Human Chorionic Gonadotropin Patents (Class 436/818)
  • Patent number: 8900881
    Abstract: The present invention relates to a quantitative assay device and a method for the determination of an analyte, based on a test strip, which contains a porous test membrane allowing for capillary flow of the analyte and complexes of the analyte, a porous upstream membrane in fluid connection with the test membrane and a porous downstream membrane in fluid connection with the test membrane, wherein the test membrane contains two bands having deposited on there high and low concentrations of different calibrator agents and a test band capable of reacting with conjugated analyte complexes giving rise to a measurable signal.
    Type: Grant
    Filed: September 12, 2011
    Date of Patent: December 2, 2014
    Inventor: Jin Po Lee
  • Patent number: 8691585
    Abstract: The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG in a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.
    Type: Grant
    Filed: June 1, 2011
    Date of Patent: April 8, 2014
    Assignee: The Trustees of Columbia University in the City of New York
    Inventors: John F. O'Connor, Galina I. Kovalevskaya, Steven Birken
  • Patent number: 8628724
    Abstract: Methods and systems to collect a sample of bodily fluid from a patient using an integrated needle and test strip assembly are provided. In this novel assembly, the test strip and needle form one unit that captures the sample of blood or interstitial fluid from the patient once the apparatus is pressed to the skin. The hollow aspiration needle includes more than one opening at a distal end, each opening coming into contact with the bodily fluid when disposed within a cutaneous or subcutaneous layer of the patient's skin. The disclosed test strip includes at least one reaction site for testing analyte concentrations and a means for linking to many commercially available test strip meters to provide readout of the analyte concentration. The sample may be captured by capillary flow, by an integrated aspirator, or by a differential vacuum device resident on the test strip meter.
    Type: Grant
    Filed: January 3, 2012
    Date of Patent: January 14, 2014
    Assignee: Charleston Area Medical Center, Inc.
    Inventor: J. Todd Kuenstner
  • Patent number: 8541245
    Abstract: The present invention provides methods and kits for assessing the state of oocyte maturation in a female mammal based on the level of PAPP-A found in the female's bodily fluid sample.
    Type: Grant
    Filed: June 11, 2010
    Date of Patent: September 24, 2013
    Assignee: Beckman Coulter, Inc.
    Inventor: William E. Roudebush
  • Patent number: 8455263
    Abstract: The present invention relates to an assay device and a method for using such for the quantitative determination of an analyte, based on a test strip, which contains a porous test membrane allowing for capillary flow of the analyte and complexes of the analyte, a porous upstream membrane in fluid connection with the test membrane and a porous downstream membrane in fluid connection with the test membrane, wherein the test membrane contains a test site having immobilized thereon a ligand capable of reacting with the analyte and binding such to the test site, and two standard band sites having immobilized thereon known high and low concentrations of a calibrator agent capable of reacting with a label conjugate and binding such to the standard sites, wherein the upstream membrane has a site for the application of a sample to be analyzed, and has a site downstream from the sample application site for depositing label conjugates capable of reacting with the analyte and label conjugates capable of reacting with the
    Type: Grant
    Filed: December 30, 2008
    Date of Patent: June 4, 2013
    Inventor: Jin Po Lee
  • Patent number: 7977104
    Abstract: The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG in a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.
    Type: Grant
    Filed: September 27, 2006
    Date of Patent: July 12, 2011
    Assignee: The Trustees of Columbia University in the City of New York
    Inventors: John F. O'Connor, Galina I. Kovalevskaya, Steven Birken
  • Patent number: 7790403
    Abstract: The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG in a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.
    Type: Grant
    Filed: October 22, 2007
    Date of Patent: September 7, 2010
    Assignee: The Trustees of Columbia University in the City of New York
    Inventors: John O'Connor, Steven Birken, Galina Kovalevskaya
  • Patent number: 7771928
    Abstract: Disclosed are an immunoassay device which comprises a labeled substance dotting portion and a specimen dotting portion provided thereon, and an immunoassay method using the device.
    Type: Grant
    Filed: August 28, 2002
    Date of Patent: August 10, 2010
    Assignee: Fujirebio Inc.
    Inventors: Akira Hasegawa, Yoshihiro Ashihara, Mitsuo Isomura
  • Patent number: 7718444
    Abstract: This invention provides a simple detection method with excellent sensitivity and specificity, which allows prompt detection of an analyte by allowing a labeled reagent to effectively react with the analyte in the process of treating an analyte-containing specimen, such as during removal of impurities, a detection apparatus, and a detection kit. This method for detecting an analyte in specimens comprises steps of: bringing a labeled reagent containing a ligand that specifically binds to the analyte into contact with a specimen; and supplying the mixture of the specimen and the labeled reagent to a solid-phase support onto which a capture reagent that specifically binds to the analyte has been immobilized, wherein the step of bringing the specimen into contact with the labeled reagent is carried out at a site that is not on the solid-phase support and that is detached from the solid-phase support.
    Type: Grant
    Filed: January 27, 2005
    Date of Patent: May 18, 2010
    Assignee: Denka Seiken Co., Ltd.
    Inventors: Kazuyuki Takizawa, Ryo Shida
  • Patent number: 7682836
    Abstract: A template (a molecule preferably of molecular size >500 Da, or a larger entity such as a cell, virus or tissue sample) is dissolved or suspended in a fluid. The fluid is frozen, and the template is removed (e.g. by dissolution or electrophoresis, or mechanically) to leave an “imprinted” frozen fluid. This is capable of selectively adsorbing the template substance. It is usable as a separation medium, a recognition element in sensors and assays, and as a catalyst.
    Type: Grant
    Filed: October 4, 2001
    Date of Patent: March 23, 2010
    Assignee: Cranfield University
    Inventors: Sergiy Anatoliyovich Piletsky, Olena Volodimirivna Piletska, Khalku Karim, Anthony Peter Francis Turner, Alessandra Bossi
  • Patent number: 7569397
    Abstract: An immunoassay device has a housing defining a first opening for receiving a solution and a second opening through which a liquid sample is deposited, a strip of sorbent material having a test site with immobilized antigen or antibody for the ligand to be tested, and a filter for filtering the sample. The filter is located at the second opening and directly above the test site. The sorbent material defines a horizontal flow path in the housing for the solution from the first opening to the test site. In use, the sample is first applied via the filter to the test site, and then, after the ligand has been captured, a buffer added through the first opening is used to cause a secondary specific binder conjugated to a marker to migrate horizontally by capillary action to the test site where it can bind to the already captured ligand. This immunoassay offer several advantages over the traditional chromatographic immunoassays.
    Type: Grant
    Filed: June 13, 2008
    Date of Patent: August 4, 2009
    Assignee: Chembio Diagnostic Systems, Inc.
    Inventor: Javanbakhsh Esfandiari
  • Patent number: 7410768
    Abstract: A method and test device for differentiating between states of an analyte that can exist in different forms, such as follicle stimulating hormone (FSH). The method or test device uses a pair of specific binding agents, especially monoclonal antibodies, in two assays for the same analyte. The assays, applied to contemporaneous samples, differ from one another in format, one being a two step assay and the other being one step. A novel pair of anti-FSH monoclonal antibodies that can be used together in two such assays to differentiate pre-menopausal and post-menopausal FSH samples is disclosed.
    Type: Grant
    Filed: April 3, 2001
    Date of Patent: August 12, 2008
    Assignee: Inverness Medical Switzerland GmbH
    Inventors: Lorraine D. Butlin, John Coley, Stephen J. Eida, Mohamed M. Gani
  • Patent number: 7332350
    Abstract: A one-step diagnostic device for simultaneously detecting and distinguishing between a normal pregnancy and an ectopic pregnancy and methods for preparing the device are disclosed. Utilizing the device and principles of the present invention, normal pregnancy and ectopic pregnancy can be rapidly and accurately determined at an early stage by immunologically detecting the morphological differences between human chorionic gonadotropin (hCG) and modified forms thereof, which are secreted into the body fluid of a pregnant female.
    Type: Grant
    Filed: February 10, 2003
    Date of Patent: February 19, 2008
    Assignee: Humasis Co., Ltd.
    Inventors: Jin-Dong Chang, Jung-Hak Cha, Jung-Hyun Nam
  • Patent number: 7285391
    Abstract: The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG in a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.
    Type: Grant
    Filed: September 1, 2004
    Date of Patent: October 23, 2007
    Assignee: The Trustees of Columbia Univeristy in the City of New York
    Inventors: John O'Connor, Steven Birken, Galina Kovalevskaya
  • Patent number: 7238537
    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 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: Grant
    Filed: September 4, 2001
    Date of Patent: July 3, 2007
    Assignee: Inverness Medical Switzerland GmbH
    Inventors: Paul James Davis, Michael Evans Prior, Keith May
  • Patent number: 7238538
    Abstract: 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: Grant
    Filed: September 16, 2004
    Date of Patent: July 3, 2007
    Inventors: Helmut E. Freitag, Qinwei Shi
  • Patent number: 7192786
    Abstract: This invention relates to a biospecific assay method, in which microparticles coated with the bioaffinity reactant A binding the analyte to be assayed; the sample to be analyzed, and the labelled bioaffinity reactant B are mixed. After the binding reaction the signal strength from the labelled bioaffinity reactant B bound to the microparticles is quantitated for the determination of the concentration of the analyte in the sample. According to the invention, such an amount of sample and microparticles is used in the assay that after binding of the analyte of the sample to the said amount of microparticles, each individual microparticle will emit such a signal strength as to allow the measurement of the analyte concentration over the whole range of typical analyte concentrations, and the signal strength from each microparticle is measured separately.
    Type: Grant
    Filed: June 7, 1995
    Date of Patent: March 20, 2007
    Assignee: Wallac Oy
    Inventors: Timo Nils-Erik Lövgren, Antti Juhana Iitiä, Kim Sverker Immanuel Pettersson
  • Patent number: 7109042
    Abstract: 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 mea
    Type: Grant
    Filed: February 12, 2001
    Date of Patent: September 19, 2006
    Assignee: Inverness Medical Switzerland GmbH
    Inventors: Keith May, Michael Evans Prior, Ian Richards
  • Patent number: 6927034
    Abstract: The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG in a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.
    Type: Grant
    Filed: May 13, 1999
    Date of Patent: August 9, 2005
    Assignee: The Trustees of Columbia University in the City of New York
    Inventors: John O'Connor, Steven Birken, Galina Kovalevskaya
  • Patent number: 6818455
    Abstract: 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 me
    Type: Grant
    Filed: February 28, 2001
    Date of Patent: November 16, 2004
    Assignee: Inverness Medical Switzerland GmbH
    Inventors: Keith May, Michael Evans Prior, Ian Richards
  • Patent number: 6689615
    Abstract: Approaches are described for separating plasma from whole blood samples and include the use of magnetically attractable particles associated with an agglutinating agent. The magnetically attractable particles bind the cellular components in a whole blood sample. Application of a magnetic field gradient to a container with the blood sample and the magnetically attractable particles draws the particles to the surface of the container near the source of the magnetic field gradient. The plasma can be removed and stored or used for monitoring or detecting analytes in the plasma.
    Type: Grant
    Filed: October 4, 2000
    Date of Patent: February 10, 2004
    Inventors: James Murto, Michael Salvati
  • Patent number: 6677123
    Abstract: An increased risk of a fetal chromosomal abnormality, for example, fetal Down syndrome can be detected by separating or discriminating &agr;-fetoproteins present in the body fluid of a pregnant woman, and measuring the proportion of one or more of the &agr;-fetoproteins which have a specific sugar chain structure, relative to the total &agr;-fetoproteins.
    Type: Grant
    Filed: February 1, 1999
    Date of Patent: January 13, 2004
    Assignee: Wako Pure Chemical Industries, Ltd.
    Inventors: Ritsu Yamamoto, Shinji Satomura
  • Patent number: 6627457
    Abstract: Methods for detecting pregnancy in a woman comprise screening a biological sample of the woman for pregnancy markers. The methods of the invention include chemiluminescent assays for the pregnancy markers. The methods of the invention also comprise utilizing at least two capture antibodies that specifically bind different epitopes of the pregnancy marker in one assay. The methods of the invention permit detection of pregnancy within about 7 days after ovulation or implantation.
    Type: Grant
    Filed: July 30, 2001
    Date of Patent: September 30, 2003
    Assignee: Quest Diagnostics Investments Incorporated
    Inventors: Murugan R. Pandian, Julie Y. Lu
  • 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: 6573103
    Abstract: A method of screening for fetal Down's syndrome is described. Screening marker levels are measured. These may be measurements of a biochemical marker in a maternal sample or measurements of a marker from an ultrasound scan. The marker levels are used to calculate a risk of Down's syndrome. Instead of using markers from a single stage of pregnancy, the method uses markers from two or more different stages of pregnancy, typically one being in the first and another being in second trimester. The method may be automated.
    Type: Grant
    Filed: April 29, 1999
    Date of Patent: June 3, 2003
    Inventor: Nicholas J Wald
  • Patent number: 6548309
    Abstract: In qualitative or quantitative assays which employ a test device comprising a test strip pretreated for detection of a specified target analyte dissolved in a liquid medium, the presence of solid, semisolid and/or colloidal materials in the liquid medium may interfere with the assay results. The present invention involves collecting the sample from a flowing or quiescent pool of liquid also containing solid, semisolid or colloidal material with a swab comprised of a handle and a mass of fibrous material or foamed, open cell material which, when immersed in and thoroughly wetted by the liquid, entraps solid, semisolid and/or colloidal material and delivers only the liquid to the sample receiving zone of the test strip.
    Type: Grant
    Filed: March 19, 1998
    Date of Patent: April 15, 2003
    Assignee: Binax, Inc.
    Inventors: Norman James Moore, Vincent Anthony Sy
  • Publication number: 20030059946
    Abstract: There are provided methods for assaying biological specimens for one or more of leptin, prorenin or renin in order to provide predictive information about the likelihood of a woman carrying a Downs Syndrome affected fetus.
    Type: Application
    Filed: September 26, 2002
    Publication date: March 27, 2003
    Inventor: M. R. Pandian
  • 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: 6500627
    Abstract: The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG is a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.
    Type: Grant
    Filed: February 3, 1998
    Date of Patent: December 31, 2002
    Assignee: The Trustees of Columbia University in the City of New York
    Inventors: John F. O'Connor, Galina I. Kovalevskaya, Steven Birken
  • Patent number: 6492178
    Abstract: There are provided methods for assaying biological specimens for one or more of leptin, prorenin or renin in order to provide predictive information about the likelihood of a woman carrying a Downs Syndrome affected fetus.
    Type: Grant
    Filed: August 8, 2000
    Date of Patent: December 10, 2002
    Assignee: Quest Diagnostic Investments, Incorporated
    Inventor: Murugan R. Pandian
  • 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: 6448022
    Abstract: A substance having an inhibitory effect on the production of human choriogonadotropin (hCG) is described, which comprises a protein isolated from human decidual cells with a preliminary amino acid analysis and a molecular weight of about 7,000 to about 10,000 daltons, and useful for use in inhibiting production of hCG in vivo or in vitro, may be measured as an indication of a cause of hCG inhibition, or used in the treatment of hCG-secreting tumors.
    Type: Grant
    Filed: July 19, 1994
    Date of Patent: September 10, 2002
    Assignee: Cedars-Sinai Medical Center
    Inventors: Glenn D. Braunstein, Song-Guang Ren
  • Patent number: 6429018
    Abstract: A prenatal screening method for Down's syndrome involves assaying for hyperglycosylated gonadotropin in biological test samples such as urine, plasma or serum obtained from pregnant women. Hyperglycosylated gonadotropin comprises a variant population of chorionic gonadotropin, chorionic gonadotropin-free &bgr;-subunit, &bgr;-core fragment, and/or free &agr;-subunit exhibiting differences in the carbohydrate content from what is observed in samples obtained from pregnant women carrying normal fetuses. Qualitative or quantitative observation of differences in the carbohydrate content of the hyperglycosylated gonadotropin population from corresponding control samples containing a normal gonadotropin population, or direct observation of the variant species seen in Down's syndrome, indicates that the woman's fetus has Down's syndrome. Typical screens involve carbohydrate analyses, immunoassays, or combinations of these methods.
    Type: Grant
    Filed: November 29, 1999
    Date of Patent: August 6, 2002
    Assignee: Yale University
    Inventors: Laurence A. Cole, Andrew Kardana
  • Patent number: 6395503
    Abstract: The present invention provides a novel chemiluminescent reagent producing chemiluminescence in the presence of hydrogen peroxide, extent of which depends on peroxidase concentration, chemiluminescent analysis method using the same, in particular useful for detection and quantitative analysis of various types of materials by measuring peroxidase enzyme activity or enzyme immunoassay with peroxidase enzyme as the marker. More particularly, the present invention provides a chemiluminescent reagent containing, as the major ingredients, a charge-transferring complex of N,N′-disubstituted-9,9′-bisacridinium salt and N,N-disubstituted carboxylic amide compound; chemiluminescent reagent containing further containing a specific aminoalcohol compound, in addition to the above; and method for measuring peroxidase activity at a high sensitivity in the presence of a peroxide, using the above chemiluminescent reagent.
    Type: Grant
    Filed: April 14, 2000
    Date of Patent: May 28, 2002
    Assignee: Dainichiseika Color & Chemicals Mfg. Co., Ltd.
    Inventors: Hideaki Suzuki, Kiyoshi Takahashi, Gen-ichiro Araya, Hisashi Katsuragi, Mio Hosogoe
  • 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: 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: 6251688
    Abstract: A method and apparatus for measuring binding between a plurality of molecules of a first type and a plurality of molecules of a second type is presented. Apparatus utilizes a sensor possessing a waveguide to which have been attached in close proximity to its surface, features resembling molecules of said first type. Light is injected into said waveguide so as to produce an evanescent field at its surface. Molecules of said second type are tagged with a tag belonging to that class of chemicals which alters a characteristic of light, when said light passes through said chemical tag. Apparatus utilizes a rapid means of monitoring the change in optical signal coming from said waveguide as binding proceeds between tagged molecules of type 2 and the feature resembling molecules of type 1 on said waveguide. This allows direct measurement of binding and dissociation rates between the two types of molecules.
    Type: Grant
    Filed: March 20, 1998
    Date of Patent: June 26, 2001
    Assignee: IA, Inc.
    Inventors: Judith L. Erb, James G. Downward, John R. Erb-Downward, Otho Ulrich
  • Patent number: 6228660
    Abstract: 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 immobilized 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 mea
    Type: Grant
    Filed: June 7, 1995
    Date of Patent: May 8, 2001
    Assignee: Conopco Inc.
    Inventors: Keith May, Michael Evans Prior, Ian Richards
  • Patent number: 6204002
    Abstract: The invention provides a compound represented by the following formula (I) wherein m is an integer of 2-15; n is an integer of 0-12; R represents a sugar chain or a derivative thereof; R′ represents a general formula (II) (wherein p is an integer of 0-4, q is an integer of 0-5; r is an integer of 2-5; R12 and R13 are the same or different and each represents a hydrogen atom, a lower alkyl group, an aliphatic acyl group, a nitro group or a nitrile group), R1 represents a hydrogen atom or a protective group of carboxylic acid, R2, R4 and R5 are the same or different and each represents a hydrogen atom, an aliphatic or aromatic acyl group; R3 represents an acetyl group, a glycolyl group or a trifluoroacetyl group; useful as reagent for detecting influenza virus A.
    Type: Grant
    Filed: December 23, 1998
    Date of Patent: March 20, 2001
    Assignee: Daikin Industries, Ltd.
    Inventors: Takao Iida, Yutaka Ohira
  • Patent number: 6194222
    Abstract: The invention relates in part to the use of independent assay controls (IACs) for the optical communication between an assay device and an instrument in monitoring and performing assays, preferably immunoassays.
    Type: Grant
    Filed: January 5, 1998
    Date of Patent: February 27, 2001
    Assignee: Biosite Diagnostics, Inc.
    Inventors: Kenneth F. Buechler, Joseph M Anderberg, Paul H. McPherson
  • Patent number: 6187598
    Abstract: 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 mea
    Type: Grant
    Filed: June 7, 1995
    Date of Patent: February 13, 2001
    Assignee: Conopco Inc.
    Inventors: Keith May, Michael Evans Prior, Ian Richards
  • Patent number: 6143576
    Abstract: The assay devices, assay systems and device components of this invention comprise at least two opposing surfaces disposed a capillary distance apart, at least one of which is capable of immobilizing at least one target ligand or a conjugate in an amount related to the presence or amount of target ligand in the sample from a fluid sample in a zone for controlled fluid movement to, through or away the zone. The inventive device components may be incorporated into conventional assay devices with membranes or may be used in the inventive membrane-less devices herein described and claimed. These components include, flow control elements, measurement elements, time gates, elements for the elimination of pipetting steps, and generally, elements for the controlled flow, timing, delivery, incubation, separation, washing and other steps of the assay process.
    Type: Grant
    Filed: March 3, 1997
    Date of Patent: November 7, 2000
    Assignee: Biosite Diagnostics, Inc.
    Inventor: Kenneth F. Buechler
  • Patent number: 6127186
    Abstract: There are provided methods for assaying biological specimens for one or more of leptin, prorenin or renin in order to provide predictive information about the likelihood of a woman carrying a Downs Syndrome affected fetus.
    Type: Grant
    Filed: January 12, 1999
    Date of Patent: October 3, 2000
    Inventor: M. R. Pandian
  • Patent number: 6046057
    Abstract: The invention is an improved single-step test device for detecting the presence of a pre-selected analyte in a urine stream. The device includes a hollow rectangular outer casing and an assay material disposed within co-joined upper and lower sections of the casing. The outer casing includes a urine inlet port; a viewing window in the upper section; at least the upper section consisting of transparent material; and may also include at least one drainage vent spaced about the urine inlet port. The assay material is a sorptive material including: a urine sample application region adjacent to, and in fluid communication with the urine inlet port; a capture region adjacent to the viewing window; and a fluid flow path for transporting a liquid sample between the urine sample application region and the analyte capture region. The flow of urine in the fluid path is observable through the transparent upper section for confirming a test is operative.
    Type: Grant
    Filed: October 24, 1997
    Date of Patent: April 4, 2000
    Assignee: Carter-Wallace, Inc.
    Inventors: Albert R. Nazareth, Mary Beth Boyle, Yea-Shun Cheng
  • Patent number: 6010912
    Abstract: A method for antenatal screening for chromosomal abnormalities in which maternal blood from a pregnant woman is measured for levels of free beta hCG and at least a second serum marker and/or precursors and metabolites of these markers and the measured levels of these markers together with the gestational age of the pregnant woman are compared to reference values at various gestational ages of the levels for free beta hCG and the second serum marker in (a) pregnant women carrying foetuses having the abnormalitie(s) subject to the screen and (b) pregnant women carrying normal foetuses, the comparison being indicative of the risk of the pregnant woman carrying a foetus with an abnormality subject to the screen characterised in that the second serum marker is pregnancy associated plasma protein A (PAPPA) and the screen is carried out by the end of the thirteenth (13th) completed week of pregnancy.
    Type: Grant
    Filed: December 4, 1995
    Date of Patent: January 4, 2000
    Assignee: Johnson & Johnson Clinical Diagnostics, Inc.
    Inventor: Christopher John Davies
  • Patent number: 5965458
    Abstract: A test strip for a rapid immunoassay containing specific immunochemical reagent zones (7, 8, 9) is described. The test strip (10) has a backing sheet (1) and attached thereto a receiving end pad (3) and at a distance therefrom a finishing end pad (5). A test membrane (2) is provided between said pads (3, 5). Said membrane (2) is positioned in parallel relationship to said backing (1) at a distance therefrom so that said backing (1) and said membrane (2) limit between themselves an air gap (4) which is open at its edges. Said gap (4) functions as a sheltered reaction chamber for the immunolgical reaction taking place as a liquid is made to flow through said membrane (2). The test strip is simple to manufacture by lamination and easy to use and it is suitable for both diagnostic and environmental immunoassays.
    Type: Grant
    Filed: April 9, 1997
    Date of Patent: October 12, 1999
    Assignee: Oy Medix Biochemica A.B.
    Inventors: Ilkka Sakari Kouvonen, Eivor Helena Svens, Sari Hannele Tikanoja, Pekka Antero Turunen, Lauri Markus Sivonen
  • Patent number: 5958789
    Abstract: A method of preventing false detection of signal due to splashing of reagent liquid used to produce such signal, when dispensing at least one such liquid from a metering tip into a second liquid, comprising the steps of: a) positioning the metering tip a predetermined distance above the upper level of the second liquid prior to dispensing the one liquid; andb) while maintaining the distance throughout the dispensing of the one liquid, dispensing the one liquid;wherein the predetermined distance is between about 1.0 mm and about 2.0 mm so that splashing during dispensing is reduced.
    Type: Grant
    Filed: July 29, 1997
    Date of Patent: September 28, 1999
    Assignee: Johnson & Johnson Clinical Diagnostics, Inc.
    Inventors: David Donald Hyde, Merrit Nyles Jacobs, James Daniel Riall
  • Patent number: 5763164
    Abstract: The present invention relates to tumor specific antigens and functional proteins of a tumor cell preparable by identifying protein presents in the tumor cell that are selectively immunogenic for tumor patients. The present invention still further provides a process of making a peptide library of tumor specific humoral antigens, a process of increasing the immunogenic specificity of a tumor-associated antigen, an assay kit for detecting the presence of an antibody immunoreactive with a tumor-specific antigen, and a process of making T cells sensitized to a tumor-specific antigen.
    Type: Grant
    Filed: February 3, 1994
    Date of Patent: June 9, 1998
    Assignee: Northwestern University
    Inventor: Emanuel Calenoff
  • Patent number: RE38688
    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: March 30, 2001
    Date of Patent: January 18, 2005
    Assignee: Dade Behring Marburg GmbH
    Inventors: Heinz-Jürgen Friesen, Gerd Grenner, Hans-Erwin Pauly, Helmut Kohl, Klaus Habenstein, Joseph Stärk
  • 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