Plural Superposed Layers Patents (Class 436/170)
  • Publication number: 20020192835
    Abstract: 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: Application
    Filed: March 15, 2002
    Publication date: December 19, 2002
    Applicant: KOREAN GREENCROSS CORPORATION
    Inventors: Min Cho, Yoo Deok Won, In Wook Kim
  • Patent number: 6479249
    Abstract: 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: Grant
    Filed: August 6, 1998
    Date of Patent: November 12, 2002
    Assignee: Denka Seiken Co., Ltd.
    Inventors: Hiroshi Matsui, Yasuki Ito, Shuichi Ohara, Akira Fujiwara
  • Patent number: 6436649
    Abstract: 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 ha
    Type: Grant
    Filed: June 11, 1999
    Date of Patent: August 20, 2002
    Assignee: Le Region Wallone
    Inventors: Michel Kohl, Roger Renotte, Gianangelo Ghitti, Guy Sarlet, Robert Lejeune
  • Patent number: 6420183
    Abstract: 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: Grant
    Filed: November 20, 1998
    Date of Patent: July 16, 2002
    Assignee: Bayer Aktiengesellschaft
    Inventors: Thoams Krahn, Wolfgang Paffhausen, Andreas Schade, Martin Bechem, Delf Schmidt
  • Publication number: 20020086435
    Abstract: 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: Application
    Filed: December 28, 2000
    Publication date: July 4, 2002
    Inventor: Aurora L. Fernandez Decastro
  • Patent number: 6413725
    Abstract: 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: Grant
    Filed: August 6, 1999
    Date of Patent: July 2, 2002
    Assignee: California Institute of Technology
    Inventors: Raymond J. Deshaies, R. M. Renny Feldman
  • Patent number: 6379620
    Abstract: 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: Grant
    Filed: November 16, 1998
    Date of Patent: April 30, 2002
    Inventors: Barry M. Tydings, James P. Lee
  • Patent number: 6372511
    Abstract: 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: Grant
    Filed: August 9, 1999
    Date of Patent: April 16, 2002
    Assignee: International Food Protection, INC
    Inventors: Lawrence Stanley Silver, Michael Juliano
  • Publication number: 20020036170
    Abstract: 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: Application
    Filed: August 10, 2001
    Publication date: March 28, 2002
    Inventors: Michael A. Harvey, Daniel S. Osborn, John L. Tonkinson
  • Patent number: 6350620
    Abstract: 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: Grant
    Filed: December 1, 2000
    Date of Patent: February 26, 2002
    Assignee: Genemaster Lifescience Co., LTD
    Inventors: Rong-Seng Chang, Yu-Chan Chao
  • Patent number: 6346290
    Abstract: 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: Grant
    Filed: July 31, 1998
    Date of Patent: February 12, 2002
    Assignees: Symyx Technologies, Inc., The Regents of the University of California
    Inventors: Peter G. Schultz, Xiaodong Xiang, Isy Goldwasser
  • Patent number: 6335428
    Abstract: 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: Grant
    Filed: April 8, 1999
    Date of Patent: January 1, 2002
    Assignee: The United States of America as represented by the Department of Health and Human Services
    Inventors: Harry V. Gelboin, Frank J. Gonzalez, Tian J. Yang
  • Patent number: 6328931
    Abstract: 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: Grant
    Filed: February 22, 2000
    Date of Patent: December 11, 2001
    Assignee: International Food Protection, Inc.
    Inventors: Lawrence Stanley Silver, Michael Juliano
  • Patent number: 6323325
    Abstract: 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: Grant
    Filed: April 8, 1999
    Date of Patent: November 27, 2001
    Assignee: The United States of America as represented by the Department of Health and Human Services
    Inventors: Harry V. Gelboin, Frank J. Gonzalez
  • Patent number: 6323321
    Abstract: 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: Grant
    Filed: June 30, 1999
    Date of Patent: November 27, 2001
    Assignee: Eberhard-Karls-Universitat Tubingen Universitatsklinikum
    Inventor: Hans-Jörg Bühring
  • Patent number: 6306665
    Abstract: 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: Grant
    Filed: October 13, 1999
    Date of Patent: October 23, 2001
    Assignee: A-Fem Medical Corporation
    Inventors: Robert Lee Buck, Huiying Wang, Timothy Patrick Hyatt, Paul Andrew Mueggler
  • Patent number: 6297060
    Abstract: 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: Grant
    Filed: February 11, 1999
    Date of Patent: October 2, 2001
    Assignee: Biosite Diagnostics, Inc.
    Inventors: Mark R. Nowakowski, Kenneth F. Buechler, Richard R. Anderson, Gunars E. Valkirs
  • Patent number: 6287783
    Abstract: 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: Grant
    Filed: March 18, 1999
    Date of Patent: September 11, 2001
    Assignee: Biostar, Inc.
    Inventors: James E. Maynard, Mark A. Crosby, Alan J. Fujii
  • Patent number: 6287867
    Abstract: 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: Grant
    Filed: August 26, 1994
    Date of Patent: September 11, 2001
    Assignee: Roche Diagnostics GmbH
    Inventors: Herbert Harttig, Hartmut Merdes, Hans Lange, Manfred Zeiler
  • Patent number: 6284550
    Abstract: 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: Grant
    Filed: June 25, 1999
    Date of Patent: September 4, 2001
    Assignee: Home Diagnostics, Inc.
    Inventors: Patrick Carroll, Jon Schneider, Douglas E. Bell
  • Patent number: 6284198
    Abstract: 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: Grant
    Filed: September 30, 1998
    Date of Patent: September 4, 2001
    Assignee: K&M Environmental Inc.
    Inventors: Kirollos Salama Kirollos, Gueorgui Milev Mihaylov
  • Patent number: 6271045
    Abstract: 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: Grant
    Filed: May 7, 1999
    Date of Patent: August 7, 2001
    Assignee: Amira Medical
    Inventors: Joel S. Douglas, Ryszard Radwanski, Brent G. Duchon, John H. Priest, David A. Hasker, John M. Gleisner
  • Patent number: 6271040
    Abstract: 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: Grant
    Filed: July 30, 1997
    Date of Patent: August 7, 2001
    Assignee: Biosite Diagnostics Incorporated
    Inventor: Kenneth Francis Buechler
  • Publication number: 20010007773
    Abstract: 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: Application
    Filed: September 16, 1997
    Publication date: July 12, 2001
    Inventors: ALEXANDER MICHAELOVICH MALEEV, YEVGENEY BORISOVICH BABLYUK, IVAN ALEXANDROVICH KOCHETOV, ALEXANDR SERGEIVICH PARFENOV, YURY MICHAELOVICH LOPUKHIN, ALXANDR B. RABOVSKI
  • Patent number: 6224831
    Abstract: 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: Grant
    Filed: March 31, 1998
    Date of Patent: May 1, 2001
    Assignee: John Co., Inc.
    Inventors: Alan P. Stafford, H. Kevin Smith, David Yarnes
  • Patent number: 6221620
    Abstract: 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: Grant
    Filed: April 24, 1991
    Date of Patent: April 24, 2001
    Assignee: The United States of America as represented by the Department of Health and Human Services
    Inventors: Patrick G. Johnston, Carmen J. Allegra, Bruce A. Chabner, Chi-Ming Liang
  • Patent number: 6200817
    Abstract: 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: Grant
    Filed: March 17, 1998
    Date of Patent: March 13, 2001
    Assignee: Litmus Concepts, Inc.
    Inventor: Paul J. Lawrence
  • Patent number: 6197598
    Abstract: 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: Grant
    Filed: August 19, 1997
    Date of Patent: March 6, 2001
    Assignee: Beckman Coulter, Inc.
    Inventors: Wayne H. Schrier, Corey L. Jaseph, Ronald J. Schoengold, Franco Ruggeri
  • Patent number: 6190918
    Abstract: 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: Grant
    Filed: March 6, 1995
    Date of Patent: February 20, 2001
    Assignee: Bayer Corporation
    Inventors: Amy H. Chu, Michael J. Wilcox
  • Patent number: 6187268
    Abstract: 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: Grant
    Filed: September 27, 1999
    Date of Patent: February 13, 2001
    Assignee: Bayer Corporation
    Inventors: James P. Albarella, Karl-Heinz Hildenbrand, Spencer H. Lin, Michael J. Pugia, LLoyd S. Schulman
  • Patent number: 6174688
    Abstract: 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: Grant
    Filed: December 22, 1999
    Date of Patent: January 16, 2001
    Assignee: The United States of America as represented by the Secretary of the Navy
    Inventor: Robert A. Brizzolara
  • Patent number: 6168957
    Abstract: 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: Grant
    Filed: June 25, 1997
    Date of Patent: January 2, 2001
    Assignee: Lifescan, Inc.
    Inventors: David Matzinger, Ian Harding, Michael O'Neil
  • Patent number: 6162397
    Abstract: 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: Grant
    Filed: August 13, 1998
    Date of Patent: December 19, 2000
    Assignee: Lifescan, Inc.
    Inventors: Franklin A. Jurik, Andrea Stubbs, Mimi Diemmy Dao, Carol Chang
  • Patent number: 6162639
    Abstract: 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: Grant
    Filed: December 18, 1998
    Date of Patent: December 19, 2000
    Assignee: Amira Medical
    Inventor: Joel S. Douglas
  • Patent number: 6146589
    Abstract: 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: Grant
    Filed: October 3, 1997
    Date of Patent: November 14, 2000
    Assignee: British Biocell International Limited
    Inventor: John Anthony Chandler
  • Patent number: 6143574
    Abstract: 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 the
    Type: Grant
    Filed: October 19, 1998
    Date of Patent: November 7, 2000
    Assignee: Biacore AB
    Inventors: Robert Karlsson, Stefan Lof.ang.s, Ralf W. Glaser
  • Patent number: 6140062
    Abstract: 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: Grant
    Filed: March 1, 1999
    Date of Patent: October 31, 2000
    Assignee: Universiteit Maastricht
    Inventors: Robert Johan Wagenvoord, Hendrik Coenraad Hemker
  • Patent number: 6127130
    Abstract: 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: Grant
    Filed: March 13, 1998
    Date of Patent: October 3, 2000
    Assignee: The United States of America as represented by the Secretary of the Navy
    Inventor: Robert A. Brizzolara
  • Patent number: 6117685
    Abstract: 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: Grant
    Filed: May 22, 1998
    Date of Patent: September 12, 2000
    Assignee: Sakura Color Products Corporation
    Inventors: Takeshi Omatsu, Hiroshi Inoue
  • Patent number: 6106732
    Abstract: 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: Grant
    Filed: April 16, 1998
    Date of Patent: August 22, 2000
    Assignee: Binax Services, Inc.
    Inventors: James Bennett Johnston, Kenneth Grady
  • Patent number: 6106779
    Abstract: 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: Grant
    Filed: October 2, 1997
    Date of Patent: August 22, 2000
    Assignee: Biosite Diagnostics, Inc.
    Inventors: Kenneth F. Buechler, Jason Christopher Briggs, Scott Harold Rongey
  • Patent number: 6099801
    Abstract: 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: Grant
    Filed: March 17, 1998
    Date of Patent: August 8, 2000
    Assignee: Litmus Concepts, Inc.
    Inventors: Paul J. Lawrence, Peter U. Ly, David R. Shockey
  • Patent number: 6069014
    Abstract: 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: Grant
    Filed: August 19, 1997
    Date of Patent: May 30, 2000
    Assignee: Beckman Coulter, Inc.
    Inventors: Wayne H. Schrier, Corey L. Jaseph, Ronald J. Schoengold, Franco Ruggeri
  • Patent number: 6046052
    Abstract: 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: Grant
    Filed: April 24, 1998
    Date of Patent: April 4, 2000
    Assignee: Ortho Clinical Diagnostics, Inc.
    Inventors: Thomas Arter, David B. LaTart, John C. Mauck, Richard C. Sutton, Wayne Weber, Robert Winterkorn, James Schaeffer
  • Patent number: 6040195
    Abstract: 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: Grant
    Filed: June 10, 1997
    Date of Patent: March 21, 2000
    Assignee: Home Diagnostics, Inc.
    Inventors: Patrick Carroll, Jon Schneider, Douglas E. Bell
  • Patent number: 6036919
    Abstract: 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 the
    Type: Grant
    Filed: July 21, 1997
    Date of Patent: March 14, 2000
    Assignee: Roche Diagnostic GmbH
    Inventors: Detlef Thym, Wofgang-Reinhold Knappe, Rudolf Pachl, Hartmut Merdes, Robert Lorenz
  • Patent number: 6025203
    Abstract: 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: Grant
    Filed: July 21, 1997
    Date of Patent: February 15, 2000
    Assignee: Roche Diagnostics GmbH
    Inventors: Peter Vetter, Helmut Leininger
  • Patent number: 6008059
    Abstract: 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: Grant
    Filed: August 19, 1997
    Date of Patent: December 28, 1999
    Assignee: Beckman Coulter, Inc.
    Inventors: Wayne H. Schrier, Corey L. Jaseph, Ronald J. Schoengold, Franco Ruggeri
  • Patent number: 5985356
    Abstract: 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: Grant
    Filed: October 18, 1994
    Date of Patent: November 16, 1999
    Assignees: The Regents of the University of California, Symyx Technologies
    Inventors: Peter G. Schultz, Xiaodong Xiang, Isy Goldwasser
  • Patent number: 5976813
    Abstract: 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: Grant
    Filed: December 12, 1997
    Date of Patent: November 2, 1999
    Assignee: Abbott Laboratories
    Inventors: Bruce A. Beutel, Mark E. Schurdak, Martin J. Voorbach, David J. Burns, Mary K. Joseph