Glucose, Ketone, Nitrate Standard Or Control Patents (Class 436/14)
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Patent number: 6964871Abstract: A system for measuring a glucose level in a blood sample includes a test strip and a meter. The test strip includes a sample chamber or other testing zone, a working electrode, a counter electrode, fill-detect electrodes, and an auto-on conductor. A reagent layer is disposed in the testing zone. The auto-on conductor causes the meter to wake up and perform a test strip sequence when the test strip is inserted in the meter. The meter uses the working and counter electrodes to initially detect the blood sample in the sample chamber and uses the fill-detect electrodes to check that the blood sample has mixed with the reagent layer. The meter applies an assay voltage between the working and counter electrodes and measures the resulting current. The meter calculates the glucose level based on the measured current and calibration data saved in memory from a removable data storage device associated with the test strip.Type: GrantFiled: January 26, 2004Date of Patent: November 15, 2005Assignee: Home Diagnostics, Inc.Inventors: Douglas E. Bell, Gary T. Neel, T. Philip Wong
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Patent number: 6946299Abstract: A system for measuring a glucose level in a blood sample includes a test strip and a meter. The test strip includes a sample chamber, a working electrode, a counter electrode, fill-detect electrodes, and an auto-on conductor. A reagent layer is disposed in the sample chamber. The auto-on conductor causes the meter to wake up and perform a test strip sequence when the test strip is inserted in the meter. The meter uses the working and counter electrodes to initially detect the blood sample in the sample chamber and uses the fill-detect electrodes to check that the blood sample has mixed with the reagent layer. The meter applies an assay voltage between the working and counter electrodes and measures the resulting current. The meter calculates the glucose level based on the measured current and calibration data saved in memory from a removable data storage device associated with the test strip.Type: GrantFiled: April 21, 2003Date of Patent: September 20, 2005Assignee: Home Diagnostics, Inc.Inventors: Gary T. Neel, Douglas E. Bell, T. Philip Wong, Houston F. Voss, Allan Javier Caban, David K. Boehm
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Patent number: 6900058Abstract: An aqueous control solution is disclosed for use with a spectrophotometer or photometric test strip that includes a predetermined amount of an analyte, a hydrophobic reference dye and a surfactant. In one embodiment, the aqueous control solution is applied to a photometric test strip having a chemical that oxidizes glucose and consequently forms hydrogen peroxide which reacts with an indicator dye that is also present on the strip. In this embodiment, the control solution includes a predetermined amount of glucose, an infrared reference dye, sodium dodecyl sulfate, and the indicator dye, such as sulforhodamine B.Type: GrantFiled: March 11, 2003Date of Patent: May 31, 2005Assignee: Bionostics, Inc.Inventors: Minna A. Rannikko, Donna M. Murray, Donna M. Rafferty
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Patent number: 6878550Abstract: Use of 13C glucose in an analytical assay to monitor glucose metabolism by measurement of labeled exhaled CO2 is provided. A breath test and kit for performing the breath test are described for the diagnosis of diabetic indications and monitoring of glycemic control. The breath test utilizes the measurement of expired 13C-labeled CO2 following the ingestion of a 13C-enriched glucose source.Type: GrantFiled: May 16, 2003Date of Patent: April 12, 2005Assignee: Isotechnika Inc.Inventors: Randall W. Yatscoff, Robert T. Foster, Launa J. Aspeslet, Richard Lewanczuk
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Patent number: 6844166Abstract: The invention is based on the discovery of reduced valency carbohydrate binding ligands (CBLs) that can be used to to detect or quantitate (i.e., evaluate) carbohydrates in a sample. CBLs can be used with fluorescence resonance energy transfer (FRET) to evaluate free carbohydrates or those within a carbohydrate containing compound.Type: GrantFiled: September 10, 1999Date of Patent: January 18, 2005Assignee: Sensor Technologies Inc.Inventor: David E. Wolf
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Patent number: 6835571Abstract: Multi-analyte reference solutions having a stable partial pressure of oxygen (pO2) in zero headspace packaging and methods for preparing such solutions are disclosed. The solutions have long shelf and use lives when stored at room temperature and are packaged in laminated foil containers having low or no oxygen reactivity. Access devices are also disclosed.Type: GrantFiled: August 29, 2003Date of Patent: December 28, 2004Assignee: Bayer CorporationInventors: Dennis R. Conlon, Minna A. Rannikko, Kevin J. Sullivan, Robert B. Green
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Publication number: 20040180444Abstract: An aqueous control solution is disclosed for use with a spectrophotometer or photometric test strip that includes a predetermined amount of an analyte, a hydrophobic reference dye and a surfactant. In one embodiment, the aqueous control solution is applied to a photometric test strip having a chemical that oxidizes glucose and consequently forms hydrogen peroxide which reacts with an indicator dye that is also present on the strip. In this embodiment, the control solution includes a predetermined amount of glucose, an infrared reference dye, sodium dodecyl sulfate, and the indicator dye, such as sulforhodamine B.Type: ApplicationFiled: March 11, 2003Publication date: September 16, 2004Applicant: Bionostics, Inc.Inventors: Minna A. Rannikko, Donna M. Murray, Donna M. Rafferty
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Patent number: 6780645Abstract: A diagnostic kit for measuring a characteristic of a fluid sample includes a test strip (e.g., a disposable blood glucose test strip) and device (e.g., a hand-held meter) for measuring a property (e.g., an optical or electrochemical property) of the test strip. The device also calculates, based on the measured property of the test strip, a characteristic (e.g., blood glucose concentration or INR) of a fluid sample applied to the test strip. Stored in a memory of the device are test strip calibration codes that represent geometric regions (e.g., polygonal or hexagonal geometric regions) of a multi-dimensional calibration parameter space. The test strip calibration codes and geometric regions are distributed across the multi-dimensional calibration parameter space such that a quantization error of assigning one of test strip calibration codes to the test strip is optimally reduced.Type: GrantFiled: August 21, 2002Date of Patent: August 24, 2004Assignee: Lifescan, Inc.Inventors: Paul G. Hayter, Manoj K. Sharma, Timothy J. Ohara, Darwin Poulos, Maria Aquino
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Publication number: 20040143370Abstract: A valve control system for a semiconductor processing chamber includes a system control computer and a plurality of electrically controlled valves associated with the processing chamber. The system further includes a programmable logic controller in communication with the system control computer and operatively coupled to the electrically controlled valves. The refresh time for control of the valves may be less than 10 milliseconds. Consequently, valve control operations do not significantly extend the period of time required for highly repetitive cycling in atomic layer deposition processes. A hardware interlock may be implemented through the output power supply of the programmable logic controller.Type: ApplicationFiled: December 9, 2003Publication date: July 22, 2004Inventors: Siqing Lu, Yu Chang, Dongxi Sun, Vinh Dang, Michael X. Yang, Anzhong Chang, Anh N. Nguyen, Ming Xi
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Patent number: 6743635Abstract: A system for measuring a glucose level in a blood sample includes a test strip and a meter. The test strip includes a sample chamber, a working electrode, a counter electrode, fill-detect electrodes, and an auto-on conductor. A reagent layer is disposed in the sample chamber. The auto-on conductor causes the meter to wake up and perform a test strip sequence when the test strip is inserted in the meter. The meter uses the working and counter electrodes to initially detect the blood sample in the sample chamber and uses the fill-detect electrodes to check that the blood sample has mixed with the reagent layer. The meter applies an assay voltage between the working and counter electrodes and measures the resulting current. The meter calculates the glucose level based on the measured current and calibration data saved in memory from a removable data storage device associated with the test strip.Type: GrantFiled: November 1, 2002Date of Patent: June 1, 2004Assignee: Home Diagnostics, Inc.Inventors: Gary T. Neel, Douglas E. Bell, T. Philip Wong, Houston F. Voss
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Publication number: 20040038411Abstract: A diagnostic kit for measuring a characteristic of a fluid sample includes a test strip (e.g., a disposable blood glucose test strip) and device (e.g., a hand-held meter) for measuring a property (e.g., an optical or electrochemical property) of the test strip. The device also calculates, based on the measured property of the test strip, a characteristic (e.g., blood glucose concentration or INR) of a fluid sample applied to the test strip. Stored in a memory of the device are test strip calibration codes that represent geometric regions (e.g., polygonal or hexagonal geometric regions) of a multi-dimensional calibration parameter space. The test strip calibration codes and geometric regions are distributed across the multi-dimensional calibration parameter space such that a quantization error of assigning one of test strip calibration codes to the test strip is optimally reduced.Type: ApplicationFiled: August 21, 2002Publication date: February 26, 2004Inventors: Paul G. Hayter, Manoj K. Sharma, Timothy J. Ohara, Darwin Poulos, Maria Aquino
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Publication number: 20030211617Abstract: Methods, program product, and apparatus are provided for implementing a blood glucose meter that will remind the user to test his or her blood glucose after a programmable wait when a hypoglycemic event is detected. Diabetics frequently have a “rebound” hyperglycemic event (high blood glucose) occur as a result of a hypoglycemic event (low blood glucose). The disclosed invention allows the user to program the meter with a waiting period which he or she determines is appropriate to wait following a low blood glucose reading. At the end of this period, the meter will alert the user by way of an audible or tactile warning.Type: ApplicationFiled: May 7, 2002Publication date: November 13, 2003Applicant: International Business Machines CorporationInventor: Steven Paul Jones
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Publication number: 20030203498Abstract: A system for measuring a glucose level in a blood sample includes a test strip and a meter. The test strip includes a sample chamber, a working electrode, a counter electrode, fill-detect electrodes, and an auto-on conductor. A reagent layer is disposed in the sample chamber. The auto-on conductor causes the meter to wake up and perform a test strip sequence when the test strip is inserted in the meter. The meter uses the working and counter electrodes to initially detect the blood sample in the sample chamber and uses the fill-detect electrodes to check that the blood sample has mixed with the reagent layer. The meter applies an assay voltage between the working and counter electrodes and measures the resulting current. The meter calculates the glucose level based on the measured current and calibration data saved in memory from a removable data storage device associated with the test strip.Type: ApplicationFiled: November 1, 2002Publication date: October 30, 2003Applicant: Home Diagnostics, Inc.Inventors: Gary T. Neel, Douglas E. Bell, T. Philip Wong, Houston F. Voss, Allan Javier Caban, David K. Boehm
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Patent number: 6637257Abstract: A method and device for performing fluid analysis by separating cells and/or particles from a fluid, such as a biological, vehicular or industrial fluid. The device is a micromachined filtering device comprising a substrate with through-thickness vias having approximately equal diameters that prevent passage through the substrate of a first material while permitting passage through the substrate of other materials having diametrical dimensions less than the diameter of the vias. Electrodes are located on a surface of the substrate between vias so that as the first material collects at the surface of the substrate, the electrodes become electrically connected to produce an output signal in some proportion to the amount of the first material collected. The device can incorporate multiple micromachined substrates, yielding an analysis system that produces an electrical output for each of a number of properties or parameters.Type: GrantFiled: October 31, 2002Date of Patent: October 28, 2003Assignee: Integrated Sensing SystemsInventor: Douglas Ray Sparks
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Patent number: 6632675Abstract: Multi-analyte reference solutions having a stable partial pressure of oxygen (pO2) in zero headspace packaging and methods for preparing such solutions are disclosed. The solutions have long shelf and use lives when stored at room temperature and are packaged in laminated foil containers having low or no oxygen reactivity. Access devices are also disclosed.Type: GrantFiled: August 16, 2000Date of Patent: October 14, 2003Assignee: Bayer CorporationInventors: Dennis R. Conlon, Minna A. Rannikko, Kevin J. Sullivan, Robert B. Green
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Patent number: 6613570Abstract: An aqueous control liquid is provided that contains glucose at a known concentration and cyclodextrin. A method is also provided that binds a wetting agent from a region of a test element that comes into contact with a sample. The method includes contacting the region with a control liquid that has a substance selected from the group of cyclodextrin derivatives and dispersed materials having a specific surface of 100 m2/g to over 1000 m2/g. A method for controlling the function of a measuring system having test strips and a measuring instrument for the determination of glucose in liquid samples is provided that includes contacting the test strip with a control liquid containing glucose at a known concentration and at least one substance selected from the group consisting of cyclodextrins and cyclodextrin derivatives and detecting a signal caused by the glucose contained in the control liquid.Type: GrantFiled: June 29, 2001Date of Patent: September 2, 2003Assignee: Roche Diagnostics CorporationInventors: Wolfgang-Reinhold Knappe, Otto Gaa, Volker Zimmer, Joachim Hoenes, Bernd Hiller, Franz Wittmann, Beate Koschorreck
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Patent number: 6602715Abstract: A breath test and kit for performing the breath test are described for the diagnosis of diabetic indications and monitoring of glycemic control. The breath test utilizes the measurement of expired 13C-labeled CO2 following the ingestion of a 13C-enriched glucose source.Type: GrantFiled: August 27, 2002Date of Patent: August 5, 2003Assignee: Isotechnika Inc.Inventors: Randall W. Yatscoff, Robert T. Foster, Launa J. Aspeslet, Richard Lewanczuk
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Publication number: 20030143746Abstract: A wearable periodic self-calibrating body analyte monitoring system based on the principles of microdialysis for measurement of a body analyte is disclosed. In a preferred embodiment, the system is designed to measure glucose, and can be held on the body with a skin adhesive for comfort. The system may be combined with an insulin delivery system to create an artificial pancreas.Type: ApplicationFiled: January 31, 2002Publication date: July 31, 2003Inventor: Burton H. Sage
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Patent number: 6599750Abstract: Use of 13C glucose in an analytical assay to monitor glucose metabolism by measurement of labeled exhaled CO2 is provided. A breath test and kit for performing the breath test are described for the diagnosis of diabetic indications and monitoring of glycemic control. The breath test utilizes the measurement of expired 13C-labeled CO2 following the ingestion of a 13C-enriched glucose source.Type: GrantFiled: August 27, 2002Date of Patent: July 29, 2003Assignee: Isotechnika Inc.Inventors: Randall W. Yatscoff, Robert T. Foster, Launa J. Aspeslet, Richard Lewanczuk
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Publication number: 20030044993Abstract: A breath test and kit for performing the breath test are described for the diagnosis of diabetic indications and monitoring of glycemic control. The breath test utilizes the measurement of expired 13C-labeled CO2 following the ingestion of a 13C-enriched glucose source.Type: ApplicationFiled: August 27, 2002Publication date: March 6, 2003Inventors: Randall W. Yatscoff, Robert T. Foster, Launa J. Aspeslet, Richard Lewanczuk
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Publication number: 20020155615Abstract: A method of non-invasive determination of a glucose concentration in blood based on the measurements of the total impedance of the skin of a patient is disclosed. The method is based on a linear model of a first order correlation between the glucose concentration and the total impedance, the model taking into account the rate of change of the glucose concentration. The coefficients used in an approximating function are determined at the preliminary stage measurements by an invasive method.Type: ApplicationFiled: February 5, 2002Publication date: October 24, 2002Inventors: Igor A. Novikov, Alexander V. Kislov
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Patent number: 6468802Abstract: A breath test and kit for performing the breath test are described for the diagnosis of diabetic indications and monitoring of glycemic control. The breath test utilizes the measurement of expired 13C-labeled CO2 following the ingestion of a 13C-enriched glucose source.Type: GrantFiled: February 8, 2001Date of Patent: October 22, 2002Assignee: Isotechnika, Inc.Inventors: Randall W. Yatscoff, Robert T. Foster, Launa J. Aspeslet, Richard Lewanczuk
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Patent number: 6461870Abstract: Use of 13C glucose in an analytical assay to monitor glucose metabolism by measurement of labeled exhaled CO2 is provided. A breath test and kit for performing the breath test are described for the diagnosis of diabetic indications and monitoring of glycemic control. The breath test utilizes the measurement of expired 13C-labeled CO2 following the ingestion of a 13C-enriched glucose source.Type: GrantFiled: July 20, 2001Date of Patent: October 8, 2002Assignee: Isotechnika Inc.Inventors: Randall W. Yatscoff, Robert T. Foster, Launa J. Aspeslet, Richard Lewanczuk
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Publication number: 20020081740Abstract: The invention concerns an aqueous control liquid (control solution) containing glucose at a known concentration and at least one substance selected from the group comprising cyclodextrins, cyclodextrin derivatives and finely dispersed materials having a large specific surface.Type: ApplicationFiled: June 29, 2001Publication date: June 27, 2002Inventors: Wolfgang-Reinhold Knappe, Otto Gaa, Volker Zimmer, Joachim Hoenes, Bernd Hiller, Franz Wittmann, Beate Koschorreck
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Patent number: 6391643Abstract: An automated system for continual transdermal extraction of analytes present in a biological system is described. The system optionally uses reverse iontophoresis to carry out the continual transdermal extraction of the analytes. The present invention describes quality control test kits, and methods of use thereof, for testing the ability of the system to provide reliable, effective, and accurate determination of analyte concentration.Type: GrantFiled: October 27, 1999Date of Patent: May 21, 2002Assignee: Cygnus, Inc.Inventors: Qiang Chen, David M. Liu, Brian S. Kersten, Christine M. Wu
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Patent number: 6309884Abstract: A method is provided for calibrating a noninvasive glucose monitor for prospective noninvasive glucose determination. Spectroscopic transflectance readings are measured on the patient's skin using a noninvasive glucose monitor. The patient's blood glucose level is measured with an invasive glucose monitor. The noninvasive and invasive measurements are correlated to form an individual algorithm for each patient. Preferably, the position of the patient's skin with respect to the probe of the noninvasive monitor is spatially adjusted while collecting the transflectance measurements such that multiple readings are taken on the patient's skin. The measurements are preferably taken over a period of time and over a plurality of glucose levels in the patient.Type: GrantFiled: December 7, 1999Date of Patent: October 30, 2001Assignee: Diasense, Inc.Inventors: Patrick J. Cooper, Todd Q. Barker
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Patent number: 6232130Abstract: A method of evaluating a carbohydrate in a sample. The method includes providing a low valency carbohydrate binding ligand, providing a glycoconjugate which includes a label, and a carbohydrate moiety, contacting the low valency carbohydrate binding ligand and the glycoconjugate with the sample, determining the extent of binding of the low valency carbohydrate binding ligand with the glycoconjugate, the binding of the low valency carbohydrate binding ligand with the glycoconjugate being correlated with the amount of carbohydrate in the sample.Type: GrantFiled: June 4, 1998Date of Patent: May 15, 2001Assignee: Sensor Technologies, Inc.Inventor: David E. Wolf
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Patent number: 6177283Abstract: For blood or other physiological fluid sample collection kits that use filter paper to collect the sample, the performance of the kit and associated analytical method can be improved by using a material having properties which are superior to those of standard filter paper or modified filter paper routinely used in standard biological assays. Certain materials currently available for uses other than blood collection, storage, or transport have properties that are advantageous as employed in assays of biological fluids, including the use of specific cellulose blotting materials for collecting blood samples for hemoglobin or hemoglobin A1c monitoring.Type: GrantFiled: May 28, 1998Date of Patent: January 23, 2001Assignee: FlexSite Diagnostics, Inc.Inventor: Robert A. Ray
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Patent number: 6136607Abstract: Multi-analyte reference solutions having a stable partial pressure of oxygen (pO.sub.2) in zero headspace packaging and methods for preparing such solutions are disclosed. The solutions have long shelf and use lives when stored at room temperature and are packaged in laminated foil containers having low or no oxygen reactivity. Access devices are also disclosed.Type: GrantFiled: February 3, 1998Date of Patent: October 24, 2000Assignee: Bayer CorporationInventors: Dennis R. Conlon, Minna A. Rannikko, Kevin J. Sullivan, Robert B. Green
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Patent number: 6136618Abstract: A semiconductor device manufacturing process diagnosis system including a visual inspection device for detecting a physically abnormal part of a semiconductor device to be diagnosed, an LSI tester for measuring electrical characteristics of a semiconductor device and a diagnosis device and characterized in that the diagnosis device extracts, from among circuit blocks constituting a semiconductor device, a block contained in a predetermined region covering a physically abnormal part, determines whether an extracted block and an abnormal block causing abnormality of electrical characteristics are the same, with respect to a block discriminated as an abnormal block, detects a position causing abnormality of electrical characteristics within the block, and depending on whether a detected position substantially coincides with a physically abnormal part, determines whether abnormality of electrical characteristics derives from physical abnormality.Type: GrantFiled: November 20, 1998Date of Patent: October 24, 2000Assignee: NEC CorporationInventor: Masaru Sanada
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Patent number: 6077708Abstract: The invention provides a method of determining the content of progenitor cells in a hematopoietic cell culture. The method comprises measuring one or more metabolic parameters of the culture, such as oxygen consumption, glucose consumption and/or lactate production, and using the measured parameter(s) to determine the content of progenitor cells.Type: GrantFiled: September 24, 1998Date of Patent: June 20, 2000Inventors: Paul C. Collins, E. Terry Papoutsakis, William M. Miller
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Patent number: 5904915Abstract: A diagnostic agent for glycometabolic function comprising a glucose derivative of the formula (I): ##STR1## wherein R.sup.1, R.sup.2, R.sup.3 and R.sup.4 are the same or different and each represents hydrogen or acyl having 2 to 8 carbon atoms, with the proviso that at least one of R.sup.1, R.sup.2, R.sup.3 and R.sup.4 is acyl and R.sup.5 represents X or --NHCOR.sup.6 X wherein X is a radioisotope of halogen and R.sup.6 is arylene or alkylene having 1 to 3 carbon atoms.Type: GrantFiled: March 27, 1997Date of Patent: May 18, 1999Assignee: Nihon Medi-Physics Co., Ltd.Inventors: Yasuhisa Fujibayashi, Atsuo Waki, Akira Yokoyama
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Patent number: 5858796Abstract: Reagent and method are offered for the screening of the functional condition of the body by the person's saliva. Reagent presents itself as an H2O solution, containing ions of Fe3+, chloride ions and multi-atom alcohol .n the concentrations 0.05-3.0M; 0.05-4.0M, and 0.1-5.0M accordingly. Screening is conducted by means of mixing of the persons saliva with the reagent in the following comparison of colour mix with control; during this an orange colour is correlated with the norm; yellow-diabetes SD-1, functional disorders of pancreas; bright-pink and red initial stages of hypertonic disease, diabetes SD-2, pathological influence of smoking; dark-red, developed forms of hypertension, diabetes SD-2, pathogenic-influence of smoking or other toxic substances, leading to the emphasized energetic disorder.Type: GrantFiled: March 8, 1995Date of Patent: January 12, 1999Assignee: Serguei V. KhartchenkoInventors: Kiril Erastovitch Giatsintov, Serguei V. Khartchenko, Andrea Victorovich Aleksandrov, Nadejda Petrovna Khartchenko
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Patent number: 5856195Abstract: A method and apparatus are provided for calibrating a sensor for determination of analyte concentration. The meter includes a sensor for receiving a user sample to be measured and a processor for performing a predefined test sequence for measuring a predefined parameter value. A memory can be coupled to the processor for storing predefined parameter data values. A calibration code is associated with the sensor and read by the processor before the user sample to be measured is received. The calibration code is used in measuring the predefined parameter data value to compensate for different sensor characteristics.Type: GrantFiled: October 30, 1996Date of Patent: January 5, 1999Assignee: Bayer CorporationInventors: Steven C. Charlton, Larry D. Johnson, Matthew K. Musho, Joseph E. Perry
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Patent number: 5814664Abstract: The present invention relates to advanced glycosylation endproducts, and particularly to the use of novel cyclopentenone aminoreductones, 3-alkylamino-2 -hydroxy-4-hydroxymethyl-2-cyclopenten-1-ones. Such AGEs can be used in various diagnostic and therapeutic methods.Type: GrantFiled: June 23, 1997Date of Patent: September 29, 1998Assignee: Picower Institute for Medical ResearchInventors: Peter C. Ulrich, Xini Zhang
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Patent number: 5736103Abstract: A meter is used in conjunction with a hollow, frustum-shaped disposable device to measure the concentration of an analyte in a sample of a biological fluid. The smaller end of the frustum has a porous membrane, to which a sample of the fluid may be applied. Preferably, a reagent in the membrane reacts with the analyte to cause a color change. The meter has a frustum-shaped distal section that mates with the device. The meter measures the color change and computes from the change the analyte concentration in the sample. The meter and disposable device permit remote dosing of the device, which minimizes the likelihood of cross-contamination between the user and the meter. Devices can be mounted on the meter and released from the meter without touching them, to further protect against contamination.Type: GrantFiled: August 9, 1996Date of Patent: April 7, 1998Assignee: Lifescan, Inc.Inventor: Jerry Thomas Pugh
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Patent number: 5633143Abstract: Disclosed is a method for the quantitative determination of D-3-hydroxybutyric acid and acetoacetic acid, which comprises reacting a biological sample containing D-3-hydroxybutyric acid and acetoacetic acid, with a reagent comprising: (1) a D-3-hydroxybutyrate dehydrogenase, (2) A.sub.1 and (3) B.sub.1, the components (1), (2) and (3) participating in the following cycling reaction: ##STR1## thereby effecting the enzymatic cycling reaction, and measuring a change in the amount of A.sub.2 formed or the amount of B.sub.1 consumed. Also disclosed is an analytical reagent comprising the components (1), (2) and (3) for use in the above method. The method and the analytical reagent ensure rapidness and accuracy in the determination of D-3-hydroxybutyric acid and acetoacetic acid, even with the use of a small quantity of a biological sample, so that they are very useful in application fields, such as clinical diagnosis and food testing.Type: GrantFiled: May 26, 1994Date of Patent: May 27, 1997Assignee: Asahi Kasei Kogyo Kabushiki KaishaInventors: Shigeru Ueda, Hideo Misaki, Shigeru Ikuta, Mamoru Takahashi
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Patent number: 5633166Abstract: In high volume laboratory analysis of patient medical specimens, control materials are inserted at periodical intervals (e.g. once per eight hours) and analyzed. If the results of the analysis deviate from the mean according to statistical rules, the run of analyses prior to the insertion of control materials has in the past been rejected, often causing a substantial loss of results because the control materials were not inserted sufficiently frequently. According to the invention the patient mean of a test is determined, and when the mean deviates from the predetermined mean by more than a selected amount, this determination is used, not to reject the run, but rather to trigger insertion and analysis of control materials. If the analysis of control materials shows that the run is in control, the analyses made prior thereto are reported and the run is resumed. If the control material analysis shows that the run is out of control, then the prior analyses are rejected.Type: GrantFiled: January 19, 1995Date of Patent: May 27, 1997Assignee: MDS Health Group LimitedInventors: James O. Westgard, Paul Mountain
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Patent number: 5627075Abstract: The inclusion of succinic acid or a salt thereof to stabilize compositions that include glucose oxidase and/or ferricyanide. Typically, the succinic acid or succinic acid salt is included in a diagnostic reagent utilized in test strips or test solutions useful for the analysis of glucose from a fluid sample.Type: GrantFiled: March 20, 1996Date of Patent: May 6, 1997Assignee: Boehringer Mannheim CorporationInventor: Joseph E. Bateson
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Patent number: 5618686Abstract: A method of measuring the total ketone body in a sample comprising converting acetoacetic acid in the sample to 3-hydroxybutyric acid in advance and subsequently converting the whole 3-hydroxybutyric acid including 3-hydroxybutyric acid existing in the sample originally to acetoacetic acid to lead the reduction of nicotinamide adenine dinucleotide according to the action of 3-hydroxybutyrate dehydrogenase and a sample reagent thereof is disclosed. According to this invention an assay of the total ketone body in samples can be carried out conveniently, highly precisely and quickly.Type: GrantFiled: March 4, 1994Date of Patent: April 8, 1997Assignee: Nitto Boseki Co., Ltd.Inventors: Ryo Kojima, Yoshiro Sato, Akiko Takekawa, Katsuhiro Katayama
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Patent number: 5618734Abstract: For determining 3-deoxyglucosone derivatives which are intermediate metabolites of the Maillard reaction in body fluids such as blood, urine, serum, plasma and the like in gas chromatography/mass spectrometry, .sup.13 C-labelled compounds or .sup.14 C-labelled compounds are useful as an internal standard substance. More specifically, 3-deoxyglucosone derivatives having the formula (I): ##STR1## wherein *C is .sup.13 C or .sup.14 C, X is O or N--OR wherein R is Me, Et or H, and Y is SiMe.sub.3 or SiMe.sub.2 tBu, and their production are provided. The measurement of 3-deoxyglucosone derivatives is useful in diagnosing diseases such as diabetes and diseases complicated with diabetes, including diabetic nephrosis, various renal disorders, renal insufficiency, metabolic diseases of carbohydrate and the like.Type: GrantFiled: March 20, 1995Date of Patent: April 8, 1997Assignee: Kureha Chemical Industry Co., Ltd.Inventors: Toshimitsu Niwa, Koichi Niimura, Minoru Ohara, Sigemi Tomiyama
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Patent number: 5605837Abstract: A control solution for use with a photometric blood glucose strip contains glucose in an aqueous suspension of carbon black. The control solution mimics blood when applied to a whole blood glucose test strip, which is then inserted into a meter. A meter reading within a predetermined range indicates that meter and strip are operating satisfactorily. Preferably the control solution is buffered to a neutral pH and includes chloride ion to provide a stable end point for the glucose reaction. Depending on the glucose concentration, the solution checks meter and strip operation at high, low, and normal blood glucose levels.Type: GrantFiled: February 14, 1996Date of Patent: February 25, 1997Assignee: LifeScan, Inc.Inventors: Saker A. Karimi, Geoffrey McGarraugh, Yeung S. Yu
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Patent number: 5580747Abstract: The present invention is directed to the assay and purification of proteins, and particularly to the non-radioactive assay and purification of protein kinases, phosphatases and protease by incubating the enzyme with a substrate modified peptide to form a product modified peptide under conditions where the enzyme is active. The product modified peptide and substrate modified peptide are then separated, and the product modified peptide is measured. The present invention is also directed to kits and bioreagents for performing the assays.Type: GrantFiled: January 21, 1994Date of Patent: December 3, 1996Assignee: Promega CorporationInventors: John W. Shultz, Douglas H. White
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Patent number: 5571723Abstract: An improved method of testing individuals for diabetes, even if they have levels of interfering substances (e.g., uric acid, bilirubin, and glutathione) that would otherwise interfere with such testing, is disclosed. The individual's protein-bound glucose level and glucose level are compared to the analogous values for a reference population to enable the risk of that individual's having diabetes to be assessed. The substances that would otherwise tend to interfere with the assay for protein-bound glucose are removed before the assay, desirably by precipitating the protein-bound glucose using uranyl acetate, which desirably leaves substantially all of the interfering substances in the supernatant, then separating the precipitate from the supernatant, redissolving the precipitate, and conducting the colorimetric assay on the resulting solution. An improved colorimetric test for protein-bound glucose using viologens as the colorimetric electron acceptors is also disclosed.Type: GrantFiled: May 3, 1993Date of Patent: November 5, 1996Inventors: Cody A. Evans, Harold M. Bates
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Patent number: 5559003Abstract: The method is directed to assaying for biological components in a sample comprising step (A) generating an oxidase substrate in the presence of an amphoteric surfactant and in the absence of ferrocyanide; (B) initially generating hydrogen peroxide through said oxidase reaction on said substrate of oxidase with subsequent detection of the generated hydrogen peroxide using peroxidase and a color developer capable of being oxidized in the presence of amphoteric surfactant and ferrocyanide; and (C) correlating the amount of color developed to the amount of biological components in the biological sample. Even when the biological component to be detected is present in a very small amount, the interference of bilirubin can be eliminated in assays of biological components in which peroxidase generated from an enzymatic reaction is detected using peroxidase and a color developer capable of being oxidized.Type: GrantFiled: November 29, 1994Date of Patent: September 24, 1996Assignee: Daiichi Pure Chemicals Co., Ltd.Inventors: Sumi Kawahara, Toshikatsu Abe, Kenji Hosoi
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Patent number: 5556761Abstract: A test strip for determining blood glucose levels comprising a reagent which incorporates a dye color. Whole blood reacts with the reagent of the test strip resulting in a color change on the reagent portion of the strip which is controlled by the dye color, indicating the blood glucose level by visual comparison with a color chart, or by the use a photometer. The use of a copolymer in the reagent which provides complete coalescence and a resulting smooth surface particle structure provides accurate readings of the reacted test strip by the photometer.Type: GrantFiled: April 26, 1994Date of Patent: September 17, 1996Inventor: Kevin J. Phillips
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Patent number: 5520883Abstract: Test devices are disclosed which are useful for determining glucose or occult blood comprising a carrier matrix, glucose oxidase, an indicator system and a glucose derivative that upon addition of water hydrolizes to produce glucose.Type: GrantFiled: September 5, 1989Date of Patent: May 28, 1996Assignee: Miles Inc.Inventors: Steven C. Charlton, Robert P. Hatch, Paul R. Hemmes
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Patent number: 5453378Abstract: Disclosed is a serum free control reagent formulation useful for the determination of a pre-selected analyte. The formulation involves an aqueous solution of a predetermined amount of the analyte together with a polymerized quaternary salt of di- or mono- allyl, di- or tri- alkyl ammonium characterized by the formulae: ##STR1## where R is straight or branched chain alkyl of 1 to 4 carbon atoms, n is a number of at least 9 and .theta. represents a counteranion. The formulation typically contains a buffer to maintain its pH at a level of about 7.5 and a preservative.Type: GrantFiled: February 24, 1994Date of Patent: September 26, 1995Assignee: Miles Inc.Inventors: Douglas E. Bell, Amy H. Chu, Karen L. Marfurt
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Patent number: 5385844Abstract: Described are control reagents useful in analyte determination. The reagents contain a known concentration or amount of the analyte to be assayed, and a polymer. The polymer is made up of monomers of either water soluble acrylic monomers, water soluble quaternary amines, or mixtures of these two types of molecules. Various control reagent formulations, as well as new polymers useful in control reagents, are disclosed.Type: GrantFiled: April 22, 1993Date of Patent: January 31, 1995Assignee: Boehringer Mannheim CorporationInventors: Jim Kennamer, Arthur Usmani
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Patent number: 5308767Abstract: A method for control or calibration in a chemical analytical determination using a dry analysis element comprising at least one color-producing reagent and a porous layer, wherein the method comprises applying an aqueous dispersion onto the porous layer and measuring the optical density of the color produced, wherein the aqueous dispersion comprises a substance which is the same as or similar to an analyte to be determined and water-insoluble particles dispersed therein, wherein the particles are particles of a homopolymer, a copolymer, phthalates, trimellitates, phosphates, benzoates, amides, phenols, aliphatic esters, hydrocarbons, halogenated hydrocarbons, adipates, sebacates and natural polymers.Type: GrantFiled: July 20, 1992Date of Patent: May 3, 1994Assignee: Fuji Photo Film Co., Ltd.Inventor: Masaaki Terashima