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：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：US20150076010A1

公开(公告)日：2015-03-19

申请号：US14542755

申请日：2014-11-17

Applicant: Roche Diagnostics Operations, Inc.

Inventor： John T. Austera ,  Terry A. Beaty ,  Abner D. Joseph ,  Nathan E. Manlove ,  Steven K. Moore ,  James L. Pauley, JR. ,  Randall K. Riggles

IPC: G01N27/327 ,  G01N33/487

CPC classification number: G01N27/3272 ,  G01N33/48771

Abstract: An analyte test sensor strip is disclosed having information coded thereon as well as a method of forming the same and conducting an analyte test using the analyte test sensor strip. Information relating to an attribute of the strip or batch/lot of strips may be coded based on resistance values pertaining to electrical aspects of the strip, such as a primary resistive element and a secondary resistive element, the secondary resistive element having one of a plurality of states defined by a location of a closed tap to form a unique resistive path for the secondary resistive element that includes a portion of the primary resistive element depending on the location of the closed tap. The states may be formed on the strip by a secondary processing step in the manufacture of the strip in which a plurality of taps are severed leaving only one tap in a closed state.

Abstract translation: 公开了一种分析物测试传感器带，其具有编码信息的方法以及其形成方法，并使用分析物测试传感器条进行分析物测试。 可以基于条带的电气方面的电阻值（例如主要电阻元件和次级电阻元件）来编码与条带或批/条带的属性有关的信息，次电阻元件具有多个 的状态由闭合抽头的位置限定，以形成用于辅助电阻元件的唯一电阻性通路，该电阻元件包括主电阻元件的一部分，取决于封闭抽头的位置。 这些状态可以通过二次加工步骤形成在条带的制造中，其中多个抽头被切断，在关闭状态下仅留下一个龙头。

公开(公告)号：US20130277235A1

公开(公告)日：2013-10-24

申请号：US13920117

申请日：2013-06-18

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Terry A. Beaty

IPC: G01N27/48

CPC classification number: G01N27/48 ,  G01N27/3273

Abstract: Measurement systems and methods are disclosed for minimizing the effects created by a meter's output amplifier during electrochemical measurements. In the systems and methods, transition of an excitation potential applied between electrodes of a test strip is controlled so that it is at a sufficiently slow rate below a slew rate capability of the system (but still fast enough to minimally impact overall test time) to reduce variability in the test results. The methods and systems therefore use a transition having a ramp-shaped waveform, a sinusoidal-shaped waveform or an exponential-shaped waveform. Additionally, the excitation potential can be purposefully controlled by a processor, memory driven digital-to-analog converter or external circuitry at a rate sufficiently slow to make variations in the analog electronics slew rate insignificant for all sample types and test conditions.

Abstract translation: 公开了用于在电化学测量期间最小化由仪表的输出放大器产生的影响的测量系统和方法。 在系统和方法中，施加在测试条的电极之间的激发电位的转变被控制，使得其处于比系统的压摆率能力低的足够慢的速率（但仍足够快以最小程度地影响整体测试时间）至 降低测试结果的变异性。 因此，方法和系统使用具有斜坡波形，正弦波形或指数波形的转变。 此外，激励电位可以由处理器，存储器驱动的数模转换器或外部电路以足够慢的速率有目的地控制，以使得模拟电子器件的转换速率在所有样品类型和测试条件下都不显着。

公开(公告)号：US20140262773A1

公开(公告)日：2014-09-18

申请号：US13837083

申请日：2013-03-15

Applicant: ROCHE DIAGNOSTICS OPERATIONS, INC.

Inventor： Randall K. Riggles ,  Abner D. Joseph ,  Scott E. Carpenter ,  Harvey E. Buck, JR. ,  Georgeta C. Lica ,  Terry A. Beaty

IPC: G01N27/413

CPC classification number: G01N27/3272

Abstract: A biosensor including a capillary chamber having an inner boundary, a working electrode including an effective working electrode portion positioned within the capillary chamber, and a counter electrode including an effective counter electrode portion positioned within the capillary chamber, and with the working and counter electrodes each having a neck that constitutes the sole portion of the electrodes that extends across the inner boundary and out of the capillary chamber. In one embodiment, the effective working electrode portion defines an average working electrode width, and the working electrode neck defines a working electrode neck width that is reduced relative to the average working electrode width. In another embodiment, a ratio between the area of the effective working electrode portion exposed to the capillary chamber and the area of the effective counter electrode portion exposed to the capillary chamber is substantially constant as a position of the inner boundary of the capillary chamber is varied along a length of the working and counter electrode necks.

Abstract translation: 一种生物传感器，包括具有内边界的毛细管腔，包括位于毛细管腔内的有效工作电极部分的工作电极以及包括位于毛细管腔内的有效对电极部分的对电极，以及每个 具有构成电极的唯一部分的颈部，该颈部延伸穿过内部边界并且从毛细管腔中延伸出来。 在一个实施例中，有效工作电极部分限定平均工作电极宽度，并且工作电极颈部限定相对于平均工作电极宽度减小的工作电极颈部宽度。 在另一个实施例中，暴露于毛细管腔室的有效工作电极部分的面积与暴露于毛细管腔室的有效对置电极部分的面积之间的比例基本上是恒定的，因为毛细管腔的内边界的位置是变化的 沿着工作和对电极颈部的长度。

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。