) measuring the signal at a second predetermined reaction time for which a second calibration graph according to (b) is provided; (g) checking whether the signal measured according to (f(ii)) enables a quantitative determination of the analyte with a desired accuracy; and (h) (i) quantitatively determining the analyte on the basis of the signal measured according to f(ii) if the desired accuracy is reached, or (ii) continuing the determination at at least one further predetermined reaction time (corresponding to (f)(ii), (g), (h)(i)).

Abstract translation: 提供了用于定量测定样品中分析物的方法，其包括：（a）提供分析物特异性物质，其能够经历当与分析物接触时产生可检测信号的反应; （b）提供至少两个校准图，其通过在每种情况下使相同的分析物特异性物质与每种情况下具有不同量的相同测试分析物在每种情况下具有预定的反应时间而反应而产生; （c）使分析物特异性物质与含有待检测分析物的样品接触; （d）在提供根据（b）的第一校准曲线的第一预定反应时间测量信号; （c）检查根据（d）测量的信号是否能够以期望的精度定量分析分析物; （f）（i）如果达到期望的精度，则基于根据（d）测量的信号定量测定分析物，或（ii）在第二预定反应时间测量信号，根据 （b）; （g）检查根据（f（ii））测量的信号是否能够以期望的精度定量分析分析物; 和（h）（i）如果达到期望的准确度，则基于根据f（ii）测量的信号定量测定分析物，或（ii）在至少一个进一步的预定反应时间（对应于 f）（ii），（g），（h）（i））。