公开(公告)号：US20040241879A1

公开(公告)日：2004-12-02

申请号：US10859630

申请日：2004-06-02

Inventor： Joseph R. Robinson

IPC: G01N033/558

CPC classification number: G01N33/74 ,  G01N33/558

Abstract: The present invention provides a test device for detecting the presence or absence of a selected analyte in a liquid sample. The test device includes a reagent member having a body, a first color-labeled binding reagent specific for a first binding site of said analyte; wherein said body is adapted to retain said first color-labeled specific binding reagent when said body and said first color-labeled binding reagent are dry, and to release said first color-labeled specific binding reagent when said body and said first color-labeled specific binding reagents are moist, a porous carrier; and a detection zone having a second color-labeled binding reagent specific for a second binding site of said analyte, wherein said second color-labeled specific binding reagent is immobilized in said detection zone, wherein said first specific binding site and said second binding site are different, and wherein in said first and second labeled specific binding reagents are capable of forming a third color-labeled complex with said analyte, said complex comprising said first color-labeled specific binding reagent, said analyte, and said second color-labeled specific binding reagent; wherein said first color, said second color-label, and said third color are visually distinguishable from one another by the human eye; wherein said reagent member, porous carrier, and detection zone are arranged so that a fluid applied to said test device would travel sequentially from said reagent member to said porous carrier and to said detection zone. The test device is typically dry before use and moist during use.

Abstract translation: 本发明提供了一种用于检测液体样品中选定的分析物的存在或不存在的测试装置。 测试装置包括具有身体的试剂构件，对所述分析物的第一结合位点特异的第一颜色标记的结合试剂; 其中所述体适于在所述体和所述第一颜色标记的结合试剂干燥时保留所述第一颜色标记的特异性结合试剂，并且当所述身体和所述第一颜色标记的特异性结合试剂干燥时释放所述第一颜色标记的特异性结合试剂 结合剂是潮湿的，多孔载体; 以及检测区，其具有对所述分析物的第二结合位点特异的第二颜色标记的结合试剂，其中所述第二颜色标记的特异性结合试剂固定在所述检测区中，其中所述第一特异性结合位点和所述第二结合位点是 并且其中在所述第一和第二标记的特异性结合试剂中能够与所述分析物形成第三颜色标记的复合物，所述复合物包含所述第一颜色标记的特异性结合试剂，所述分析物和所述第二颜色标记的特异性结合 试剂; 其中所述第一颜色，所述第二颜色标签和所述第三颜色通过人眼可视地彼此区分; 其中所述试剂构件，多孔载体和检测区域布置成使得施加到所述测试装置的流体将从所述试剂构件顺序地移动到所述多孔载体和所述检测区域。 测试装置在使用前通常是干燥的并且在使用期间是潮湿的。

公开(公告)号：US20040241877A1

公开(公告)日：2004-12-02

申请号：US10490003

申请日：2004-03-18

Inventor： Paul Price ,  Bruno Oesch ,  Eric Kubler

IPC: G01N033/558

CPC classification number: G01N33/6896 ,  G01N33/558 ,  G01N2800/2828

Abstract: A test strip for detecting an analyte in liquid or homogenised samples, with a section which may be brought into contact with the sample and with at least one first defined region on the test strip in which detection reagents are immobilised which bind the prion protein. A device is also provided that permits simultaneous testing of several samples in sample containers, provided in a group with a defined geometrical arrangement. The device includes a holder in which several test strips are fixed in an arrangement corresponding to the defined geometrical arrangement of the sample containers, such that the lower section thereof may be introduced into each of the sample containers.

Abstract translation: 用于检测液体或均质样品中的分析物的测试条，其中可以与样品接触的部分和测试条上的至少一个第一限定区域，其中固定有结合朊蛋白的检测试剂。 还提供了一种装置，其允许在具有确定的几何布置的组中提供的样品容器中的几个样品的同时测试。 该装置包括一个保持器，其中若干个测试条以对应于所述样品容器的限定几何布置的布置固定，使得其下部可以被引入每个样品容器中。

公开(公告)号：US20040171092A1

公开(公告)日：2004-09-02

申请号：US10714318

申请日：2003-11-14

Applicant: Response Biomedical Corporation

Inventor： Paul C. Harris ,  Brian G. Richards

IPC: G01N033/53 ,  G01N033/537 ,  G01N033/543 ,  G01N033/558

CPC classification number: G01N33/558 ,  G01N33/54386

Abstract: Methods for quantitatively measuring the amount of an analyte of interest in a fluid sample are disclosed. The methods involve providing a membrane having an application point, a contact region comprising analyte-binding particles, a sample capture zone, and a control capture zone, where the contact region is between the application point and the sample capture zone, and the sample capture region is between the contact region and the control capture zone. In the assays, a fluid allows transport components of the assay by capillary action through the contact region, to and through the sample capture zone and subsequently to and through the control capture zone. In a nullsandwich assaynull embodiment, the amount of analyte in the fluid sample is related to a corrected analyte-binding particle amount, which can be determined, for example, as a ratio of the amount of analyte-binding particles in the sample capture zone and the amount of analyte-binding particles in the control capture zone. In a nullcompetitive assaynull embodiment, the membrane has an application point, a contact region comprising analyte-coated particles, a sample capture zone, and a control capture zone, where the contact region is between the application point and the sample capture zone, and the sample capture zone is between the contact region and the control capture zone. In this nullcompetitive assaynull embodiment, the amount of analyte in the fluid sample is inversely related to a corrected analyte-coated particle amount, which can be determined, for example, as a ratio of the amount of analyte-coated particles in the sample capture zone and the amount of analyte-coated particles in the control capture zone.

Abstract translation: 公开了用于定量测量流体样品中目标分析物的量的方法。 所述方法包括提供具有施加点的膜，包含分析物结合颗粒的接触区域，样品捕获区域和对照捕获区域，其中接触区域在施加点和样品捕获区域之间，并且样品捕获 区域在接触区域和控制捕获区之间。 在测定中，流体允许通过毛细管作用通过接触区域到达并通过样品捕获区域并随后通过控制捕获区域将测定的传输成分传输。 在“夹心测定”实施方案中，流体样品中的分析物的量与校正的分析物结合粒子量相关，其可以例如由样品捕捉中的分析物结合颗粒的量的比例确定 区域和对照捕获区域中分析物结合颗粒的量。 在“竞争性测定”实施例中，膜具有应用点，包括分析物包被的颗粒的接触区域，样品捕获区域和控制捕获区域，其中接触区域在施加点和样品捕获区域之间， 并且样品捕获区位于接触区域和控制捕获区之间。 在该“竞争性测定”实施方案中，流体样品中的分析物的量与校正的分析物涂覆的颗粒量成反比，其可以例如确定为样品中分析物包被的颗粒的量的比例 捕获区域和对照捕获区域中分析物包被的颗粒的量。

公开(公告)号：US20040171002A1

公开(公告)日：2004-09-02

申请号：US10474284

申请日：2004-04-22

Inventor： Gert Desmet ,  Gino Baron

IPC: C12Q001/68 ,  G01N033/558

CPC classification number: B01F5/061 ,  B01F11/0042 ,  B01F11/0048 ,  B01F13/0059 ,  B01F15/00824 ,  B01F2005/0621 ,  B01F2005/0636 ,  B01L3/502746 ,  B01L2200/0673 ,  B01L2300/0636 ,  B01L2300/0803 ,  B01L2300/0812 ,  B01L2300/1827 ,  B01L2400/0475 ,  B01L2400/086 ,  G01N30/38 ,  G01N30/6095 ,  G01N30/92 ,  G01N35/00069 ,  G01N2030/326

Abstract: The present invention relates to a device for the simultaneous conduction of a multiplicity of binding reactions on a substrate with a first surface, said surface comprising discrete and isolated locations of one such binding reaction, said binding reaction being generated upon contact between the substrate and a fluidic sample comprising one or more target molecules capable of binding with at least one receptor molecule at least partly tethered to said first surface of the substrate, and further comprising means for enhancing the diffusion fluidic flow of the sample over the substrate, whereby said means for enhancing the diffusion fluidic flow comprises shear-force field generating means, whereby said means comprise a second surface positioned in a flow interacting manner in said flow channel, said second surface is able to be moved in a substantial parallel mode over the first surface. The invention further relates to a method for binding one or more target molecules comprised within a fluid sample to at least one receptor molecule at least partly tethered to a first surface in a flow channel, wherein said target molecules are transported parallel to said first surface by means of shear-force field generating means, wherein the shear-force field generating means comprises a second surface, which second surface is moved in a substantially parallel mode past or over said first surface.

Abstract translation: 本发明涉及一种用于在衬底上同时传导多个结合反应的装置，其具有第一表面，所述表面包含一个这样的结合反应的离散和分离的位置，所述结合反应是在基底和 流体样品包含一种或多种能够与至少部分连接至衬底的第一表面的受体分子结合的靶分子，并且还包括用于增强样品在衬底上的扩散流体流动的装置，由此所述用于 增强扩散流体流包括剪切力场产生装置，由此所述装置包括以流动相互作用的方式定位在所述流动通道中的第二表面，所述第二表面能够以基本平行模式移动到第一表面上。 本发明还涉及将包含在流体样品内的一种或多种目标分子与至少一种至少部分连接在流动通道中的第一表面的受体分子结合的方法，其中所述靶分子通过 剪切力场产生装置的装置，其中剪切力场产生装置包括第二表面，该第二表面以基本上平行的模式移动经过或超过所述第一表面。

公开(公告)号：US20040161859A1

公开(公告)日：2004-08-19

申请号：US10775274

申请日：2004-02-10

Inventor： Huiyan Guo ,  Min Wang ,  Tao Shang ,  Hui-Kang Chen ,  Fei Gao

IPC: G01N033/558

CPC classification number: G01N33/521 ,  Y10S436/808 ,  Y10S436/81

Abstract: Rapid lateral flow immunoassays have an extensive history of use in both the clinical and home settings. These devices are used to test for a variety of analytes, such as drugs of abuse, hormones, proteins, urine or plasma components and the like. The present invention provides an improved procedural control that indicates to the test user that at least a portion of the applied sample has passed through the test result zone of the test strip, and optionally that the test is complete and the test results may be read.

Abstract translation: 快速侧流免疫测定在临床和家庭环境中具有广泛的应用历史。 这些装置用于测试各种分析物，例如滥用药物，激素，蛋白质，尿液或血浆成分等。 本发明提供了一种改进的程序控制，其向测试用户指示所应用样品的至少一部分已经通过测试条的测试结果区域，并且可选地，测试完成并且可以读取测试结果。

公开(公告)号：US20040161858A1

公开(公告)日：2004-08-19

申请号：US10632929

申请日：2003-08-04

Applicant: Yeda Research and Development Co., Ltd.

Inventor： David Wallach ,  Jacek Bigda ,  Igor Beletsky ,  Igor Mett ,  Hartmut Engelmann

IPC: G01N033/558

CPC classification number: C07K16/2866 ,  A61K38/00 ,  C07K14/7151 ,  C07K2319/00 ,  Y02A50/412

Abstract: Antibodies to tumor necrosis factor receptors (TNF-Rs) are disclosed together with methods of producing them and methods of use of such antibodies in immunoassays and purification of TBP-II by affinity chromatography. A diagnostic assay for endogenous antibodies to TBP-II is also disclosed.

Abstract translation: 公开了肿瘤坏死因子受体（TNF-Rs）的抗体及其制备方法以及免疫测定中使用此类抗体的方法，并通过亲和层析纯化TBP-II。 还公开了对TBP-II的内源性抗体的诊断测定。

公开(公告)号：US20040115833A1

公开(公告)日：2004-06-17

申请号：US10720532

申请日：2003-11-24

Applicant: Genset, S.A.

Inventor： Jan Sudor

IPC: C12Q001/68 ,  G01N033/558

CPC classification number: G01N33/54393

Abstract: The invention provides methods for the treatment of surfaces using surface adsorbing polymers, methods for decreasing the adsorption of organic materials onto the surface of treated devices or vessels, methods for performing fluid operations involving the treatment of surfaces, and apparatus and systems comprising the treated surfaces. Further, the present invention provides a method for treating the surface of microfluidics channel wherein the microfluidics surface is coated for deactivation and wherein this coating can be easily regenerated. The present invention also provides a method for treating the surface of a plastic device. The surface adsorbing polymers of the invention are particularly stable at temperatures and conditions required for biochemical reactions, especially in applications involving temperature cycling or polymerization of polynucleotides or polypeptides.

公开(公告)号：US20040063218A1

公开(公告)日：2004-04-01

申请号：US10433975

申请日：2003-10-14

Inventor： Frederic Buffiere ,  Christine Betremieux ,  Jean Alain Chevaleyre ,  Laetitia Gaillard ,  Sandie Menard ,  Gerard Ovlaque ,  Vinzia Christophe

IPC: G01N033/558 ,  C12M001/34

CPC classification number: G01N33/80 ,  G01N33/54393

Abstract: The invention concerns a biological assay device using a reaction between an analyte present in a fluid and a reagent capable of forming a complex with said analyte, wherein the analyte is in the form of cellular elements, said device comprising at least a reaction container (1) provided with a reaction zone (2) wherein are introduced the fluid and the reagent, and with an immobilizing zone (3) whereon is fixed a substance (4) capable of specifically binding with the possibly formed complexes, the reaction zone (2) and the immobilizing zone (3) being separated from each other by a material layer (8), said material being capable of shifting from one first state wherein the layer (8) is substantially impermeable to a second state wherein the layer (8) is capable of allowing through the cellular elements, whether complexed or not.

Abstract translation: 本发明涉及使用流体中存在的分析物和能够与所述分析物形成复合物的试剂之间的反应的生物测定装置，其中所述分析物是细胞元件的形式，所述装置至少包括反应容器（1 ），其中引入流体和试剂，并且固定区（3）固定有能够与可能形成的络合物特异性结合的物质（4），反应区（2） 并且所述固定区域（3）通过材料层（8）彼此分离，所述材料能够从所述层（8）基本上不可渗透的第一状态转移到所述层（8）为 能够通过细胞元件，无论是否复杂。

公开(公告)号：US20040043511A1

公开(公告)日：2004-03-04

申请号：US10228836

申请日：2002-08-27

Applicant: Kimberly-Clark Worldwide, Inc.

Inventor： Xuedong Song ,  Rosann Kaylor

IPC: G01N033/558

CPC classification number: G01N33/54326 ,  G01N21/274 ,  G01N21/6408 ,  G01N33/525 ,  G01N33/558 ,  G01N33/582 ,  G01N2021/6439 ,  Y10S435/803 ,  Y10S435/805 ,  Y10S435/97 ,  Y10S436/80 ,  Y10S436/806 ,  Y10S436/824 ,  Y10T436/13

Abstract: A membrane-based assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes a self-calibrated magnetic binding assay format (e.g., sandwich, competitive, etc.) that includes detection probes capable of generating a detection signal (e.g., fluorescent non-magnetic particles) and calibration probes capable of generating a calibration signal (e.g., fluorescent magnetic particles). The amount of the analyte within the test sample is proportional (e.g., directly or inversely) to the intensity of the detection signal calibrated by the intensity of the calibration signal. It has been discovered that the fluidics-based device of the present invention provides an accurate, inexpensive, and readily controllable method of determining the presence of an analyte in a test sample.

Abstract translation: 提供了一种用于检测驻留在测试样品中的分析物的存在或数量的基于膜的测定装置。 该装置使用包括能够产生检测信号的检测探针（例如，荧光非磁性颗粒）和能够产生校准信号的校准探针的自校准磁结合测定格式（例如，夹层，竞争性等） 例如荧光磁性颗粒）。 测试样品内的分析物的量与由校准信号的强度校准的检测信号的强度成正比（例如，直接或反向）。 已经发现，本发明的基于流体的装置提供了确定测试样品中分析物的存在的精确，便宜且易于控制的方法。

公开(公告)号：US20040018637A1

公开(公告)日：2004-01-29

申请号：US10393670

申请日：2003-03-19

Inventor： Alan J. Polito ,  Richard M. Thayer ,  Robert K. DiNello ,  George H. Sierra ,  Dennis Nixon ,  Alan Phillips ,  Stuart Neubarth

IPC: G01N033/558

CPC classification number: G01N27/227 ,  B01L3/5023 ,  G01N33/4875 ,  G01N33/54386 ,  G01N33/54393 ,  G01N33/558 ,  Y10S436/806 ,  Y10S436/807 ,  Y10T436/114998

Abstract: An embodiment of the present invention provides a method for performing a lateral flow assay. The method includes depositing a sample on a test strip at an application region, detecting a first detection signal arising from the test strip in the first detection zone, and generating a baseline for the first measurement zone by interpolating between values of the detection signal outside of the first measurement zone and inside of the first detection zone. The method may include locating a beginning boundary and an ending boundary for the first measurement zone on the test strip. Additional detection zones having measurement zones may also be incorporated with the embodiment.

Abstract translation: 本发明的一个实施方案提供了一种用于进行侧流测定的方法。 该方法包括将样品沉积在应用区域的测试条上，检测在第一检测区域中由测试条产生的第一检测信号，以及通过在第一检测区域之外的检测信号的值之间进行内插来生成第一测量区域的基线 第一测量区域和第一检测区域内部。 该方法可以包括在测试条上定位用于第一测量区域的开始边界和结束边界。 具有测量区域的附加检测区域也可以结合实施例。