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1. 发明申请

US20150268238A1 METHOD AND KIT FOR ANALYTE DETERMINATION AT ACIDIC CONDITIONS 审中-公开
标题翻译：酸性条件下分析测定方法和试剂盒
公开(公告)号：US20150268238A1
公开(公告)日：2015-09-24
申请号：US14433276
申请日：2013-10-03
申请人： GYROS Patent AB
发明人： Mats Inganäs , Pirjo Lehtonen
IPC分类号： G01N33/543
CPC分类号： G01N33/54393 , G01N33/5306 , G01N33/5375 , G01N2333/195
摘要： A method of quantitatively determining an analyte in a fluid sample by an immunoassay comprises binding of the analyte to a ligand capable of specifically binding to the analyte, wherein at least part of the analyte is present as an analyte complex is disclosed. The method comprises the steps of: a) subjecting the sample to a first acidic pH to at least substantially dissociate any analyte complex present and provide substantially all analyte in free form, b) raising the first acidic pH to a second acidic pH where re-formation of complexes is prevented but where binding of analyte to the ligand is permitted, and c) determining the binding of analyte to the ligand to quantitatively determine the analyte in the sample.
摘要翻译：通过免疫测定定量测定流体样品中的分析物的方法包括将分析物结合到能够特异性结合分析物的配体，其中至少部分分析物作为分析物复合物存在。该方法包括以下步骤：a）使样品经受第一酸性pH至少基本上解离所存在的任何分析物复合物，并基本上提供游离形式的所有分析物，b）将第一酸性pH提高至第二酸性pH，防止复合物的形成，但是其中允许分析物与配体的结合，和c）测定分析物与配体的结合以定量测定样品中的分析物。

2. 发明授权

US10620194B2 Characterization of reaction variables 有权
公开(公告)号：US10620194B2
公开(公告)日：2020-04-14
申请号：US14215745
申请日：2014-03-17
申请人： Gyros Patent AB
发明人： Per Andersson , Mats Inganas , Gunnar Thorsén , Gunnar Kylberg
IPC分类号： G01N33/543 , B01F5/06 , B01L3/00 , G01N35/00 , B01F13/00 , B01J19/00 , H01J49/04 , G01N30/60 , G01N30/72
CPC分类号： G01N33/54306 , B01F5/0646 , B01F5/0647 , B01F5/0655 , B01F13/0059 , B01J19/0093 , B01L3/5025 , B01L3/5027 , B01L3/502738 , B01L3/502746 , G01N33/54366 , G01N35/00069 , H01J49/04 , B01J2219/0086 , B01J2219/00788 , B01J2219/00833 , B01J2219/00862 , B01J2219/00891 , B01L2200/06 , B01L2200/0605 , B01L2200/10 , B01L2200/142 , B01L2300/069 , B01L2300/0803 , B01L2300/0806 , B01L2300/087 , B01L2300/0861 , B01L2300/0864 , B01L2300/0867 , B01L2300/14 , B01L2300/16 , B01L2400/0406 , B01L2400/0409 , B01L2400/0633 , B01L2400/0688 , B01L2400/086 , G01N30/6095 , G01N30/7266 , G01N2035/00504 , Y10S435/973
摘要： A microscale method for the characterization of one or more reaction variables that influence the formation or dissociation of an affinity complex comprising a ligand and a binder, which have mutual affinity for each other. The method is characterized in comprising the steps of: (i) providing a microfluidic device comprising a microchannel structures that are under a common flow control, each microchannel structure comprising a reaction microactivity; (ii) performing essentially in parallel an experiment in each of two or more of the plurality of microchannel structures, the experiment in these two or more microchannel structures comprising either a) formation of an immobilized form of the complex and retaining under flow conditions said form within the reaction microactivity, or b) dissociating, preferably under flow condition, an immobilized form of the complex which has been included in the microfluidic device provided in step (i), at least one reaction variable varies or is uncharacterized for said two or more microchannel structures while the remaining reaction variables are kept essentially constant; (iii) measuring the presentation of the complex in said reaction microactivity in said two or more microchannel structures; and (iv) characterizing said one or more reaction variables based on the values for presentation obtained in step (iii).

3. 发明授权

US10036745B2 Method and kit for analyte determination at acidic conditions 有权
公开(公告)号：US10036745B2
公开(公告)日：2018-07-31
申请号：US14433276
申请日：2013-10-03
申请人： GYROS Patent AB
发明人： Mats Inganäs , Pirjo Lehtonen
IPC分类号： G01N33/537 , G01N33/543 , G01N33/53
CPC分类号： G01N33/54393 , G01N33/5306 , G01N33/5375 , G01N2333/195
摘要： A method of quantitatively determining an analyte in a fluid sample by an immunoassay comprises binding of the analyte to a ligand capable of specifically binding to the analyte, wherein at least part of the analyte is present as an analyte complex is disclosed. The method comprises the steps of: a) subjecting the sample to a first acidic pH to at least substantially dissociate any analyte complex present and provide substantially all analyte in free form, b) raising the first acidic pH to a second acidic pH where re-formation of complexes is prevented but where binding of analyte to the ligand is permitted, and c) determining the binding of analyte to the ligand to quantitatively determine the analyte in the sample.

4. 发明申请

US20160097777A1 IMMUNOLOGICAL METHOD 审中-公开
标题翻译：免疫学方法
公开(公告)号：US20160097777A1
公开(公告)日：2016-04-07
申请号：US14849326
申请日：2015-09-09
申请人： GYROS Patent AB
发明人： Cecilia Bill , Ann-Charlott Steffen , Mats Inganäs
IPC分类号： G01N33/68
CPC分类号： G01N33/6854 , G01N33/94
摘要： The present invention relates to an in vitro method for the detection of an anti-drug antibody (ADA) against a therapeutic drug antibody (TDA) in a biological sample. The in vitro method comprises detecting and capturing said ADA using affinity moieties obtained from an intact therapeutic drug antibody, or a Fab fragment thereof, in a certain manner. Avoiding using only intact therapeutic drug antibodies or only Fab fragments thereof as reagents in such a method has been proven as an efficient way of increasing sensitivity, decreasing unspecific binding and the formation of large protein complexes. Such a method has great utility in therapeutic drug development or in the evaluation of a particular treatment of a patient.
摘要翻译：本发明涉及用于检测针对生物样品中治疗药物抗体（TDA）的抗药物抗体（ADA）的体外方法。体外方法包括使用从完整治疗药物抗体或其Fab片段获得的亲和部分以某种方式检测和捕获所述ADA。已经证明避免在这种方法中仅使用完整的治疗药物抗体或其Fab片段作为试剂，这是提高灵敏度，减少非特异性结合和形成大蛋白复合物的有效途径。这种方法在治疗药物开发或评估患者的特定治疗方面具有很大的用途。

5. 发明申请

US20150377873A9 CHARACTERIZATION OF REACTION VARIABLES 审中-公开
标题翻译：反应变量的表征
公开(公告)号：US20150377873A9
公开(公告)日：2015-12-31
申请号：US14215745
申请日：2014-03-17
申请人： Gyros Patent AB
发明人： Per Andersson , Mats Inganas , Gunnar Thorsén , Gunnar Kylberg
IPC分类号： G01N33/543
CPC分类号： G01N33/54306 , B01F5/0646 , B01F5/0647 , B01F5/0655 , B01F13/0059 , B01J19/0093 , B01J2219/00788 , B01J2219/00833 , B01J2219/0086 , B01J2219/00862 , B01J2219/00891 , B01L3/5025 , B01L3/5027 , B01L3/502738 , B01L3/502746 , B01L2200/06 , B01L2200/0605 , B01L2200/10 , B01L2200/142 , B01L2300/069 , B01L2300/0803 , B01L2300/0806 , B01L2300/0861 , B01L2300/0864 , B01L2300/0867 , B01L2300/087 , B01L2300/14 , B01L2300/16 , B01L2400/0406 , B01L2400/0409 , B01L2400/0633 , B01L2400/0688 , B01L2400/086 , G01N30/6095 , G01N30/7266 , G01N33/54366 , G01N35/00069 , G01N2035/00504 , H01J49/04 , Y10S435/973
摘要： A microscale method for the characterization of one or more reaction variables that influence the formation or dissociation of an affinity complex comprising a ligand and a binder, which have mutual affinity for each other. The method is characterized in comprising the steps of: (i) providing a microfluidic device comprising a microchannel structures that are under a common flow control, each microchannel structure comprising a reaction microactivity; (ii) performing essentially in parallel an experiment in each of two or more of the plurality of microchannel structures, the experiment in these two or more microchannel structures comprising either a) formation of an immobilized form of the complex and retaining under flow conditions said form within the reaction microactivity, or b) dissociating, preferably under flow condition, an immobilized form of the complex which has been included in the microfluidic device provided in step (i), at least one reaction variable varies or is uncharacterized for said two or more microchannel structures while the remaining reaction variables are kept essentially constant; (iii) measuring the presentation of the complex in said reaction microactivity in said two or more microchannel structures; and (iv) characterizing said one or more reaction variables based on the values for presentation obtained in step (iii).
摘要翻译：用于表征影响包含配体和粘合剂的亲和络合物的形成或解离的一个或多个反应变量的微观方法，其彼此具有相互亲和力。该方法的特征在于包括以下步骤：（i）提供包含处于共同流量控制下的微通道结构的微流体装置，每个微通道结构包含反应微活性; （ii）在两个或多个多个微通道结构的每一个中基本上并行地进行实验，这两个或更多个微通道结构中的实验包括a）形成复合物的固定形式并在流动条件下保持所述形式或者b）优选在流动条件下解离包含在步骤（i）中提供的微流体装置中的复合物的固定化形式，至少一个反应变量对于所述两个或更多个变化是变化的或没有表征的微通道结构，而剩余的反应变量保持基本恒定; （iii）测量所述两个或多个微通道结构中所述反应微活性物中复合物的表现; 和（iv）基于在步骤（iii）中获得的呈现值来表征所述一个或多个反应变量。

6. 发明申请

US20140199783A1 CHARACTERIZATION OF REACTION VARIABLES 审中-公开
标题翻译：反应变量的表征
公开(公告)号：US20140199783A1
公开(公告)日：2014-07-17
申请号：US14215745
申请日：2014-03-17
申请人： Gyros Patent AB
发明人： Per Andersson , Mats Inganas , Gunnar Thorsén , Gunnar Kylberg
IPC分类号： G01N33/543
CPC分类号： G01N33/54306 , B01F5/0646 , B01F5/0647 , B01F5/0655 , B01F13/0059 , B01J19/0093 , B01J2219/00788 , B01J2219/00833 , B01J2219/0086 , B01J2219/00862 , B01J2219/00891 , B01L3/5025 , B01L3/5027 , B01L3/502738 , B01L3/502746 , B01L2200/06 , B01L2200/0605 , B01L2200/10 , B01L2200/142 , B01L2300/069 , B01L2300/0803 , B01L2300/0806 , B01L2300/0861 , B01L2300/0864 , B01L2300/0867 , B01L2300/087 , B01L2300/14 , B01L2300/16 , B01L2400/0406 , B01L2400/0409 , B01L2400/0633 , B01L2400/0688 , B01L2400/086 , G01N30/6095 , G01N30/7266 , G01N33/54366 , G01N35/00069 , G01N2035/00504 , H01J49/04 , Y10S435/973
摘要： A microscale method for the characterization of one or more reaction variables that influence the formation or dissociation of an affinity complex comprising a ligand and a binder, which have mutual affinity for each other. The method is characterized in comprising the steps of: (i) providing a microfluidic device comprising a microchannel structures that are under a common flow control, each microchannel structure comprising a reaction microactivity; (ii) performing essentially in parallel an experiment in each of two or more of the plurality of microchannel structures, the experiment in these two or more microchannel structures comprising either a) formation of an immobilized form of the complex and retaining under flow conditions said form within the reaction microactivity, or b) dissociating, preferably under flow condition, an immobilized form of the complex which has been included in the microfluidic device provided in step (i), at least one reaction variable varies or is uncharacterized for said two or more microchannel structures while the remaining reaction variables are kept essentially constant; (iii) measuring the presentation of the complex in said reaction microactivity in said two or more microchannel structures; and (iv) characterizing said one or more reaction variables based on the values for presentation obtained in step (iii).
摘要翻译：用于表征影响包含配体和粘合剂的亲和络合物的形成或解离的一个或多个反应变量的微观方法，其彼此具有相互亲和力。该方法的特征在于包括以下步骤：（i）提供包含处于共同流量控制下的微通道结构的微流体装置，每个微通道结构包含反应微活性; （ii）在两个或更多个微通道结构的每一个中基本上并行地进行实验，这两个或更多个微通道结构中的实验包括a）形成固定化形式的复合物并在流动条件下保留所述形式或者b）优选在流动条件下解离已经包含在步骤（i）中提供的微流体装置中的复合物的固定形式，至少一个反应变量对于所述两个或更多个变化是变化的或没有表征的微通道结构，而剩余的反应变量保持基本恒定; （iii）测量所述两个或多个微通道结构中所述反应微活性物中复合物的表现; 和（iv）基于在步骤（iii）中获得的呈现值来表征所述一个或多个反应变量。

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