Test Papers Patents (Class 435/805)
  • Patent number: 6737277
    Abstract: An immunochemical assay device comprising a base member, an array disposed on the base member, and at least one assay indicia zone. The array comprises (i) a reservoir pad to receive sample liquid, (ii) a wicking membrane, and (iii) at least one filter zone interposed between the wicking membrane and the reservoir pad. The filter zone being operable to permit passage of any specific immunocomplex to the wicking membrane while impeding passage of larger components.
    Type: Grant
    Filed: June 23, 2000
    Date of Patent: May 18, 2004
    Assignee: PMB-Selfcare LLC
    Inventors: Jemo Kang, Byungwoo Youn, Young Ho Oh
  • Patent number: 6716639
    Abstract: The invention relates to an immunoassay apparatus, comprising a dry, porous substrate having at least two sections (1, 2), communicating with one another in the moist state by capillary action, wherein the first section (1) has a marked detection reagent for the substance to be detected and the second section (2) has an immobilized binder reagent for the substance to be detected, and wherein the reaction product comprising the substance to be detected and the marked detection reagent migrates by capillary action from the first section into the second section in the moist state, and is characterized in that the marked detection reagent is a dye-carrying reagent for nicotine or cotinine.
    Type: Grant
    Filed: November 9, 1998
    Date of Patent: April 6, 2004
    Assignee: ulti med Products (Deutschland) GmbH
    Inventor: Matthias Werner Engel
  • Patent number: 6713271
    Abstract: Novel magnetic assay methods and systems. According to a preferred embodiment, a chromatographic medium, which preferably comprises a test strip, is provided that is designed to be contacted with a test solution having activated magnetic particles such that the solution flows bilaterally thereacross. A magnetic field, generated by a magnet or electromagnet, is selectively applied to the medium which causes the charged particles to become substantially bound at a site on the medium specified by the position off the magnet, to thus form a captured line or zone. In one preferred embodiment, the magnetic field is applied at the site on the medium at which the test solution is contacted. The degree of magnetic force applied to the membrane may be selectively adjusted to vary the width or surface area of the capture line or zone.
    Type: Grant
    Filed: September 25, 2000
    Date of Patent: March 30, 2004
    Assignee: Wavesense, LLC
    Inventor: Christopher Feistel
  • Patent number: 6703196
    Abstract: The invention concerns an analytical element for the determination of an analyte containing in or on material which enables liquid transport between zones, a sample application zone and a detection zone located downstream thereof, wherein the detection zone contains a partner 1 of a specific binding pair 1 immobilized in such a manner that it is able to bind to partner 2 of the specific binding pair 1 which is not the analyte when it contacts it, wherein a labelled partner 1 of a specific binding pair 2 is present upstream of the detection zone impregnated on a material such that it can be detached by liquid and is able to bind to partner 2 of the specific binding pair 2 which is not the analyte when this contacts it as well as a method for the determination of an analyte using this analytical element.
    Type: Grant
    Filed: December 18, 1998
    Date of Patent: March 9, 2004
    Assignee: Roche Diagnostics Corporation
    Inventors: Jürgen Klepp, Gerhard Hiller, Alfons Nichtl, Ulrike Fischer, Martina Hösch
  • Patent number: 6686167
    Abstract: A test device (20) for detecting semen includes a strip (22) having an introduction station (24), a test station (26), and a control station (28) disposed in spaced apart relationship. The introduction station (24) has labeled p30 antibodies, the test station (26) has immobilized p30 antibodies, and the control station has immobilized polyclonal antibodies. A test sample (500) is deposited in the introduction station (24). If semen is present in the test sample (500), a colored line will appear at the test station (26) and at the control station (28). If no semen is present in the test sample (500), a colored line will only appear at the control station (28).
    Type: Grant
    Filed: February 3, 2001
    Date of Patent: February 3, 2004
    Inventor: Padma S. Bagaria
  • Patent number: 6660534
    Abstract: A method of determining the concentration of IgG antibodies in the biological fluids of mammals. The assay may be performed in a lateral flow cassette or dipstick format where dehydrated immobilized reagents are spaced along a membrane. A sample of a mammalian biological fluid is exposed first to an IgG complexing agent to yield a conjugate. The conjugate then moves along the membrane and is exposed to a standard mammalian IgG applied to the membrane at a test position. Binding of the IgG is indicated by a color change at the test position on the membrane. A control reagent of dehydrated anti-IgG complexing agent may be applied to the membrane at the control position spaced downstream from the test position. Interaction of the IgG complexing agent with the anti-IgG complexing agent forms a visible line at the control position on the membrane.
    Type: Grant
    Filed: May 8, 2001
    Date of Patent: December 9, 2003
    Assignee: Midland Bioproducts Corp.
    Inventors: Jerry K. McVicker, Glenda C. Rouse, Denny M. Barrantes
  • Patent number: 6656744
    Abstract: The efficiency and accuracy of one-step lateral flow assays can be improved by employing more efficient binding between participants in labeling and capture. Thus, in addition to analyte/anti-analyte interactions, specific binding is achieved through members of an irrelevant specific binding pair. Also included within the invention is a format wherein unlabeled competitor for analyte serves as a gatekeeper in the capture zone, competing with analyte for labeled anti-analyte, which analyte will be captured in a detecting portion of a capture zone.
    Type: Grant
    Filed: February 22, 2000
    Date of Patent: December 2, 2003
    Assignee: Quidel Corporation
    Inventors: Allan D. Pronovost, Hans Boehringer, Ya-Chen Hsu
  • Patent number: 6656745
    Abstract: The present invention relates to an immunoassay device featuring a semi-quantitative, multi-level method for determining the presence and an amount of an analyte. The immunoassay involves a device comprising a layer with a porous medium deposited thereon. The device has several binding zones in which each zone comprises a defined amount of a binding reagent to bind and immobilize the analyte. The present invention also features an inscribed capillary channel having fluid barriers that allow control of a rate of migration of fluid along the porous medium. The device typically provides at least some of the binding zones within the capillary channels such that a solvent quickly traverses through the capillary channels and provides a semi-quantitative result. Preferably, any binding of an analyte is accompanied by a visual change in the binding zone such that one can easily detect visually an amount of analyte present in the sample.
    Type: Grant
    Filed: June 2, 2000
    Date of Patent: December 2, 2003
    Inventor: Francis X. Cole
  • Patent number: 6638728
    Abstract: New protein coated surfaces, which have a high capacity for capturing target molecules, thus yielding assays with enhanced sensitivity, are disclosed. Surfaces prepared according to the present invention contain a coating consisting essentially of streptavidin, avidin or “NeutrAvidin” in polymeric form, wherein polymerization has been controlled to an extent such that the polymer is predominantly dimers, trimers and tetramers of the native molecule.
    Type: Grant
    Filed: June 15, 2001
    Date of Patent: October 28, 2003
    Assignee: Pierce Biotechnology, Inc.
    Inventors: Surbhi Desai, Mark Rickerd, Ineabel Horneij
  • Patent number: 6627459
    Abstract: A device and method for performing a rapid immunoassay for a biological analyte containing a positive control analyte which is concurrently tested using the same device and immunochemical reaction as the biological analyte. The positive control analyte is non-crossreactive with the biological analyte to be detected and may be an immunogen or a hapten. The device and method permit operators of the test device, particularly non-laboratory professionals, to determine that an assay is performed correctly and that the device is functioning properly, thereby allowing the operator to have confidence in the accuracy of either a positive or negative result. This is particularly important when a positive result is indicated by the absence of color at a test site, which is counterintuitive with many operators and which frequently occurs with a competitive immunoassay.
    Type: Grant
    Filed: April 19, 2000
    Date of Patent: September 30, 2003
    Assignee: Applied Biotech, Inc.
    Inventors: Ker-kong Tung, He Huang
  • Patent number: 6620626
    Abstract: A monitor having a hollow semipermeable casing with a test strip is agitated in a sample volume of suspect liquid. The monitor is partially filled with tiny colored beads confined to its interior by the size of the openings in the semipermeable structure. Adhered to the beads are antibodies matched to the antigen characterizing the suspect substance. The test strip is segregated into collection and control regions. Antibodies matched to the suspect antigen are adhered only to the collection region. If the sample fluid contains the suspect substance, it will bind to both the bead antibodies and the collector antibodies, resulting in an accumulation of colored beads in the collection region but not the control region. A significant color differential between the two is a positive indication of the suspect substance. This invention has significant potential in screening for the date rape drugs, GHB and rohypnol.
    Type: Grant
    Filed: August 9, 2000
    Date of Patent: September 16, 2003
    Assignee: Mission Research Corp.
    Inventor: Gary R. Bodily
  • Patent number: 6607896
    Abstract: A method for the detection of a disease comprising the steps of: (i) obtaining a biological sample from a human subject; (ii) applying the biological sample to a sialidase substrate which has been immobilized on a solid support medium; and (iii) detecting a change in the immobilized sialidase substrate is provided. The substrate is preferably 5-bromo-4-chloro-3-indoyl &agr;-D-N-acetyl neuraminic acid or a salt thereof.
    Type: Grant
    Filed: January 18, 2002
    Date of Patent: August 19, 2003
    Assignee: University of Bristol
    Inventors: Michael Millar, Tony Corfield
  • Patent number: 6605440
    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: Grant
    Filed: September 16, 1997
    Date of Patent: August 12, 2003
    Assignee: IMI International Medical Innovations Inc.
    Inventors: Alexander Michaelovich Maleev, Yevgeney Borisovich Bablyuk, Ivan Alexandrovich Kochetov, Alexandr Sergeivich Parfenov, Yury Michaelovich Lopukhin, Alxandr B. Rabovski
  • Patent number: 6605476
    Abstract: A chromatography immunoassay device is described which can be used more easily, is protected from moisture and/or oxygen more effectively and can be produced at a lower cost than known chromatography immunoassay devices. The chromatography immunoassay device of the present invention is one in which one or more chromatography strips are stuck on a substrate made of a plate, each of the chromatography strips is sealed by closely adhering a substrate portion surrounding each chromatography strip to a seal film located on the chromatography strip, and the seal film and/or substrate possesses a film containing a dehumidifying agent and/or a film containing an oxygen absorbing agent.
    Type: Grant
    Filed: November 1, 1999
    Date of Patent: August 12, 2003
    Assignee: Abbott Laboratories
    Inventor: Eiji Kobayashi
  • Patent number: 6582969
    Abstract: Methods for the parallel, in vitro screening of biomolecular activity using miniaturized microfabricated devices are provided. The biomolecules that can be immobilized on the surface of the devices of the present invention include proteins, polypeptides, nucleic acids, polysaccharides, phospholipids, and related unnatural plyomers of biological relevance. These devices are useful in high-throughput drug screening and clinical diagnostics and are preferably used for the parallel screening of families of related proteins.
    Type: Grant
    Filed: May 12, 2000
    Date of Patent: June 24, 2003
    Assignee: Zyomyx, Inc.
    Inventors: Peter Wagner, Dana Ault-Riche, Steffen Nock, Christian Itin
  • Patent number: 6558959
    Abstract: An analytical device comprising a surfactant-treated porous reaction membrane having an exposed sample-contacting surface and at least one receptor area located in a limited region of the exposed sample-contacting surface. The limited region has a higher concentration of surfactant than areas of the sample-contacting surface that are peripheral to the limited region. To make the device, a surfactant-containing solution comprising at least 0.2% surfactant is added to the reaction membrane and allowed to dry. Then, a receptor reagent is added to a limited region of the reaction membrane. In the assay, the surfactant causes the liquid sample to flow faster through the portion(s) of the reaction membrane where receptor molecules are located.
    Type: Grant
    Filed: July 11, 2001
    Date of Patent: May 6, 2003
    Inventor: Albert E. Chu
  • Patent number: 6555390
    Abstract: A chromatographic assay or test device for detection and/or determination of an analyte in a test sample, comprises a base member, and a chromatographic medium located in or on said base member, the base member being provided with a receptacle to receive an applicator having the sample applied thereto, and the applicator being movable when located in said receptacle between a first position in which the applicator is out of fluid contact with the chromatographic medium, and a second position in which the applicator is in fluid contact with the chromatographic medium so as to apply a sample on the applicator to the chromatographic medium. In an alternative aspect, the test device comprises a base member, and a second member, at least one of the base member and the second member including a chromatographic medium, and the second member being slidably movable with respect to the base member from a first position to a second position.
    Type: Grant
    Filed: May 10, 1999
    Date of Patent: April 29, 2003
    Inventor: Howard Milne Chandler
  • Patent number: 6541277
    Abstract: An immunochemical assay device comprising a base member, an array disposed on the base member, and at least one assay indicia zone. The array comprises (I) a reservoir pad to receive sample liquid, (ii) a wicking membrane, and (iii) at least one filter zone interposed between the wicking membrane and the reservoir pad. The filter zone being operable to permit passage of any specific immunocomplex to the wicking membrane while impeding passage of larger components.
    Type: Grant
    Filed: June 23, 2000
    Date of Patent: April 1, 2003
    Assignee: Princeton Biomeditech Corporation
    Inventors: Jemo Kang, Byungwoo Youn, Young Ho Oh
  • Patent number: 6537828
    Abstract: An immunoassay device which comprises a Chromatography strip having a substrate adhered to the under surface thereof and a protective laminate adhered to the top surface thereof, wherein a space is arranged on the top and/or under surface of at least a partial region of a coloring region of the chromatography strip.
    Type: Grant
    Filed: December 13, 1999
    Date of Patent: March 25, 2003
    Assignee: Dainabot Co., Ltd.
    Inventors: Miho Nakaya, Ryotaro Chiba
  • Patent number: 6534324
    Abstract: A competitive assay strip and method of rapid competitive assay incorporating an additional step, allowing optimization or at least substantial improvement of conditions for competition between analyte conjugates and analytes or alternatively, binding of analyte, which is tailored to each particular analyte.
    Type: Grant
    Filed: May 12, 2000
    Date of Patent: March 18, 2003
    Assignee: Mizuho USA, Inc.
    Inventor: Benedict L. Zin
  • Patent number: 6528321
    Abstract: A chromatographic assay device according to the present invention provides a unidirectional immunoassay for an analyte in a whole blood sample with improved sensitivity and freedom from interference.
    Type: Grant
    Filed: June 26, 2000
    Date of Patent: March 4, 2003
    Assignee: Beckman Coulter, Inc.
    Inventors: Daniel Fitzgerald, Howard M. Chandler, Larry LaPointe
  • Patent number: 6509196
    Abstract: Methods for quantitatively measuring the amount of an analyte of interest in a fluid sample are disclosed. The methods involve providing a membrane having an application point, a detection zone, and a contact region, where the contact region is between the application point and the detection zone, and has test particles and internal control particles imbedded within it; contacting the application point with the fluid sample; maintaining the membrane under conditions sufficient to allow fluid to transport analyte by capillary action to the contact region, where the analyte binds to the test particles; further maintaining the membrane under conditions sufficient to allow fluid to transport analyte-bound test particles and internal control particles to the detection zone, where they interact with a detection reagent; and detecting the amount of test particles and the amount of internal control particles in the detection zone.
    Type: Grant
    Filed: January 4, 2000
    Date of Patent: January 21, 2003
    Assignee: Response Biomedical Corp.
    Inventors: Donald Elliott Brooks, Paul C. Harris, Andrew D. Olal, Zongcen Charles Xie, Brian G. Richards
  • Patent number: 6503725
    Abstract: Thiazole esters are suitable for detecting the presence of leukocytes in urine. Such thiazole esters are suitable for use in compositions, diagnostic devices, and methods for detecting the presence of leukocytes. In one embodiment, a thiazole ester is of the formula: or a salt or solvated salt thereof, in which A is an N-blocked amino acid residue or an N-blocked peptide chain, preferably N-blocked alanine or N-blocked polyalanine; and R1 is unsubstituted or substituted heteroaryl; alkenyl substituted with unsubstituted or substituted aryl; or alkenyl substituted with unsubstituted or substituted heteroaryl. For example, R1 may be thienyl, pyridyl, furyl, styryl, pyrrolyl, or indolyl. In still another embodiment, the thiazole ester includes unsubstituted or substituted fused hydrocarbyl rings as a substituent. In one embodiment, fused hydrocarbyl rings include naphthyl. In another embodiment, fused hydrocarbyl rings include anthryl.
    Type: Grant
    Filed: December 18, 2001
    Date of Patent: January 7, 2003
    Assignee: Hypoguard America Limited
    Inventor: Nam-Won Huh
  • Patent number: 6500665
    Abstract: A device for detecting and indicating the caffeine concentration of a beverage includes a disposable test sheet having a reagent section and a color chart. The reagent section is impregnated with a reagent which, when reacted with caffeine, produces a characteristic chromogenic and color change. These changes vary according to the caffeine concentration of a tested beverage sample. The color chart includes a plurality of color gradations corresponding to ranges of caffeine concentrations and includes numerical indicia corresponding to respective color gradations. The color chart further includes indicia indicative of representative beverages corresponding to respective color gradations and numerical ranges. The color chart may be arranged concentrically about the reagent section or in tabular list form. The test sheet includes a polymeric layer to prevent a beverage sample from soaking through the reagent section.
    Type: Grant
    Filed: March 13, 2001
    Date of Patent: December 31, 2002
    Inventor: John H. Deegan
  • Patent number: 6472226
    Abstract: Device for assaying an analyte, comprising a labelling zone, where a label can bind to the analyte, in communication with a capture zone, wherein the pore size of the capture zone is such that label which is not bound to the analyte can migrate therethrough, whereas label which is bound to the analyte cannot. During migration from the labelling zone (large pore size) to the capture zone (small pore size), unbound label can pass into and through the capture zone, whereas bound label will be captured at the junction of the labelling zone a the capture zone. The device relies upon the label being smaller than the analyte, such that free label is not retarded by the capture zone. It is particularly suitable for assying analytes such as spermatozoa, which are large in comparison with a label such as a labelled antibody.
    Type: Grant
    Filed: September 8, 2000
    Date of Patent: October 29, 2002
    Assignee: Genosis Limited
    Inventors: Martin Barradine, Tracey Gurmin
  • 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: 6406862
    Abstract: A C-reactive protein concentration level test and kit for on-site determination of C-reactive protein levels in biological samples is disclosed.
    Type: Grant
    Filed: October 6, 1999
    Date of Patent: June 18, 2002
    Assignee: The United States of America as represented by the Secretary of the Army
    Inventor: Teresa Krakauer
  • Patent number: 6399398
    Abstract: An assay device comprises a sample-collecting wick made from non-woven fabric material laminated to plastics sheet. Preferably, the fabric is a 30:70 blend of viscose and polyester, and has a fibrous structure in which more than two thirds of the fibers run substantially parallel to the intended direction of liquid flow in the wick.
    Type: Grant
    Filed: September 22, 1995
    Date of Patent: June 4, 2002
    Assignee: Unipath Limited
    Inventors: Carole R Cunningham, Stewart J Wilson
  • Patent number: 6379906
    Abstract: Compositions and methods for the detection of adult Taenia solium and the diagnosis and treatment of T. solium infection are described. The compositions contain one or more adult T. solium polypeptides. The polypeptides are useful as diagnostic agents for the detection of adult tapeworm infection. More preferably, the polypeptides are T. solium glycoprotein antigens referred to herein as T. solium excretory/secretory (TS/ES) polypeptides. The most preferred TS/ES polypeptide has a molecular weight of approximately 33 kDa, 38 kDa, or 42 kDa as determined by SDS-PAGE analysis.
    Type: Grant
    Filed: December 6, 1999
    Date of Patent: April 30, 2002
    Assignee: The United States of America as represented by the Department of Health and Human Services
    Inventors: Victor C. W. Tsang, Patricia P. Wilkins, James C. Allan
  • Patent number: 6379955
    Abstract: Fiberless optical sensors (plasticized PVC, acrylamide or gold particles) are described having a size ranging from between approximately 1 micrometer and 1 nanometer in diameter. The sensors comprise ionophores useful for the detection of intracellular analytes.
    Type: Grant
    Filed: September 20, 2000
    Date of Patent: April 30, 2002
    Assignee: Regents of the University of Michigan
    Inventors: Raoul Kopelman, Heather Clark, Eric Monson, Stephen Parus, Martin Philbert, Bjorn Thorsrud
  • Patent number: 6372514
    Abstract: Test strip device for accepting a liquid sample and forming an even fluid front across the test strip. When the sample is applied to a contacting surface, it runs down the surface where it collects between the contacting surface and a slope surface. As the sample collects, it evenly reaches fluid flow contact with an absorbent membrane. As a result, the sample forms an even fluid front across the membrane, improving the performance of the test strip device. Methods for using the device to accept a sample and to detect an analyte in the liquid sample are also provided.
    Type: Grant
    Filed: September 18, 1998
    Date of Patent: April 16, 2002
    Assignee: Syntron Bioresearch, Inc.
    Inventor: Jin Po Lee
  • Patent number: 6372515
    Abstract: A test card for drugs of abuse has a thin flat member having the size and shape of a business card. A plurality of immunoassay test strips extend longitudinally from top to bottom at the card and are fastened side by side in parallel on one or both sides of the test card within the outline of the card. Each test strip is reactive to provide a visual indication in response to a particular drug of abuse. The test card thus provides for the simultaneous detection of multiple analytes. Processes are also disclosed for making the drug test card with test strips on one and both sides of the card.
    Type: Grant
    Filed: April 21, 1999
    Date of Patent: April 16, 2002
    Assignee: American Bio Medica Corporation
    Inventors: Douglas Casterlin, Henry J. Wells, Stan Cipkowski
  • Patent number: 6368876
    Abstract: This invention relates to a lateral flow immunochromatographic assay device without a plastic housing. The assay includes a sample receiving region, analyte detection region and end region all made of porous material and capable of lateral flow. The analyte detection region includes labeling reagents, a capture reagent and a control reagent. The back of the porous material is laminated with a semi-rigid material with adequate mechanical strength. The top is partially covered with a thin plastic material so as to leave a portion of the sample receiving region exposed for sample application.
    Type: Grant
    Filed: January 9, 1998
    Date of Patent: April 9, 2002
    Assignee: Genzyme Diagnostics
    Inventors: Ching Huang, Eugene Fan
  • Patent number: 6365417
    Abstract: A device for collecting oral liquids includes a lateral flow chromatography strip having a collection pad for insertion into the mouth. The collection pad is separated from the remainder of the chromatography strip by a liquid impermeable removable barrier which prevents liquid in the collection pad from entering the chromatography strip. Once adequate oral liquid has been collected (as indicated by a sample sufficiency indicator), the device is withdrawn from the mouth and the barrier is removed to allow oral liquids to flow through the strip. The liquids interact with binding partners in the strip to provide test results, such as an indication that an analyte of interest is present in the liquid. The strip may be contained in a housing with an access opening through which the removable barrier may be manipulated, and windows through which test results may be viewed. This device avoids reflux of reagents from the strip into the mouth of a test subject during use.
    Type: Grant
    Filed: February 9, 2000
    Date of Patent: April 2, 2002
    Assignee: A-Fem Medical Corporation
    Inventors: William H. Fleming, Timothy P. Hyatt, Dudley B. Thomas
  • Patent number: 6352862
    Abstract: An analytical test device incorporating a dry porous carrier to which a liquid sample, eg. urine, suspected of containing an analyte such as HCG or LH can be applied indirectly, the device also incorporating a labelled specific binding reagent which is freely mobile in the porous carrier when in the moist state, and an unlabelled specific binding reagent which is permanently immobilised in a detection zone on the carrier material, the labelled and unlabelled specific binding reagents being capable of participating in either a sandwich reaction or a competition reaction in the presence of the analyte, in which prior to the application to the device of a liquid sample suspected of containing the analyte, the labelled specific binding reagent is retained in the dry state in a macroporous body, eg.
    Type: Grant
    Filed: June 9, 1997
    Date of Patent: March 5, 2002
    Assignee: Unilever Patent Holdings B.V.
    Inventors: Paul James Davis, Michael Evans Prior, Keith May
  • 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: 6335205
    Abstract: The invention concerns a method for the immunological determination of an analyte on a chromatographic test strip containing one or several absorbent matrices on a carrier material which are in liquid-transferring contact with one another wherein the matrices form an application zone at one end and a suction zone at the other end of the carrier material, a conjugate zone in the application zone or adjoining the application zone which contains a visually detectable, particle-labelled analyte binding partner, a chromatographic zone adjoining the conjugate zone and a capture zone between the chromatographic zone and suction zone wherein the capture zone contains solid phase-bound binding partners for the analyte or for an unlabelled analyte-specific binding partner by applying the analyte solution to the application zone and measuring the bound label in the capture zone as a measure of the analyte characterized in that a fluorescent dye is applied to the application zone or to a matrix between the application zo
    Type: Grant
    Filed: September 11, 1998
    Date of Patent: January 1, 2002
    Assignee: Roche Diagnostics GmbH
    Inventor: Jörg Bausback
  • Patent number: 6326214
    Abstract: An immunity testing device formed of a thin sheet of material folded to three portions, and the two end portions; named “front cover”0 and “back cover”; fold back to different sides of the center part; named base seat; to provide protection on both sides of the base seat. Two absorbent sheets bridged with a test paper are fixed on the side of base seat that's facing the front cover. A hole is present at the position of the first absorbent sheet on base seat for specimen application. The front cover is disposed with observation cover plates at the position corresponding to the test paper and/or water-absorbing sheets for observation of test result as well as for preventing pollution before, and after use. The test paper is pre-embedded with antibodies/antigens to capture the corresponding antigens/antibodies in the test specimen as in Immunity method. The used testing device can be burned down to ensure environmental protection.
    Type: Grant
    Filed: March 3, 1999
    Date of Patent: December 4, 2001
    Inventors: Yung Hsiang Liu, Wing-yee Chan
  • 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: 6319676
    Abstract: The invention provides an improved test cell for detecting the presence of an analyte in a liquid sample. The device has an elongate casing defining a liquid sample inlet, a reservoir volume, a test volume, and a window through the casing at the test volume. Disposed within the cell is a sample absorbent, a novel biphasic substrate and a reservoir, together capable of transporting an aqueous solution within the casing along a flow path extending from the sample inlet through the test volume and into the reservoir volume. The invention further comprises a method for detecting the presence of an analyte in a liquid sample using the device and a biphasic chromatographic material for carrying out the method.
    Type: Grant
    Filed: May 2, 1995
    Date of Patent: November 20, 2001
    Assignee: Carter Wallace, Inc.
    Inventors: Albert Nazareth, Mary Beth Boyle, Yea-Shun Cheng
  • Publication number: 20010039005
    Abstract: The present invention relates to a method of screening for drug binding to serum proteins by: preparing at least two solutions each including a concentration of a serum protein and a concentration of a candidate drug, wherein the concentration of the candidate drug is different for each of the at least two solutions; exposing each of the at least two solutions to a light source; measuring fluorescent emission by the serum protein or a serum protein-candidate drug complex for each of the at least two solutions upon said exposing; and determining whether a change in fluorescence emission is measured for an increased concentration of the candidate drug, wherein the change in fluorescence emission indicates binding of the candidate drug to the serum protein. A kit useful for performing a fluorimetric screening of drug binding to serum proteins is also disclosed.
    Type: Application
    Filed: January 23, 2001
    Publication date: November 8, 2001
    Inventors: Murali Ramanathan, Marilyn E. Morris
  • Patent number: 6309844
    Abstract: A novel monoclonal antibody which specifically binds to apo-B-48 is disclosed. The monoclonal antibody specifically binds to apo-B-48 but does not bind to apo-B-100.
    Type: Grant
    Filed: October 15, 1998
    Date of Patent: October 30, 2001
    Assignee: Fujirebio Inc.
    Inventors: Yoshiaki Uchida, Yoshihiro Kurano
  • Patent number: 6303326
    Abstract: The present invention includes the characterization of the major salivary protein or enzyme of the corn earworm Helicoverpa zea for triggering resistance to bacterial blight and frogeye leafspot in soybeans and for triggering resistance to insects in tomatoes. The invention includes an enzyme or a novel protein secreted from the salivary glands of certain insects including the saliva of species belonging to the order Hymenoptera and Lepidoptera. The regurgitant of Helocoverpa zea obtained from the functional salivary glands contains a protein that possesses glucose oxidase activity. The amino acid sequence of the protein is unique and when the protein is applied to plants, it triggers disease and insect resistance systematically. The physical and kinetic attributes of the enzyme are a pH of 7.0, a pI of 4.4 and a molecular weight of 88 kd. The km and Vmax of the enzyme for glucose is 26.9 mmol and 26.7 &mgr;mol min−1 mg−1, respectively.
    Type: Grant
    Filed: December 3, 1998
    Date of Patent: October 16, 2001
    Assignee: University of Arkansas
    Inventors: Gary W. Felton, Mary C. Mathews, Jianlong Bi, John B. Murphy
  • Patent number: 6297020
    Abstract: Disclosed is an improvement to a dry assay device for determining the concentration of a first analyte in a sample of body fluid and a second analyte in the same sample of body fluid. The device involves the use of a strip of an absorbent material through which the sample of body fluid flows and wherein the first analyte is determined calorimetrically in a first region of the strip and the second analyte is determined by an immunoassay which takes place in a second region of the strip located downstream from the first region. The improvement involves placing the strip in a hollow casing having a top and a bottom and which is so constructed that when the top and bottom of the casing are mated there is formed a U shaped, body fluid impervious barrier around the first region of the strip to prevent the sample of body fluid from flowing in any direction other than in the direction of the second region of the strip.
    Type: Grant
    Filed: March 1, 1999
    Date of Patent: October 2, 2001
    Assignee: Bayer Corporation
    Inventor: David A. Brock
  • 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: 6287791
    Abstract: This invention relates to an improved method for the multi-parameter analysis of cells from peripheral blood or bone marrow. The method uses a nucleic acid dye, at least two fluorescently labelled monoclonal antibodies and at least two light scatter parameters to differentiate and discriminate between and among different cells in the blood or bone marrow.
    Type: Grant
    Filed: May 6, 1994
    Date of Patent: September 11, 2001
    Assignee: Becton Dickinson and Company
    Inventors: Leon W M M Terstappen, Chia-Huei Chen
  • 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: 6284194
    Abstract: An analytical device comprising a surfactant-treated porous reaction membrane having an exposed sample-contacting surface and at least one receptor area located in a limited region of the exposed sample-contacting surface. The limited region has a higher concentration of surfactant than areas of the sample-contacting surface that are peripheral to the limited region. To make the device, a surfactant-containing solution comprising at least 0.2% surfactant is added to the reaction membrane and allowed to dry. Then, a receptor reagent is added to a limited region of the reaction membrane. In the assay, the surfactant causes the liquid sample to flow faster through the portion(s) of the reaction membrane where receptor molecules are located.
    Type: Grant
    Filed: March 11, 1998
    Date of Patent: September 4, 2001
    Inventor: Albert E. Chu
  • Patent number: RE37437
    Abstract: A solid diagnostic device for the quantitative determination of substances of biological affinity in biological fluids is described. A process is also described in which the biological fluid is brought into contact with a specific functional sector of the device, the fluid migrates through several functional sectors situated beside one another and containing suitable reagent components, and one or more substances of biological affinity are detected in such functional sectors which contain, for each substance to be detected, at least one combination partner of biological affinity, attached to a solid phase.
    Type: Grant
    Filed: October 18, 1995
    Date of Patent: November 6, 2001
    Assignee: Dade Behring Marburg, GmbH
    Inventors: Heinz-Jürgen Friesen, Gerd Grenner, Hans-Erwin Pauly, Helmut Kohl, Klaus Habenstein, Joseph Stärk
  • Patent number: RE38430
    Abstract: A chromatographic test strip comprising a solid support having at least a first portion and a second portion with said portions being in the same plane so as to permit capillary flow communication with each other. The sample is added to the first portion. The first portion also may comprise a tracer portion having a tracer movably supported therein. The tracer consists of a visible particulate marker. In the second portion, a binder is immobilized. The test strip is useful in a variety of immunoassays.
    Type: Grant
    Filed: October 6, 1998
    Date of Patent: February 17, 2004
    Assignee: Becton, Dickinson and Company
    Inventor: Robert W. Rosenstein