公开(公告)号：US09377457B1

公开(公告)日：2016-06-28

申请号：US14887179

申请日：2015-10-19

Applicant: Naishu Wang ,  David F. Zhou

Inventor： Naishu Wang ,  David F. Zhou

IPC: G01N21/75 ,  G01N33/543 ,  G01N21/78 ,  G01N33/558 ,  G01N21/77

CPC classification number: G01N33/54386 ,  G01N21/78 ,  G01N21/8483 ,  G01N33/558 ,  G01N33/56983 ,  G01N2021/7759

Abstract: A cartridge and method for conducting a labeled molecular affinity binding test such as antibody/antigen, ligand/receptor, and colorometric reactions, and other chemical reactions for which one or more analytes is present in a liquid sample formate. A progressive compression structure progressively forces a liquid flow out of a conjugate pad toward a reaction region to more thoroughly and rapidly mix the liquid, encouraging specific first affinity binding to the analytes in question. A specially dimensioned constricting passageway surrounding the reaction region including the result zones provides an additional siphoning force to the flow. These combined forces rapidly and more evenly guide the flow of liquid through the reaction region so that the rushed rate of uptake of analytes at the strip lines are more evenly distributed, adhesive attachment of non-specific molecules is largely avoided, vastly improving sensitivity and specificity, and providing quantitative results in some tests.

Abstract translation: 用于进行标记的分子亲和力结合试验例如抗体/抗原，配体/受体和着色反应的药筒和方法以及其中一种或多种分析物存在于液体样品甲酸盐中的其它化学反应。 渐进的压缩结构逐渐迫使液体流出共轭垫朝向反应区域，以更彻底和快速地混合液体，鼓励与所讨论的分析物的特异性第一亲和力结合。 围绕包括结果区域的反应区域的特别尺寸的收缩通道向流动提供额外的虹吸力。 这些组合力迅速且均匀地引导液体流过反应区域，使得剥离线处的分析物的冲洗速率更均匀分布，很大程度上避免了非特异性分子的粘附性附着，大大提高了敏感性和特异性 ，并在一些测试中提供定量结果。

公开(公告)号：US07655184B2

公开(公告)日：2010-02-02

申请号：US11738356

申请日：2007-04-20

Applicant: Naishu Wang ,  David F. Zhou

Inventor： Naishu Wang ,  David F. Zhou

IPC: G01N21/00 ,  G01N15/06 ,  G01N33/53 ,  B01L3/00 ,  B01L1/00 ,  B32B5/02 ,  C12Q1/00 ,  C12M1/36 ,  C12M3/00 ,  C12M1/34

CPC classification number: G01N33/5302 ,  B01L3/5023 ,  B01L3/502746 ,  B01L2200/0621 ,  B01L2300/0672 ,  B01L2300/0825 ,  B01L2300/0867 ,  B01L2400/0406 ,  B01L2400/084 ,  G01N33/558

Abstract: A self-contained apparatus using a gravitationally encouraged, interrupted, downward, diffusive and programmed flow of fluid to provide for rapid confirmatory immunological testing (“RCIT”) in, for example, a clinical, point-of-care setting. A fluid specimen such as blood, saliva or urine is deposited into a first chamber carrying a source of conjugate having mobilizable binding members such as immunographic antigens or antibodies specific to the condition being tested conjugated to a detectable label such as colloidal gold. The specimen is premixed with a first measured, reactive mix buffer solution carried within an openable tank. The specimen and solution are temporarily held within an incubation reservoir formed behind a dam made from porous, diffusive material. The delay and flow through the diffusive dam causes mixing of the specimen and solution to form a premixture which exhibits a more uniformly high degree of first affinity binding before flowing out of the first chamber toward one or more chromatographic test strips in a second chamber. In one embodiment, after a waiting period, a bladder containing a stop-wash buffer solution is opened to flow onto the strips. Additional embodiments provide one or more diffusive structures that can be pretreated with mixture enhancing chemicals such as surfactants. It is a rapid confirmatory immunological test apparatus having an analytical panel which can provide profile diagnostic results.

Abstract translation: 使用重力鼓励，中断，向下，扩散和编程的流体流的独立装置，用于在例如临床，护理点设置中提供快速确认免疫测试（“RCIT”）。 流体样品如血液，唾液或尿液沉积在携带具有可移动结合成员的缀合物源的第一室中，例如免疫印迹抗原或被检测条件特异的抗体与可检测标记如胶体金缀合。 样品与携带在可开罐内的第一测量的反应性混合缓冲溶液预混合。 试样和溶液临时保存在形成在由多孔扩散材料制成的坝后面的孵化池中。 通过扩散坝的延迟和流动导致样品和溶液的混合以形成预混合物，其在从第一室流出到第二室中的一个或多个色谱测试条之前，呈现出更均匀的高度的第一亲和力结合。 在一个实施例中，在等待时间之后，打开包含停止洗涤缓冲溶液的气囊以流动到条上。 另外的实施方案提供一种或多种可以用混合物增强化学物质例如表面活性剂预处理的扩散结构。 它是具有能够提供轮廓诊断结果的分析面板的快速确认性免疫测试装置。

公开(公告)号：USD477669S1

公开(公告)日：2003-07-22

申请号：US29164582

申请日：2002-08-20

Applicant: David F. Zhou ,  Naishu Wang ,  Claudia J. R. Shen ,  Angela J. Q. Shen

Designer： David F. Zhou ,  Naishu Wang ,  Claudia J. R. Shen ,  Angela J. Q. Shen

公开(公告)号：US20170108498A1

公开(公告)日：2017-04-20

申请号：US15188859

申请日：2016-06-21

Applicant: Naishu Wang ,  David F. Zhou

Inventor： Naishu Wang ,  David F. Zhou

IPC: G01N33/543 ,  G01N33/569

CPC classification number: G01N33/54386 ,  G01N21/78 ,  G01N21/8483 ,  G01N33/558 ,  G01N33/56983 ,  G01N2021/7759

Abstract: A cartridge and method for conducting a labeled molecular affinity binding test such as antibody/antigen, ligand/receptor, and colorometric reactions, and other chemical reactions for which one or more analytes is present in a liquid sample formate. A progressive compression structure progressively forces a liquid flow out of a conjugate pad toward a reaction region to more thoroughly and rapidly mix the liquid, encouraging specific first affinity binding to the analytes in question. A specially dimensioned constricting passageway surrounding the reaction region including the result zones provides an additional siphoning force to the flow. These combined forces rapidly and more evenly guide the flow of liquid through the reaction region so that the rushed rate of uptake of analytes at the strip lines are more evenly distributed, adhesive attachment of non-specific molecules is largely avoided, vastly improving sensitivity and specificity, and providing quantitative results in some tests.

公开(公告)号：US07638093B2

公开(公告)日：2009-12-29

申请号：US11090463

申请日：2005-03-25

Applicant: Naishu Wang ,  David F. Zhou

Inventor： Naishu Wang ,  David F. Zhou

IPC: G01N21/05 ,  G01N33/53 ,  B01L3/00 ,  C12M1/34

CPC classification number: B01L3/5023 ,  B01L3/502746 ,  B01L2200/0621 ,  B01L2300/0672 ,  B01L2300/0825 ,  B01L2300/0867 ,  B01L2400/0406 ,  B01L2400/084

Abstract: A self-contained device using a gravitationally encouraged, interrupted downward and programmed flow of fluid to provide for rapid confirmatory immunological testing (“RCIT”) in a point-of-care setting. A fluid specimen such as blood, saliva or urine is deposited into a first chamber carrying a colloidal conjugate of antigens or antibodies pathogenically specific to the condition being tested and premixed with a first measured, reactive mix buffer solution carried within an openable tank. Alternately, the buffer solution is preformulated to carry the colloidal conjugate in suspension. The premixture flows out of the first chamber toward chromatographic test strips having a single layer of uniformly dispersed porous matrix material such as polyethylene and inclined in a downward flow orientation. The flow is interrupted by a holding reservoir which is drained by siphoning, gravity and capillary forces. The delayed and regulated flow provides an incubation time for a better affinity binding of the specimen. In one embodiment, after a waiting period a bladder containing a stop-wash buffer solution is opened to flow into the reservoir and onto the strips. An absorbant pad collects excess fluid at the bottom end of the strips. It is a rapid confirmatory immunological test device having an analytical panel which can provide profile diagnostic results.

Abstract translation: 一个独立的设备，使用重力鼓励，中断向下和编程的流体流动，以便在一个护理环境中提供快速确认的免疫测试（“RCIT”）。 流体样品如血液，唾液或尿液沉积在携带抗原或抗体的胶体缀合物的第一室中，所述抗体或抗体对所测试的病症具有特异性特异性，并与携带在可开启罐内的第一测量的反应性混合缓冲溶液预混合。 或者，预先配制缓冲溶液以携带悬浮液中的胶体缀合物。 预混合物从第一室流出到具有单层均匀分散的多孔基体材料如聚乙烯并且以向下流动方向倾斜的色谱测试条。 流动被一个通过虹吸，重力和毛细管力排出的保持储存器中断。 延迟和调节的流动提供了孵育时间以更好地亲和地结合样品。 在一个实施方案中，在等待期之后，打开包含停止洗涤缓冲溶液的气囊以流入储存器和条上。 吸收垫在条的底端收集多余的流体。 它是一种具有可提供轮廓诊断结果的分析面板的快速确证免疫测试装置。

公开(公告)号：US08021625B2

公开(公告)日：2011-09-20

申请号：US11881455

申请日：2007-07-27

Applicant: Naishu Wang ,  David F. Zhou

Inventor： Naishu Wang ,  David F. Zhou

IPC: G01N31/22

CPC classification number: G01N33/54386 ,  G01N33/536 ,  G01N33/558 ,  Y10T436/117497 ,  Y10T436/118339 ,  Y10T436/119163 ,  Y10T436/2575

Abstract: A device and method for enhancing rapid confirmatory immunological testing (“RCIT”) in chromatography strip-type rapid IVD devices useful in, for example, clinical, point-of-care, laboratory or over-the-counter settings. The device drives a flow fluid, primarily under the force of gravity alone, through a first chamber having a porous dam structure to enhance and substantially complete the first affinity binding reaction between a source of mobilizable labeled binding members and an analyte in the fluid. Flow through the dam causes a delay, mixing and trapping of the typically chemically disuniform initial fluid front so that fluid exiting the dam exhibits a more uniformly high degree of first affinity binding and decreased non-affinity binding. Afterward, and without further human interaction, the fluid then flows under the combined, turbulence creating forces of gravity, siphoning, and capillarity, through a second chamber containing a chromatographic strip which captures the labeled analytes in a second affinity binding reaction. By separating the two affinity binding reactions, competition for analytes during each reaction is reduced, and thus accuracy improved.

Abstract translation: 用于例如在临床，护理点，实验室或非处方设置中有用的色谱条带型快速IVD装置中的快速确认免疫测试（“RCIT”）的装置和方法。 该装置主要在重力作用下驱动流体流体通过具有多孔坝结构的第一室，以增强并基本上完成可移动标记的结合构件的源和流体中的分析物之间的第一亲和结合反应。 通过大坝的流动导致典型的化学不均匀初始流体前沿的延迟，混合和捕获，使得离开坝的流体表现出更均匀的高度的第一亲和力结合和减少的非亲和力结合。 之后，并且在没有进一步的人类相互作用的情况下，流体在组合的湍流之下通过包含在第二亲和力结合反应中捕获标记分析物的色谱条的第二室产生重力，虹吸和毛细作用力。 通过分离两种亲和力结合反应，减少了每次反应期间对分析物的竞争，从而提高了精确度。

公开(公告)号：USD626249S1

公开(公告)日：2010-10-26

申请号：US29340604

申请日：2009-07-21

Applicant: Naishu Wang ,  David F. Zhou ,  Wei Jin

Designer： Naishu Wang ,  David F. Zhou ,  Wei Jin

公开(公告)号：US07238322B2

公开(公告)日：2007-07-03

申请号：US11258636

申请日：2005-10-26

Applicant: Naishu Wang ,  David F. Zhou

Inventor： Naishu Wang ,  David F. Zhou

IPC: G01N21/00 ,  G01N15/06 ,  G01N33/53 ,  B01L3/00 ,  B01L11/00 ,  B32B5/02 ,  C12Q1/00 ,  C12M1/36 ,  C12M3/00 ,  C12M1/34

CPC classification number: G01N33/5302 ,  B01L3/5023 ,  B01L3/502746 ,  B01L2200/0621 ,  B01L2300/0672 ,  B01L2300/0825 ,  B01L2300/0867 ,  B01L2400/0406 ,  B01L2400/084 ,  G01N33/558

Abstract: A self-contained apparatus using a gravitationally encouraged, interrupted, downward, diffusive and programmed flow of fluid to provide for rapid confirmatory immunological testing (“RCIT”) in, for example, a clinical, point-of-care setting. A fluid specimen such as blood, saliva or urine is deposited into a first chamber carrying a source of conjugate having mobilizable binding members such as immunographic antigens or antibodies specific to the condition being tested conjugated to a detectable label such as colloidal gold. The specimen is premixed with a first measured, reactive mix buffer solution carried within an openable tank. The specimen and solution are temporarily held within an incubation reservoir formed behind a dam made from porous, diffusive material. The delay and flow through the diffusive dam causes mixing of the specimen and solution to form a premixture which exhibits a more uniformly high degree of first affinity binding before flowing out of the first chamber toward one or more chromatographic test strips in a second chamber. In one embodiment, after a waiting period, a bladder containing a stop-wash buffer solution is opened to flow onto the strips. Additional embodiments provide one or more diffusive structures that can be pretreated with mixture enhancing chemicals such as surfactants. It is a rapid confirmatory immunological test apparatus having an analytical panel which can provide profile diagnostic results.

Abstract translation: 使用重力鼓励，中断，向下，扩散和编程的流体流的独立装置，用于在例如临床，护理点设置中提供快速确认免疫测试（“RCIT”）。 流体样品如血液，唾液或尿液沉积在携带具有可移动结合成员的缀合物源的第一室中，例如免疫印迹抗原或被检测条件特异的抗体与可检测标记如胶体金缀合。 样品与携带在可开罐内的第一测量的反应性混合缓冲溶液预混合。 试样和溶液临时保存在形成在由多孔扩散材料制成的坝后面的孵化池中。 通过扩散坝的延迟和流动导致样品和溶液的混合以形成预混合物，其在从第一室流出到第二室中的一个或多个色谱测试条之前，呈现出更均匀的高度的第一亲和力结合。 在一个实施例中，在等待时间之后，打开包含停止洗涤缓冲溶液的气囊以流动到条上。 另外的实施方案提供一种或多种可以用混合物增强化学物质例如表面活性剂预处理的扩散结构。 它是具有能够提供轮廓诊断结果的分析面板的快速确认性免疫测试装置。

公开(公告)号：US20070269906A1

公开(公告)日：2007-11-22

申请号：US11881455

申请日：2007-07-27

Applicant: Naishu Wang ,  David Zhou

Inventor： Naishu Wang ,  David Zhou

IPC: G01N33/536 ,  G01N33/00

CPC classification number: G01N33/54386 ,  G01N33/536 ,  G01N33/558 ,  Y10T436/117497 ,  Y10T436/118339 ,  Y10T436/119163 ,  Y10T436/2575

Abstract: A device and method for enhancing rapid confirmatory immunological testing (“RCIT”) in chromatography strip-type rapid IVD devices useful in, for example, clinical, point-of-care, laboratory or over-the-counter settings. The device drives a flow fluid, primarily under the force of gravity alone, through a first chamber having a porous dam structure to enhance and substantially complete the first affinity binding reaction between a source of mobilizable labeled binding members and an analyte in the fluid. Flow through the dam causes a delay, mixing and trapping of the typically chemically disuniform initial fluid front so that fluid exiting the dam exhibits a more uniformly high degree of first affinity binding and decreased non-affinity binding. Afterward, and without further human interaction, the fluid then flows under the combined, turbulence creating forces of gravity, siphoning, and capillarity, through a second chamber containing a chromatographic strip which captures the labeled analytes in a second affinity binding reaction. By separating the two affinity binding reactions, competition for analytes during each reaction is reduced, and thus accuracy improved.

Abstract translation: 用于例如在临床，护理点，实验室或非处方设置中有用的色谱条带型快速IVD装置中的快速确认免疫测试（“RCIT”）的装置和方法。 该装置主要在重力作用下驱动流体流体通过具有多孔坝结构的第一室，以增强并基本上完成可移动标记的结合构件的源和流体中的分析物之间的第一亲和结合反应。 通过大坝的流动导致典型的化学不均匀初始流体前沿的延迟，混合和捕获，使得离开坝的流体表现出更均匀的高度的第一亲和力结合和减少的非亲和力结合。 之后，并且在没有进一步的人类相互作用的情况下，流体在组合的湍流之下通过包含在第二亲和力结合反应中捕获标记分析物的色谱条的第二室产生重力，虹吸和毛细作用力。 通过分离两种亲和力结合反应，减少了每次反应期间对分析物的竞争，从而提高了精确度。

公开(公告)号：US20060292700A1

公开(公告)日：2006-12-28

申请号：US11158547

申请日：2005-06-22

Applicant: Naishu Wang ,  David Zhou

Inventor： Naishu Wang ,  David Zhou

IPC: G01N33/558

CPC classification number: G01N33/558 ,  G01N33/54386

Abstract: A lateral flow chromatographic immunoassay rapid test device having an additional interrupting, porous, diffusive pad pretreated with a surfactant interposed between the conjugate pad and the reaction membrane. The diffusive pad causes improved mixing of the fluid to provide a more mixture of molecules in the fluid and a more uniformly dispersed fluid flow having a more uniformly high degree of first affinity binding and a more even fluid front to cross into the reaction membrane, thereby increasing the sensitivity and specificity of the second affinity binding at both test and control lines, and thereby providing an important advancement of the existing lateral flow rapid test technology.

Abstract translation: 一种侧流色谱免疫测定快速测试装置，其具有预先用表面活性剂预处理的另外的中断，多孔扩散垫，所述表面活性剂插入在所述共轭垫和所述反应膜之间。 扩散垫引起改善的流体混合以在流体中提供更多的分子混合物，以及更均匀地分散的流体流，其具有更均匀的高度的第一亲和力结合和更均匀的流体前沿以穿过反应膜，由此 增加了测试和对照线上第二亲和力结合的灵敏度和特异性，从而提供了现有侧流快速测试技术的重要进步。