Glucose, Ketone, Nitrate Standard Or Control Patents (Class 436/14)
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Patent number: 5296377Abstract: Control reagents an oxidant or a hydroxylamine compound together with other ingredients, the most important of which is a known amount of the analyte for which the reagent acts as a control.Type: GrantFiled: December 15, 1992Date of Patent: March 22, 1994Assignee: Boehringer Mannheim CorporationInventors: Myron Rapkin, David Tabb, Eric Diebold
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Patent number: 5204267Abstract: A method of stabilizing the glucose content of a blood sample applied to a sorbent for drying is provided. A solution of sodium fluoride or other glycolysis inhibitor is applied to a sorbent. A blood sample for glucose determination is then applied to the sorbent whereupon glycolysis is immediately inhibited. The blood sample may then be dried for shipping without loss of glucose content during the drying period.Type: GrantFiled: December 17, 1991Date of Patent: April 20, 1993Assignee: Osborn Laboratories, Inc.Inventors: Jangbir S. Sangha, Linda R. Pflatzgraff, Melinda L. Van Hercke
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Patent number: 5187100Abstract: A control solution for use with a porous reagent strip comprises a flexible semisolid polymer dispersed in water, such as polyvinyl acetate in distilled water, with appropriate control glucose concentration levels. This solution is useful in mimicking whole blood in conjunction with porous reagent strips to determine compliance of the strips and meters to established measurement and performance criteria.Type: GrantFiled: November 19, 1991Date of Patent: February 16, 1993Assignee: Lifescan, Inc.Inventors: David P. Matzinger, Maria Teodorczyk, Darwin R. Poulos
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Patent number: 5155025Abstract: Hydrogen peroxide stabilized in the presence of blood components by the addition of a metal oxide oxidant, an anionic chelating agent, particularly hydroxylic carboxylate and nitroprusside, and a catalase inhibitor. The composition finds particular application for stabilizing hydrogen peroxide in a diagnostic assay on a bibulous support.Type: GrantFiled: February 18, 1992Date of Patent: October 13, 1992Assignee: ChemTrakInventors: Michael P. Allen, Sheng-Fen Li
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Patent number: 5142031Abstract: Disclosed herein is a method of labelling a sugar at its reducing end by using 1-(p-methoxyphenyl)-3-methyl-5-pyrazolone, thereby analyzing said sugar with high sensitivity, and to a kit to be used for sugar labelling by this method.Type: GrantFiled: October 11, 1991Date of Patent: August 25, 1992Assignee: Takara Shuzo Co., Ltd.Inventors: Yuan C. Lee, Susumu Honda, Kazuaki Kakehi
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Primary standard and method of making secondary standards for calibration of glycated protein assays
Patent number: 5132230Abstract: This invention provides a primary standard and/or secondary standards for assay for glycated proteins in samples such as blood. The primary standard is composed of a polymer or copolymer of an amino acid, such as lysine, serine or those listed on table 37 (pages 100-110 of the second edition of Organic Chemistry by Robert Morris and Robert Nielson-Boyd) glycated with a known amount of glucose, preferably .sup.14 C glucose or .sup.3 H glucose, and free of unbound glucose. The preferred secondary standards are composed of glycated native protein per se, or a mixture of a glycated native protein and native protein that has been standardized against a primary standard to give the actual glycated protein value. These primary standards and secondary standards may be packaged and sold as a kit that contains a primary standard and/or a secondary standard and the reagents needed to perform the glycated protein assay.Type: GrantFiled: March 28, 1989Date of Patent: July 21, 1992Assignee: Isolab, Inc.Inventors: Murray A. Rosenthal, Michael E. Jackson -
Patent number: 5128171Abstract: A test strip for the detection of a predetermined substance in a fluid is described. This test strip is stable to storage and accelerated keeping test conditions and comprises a support having thereof a reagent layer wherein the reagent layer contains a dialyzed latex polymer and a reagent detection system which reacts with the substance to provide a detectable change.Type: GrantFiled: June 26, 1990Date of Patent: July 7, 1992Assignee: Polymer Technology InternationalInventor: John M. Gleisner
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Patent number: 5071767Abstract: For the determination of fructosamine in body fluids a solution containing fructosamine and albumin is used as the standard solution for calibration which standard solution is essentially free of glucose and which has a pH between 5.0 and 6.0 and contains at least 10 mmol/l buffer.Type: GrantFiled: July 5, 1989Date of Patent: December 10, 1991Assignee: Boehringer Mannheim GmbHInventors: Rudolf Portenhauser, Bernd Vogt
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Patent number: 5028542Abstract: The invention relates to a non-serum based control reagent for glucose determination. Rather than using modified serum, the control reagent contains water, glucose, and the viscosity agent polystyrene sulphonate. The control reagent may also contain a buffer, preservatives, surfactants or surface active agents. A method of making the control reagent is also disclosed.Type: GrantFiled: February 7, 1990Date of Patent: July 2, 1991Assignee: Boehringer Mannheim CorporationInventors: Jim Kennamer, Diane Storhoff, Roger Bontrager, David Tabb, Arthur Usmani
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Patent number: 4975248Abstract: Serum is passed through a column containing silica gel alkylated with lower alkyl groups. The column is then washed with dilute acid and water and the digoxin eluted with aqueous methanol at a volume less than about the volume of the serum to provide a digoxin concentrate that may be used in assay determinations. The invention also includes a kit comprising in a packaged combination for use in an assay for digoxin (a) a column containing silica gel alkylated with alkyl groups containing 1 to 2 carbon atoms and (b) an aqueous eluent solution which is 50%-70% by volume organic solvent. The organic solvent comprises from 1-4 carbon atoms and from 1-3 heteroatoms selected from the group consisting of oxygen and nitrogen.Type: GrantFiled: October 16, 1986Date of Patent: December 4, 1990Assignee: Syntex (U.S.A.) Inc.Inventors: Pyare Khanna, Roberta D. Ernst, Anne J. Stone
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Patent number: 4876207Abstract: A dye development composition comprising 1,10-phenanthroline and 1,7-dihydroxynaphthalene is disclosed for use in assaying high levels of hydrogen peroxide.Type: GrantFiled: February 16, 1988Date of Patent: October 24, 1989Assignee: Eastman Kodak CompanyInventors: Arthur R. Mack, II, John W. H. Sutherland, Jr.
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Patent number: 4833090Abstract: Inclusion in a blood sample of an isomer of glucose which is capable of replacing glucose in blood cell metabolism ensures accuracy of glucose assay.Type: GrantFiled: March 1, 1988Date of Patent: May 23, 1989Inventors: Eberhard Liss, Inge Liss
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Patent number: 4814142Abstract: A diagnostic test strip for the detection of a analyte in a test fluid. The test strip has a reagent layer on a support layer. The reagent layer contains an analyte detection system in a non-particulate dialyzed latex polymer.Type: GrantFiled: May 22, 1987Date of Patent: March 21, 1989Assignee: Polymer Technology International Corp.Inventor: John M. Gleisner
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Patent number: 4801531Abstract: The invention offers an early detection method for atherosclerosis using genetic analysis to detect a polymorphisms shown to be correlated with this disease which are proximal to the apolipoprotein AI (apoAI) and aplipoprotein CIII (apoCIII) gene complex. All individuals with a 300 bp deletion 4 kb upstream of the apoAI gene are destined to experience severe atherosclerotic symptomologies. Individuals with a polymorphism 5.4 kb 5' of the apoAI gene or a PvuII polymorphism in the first intron of the apoCIII gene also seem to be at greater risk. A haplotype with MspI and XmnI/7.2 polymorphisms in this general region seem to be protected. Additional polymorphic sites in the DNA sequence associated with the apoAI/CIII gene complex provide a means for genetically fingerprinting individuals, and for identifying persons at risk with respect to disorders relating to lipid metabolism and transport.Type: GrantFiled: September 30, 1985Date of Patent: January 31, 1989Assignee: Biotechnology Research Partners, Ltd.Inventor: Philippe M. Frossard
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Patent number: 4729959Abstract: A stable glucose reference control has been found in which the true value and the measured value of glucose in blood, colorimetrically obtained with glucose test strips, is approximately the same. The glucose reference control comprises an aqueous suspension of:(i) 40 to 500 mg/dL of glucose, and(ii) about 0.1 to 0.3.times.10.sup.12 /dL red blood cells fixed with a fixing agent to render the red blood cells incapable of metabolizing glucose.Type: GrantFiled: February 24, 1986Date of Patent: March 8, 1988Assignee: Streck Laboratories, Inc.Inventor: Wayne L. Ryan
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Patent number: 4683209Abstract: A viability test device wherein the viability of a test composition for the determination of an analyte of interest can be determined by simply wetting the device with ordinary water. The viability device can be prepared in three formats: a control or calibrator device, an internal control device and a self indicating device. Unreacted analyte, or an analog thereof, can be incorporated in a limited defined portion of a dried carrier matrix incorporated with a test composition to provide an internal control test device. When wetted with water, a positive optical response, usually color, indicates the test composition can provide a viable test for the analyte. The internal control test device is particularly advantageously used by diabetics in their own homes where a negative test response could be due to the desired control of the user's condition or due to deterioration of a test composition because of unfavorable storage conditions.Type: GrantFiled: July 21, 1986Date of Patent: July 28, 1987Assignee: Miles Laboratories, Inc.Inventors: Ibrahim A. Ismail, Paul Hemmes, Mark T. Skarstedt, Adam Zipp
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Patent number: 4649121Abstract: A viability test device wherein the viability of a test composition for the determination of an analyte of interest can be determined by simply wetting the device with ordinary water. The viability device can be prepared in three formats: a control or calibrator device, an internal control device and a self indicating device. Unreacted analyte, or an analog thereof, can be incorporated in a limited defined portion of a dried carrier matrix incorporated with a test composition to provide an internal control test device. When wetted with water, a positive optical response, usually color, indicates the test composition can provide a viable test for the analyte. The internal control test device is particularly advantageously used by diabetics in their own homes where a negative test response could be due to the desired control of the user's condition or due to deterioration of a test composition because of unfavorable storage conditions.Type: GrantFiled: February 26, 1985Date of Patent: March 10, 1987Assignee: Miles Laboratories, Inc.Inventors: Ibrahim A. Ismail, Paul Hemmes, Mark T. Skarstedt, Adam Zipp
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Patent number: 4645742Abstract: The determination of fructosamine levels in at least part of a blood sample for use in detecting diabetes in patients or deciding treatment levels is effected by controlling the temperature and pH of the sample, adding a coloring agent such as a nitro-blue tetrazolium and after a first delay in time taking a first color measurment at a predetermined wavelength and after a second delay in time taking a second color measurement at the predetermined wavelength, then comparing any resultant change between the first and second color measurements with those of standard solutions, the selected timing delays, wavelength, coloring agent and pH conditions being such that any change of color in the coloring agent between the first and second color measurements is caused predominantly by the glucose in the sample that is reacted with an amine group of protein and has undergone a molecular rearrangement to form fructosamine and not materially by any non-specific reducing substance which may be present in the sample.Type: GrantFiled: July 18, 1984Date of Patent: February 24, 1987Inventor: John R. Baker
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Patent number: 4642295Abstract: The determination of fructosamine levels in at least part of a blood sample for use in detecting diabetes in patients or deciding treatment levels is effected by controlling the temperature and pH of the sample, adding a coloring agent such as a nitro-blue tetrazolium and after a first delay in time taking a first color measurement at a predetermined wavelength and after a second delay in time taking a second color measurement at the predetermined wavelength, then comparing any resultant change between the first and second color measurements with those of standard solutions, the selected timing delays, wavelength, coloring agent and pH conditions being such that any change of color in the coloring agent between the first and second color measurements is caused predominantly by the glucose in the sample that is reacted with an amine group of protein and has undergone a molecular rearrangement to form fructosamine and not materially by any non-specific reducing substance which may be present in the sample.Type: GrantFiled: December 15, 1982Date of Patent: February 10, 1987Inventor: John R. Baker
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Patent number: 4529704Abstract: A device for preparing a control solution for ketone analysis is disclosed, as well as a method for preparing it. The device comprises a carrier vehicle incorporated with an ester of a .beta.-ketoalkanoic acid, and a hydrolyzing substance capable of converting the ester to the corresponding .beta.-ketoalkanoic acid. The ester has the structure ##STR1## in which R is a lower alkyl group and R' is an aliphatic or cyclic group having 1 to about 7 carbon atoms. The method comprises contacting a predetermined volume of solvent with the device.Type: GrantFiled: November 25, 1981Date of Patent: July 16, 1985Assignee: Miles Laboratories, Inc.Inventors: Robert W. Trimmer, William I. White
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Patent number: 4517301Abstract: A composition, device and method for preparing a ketone control solution are disclosed. The composition comprises dimethylformamide and a Group I, II or III metal salt of a .beta.-keto acid ester. The salt has the structure ##STR1## in which R is lower alkyl of 1 to 6 carbon atoms, R' is an aliphatic or cyclic group having 1 to about 7 carbon atoms, M is a Group I, II or III metal ion and n is 1, 2 or 3. A carrier matrix incorporated with the composition can be affixed to a support member to form the device. Preferably, a hydrolyzing agent is included on the device in the same or another carrier matrix. The method for preparing the control solution comprises contacting a predetermined volume of an aqueous solution with the device for a predetermined time.Type: GrantFiled: December 6, 1982Date of Patent: May 14, 1985Assignee: Miles Laboratories, Inc.Inventor: Carmine M. Greene
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Patent number: 4448888Abstract: Artificially constituted storage-stable hemoglobin compositions for use in the temperature correction of a cation exchange column chromatographic assay for hemoglobin A.sub.1 or A.sub.1c in a sample of human blood. The relative amounts of hemoglobin components in the composition conform approximately to the following formula:______________________________________ y = mx + b where y = weight percent A.sub.1c with respect to A.sub.1 x = weight percent A.sub.1 with respect to total hemoglobin m = -1.7 and b = 85 when x < 10, and m = -1.2 and b = 80 when x > 10. ______________________________________The compositions when analyzed in a cation exchange assay produce a result which varies with temperature in substantially the same manner as that from a true sample of human blood.Type: GrantFiled: August 24, 1982Date of Patent: May 15, 1984Assignee: Bio-Rad Laboratories, Inc.Inventors: Dennis M. Bleile, Diane M. Allen, Steve K. Tanaka, Francis J. Matarrese, Jr.