公开(公告)号：US20110005941A1

公开(公告)日：2011-01-13

申请号：US12553976

申请日：2009-09-03

申请人： Stephen Patrick BLYTHE ,  Marco F. Cardosi ,  Leanne Mills ,  Manuel Alvarez-Icaza ,  Emma Vanessa Jayne Day ,  Richard Michael Day ,  Christopher Philip Leach

发明人： Stephen Patrick BLYTHE ,  Marco F. Cardosi ,  Leanne Mills ,  Manuel Alvarez-Icaza ,  Emma Vanessa Jayne Day ,  Richard Michael Day ,  Christopher Philip Leach

IPC分类号： C12Q1/00 ,  G01N27/26

CPC分类号： G01N27/3273

摘要： A method for determining an analyte concentration in blood is described that reduces the effects of hematocrit using a test strip attached to a test meter. The test strip includes a working electrode and a reference electrode. The test meter applies a test voltage between the working electrode and the reference electrode. After a user applies a blood sample containing an analyte onto the test strip, the test meter measures a plurality of test currents for a test time interval.

摘要翻译： 描述了用于测定血液中分析物浓度的方法，其使用连接到测试仪的测试条减少了血细胞比容的影响。 测试条包括工作电极和参考电极。 测试仪在工作电极和参比电极之间施加测试电压。 在用户将含有分析物的血液样本应用到测试条上之后，测试仪测量测试时间间隔的多个测试电流。

公开(公告)号：US08293096B2

公开(公告)日：2012-10-23

申请号：US12692120

申请日：2010-01-22

申请人： Marco F. Cardosi ,  Stephen Patrick Blythe ,  Matthew Finch ,  Arlene Thompson ,  Nina Antonia Naylor ,  Eric Jason Bailey ,  Michael Patrick Dolan ,  Gretchen Anderson ,  Lorraine Comstock ,  Mary McEvoy ,  Thomas Sutton ,  Richard Michael Day ,  Leanne Mills ,  Emma Vanessa Jayne Day ,  Christopher Philip Leach

发明人： Marco F. Cardosi ,  Stephen Patrick Blythe ,  Matthew Finch ,  Arlene Thompson ,  Nina Antonia Naylor ,  Eric Jason Bailey ,  Michael Patrick Dolan ,  Gretchen Anderson ,  Lorraine Comstock ,  Mary McEvoy ,  Thomas Sutton ,  Richard Michael Day ,  Leanne Mills ,  Emma Vanessa Jayne Day ,  Christopher Philip Leach

IPC分类号： G01N27/327

CPC分类号： G01N27/3274

摘要： A method and system is provided to allow for determination of substantially Hematocrit independent analyte concentration. In one example, an analyte measurement system is provided that includes a test strip and a test meter. The test strip includes a reference electrode and a working electrode, in which the working electrode is coated with a reagent layer. The test meter includes an electronic circuit and a signal processor. The electronic circuit applies a plurality of voltages to the reference electrode and the working electrode over respective durations. The signal processor is configured to determine a substantially hematocrit-independent concentration of the analyte from a plurality of current values as measured by the processor upon application of a plurality of test voltages to the reference and working electrodes over a plurality of durations interspersed with rest voltages lower than the test voltages being applied to the electrodes.

摘要翻译： 提供了一种方法和系统，用于确定基本上血细胞比容的独立分析物浓度。 在一个示例中，提供了包括测试条和测试仪的分析物测量系统。 测试条包括参考电极和工作电极，其中工作电极涂覆有试剂层。 测试仪包括电子电路和信号处理器。 电子电路在相应的持续时间内对参考电极和工作电极施加多个电压。 所述信号处理器被配置成确定来自多个电流值的分析物的基本上与血细胞比容无关的浓度，所述多个电流值在由静止电压施加多个测试电压至参考电极和工作电极的多个持续时间时由处理器测量 低于施加到电极的测试电压。

公开(公告)号：US08486244B2

公开(公告)日：2013-07-16

申请号：US12644421

申请日：2009-12-22

申请人： Marco F. Cardosi ,  Leanne Mills ,  Emma Vanessa Jayne Day ,  Richard Michael Day ,  Christopher Philip Leach

发明人： Marco F. Cardosi ,  Leanne Mills ,  Emma Vanessa Jayne Day ,  Richard Michael Day ,  Christopher Philip Leach

IPC分类号： G01N27/26 ,  C12N1/00

CPC分类号： G01N27/3272 ,  Y10T156/10

摘要： Described herein is an electrochemical enzymatic analyte test strip and method for making the test strip. The test strip utilizes isolated conductive areas inside the electrodes to define electrode whiskers. The method utilizes laser ablation to define electrode patterns.

摘要翻译： 本文描述的是用于制备测试条的电化学酶分析物测试条和方法。 测试条使用电极内部的隔离导电区域来限定电极晶须。 该方法利用激光消融来定义电极图案。

公开(公告)号：US20100206727A1

公开(公告)日：2010-08-19

申请号：US12644421

申请日：2009-12-22

申请人： Marco F. Cardosi ,  Leanne Mills ,  Emma Vanessa Jayne Day ,  Richard Michael Day ,  Christopher Philip Leach

发明人： Marco F. Cardosi ,  Leanne Mills ,  Emma Vanessa Jayne Day ,  Richard Michael Day ,  Christopher Philip Leach

IPC分类号： G01N27/26 ,  B05D5/12 ,  B05D3/06 ,  B29C65/52

CPC分类号： G01N27/3272 ,  Y10T156/10

摘要： Described herein is an analyte test strip and method for making the test strip. The test strip utilizes isolated conductive areas to define electrode whiskers. The method utilizes laser ablation to define electrode patterns.

摘要翻译： 本文描述了用于制造测试条的分析物测试条和方法。 测试条使用隔离的导电区域来限定电极晶须。 该方法利用激光消融来定义电极图案。

公开(公告)号：US08388821B2

公开(公告)日：2013-03-05

申请号：US12305363

申请日：2007-10-05

申请人： Stephen Patrick Blythe ,  Marco F. Cardosi ,  Andrew Gill ,  Leanne Mills ,  Christopher Philip Leach

发明人： Stephen Patrick Blythe ,  Marco F. Cardosi ,  Andrew Gill ,  Leanne Mills ,  Christopher Philip Leach

IPC分类号： G01N27/327

CPC分类号： C12Q1/006 ,  G01N27/3271

摘要： Description is provided herein for an embodiment of a method determining a hematocrit-corrected glucose concentration. The exemplary method includes providing a test strip having a reference electrode and a working electrode, wherein the working electrode includes a plurality of microelectrodes and is coated with at least an enzyme and a mediator. The method can be achieved by: providing a test strip comprising a reference electrode and a working electrode formed with a plurality of microelectrodes and coated with a reagent layer; applying a fluid sample to the test strip for a reaction period; applying a test voltage between the reference electrode and the working electrode; measuring a test current as a function of time; measuring a steady state current value when the test current has reached an equilibrium; calculating a ratio of the test current to the steady state current value; plotting the ratio of the test current to the steady state current value as a function of the inverse square root of time; calculating an effective diffusion coefficient from the slope of the linearly regressed plot of the ratio of the test current to the steady state current value as a function of the inverse square root of time; and calculating a hematocrit-corrected concentration of analyte.

摘要翻译： 本文提供了确定血细胞比容校正葡萄糖浓度的方法的实施方案的描述。 该示例性方法包括提供具有参考电极和工作电极的测试条，其中工作电极包括多个微电极并且至少涂覆有酶和介体。 该方法可以通过以下方式实现：提供包括参考电极和形成有多个微电极并涂覆有试剂层的工作电极的测试条; 将流体样品施加到测试条上一段反应期; 在参考电极和工作电极之间施加测试电压; 测量作为时间的函数的测试电流; 当测试电流达到平衡时测量稳态电流值; 计算测试电流与稳态电流值的比值; 将测试电流与稳态电流值的比率绘制为时间的逆平方根的函数; 根据测试电流与稳态电流值的比值的线性回归曲线的斜率计算有效扩散系数作为时间的平方根的函数; 并计算分析物的血细胞比容校正浓度。

公开(公告)号：US20100219084A1

公开(公告)日：2010-09-02

申请号：US12305363

申请日：2007-10-05

申请人： Stephen Patrick Blythe ,  Marco F. Cardosi ,  Andrew Gill ,  Leanne Mills ,  Christopher Philip Leach

发明人： Stephen Patrick Blythe ,  Marco F. Cardosi ,  Andrew Gill ,  Leanne Mills ,  Christopher Philip Leach

IPC分类号： G01N27/26 ,  C12Q1/00

CPC分类号： C12Q1/006 ,  G01N27/3271

摘要： Description is provided herein for an embodiment of a method determining a hematocrit-corrected glucose concentration. The exemplary method includes providing a test strip having a reference electrode and a working electrode, wherein the working electrode includes a plurality of microelectrodes and is coated with at least an enzyme and a mediator. The method can be achieved by: providing a test strip comprising a reference electrode and a working electrode formed with a plurality of microelectrodes and coated with a reagent layer; applying a fluid sample to the test strip for a reaction period; applying a test voltage between the reference electrode and the working electrode; measuring a test current as a function of time; measuring a steady state current value when the test current has reached an equilibrium; calculating a ratio of the test current to the steady state current value; plotting the ratio of the test current to the steady state current value as a function of the inverse square root of time; calculating an effective diffusion coefficient from the slope of the linearly regressed plot of the ratio of the test current to the steady state current value as a function of the inverse square root of time; and calculating a hematocrit-corrected concentration of analyte.

摘要翻译： 本文提供了确定血细胞比容校正葡萄糖浓度的方法的实施方案的描述。 该示例性方法包括提供具有参考电极和工作电极的测试条，其中工作电极包括多个微电极并且至少涂覆有酶和介体。 该方法可以通过以下方式实现：提供包括参考电极和形成有多个微电极并涂覆有试剂层的工作电极的测试条; 将流体样品施加到测试条上一段反应期; 在参考电极和工作电极之间施加测试电压; 测量作为时间的函数的测试电流; 当测试电流达到平衡时测量稳态电流值; 计算测试电流与稳态电流值的比值; 将测试电流与稳态电流值的比率绘制为时间的逆平方根的函数; 根据测试电流与稳态电流值的比值的线性回归曲线的斜率计算有效扩散系数作为时间的平方根的函数; 并计算分析物的血细胞比容校正浓度。

公开(公告)号：US20090280551A1

公开(公告)日：2009-11-12

申请号：US12305361

申请日：2007-10-05

申请人： Marco F. Cardosi ,  Leanne Mills ,  Christopher Philip Leach

发明人： Marco F. Cardosi ,  Leanne Mills ,  Christopher Philip Leach

IPC分类号： C12N9/04 ,  G01N27/00 ,  C12N9/00 ,  C12M1/00

CPC分类号： C12Q1/004

摘要： Described herein are various embodiments of a test strip, which may be capable of measuring an analyte. The test strip may include a working electrode and a reference electrode where the reagent formulation is disposed on the working electrode. The reagent formulation may be coated onto the test strip. The reagent formulation includes an enzyme, a ruthenium hexamine mediator, and a solution for dissolving the enzyme and the ruthenium hexamine mediator. The reagent formulation may be coated onto the test strip. The reagent formulation includes an enzyme, a ruthenium hexamine mediator, and a solution for dissolving the enzyme and the ruthenium hexamine mediator. The ruthenium hexamine has a concentration range from about 15% to about 20% (weight of mediator/volume) of solution. The enzyme may be either glucose oxidase and glucose dehydrogenase.

摘要翻译： 这里描述的是可以测量分析物的测试条的各种实施例。 测试条可以包括工作电极和参考电极，其中试剂制剂设置在工作电极上。 试剂制剂可以涂在试纸上。 试剂制剂包括酶，六氯化钌介体和用于溶解酶和钌六胺介体的溶液。 试剂制剂可以涂在试纸上。 试剂制剂包括酶，六氯化钌介体和用于溶解酶和钌六胺介体的溶液。 钌六胺的浓度范围为溶液的约15％至约20％（介体/体积的重量）。 酶可以是葡萄糖氧化酶和葡萄糖脱氢酶。

公开(公告)号：US08323467B2

公开(公告)日：2012-12-04

申请号：US12606467

申请日：2009-10-27

申请人： Gavin MacFie ,  Graeme Webster ,  Marco F. Cardosi ,  Christopher Philip Leach ,  Steven Setford ,  Selwayan Saini

发明人： Gavin MacFie ,  Graeme Webster ,  Marco F. Cardosi ,  Christopher Philip Leach ,  Steven Setford ,  Selwayan Saini

IPC分类号： G01N27/327

CPC分类号： G01N27/3272 ,  G01N2035/00118

摘要： A dual chamber, multi-analyte test strip has a first insulating layer, a first electrically conductive layer, with a first working electrode, disposed on the first insulating layer and a first patterned spacer layer positioned above the first electrically conductive layer. The first patterned spacer layer has a first sample-receiving chamber, with first and second end openings, defined therein that overlies the first working electrode. The test strip also includes a first counter/reference electrode layer that is exposed to the first sample receiving chamber and is in an opposing relationship to the first working electrode. The test strip further includes a counter/reference insulating layer disposed over the first counter/reference electrode layer and a second counter/reference electrode layer disposed on the counter/reference substrate. Also included in the test strip is a second patterned spacer layer that is positioned above the second counter/reference electrode layer. The second patterned spacer layer has a second sample-receiving chamber, with first and second end openings, defined therein. The test strip additionally has a second electrically conductive layer, with a second working electrode, disposed above the second patterned spacer layer, a second insulating layer disposed above the second electrically conductive layer, a first analyte reagent layer disposed on the first working electrode within the first sample-receiving chamber; and a second analyte reagent layer disposed on the second working electrode within the second sample-receiving chamber. The second counter/reference electrode layer is exposed to the second sample receiving chamber and is in an opposing relationship to the second working electrode.

摘要翻译： 双室多分析物测试条具有设置在第一绝缘层上的第一绝缘层，第一导电层和第一工作电极，以及位于第一导电层上方的第一图案化间隔层。 第一图案化间隔层具有第一样品接收室，其中限定在其中的第一和第二端部开口覆盖在第一工作电极上。 测试条还包括暴露于第一样品接收室并与第一工作电极相对关系的第一计数器/参考电极层。 测试条还包括设置在第一计数器/参考电极层上的计数器/参考绝缘层和设置在反向/参考基板上的第二计数器/参考电极层。 还包括在测试条中的是位于第二计数器/参考电极层上方的第二图案化间隔层。 第二图案化间隔层具有第二样品接收室，其中限定有第一和第二端部开口。 测试条另外具有第二导电层，第二工作电极设置在第二图案化间隔层上方，设置在第二导电层上方的第二绝缘层，设置在第二工作电极内的第一分析物试剂层， 第一采样室; 以及设置在第二样品接收室内的第二工作电极上的第二分析物试剂层。 第二计数器/参考电极层暴露于第二样品接收室，并且与第二工作电极相对。

公开(公告)号：US20110094896A1

公开(公告)日：2011-04-28

申请号：US12606467

申请日：2009-10-27

申请人： Gavin MACFIE ,  Graeme Webster ,  Marco F. Cardosi ,  Christopher Philip Leach ,  Steven Setford ,  Selwayan Saini

发明人： Gavin MACFIE ,  Graeme Webster ,  Marco F. Cardosi ,  Christopher Philip Leach ,  Steven Setford ,  Selwayan Saini

IPC分类号： G01N27/26

CPC分类号： G01N27/3272 ,  G01N2035/00118

摘要： A dual chamber, multi-analyte test strip has a first insulating layer, a first electrically conductive layer, with a first working electrode, disposed on the first insulating layer and a first patterned spacer layer positioned above the first electrically conductive layer. The first patterned spacer layer has a first sample-receiving chamber, with first and second end openings, defined therein that overlies the first working electrode. The test strip also includes a first counter/reference electrode layer that is exposed to the first sample receiving chamber and is in an opposing relationship to the first working electrode. The test strip further includes a counter/reference insulating layer disposed over the first counter/reference electrode layer and a second counter/reference electrode layer disposed on the counter/reference substrate. Also included in the test strip is a second patterned spacer layer that is positioned above the second counter/reference electrode layer. The second patterned spacer layer has a second sample-receiving chamber, with first and second end openings, defined therein. The test strip additionally has a second electrically conductive layer, with a second working electrode, disposed above the second patterned spacer layer, a second insulating layer disposed above the second electrically conductive layer, a first analyte reagent layer disposed on the first working electrode within the first sample-receiving chamber; and a second analyte reagent layer disposed on the second working electrode within the second sample-receiving chamber. The second counter/reference electrode layer is exposed to the second sample receiving chamber and is in an opposing relationship to the second working electrode.

摘要翻译： 双室多分析物测试条具有设置在第一绝缘层上的第一绝缘层，第一导电层和第一工作电极，以及位于第一导电层上方的第一图案化间隔层。 第一图案化间隔层具有第一样品接收室，其中限定在其中的第一和第二端部开口覆盖在第一工作电极上。 测试条还包括暴露于第一样品接收室并与第一工作电极相对关系的第一计数器/参考电极层。 测试条还包括设置在第一计数器/参考电极层上的计数器/参考绝缘层和设置在反向/参考基板上的第二计数器/参考电极层。 还包括在测试条中的是位于第二计数器/参考电极层上方的第二图案化间隔层。 第二图案化间隔层具有第二样品接收室，其中限定有第一和第二端部开口。 测试条另外具有第二导电层，第二工作电极设置在第二图案化间隔层上方，设置在第二导电层上方的第二绝缘层，设置在第二工作电极内的第一分析物试剂层， 第一采样室; 以及设置在第二样品接收室内的第二工作电极上的第二分析物试剂层。 第二计数器/参考电极层暴露于第二样品接收室，并且与第二工作电极相对。

公开(公告)号：US20110048972A1

公开(公告)日：2011-03-03

申请号：US12551157

申请日：2009-08-31

申请人： James MOFFAT ,  Kathryn Macleod ,  Christopher Philip Leach ,  Gavin Macfie ,  Geoffrey Lillie ,  Marco F. Cardosi

发明人： James MOFFAT ,  Kathryn Macleod ,  Christopher Philip Leach ,  Gavin Macfie ,  Geoffrey Lillie ,  Marco F. Cardosi

IPC分类号： G01N27/26

CPC分类号： C12Q1/001 ,  G01N27/3272

摘要： A multi-analyte test strip includes a first insulating layer and an electrically conductive layer disposed on the first insulating layer. The electrically conductive layer has a first working electrode with a first analyte contact pad, a shared counter/reference electrode with a counter/reference electrode contact pad, and a second working electrode with a second analyte contact pad. The multi-analyte test strip also includes a second insulating layer disposed above the first insulating layer and a patterned spacer layer positioned between the first insulating layer and the first electrically conductive layer with the patterned spacer layer defining a bodily fluid sample-receiving chamber that overlies the first working electrode, the shared counter/reference electrode and the second working electrode. The multi-analyte test strip further includes a mediator reagent layer disposed over the first working electrode, the shared counter/reference electrode and the second working electrode; a first analyte reagent layer disposed over the first working electrode and mediator reagent layer; and a second analyte reagent layer disposed over the second working electrode and mediator reagent layer. Furthermore, the first analyte electrode, shared counter/reference electrode and second analyte electrode of the multi-analyte test strip are disposed on the first insulating layer in a planar inline configuration.

摘要翻译： 多分析物测试条包括设置在第一绝缘层上的第一绝缘层和导电层。 导电层具有第一工作电极，其具有第一分析物接触焊盘，共用的计数器/参考电极，其具有计数器/参考电极接触焊盘，以及具有第二分析物接触焊盘的第二工作电极。 多分析物测试条还包括设置在第一绝缘层上方的第二绝缘层和位于第一绝缘层和第一导电层之间的图案化间隔层，其中图案化间隔层限定体液样品接收室， 第一工作电极，共用计数器/参考电极和第二工作电极。 多分析物测试条还包括设置在第一工作电极，共用计数器/参考电极和第二工作电极之上的介体试剂层; 设置在第一工作电极和介体试剂层上的第一分析物试剂层; 以及设置在第二工作电极和介体试剂层上的第二分析物试剂层。 此外，多分析物测试条的第一分析物电极，共用计数器/参考电极和第二分析物电极以平面一字排列配置在第一绝缘层上。