Human Chorionic Gonadotropin Patents (Class 436/818)
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Patent number: 8900881Abstract: 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: GrantFiled: September 12, 2011Date of Patent: December 2, 2014Inventor: Jin Po Lee
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Patent number: 8691585Abstract: 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: GrantFiled: June 1, 2011Date of Patent: April 8, 2014Assignee: The Trustees of Columbia University in the City of New YorkInventors: John F. O'Connor, Galina I. Kovalevskaya, Steven Birken
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Patent number: 8628724Abstract: 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: GrantFiled: January 3, 2012Date of Patent: January 14, 2014Assignee: Charleston Area Medical Center, Inc.Inventor: J. Todd Kuenstner
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Patent number: 8541245Abstract: 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: GrantFiled: June 11, 2010Date of Patent: September 24, 2013Assignee: Beckman Coulter, Inc.Inventor: William E. Roudebush
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Patent number: 8455263Abstract: 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 theType: GrantFiled: December 30, 2008Date of Patent: June 4, 2013Inventor: Jin Po Lee
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Patent number: 7977104Abstract: 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: GrantFiled: September 27, 2006Date of Patent: July 12, 2011Assignee: The Trustees of Columbia University in the City of New YorkInventors: John F. O'Connor, Galina I. Kovalevskaya, Steven Birken
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Patent number: 7790403Abstract: 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: GrantFiled: October 22, 2007Date of Patent: September 7, 2010Assignee: The Trustees of Columbia University in the City of New YorkInventors: John O'Connor, Steven Birken, Galina Kovalevskaya
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Patent number: 7771928Abstract: 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: GrantFiled: August 28, 2002Date of Patent: August 10, 2010Assignee: Fujirebio Inc.Inventors: Akira Hasegawa, Yoshihiro Ashihara, Mitsuo Isomura
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Patent number: 7718444Abstract: 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: GrantFiled: January 27, 2005Date of Patent: May 18, 2010Assignee: Denka Seiken Co., Ltd.Inventors: Kazuyuki Takizawa, Ryo Shida
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Patent number: 7682836Abstract: 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: GrantFiled: October 4, 2001Date of Patent: March 23, 2010Assignee: Cranfield UniversityInventors: Sergiy Anatoliyovich Piletsky, Olena Volodimirivna Piletska, Khalku Karim, Anthony Peter Francis Turner, Alessandra Bossi
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Patent number: 7569397Abstract: 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: GrantFiled: June 13, 2008Date of Patent: August 4, 2009Assignee: Chembio Diagnostic Systems, Inc.Inventor: Javanbakhsh Esfandiari
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Patent number: 7410768Abstract: 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: GrantFiled: April 3, 2001Date of Patent: August 12, 2008Assignee: Inverness Medical Switzerland GmbHInventors: Lorraine D. Butlin, John Coley, Stephen J. Eida, Mohamed M. Gani
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Patent number: 7332350Abstract: 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: GrantFiled: February 10, 2003Date of Patent: February 19, 2008Assignee: Humasis Co., Ltd.Inventors: Jin-Dong Chang, Jung-Hak Cha, Jung-Hyun Nam
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Patent number: 7285391Abstract: 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: GrantFiled: September 1, 2004Date of Patent: October 23, 2007Assignee: The Trustees of Columbia Univeristy in the City of New YorkInventors: John O'Connor, Steven Birken, Galina Kovalevskaya
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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: 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: 7192786Abstract: 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: GrantFiled: June 7, 1995Date of Patent: March 20, 2007Assignee: Wallac OyInventors: Timo Nils-Erik Lövgren, Antti Juhana Iitiä, Kim Sverker Immanuel Pettersson
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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: 6927034Abstract: 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: GrantFiled: May 13, 1999Date of Patent: August 9, 2005Assignee: The Trustees of Columbia University in the City of New YorkInventors: John O'Connor, Steven Birken, Galina Kovalevskaya
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Patent number: 6818455Abstract: 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 meType: GrantFiled: February 28, 2001Date of Patent: November 16, 2004Assignee: Inverness Medical Switzerland GmbHInventors: Keith May, Michael Evans Prior, Ian Richards
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Patent number: 6689615Abstract: 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: GrantFiled: October 4, 2000Date of Patent: February 10, 2004Inventors: James Murto, Michael Salvati
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Patent number: 6677123Abstract: 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: GrantFiled: February 1, 1999Date of Patent: January 13, 2004Assignee: Wako Pure Chemical Industries, Ltd.Inventors: Ritsu Yamamoto, Shinji Satomura
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Patent number: 6627457Abstract: 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: GrantFiled: July 30, 2001Date of Patent: September 30, 2003Assignee: Quest Diagnostics Investments IncorporatedInventors: Murugan R. Pandian, Julie Y. Lu
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Patent number: 6582970Abstract: 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: GrantFiled: June 22, 2000Date of Patent: June 24, 2003Assignee: Teikoku Hormone MFG. Co, Ltd.Inventor: Hideaki Manita
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Patent number: 6573103Abstract: 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: GrantFiled: April 29, 1999Date of Patent: June 3, 2003Inventor: Nicholas J Wald
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Patent number: 6548309Abstract: 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: GrantFiled: March 19, 1998Date of Patent: April 15, 2003Assignee: Binax, Inc.Inventors: Norman James Moore, Vincent Anthony Sy
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Publication number: 20030059946Abstract: 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: ApplicationFiled: September 26, 2002Publication date: March 27, 2003Inventor: M. R. Pandian
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Patent number: 6500629Abstract: 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: GrantFiled: September 13, 2000Date of Patent: December 31, 2002Assignee: Equitech Laboratories, Inc.Inventors: Brian D. Cleaver, Mike L. Green
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Patent number: 6500627Abstract: 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: GrantFiled: February 3, 1998Date of Patent: December 31, 2002Assignee: The Trustees of Columbia University in the City of New YorkInventors: John F. O'Connor, Galina I. Kovalevskaya, Steven Birken
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Patent number: 6492178Abstract: 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: GrantFiled: August 8, 2000Date of Patent: December 10, 2002Assignee: Quest Diagnostic Investments, IncorporatedInventor: Murugan R. Pandian
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Patent number: 6485982Abstract: 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: GrantFiled: June 6, 1995Date of Patent: November 26, 2002Assignee: Armkel, LLCInventor: David E. Charlton
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Patent number: 6448022Abstract: 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: GrantFiled: July 19, 1994Date of Patent: September 10, 2002Assignee: Cedars-Sinai Medical CenterInventors: Glenn D. Braunstein, Song-Guang Ren
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Patent number: 6429018Abstract: 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: GrantFiled: November 29, 1999Date of Patent: August 6, 2002Assignee: Yale UniversityInventors: Laurence A. Cole, Andrew Kardana
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Patent number: 6395503Abstract: 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: GrantFiled: April 14, 2000Date of Patent: May 28, 2002Assignee: Dainichiseika Color & Chemicals Mfg. Co., Ltd.Inventors: Hideaki Suzuki, Kiyoshi Takahashi, Gen-ichiro Araya, Hisashi Katsuragi, Mio Hosogoe
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Patent number: 6368876Abstract: 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: GrantFiled: January 9, 1998Date of Patent: April 9, 2002Assignee: Genzyme DiagnosticsInventors: Ching Huang, Eugene Fan
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Patent number: 6352862Abstract: 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: GrantFiled: June 9, 1997Date of Patent: March 5, 2002Assignee: Unilever Patent Holdings B.V.Inventors: Paul James Davis, Michael Evans Prior, Keith May
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Patent number: 6251688Abstract: 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: GrantFiled: March 20, 1998Date of Patent: June 26, 2001Assignee: IA, Inc.Inventors: Judith L. Erb, James G. Downward, John R. Erb-Downward, Otho Ulrich
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Patent number: 6228660Abstract: 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 meaType: GrantFiled: June 7, 1995Date of Patent: May 8, 2001Assignee: Conopco Inc.Inventors: Keith May, Michael Evans Prior, Ian Richards
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Patent number: 6204002Abstract: 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: GrantFiled: December 23, 1998Date of Patent: March 20, 2001Assignee: Daikin Industries, Ltd.Inventors: Takao Iida, Yutaka Ohira
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Patent number: 6194222Abstract: 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: GrantFiled: January 5, 1998Date of Patent: February 27, 2001Assignee: Biosite Diagnostics, Inc.Inventors: Kenneth F. Buechler, Joseph M Anderberg, Paul H. McPherson
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Patent number: 6187598Abstract: 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: June 7, 1995Date of Patent: February 13, 2001Assignee: Conopco Inc.Inventors: Keith May, Michael Evans Prior, Ian Richards
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Patent number: 6143576Abstract: 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: GrantFiled: March 3, 1997Date of Patent: November 7, 2000Assignee: Biosite Diagnostics, Inc.Inventor: Kenneth F. Buechler
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Patent number: 6127186Abstract: 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: GrantFiled: January 12, 1999Date of Patent: October 3, 2000Inventor: M. R. Pandian
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Patent number: 6046057Abstract: 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: GrantFiled: October 24, 1997Date of Patent: April 4, 2000Assignee: Carter-Wallace, Inc.Inventors: Albert R. Nazareth, Mary Beth Boyle, Yea-Shun Cheng
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Patent number: 6010912Abstract: 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: GrantFiled: December 4, 1995Date of Patent: January 4, 2000Assignee: Johnson & Johnson Clinical Diagnostics, Inc.Inventor: Christopher John Davies
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Patent number: 5965458Abstract: 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: GrantFiled: April 9, 1997Date of Patent: October 12, 1999Assignee: Oy Medix Biochemica A.B.Inventors: Ilkka Sakari Kouvonen, Eivor Helena Svens, Sari Hannele Tikanoja, Pekka Antero Turunen, Lauri Markus Sivonen
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Patent number: 5958789Abstract: 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: GrantFiled: July 29, 1997Date of Patent: September 28, 1999Assignee: Johnson & Johnson Clinical Diagnostics, Inc.Inventors: David Donald Hyde, Merrit Nyles Jacobs, James Daniel Riall
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Patent number: 5763164Abstract: 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: GrantFiled: February 3, 1994Date of Patent: June 9, 1998Assignee: Northwestern UniversityInventor: Emanuel Calenoff
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Patent number: RE38688Abstract: 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: GrantFiled: March 30, 2001Date of Patent: January 18, 2005Assignee: Dade Behring Marburg GmbHInventors: Heinz-Jürgen Friesen, Gerd Grenner, Hans-Erwin Pauly, Helmut Kohl, Klaus Habenstein, Joseph Stärk
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Patent number: RE37437Abstract: 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: GrantFiled: October 18, 1995Date of Patent: November 6, 2001Assignee: Dade Behring Marburg, GmbHInventors: Heinz-Jürgen Friesen, Gerd Grenner, Hans-Erwin Pauly, Helmut Kohl, Klaus Habenstein, Joseph Stärk