Test Strip Or Test Slide Patents (Class 435/970)
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Patent number: 7238537Abstract: 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 immobilized 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: GrantFiled: September 4, 2001Date of Patent: July 3, 2007Assignee: Inverness Medical Switzerland GmbHInventors: Paul James Davis, Michael Evans Prior, Keith May
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Patent number: 7238519Abstract: An immunoassay cassette, apparatus, and method for detecting an analyte in a liquid body-fluid sample are disclosed. The cassette has a body and a support mounted on the body, for movement relative to the body to first and second transfer positions. Sample supplied to a sample well in the cassette body is transferred to a reagent reservoir on the cassette body, by moving the support to its first transfer position. Here the sample reacts with a first reagent composition in the reservoir effective to form a modified sample. The modified sample is then transferred to a reagent strip on the support by moving the support to its second transfer position. The reagent strip has a transfer zone at which sample material is transferred to the strip, a second reagent composition effective to react with the modified sample to form a detectable analyte-dependent product, and a detection zone located downstream at which the detectable product can be observed.Type: GrantFiled: December 17, 2004Date of Patent: July 3, 2007Assignee: Cholestech CorporationInventors: Neal F. Bellet, Jeffrey Shindelman, Thomas E. Worthy, Kimberly Haley, Richard K-T Lee, Jane Eunhee Kyung, Suyue Qian
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Patent number: 7238538Abstract: A chromatographic assay device for the analysis of an analyte in a liquid sample has a proximal sample application zone and a distal test zone. The test zone contains a first ligand capable of binding with the analyte to form an analyte-ligand complex. The device also includes a spatially distinct reservoir containing a labeled reagent capable of binding to the analyte-ligand complex; an absorbent sink which is positioned to be capable of drawing the contents of the spatially distinct reservoir through the test zone; and structures for contacting the spatially distinct reservoir with the chromatographic medium so that the labeled reagent migrates from the reservoir to the absorbent sink, and thereby through the test zone to determine the presence or absence of the analyte. The device is used in a method for detecting analyte.Type: GrantFiled: September 16, 2004Date of Patent: July 3, 2007Inventors: Helmut E. Freitag, Qinwei Shi
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Patent number: 7229839Abstract: 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: GrantFiled: January 17, 2003Date of Patent: June 12, 2007Assignee: Relia Diagnostic Systems, LLCInventors: Richard M. Thayer, Alan J. Polito, Robert K. Dinello, George H. Sierra, Henry J. Wieck
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Patent number: 7220595Abstract: An immunoassay cassette, apparatus, and method for detecting an analyte in a liquid body-fluid sample are disclosed. The cassette has a body and a support mounted on the body, for movement toward and away from a sample transfer position. Sample supplied to a sample well in the cassette body is taken up by a reagent reservoir containing a first reagent composition effective to form a modified sample. The support provides a reagent strip having a transfer zone that is brought into contact with the reservoir, when the support is in the transfer position, a detection zone located downstream of the transfer zone, and a second reagent composition effective to react with the modified sample to form a detectable analyte-dependent product. By controlling movement of the support, volume and rate of sample flow from the reservoir to the strip can be controlled to optimize and/or standardize sample-transfer conditions in the assay.Type: GrantFiled: June 6, 2003Date of Patent: May 22, 2007Assignee: Cholestech CorporationInventors: Anthony J. Nugent, Leanne M. Cowley, Neal F. Bellet, Jeffrey Shindelman, Michael E. Leos, Thomas E. Worthy, Kimberly Haley
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Patent number: 7214531Abstract: An assay system has a chamber that receives a test strip onto which a sample comprising an analyte has been placed. The chamber is in gaseous communication with a piezoelectric material that generates an electrical signal in response to a pressure change in the chamber that is caused by a reaction between the analyte and a reagent.Type: GrantFiled: April 15, 2002Date of Patent: May 8, 2007Assignee: Disan, Inc.Inventors: Mahmoud Ladjevardi, Theodore Sand
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Patent number: 7195923Abstract: The present invention provides methods for determining a ratio of an amount of a glycated form of a protein to a total amount of the protein in a sample containing the glycated protein, the glycosylated protein, or the glycoprotein. The method incorporates lateral flow test strip or vertical flow test strip devices having negatively charged carboxyl or carboxylate groups and hydroxyboryl groups immobilized and interspersed on a solid support matrix. The solid support matrix may include derivatives of cellulose (e.g., carboxy cellulose) derivatized with carboxylic acid (e.g., carboxylate, carboxyl) groups and hydroxyboryl compounds including phenylboronic acid (e.g., phenylborate), aminophenylboronic acid, boric acid (e.g., borate), or other boronic acid (e.g., boronate) compounds. The present invention is usefi.il for monitoring glycation or glycosylation of hemoglobin or albumin for monitoring glycemic control (e.g., glycemia in diabetes).Type: GrantFiled: January 31, 2002Date of Patent: March 27, 2007Assignee: Scripps Laboratories, Inc.Inventors: Ralph P. McCroskey, Cameron E. Melton
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Patent number: 7195924Abstract: Provided is a method for immobilizing a biomolecule on a solid substrate. The method includes coating the solid substrate with silane anhydride to introduce an anhydride functional group onto a surface of the solid substrate; obtaining a carboxyl group from the anhydride functional group by hydrolysis; reacting the carboxyl group with carbodiimide and succinimide to activate the carboxyl group; and contacting the biomolecule with the solid substrate having the activated carboxyl group on its surface to immobilize the biomolecule on the solid substrate.Type: GrantFiled: January 4, 2005Date of Patent: March 27, 2007Assignee: Samsung Electronics Co., Ltd.Inventor: Kyu-youn Hwang
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Patent number: 7183067Abstract: A versatile linker compound has a structure represented by following general formula (1), wherein Y has a structure represented by O or NH, and X has a structure serving as a multi-branched moiety including four hydrocarbon derivative chains each of which has an aromatic amino group at an end thereof, and may or may not have a carbon-nitrogen bond in a backbone thereof. With the versatile linker compound, sugar molecules can be two-dimensionally arranged on a surface of a protein-analyzing supporter with high reproducibility. Also, a ligand includes the versatile linker compound and a sugar molecule introduced thereinto.Type: GrantFiled: August 6, 2003Date of Patent: February 27, 2007Assignees: Japan Science and Technology Agency, National University Corporation Kagoshima UniversityInventors: Yasuo Suda, Akio Arano, Hideki Hayashi, Shoichi Kusumoto, Michael Sobel
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Patent number: 7179640Abstract: The present invention provides antibodies which specifically bind early conception factor, which can be found in body fluids of animals including but not limited to the cow, cat, dog, horse, human, sheep, and pig. The invention provides methods for detecting conception or the absence of conception in an animal, the latter being recognized by the absence of early conception factor in a suitable body fluid collected from the animal. Apparati for detecting early conception factor in a body fluid from an animal comprising the antibodies which specifically bind early conception factor are also provided.Type: GrantFiled: January 6, 2006Date of Patent: February 20, 2007Assignee: EDP Biotech CorporationInventors: Nancy Tommye Jordan, John Douglas Jordan
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Patent number: 7144709Abstract: A reagent is suitable for measuring the concentration of an analyte in a hemoglobin-containing biological fluid, such as whole blood. The reagent comprises a flavin-dependent enzyme that has specificity for the analyte, a flavin cofactor if, and only if, a flavin is not bound to the enzyme, a tetrazolium dye precursor, an electron transfer agent, and a nitrite salt. The reagent causes dye formation that is a measure of the analyte concentration. The nitrite salt suppresses interfering dye formation caused non-enzymatically by the hemoglobin. Preferably, the reagent is used in a dry strip for measuring glucose in whole blood.Type: GrantFiled: November 16, 2004Date of Patent: December 5, 2006Assignee: LifeScan, Inc.Inventors: Tianmei Ouyang, Yeung Siu Yu
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Patent number: 7144705Abstract: Heart and brain fatty acid binding proteins (H-FABP, B-FABP) are markers for stroke. The invention provides a diagnostic assay for either of these markers, preferably by ELISA using anti-H-FABP or B-FABP antibody. Since H-FABP is also a marker for acute myocardial infarction (AMI), to distinguish stroke from AMI requires an assay specific to AMI, e.g. using troponin-I or creatine kinase-MB as a marker, also to be carried out.Type: GrantFiled: June 7, 2002Date of Patent: December 5, 2006Assignee: ElectroPhoretics LimitedInventors: Denis Francois Hochstrasser, Jean-Charles Sanchez, Catherine Gabrielle Zimmerman
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Patent number: 7144742Abstract: This invention provides solid phase specific binding lateral flow assay methods, devices and kits for quantitating high and low molecular weight analytes. The methods and devices of the invention employ labelled reagents which are either analyte analogs or complementary specific binding pair members for the analyte and a novel arrangement of capture zones comprising immobilized specific binding substances for either the analyte or the labelled reagent to effect bound from unbound labelled reagent as a function of analyte concentration. The capture zones are disposed on a non-bibulous matrix defining a flow path from a sample receiving zone to the capture zone. The devices of this invention also include multilane flow paths and multiple capture zones to quantitate analyte.Type: GrantFiled: December 17, 2004Date of Patent: December 5, 2006Assignee: Quidel CorporationInventors: Hans Boehringer, Gerald Rowley, Allan D. Pronovost
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Patent number: 7135329Abstract: An immunochemical assay device for determining the presence of NT-proBNP alone or conjunctively with Cardiac Troponin I 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: GrantFiled: February 4, 2003Date of Patent: November 14, 2006Assignee: Princeton Biomeditech CorporationInventors: Jemo Kang, Kyung-ah Kim, Joo Young Choi, George Jackowski
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Patent number: 7129038Abstract: A method for selectively combining multiple membranes for assembly into test strips (such as visual blood glucose test strips with side-by-side membranes). The method includes first measuring a plurality of color parameters (e.g., L*, a* and b*color parameters) associated with membrane samples from at least two membrane lots. Next, response characteristics (e.g., blood glucose response levels) are simulated for a speculative test strip that includes, for purposes of the simulation, combined multiple membranes tentatively selected from the at least two membrane lots. The simulated response characteristics are based on the measured plurality of color parameters of the tentative selection of combined multiple membranes. Optionally, the simulated response characteristics can also be based on simulated color parameters of the tentative selection of combined multiple membranes.Type: GrantFiled: June 21, 2002Date of Patent: October 31, 2006Assignee: Lifescan, Inc.Inventors: Ramanan Gopalan, Jon Michael Messamer, Manoj Sharma
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Patent number: 7112453Abstract: This invention provides methods of retentate chromatography for resolving analytes in a sample. The methods involve adsorbing the analytes to a substrate under a plurality of different selectivity conditions, and detecting the analytes retained on the substrate by desorption spectrometry. The methods are useful in biology and medicine, including clinical diagnostics and drug discovery.Type: GrantFiled: August 5, 2002Date of Patent: September 26, 2006Assignee: Ciphergen Biosystems, Inc.Inventors: T. William Hutchens, Tai-Tung Yip
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Patent number: 7112451Abstract: A biosensor is provided with an area in which a reagent having bleaching action is carried in a state where it can be dissolved, at least in a part of a sample application area to which an inspection target solution is applied or the downstream of the sample application area in the direction of the inspection target solution permeating, in a development layer. In the so-constituted biosensor, a colored component in the inspection target solution can be faded by the bleaching reagent, so that the color in parts other than a reactive area is reduced in consequence, whereby a visual judgment is possible and a more accurate measurement result in which a reading error by a measuring device is extremely suppressed can be obtained.Type: GrantFiled: June 28, 2001Date of Patent: September 26, 2006Assignee: Matsushita Electric Industrial Co., Ltd.Inventors: Mie Takahashi, Masataka Nadaoka, Hirotaka Tanaka, Fumihisa Kitawaki
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Patent number: 7108993Abstract: A method and device for carrying out immunoassays in which non analyte specific binding of heterophilic antibodies to a labeled antibody in a capture region produces an incorrect measure of the amount of an analyte attached to the antibody. Immunoglobulin from the same animal source as the labeled antibody is added to the sample fluid to prevent non-specific binding of the heterophilic antibodies in the capture region. One part of specific binding pair is added to said antibody or its label capable of binding to a second part of the binding pair immobilized in a control region downstream of said capture region for trapping the portion of the labeled anti-body which is not bound to the analyte. Preferably said binding pair is biotin/avidin or fluoroscein/anti-fluoroscein.Type: GrantFiled: July 19, 2002Date of Patent: September 19, 2006Assignee: Bayer Healthcare LLCInventors: Ronald Sommer, Lloyd Schulman, Daya C. Wijesuriya
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Patent number: 7109023Abstract: An immunochemical assay device for determining the presence of NT-proBNP alone or conjunctively with Cardiac Troponin I 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: GrantFiled: November 18, 2002Date of Patent: September 19, 2006Assignee: Princeton BioMeditech CorporationInventors: Jemo Kang, Kyung-ah Kim, Joo Young Choi, George Jackowski
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Patent number: 7109042Abstract: An analytical test device useful for example in pregnancy testing, comprises a hollow casing (500) constructed of moisture-impervious solid material, such as plastics materials, containing a dry porous carrier (510) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member (506) which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the two zones being arranged such that liquid sample applied to the porous carrier can permeate via the first zone into the second zone, and the device incorporating meaType: GrantFiled: February 12, 2001Date of Patent: September 19, 2006Assignee: Inverness Medical Switzerland GmbHInventors: Keith May, Michael Evans Prior, Ian Richards
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Patent number: 7097983Abstract: The invention features a method of determining whether one or more members of an analyte family are present in a sample. The method makes use of a test zone binder, e.g., a receptor that can bind one or a plurality of analytes within an analyte family, the analytes family defined by similar structural binding sites. Members of an analyte family can have different detection level requirements and, therefore, additional analyte binders can be employed to adjust test sensitivity for a subset of the analytes in the analyte family individually, so that each analyte can be detected only if it is present in the sample above a predetermined threshold.Type: GrantFiled: September 24, 2001Date of Patent: August 29, 2006Assignee: Charm Sciences, Inc.Inventors: Robert J. Markovsky, Cheryl A. Boyer, Stanley E. Charm, Paul R. Donahue, Yael Agi Glickman, Steven J. Saul, Joan L. Scheemaker, Richard T. Skiffington, Shefali B. Trivedi, Eliezer Zomer
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Patent number: 7097974Abstract: A method for producing a support for determining analytes. The method comprises the steps of (a) providing a support comprising at least one channel, comprising a conduit having an intake and an outlet for passing fluid from the intake to the outlet, in the support body, (b) passing liquid with building blocks for synthesizing polymeric receptors through the channel or channels of the support body, (c) site- and/or time-specifically immobilizing the receptor building blocks in each case on predetermined positions in the channel or channels by illumination and (d) repeating steps (b) and (c) until the required receptors have been synthesized in each case on the predetermined positions.Type: GrantFiled: August 27, 1999Date of Patent: August 29, 2006Assignee: febit biotech GmbHInventors: Cord F. Stähler, Peer F. Stähler, Manfred Müller, Fritz Stähler, Hans Lindner
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Patent number: 7098040Abstract: A diagnostic test unit is provided. The test unit comprises a stem having a first end and a second end, the stem defining at least one flow channel extending between the first end and the second end. A swab is disposed at the first end of the stem, the swab being configured to collect a test sample derived from a biological source that is suspected of containing an analyte. The test unit also comprises a fluid chamber configured to contain a fluid, wherein the fluid chamber is in fluid communication with the swab via the flow channel. The test unit also comprises a rupturable seal that inhibits leakage of the fluid from the fluid chamber prior to use, and an assay for detecting the presence or absence of the analyte. The assay is in fluid communication with the swab, the flow channel, and the fluid chamber.Type: GrantFiled: December 23, 2003Date of Patent: August 29, 2006Assignee: Kimberly-Clark Worldwide, Inc.Inventors: Rosann Marie Matthews Kaylor, RameshBabu Boga, Kaiyuan Yang, David Samuel Cohen, Herb Velazquez, Amanda Lee O'Connor
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Patent number: 7077996Abstract: Optical bio-discs for biochemical analysis, bio-disc analysis systems and biochemical analysis methods are described herein. In one embodiment, the bio-disc includes a sample analysis circuit that includes a separation membrane for separating an investigational feature of a sample. The bio-disc also includes a conjugate release pad, and an analysis membrane containing analysis zones that may be analyzed for the presence of analytes. An analysis method includes providing a sample to a separation membrane in a bio-disc, separating an investigational feature from the sample using a separation membrane, mixing reagents that include signal elements for detecting an analyte with the investigational feature so as to form a reagent-investigational feature mixture and capturing an analyte with a signal element bound thereto in an analysis zone on an analysis membrane.Type: GrantFiled: July 13, 2004Date of Patent: July 18, 2006Inventors: Brandon L. Randall, Raveendra Pottathil, Shuguang Li
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Patent number: 7070920Abstract: A screening device for performing an immunoassay test to detect the presence of a compound in a body fluid. The device includes a holder for removably receiving a membrane to which the fluid has been applied. A light is directed to the membrane. A photodetector measures the concentration of the light reflected back from the membrane. Specifically, the concentrations of reflected light from a control zone and a test zone are measured. Signals representative of the measured light concentrations are applied to a processor. If a specified concentration of predetermined light from a control zone on the membrane is detected, the processor considers the test to be successful. In the test is successful, the processor, based upon the measured concentration of reflected light from the test zone, generates data representative of the presence of the compound.Type: GrantFiled: January 12, 2001Date of Patent: July 4, 2006Assignee: Cozart Bioscience LimitedInventors: Robin James Spivey, Christopher William Hand, Dene Baldwin, Osborn Pierce Jones
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Patent number: 7067264Abstract: A test device (20) for detecting human blood includes a strip (22) having an introduction station (24), a test station (26), and a control station (28) disposed in spaced apart relationship. The test sample introduction station (24) has labeled antihuman Hb antibodies, the test station (26) has immobilized antihuman Hb antibodies, and the control station has immobilized polyclonal antibodies. A test sample (500) is deposited at the introduction station (24). If human hemoglobin 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 human hemoglobin is present in the test sample (500), a colored line will only appear at the control station (28).Type: GrantFiled: July 23, 2001Date of Patent: June 27, 2006Inventor: Padma S. Bagaria
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Patent number: 7060505Abstract: 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: GrantFiled: March 8, 2004Date of Patent: June 13, 2006Assignee: La Mina, Inc.Inventor: Raouf Guirguis
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Patent number: 7049150Abstract: A binding assay device includes a porous membrane comprising a material enabling capillary movement of a liquid sample from a first area on the membrane on a second area on the membrane. A detection site is disposed on the membrane between the first and second areas in a non-absorbent medium disposed on the membrane between the detection site and the membrane first area is attached by an adhesion with a dry reagent disposed between the medium and the membrane in order to enable mobilization of the reagent by passage of a liquid sample therepast.Type: GrantFiled: December 28, 2001Date of Patent: May 23, 2006Assignee: Varian, Inc.Inventor: Steven S. Bachand
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Patent number: 7049130Abstract: 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.Type: GrantFiled: March 21, 2005Date of Patent: May 23, 2006Assignee: Home Diagnostics, Inc.Inventors: Patrick Carroll, Jon Schneider, Douglas E. Bell
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Patent number: 7045342Abstract: 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: GrantFiled: March 5, 2004Date of Patent: May 16, 2006Assignee: Church & Dwight Co., Inc.Inventors: Albert Nazareth, Mary Beth Boyle, Yea-Shun Cheng
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Patent number: 7045297Abstract: Assays are provided for rapid detection, with high specificity of the pathogenic form of prion protein responsible for neurodegenerative diseases affecting humans and animals, such as transmissible spongiform encephalopathy in bovine, sheep, and cats. Also provided are assays for testing animal feedstock, such as animal feed, for the presence or concentration of pathogenic prion protein. Results are available in from about 0.5 to about 20 minutes and preferably within from about 5 to about 10 minutes. The assays employ proteinase-K to remove normal prion protein from a biological sample, so that the sample may be analyzed by immunochromatography to determine the presence and concentration of pathogenic prion protein. Because the proteinase-K is immobilized on a solid support for in situ removal of interfering components, the present invention obviates the need for subsequent extraction of the desired analyte.Type: GrantFiled: November 14, 2001Date of Patent: May 16, 2006Assignee: Prion Developmental Laboratories, Inc.Inventors: Kiamars Hajizadeh, Zakir S. Murtaza
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Patent number: 7041509Abstract: The present invention provides novel microfluidic devices and methods that are useful for performing high-throughput screening assays. In particular, the devices and methods of the invention are useful in screening large numbers of different compounds for their effects on a variety of chemical, and preferably, biochemical systems.Type: GrantFiled: April 2, 2002Date of Patent: May 9, 2006Assignee: Caliper Life Sciences, Inc.Inventors: J. Wallace Parce, Anne R. Kopf-Sill, Luc J. Bousse
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Patent number: 7041468Abstract: A measurement module for glucose testing includes a glucose testing measurement module housing, a test strip receptacle formed in the housing, and a connector portion formed in the housing and shaped to permit mechanical removable attachment of the housing to a hand-held computer. Electronics determine the amount of glucose present in a sample of body fluid, when the test strip is positioned in the receptacle and the body fluid is placed on a test strip, and communicate the glucose amount to the hand-held computer via the connector portion.Type: GrantFiled: March 29, 2002Date of Patent: May 9, 2006Assignee: TheraSense, Inc.Inventors: Steven Drucker, Charles T. Liamos, Fredric Colman, Mark Lortz, Kelley Lipman, Feng Jiang, Henrik Bacho
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Patent number: 7026002Abstract: The invention concerns an element for the determination of an analyte in a liquid by means of a specific binding reaction of two bioaffine binding partners containing in or on material which enables liquid transport between the zones. The element comprises a sample application zone; a detection zone located downstream thereof that is devoid of binding reagents and is the last zone on the element that allows liquid transport; a zone containing immobilized analyte or analyte analogue between the sample application zone and the detection zone; and impregnated conjugate that can be detached by liquid located in the sample application zone or upstream or downstream thereof composed of a bioaffine binding partner capable of a specific binding reaction with the analyte to be determined and a detectable label.Type: GrantFiled: June 15, 2000Date of Patent: April 11, 2006Assignee: Roche Diagnostics GmbHInventors: Ada Goerlach-Graw, Reiner Schlipfenbacher
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Patent number: 7018849Abstract: Superparamagnetic (“SPM”) subunits of 1–30 nm average mean diameter (e.g. ferro fluid) subparticles are treated with a magnetically noninterfering substance capable of coating and covering them (e.g, BSA) and they spontaneously form agglomerates of about 100 nm to about 450 nm or higher average mean diameter and are then used to form complexes with target biological ligands such as viruses, contained in large volumes of liquid. The complexes are subjected to the gradient intensity of a strong magnetic field, and excess liquid is removed, where upon an immunochromatographic assay is conducted to determine the identity and/or amount of target ligand present, in which operation SPM particles that bonded to the ligand function as tags for ligand detection.Type: GrantFiled: January 15, 2002Date of Patent: March 28, 2006Inventors: Roger N. Piasio, Nathan Turner
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Patent number: 7018847Abstract: An assay device for determining an analyte in an aqueous sample comprises: (i) an elongate flow matrix (6) allowing lateral transport of fluid therethrough by capillary action, wherein the matrix comprises a liquid application zone (3) and downstream thereof, a detection zone (8) having an immobilized capture agent capable of directly or indirectly binding to said analyte, (ii) a wicking member (13) placed at the downstream end of the flow matrix and having an upstream end and a downstream end, and (iii) a time indicator (14) placed downstream of the detection zone (8) for indicating when liquid applied to the liquid application zone has reached the time indicator. The time indicator comprises an indicator substance or substance combination which is capable of exhibiting a visible color change when hydrated by the aqueous sample.Type: GrantFiled: May 4, 2001Date of Patent: March 28, 2006Assignee: Pharmacia Diagnostics ABInventors: Ib Mendel-Hartvig, Erik Unger
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Patent number: 7011954Abstract: A reagent is suitable for measuring the concentration of an analyte in a hemoglobin-containing biological fluid, such as whole blood. The reagent comprises a flavin-dependent enzyme that has specificity for the analyte, a flavin cofactor if, and only if, a flavin is not bound to the enzyme, a tetrazolium dye precursor, an electron transfer agent, and a nitrite salt. The reagent causes dye formation that is a measure of the analyte concentration. The nitrite salt suppresses interfering dye formation caused non-enzymatically by the hemoglobin. Preferably, the reagent is used in a dry strip for measuring glucose in whole blood.Type: GrantFiled: September 15, 2003Date of Patent: March 14, 2006Assignee: Lifescan, Inc.Inventors: Tianmei Ouyang, Yeung Siu Yu
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Patent number: 7001776Abstract: 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. The device can be modified so that a plurality of slides are prepared at the same time.Type: GrantFiled: April 4, 2001Date of Patent: February 21, 2006Assignee: Digene CorporationInventors: Gerson Botacini das Dores, Iwona Mielzynska-Lohnas, Eliane Taromaru, William J. Payne, Joseph P. Slattery, James G. Lazar
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Patent number: 6998273Abstract: 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: GrantFiled: April 1, 2002Date of Patent: February 14, 2006Assignee: A-Fem Medical CorporationInventors: William H. Fleming, Timothy P. Hyatt, Dudley B. Thomas
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Patent number: 6991940Abstract: 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.Type: GrantFiled: October 31, 2001Date of Patent: January 31, 2006Assignee: Home Diagnostics, Inc.Inventors: Patrick Carroll, Jon Schneider, Douglas E. Bell
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Patent number: 6991898Abstract: A self contained diagnostic test device is provided for use in the collection and detection of a biological specimen or the like. The device comprises a tubular swab and reagent dispensing cap component for receiving specimens. The reagent dispensing cap component includes barrel, reagent chamber, and results window subcomponents, and delivers one or more selected reagents to a specimen testing chamber for contacting the collected specimen, upon the rotation of the reagent chamber component.Type: GrantFiled: October 20, 2003Date of Patent: January 31, 2006Assignee: Kimberly-Clark Worldwide, Inc.Inventor: Amanda Lee O'Connor
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Patent number: 6991912Abstract: 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 of 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: GrantFiled: February 5, 2002Date of Patent: January 31, 2006Assignee: Wavesesense, LLCInventor: Christopher Feistel
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Patent number: 6977173Abstract: Disclosed is a testing device and methods for the identification of an analyte of interest in a sample. In a preferred embodiment, the testing device includes a front panel having at least one sample application aperture; a rear panel having at least one solvent application aperture; a sample collection matrix disposed between the rear panel and the front panel, the sample collection matrix being in communication with the sample and solvent application apertures of the front and rear panels; and at least one insertable test strip containing a reagent enabling detection of the analyte of interest.Type: GrantFiled: January 18, 2001Date of Patent: December 20, 2005Assignee: Enterix, Inc.Inventor: Howard Milne Chandler
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Patent number: 6927068Abstract: An assay method and kit for detecting the presence of a predesignated, target IgG antibody in a sample selected from one or more patient bodily fluids. The method comprises the following steps: (a) contacting the sample of one or more patient bodily fluids with a membrane-bound recombinant protective antigen to bind to the target IgG antibody in the sample; (b) previously, simultaneously or subsequently to step (a), binding the protective antigen (PA) with a conjugated label producing a detectable signal; and (c) detecting the signal whereby the presence of the target IgG antibody is determined in the sample by the intensity of the signal. The method can further comprise the step of evaluating immunization status of the patient from whom the sample came by comparing the signal or lack thereof with immunizations previously received by the patient. In a preferred embodiment, the recombinant protective antigen (PA) specifically binds to anthrax protective antigen-specific IgG antibodies.Type: GrantFiled: January 30, 2002Date of Patent: August 9, 2005Assignee: The United States of America as represented by the Secretary of the NavyInventors: Lloyd G. Simonson, John R. Kelly
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Patent number: 6924153Abstract: This invention provides solid phase specific binding lateral flow assay methods, devices and kits for quantitating high and low molecular weight analytes. The methods and devices of the invention employ labelled reagents which are either analyte analogs or complementary specific binding pair members for the analyte and a novel arrangement of capture zones comprising immobilized specific binding substances for either the analyte or the labelled reagent to effect bound from unbound labelled reagent as a function of analyte concentration. The capture zones are disposed on a non-bibulous matrix defining a flow path from a sample receiving zone to the capture zone. The devices of this invention also include multilane flow paths and multiple capture zones to quantitate analyte.Type: GrantFiled: March 6, 1997Date of Patent: August 2, 2005Assignee: Quidel CorporationInventors: Hans Boehringer, Gerald Rowley, Allan Pronovost
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Patent number: 6905835Abstract: A non-instrumental assay for the diagnosis of celiac disease based on the general immunochromatographic assay principles. The assay is rapid and simple and allows the reliable detection of anti transglutaminase antibodies, of both IgA and IgG isotype, in samples of human serum, plasma or blood, using as tracer the antigen transglutaminase conjugated to a colored substance, like colloidal gold or colored latex particles. The conjugated antigen is deposited onto an inert fibrous support, from where it can be released by a liquid sample. The antibodies in the sample react with the conjugated antigen developing an immunocomplex that migrates through a carrier membrane, like nitrocellulose or nylon with a pore size that allows a laminar flow of the reagents, until it reacts with the same antigen transglutaminase immobilized onto a reactive zone of the membrane. As a consequence of this reaction the immunocomplex will be trapped in the reaction site and a colored signal will be seen.Type: GrantFiled: May 25, 2001Date of Patent: June 14, 2005Assignee: Centro De Ingenieria Genetica Y Biotecnologia CIGBInventors: Luis Tomás Sorell Gómez, Boris Ernesto Acevedo Castro
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Patent number: 6893816Abstract: An improved microfabricated apparatus for conducting a multiplicity of individual and simultaneous binding reactions is described. The apparatus comprises a substrate on which are located discrete and isolated sites for binding reactions. The apparatus is characterized by discrete and isolated regions that extend through said substrate and terminate on a second surface thereof such that when a test sample is applied to the substrate, it is capable of penetrating through each such region during the course of said binding reaction. The apparatus is especially useful for sequencing by hybridization of DNA molecules.Type: GrantFiled: April 21, 1998Date of Patent: May 17, 2005Assignee: Houston Advanced Research CenterInventor: Kenneth L. Beattie
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Patent number: 6893880Abstract: The present invention provides a method and a device that utilizes capillarity-mediated, chromatographic transport, for the qualitative or semi-quantitative analysis of selected analytes in liquid samples. The device utilizes an applicator/collection device for collecting and administering the sample to the flow path such that reagent(s) flow through the applicator/collection device, washing the sample into the reaction pathway. The device further utilizes an air gap between the initial location of the reagent and the reaction pathway to funnel the reagent efficiently through the sample so as to collect all or substantially all of the sample and make it available for the reaction(s).Type: GrantFiled: April 27, 2001Date of Patent: May 17, 2005Assignee: IDEXX LaboratoriesInventor: Charles Carpenter
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Patent number: 6890729Abstract: 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: GrantFiled: May 22, 2002Date of Patent: May 10, 2005Assignee: Digene CorporationInventors: Iwona Mielzynska, Jay Payne, James Lazar
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Patent number: RE39664Abstract: The present invention relates to improved specific binding assay devices comprising a chromatographic medium including a reaction site at which a specific binding reagent is immobilized, a sample application well located adjacent to the chromatographic medium and offset upstream from the reaction site, and liquid absorption blotter offset downstream from the reaction site.Type: GrantFiled: November 21, 1995Date of Patent: May 29, 2007Assignee: Inverness Medical Switzerland GmbHInventors: Julian Gordon, Charles Stuart Gredell Pugh