公开(公告)号：US20060205087A1

公开(公告)日：2006-09-14

申请号：US11079730

申请日：2005-03-14

申请人： Shawn Feaster ,  Kaiyuan Yang

发明人： Shawn Feaster ,  Kaiyuan Yang

IPC分类号： G01N33/558

CPC分类号： G01N33/558 ,  G01N33/583 ,  Y10S435/805 ,  Y10S435/81 ,  Y10S435/97 ,  Y10S436/805 ,  Y10S436/81

摘要： 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 wicking pad. The porous membrane has a detection zone which has a chromophore configured to chemically react with an analyte or a secondary trigger or a reaction product from the analyte and a trigger generating reagent(s), to generate a visually detectible signal. Additional chrmophore zones may be located downstream from the first chrmophore zone to generate signals of varying color. Scavenging zones may be included between chromophore zones to attenuate the signal by reacting with the analyte without generating a visually detectable signal.

摘要翻译： 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芯吸垫连通的多孔膜。 多孔膜具有检测区，其具有配置成与分析物或辅助触发剂或来自分析物和触发产生试剂的反应产物发生化学反应的发色团，以产生视觉上可检测的信号。 另外的chrmophore区域可以位于第一chrmophore区域的下游，以产生变化颜色的信号。 清除区域可以包括在发色团区域之间，以通过与分析物反应来衰减信号，而不产生视觉上可检测的信号。

公开(公告)号：US20080026484A1

公开(公告)日：2008-01-31

申请号：US11867788

申请日：2007-10-05

申请人： James Takeuchi ,  Xuedong Song ,  Kaiyuan Yang ,  Ning Wei ,  Shawn Feaster

发明人： James Takeuchi ,  Xuedong Song ,  Kaiyuan Yang ,  Ning Wei ,  Shawn Feaster

IPC分类号： G01N1/28 ,  G01N1/38

CPC分类号： G01N33/558 ,  Y10S436/825 ,  Y10T436/107497 ,  Y10T436/108331 ,  Y10T436/25375 ,  Y10T436/25625

摘要： A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. A sample membrane is utilized having a collection region and a detection region, the collection region having a known saturation volume for the intended test sample. A barrier is defined between the collection region and the detection region. The collection region is saturated with the test sample having a volume of less than about 100 microliters so that a known volume of the test sample is contained in the collection region. The barrier is removed from between the collection region and detection region of the membrane and a diluent is supplied to the collection region of the membrane to facilitate flow of the test sample from the collection region to the detection region of the membrane.

摘要翻译： 提供了用于检测驻留在测试样品中的分析物的诊断方法和相关测试试剂盒。 使用具有收集区域和检测区域的样品膜，所述收集区域具有用于预期测试样品的已知饱和体积。 在收集区域和检测区域之间限定屏障。 收集区域用体积小于约100微升的测试样品饱和，使得已知体积的测试样品被包含在收集区域中。 从收集区域和膜的检测区域之间移除屏障，并且将稀释剂供应到膜的收集区域，以促进测试样品从收集区域流到膜的检测区域。

公开(公告)号：US20050136500A1

公开(公告)日：2005-06-23

申请号：US10742590

申请日：2003-12-19

申请人： Kaiyuan Yang ,  RameshBabu Boga ,  Shawn Feaster ,  Rosann Marie Kaylor ,  David Cohen

发明人： Kaiyuan Yang ,  RameshBabu Boga ,  Shawn Feaster ,  Rosann Marie Kaylor ,  David Cohen

IPC分类号： G01N33/52 ,  G01N33/543 ,  G01N33/558 ,  C12Q1/54

CPC分类号： G01N33/558 ,  G01N33/52 ,  G01N33/5438

摘要： A flow-through assay device capable of detecting the presence or quantity of an analyte of interest is provided that is accurate, reliable, and easy-to-use. The device contains a substrate printed with a channel to facilitate the flow of a test sample to a detection working electrode. The detection working electrode communicates with affinity reagents, such as redox mediators and capture ligands. For instance, capture ligands that are specific binding members for the analyte of interest are applied to the detection electrode to serve as the primary location for detection of the analyte.

摘要翻译： 提供了能够检测感兴趣的分析物的存在或数量的流通测定装置，其是准确，可靠和易于使用的。 该装置包含印刷有通道以便于将测试样品流动到检测工作电极的基底。 检测工作电极与亲和试剂如氧化还原介体和捕获配体连通。 例如，将作为感兴趣的分析物的特异性结合成员的捕获配体施加到检测电极，以用作检测分析物的主要位置。

公开(公告)号：US20050131287A1

公开(公告)日：2005-06-16

申请号：US10736662

申请日：2003-12-16

申请人： Rosann Kaylor ,  RameshBabu Boga ,  Kaiyuan Yang ,  Shawn Feaster ,  Curtis Sayre ,  David Cohen ,  Ning Wei ,  Chibueze Chidebelu-Eze ,  Stephen Quirk

发明人： Rosann Kaylor ,  RameshBabu Boga ,  Kaiyuan Yang ,  Shawn Feaster ,  Curtis Sayre ,  David Cohen ,  Ning Wei ,  Chibueze Chidebelu-Eze ,  Stephen Quirk

IPC分类号： A61B5/00 ,  A61F13/15 ,  B65D81/00

CPC分类号： A61F13/84 ,  A61B5/00 ,  A61F2013/8473 ,  A61F2013/8491

摘要： The premature rupture of amniotic fluid (PROM) may be discovered through a number of inventive means. Methods of evaluating whether PROM is present include; a) through the testing of the pH of vaginal fluids using an irreversible pH test; b) through the detection of analytes (e.g. enzymes) specific to amniotic fluid in the vaginal fluids; c) though the detection of hydrogen peroxide (H2O2) in the vaginal fluid; and d) through the detection of cholesterol in vaginal fluid. While individually indicative of PROM, it is desirable to combine at least two of these techniques to yield a powerful tool of even greater reliability. Test devices and feminine hygiene pads into which the test methods may be incorporated are also included herein.

摘要翻译： 通过许多创造性手段可以发现羊水过早破裂（PROM）。 评估PROM是否存在的方法包括： a）通过使用不可逆的pH测试来测试阴道液的pH值; b）通过检测阴道液中特异于羊水的分析物（例如酶）; c）尽管在阴道液中检测过氧化氢（H 2 O 2 O 2）; 和d）通过检测阴道液中的胆固醇。 虽然单独指示PROM，但是期望将这些技术中的至少两种组合以产生更大可靠性的强大工具。 本文还包括其中可以并入测试方法的测试装置和女性卫生衬垫。

公开(公告)号：US20060246600A1

公开(公告)日：2006-11-02

申请号：US11118079

申请日：2005-04-29

申请人： Kaiyuan Yang ,  Ning Wei ,  Shawn Feaster

发明人： Kaiyuan Yang ,  Ning Wei ,  Shawn Feaster

IPC分类号： G01N33/558

CPC分类号： G01N33/558 ,  G01N33/54366

摘要： 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.

摘要翻译： 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。 这种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，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。

公开(公告)号：US20060242780A1

公开(公告)日：2006-11-02

申请号：US11118078

申请日：2005-04-29

申请人： Kaiyuan Yang ,  Jeffrey Fish ,  Shawn Feaster

发明人： Kaiyuan Yang ,  Jeffrey Fish ,  Shawn Feaster

IPC分类号： A47L13/18

CPC分类号： A47L21/04 ,  A45D34/04 ,  A45D2200/1018 ,  A45D2200/1063 ,  A46B5/04 ,  A46B2200/01 ,  A46B2200/1046 ,  A46B2200/1066 ,  A47L23/10 ,  A61F13/105 ,  A61M35/003

摘要： A finger cover, such as a finger wipe that can fit onto a human finger, is provided with an improved seam structure. The cover includes a pocket member having an open end for the insertion of a finger. The pocket member is formed by a first panel attached to a second panel along a flush outwardly facing circumferential edge seam. The seam is less than about 1 millimeter (mm) in width and about 1 mm in height. Additional reinforcing weld points may be provided at various locations along the seam.

公开(公告)号：US07314763B2

公开(公告)日：2008-01-01

申请号：US10228838

申请日：2002-08-27

申请人： Xuedong Song ,  Rosann Kaylor ,  Shawn Feaster ,  Kaiyuan Yang

发明人： Xuedong Song ,  Rosann Kaylor ,  Shawn Feaster ,  Kaiyuan Yang

IPC分类号： G01N33/553 ,  G01N31/00 ,  G01N33/31 ,  G01N33/53

CPC分类号： G01N33/54366 ,  B01L3/502761 ,  B01L2200/0668 ,  B01L2300/0825 ,  B01L2400/0406 ,  B01L2400/043 ,  B01L2400/0677 ,  G01N33/54333 ,  Y10S435/969 ,  Y10S435/97 ,  Y10T436/10

摘要： A fluidics-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.

摘要翻译： 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流体学的测定装置。 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：US20070134811A1

公开(公告)日：2007-06-14

申请号：US11301631

申请日：2005-12-13

申请人： James Takeuchi ,  Xuedong Song ,  Kaiyuan Yang ,  Ning Wei ,  Shawn Feaster

发明人： James Takeuchi ,  Xuedong Song ,  Kaiyuan Yang ,  Ning Wei ,  Shawn Feaster

IPC分类号： G01N33/558

CPC分类号： G01N33/558 ,  Y10S436/825 ,  Y10T436/107497 ,  Y10T436/108331 ,  Y10T436/25375 ,  Y10T436/25625

摘要： A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. A sample membrane is utilized having a collection region and a detection region, the collection region having a known saturation volume for the intended test sample. A barrier is defined between the collection region and the detection region. The collection region is saturated with the test sample having a volume of less than about 100 microliters so that a known volume of the test sample is contained in the collection region. The barrier is removed from between the collection region and detection region of the membrane and a diluent is supplied to the collection region of the membrane to facilitate flow of the test sample from the collection region to the detection region of the membrane.

摘要翻译： 提供了用于检测驻留在测试样品中的分析物的诊断方法和相关测试试剂盒。 使用具有收集区域和检测区域的样品膜，所述收集区域具有用于预期测试样品的已知饱和体积。 在收集区域和检测区域之间限定屏障。 收集区域用体积小于约100微升的测试样品饱和，使得已知体积的测试样品被包含在收集区域中。 从收集区域和膜的检测区域之间移除屏障，并且将稀释剂供应到膜的收集区域，以促进测试样品从收集区域流到膜的检测区域。

公开(公告)号：US20070134810A1

公开(公告)日：2007-06-14

申请号：US11300650

申请日：2005-12-14

申请人： Kaiyuan Yang ,  Shawn Feaster ,  Ning Wei ,  Rosann Kaylor ,  Chibueze Chidebelu-Eze

发明人： Kaiyuan Yang ,  Shawn Feaster ,  Ning Wei ,  Rosann Kaylor ,  Chibueze Chidebelu-Eze

IPC分类号： G01N33/558

CPC分类号： G01N33/54366 ,  B01L3/5023 ,  B01L2200/027 ,  B01L2300/0681 ,  B01L2300/0825 ,  B01L2300/0867 ,  B01L2400/0406 ,  B01L2400/0683 ,  G01N33/558 ,  Y10S436/825 ,  Y10T436/107497 ,  Y10T436/108331

摘要： A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. The kit includes a housing, and a membrane disposed within the housing having a detection region and a collection region. A blood sample meter is provided having a first end for absorption of a blood sample, a filtering section adjacent to the first end that filters red blood cell components from the blood sample, and a storage section adjacent to the filtering section that receives plasma or serum from the filtering section. An opening in the housing is sized for insertion of the sample meter into the housing such that the storage section of the sample meter is disposed in fluid communication with the collection region of the membrane. The plasma or serum is transferred from the storage section of the sample meter to the collection region of the membrane for subsequent migration to the detection region.

摘要翻译： 提供了用于检测驻留在测试样品中的分析物的诊断方法和相关测试试剂盒。 套件包括壳体和设置在壳体内的膜，其具有检测区域和收集区域。 提供血样计，其具有用于吸收血液样本的第一端，与第一端相邻的过滤部分，其从血液样品中过滤红细胞成分，以及与过滤部相邻的存储部，其接收血浆或血清 从过滤部分。 壳体中的开口的尺寸适于将样品计量器插入壳体中，使得样品计量器的存储部分设置成与膜的收集区域流体连通。 将血浆或血清从样品计量器的储存部分转移到膜的收集区域，以便随后迁移到检测区域。

公开(公告)号：US20060246597A1

公开(公告)日：2006-11-02

申请号：US11119394

申请日：2005-04-29

申请人： Shawn Feaster ,  Kaiyuan Yang

发明人： Shawn Feaster ,  Kaiyuan Yang

IPC分类号： G01N31/22

CPC分类号： G01N33/558 ,  G01N33/52

摘要： 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.

摘要翻译： 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。