Analyte test system for determining the concentration of an analyte in a physiological or aqueous fluid
    1.
    发明授权
    Analyte test system for determining the concentration of an analyte in a physiological or aqueous fluid 失效
    用于测定生理或含水流体中分析物浓度的分析物测试系统

    公开(公告)号:US07901875B2

    公开(公告)日:2011-03-08

    申请号:US11073254

    申请日:2005-03-04

    Inventor: Matthias Stiene

    Abstract: This invention provides a device for determining the concentration of an analyte like glucose, cholesterol, free fatty acids, triglycerides, proteins, ketones, phenylalanine or enzymes, in a physiological or aqueous fluid like blood, serum, plasma, saliva, urine, interstitial and/or intra-cellular fluid, the device having an integrated calibration and quality control system suitable for dry reagent test strips with a very small sample volume of about 0.5 μL based on to a new sample distribution system. The production of the inventive analyte test element involves only a small number of uncomplicated production steps enabling an inexpensive production of the strips.

    Abstract translation: 本发明提供一种用于在诸如血液,血清,血浆,唾液,尿液,间质的生理或水性流体中测定分析物如葡萄糖,胆固醇,游离脂肪酸,甘油三酸酯,蛋白质,酮,苯丙氨酸或酶的浓度的装置, /或细胞内液体,该装置具有集成的校准和质量控制系统,其适用于基于新样品分配系统的具有约0.5μL的非常小的样品体积的干试剂测试条。 本发明的分析物测试元件的生产仅涉及少量不复杂的生产步骤,从而能够廉价地生产条带。

    Process for manufacturing an analysis module with accessible electrically conductive contact pads for a microfluidic analytical system
    2.
    发明申请
    Process for manufacturing an analysis module with accessible electrically conductive contact pads for a microfluidic analytical system 审中-公开
    用于制造具有用于微流体分析系统的可触及导电接触垫的分析模块的方法

    公开(公告)号:US20060065361A1

    公开(公告)日:2006-03-30

    申请号:US10957440

    申请日:2004-09-30

    Abstract: A method for manufacturing an analysis module with accessible electrically conductive contact pads includes forming an insulating substrate with an upper surface, a microchannel(s) within the upper surface, and electrically conductive contact pad(s) disposed on the upper surface. The method also includes producing a laminate layer with a bottom surface, electrode(s) on the laminate layer bottom surface, and electrically conductive trace(s) on the laminate layer bottom surface. The method further includes adhering the laminate layer to the insulating substrate such that a portion of the bottom surface of the laminate layer is adhered to a portion of the upper surface of the insulating substrate, each electrode is exposed to at least one microchannel; and each electrically conductive trace is electrically contacted to at least one electrically conductive contact pad. Furthermore, the adhering is such that at least one surface of the electrically conductive contact pad remains exposed and accessible for electrical connection.

    Abstract translation: 用于制造具有可触及的导电接触焊盘的分析模块的方法包括:形成具有上表面的绝缘衬底,上表面内的微通道和设置在上表面上的导电接触焊盘。 该方法还包括制备具有底表面的层压层,层压层底表面上的电极以及层压层底表面上的导电迹线。 该方法还包括将层压层粘合到绝缘基板上,使得层压层的底表面的一部分粘附到绝缘基板的上表面的一部分,每个电极暴露于至少一个微通道; 并且每个导电迹线与至少一个导电接触焊盘电接触。 此外,粘合使得导电接触焊盘的至少一个表面保持暴露并且可访问用于电连接。

    Coagulation test system
    3.
    发明申请
    Coagulation test system 审中-公开
    凝血试验系统

    公开(公告)号:US20090221011A1

    公开(公告)日:2009-09-03

    申请号:US11990695

    申请日:2005-08-31

    Abstract: A test element for the determination of coagulation in a plasma or whole blood sample having a first surface (2a) and a second surface (4a) in a predetermined distance opposite from each other, said both surfaces being provided with two substantially equivalent patterns forming areas of high and low surface energy which are aligned mostly congruent, whereby the areas of high surface energy create a sample distribution system (6) with at least one detection area (6a), wherein the detection area(s) (6a, 6′a) of the first and second surfaces (2a, 4a) is/are provided with at least one coagulation stimulation reagent. The coagulation test element is provided with an integrated quality control system suitable for dry reagent test strip format with a very small sample volume of about 0.5 μL. The production of the inventive coagulation test element involves only a small number of uncomplicated production steps enabling an inexpensive production of the element.

    Abstract translation: 一种用于确定具有第一表面(2a)和第二表面(4a)的等离子体或全血样品中的凝固的测试元件,所述第一表面(2a)和第二表面(4a)彼此相对于预定距离,所述两个表面设置有两个基本相等的图案形成区域 高表面能和低表面能,其大部分是一致的,由此高表面能的区域产生具有至少一个检测区域(6a)的样品分配系统(6),其中检测区域(6a,6'a )的第一和第二表面(2a,4a)设置有至少一种凝血刺激试剂。 凝固测试元件提供了一个综合质量控制系统,适用于干试剂测试条格式,样品体积非常小约为0.5微升。 本发明的凝结测试元件的生产仅涉及少量不复杂的生产步骤,从而能够廉价地生产元件。

    Analyte test system using non-enzymatic analyte recognition elements
    6.
    发明申请
    Analyte test system using non-enzymatic analyte recognition elements 审中-公开
    使用非酶分析物识别元素的分析物测试系统

    公开(公告)号:US20100035245A1

    公开(公告)日:2010-02-11

    申请号:US11990701

    申请日:2005-08-31

    Abstract: An analyte test element for the qualitative and/or quantitative determination of at least one analyte in a physiological or aqueous sample fluid having a first surface (2a) and a second surface (4a) in a predetermined distance opposite from each other, said both surfaces are provided with two substantially equivalent patterns forming areas of high and low surface energy which are aligned mostly congruent, whereby the areas of high surface energy (6, 6′) create a sample distribution system with at least two detection areas (6a, 6′a), said at least one of the detection areas (6a, 6′a) of the first and second surfaces (2a, 4a) is provided with at least one non-enzymatic recognition element (32). The analyte test element is suitable for analyte test systems evaluating the affinity reaction between an analyte of interest and a recognition element and therefore provides a suitable test system to perform immunoassays, receptor-assays, or other affinity assays with a simple test element containing qualitative or quantitative calibration mechanisms suitable for point of care and home settings.

    Abstract translation: 一种分析物测试元件,用于定性和/或定量测定具有第一表面(2a)和第二表面(4a)的生理或水性样品流体中至少一种分析物彼此相对的预定距离,所述两个表面 具有两个基本上等效的图案,其形成高度和低表面能的区域,其大体上等同排列,由此高表面能(6,6')的区域产生具有至少两个检测区域(6a,6')的样品分布系统, 所述第一和第二表面(2a,4a)的所述检测区域(6a,6'a)中的至少一个设置有至少一个非酶识别元件(32)。 分析物测试元件适用于分析物测试系统,用于评估感兴趣分析物与识别元件之间的亲和力反应,因此提供合适的测试系​​统,以进行免疫测定,受体测定或其他亲和力测定,其中包含定性或 定量校准机制适用于护理点和家庭设置。

    Combined lancet and electrochemical analyte-testing apparatus
    8.
    发明申请
    Combined lancet and electrochemical analyte-testing apparatus 有权
    联合柳叶刀和电化学分析物检测仪

    公开(公告)号:US20050011759A1

    公开(公告)日:2005-01-20

    申请号:US10638752

    申请日:2003-08-11

    Abstract: An apparatus for detection and quantitation of an electrochemically-detectable analyte, such as glucose, in blood or interstitial fluid includes a meter unit, a lancet and an electrochemical sensor. Of these components, the meter is preferably reusable, while the lancet and the electrochemical sensor are preferably incorporated in assemblies intended for single-use. The meter unit has a housing, within which a lancet is engaged with a mechanism for moving then lancet; a connector disposed within the housing for engaging an electrochemical sensor specific for the analyte and transmitting a signal indicative of the amount of analyte, and a display operatively-associated with a connector for displaying the amount of the analyte to user. The electrochemical sensor is adapted for detection of a particular analyte. In addition, the electrochemical sensor has an absorptive member for uptake of a sample of blood or interstitial fluid. In one version, the lancet moves from a initial position to a piercing position in which skin of the user is pierced and optionally back to a retracted position. The electrochemical sensor is disposed such that the absorptive member takes up a sample from the pierced skin of the user when it is pierced by the lancet without movement of the apparatus. In an alternative version, the lancet is a hollow cannula through which blood or interstitial fluid is transported from the puncture site to an absorbent portion of the electrochemical sensor. In either version, the apparatus provides single-step operation in which sample acquisition and analysis occur as a result of the single action of pressing, the apparatus against the users skin.

    Abstract translation: 用于检测和定量血液或组织液中的电化学可检测分析物例如葡萄糖的装置包括仪表单元,刺血针和电化学传感器。 在这些组件中,仪表优选是可重复使用的,而柳叶刀和电化学传感器优选地并入用于单次使用的组件中。 仪表单元具有壳体,其中刺血针与用于移动柳叶刀的机构接合; 连接器,其设置在壳体内,用于接合特定于分析物的电化学传感器,并传输指示分析物量的信号,以及与用于向用户显示分析物的量的连接器可操作地相关联的显示器。 电化学传感器适用于检测特定分析物。 此外,电化学传感器具有用于摄取血液或间质液样品的吸收构件。 在一个版本中,柳叶刀从初始位置移动到刺穿使用者的皮肤的刺穿位置,并且可选地返回到缩回位置。 电化学传感器被布置成使得当刺血针刺穿刺血针而不移动设备时,吸收构件从使用者的穿孔皮肤中吸收样品。 在替代方案中,刺血针是中空套管,血液或间质液通过该中空套管从穿刺部位输送到电化学传感器的吸收部分。 在任一版本中,该装置提供单步操作,其中由于按照使用者皮肤的装置的单次动作的结果而发生样品采集和分析。

    ANALYTE TEST SYSTEM FOR DETERMINING THE CONCENTRATION OF AN ANALYTE IN A PHYSIOLOGICAL OR AQUEOUS FLUID
    9.
    发明申请
    ANALYTE TEST SYSTEM FOR DETERMINING THE CONCENTRATION OF AN ANALYTE IN A PHYSIOLOGICAL OR AQUEOUS FLUID 审中-公开
    用于确定生理或水质流体中分析物浓度的分析测试系统

    公开(公告)号:US20110297555A1

    公开(公告)日:2011-12-08

    申请号:US13189035

    申请日:2011-07-22

    Abstract: An analyte test element for determining the concentration of at least one analyte in a physiological sample fluid having a first and a second surface in a predetermined distance opposite from each other, said both surfaces are provided with two substantially equivalent patterns forming areas of high and low surface energy which are aligned mostly congruent, whereby the areas with high surface energy create a sample distribution system with at least two detection areas, characterized in that the detection areas of first and second surface are also provided with two corresponding patterns of working and reference electrodes of electrochemical detection means.

    Abstract translation: 一种分析物测试元件,用于确定具有彼此相对的预定距离的第一和第二表面的生理样品流体中的至少一种分析物的浓度,所述两个表面设置有两个基本相等的图案,形成高和低的区域 表面能量大致一致地排列,由此具有高表面能的区域产生具有至少两个检测区域的样品分布系统,其特征在于,第一和第二表面的检测区域还设置有两个对应的工作和参考电极图案 的电化学检测装置。

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