公开(公告)号：US20130292033A1

公开(公告)日：2013-11-07

申请号：US13938791

申请日：2013-07-10

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Henning Groll

IPC: B29C65/74

CPC classification number: B29C65/74 ,  G01N27/3272 ,  G01N33/48771

Abstract: The present invention provides a system of biosensors whose dose-response curves are maintained within a predetermined and desired range or tolerance during production by selecting a feature of the biosensors that can be varied during production. For example, in one exemplary embodiment the effective area of the working electrode of an electrochemical biosensor can be varied during production as needed to offset variations that occur, e.g., in the reagent of the biosensors as production proceeds. In another exemplary embodiment, the dose-response curve of biosensors not yet produced can be predicted and one or more features of these biosensors can be selected to maintain the dose-response curve within a predetermined range or tolerance.

Abstract translation: 本发明提供一种生物传感器系统，其生物传感器的剂量 - 反应曲线在生产过程中通过选择可在生产过程中变化的生物传感器的特征而保持在预定和期望的范围或公差范围内。 例如，在一个示例性实施例中，电化学生物传感器的工作电极的有效面积可以根据需要在生产过程中变化，以抵消例如当生产进行时在生物传感器的试剂中发生的变化。 在另一个示例性实施方案中，可以预测尚未产生的生物传感器的剂量 - 反应曲线，并且可以选择这些生物传感器的一个或多个特征，以将剂量 - 反应曲线保持在预定范围或公差范围内。

公开(公告)号：US08574496B2

公开(公告)日：2013-11-05

申请号：US13743754

申请日：2013-01-17

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Werner Ruhl ,  Hugo Schrem ,  Volker Zimmer

IPC: G01N21/00

CPC classification number: A61B5/145 ,  A61B5/14514 ,  A61B5/150022 ,  A61B5/150358 ,  A61B5/151 ,  A61B5/157 ,  A61B10/0096 ,  A61B2010/008 ,  G01N33/48764 ,  G01N2035/00019

Abstract: Body fluid testing device for analyzing a body fluid comprises a test media tape adapted to collect the body fluid. The test media tape comprises a tape and test media portions. A free tape portion without test medium is located between successive test media portions. The testing device further comprises a supply portion. The supply portion comprises a housing in which uncontaminated test media tape is contained. The housing further has an opening for withdrawing test media tape from the housing. The testing device further has a sealing means for closing the opening against the surrounding. A free tape portion of the test media tape is located between a wall of the housing and the sealing means when the sealing means closes the opening. Further aspects concern a test media cassette with sealing means and a method for providing test media while holding them sealed against humidity during onboard storage.

公开(公告)号：US20130288267A1

公开(公告)日：2013-10-31

申请号：US13923646

申请日：2013-06-21

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Michael Gerg ,  Dieter Heindl ,  Alfred Mertens ,  Christoph Rutz ,  Michael Schraeml ,  Monika Soukupova ,  Claudio Sustmann ,  Michael Tacke ,  Jan van Dieck

IPC: C07K16/46

CPC classification number: C07K16/468 ,  C07K16/18 ,  C07K16/2863 ,  C07K16/32 ,  C07K16/44 ,  C07K2317/31 ,  C07K2317/34 ,  C07K2317/55 ,  C07K2317/92 ,  C07K2317/94 ,  G01N33/6857

Abstract: A bivalent binding agent, capable of binding a polypeptide dimer, consisting of two monovalent binders linked to each other via a linker, the first monovalent binder binds an epitope of a first target polypeptide comprised in said dimer and the second monovalent binder binds to an epitope of a second target polypeptide comprised in said dimer. Each monovalent binder has a Kdiss in the range of 5×10−3/sec to 10−4/sec, and the bivalent binding agent has a Kdiss of 3×10−5/sec or less. Methods of making and using such bivalent binding agent in histological staining procedures are also disclosed.

Abstract translation: 能够结合多肽二聚体的二价结合剂，其由通过接头彼此连接的两个单价结合物组成，所述第一单价键合物结合包含在所述二聚体中的第一目标多肽的表位，并且所述第二单价键合物结合表位 的包含在所述二聚体中的第二目标多肽。 每个一价粘合剂的Kdiss在5×10-3 /秒至10-4 /秒的范围内，二价结合剂的Kdiss为3×10-5 /秒或更小。 还公开了在组织学染色方法中制备和使用这种二价结合剂的方法。

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：US20130230428A1

公开(公告)日：2013-09-05

申请号：US13863779

申请日：2013-04-16

Applicant: ROCHE DIAGNOSTICS OPERATIONS, INC.

Inventor： Peter Seelig ,  Helmut Leininger

IPC: G01N21/55 ,  G01N33/66

CPC classification number: G01N21/55 ,  A61B5/14532 ,  A61B5/1455 ,  A61B2562/0295 ,  B01L3/505 ,  B01L9/523 ,  B01L2300/0654 ,  B01L2300/0812 ,  B01L2300/0825 ,  B01L2300/0841 ,  G01N21/8483 ,  G01N33/48764 ,  G01N33/66

Abstract: The invention concerns a diagnostic tape unit with a test tape that can be wound onto a spool which comprises a transport tape and a plurality of test elements mounted thereon, where the test elements have an analytical reagent layer, a carrier foil supporting the reagent layer and a piece of adhesive tape connecting the carrier foil with the transport tape, and where the front side of the reagent layer facing away from the carrier foil is designed for the application of a sample substance. According to the invention it is proposed that the test elements in combination with the light transmitting transport tape in each case form an optical multi-layer system for a rear-side reflection-photometric measurement of the reagent layer.

Abstract translation: 本发明涉及一种诊断带单元，其具有可以缠绕在卷轴上的测试带，该卷轴包括传送带和安装在其上的多个测试元件，其中测试元件具有分析试剂层，载体箔支撑试剂层， 将载体箔与输送带连接的一段粘合带，并且试剂层的背离载体箔的前侧被设计用于施加样品物质。 根据本发明，提出了与各透光性输送带组合的测试元件形成用于对试剂层进行背面反射测光的光学多层系统。

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：US20130173307A1

公开(公告)日：2013-07-04

申请号：US13728341

申请日：2012-12-27

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Igor Gejdos ,  Paul J. Galley

IPC: G06F19/00

CPC classification number: G06F19/324 ,  G16H10/60

Abstract: An interface for an electronic medical record (EMR) system is configured to receive messages and documents having a message data format and a document data format respectively, transmitted to EMR system in accordance with a first and second device healthcare interoperability standard. The interface is further configured to determine whether a given message or document pertains to blood glucose measures and to generate records in a custom format of the EMR system. The interface is further configured to parse the messages and documents for a structure collection procedure from a comment field in the given messages and documents and to map the structured collection procedure data to applicable data fields in a corresponding record of the EM system.

Abstract translation: 用于电子医疗记录（EMR）系统的接口被配置为分别接收根据第一和第二设备保健互操作性标准传送到EMR系统的消息数据格式和文档数据格式的消息和文档。 该接口还被配置为确定给定消息或文档是否与血糖测量相关并且以EMR系统的自定义格式生成记录。 该接口还被配置为从给定消息和文档中的注释字段解析结构收集过程的消息和文档，并将结构化收集过程数据映射到EM系统的对应记录中的适用数据字段。

公开(公告)号：US20130172708A1

公开(公告)日：2013-07-04

申请号：US13661082

申请日：2012-10-26

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Mark G. Mears ,  Mark Nierzwick ,  Phillip E. Pash ,  Vincent R. Rizzo ,  Bettina Steiner ,  Kristin M. Westerfield

IPC: A61B5/145

CPC classification number: H04B7/26 ,  A61B5/0002 ,  A61B5/14532 ,  A61B5/7435 ,  A61B2562/0295 ,  A61M5/14244 ,  A61M5/1723 ,  A61M2205/35 ,  A61M2205/3569 ,  A61M2205/3584 ,  A61M2205/3592 ,  A61M2205/502 ,  A61M2205/505 ,  A61M2230/201 ,  F04C2270/0421 ,  G01N33/66 ,  G05B15/02 ,  G06F19/00 ,  G06F19/3468 ,  G16H40/63 ,  H04B15/02 ,  H04W4/50 ,  H04W84/20

Abstract: A handheld diabetes manager has a graphical user interface for displaying status of an external medical device and includes a port configured to receive a test strip and a blood glucose measurement module. The diabetes manager includes a communications module that selectively communicates via a wireless data link with an external medical device to receive status data pertaining to the operation of the external medical device, and a user interface module in data communication with the blood glucose measurement module and the communications module. The graphical user interface includes a status screen that presents data pertaining to a glucose measure determined by the blood glucose measurement module concurrently with the status data received from the external medical device, such that the status data of the external medical device is presented on the status screen only when the communication module is in data communication with the external medical device.

Abstract translation: 手持式糖尿病管理器具有用于显示外部医疗装置的状态的图形用户界面，并且包括被配置为接收测试条和血糖测量模块的端口。 糖尿病管理者包括通过无线数据链路选择性地与外部医疗装置通信的通信模块，以接收与外部医疗装置的动作有关的状态数据，以及与血糖值测量模块进行数据通信的用户界面模块， 通讯模块 所述图形用户接口包括状态画面，其与由所述外部医疗装置接收到的所述状态数据同时呈现与由所述血糖测定模块确定的葡萄糖量相关的数据，使得所述外部医疗装置的状态数据呈现在所述状态 只有通信模块与外部医疗设备进行数据通信时才会显示。

公开(公告)号：US20130158373A1

公开(公告)日：2013-06-20

申请号：US13771307

申请日：2013-02-20

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Carlo Effenhauser ,  Heinz-Michael Hein ,  Karl-Heinz Koelker ,  Frank Deck

IPC: A61B5/15 ,  A61B5/1455 ,  A61B5/145 ,  A61B5/157 ,  A61B5/151

CPC classification number: A61B5/150419 ,  A61B5/1411 ,  A61B5/14532 ,  A61B5/1455 ,  A61B5/150022 ,  A61B5/150282 ,  A61B5/150358 ,  A61B5/15045 ,  A61B5/150503 ,  A61B5/15113 ,  A61B5/15115 ,  A61B5/15186 ,  A61B5/157 ,  Y10T29/49826

Abstract: A system is provided for withdrawing small amounts of body fluid from an animal or human. The system includes a holder and a disposable lancing unit attached to the holder. The lancing unit also includes an open capillary channel for transporting the body fluid and piercing the skin.

Abstract translation: 提供一种用于从动物或人中抽出少量体液的系统。 该系统包括附接到支架的支架和一次性穿刺单元。 穿刺单元还包括用于运输体液和刺穿皮肤的开放毛细管通道。

公开(公告)号：US20130153152A1

公开(公告)日：2013-06-20

申请号：US13764999

申请日：2013-02-12

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Wolfgang Schwoebel ,  Joerg Dreibholz

IPC: B32B38/00 ,  B05C11/00

CPC classification number: B32B38/0008 ,  B05C11/00 ,  G01N35/00009 ,  G01N35/00029 ,  G01N35/00732 ,  G01N2035/00168 ,  Y10T29/49826 ,  Y10T156/10

Abstract: A method for producing an analytical consumable is proposed. The analytical consumable comprises at least one carrier and at least one analytical aid connected to the carrier. At least one optically sensitive material is applied to the carrier, said material being designed to carry out at least one optically detectable alteration in the event of action of an electromagnetic radiation. In at least one coding step, at least one function information item about the analytical consumable is introduced into the optically sensitive material by means of electromagnetic radiation. The function information item is designed to enable at least one analytical instrument to use the analytical consumable correctly.

Abstract translation: 提出了生产分析消耗品的方法。 分析消耗品包括至少一个载体和连接到载体的至少一种分析助剂。 至少一种光敏材料被施加到载体上，所述材料被设计成在电磁辐射的作用的情况下执行至少一种可光学检测的改变。 在至少一个编码步骤中，通过电磁辐射将关于分析耗材的至少一个功能信息项引入到光敏材料中。 功能信息项旨在使至少一个分析仪器正确使用分析耗材。