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    • 1. 发明申请
    • METERING TECHNIQUE FOR LATERAL FLOW ASSAY DEVICES
    • 侧流测量装置的测量技术
    • WO2006118622A1
    • 2006-11-09
    • PCT/US2006/002251
    • 2006-01-19
    • KIMBERLY-CLARK WORLDWIDE, INC.YANG, KaiyuanWEI, NingFEASTER, Shawn, Ray
    • YANG, KaiyuanWEI, NingFEASTER, Shawn, Ray
    • G01N33/543A61K39/00
    • G01N33/558G01N33/54366
    • A diagnostic test kit for detecting an analyte residing in a test sample is provided. The kit employs a lateral flow device that contains a membrane. A metering channel is formed in the membrane that is capable of delivering a controlled volume of the test sample to a detection zone upon initiation of the assay. Such a metering channel is particularly effective for embodiments in which the test sample has a relatively low volume, such as less than about 100 microliters, in some embodiments less than about 25 microliters, and in some embodiments, less than about 10 microliters. For example, whole blood drops obtained from patients with a lancet from low-pain areas (due to reduced nerve endings than finger), such as the forearm, thigh, or other alternate sites, may have a volume of from about 0.1 to about 5 microliters. Despite their low volume, the present inventors have discovered that the blood drops may still be accurately analyzed for the presence of an analyte using lateral flow detection techniques.
    • 提供了用于检测驻留在测试样品中的分析物的诊断测试试剂盒。 该套件采用包含膜的侧向流动装置。 在膜中形成计量通道,其能够在测定开始时将受控体积的测试样品输送到检测区。 这样的计量通道对于其中测试样品具有相对较低的体积,例如小于约100微升,在一些实施方案中小于约25微升,并且在一些实施方案中小于约10微升的实施方案是特别有效的。 例如,从患有低疼痛区域的刺血针(由于神经末梢比手指减少)的患者(例如前臂,大腿或其他替代部位)获得的全血滴可具有约0.1至约5的体积 微升。 尽管本发明人的体积小,但是本发明人已经发现,使用侧流检测技术仍然可以精确地分析血液滴定分析物的存在。
    • 5. 发明申请
    • MICROFLUIDIC ASSAY DEVICES
    • 微流感测定装置
    • WO2006071307A1
    • 2006-07-06
    • PCT/US2005/034168
    • 2005-09-23
    • KIMBERLY-CLARK WORLDWIDE, INC.COHEN, David, SamuelFEASTER, Shawn, Ray
    • COHEN, David, SamuelFEASTER, Shawn, Ray
    • B01L3/00
    • B01L3/502746B01L2300/069B01L2300/0803B01L2300/0816B01L2300/0864B01L2400/0406
    • A microfluidic assay device for determining the presence or absence of an analyte within a fluid test sample is provided. The present invention provides a technique for achieving continuous flow in a microfluidic device by using at least one input channel, an analysis zone, and a plurality of wicking channels disposed about the perimeter of the analysis zone. In one embodiment, for example, the wicking channels extend radially from the analysis zone. As a result of the particular configuration of the microfluidic device, an assay may performed in a "single step" without the need for active forces, such as a pressure source, electrokinetic force, etc., to induce flow of the fluid test sample through the device. Likewise, flow rate is controlled so that the dwell time of the fluid test sample within the analysis zone is long enough to allow for the desired reactions and/or detection.
    • 提供了用于确定流体测试样品中分析物的存在或不存在的微流控测定装置。 本发明提供了一种通过使用至少一个输入通道,分析区和围绕分析区的周边设置的多个芯吸通道来实现微流体装置中的连续流动的技术。 在一个实施例中,例如,芯吸通道从分析区域径向延伸。 作为微流体装置的特定构造的结果,可以以“单步”进行测定,而不需要诸如压力源,电动力等的主动力来引起流体测试样品通过的流动 装置。 同样地,控制流速,使得分析区内的流体测试样品的停留时间足够长以允许所需的反应和/或检测。
    • 6. 发明申请
    • SAMPLE-EFFICIENT LATERAL FLOW IMMUNOASSAY
    • 样本效率的横向流动免疫
    • WO2006065314A1
    • 2006-06-22
    • PCT/US2005/034653
    • 2005-09-28
    • KIMBERLY-CLARK WORLDWIDE, INC.KAYLOR, Rosann, MarieWEI, NingCHIDEBELU-EZE, ChibuezeFEASTER, Shawn, RayCHRISTOPHER, Paul
    • KAYLOR, Rosann, MarieWEI, NingCHIDEBELU-EZE, ChibuezeFEASTER, Shawn, RayCHRISTOPHER, Paul
    • G01N33/543
    • G01N33/558
    • There is provided a lateral flow assay device for detecting the presence or quantity of an analyte residing in a test sample where the lateral flow assay device has a porous membrane in communication with a conjugate pad and a wicking pad. The porous membrane has a detection zone which has an immobilized first capture reagent configured to bind to at least a portion of the analyte and analyte-conjugate complexes to generate a detection signal. A control zone may be located downstream from the detection zone on the porous membrane and has a second capture reagent immobilized within the control zone. The conjugate pad is located upstream from the detection zone, and has detection probes with specific binding members for the analyte. The sample is deposited between the control and detection zones. A buffer release zone is located upstream of the conjugate pad and provides for buffer addition to the device, the buffer serving to move the detection probes to the detection and control zones.
    • 提供了一种侧流测定装置,用于检测驻留在测试样品中的分析物的存在或数量,其中侧流测定装置具有与缀合垫和芯吸垫连通的多孔膜。 多孔膜具有检测区,其具有被配置为结合至少一部分分析物和分析物 - 共轭复合物的固定的第一捕获试剂以产生检测信号。 控制区可以位于多孔膜上的检测区的下游,并且具有固定在控制区内的第二捕获试剂。 缀合垫位于检测区的上游,并具有用于分析物的具有特异性结合构件的检测探针。 样品沉积在控制区和检测区之间。 缓冲区释放区位于缀合垫的上游,并为缓冲器添加缓冲区,该缓冲器用于将检测探针移动到检测和控制区。
    • 7. 发明申请
    • FLOW CONTROL TECHNIQUE FOR ASSAY DEVICES
    • 流量控制技术用于测试装置
    • WO2006118707A2
    • 2006-11-09
    • PCT/US2006011190
    • 2006-03-27
    • KIMBERLY CLARK COFEASTER SHAWN RAYYANG KAIYUAN
    • FEASTER SHAWN RAYYANG KAIYUAN
    • G03B42/02G01T1/29G03B42/04G06F19/00H05G1/02
    • G01N33/558G01N33/52
    • A method for controlling fluid flow in an assay device that employs a membrane is provided. Specifically, one or more recessed regions are formed in the membrane by applying a solvent treatment thereto. The solvent treatment is selected based on its particular dissolving capacity for the material used to form the membrane. For example, an alcohol-based solvent, such as methanol, may be used as a solvent for nitrocellulose membranes. Upon contact with the solvent treatment, a recessed region is formed that may serve a variety of different functions relating to flow control. In one particular embodiment, the recessed region may function as a metering channel that is capable of delivering a controlled volume of the test sample to a detection zone upon initiation of the assay.
    • 提供了一种用于控制采用膜的测定装置中的流体流动的方法。 具体地,通过对膜进行溶剂处理,在膜中形成一个或多个凹陷区域。 基于其用于形成膜的材料的特定溶解能力来选择溶剂处理。 例如,醇类溶剂如甲醇可用作硝酸纤维素膜的溶剂。 在与溶剂处理接触时,形成可以用于与流量控制有关的各种不同功能的凹陷区域。 在一个具体实施方案中,凹陷区域可用作计量通道,其能够在测定开始时将受控体积的测试样品递送到检测区域。