公开(公告)号：US08992750B1

公开(公告)日：2015-03-31

申请号：US13933697

申请日：2013-07-02

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Terry A. Beaty ,  Eric R. Diebold ,  Abner D. Joseph ,  Randall K. Riggles

IPC: G01N27/00 ,  G01N27/07 ,  G01N27/02

CPC classification number: G01N27/02 ,  G01N27/3272

Abstract: Embodiments of the invention include a test strip with a sample chamber opening spanning the width of the test strip at the sampling end and including a portion of the lateral sides at that end. The chamber is vertically bounded by upper and lower substrate layers, horizontally bounded by the front face of a spacer layer, and open on the remaining sides. The test strip fills rapidly and requires small sample volumes. Both 1-up and 2-up manufacturing techniques for producing such test strips eliminate registration and alignment steps, and other techniques relating to the 2-up technique (simultaneously manufacturing test strips arranged in multiple columns) are also disclosed.

Abstract translation: 本发明的实施例包括具有样品室开口的测试条，其跨越采样端处的测试条的宽度，并且包括在该端的侧面的一部分。 该室由上下基板层垂直界定，水平地由间隔层的前表面限定，并在其余的侧面上敞开。 测试条快速填充并需要较小的样品体积。 还公开了用于生产这种测试条的1-up和2-up制造技术消除了对准和对准步骤，并且还公开了与2层技术相关的其它技术（同时制造布置在多列中的测试条）。

公开(公告)号：US20130105074A1

公开(公告)日：2013-05-02

申请号：US13712072

申请日：2012-12-12

Applicant: ROCHE DIAGNOSTICS OPERATIONS, INC.

Inventor： Randall K. Riggles ,  Eric R. Diebold ,  Abner D. Joseph ,  Terry A. Beaty

IPC: G01N27/327

CPC classification number: G01N27/327 ,  B01L3/502707 ,  B01L2200/0684 ,  B01L2300/0645 ,  B01L2300/0825 ,  B01L2400/0406 ,  G01N27/3272 ,  Y10T156/1084

Abstract: Some embodiments of the invention include a 2-up manufacturing technique for producing test strips to reduce costs, reduce waste, and increase output. Other techniques relating to the 2-up technique, such as simultaneously manufacturing test strips arranged in multiple columns, are also disclosed. Yet other techniques include cutting through the upper and lower substrates to form an overhang of either the upper or the lower substrate. Other embodiments include a dual-use biosensor in which a user can apply a sample of bodily fluid to both test strips simultaneously.

Abstract translation: 本发明的一些实施方案包括用于生产测试条以降低成本，减少浪费并增加产量的2层制造技术。 还公开了与双向技术相关的其它技术，例如同时制造布置在多列中的测试条。 其他技术包括切割上下基板以形成上基板或下基板的突出端。 其他实施方案包括双用途生物传感器，其中使用者可以同时将两个测试条的体液样品施加。

公开(公告)号：US08557989B2

公开(公告)日：2013-10-15

申请号：US13626358

申请日：2012-09-25

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Eric R. Diebold ,  Mitali Ghoshal ,  David Z. Deng ,  Jane Shiow-Chuan Tsai

IPC: C07F15/00 ,  G01N27/26 ,  C07K14/00

CPC classification number: G01N33/5306 ,  C07F15/002 ,  C07F15/0026 ,  C12Q1/004 ,  G01N33/5438 ,  G01N2458/30

Abstract: The present invention provides novel osmium-based electrochemical species for the detection of wide variety of analytes using immunological techniques. The present invention also provides diagnostic kits and test sensors supporting electrode structures that can be used with the osmium-based electrochemical species. The test sensor can be fabricated to support interdigitated arrays of electrodes that have been designed to provide amplification of the electrical signal amplification desired to analyze analytes that may be present at low concentrations.

Abstract translation: 本发明提供用于使用免疫学技术检测多种分析物的新型锇基电化学物质。 本发明还提供了可与锇基电化学物质一起使用的支持电极结构的诊断试剂盒和测试传感器。 可以制造测试传感器以支持指数的电极阵列，其被设计为提供期望分析可能以低浓度存在的分析物的电信号放大的放大。

公开(公告)号：US08420404B2

公开(公告)日：2013-04-16

申请号：US13659189

申请日：2012-10-24

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Eric R. Diebold ,  Terry A. Beaty ,  Harvey B. Buck, Jr.

IPC: G01N27/00 ,  G01N27/06

CPC classification number: G01N27/3274 ,  G01N33/49

Abstract: The present disclosure relates to various methods for measuring the amount of an analyte present in a biological fluid using an electrochemical testing process. Various embodiments are disclosed, including the use of AC test signals and the performance of tests having a Total Test Time within about 3.0 seconds or less, and/or having a clinically low Total System Error.

Abstract translation: 本公开涉及使用电化学测试方法测量存在于生物流体中的分析物的量的各种方法。 公开了各种实施例，包括使用AC测试信号和在大约3.0秒或更短时间内具有总测试时间的测试和/或具有临床上低的总系统误差的测试。

公开(公告)号：US20130213822A1

公开(公告)日：2013-08-22

申请号：US13626358

申请日：2012-09-25

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Eric R. Diebold ,  Mitali Ghoshal ,  David Z. Deng ,  Jane Shiow-Chuan Tsai

IPC: G01N33/53 ,  C07F15/00

CPC classification number: G01N33/5306 ,  C07F15/002 ,  C07F15/0026 ,  C12Q1/004 ,  G01N33/5438 ,  G01N2458/30

Abstract: The present invention provides novel osmium-based electrochemical species for the detection of wide variety of analytes using immunological techniques. The present invention also provides diagnostic kits and test sensors supporting electrode structures that can be used with the osmium-based electrochemical species. The test sensor can be fabricated to support interdigitated arrays of electrodes that have been designed to provide amplification of the electrical signal amplification desired to analyze analytes that may be present at low concentrations.

Abstract translation: 本发明提供用于使用免疫学技术检测多种分析物的新型锇基电化学物质。 本发明还提供了可与锇基电化学物质一起使用的支持电极结构的诊断试剂盒和测试传感器。 可以制造测试传感器以支持指数的电极阵列，其被设计为提供期望分析可能以低浓度存在的分析物的电信号放大的放大。

公开(公告)号：US08920628B2

公开(公告)日：2014-12-30

申请号：US13667154

申请日：2012-11-02

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Martin T. Gerber ,  Eric R. Diebold

IPC: G01N27/327 ,  C12Q1/54 ,  A61B5/00 ,  G01N33/49 ,  G01N33/66

CPC classification number: G01N27/307 ,  A61B5/0002 ,  A61B5/14532 ,  A61B5/1486 ,  A61B2562/0295 ,  C12Q1/54 ,  G01N27/327 ,  G01N27/3272 ,  G01N27/3273 ,  G01N27/416 ,  G01N33/492 ,  G01N33/66

Abstract: Systems and methods for multiple analyte analysis are provided. In one embodiment, a method includes determining concentrations of first and second analytes in a sample. The first and second analytes may be, for example, glucose and hydroxybutyrate. In this form, an indication related to the measured concentration of hydroxybutyrate is provided in response to determining that the concentration of hydroxybutyrate is above a predetermined value. In a further aspect of this form, a quantitative indication representative of the measured glucose concentration is automatically provided regardless of the value of the measured glucose concentration. In another embodiment, a system includes a meter configured to interact with a test element to assess first and second analytes in a sample. Further embodiments, forms, objects, features, advantages, aspects, and benefits shall become apparent from the description and drawings.

Abstract translation: 提供了多个分析物分析的系统和方法。 在一个实施方案中，一种方法包括确定样品中第一和第二分析物的浓度。 第一和第二分析物可以是例如葡萄糖和羟基丁酸酯。 在这种形式中，响应于确定羟基丁酸酯的浓度高于预定值而提供与所测量的羟基丁酸酯浓度相关的指示。 在该形式的另一方面，自动提供代表测量的葡萄糖浓度的定量指示，而与所测量的葡萄糖浓度的值无关。 在另一个实施方案中，系统包括配置成与测试元件相互作用以评估样品中的第一和第二分析物的仪表。 进一步的实施例，形式，对象，特征，优点，方面和优点将从描述和附图中变得显而易见。

公开(公告)号：US20140124384A1

公开(公告)日：2014-05-08

申请号：US13667154

申请日：2012-11-02

Applicant: ROCHE DIAGNOSTICS OPERATIONS, INC.

Inventor： Martin T. Gerber ,  Eric R. Diebold

IPC: G01N27/26

CPC classification number: G01N27/307 ,  A61B5/0002 ,  A61B5/14532 ,  A61B5/1486 ,  A61B2562/0295 ,  C12Q1/54 ,  G01N27/327 ,  G01N27/3272 ,  G01N27/3273 ,  G01N27/416 ,  G01N33/492 ,  G01N33/66

Abstract: Systems and methods for multiple analyte analysis are provided. In one embodiment, a method includes determining concentrations of first and second analytes in a sample. The first and second analytes may be, for example, glucose and hydroxybutyrate. In this form, an indication related to the measured concentration of hydroxybutyrate is provided in response to determining that the concentration of hydroxybutyrate is above a predetermined value. In a further aspect of this form, a quantitative indication representative of the measured glucose concentration is automatically provided regardless of the value of the measured glucose concentration. In another embodiment, a system includes a meter configured to interact with a test element to assess first and second analytes in a sample. Further embodiments, forms, objects, features, advantages, aspects, and benefits shall become apparent from the description and drawings.

Abstract translation: 提供了多个分析物分析的系统和方法。 在一个实施方案中，一种方法包括确定样品中第一和第二分析物的浓度。 第一和第二分析物可以是例如葡萄糖和羟基丁酸酯。 在这种形式中，响应于确定羟基丁酸酯的浓度高于预定值而提供与所测量的羟基丁酸酯浓度相关的指示。 在该形式的另一方面，自动提供代表测量的葡萄糖浓度的定量指示，而与所测量的葡萄糖浓度的值无关。 在另一个实施方案中，系统包括配置成与测试元件相互作用以评估样品中的第一和第二分析物的仪表。 进一步的实施例，形式，对象，特征，优点，方面和优点将从描述和附图中变得显而易见。

公开(公告)号：US20130043141A1

公开(公告)日：2013-02-21

申请号：US13659163

申请日：2012-10-24

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Eric R. Diebold ,  Terry A. Beaty ,  Harvey B. Buck, JR.

IPC: G01N27/26

CPC classification number: G01N27/3274 ,  G01N33/49

Abstract: The present disclosure relates to various methods for measuring the amount of an analyte present in a biological fluid using an electrochemical testing process. Various embodiments are disclosed, including the use of AC test signals and the performance of tests having a Total Test Time within about 3.0 seconds or less, and/or having a clinically low Total System Error.

Abstract translation: 本公开涉及使用电化学测试方法测量存在于生物流体中的分析物的量的各种方法。 公开了各种实施例，包括使用AC测试信号和在大约3.0秒或更短时间内具有总测试时间的测试和/或具有临床上低的总系统误差的测试。