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公开(公告)号:US06312888B1
公开(公告)日:2001-11-06
申请号:US09688636
申请日:2000-10-16
申请人: Sie Ting Wong , Robert G. Hiltibran , Tung-Ming Huang , Brenda B. Calfin , Mark R. Pope , Thomas G. Schapira , Eric B. Shain , Douglas F. Young
发明人: Sie Ting Wong , Robert G. Hiltibran , Tung-Ming Huang , Brenda B. Calfin , Mark R. Pope , Thomas G. Schapira , Eric B. Shain , Douglas F. Young
IPC分类号: C12Q100
CPC分类号: G01N33/558 , G01N33/525
摘要: An article and a method for monitoring the concentration of an analyte, e. g., glucose, in blood. In one aspect, the invention involves an article comprising a multiple-layer element. In one embodiment, the article comprises: a multiple-layer element comprising: (a) a base layer (b) a cover layer, the cover layer having a first opening for venting the multiple-layer element and a second opening for receiving a biological sample; and (c) a core layer having a first major surface and a second major surface, the core layer disposed between the base layer and the cover layer, the core layer comprising a sample introduction chamber and a optical reading chamber, the first major surface of the core layer in face-to-face contact with the base layer, the second major surface of the core layer in face-to-face contact with the cover layer. The multiple-layer element of this invention allows the use of samples of blood or other biological fluids, such as interstitial fluid, to provide extremely sensitive assay results. The device has been shown to provide accurate and reproducible results with samples having volumes ranging from about 5 &mgr;L to about 20 &mgr;L. In another aspect, the invention involves a method for using the aforementioned article.
摘要翻译: 用于监测分析物浓度的文章和方法, 例如血糖中的葡萄糖。 一方面,本发明涉及包含多层元件的制品。 在一个实施例中,所述制品包括:多层元件,包括:(a)基层(b)覆盖层,所述覆盖层具有用于排出所述多层元件的第一开口和用于接收生物 样品; 和(c)具有第一主表面和第二主表面的芯层,所述芯层设置在所述基底层和所述覆盖层之间,所述芯层包括样品引入室和光学读取室,所述芯层的第一主表面 芯层与基层面对面接触,芯层的第二主表面与覆盖层面对面接触。本发明的多层元件允许使用血液样品 或其他生物流体,例如间质液,以提供极敏感的测定结果。 该装置已被证明可以提供具有约5至20微米的体积的样品的准确和可重复的结果。 另一方面,本发明涉及使用上述制品的方法。
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公开(公告)号:US06468229B1
公开(公告)日:2002-10-22
申请号:US09529148
申请日:2001-01-26
申请人: John P. Grace , Neil W. Loomis , Thomas G. Schapira , Sie Ting Wong , Kristin M. Noonan , Michael G. Lowery , Pete M. Bojan , Daniel P. Schmidt , Tung-Ming Huang , Robert G. Hiltibran , Mark R. Pope , John J. Kotlarik , Brian Joseph Tarkowski , David Dean Cunningham
发明人: John P. Grace , Neil W. Loomis , Thomas G. Schapira , Sie Ting Wong , Kristin M. Noonan , Michael G. Lowery , Pete M. Bojan , Daniel P. Schmidt , Tung-Ming Huang , Robert G. Hiltibran , Mark R. Pope , John J. Kotlarik , Brian Joseph Tarkowski , David Dean Cunningham
IPC分类号: A61B500
CPC分类号: A61B10/0045 , A61B2010/008 , A61B2017/00765
摘要: The present invention involves apparatus and methods for use in collecting bodily fluids, such as interstitial fluids, from the epidermal layer of an animal. A preferred apparatus includes a pressure head and, optionally, a holder therefor for supplying a positive pressure to the head. The methods include the application of a positive pressure to the area surrounding an epidermal site from which stratum corneum has been breached, such as by laser ablation, to cause bodily fluids, such as interstitial fluids, to exude from the site and collecting the fluids exuding therefrom.
摘要翻译: 本发明涉及用于从动物的表皮层收集诸如间质液体的体液的装置和方法。 优选的装置包括压头和可选的用于向头部供应正压力的保持器。 所述方法包括对已被破坏角质层的表皮部位周围的区域施加正压,例如通过激光消融,使体液如间质液从所述部位渗出并收集流出的液体 由此。
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公开(公告)号:US06786874B2
公开(公告)日:2004-09-07
申请号:US10243584
申请日:2002-09-13
申请人: John P. Grace , Neil W. Loomis , Thomas G. Schapira , Sie Ting Wong , Kristin M. Noonan , Michael G. Lowery , Pete M. Bojan , Daniel P. Schmidt , Tung-Ming Huang , Robert G. Hiltibran , Mark R. Pope , John J. Kotlarik , Brian Joseph Tarkowski , David Dean Cunningham
发明人: John P. Grace , Neil W. Loomis , Thomas G. Schapira , Sie Ting Wong , Kristin M. Noonan , Michael G. Lowery , Pete M. Bojan , Daniel P. Schmidt , Tung-Ming Huang , Robert G. Hiltibran , Mark R. Pope , John J. Kotlarik , Brian Joseph Tarkowski , David Dean Cunningham
IPC分类号: A61B1000
CPC分类号: A61B10/0045 , A61B2010/008 , A61B2017/00765
摘要: The present invention involves apparatus and methods for use in collecting bodily fluids, such as interstitial fluids, from the epidermal layer of an animal. A preferred apparatus includes a pressure head and, optionally, a holder therefor for supplying a positive pressure to the head. The methods include the application of a positive pressure to the area surrounding an epidermal site from which stratum corneum has been breached, such as by laser ablation, to cause bodily fluids, such as interstitial fluids, to exude from the site and collecting the fluids exuding therefrom.
摘要翻译: 本发明涉及用于从动物的表皮层收集诸如间质液体的体液的装置和方法。 优选的装置包括压头和可选的用于向头部供应正压力的保持器。 所述方法包括对已被破坏角质层的表皮部位周围的区域施加正压,例如通过激光消融,使体液如间质液从所述部位渗出并收集流出的液体 由此。
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公开(公告)号:US06837858B2
公开(公告)日:2005-01-04
申请号:US09972444
申请日:2001-10-05
申请人: David D. Cunningham , Timothy P. Henning , Eric B. Shain , Douglas F. Young , Andrew J. Muetterties , Thomas G. Schapira , Geoffrey R. Chambers , Graham J. Hughes , Jared L. Watkin , Gary F. Prokop , Joshua P. Goldfarb
发明人: David D. Cunningham , Timothy P. Henning , Eric B. Shain , Douglas F. Young , Andrew J. Muetterties , Thomas G. Schapira , Geoffrey R. Chambers , Graham J. Hughes , Jared L. Watkin , Gary F. Prokop , Joshua P. Goldfarb
IPC分类号: A61B5/151 , A61B5/00 , A61B5/145 , A61B5/1459 , A61B5/1473 , A61B5/15 , A61B5/154 , A61B5/157 , G01N33/48 , G01N33/66
CPC分类号: A61B5/15186 , A61B5/14532 , A61B5/1486 , A61B5/150022 , A61B5/150068 , A61B5/150076 , A61B5/150099 , A61B5/150221 , A61B5/150358 , A61B5/150412 , A61B5/150503 , A61B5/150664 , A61B5/15113 , A61B5/15125 , A61B5/1519 , A61B5/15194 , A61B5/157 , A61B5/411 , A61B2562/0295
摘要: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of: (a) placing a blood collection device over a region on the surface of the skin from which said sample is to be obtained, (b) forming a seal between said blood collection device and said surface of the skin, (c) creating a vacuum sufficient to result in said surface of the skin becoming stretched and engorged with blood, (d) triggering a lancing assembly and causing a lancet to penetrate said skin, (e) retracting said lancet, (f) withdrawing blood toward and onto a fluid collector, and (g) releasing the vacuum. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises: (a) a housing having a sealable chamber located therein and a sealable opening in fluid communication with said sealable chamber, (b) a power source, (c) a vacuum pump operably connected to said power source, said vacuum pump in communication with said sealable chamber, (d) a lancing assembly positioned within said housing, said lancing assembly capable of moving a lancet towards said sealable opening, and (e) a fluid collector positioned in said sealable chamber, said fluid collector in fluid communication with said sealable opening.
摘要翻译: 用于从患者获得血样的方法和装置用于随后的诊断测试,例如葡萄糖监测。 在本发明的一个方面,所述方法包括以下步骤:(a)将血液收集装置放置在要获得所述样品的皮肤表面上的区域上,(b)在所述血液收集器之间形成密封 装置和皮肤表面,(c)产生足以导致皮肤表面变得伸展和凝结的真空的真空,(d)触发穿刺组件并使刺血针穿透所述皮肤,(e)缩回 所述刺血针,(f)朝向流体收集器排出血液,和(g)释放真空。在本发明的另一方面,提供一种用于执行前述方法的装置。 该设备包括:(a)壳体,其中具有位于其中的可密封腔室和与所述可密封腔室流体连通的可密封开口,(b)动力源,(c)可操作地连接到所述动力源的真空泵,所述真空泵 与所述可密封腔室连通,(d)位于所述壳体内的采血组件,所述穿刺组件能够将刺血针移向所述可密封开口,以及(e)定位在所述可密封腔室中的流体收集器,所述流体收集器处于流体连通 具有所述可密封的开口。
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公开(公告)号:US6093156A
公开(公告)日:2000-07-25
申请号:US982721
申请日:1997-12-02
申请人: David D. Cunningham , Timothy P. Henning , Eric B. Shain , Douglas F. Young , Andrew J. Muetterties , Thomas G. Schapira , Geoffrey R. Chambers , Graham J. Hughes , Jared L. Watkin , Gary F. Prokop , Joshua P. Goldfarb
发明人: David D. Cunningham , Timothy P. Henning , Eric B. Shain , Douglas F. Young , Andrew J. Muetterties , Thomas G. Schapira , Geoffrey R. Chambers , Graham J. Hughes , Jared L. Watkin , Gary F. Prokop , Joshua P. Goldfarb
IPC分类号: A61B5/151 , A61B5/00 , A61B5/145 , A61B5/1459 , A61B5/1473 , A61B5/15 , A61B5/154 , A61B5/157 , G01N33/48 , G01N33/66
CPC分类号: A61B5/15186 , A61B5/14532 , A61B5/1486 , A61B5/150022 , A61B5/150068 , A61B5/150076 , A61B5/150099 , A61B5/150221 , A61B5/150412 , A61B5/150503 , A61B5/150664 , A61B5/15113 , A61B5/15125 , A61B5/1519 , A61B5/15194 , A61B5/157 , A61B5/411 , A61B2562/0295 , A61B5/150358
摘要: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of:(a) placing a blood collection device over a region on the surface of the skin from which said sample is to be obtained,(b) forming a seal between said blood collection device and said surface of the skin,(c) creating a vacuum sufficient to result in said surface of the skin becoming stretched and engorged with blood,(d) triggering a lancing assembly and causing a lancet to penetrate said skin,(e) retracting said lancet,(f) withdrawing blood toward and onto a fluid collector, and(g) releasing the vacuum.In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises:(a) a housing having a sealable chamber located therein and a sealable opening in fluid communication with said sealable chamber,(b) a power source,(c) a vacuum pump operably connected to said power source, said vacuum pump in communication with said sealable chamber,(d) a lancing assembly positioned within said housing, said lancing assembly capable of moving a lancet towards said sealable opening, and(e) a fluid collector positioned in said sealable chamber, said fluid collector in fluid communication with said sealable opening.
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公开(公告)号:US06306104B1
公开(公告)日:2001-10-23
申请号:US09612722
申请日:2000-07-10
申请人: David D. Cunningham , Timothy P. Henning , Eric B. Shain , Douglas F. Young , Andrew J. Muetterties , Thomas G. Schapira , Geoffrey R. Chambers , Graham J. Hughes , Jared L. Watkin , Gary F. Prokop , Joshua P. Goldfarb
发明人: David D. Cunningham , Timothy P. Henning , Eric B. Shain , Douglas F. Young , Andrew J. Muetterties , Thomas G. Schapira , Geoffrey R. Chambers , Graham J. Hughes , Jared L. Watkin , Gary F. Prokop , Joshua P. Goldfarb
IPC分类号: A61B500
CPC分类号: A61B5/15186 , A61B5/14532 , A61B5/1486 , A61B5/150022 , A61B5/150068 , A61B5/150076 , A61B5/150099 , A61B5/150221 , A61B5/150358 , A61B5/150412 , A61B5/150503 , A61B5/150664 , A61B5/15113 , A61B5/15125 , A61B5/1519 , A61B5/15194 , A61B5/157 , A61B5/411 , A61B2562/0295
摘要: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of: (a) placing a blood collection device over a region on the surface of the skin from which said sample is to be obtained, (b) forming a seal between said blood collection device and said surface of the skin, (c) creating a vacuum sufficient to result in said surface of the skin becoming stretched and engorged with blood, (d) triggering a lancing assembly and causing a lancet to penetrate said skin, (e) retracting said lancet, (f) withdrawing blood toward and onto a fluid collector, and (g) releasing the vacuum. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises: (a) a housing having a sealable chamber located therein and a sealable opening in fluid communication with said sealable chamber, (b) a power source, (c) a vacuum pump operably connected to said power source, said vacuum pump in communication with said sealable chamber, (d) a lancing assembly positioned within said housing, said lancing assembly capable of moving a lancet towards said sealable opening, and (e) a fluid collector positioned in said sealable chamber, said fluid collector in fluid communication with said sealable opening.
摘要翻译: 用于从患者获得血样的方法和装置用于随后的诊断测试,例如葡萄糖监测。 在本发明的一个方面,所述方法包括以下步骤:(a)将血液收集装置放置在要获得所述样品的皮肤表面上的区域上,(b)在所述血液收集器之间形成密封 装置和皮肤表面,(c)产生足以导致皮肤表面变得伸展和凝结的真空的真空,(d)触发穿刺组件并使刺血针穿透所述皮肤,(e)缩回 所述刺血针,(f)朝向流体收集器排出血液,和(g)释放真空。在本发明的另一方面,提供一种用于执行前述方法的装置。 该设备包括:(a)壳体,其中具有位于其中的可密封腔室和与所述可密封腔室流体连通的可密封开口,(b)动力源,(c)可操作地连接到所述动力源的真空泵,所述真空泵 与所述可密封腔室连通,(d)位于所述壳体内的采血组件,所述穿刺组件能够将刺血针移向所述可密封开口,以及(e)定位在所述可密封腔室中的流体收集器,所述流体收集器处于流体连通 具有所述可密封的开口。
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公开(公告)号:US06206841B1
公开(公告)日:2001-03-27
申请号:US09546948
申请日:2000-04-11
申请人: David D. Cunningham , Timothy P. Henning , Eric B. Shain , Douglas F. Young , Michael G. Lowery , Thomas G. Schapira
发明人: David D. Cunningham , Timothy P. Henning , Eric B. Shain , Douglas F. Young , Michael G. Lowery , Thomas G. Schapira
IPC分类号: A61B500
CPC分类号: A61B5/15186 , A61B5/14532 , A61B5/1486 , A61B5/150022 , A61B5/150068 , A61B5/150076 , A61B5/150099 , A61B5/150221 , A61B5/150358 , A61B5/150412 , A61B5/150503 , A61B5/150664 , A61B5/15113 , A61B5/15125 , A61B5/1519 , A61B5/15194 , A61B5/157 , A61B5/411 , A61B2562/0295
摘要: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of: (a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and (b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises: (a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and (b) a vacuum pump. Preferably, the apparatus also includes a housing. In another aspect of this invention, an article is provided for an article capable of both collecting blood and detecting an analyte in that blood is provided. The article, which contains an appropriate detection element for determining the amount of analyte in the blood, can be used in conjunction with a meter that measures the signal generated by the detection element of the article. In one embodiment, the article is a multiple-layer element comprising: (a) a layer capable of receiving blood and transporting the blood received by means of chemically aided wicking; (b) a layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and (c) a layer that can be placed in contact with a meter, the meter-contactable layer overlying the blood-transporting layer, said layer (a) capable of transporting blood to said layer (b).
摘要翻译: 用于从患者获得血样的方法和装置用于随后的诊断测试,例如葡萄糖监测。 在本发明的一个方面,所述方法包括以下步骤:(a)在要从其中提取血液样本的皮肤区域中形成无障碍的开口; 并且(b)借助于皮肤的真空和拉伸,从皮肤中的无障碍的开口提取血液样品。在本发明的另一方面,提供了一种用于执行前述方法的装置。 该装置包括:(a)用于在皮肤区域形成无障碍的开口的装置,所述皮肤区域将从所述皮肤区域中提取所述样品,优选为采血组件; 优选地,该装置还包括壳体。在本发明的另一方面,提供了一种能够收集血液并检测血液中的分析物的物品。 包含用于确定血液中分析物的量的合适的检测元件的物品可以与测量由物品的检测元件产生的信号的计量器结合使用。 在一个实施方案中,制品是多层元件,其包括:(a)能够接收血液并通过化学辅助芯吸输送接收到的血液的层;(b)能够检测分析物的存在或测量 血液中分析物的量; 以及(c)可以与仪表接触的层,覆盖在血液输送层上的可测量接触层,所述层(a)能够将血液输送到所述层(b)。
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公开(公告)号:US6071251A
公开(公告)日:2000-06-06
申请号:US982323
申请日:1997-12-02
申请人: David D. Cunningham , Timothy P. Henning , Eric B. Shain , Douglas F. Young , Michael G. Lowery , Thomas G. Schapira
发明人: David D. Cunningham , Timothy P. Henning , Eric B. Shain , Douglas F. Young , Michael G. Lowery , Thomas G. Schapira
IPC分类号: A61B5/151 , A61B5/00 , A61B5/145 , A61B5/1459 , A61B5/1473 , A61B5/15 , A61B5/154 , A61B5/157 , G01N33/48 , G01N33/66
CPC分类号: A61B5/15186 , A61B5/14532 , A61B5/1486 , A61B5/150022 , A61B5/150068 , A61B5/150076 , A61B5/150099 , A61B5/150221 , A61B5/150412 , A61B5/150503 , A61B5/150664 , A61B5/15113 , A61B5/15125 , A61B5/1519 , A61B5/15194 , A61B5/157 , A61B5/411 , A61B2562/0295 , A61B5/150358
摘要: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of:(a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and(b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin.In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises:(a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and(b) a vacuum pump.Preferably, the apparatus also includes a housing.In another aspect of this invention, an article is provided for an article capable of both collecting blood and detecting an analyte in that blood is provided. The article, which contains an appropriate detection element for determining the amount of analyte in the blood, can be used in conjunction with a meter that measures the signal generated by the detection element of the article. In one embodiment, the article is a multiple-layer element comprising:(a) a layer capable of receiving blood and transporting the blood received by means of chemically aided wicking;(b) a layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and(c) a layer that can be placed in contact with a meter, the meter-contactable layer overlying the blood-transporting layer, said layer (a) capable of transporting blood to said layer (b).
摘要翻译: 用于从患者获得血样的方法和装置用于随后的诊断测试,例如葡萄糖监测。 在本发明的一个方面,所述方法包括以下步骤:(a)在要从其中提取血液样本的皮肤区域中形成无障碍的开口; 和(b)借助于真空和皮肤拉伸从皮肤中的无阻塞的开口提取血液样品。 在本发明的另一方面,提供一种用于执行前述方法的装置。 该装置包括:(a)用于在皮肤区域形成无障碍的开口的装置,所述皮肤区域将从所述皮肤区域中提取所述样品,优选为采血组件; 和(b)真空泵。 优选地,该装置还包括壳体。 在本发明的另一方面,提供了一种能够收集血液并检测血液中分析物的物品。 包含用于确定血液中分析物的量的合适的检测元件的物品可以与测量由物品的检测元件产生的信号的计量器结合使用。 在一个实施方案中,制品是多层元件,其包括:(a)能够接收血液并通过化学辅助芯吸运送接收的血液的层; (b)能够检测分析物的存在或测量血液中分析物的量的层; 以及(c)可以与仪表接触的层,覆盖在血液输送层上的可测量接触层,所述层(a)能够将血液输送到所述层(b)。
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公开(公告)号:US6009343A
公开(公告)日:1999-12-28
申请号:US606506
申请日:1996-02-23
CPC分类号: A61B5/14514 , A61B5/14532
摘要: The present disclosure provides the use of vacuum to enhance the transdermal transport of fluids in sampling methods for the detection of analytes in a patient's blood.
摘要翻译: 本公开提供了在用于检测患者血液中的分析物的取样方法中使用真空来增强流体的透皮转运。
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10.
公开(公告)号:US5952173A
公开(公告)日:1999-09-14
申请号:US917012
申请日:1997-08-21
申请人: Douglas D. Hansmann , John P. Grace , Michael G. Lowery , Gary M. Oosta , Neil W. Loomis , Eric B. Shain , Thomas G. Schapira
发明人: Douglas D. Hansmann , John P. Grace , Michael G. Lowery , Gary M. Oosta , Neil W. Loomis , Eric B. Shain , Thomas G. Schapira
IPC分类号: G01N33/48 , B01L3/00 , C08G18/00 , C08G18/08 , C08G18/10 , C12Q1/00 , G01N33/53 , G01N33/543 , G01N37/00
CPC分类号: G01N33/5304 , B01L3/502753 , C08G18/0866 , C08G18/10 , G01N33/54366 , G01N33/54393 , B01L2200/10 , B01L2300/0636 , B01L2300/0825 , B01L2400/0406 , B01L2400/086 , B01L3/502746 , Y10S435/81 , Y10S436/804 , Y10S436/805 , Y10S436/809 , Y10S436/81
摘要: The present invention relates to analytical devices for determining the presence or amount of an analyte in a test sample. The analytical devices comprise an inlet port, a vent, a channel, and an array of structures. The structures have immobilized reagent covalently or non-covalently attached to the surface of the structures. The immobilized reagent captures analyte in the test sample where it is detected by a detection system. The present invention also provides methods and reagents for performing assays utilizing the analytical devices of the present invention. The present invention also provides methods of manufacturing the analytical devices of the present invention.
摘要翻译: 本发明涉及用于确定测试样品中分析物的存在或量的分析装置。 分析装置包括入口,通气口,通道和结构阵列。 这些结构具有共价或非共价连接到结构表面的固定化试剂。 固定化的试剂捕获测试样品中的分析物,由检测系统检测。 本发明还提供用于使用本发明的分析装置进行测定的方法和试剂。 本发明还提供了制造本发明的分析装置的方法。
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