Tube, Bottle, Or Dipstick Patents (Class 436/810)
  • Patent number: 6641993
    Abstract: Apparatus and a method for mixing a liquid within a disposable aspirating probe tip so that most of the liquid is forced to move past a transition zone between two different inside diameters to cause rotational mixing. The apparatus and method can be used to provide agglutination of blood, which in turn can be used for blood typing. The probe tip can comprise a single integral piece, or two separate portions. The transition zone can comprise a sharp demarcation between inside diameters, or a smooth one.
    Type: Grant
    Filed: February 22, 2000
    Date of Patent: November 4, 2003
    Assignee: Ortho Clinical Diagnostics, Inc.
    Inventors: Merrit N. Jacobs, Zhong Ding, Ronald F. Brookes
  • Patent number: 6632681
    Abstract: A device and method for filtering a biologically derived sample and for mixing the sample with a reagent, comprising a fluid container defining a reservoir compartment and including a container outlet, a filter and a fluid flow-through matrix disposed in a flow path between the reservoir compartment and the container outlet. Water-soluble, dried reagent is retained on the matrix. Means is provided for urging sample in an aqueous liquid in the reservoir compartment through the filter and matrix and out the container outlet. Pressure is applied to the sample in an aqueous liquid in the reservoir compartment to cause the sample to flow in liquid through the filter and matrix and out of the container for analysis.
    Type: Grant
    Filed: July 24, 2000
    Date of Patent: October 14, 2003
    Assignee: EY Laboratories
    Inventor: Albert E. Chu
  • 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: 6617116
    Abstract: Assay devices, kits, and methods for detection of one or more analytes in a sample are provided. The assay device features the controlled release of reagents and hence is particularly suitable for binding assays such as immunoassays. The assay device achieves greater sensitivity than conventional rapid test assays, leading to stronger and/or more stable visual signals than those produced by conventional devices, easier interpretation of results, and reduced occurrence of indeterminate results. The device can be used for detecting analyte in a variety of biological samples without the need for conventional sample filtration techniques, and thus is suitable for use by untrained personnel without specialized equipment. In addition, the device can be used to simultaneously analyze a number of analytes using a single sample.
    Type: Grant
    Filed: January 25, 2001
    Date of Patent: September 9, 2003
    Assignee: Genelabs Diagnostics Pte. Ltd.
    Inventors: Ming Guan, Hsiao Ying Chen
  • 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: 6599708
    Abstract: A testing apparatus 10 having an absorbent matrix 12, including a membrane 14 which contains a plurality of counter-ions 16. Chromionophore (or fluorionophore)s 18 and affinophores 22 compete to carry ions into the membrane 14 and neutralize the charge of the counter-ions 16. Biological recognition molecules 42 bind to a portion of the affinophores 22 and prevent them from entering the membrane 14, thereby allowing more chromionophore (or fluorionophore)s 18 to enter the membrane 14. The portion of affinophores 22 bound to the biological recognition molecules 42 is inversely proportional to the amount or concentration of analyte 40 occurring within the solution or medium 30. The result of this is that the color of the membrane-covered matrix changes in a manner related to the concentration of the analyte. One application of this apparatus is a strip test for prediction of ovulation.
    Type: Grant
    Filed: June 19, 2001
    Date of Patent: July 29, 2003
    Assignee: IA, Inc.
    Inventors: Judith Louise Erb, Nallaperumal Chidambaram, James Germain Downward, IV
  • Patent number: 6596502
    Abstract: The invention concerns a home kit and a method for detection of the presence of a fecal parasite in a stool.
    Type: Grant
    Filed: March 15, 2001
    Date of Patent: July 22, 2003
    Assignee: Lee Research Laboratory, Inc.
    Inventor: Martin Jerome Lee
  • Patent number: 6582970
    Abstract: The present invention relates to a simple immunochemical semi-quantitative assay method according to chromatography, which comprises trapping a certain amount of an analyte in a sample with a predetermined amount of a fixed antibody for the analyte before qualitative analysis of the analyte, the certain amount corresponding to the amount of the fixed antibody, and thereby decreasing a concentration of the analyte to be subjected to subsequent immunochemical qualitative determination, and an apparatus therefor.
    Type: Grant
    Filed: June 22, 2000
    Date of Patent: June 24, 2003
    Assignee: Teikoku Hormone MFG. Co, Ltd.
    Inventor: Hideaki Manita
  • Patent number: 6573108
    Abstract: An assay device comprising: (a) a substrate comprising: (i) a porous material capable of chromatographically transporting a liquid; and (ii) one or more test reagents for an assay provided on the porous material; and (b) a transparent water-impermeable coating polymer attached to the porous material so as to define a continuous bibulous compartment.
    Type: Grant
    Filed: November 14, 1999
    Date of Patent: June 3, 2003
    Assignee: Diamatrix Limited
    Inventors: David John Hardman, James H. Slater, Adam G. Reid, William K. Lang, James Richard Jackson
  • 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: 6537744
    Abstract: Sensitive methods using a variety of biomarkers in oral saliva of humans and animals to detect, measure, and quantify the presence of infectious and non-infectious agents and the functional status of living tissues in both (1) biomedical and (2) environmental applications. With the in vivo biomedical applications, saliva samples are taken from human or animal subjects and biomarkers, such as enzyme or antibody levels, are measured. The extent of exposure to an agent is measured by the presence of specific chemical or biological constituents, by the degree of the inhibition of enzymes, or by the changes in the amount of the biochemicals in saliva. With the in vitro environmental applications, enzymes or other biochemicals from animal or human saliva can be used to monitor the presence of toxic or reactive agents in tissue samples, urine, feces, milk, air, water, soil, or plants. The amount of toxicant in samples is estimated from a standard curve for that agent.
    Type: Grant
    Filed: November 10, 1997
    Date of Patent: March 25, 2003
    Inventor: Mohammed A. S. Al-Bayati
  • Patent number: 6537762
    Abstract: The present invention provides a peptide mimotope of the non-peptide mycotoxin deoxynivalenol. In particular, the peptide mimotope competes with deoxynivalenol for binding to a monoclonal antibody and is antagonistic to the inhibitory effects of deoxynivalenol on in vitro protein synthesis. The present invention also provides a method that uses the peptide mimotope to determine whether corn, grains or mixed feed is contaminated with fungi that produces deoxynivalenol. The present invention further provides transgenic plants resistant to deoxynivalenol.
    Type: Grant
    Filed: July 27, 2000
    Date of Patent: March 25, 2003
    Assignee: Board of Trustees of Michigan State University
    Inventors: Lynn Patrick Hart, James J. Pestka, Qiaoping Yuan
  • 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: 6528323
    Abstract: A test strip adapted to receive a sample and detect an analyte therein is provided. The test strip comprises a sample addition zone to which a sample may be added; an absorbent zone proximal to the sample addition zone; one or more test zones distal to the sample addition zone, at least one of the test zones including a first analyte binding agent immobilized therein which is capable of binding to the analyte to be detected; and a terminal sample flow zone distal to the one or more test zones, the absorbent zone being positioned relative to the sample addition zone and having an absorption capacity relative to the other zones of the test strip such that a distal diffusion front of a sample added to the sample addition zone diffuses from the sample addition zone to a distal diffusion point within the terminal sample flow zone and then reverses direction and diffuses proximal relative to the one or more test zones.
    Type: Grant
    Filed: June 14, 1999
    Date of Patent: March 4, 2003
    Assignee: Praxsys Biosystems, Inc.
    Inventors: Richard M. Thayer, Alan J. Polito, Robert K. Dinello, George H. Sierra, Henry J. Wieck
  • Publication number: 20030026739
    Abstract: The invention describes a process for preparing a microtiter-microarray device that includes a bottomless microtiter plate attached to the first side of one or more substrates with microarrays of materials attached thereto. The microtiter plate and the one or more substrates are attached through one or more gaskets. Preferably, the microtiter plate is attached to one face of the one or more gaskets by an irreversible water-tight seal, and the first side of the one or more substrates is attached to the opposite face of the one or more gaskets by a reversible, water-tight seal.
    Type: Application
    Filed: June 13, 2002
    Publication date: February 6, 2003
    Inventors: Gavin MacBeath, Jennipher Grudzien
  • Patent number: 6514773
    Abstract: Subject matter of the invention is a method for detecting surface contamination by an analyte by wiping the analyte off the surface with the aid of a wiping surface, eluting the analyte from the wiping surface with an eluant, and detecting the analyte in the eluate in an immunological detection reaction, characterized in that: a) the surface to be tested for the analyte is wiped with a wiping surface, b) the wiping surface is brought into contact with the planar surface of a capillary active, chromatographic test strip which has an eluant application zone at its one end and a target zone at its other end whereby contact is made in an area between these two zones, c) eluting liquid is applied onto the zone provided for this purpose, said liquid moving toward the target zone passes the contact site with the wiping surface as a consequence of capillary forces, whereby analyte is taken up by the eluant, and d) in the target zone, the analyte is measured in an immunological binding reaction.
    Type: Grant
    Filed: July 24, 1995
    Date of Patent: February 4, 2003
    Assignee: Securetec Detektions-Systeme AG
    Inventors: Christian Klein, Hans-Peter Josel, Ada Goerlach-Graw, Reinhold Hilpert, Florian Binder, Josef Ritter, Rudolf Zimmermann
  • Patent number: 6514769
    Abstract: An assay device, a fluid analyte sample separator device and methods for use of thereof for determining whether the integrity of a fluid analyte sample has been compromised and for contemporaneously assaying the sample for the presence or absence of multiple analytes, such as drugs of abuse. The device is composed of a housing having separate slots therein for insertion of one or more analyte test strips, one end of which protrudes from the housing, and one or more units of a sample integrity monitoring system. The device may be used in dipstick or cassette form. An analyte sample separator for division of sample and retention of uncontaminated sample for further testing is also provided. The analyte test strips and sample integrity monitoring system are replaceable, so that the panel of analytes and of sample condition parameters tested can be customized.
    Type: Grant
    Filed: July 29, 1999
    Date of Patent: February 4, 2003
    Inventor: Jin Po Lee
  • 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: 6509164
    Abstract: A biological fluid collection container comprising a cup member, a lid assembly removably mounted to the cup member comprising a housing with a downwardly extending cylindrical skirt, a luer lock with a throughgoing bore extending from one side of the lid housing. A hollow tube extends from the other side of the lid housing adjacent the luer lock and is axially aligned with the throughgoing bore of the luer lock. The hollow tube is provided with a plurality of throughgoing holes leading into its lumen along its surface to provide for a sampling along various liquid level layers of the biological fluid specimen collected in the cup member so that when the biological fluid specimen is removed from the cup member a representative sampling is obtained.
    Type: Grant
    Filed: October 10, 2000
    Date of Patent: January 21, 2003
    Assignee: LaMina, Inc.
    Inventor: Raouf A. Guirguis
  • Patent number: 6500629
    Abstract: The subject invention pertains to methods and materials for accurately assessing the presence or absence of analytes of interest in samples, particularly in physiological samples. The subject invention involves utilizing a ligand binding domain (LBD) of a receptor to selectively capture the analyte target specific for that LBD. In one embodiment, the receptor is a protein or polypeptide. The ligand binding domain is allowed to react with a sample and the presence or amount of ligand (i.e., target analyte) bound by the LBD is determined. Suitable analytes include soluble analytes such as hormones, enzymes, lipoproteins, bacterial or viral antigens, immunoglobulines, lymphokines, cytokines, drugs, soluble cancer antigens, and the like. The methods of the present invention can be performed in both liquid-phase and solid-phase.
    Type: Grant
    Filed: September 13, 2000
    Date of Patent: December 31, 2002
    Assignee: Equitech Laboratories, Inc.
    Inventors: Brian D. Cleaver, Mike L. Green
  • Patent number: 6492127
    Abstract: A lateral flow testing device is provided for testing a biological fluid for the presence of methamphetamines. The device includes a substrate element such as a nitrocellulose strip, including an antibody zone and an immobilized drug conjugate zone for detecting presence of methamphetamines, and an on-board chemical reactant for preventing undesirable cross-reactivity to ephedrine and/or pseudoephedrine that may be present in the biological fluid being tested. Preferably, the on-board chemical reactant is sodium periodate. Methods for preparing test devices are provided including the step of striping a substrate sheet with a solution containing sodium periodate during manufacture of methamphetamine lateral flow test strips.
    Type: Grant
    Filed: January 23, 2001
    Date of Patent: December 10, 2002
    Assignee: Varian, Inc.
    Inventors: Raegan E. Goodell, Dennis D. Blevins
  • Patent number: 6485982
    Abstract: Disclosed is a test cell and a method for detection of a preselected ligand in a liquid sample such as a body fluid. The test cell includes an elongate outer casing which houses an interior permeable material capable of transporting an aqueous solution and defining a sample inlet, a test volume, and a reservoir volume. The reservoir volume is disposed in a section of the test cell spaced apart from the inlet and is filled with sorbent material. The reservoir acts to receive liquid transported along a flow path defined by the permeable material and extending from the inlet and through the test volume. In the test volume is a test site which includes a first protein having a binding site specific to a first epitope of the ligand immobilized in fluid communication with the flow path. The test site can be observed through a window of the casing.
    Type: Grant
    Filed: June 6, 1995
    Date of Patent: November 26, 2002
    Assignee: Armkel, LLC
    Inventor: David E. Charlton
  • Patent number: 6475805
    Abstract: A test device, system and method, the device composed of an elongated, toothbrush-shaped, transparent, plastic housing and a lateral-flow test strip for the detection of an analyte, such as a beta-lactam in milk, in the housing, the housing having an expansion cavity to receive expanded, liquid-contacted, absorbing material in the test strip, and to control lateral flow rate and times in the test strip.
    Type: Grant
    Filed: April 4, 2000
    Date of Patent: November 5, 2002
    Assignee: Charm Sciences, Inc.
    Inventors: Stanley E. Charm, Richard Skiffington, Robert J. Markovsky, Eliezer Zomer, Steven J. Saul
  • 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: 6468734
    Abstract: An object is to obtain a container for measurement of cell functions which is simplified in operation, less risky and capable of measuring the cell functions very accurately. A container for measurement of cell functions, for use in the determination of a physiologically active substance produced by blood cells, is constituted such that an amount of material capable of inducing production of the physiologically active substance, when extracted by collecting water of a volume equal to a liquid volume to be subjected to measurement, is controlled at a level insufficient to induce production of the physiologically active substance from the blood cells.
    Type: Grant
    Filed: January 4, 2001
    Date of Patent: October 22, 2002
    Assignee: Sekisui Kagaku Kogyo Kabushiki Kaisha
    Inventors: Koji Kobayashi, Yuji Setoguchi, Kiyoshi Kuriyama
  • Patent number: 6461874
    Abstract: It has been found that casein and salts of casein are useful as replacements for, or in addition to, BSA as materials for coating solid phases, particularly magnetic particles, used in immunoassays and other binding assays for separation of the desired analyte. By using casein, immunoassays having improved stability and fewer discordant samples have been developed. Casein used at a concentration of 0.05-4.0 grams per gram of paramagnetic particle (optimally approximately 0.78-1.2 grams of casein per gram of magnetic particle) has been found to confer this benefit.
    Type: Grant
    Filed: January 26, 2000
    Date of Patent: October 8, 2002
    Assignee: Bayer Corporation
    Inventors: Wei-Chao Ni, Daniel W. Eustace, Steve Chin-Shen Chang
  • Patent number: 6461873
    Abstract: The caffeine detector uses a paper chromatographic technique to measure the concentration of caffeine in a beverage. The device includes a well or other receptacle for containing a predetermined test volume of the beverage. A paper strip is suspended so that one end of the strip dips into the well. The strip is divided into two zones, the first zone being coated with at least one molecular imprint polymer (MIP) which absorbs substances which may interfere with quantification of caffeine. The second zone is coated with an MIP which selectively absorbs caffeine and chromogenic reagents which provide calorimetric visualization of the migration of caffeine through the second zone. The second zone bears indicia calibrating the paper strip so that the concentration of caffeine in the beverage may be determined by the height or distance which the caffeine migrates up the paper strip.
    Type: Grant
    Filed: March 17, 2000
    Date of Patent: October 8, 2002
    Inventors: Daniel Catania, Steven Ignelzi, Steven Baugh
  • Patent number: 6461828
    Abstract: A diagnostic tool is disclosed for accurately and rapidly diagnosing the condition of an ailing organ. Although applicable to numerous organ and organ systems, this application particularly illustrates the concept of conjunctive marker utilization as it relates to diagnosing and distinguishing congestive heart failure. The invention particularly relates to the conjunctive utilization of cardiac Troponin I (cTn-I) and natriuretic peptide, e.g. ANP, pro-ANP, BNP, pro-BNP and CNP as a retrospective tool for diagnosing the underlying mechanism of heart failure and as a prospective analytical device for monitoring disease progression and efficacy of therapeutic agents.
    Type: Grant
    Filed: September 4, 2001
    Date of Patent: October 8, 2002
    Assignee: Syn X Pharma
    Inventors: Eric B. Stanton, George Jackowski
  • Patent number: 6458548
    Abstract: A container for measurement of cell functions, for use in the determination of a physiologically active substance produced by blood cells, is constituted such that an amount of material capable of inducing production of the physiologically active substance, when extracted by collecting water of a volume equal to a liquid volume to be subjected to measurement, is controlled at a level insufficient to induce production of the physiologically active substance from the blood cells. A container for measurement of cell functions in which a material capable of inducing production of a physiologically active substance in blood when contacted with the blood is accommodated in such a condition as being contactable with blood, and in which an amount of the material capable of inducing production of the physiologically active substance in the container before use is limited to a level insufficient to influence a measured value of the physiologically active substance.
    Type: Grant
    Filed: April 1, 1998
    Date of Patent: October 1, 2002
    Assignee: Sekisui Kagaku Kogyo Kabushiki Kaisha
    Inventors: Koji Kobayashi, Yuji Setoguchi, Kiyoshi Kuriyama
  • Patent number: 6455324
    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 comprise 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: September 8, 2000
    Date of Patent: September 24, 2002
    Assignee: Amira Medical
    Inventor: Joel S. Douglas
  • Patent number: 6444436
    Abstract: A method for analyzing blood enables one to isolate, detect, enumerate and confirm under magnification the presence or absence of target cancer cells and/or hematologic progenitor cells, or other rare events which are known to circulate in blood. The analysis is performed in a sample of centrifuged anticoagulated whole blood. The analysis involves both morphometric and epitopic examination of the blood sample while the blood sample is disposed in a centrifuged blood sampling container. The epitopic analysis of the presence or absence of cancer cells relies on the detection of epitopes which are known to be present on cancer cells and not on normal circulating blood cells; and the epitopic analysis of the presence or absence of hematologic progenitor cells relies on the detection of epitopes which are known to be present on hematologic progenitor cells and not on normal circulating blood cells.
    Type: Grant
    Filed: February 22, 2000
    Date of Patent: September 3, 2002
    Inventors: David L. Rimm, Paul Fiedler, Robert A. Levine, Stephen C. Wardlaw
  • Patent number: 6436662
    Abstract: This invention provides a novel device and method for preparing cytology slides. The device comprises a book-like form including an absorbent material and filter attached to the inside surface of a front cover and a cytology slide removeably attached to an inside surface of a back cover. A sample is removed from the body of a patient, placed in a liquid-based solution, and then on the filter. When the book-like form is closed, the sample is effectively transferred to the slide.
    Type: Grant
    Filed: April 4, 2000
    Date of Patent: August 20, 2002
    Assignee: Digene Corporation
    Inventors: Iwona Mielzynska, Jay Payne, James Lazar
  • Patent number: 6413784
    Abstract: Multi-sectioned fluid delivery devices with sensor membranes for use in detection of target molecules in gas or liquid samples are provided.
    Type: Grant
    Filed: March 15, 2000
    Date of Patent: July 2, 2002
    Assignee: Idego ApS
    Inventors: Jorgen Schjerning Lundsgaard, David Morgan Thomas, Torsten Bjoern
  • Patent number: 6406920
    Abstract: A process for carrying out a specific binding assay (for example an immunoassay) in which (a) a sample under assay, possibly containing a substance being tested for, is reacted with (b) a specific binding partner for the substance being tested for, immobilised on a solid support, and (c) a specific binding partner for the substance being tested for which is conjugated to a detectable marker, thereby to form a complex by reaction between whatever quantities are present of the substance being tested for with reagents (b) and (c), in which the marker is immobilised to the support via the substance being tested for, and is detected or assayed as an index of the quantity present in the sample (a) of any of the substance being tested for; characterised in that reaction ingredients (a), (b) and (c) are all mixed in a single step for reaction in a single reaction liquid, and competitive interference between the binding reactions of the substance being tested for and reagents (b) and (c) is avoided either by use of an
    Type: Grant
    Filed: August 7, 1996
    Date of Patent: June 18, 2002
    Assignee: Inverness Medical Switzerland GmbH
    Inventors: Paul James Davis, Philip Porter
  • Patent number: 6403383
    Abstract: A diagnostic test kit has a cup-like container for retaining a fluid sample to be tested and the open top end of the container is closed by a closure cap on the open end. There is a slit in the closure cap to receive a multiple test card having a plurality of immunoassay test strips thereon with visual endpoints to indicate presence or absence of a selected antigen or antibody. The height of the container is such that the visual indication of the presence or absence of a selected antigen or antibody is visible above the closure cap when the bottom end of the test card is in contact with the fluid sample within the container.
    Type: Grant
    Filed: June 15, 1999
    Date of Patent: June 11, 2002
    Assignee: American Bio Medica Corp.
    Inventors: Douglas Casterlin, Stan Cipkowski
  • 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: 6395500
    Abstract: Antibodies capable of detecting a beer spoilage lactic acid bacterium. Lactic acid bacteria possessing beer spoilage ability are grown in beer, a mammal is immunized to produce antibodies for the detection of beer spoilage lactic acid bacteria, and the beer spoilage lactic acid bacteria are detected using the antibodies. Further, by employing the antibodies, there are provided a method and a kit for detecting a beer spoilage lactic acid bacterium specifically, rapidly, conveniently, and reproducibly, which bacterium contaminates the process of beer production, grows in the produced beer, and lowers the quality of the beer.
    Type: Grant
    Filed: July 20, 1999
    Date of Patent: May 28, 2002
    Assignee: Sapporo Breweries Limited
    Inventor: Youichi Tsuchiya
  • Patent number: 6391652
    Abstract: An immunoassay method comprising bringing an immobilized phase comprising, at different positions on a water-absorbable base material, at least two first immunity substances capable of specifically binding with at least two kinds of assay target substances selected from the group consisting of verotoxin-producing Escherichia coli, verotoxin and human hemoglobin contained in a test sample, into contact with a test sample and a liquid containing labeled immunity substances each comprising a second immunity substance that is labeled with colored particles and capable of binding with said assay target substance, thereby to form an assay target substance-labeled immunity substance complex and to bind said complex with respective first immunity substances at the immobilized phase.
    Type: Grant
    Filed: July 22, 1998
    Date of Patent: May 21, 2002
    Assignee: Nitto Denko Corporation
    Inventors: Keisaku Okada, Kenjiro Mori, Shuji Senda
  • Patent number: 6383748
    Abstract: The present invention is directed to methods for analyzing one or more fluid samples for the presence, amount or identity of one or more analytes optionally present in said samples, which uses a device having one or more round wells with a fixed diameter, the wells exposing a substrate of a specific thickness, whereby the substrate has oriented through going channels, in the area of the substrate exposed in the well is provided with at least one binding substance specific for a least one of said analytes. Using the device the sample fluid is forced to pass through the channels in the substrate from the upper side of the substrate to the lower side of the substrate and back at least one time, under conditions that are favorable to a reaction between any analyte present in the sample and the binding substances.
    Type: Grant
    Filed: September 14, 1999
    Date of Patent: May 7, 2002
    Assignee: Pamgene B.V.
    Inventors: Wilhemus M. Carpay, Roeland F. Papen
  • 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: 6365340
    Abstract: The present invention is directed to a method of detecting prostatitis comprising obtaining an expressed prostatic secretion from a patient; contacting a device having diagnostic test reagents to the expressed prostatic secretion, the diagnostic test reagents reacting with the expressed prostatic secretion to produce a change in the device; reading the change in the device to produce a positive or negative experimental test result, wherein the experimental test result is positive when the experimental test result is pre-determined to correspond with a number above 10 for the number of white blood cell per high powered field and the experimental test result is negative when the experimental test result corresponds with a number of 10 or less for the number of white blood cell per high powered field; and determining presence of prostatitis with the positive experimental test result and the absence of prostatitis with the negative experimental test result.
    Type: Grant
    Filed: November 11, 1999
    Date of Patent: April 2, 2002
    Inventor: Ronald E. Wheeler
  • 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: 6352863
    Abstract: An assay device and method are provided which allow the determination of the presence or absence of at least one analyte in a test sample, while providing specific identification of the test subject. The assay device includes a reaction medium having at least one reaction zone and at least one control zone, which is capable of providing a pattern suitable for identifying the test subject. The pattern suitable for identifying the test subject is preferably a fingerprint. In a preferred embodiment of the invention, the reaction zone and the control zone include at least one member of a ligand/receptor pair.
    Type: Grant
    Filed: January 27, 1997
    Date of Patent: March 5, 2002
    Assignee: La Mina, Inc.
    Inventor: Raouf A. Guirguis
  • 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