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    Diagnostic assay for a sample of biological fluid
    1.
    发明授权
    Diagnostic assay for a sample of biological fluid 失效
    生物流体样本的诊断测定

    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。

    Diagnostic assay requiring a small sample of biological fluid
    4.
    发明授权
    Diagnostic assay requiring a small sample of biological fluid 失效
    诊断测定需要一小部分生物液样品

    公开(公告)号：US6077660A

    公开(公告)日：2000-06-20

    申请号：US095683

    申请日：1998-06-10

    申请人： Sie Ting Wong ,  Robert G. Hiltibran ,  Tung-Ming Huang

    发明人： Sie Ting Wong ,  Robert G. Hiltibran ,  Tung-Ming Huang

    IPC分类号： G01N33/52 ,  C12Q1/32 ,  C12Q1/54 ,  G01N33/53 ,  G01N33/543 ,  G01N33/66 ,  G01N37/00 ,  C12Q1/00 ,  A01N1/02

    CPC分类号： G01N33/54373 ,  G01N33/5304

    摘要： An article and a method for monitoring the concentration of glucose in blood. In one aspect, the invention involves an article comprising a multiple-layer element utilizing reagents capable of reacting with an analyte of interest. In a preferred embodiment, the element comprises:(a) a core layer having two major surfaces, an optical reading chamber extending from a first opening in one of the two major surfaces to a second opening in the other of the two major surfaces, the core layer further having a third opening therein and a flow channel, one end of which flow channel communicates with the third opening and the other end of which flow channel communicates with the optical reading chamber;(b) a base layer in face-to-face contact with one major surface of the core layer; and(c) a cover layer in face-to-face contact with the other major surface of the core layer, the cover layer having an opening therein to vent the element.In another aspect, the invention involves a method comprising the steps of:(a) obtaining a sample of biological fluid, e.g., interstitial fluid, from the body of a patient;(b) introducing the sample to an article comprising a multiple-layer element having an optical reading chamber;(c) allowing reagents to react with an analyte of interest in the sample; and(d) measuring the concentration of analyte in the sample by means of an optical instrument.

    摘要翻译： 一种用于监测血液中葡萄糖浓度的文章和方法。 一方面，本发明涉及一种包含多层元件的制品，该多层元件利用能够与感兴趣的分析物反应的试剂。 在优选实施例中，元件包括：（a）具有两个主表面的芯层，从两个主表面中的一个主表面中的一个中的第一开口延伸到两个主表面中另一个中的第二开口的光学读取室， 芯层还具有第三开口和流动通道，其一端的流动通道与第三开口连通，另一端与光学读取室连通。 （b）与芯层的一个主表面面对面接触的基层; 和（c）与所述芯层的另一个主表面面对面接触的覆盖层，所述覆盖层在其中具有用于排出所述元件的开口。 在另一方面，本发明涉及一种方法，包括以下步骤：（a）从患者的身体获得生物流体样品，例如间质液; （b）将样品引入包含具有光学读取室的多层元件的制品; （c）允许试剂与样品中感兴趣的分析物反应; 和（d）通过光学仪器测量样品中分析物的浓度。

    Reaction cartridge and carousel for biological sample analyzer
    5.
    发明授权
    Reaction cartridge and carousel for biological sample analyzer 失效
    用于生物样品分析仪的反应盒和转盘

    公开(公告)号：US5320808A

    公开(公告)日：1994-06-14

    申请号：US227590

    申请日：1988-08-02

    申请人： James T. Holen ,  Enrique Hicaro, Jr. ,  Caryn G. Putterman ,  Tung-Ming Huang ,  Carl W. Merkh

    发明人： James T. Holen ,  Enrique Hicaro, Jr. ,  Caryn G. Putterman ,  Tung-Ming Huang ,  Carl W. Merkh

    IPC分类号： G01N33/53 ,  B01L3/00 ,  G01N33/543 ,  G01N35/00 ,  G01N35/02 ,  G01N35/04 ,  G01N35/10 ,  G01N21/01 ,  G01N21/13

    CPC分类号： B01L3/508 ,  G01N35/025 ,  B01L2200/025 ,  B01L2300/021 ,  B01L2300/044 ,  B01L2300/0809 ,  G01N2035/00752 ,  G01N2035/1025

    摘要： A semi-automated biological sample analyzer and subsystems are provided to simultaneously perform a plurality of enzyme immuno assays for human IgE class antibodies specific to a panel of preselected allergens in each of a plurality of biological samples. A carousel is provided to position and hold a plurality of reaction cartridges. Each reaction cartridge includes a plurality of isolated test sites formed in a two dimensional array in a solid phase binding layer contained within a reaction well which is adapted to contain a biological sample to be assayed. The carousel and cartridges contain structures which cooperate to precisely position the cartridges in each of three separate dimensions so that each cartridge is positioned uniformly. An optical reader operating on a principle of diffuse reflectance is provided to read the results of the assays from each test site of each cartridge. Also provided is a subsystem which provides predetermined lot-specific assay calibration data which is useful for normalizing the results of various assays with respect to predetermined common standard values.

    摘要翻译： 提供半自动生物样品分析仪和子系统以同时对多个生物样品中的每一个中的预选过敏原组特异的人IgE类抗体进行多次酶免疫测定。 提供转盘以定位和保持多个反应盒。 每个反应盒包括在包含在反应井内的固相结合层中的二维阵列中形成的多个分离的测试位点，其适于含有要测定的生物样品。 圆盘传送带和墨盒包含结构，其配合以将墨盒精确地定位在三个分开的尺寸中的每一个中，使得每个墨盒均匀地定位。 提供以漫反射原理工作的光学阅读器，以从每个盒的每个测试位置读取测定结果。 还提供了一种子系统，其提供预定的特异性测定校准数据，其可用于相对于预定的共同标准值归一化各种测定的结果。

    Method and apparatus for metering a fluid
    6.
    发明授权
    Method and apparatus for metering a fluid 失效
    用于计量流体的方法和装置

    公开(公告)号：US5834314A

    公开(公告)日：1998-11-10

    申请号：US907143

    申请日：1997-08-06

    申请人： James D. Gates ,  Jeffrey Y. Pan ,  Tung-Ming Huang ,  Donald Ver Lee ,  Alan J. Alcock ,  Conan K. N. Li ,  Karen A. Egan

    发明人： James D. Gates ,  Jeffrey Y. Pan ,  Tung-Ming Huang ,  Donald Ver Lee ,  Alan J. Alcock ,  Conan K. N. Li ,  Karen A. Egan

    IPC分类号： F16K7/17 ,  G01N1/00 ,  G01N35/08 ,  G01N35/10

    CPC分类号： G01N35/1097 ,  F16K7/17 ,  G01N35/08 ,  Y10T436/117497 ,  Y10T436/118339

    摘要： Embodiments disclosed involve methods and constructions for metering, and in some instances combining, fluids. One such method includes fluidly connecting a source of first fluid to be metered with a pressure source capable of moving the first fluid with a first valve and a conduit. The first valve is operated such that first fluid moves in the conduit. The conduit is fluidly connected with a source of second fluid that has a fluid flow rate greater than the first fluid with a second valve. The second valve is operated such that the second fluid moves into the conduit. One construction for metering a fluid comprises a source of first fluid to be metered, a pressure source for moving the first fluid to be metered, and a first valve. A conduit fluidly connects the source of first fluid, the pressure source for moving the first fluid and the first valve such that operation of the first valve causes movement of the first fluid responsive to the pressure source. A second valve fluidly connects a source of second fluid that has a fluid flow rate greater than the first fluid with the conduit such that operation of the second valve causes movement of the second fluid into the conduit.

    摘要翻译： 所公开的实施例涉及用于计量流体的方法和结构，并且在某些情况下结合流体。 一种这样的方法包括将待计量的第一流体源与能够利用第一阀和导管移动第一流体的压力源流体连接。 操作第一阀使得第一流体在导管中移动。 导管与第二流体源流体连接，第二流体源具有大于具有第二阀的第一流体的流体流速。 操作第二阀使得第二流体移动到导管中。 用于计量流体的一种结构包括要计量的第一流体源，用于移动要计量的第一流体的压力源和第一阀。 导管将第一流体的源流体连接，用于移动第一流体和第一阀的压力源，使得第一阀的操作导致响应于压力源的第一流体的运动。 第二阀将具有大于第一流体的流体流速的第二流体源与导管流体连接，使得第二阀的操作导致第二流体进入导管的运动。

    Valve construction and method of use
    7.
    发明授权
    Valve construction and method of use 失效
    阀门结构及使用方法

    公开(公告)号：US5743295A

    公开(公告)日：1998-04-28

    申请号：US686297

    申请日：1996-07-25

    申请人： Alan J. Alcock ,  Jeffrey Y. Pan ,  Karen A. Egan ,  Tung-Ming Huang

    发明人： Alan J. Alcock ,  Jeffrey Y. Pan ,  Karen A. Egan ,  Tung-Ming Huang

    IPC分类号： F16K11/07 ,  F16K11/10 ,  F16K11/22

    CPC分类号： F16K11/22 ,  Y10T137/7871

    摘要： Embodiments described herein provide a valve construction. One embodiment comprises a first valve and a second valve. A first fluid conveying conduit fluidly conveying a first fluid is fluidly connected with the first valve. A second fluid conveying conduit fluidly conveying a second fluid is fluidly connected with the second valve. A third fluid conveying conduit is fluidly connected with the first valve and the second valve. The first valve is movable between a first position where first fluid flows between the first fluid conveying conduit and the third fluid conveying conduit, and a second position where first fluid does not flow between the first fluid conveying conduit and the third fluid conveying conduit. The second valve is movable between a first position where the second fluid flows between the second fluid conveying conduit and the third fluid conveying conduit, and a second position where the second fluid does not flow between the second fluid conveying conduit and the third fluid conveying conduit.

    摘要翻译： 本文所述的实施例提供阀结构。 一个实施例包括第一阀和第二阀。 流体输送第一流体的第一流体输送管道与第一阀流体连接。 流体输送第二流体的第二流体输送管道与第二阀流体连接。 第三流体输送导管与第一阀和第二阀流体连接。 第一阀可以在第一流体在第一流体输送管道和第三流体输送管道之间流动的第一位置和第一流体不在第一流体输送管道和第三流体输送管道之间流动的第二位置之间移动。 第二阀可以在第二流体在第二流体输送管道和第三流体输送管道之间流动的第一位置和第二流体不在第二流体输送管道和第三流体输送管道之间流动的第二位置之间移动 。

    Unitized reagent containment system for clinical analyzer
    10.
    发明授权
    Unitized reagent containment system for clinical analyzer 失效
    用于临床分析仪的单元化试剂容纳系统

    公开(公告)号：US4933147A

    公开(公告)日：1990-06-12

    申请号：US99883

    申请日：1987-09-22

    申请人： Robert C. Hollar ,  Tung-Ming Huang

    发明人： Robert C. Hollar ,  Tung-Ming Huang

    IPC分类号： B01L3/00 ,  G01N35/02 ,  G01N35/04 ,  G01N35/10

    CPC分类号： B01L3/508 ,  G01N35/025 ,  G01N35/1002 ,  G01N2035/0436 ,  G01N2035/0448 ,  Y10T436/111666

    摘要： Improvements in apparatus for performing an assay to determine the presence or amount of a substance in a test sample, which apparatus comprises means for dispensing one or more reagents from containment means therefor into a reaction vessel and means for dispensing the sample from a sample container into said vessel for reaction with the reagents during performance of the assay, are disclosed. The improvements reside in the apparatus further comprising containment means for the reagents integral and in combination with the sample container and the reaction vessel.

    摘要翻译： 用于执行测定以确定测试样品中物质的存在或量的装置的改进，该装置包括用于将一种或多种试剂从其容纳装置分配到反应容器中的装置和用于将样品从样品容器分配到 所述容器用于在测定过程中与试剂反应。 改进在于该装置还包括用于试剂的容纳装置，并与样品容器和反应容器组合。