Plural Superposed Layers Patents (Class 436/170)
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Publication number: 20020192835Abstract: The present invention discloses an immunochromatographic assay strip, and an assay device using the same. The assay strip includes a sample pad for receiving a liquid phase sample, a porous membrane pad having at least one reaction zone including a detecting substance to react with an analyte in the liquid phase sample, and a transparent plastic backing for supporting the sample pad and the porous membrane pad. The immunochromatographic assay device comprises the assay strip; an upper case including with a result observation window formed on the corresponding position of the reaction zone of the assay strip, and a sample receving hole formed on the corresponding position of the sample pad; and a lower case to be combined with the upper case, wherein the transparent backing of the assay strip is disposed between the upper case and the lower case to face the observation window of the upper case.Type: ApplicationFiled: March 15, 2002Publication date: December 19, 2002Applicant: KOREAN GREENCROSS CORPORATIONInventors: Min Cho, Yoo Deok Won, In Wook Kim
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Patent number: 6479249Abstract: Disclosed is a method for quantifying cholesterol in HDL, which does not require complex fragmentation and separation operations, and by which the HDL cholesterol in test samples containing HDL and other lipoproteins such as low density lipoprotein (LDL), very low density lipoprotein (VLDL) and chylomicron (CM) may be quantified selectively, simply and accurately. The method for quantifying cholesterol in high density lipoprotein comprises a first step of erasing cholesterol in lipoproteins other than high density lipoprotein in a test sample, and a second step of adding a surfactant which specifically acts on high density lipoprotein to the product of the first step and enzymatically quantifying cholesterol in high density lipoprotein.Type: GrantFiled: August 6, 1998Date of Patent: November 12, 2002Assignee: Denka Seiken Co., Ltd.Inventors: Hiroshi Matsui, Yasuki Ito, Shuichi Ohara, Akira Fujiwara
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Patent number: 6436649Abstract: The invention discloses a method for detecting and/or quantifying a hapten in a homogeneous phase, comprising the following steps: adding a known quantity of a hapten inhibitor complex to the solution containing the hapten to be detected and/or quantified; adding to the solution a quantity of antibodies corresponding to the quantity of the hapten/inhibitor complex; adding to the solution a type C &bgr;-lactamase having an active site for two substrates in antigenic competition in the said active site, the first substrate being a reporter substrate capable of being transformed into a detectable and/or quantifiable product, preferably by visible UV radiation measurement, the second substrate being the hapten/inhibitor complex acting on the hydrolysis rate of the reporter substrate; detecting and/or quantifying the concentration of the product resulting from the transformation of the reporter substrate, the Km constant of the reporter substrate being at least a hundred times higher than the Km constant of the haType: GrantFiled: June 11, 1999Date of Patent: August 20, 2002Assignee: Le Region WalloneInventors: Michel Kohl, Roger Renotte, Gianangelo Ghitti, Guy Sarlet, Robert Lejeune
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Patent number: 6420183Abstract: In a process for the quantitative optical analysis of fluorescently labelled biological cells 5, a cell layer on a transparent support at the bottom 2 of a reaction vessel 1 is in contact with a solution 3 containing the fluorescent dye 4. The sensitivity of analytical detection can be considerably improved if to the fluorescent dye 4 already present in addition a masking dye 9, which absorbs the excitation light 6 for the fluorescent dye 4 and/or its emission light 7, is added to the solution 3 and/or if a separating layer 10 permeable to the solution and absorbing and/or reflecting the excitation light 6 or the emission light 7 is applied to the cell layer at the bottom 2. The separating layer 10 must be composed such that it has a high power of reflection for the luminescent light 11.Type: GrantFiled: November 20, 1998Date of Patent: July 16, 2002Assignee: Bayer AktiengesellschaftInventors: Thoams Krahn, Wolfgang Paffhausen, Andreas Schade, Martin Bechem, Delf Schmidt
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Publication number: 20020086435Abstract: A test strip for simultaneously measuring a plurality of analytes in blood or other fluids comprising a plurality of reagent pads containing reagents specific to particular analytes located on a support. Each reagent pad is covered and in close contact with a sample distributing layer and an optional blood filtering layer. Color produced by analytes in the sample is viewed through apertures in the support. The colors of the pads are read simultaneously with an instrument such as a reflectance meter containing individual LED's as light sources for each reagent pad. The intensity of the color of the individual pad can be used to detect semi-quantitative or quantitative concentration of analytes in a sample on site, allowing for quick communication of results to a remote site by electronic means.Type: ApplicationFiled: December 28, 2000Publication date: July 4, 2002Inventor: Aurora L. Fernandez Decastro
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Patent number: 6413725Abstract: The present invention is based on the discovery of a simplified assay for identifying modulators of ubiquitin ligase activity. This assay allows detection of compounds that affect ubiquitination and thus, cell cycle regulation in cells. An increase in ubiquitination, in comparison to a test sample lacking a test compound, indicates a stimulation of activity, whereas a reduction in ubiquitination indicates an inhibitor of activity. Also disclosed herein are methods of identifying proteins having ubiquitin ligase activity, methods of identifying substrates for ubiquitination, methods for identifying an activity relationship between a particular ubiquitin ligase and a particular ubiquitin conjugating enzyme, and chimeric proteins comprising a ubiquitin conjugating enzyme and a ubiquitination substrate, which are useful in all of the disclosed methods.Type: GrantFiled: August 6, 1999Date of Patent: July 2, 2002Assignee: California Institute of TechnologyInventors: Raymond J. Deshaies, R. M. Renny Feldman
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Patent number: 6379620Abstract: An assay device for in field urine analysis including a container having an opening for collecting a urine sample, a cover for sealing the opening of the container and an assay assembly provided in the container for chemically analyzing the urine sample. The assay assembly comprises a liquid impermeable backing, a wicking material provided on a rear surface of the backing, at least one assay strip provided on a front surface of the backing and adjacent a top edge of the backing in contact with the wicking material, a front cover provided on the front surface of the backing for sealing the assay strip to the backing at a bottom and two sides of the assay strip and a rear cover provided on the rear surface of the backing for together with the front cover sealing said wicking material and the assay strip adjacent the top edge and two sides of said wicking material.Type: GrantFiled: November 16, 1998Date of Patent: April 30, 2002Inventors: Barry M. Tydings, James P. Lee
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Patent number: 6372511Abstract: Swabbing structures and methods of use are provided that enable a test surface to be swabbed, and subsequently facilitate a quantitative determination of the quantities of analyte collected from the test surface. The swabbing structures include a pre-wetted swabbing pad having a first surface structured for contacting and suitably swabbing the test surface to collect the analyte. Dried reagents are then brought into pressure contact with the swabbing pad, within a light-tight environment, to commence an assaying reaction. The assaying reaction may produce low level luminescent emissions that are detected and quantified to indicate the quantity or volume of analyte collected.Type: GrantFiled: August 9, 1999Date of Patent: April 16, 2002Assignee: International Food Protection, INCInventors: Lawrence Stanley Silver, Michael Juliano
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Publication number: 20020036170Abstract: The present invention relates to a novel device for separating plasma from a whole blood sample on a treated microporous membrane. An advantage of the present invention is that the sample can be assayed on the membrane after separation has occurred. A lateral flow chromatographic assay membrane has a sample application zone, a separation zone, and an analysis zone. An erythrocyte binding agent is added to the membrane in an amount sufficient to bind any erythrocytes present in the sample. Methods for using such devices are disclosed also.Type: ApplicationFiled: August 10, 2001Publication date: March 28, 2002Inventors: Michael A. Harvey, Daniel S. Osborn, John L. Tonkinson
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Patent number: 6350620Abstract: The invention provides a method for producing a micro-carrier, which includes patterning pluralities of bar code on a mask; exposing the bar code to a substrate coated with photoresist; etching and removing residual photoresist and electroforming to a nickel plate; placing a bead coated with biotin or poly-L-lysine between two-nickel plates, and compressing the bar code on the surface of the bead to form a microcake-like particle with bar code; and combining the particle with the corresponding bio-molecule thereof to produce a micro-carrier with a label. The invention also provides a test method for identifying a bio-molecule, which includes mixing several micro-carriers with the labeled unknown bio-molecules; and identifying the bar code on the micro-carrier via image recognition system, wherein the numbers and types of the known micro-carrier can be flexibly adjusted.Type: GrantFiled: December 1, 2000Date of Patent: February 26, 2002Assignee: Genemaster Lifescience Co., LTDInventors: Rong-Seng Chang, Yu-Chan Chao
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Patent number: 6346290Abstract: Methods and apparatus for the preparation and use of a substrate having an array of diverse materials in predefined regions thereon. A substrate having an array of diverse materials thereon is generally prepared by delivering components of materials to predefined regions on a substrate, and simultaneously reacting the components to form at least two materials. Materials which can be prepared using the methods and apparatus of the present invention include, for example, covalent network solids, ionic solids and molecular solids. More particularly, materials which can be prepared using the methods and apparatus of the present invention include, for example, inorganic materials, intermetallic materials, metal alloys, ceramic materials, organic materials, organometallic materials, non-biological organic polymers, composite materials (e.g., inorganic composites, organic composites, or combinations thereof), etc.Type: GrantFiled: July 31, 1998Date of Patent: February 12, 2002Assignees: Symyx Technologies, Inc., The Regents of the University of CaliforniaInventors: Peter G. Schultz, Xiaodong Xiang, Isy Goldwasser
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Patent number: 6335428Abstract: The invention provides monoclonal antibodies and other binding agents to human cytochrome P450 1A2 having advantageous properties, including capacity substantially to inhibit enzyme activity of human cytochrome P450 1A2 and lack of specific binding to other human cytochromes P450. The binding agents of the invention are useful inter alia in methods for screening drugs for metabolism by cytochrome P450 1A2, and in methods of measuring p450 1A2 levels in individuals relative to p450 1A2 levels in a control population.Type: GrantFiled: April 8, 1999Date of Patent: January 1, 2002Assignee: The United States of America as represented by the Department of Health and Human ServicesInventors: Harry V. Gelboin, Frank J. Gonzalez, Tian J. Yang
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Patent number: 6328931Abstract: Swabbing and assaying structures, and selected methods of use, enable a test surface to be swabbed, and subsequently facilitate a quantitative determination of the quantities of analyte collected from the test surface. The swabbing structures include a pre-wetted swabbing pad having a first surface for contacting and suitably swabbing the test surface to collect the analyte. Dried reagents that are impregnated within or upon a porous pad are then brought into pressure contact with the swabbing pad, within a suitable light-tight environment. If sufficient analyte was collected by the swabbing of the test surface, an assaying reaction will commence that produces detectable and quantifiable low level luminescent emissions.Type: GrantFiled: February 22, 2000Date of Patent: December 11, 2001Assignee: International Food Protection, Inc.Inventors: Lawrence Stanley Silver, Michael Juliano
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Patent number: 6323321Abstract: The present invention relates to a monoclonal antibody binding an antigen on the megakaryocytic cell line UT-7. The invention further relates to hybridoma cells producing such an antibody.Type: GrantFiled: June 30, 1999Date of Patent: November 27, 2001Assignee: Eberhard-Karls-Universitat Tubingen UniversitatsklinikumInventor: Hans-Jörg Bühring
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Patent number: 6323325Abstract: The invention provides monoclonal antibodies and other binding agents to human cytochrome P450 2A6 having advantageous properties, including capacity substantially to inhibit enzyme activity of human cytochrome P450 2A6 and lack of specific binding to other human cytochromes P450. The binding agents of the invention are useful inter alia in methods for screening drugs for metabolism by cytochrome P450 2A6, and in methods of measuring p450 2A6 levels in an individual relative to p450 2A6 levels in a control population.Type: GrantFiled: April 8, 1999Date of Patent: November 27, 2001Assignee: The United States of America as represented by the Department of Health and Human ServicesInventors: Harry V. Gelboin, Frank J. Gonzalez
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Patent number: 6306665Abstract: Microporous solid phase materials that are suitable for lateral flow and other assays for detecting the presence of analytes in test samples, that are stable under variations in humidity and, even after storage for extended periods of time, can form stable covalent bonds with molecules containing a free primary or secondary amine group or sulfhydryl group are described. The invention further concerns chemically derivatized solid phase materials, and conjugates comprising such materials. Examples of lateral flow devices for the quantitative or semi-quantitative determination of an analyte in a biological sample are described.Type: GrantFiled: October 13, 1999Date of Patent: October 23, 2001Assignee: A-Fem Medical CorporationInventors: Robert Lee Buck, Huiying Wang, Timothy Patrick Hyatt, Paul Andrew Mueggler
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Patent number: 6297060Abstract: Devices for use in heterogeneous ligand-receptor assays, having a porous member in contact with a nonabsorbent textured surface, where the surface texturing is such that a capillary network is formed when in fluid communication with the porous member. More particularly, these devices comprise: (a) a porous member having (i) at least one binding agent capable of immobilizing at least one target ligand on the porous member from a fluid sample in at least one zone and (ii) a means for detecting the presence or amount of said target ligand as a result of the assay process; and (b) a nonabsorbent member in fluid communication with the porous member, the nonabsorbent member forming at least one capillary with the porous member so that when sample, alone or in combination with other fluids, is added to the porous member, fluid is drawn through the porous member.Type: GrantFiled: February 11, 1999Date of Patent: October 2, 2001Assignee: Biosite Diagnostics, Inc.Inventors: Mark R. Nowakowski, Kenneth F. Buechler, Richard R. Anderson, Gunars E. Valkirs
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Patent number: 6287783Abstract: The present invention involves an optical assay device and method of use for the detection of an analyte of interest in a sample that conveniently allows control of the flow characteristics of the sample through the device without significant user intervention. The optical assay device includes a base having an absorbent material, and a member having an optically active test stack that is rotatably coupled to the base for rotation between a lowered position and a raised position. In the lowered position, the optically active test stack contacts the absorbent material for drawing the sample through the surface. In the raised position, the optically active test stack does not contact the absorbent material.Type: GrantFiled: March 18, 1999Date of Patent: September 11, 2001Assignee: Biostar, Inc.Inventors: James E. Maynard, Mark A. Crosby, Alan J. Fujii
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Patent number: 6287867Abstract: The invention concerns the use of an asymmetric porous membrane for the evenly distributed concentration of a substance which is not or not substantially adsorbed to the membrane and which is brought into contact with the membrane in the form of a membrane-wetting solution on the fine-pored side of the membrane.Type: GrantFiled: August 26, 1994Date of Patent: September 11, 2001Assignee: Roche Diagnostics GmbHInventors: Herbert Harttig, Hartmut Merdes, Hans Lange, Manfred Zeiler
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Patent number: 6284550Abstract: An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing. The improved test strip comprises (a) an upper support strip having a fluid receiving port and (b) a lower support strip having a color change viewing port and securely sandwiched therebetween (c) a spreading mesh screen for uniformly distributing the fluid, (d) a chemically treated separating layer for removing an undesirable element, e.g.Type: GrantFiled: June 25, 1999Date of Patent: September 4, 2001Assignee: Home Diagnostics, Inc.Inventors: Patrick Carroll, Jon Schneider, Douglas E. Bell
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Patent number: 6284198Abstract: A self-appearing warning sign device and method for the manufacture of a self-appearing warning sign device including a relatively thin gas impermeable support member upon which a coating is superimposed having a composition containing one or more chromographic reagents which will cause a visible color change in the presence of a specified polluting gas. The coating has a raised thickness of between about 5-500 microns. A warning sign of defined shape is formed depositing the coating composition in a given shape identifying the presence of the polluting gas or by masking a given area to form said shape. The device also includes a hydrophobic layer and end covers in an arrangement forming a gas tight sealed enclosure except for an opening in each cover on opposite ends of the device.Type: GrantFiled: September 30, 1998Date of Patent: September 4, 2001Assignee: K&M Environmental Inc.Inventors: Kirollos Salama Kirollos, Gueorgui Milev Mihaylov
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Patent number: 6271045Abstract: A strip for testing for the presence of an analyte generally comprises a support member which contains a spreading layer and a reagent layer, and a capillary tube in communication with the support layer and spreading layer for transporting a sample of body fluid thereto. A method of testing a fluid for the presence or concentration of an analyte is also provided which generally includes providing a test strip with a support member, a spreading layer, and a reagent layer on the spreading layer. A capillary tube is provided on the support member whereby a fluid containing an analyte to be tested is introduced into the tube and flows through the tube to the spreading layer and contacts the reagent layer.Type: GrantFiled: May 7, 1999Date of Patent: August 7, 2001Assignee: Amira MedicalInventors: Joel S. Douglas, Ryszard Radwanski, Brent G. Duchon, John H. Priest, David A. Hasker, John M. Gleisner
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Patent number: 6271040Abstract: The assay devices, assay systems and device components of this invention comprise at least two opposing surfaces disposed a capillary distance apart, at least one of which is capable of immobilizing at least one target ligand or a conjugate in an amount related to the presence or amount of target ligand in the sample from a fluid sample in a zone for controlled fluid movement to, through or away the zone. The inventive device components may be incorporated into conventional assay devices with membranes or may be used in the inventive membrane-less devices herein described and claimed. These components include flow control elements, measurement elements, time gates, elements for the elimination of pipetting steps, and generally, elements for the controlled flow, timing, delivery, incubation, separation, washing and other steps of the assay process.Type: GrantFiled: July 30, 1997Date of Patent: August 7, 2001Assignee: Biosite Diagnostics IncorporatedInventor: Kenneth Francis Buechler
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Publication number: 20010007773Abstract: A multilayer analytical element for determining a level of an analyte on a substrate and adapted for use with hydrogen peroxide and an affinity-enzymatic compound of formula A—C—B, wherein A is a detecting agent having affinity for the analyte, B is an enzymatic visualizing agent consisting of peroxidase and C is a binding agent linking the detecting and visualizing agents together. The multilayer analytical element of the invention comprises a solid support and a hydrophilic layer thereon, the hydrophilic layer being formed of gelatin, polyvinyl alcohol or a mixture thereof and containing a developing agent and a hydrophobic color-producing agent in a total amount of 5 to 30 weight %, the developing agent and the color-producing agent being present in a weight ratio of 1:0.3 to 1:3.0.Type: ApplicationFiled: September 16, 1997Publication date: July 12, 2001Inventors: ALEXANDER MICHAELOVICH MALEEV, YEVGENEY BORISOVICH BABLYUK, IVAN ALEXANDROVICH KOCHETOV, ALEXANDR SERGEIVICH PARFENOV, YURY MICHAELOVICH LOPUKHIN, ALXANDR B. RABOVSKI
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Patent number: 6224831Abstract: The subject invention relates to a rapid, field-portable, modular, versatile and highly reliable assay device for substances, particularly drugs of abuse, which provides a positive signal in the presence of a specific substance for which the device has been specifically adapted to test. The subject invention also concerns methods for making and using the assay device. The device is easily and reliably manufactured by laminating a series of manufactured layers to each other to form an upper card assembly and a lower card assembly. The upper card assembly is bonded to the upper side of a layer which has an immobilized reagent specific for a test substance bound thereto, and the lower card assembly is bonded to the lower side of the layer having the immobilized reagent. The device can be manufactured and distributed in a unitary, ready-to-use form.Type: GrantFiled: March 31, 1998Date of Patent: May 1, 2001Assignee: John Co., Inc.Inventors: Alan P. Stafford, H. Kevin Smith, David Yarnes
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Patent number: 6221620Abstract: The present invention relates to monoclonal antibodies that are specific for the protein thymidylate synthase, and hybridomas producing these monoclonal antibodies. The invention further relates to methods of detection and diagnostic kits to test for the presence of thymidylate synthase. The invention also relates to the use of the monoclonal antibodies in determining the presence of colon carcinoma cells.Type: GrantFiled: April 24, 1991Date of Patent: April 24, 2001Assignee: The United States of America as represented by the Department of Health and Human ServicesInventors: Patrick G. Johnston, Carmen J. Allegra, Bruce A. Chabner, Chi-Ming Liang
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Patent number: 6200817Abstract: Tests for elevated pH and volatile amines in aqueous fluids are disclosed, including tests useful in the diagnosis of bacterial vaginosis and in other biological conditions. By using formulated indicators and indicators held in matrices that are permeable to gas but not to liquid, the tests provide clear and sharp transitions detectable by visual or machine-readable device rather than by subjective judgments such as small gradations in color or olfactory determinations. The tests lend themselves readily to iconic readouts of the test indications and to the inclusion of positive and negative controls.Type: GrantFiled: March 17, 1998Date of Patent: March 13, 2001Assignee: Litmus Concepts, Inc.Inventor: Paul J. Lawrence
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Patent number: 6197598Abstract: A device for the separation of the liquid portion of blood from the cellular components of blood comprises: (1) a pad of porous material permeable to the liquid portion of blood but capable of trapping the cellular components of blood; (2) a substrate supporting the pad; and (3) means, attached to the pad, for facilitating the flow of the liquid portion of the blood: (i) through interstices around the trapped cellular components of the blood and (ii) from the pad of porous material. The separation of the liquid portion of blood from the cellular components of the blood occurs by flow through the pad of porous material without significant hemolysis. The device can be incorporated into a device for the performance of specific binding assays such as immunoassays. The pad of porous material can contain an agglutinating agent such as a lectin or an anti-blood cell antibody, or a carbohydrate such as mannitol.Type: GrantFiled: August 19, 1997Date of Patent: March 6, 2001Assignee: Beckman Coulter, Inc.Inventors: Wayne H. Schrier, Corey L. Jaseph, Ronald J. Schoengold, Franco Ruggeri
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Patent number: 6190918Abstract: The present invention provides a device and a process for detecting an analyte in a biological fluid. The device comprises a separating matrix for separating analyte from the fluid and means for detecting the analyte, where the separating matrix contains HEPES buffer, preferably in an amount between 70 and 150 millimolar. The process comprises applying the sample to the device having a separating matrix and then detecting analyte in the sample using the detection means. The presence of HEPES in the separation layer shortened the detection time.Type: GrantFiled: March 6, 1995Date of Patent: February 20, 2001Assignee: Bayer CorporationInventors: Amy H. Chu, Michael J. Wilcox
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Patent number: 6187268Abstract: Disclosed is a diagnostic device for the colorimetric detection of an analyte in a test fluid. The device is a dry reagent layer which is overcoated with a transparent, fluid permeable membrane. The membrane is made up of a combination of a water dispersible and a water soluble polymer. The membrane may contain a surfactant and a thickener.Type: GrantFiled: September 27, 1999Date of Patent: February 13, 2001Assignee: Bayer CorporationInventors: James P. Albarella, Karl-Heinz Hildenbrand, Spencer H. Lin, Michael J. Pugia, LLoyd S. Schulman
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Patent number: 6174688Abstract: A method of determining the concentration of a sample antigen in the presence of an interferant by (1) running two immunoassays on the sample: one assay where the interferant influences the binding of both the sample antigen and a labeled antigen and a second assay where the interferant influences the binding of the sample antigen but not the labeled antigen; (2) obtaining a plot of the possible sample antigen concentrations versus the possible interferant concentrations corresponding to the readout for the sample for each of the two immunoassays; and (3) determining the sample antigen concentration and the interferant concentration which correspond to the point that appears on both of the immunoassay plots.Type: GrantFiled: December 22, 1999Date of Patent: January 16, 2001Assignee: The United States of America as represented by the Secretary of the NavyInventor: Robert A. Brizzolara
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Patent number: 6168957Abstract: A dry phase reagent test strip for measuring the concentration of an analyte in a biological fluid includes a colored indicator whose hue indicates a calibration of the strip. Preferably, the test strip measures the concentration of glucose in whole blood.Type: GrantFiled: June 25, 1997Date of Patent: January 2, 2001Assignee: Lifescan, Inc.Inventors: David Matzinger, Ian Harding, Michael O'Neil
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Patent number: 6162397Abstract: A visual blood glucose test strip has two membranes that each incorporate a reagent that reacts with glucose in a blood sample applied to the membranes to cause a color change. One of the membranes also includes an inhibitor and a dye. A blood sample applied to the strip causes the two membranes to form two different colors. Comparing the colors to a calibrated color chart permits a user to determine the glucose concentration in the blood sample.Type: GrantFiled: August 13, 1998Date of Patent: December 19, 2000Assignee: Lifescan, Inc.Inventors: Franklin A. Jurik, Andrea Stubbs, Mimi Diemmy Dao, Carol Chang
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Patent number: 6162639Abstract: The invention provides a method for measuring the amount of analyte in a sample of biological fluid using a simple low sample volume reagent test strip with a built in metering system. The test strip may include a microtitration zone to prevent oversampling and an integrated capillary to prevent problems associated with short sampling and act as means of absorbing the fluid sample. The test strip comprises a wicking layer and a reaction matrix embossed layer in the form of a pillow assembled into a microtitration pocket formed in the strip. The test strip is used in single use applications such as the determination of the concentration of glucose in blood.Type: GrantFiled: December 18, 1998Date of Patent: December 19, 2000Assignee: Amira MedicalInventor: Joel S. Douglas
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Patent number: 6146589Abstract: An assay device for detecting the presence of an analyte in a sample, wherein a visible signal indicative of the presence or absence of said analyte is produced at a detection site on a support, characterised in that said signal is generated or enhanced by means of a signal enhancement reaction between a labelled first binding reagent which is labelled and a label developing means, which are arranged to be delivered to the detection site in a single assay step but in a sequential manner such that the first binding reagent arrives at the detection site ahead of the label developing means. The sequential delivery of the reagents to the detection site is provided by techniques such as liquidic circuits, slow release agents, and others. Methods of carrying out assays and kits for use in the assays form a further aspect of the invention.Type: GrantFiled: October 3, 1997Date of Patent: November 14, 2000Assignee: British Biocell International LimitedInventor: John Anthony Chandler
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Patent number: 6143574Abstract: A method of determining affinity and kinetic properties for the solution interaction between an analyte and a binding partner therefor, which method comprises: (a) mixing a solution of said analyte with a solution of said binding partner, contacting the resulting reaction solution with (i) immobilised binding partner, or analogue, for said analyte, and/or (ii) immobilised analyte, or analogue, and monitoring the binding of said analyte and/or binding partner in said reaction solution to the respective immobilised species to determine the variation with time of the concentration of free analyte and/or binding partner in said solution; and/or (b) contacting a solution of the reaction complex of said analyte and a binding partner therefor with (i) immobilised binding partner, or analogue, and/or (ii) immobilised analyte, or analogue, and monitoring the binding of said analyte and/or binding partner in said reaction complex solution to the respective immobilised species to determine the variation with time of theType: GrantFiled: October 19, 1998Date of Patent: November 7, 2000Assignee: Biacore ABInventors: Robert Karlsson, Stefan Lof.ang.s, Ralf W. Glaser
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Patent number: 6140062Abstract: In a method of determining heparin content, a known amount of thrombin (FIIa) or activated coagulation factor X (FXa) is added to a mixture which comprises a known concentration of chromogenic substrate (S), a known concentration of antithrombin (AT) and a sample having an unknown heparin concentration. The amount of FIIa or FXa is chosen such that at most 20%, of the S present is reacted during the period which the AT needs to deactivate all the FIIa or FXa present. The final concentration of the reacted chromogenic substrate p-nitroanilide ([pNA].sub.final) is determined after completion of the reactions, and the [pNA].sub.final is used to determine the rate constant (k.sub.dec) of the reaction of FIIa or FXa with AT using the relationship: ##EQU1## The heparin concentration in the sample can then be determined using the value of k.sub.dec from a predetermined calibration curve of k.sub.dec against heparin concentration.Type: GrantFiled: March 1, 1999Date of Patent: October 31, 2000Assignee: Universiteit MaastrichtInventors: Robert Johan Wagenvoord, Hendrik Coenraad Hemker
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Patent number: 6127130Abstract: A method of determining the concentration of a sample antigen in the presence of an interferant by(1) running two immunoassays on the sample: one assay where the interferant influences the binding of both the sample antigen and a labeled antigen and a second assay where the interferant influences the binding of the sample antigen but not the labeled antigen;(2) obtaining a plot of the possible sample antigen concentrations versus the possible interferant concentrations corresponding to the readout for the sample for each of the two immunoassays; and(3) determining the sample antigen concentration and the interferant concentration which correspond to the point that appears in both the immunoassays plots.Type: GrantFiled: March 13, 1998Date of Patent: October 3, 2000Assignee: The United States of America as represented by the Secretary of the NavyInventor: Robert A. Brizzolara
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Patent number: 6117685Abstract: The invention provides a method of detecting ozone expediently and with high sensitivity. The invention, therefore, is directed to an ozone indicator comprising (1) at least one color-change layer comprised of an ozone sensor ink and (2) at least one non-color change layer both formed on a substrate, said color-change and non-color-change layers being formed in such a manner that at least a part or the whole of at least one color-change layer can be exposed to an ozone-containing atmosphere when the ozone indicator is put to use. The invention is further directed to an ozone sensor ink containing an anthraquinone dye having at least one amino group selected from primary and secondary amino groups.Type: GrantFiled: May 22, 1998Date of Patent: September 12, 2000Assignee: Sakura Color Products CorporationInventors: Takeshi Omatsu, Hiroshi Inoue
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Patent number: 6106779Abstract: A lysis chamber of an assay device capable of producing lysis of cells in a sample fluid such as whole blood, said chamber comprising a surface which contacts the sample fluid when the sample fluid is placed into the assay device; and a lytic material immobilized on the surface, whereby cells of the sample fluid are lysed when they contact the lytic material. The chamber can delimit a capillary space, and lytic material can be saponin or a detergent. Methods employing devices comprising such chambers can assay for whole blood amounts of cyclosporin or hemoglobin A1c.Type: GrantFiled: October 2, 1997Date of Patent: August 22, 2000Assignee: Biosite Diagnostics, Inc.Inventors: Kenneth F. Buechler, Jason Christopher Briggs, Scott Harold Rongey
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Patent number: 6106732Abstract: A process for separating plasma or serum from mammalian whole blood includes the steps of applying a sample of blood through a hydrophobically faced sample receiving hole positioned in a first upper layer of hydrophobic material to a first layer of fibrous hydrophilic material which has been impregnated with a blood agglutinating agent so that it acts to retain red blood cells but not plasma or serum and layer is sealed at its upper edges to the first layer of hydrophobic material and allowing the liquid portion of the sample to flow downwardly through the first layer of fibrous hydrophilic material into a second layer comprised of a different fibrous hydrophilic material which second layer is sealed at its lower edges to a second layer of hydrophobic material whereby it acts to retain the plasma or serum.Type: GrantFiled: April 16, 1998Date of Patent: August 22, 2000Assignee: Binax Services, Inc.Inventors: James Bennett Johnston, Kenneth Grady
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Patent number: 6099801Abstract: Tests for elevated pH and volatile amines in aqueous fluids are disclosed, including tests useful in the diagnosis of bacterial vaginosis and in other biological conditions. By using formulated indicators and indicators held in matrices that are permeable to gas but not to liquid, the tests provide clear and sharp transitions detectable by visual or machine-readable device rather than by subjective judgments such as small gradations in color or olfactory determinations. The tests lend themselves readily to iconic readouts of the test indications and to the inclusion of positive and negative controls.Type: GrantFiled: March 17, 1998Date of Patent: August 8, 2000Assignee: Litmus Concepts, Inc.Inventors: Paul J. Lawrence, Peter U. Ly, David R. Shockey
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Patent number: 6069014Abstract: A device for the separation of the liquid portion of blood from the cellular components of blood comprises: (1) a pad of porous material permeable to the liquid portion of blood but capable of trapping the cellular components of blood; (2) a substrate supporting the pad; and (3) means, attached to the pad, for facilitating the flow of the liquid portion of the blood: (i) through interstices around the trapped cellular components of the blood and (ii) from the pad of porous material. The separation of the liquid portion of blood from the cellular components of the blood occurs by flow through the pad of porous material without significant hemolysis. The device can be incorporated into a device for the performance of specific binding assays such as immunoassays. The pad of porous material can contain an agglutinating agent such as a lectin or an anti-blood cell antibody, or a carbohydrate such as mannitol.Type: GrantFiled: August 19, 1997Date of Patent: May 30, 2000Assignee: Beckman Coulter, Inc.Inventors: Wayne H. Schrier, Corey L. Jaseph, Ronald J. Schoengold, Franco Ruggeri
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Patent number: 6046052Abstract: A dry analytical element is disclosed which can be used to sensitively and rapidly detect and quantitate protein. The assays are carried out using a dye that reacts with protein and molybdate ion to produce a measurable change in the spectral absorption of the dye. Also disclosed are polymers which stabilize and enhance the accuracy of the assay, and compounds which reduce interference by bicarbonate.Type: GrantFiled: April 24, 1998Date of Patent: April 4, 2000Assignee: Ortho Clinical Diagnostics, Inc.Inventors: Thomas Arter, David B. LaTart, John C. Mauck, Richard C. Sutton, Wayne Weber, Robert Winterkorn, James Schaeffer
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Patent number: 6040195Abstract: An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing. The improved test strip comprises (a) an upper support strip having a fluid receiving port and (b) a lower support strip having a color change viewing port and securely sandwiched therebetween (c) a spreading mesh screen for uniformly distributing the fluid, (d) a chemically treated separating layer for removing an undesirable element, e.g.Type: GrantFiled: June 10, 1997Date of Patent: March 21, 2000Assignee: Home Diagnostics, Inc.Inventors: Patrick Carroll, Jon Schneider, Douglas E. Bell
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Patent number: 6036919Abstract: The present invention concerns a diagnostic test carrier for the determination of an analyte from whole blood with the aid of a reagent system contained in the carrier which includes a colour forming reagent with a test field which has a sample application side onto which the blood sample is applied and a detection side on which an optically detectable change takes place as a result of the reaction of analyte with the reagent system and which is constructed in such a way that erythrocytes present in the sample do not reach the detection side, which is characterized in that the test field comprises a transparent foil onto which a first and a second film layer are applied on top of one another and wherein the first layer located on the transparent foil scatters light considerably less in a wet state than the overlying second layer and wherein the side of the foil on which the first layer is applied which is opposite to the foil side is the detection side and the side of the second layer which is opposite to theType: GrantFiled: July 21, 1997Date of Patent: March 14, 2000Assignee: Roche Diagnostic GmbHInventors: Detlef Thym, Wofgang-Reinhold Knappe, Rudolf Pachl, Hartmut Merdes, Robert Lorenz
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Patent number: 6025203Abstract: The invention concerns a diagnostic test carrier (1) containing a supporting layer (2) with a detection layer (3) arranged thereon containing the reagents required to determine an analyte in a liquid sample and a network (4) covering the detection layer (3) which is larger than the detection layer (3) and which is attached to the supporting layer (2), wherein the network (4) is a plied knitted fabric the threads of which are highly roughened on the side facing the detection layer (3) whereas the threads on the side of the knitted fabric which face away from the detection layer (3) are relatively smooth as well as the use of such a test carrier to determine an analyte in a liquid and the use of such a knitted fabric as a layer spreading liquid in a diagnostic test carrier. Moreover the invention concerns a method for the determination of an analyte in a liquid sample with the aid of a test carrier according to the invention.Type: GrantFiled: July 21, 1997Date of Patent: February 15, 2000Assignee: Roche Diagnostics GmbHInventors: Peter Vetter, Helmut Leininger
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Patent number: 6008059Abstract: A device for the separation of the liquid portion of blood from the cellular components of blood comprises: (1) a pad of porous material permeable to the liquid portion of blood but capable of trapping the cellular components of blood; (2) a substrate supporting the pad; and (3) means, attached to the pad, for facilitating the flow of the liquid portion of the blood: (i) through interstices around the trapped cellular components of the blood and (ii) from the pad of porous material. The separation of the liquid portion of blood from the cellular components of the blood occurs by flow through the pad of porous material without significant hemolysis. The device can be incorporated into a device for the performance of specific binding assays such as immunoassays. The pad of porous material can contain an agglutinating agent such as a lectin or an anti-blood cell antibody, or a carbohydrate such as mannitol.Type: GrantFiled: August 19, 1997Date of Patent: December 28, 1999Assignee: Beckman Coulter, Inc.Inventors: Wayne H. Schrier, Corey L. Jaseph, Ronald J. Schoengold, Franco Ruggeri
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Patent number: 5985356Abstract: Methods and apparatus for the preparation and use of a substrate having an array of diverse materials in predefined regions thereon. A substrate having an array of diverse materials thereon is generally prepared by delivering components of materials to predefined regions on a substrate, and simultaneously reacting the components to form at least two materials. Materials which can be prepared using the methods and apparatus of the present invention include, for example, covalent network solids, ionic solids and molecular solids. More particularly, materials which can be prepared using the methods and apparatus of the present invention include, for example, inorganic materials, intermetallic materials, metal alloys, ceramic materials, organic materials, organometallic materials, non-biological organic polymers, composite materials (e.g., inorganic composites, organic composites, or combinations thereof), etc.Type: GrantFiled: October 18, 1994Date of Patent: November 16, 1999Assignees: The Regents of the University of California, Symyx TechnologiesInventors: Peter G. Schultz, Xiaodong Xiang, Isy Goldwasser
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Patent number: 5976813Abstract: Continuous format high throughput screening (CF-HTS) using at least one porous matrix allows the pharmaceutical industry to simultaneously screen large numbers of chemical entities for a wide range of biological or biochemical activity. In addition, CF-HTS is useful to perform multi-step assays.Type: GrantFiled: December 12, 1997Date of Patent: November 2, 1999Assignee: Abbott LaboratoriesInventors: Bruce A. Beutel, Mark E. Schurdak, Martin J. Voorbach, David J. Burns, Mary K. Joseph