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））。

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））。