Composition For Standardization, Calibration, Simulation, Stabilization, Preparation Or Preservation; Processes Of Use In Preparation For Chemical Testing Patents (Class 436/8)
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Publication number: 20080057586Abstract: An optically clear, fluorescent acrylic adapted for use as a calibration material. In particular, the fluorescent acrylic cartridge may used as a calibration tool for a microarray reader, such as, the Nanogen NC400® microarray system.Type: ApplicationFiled: August 30, 2007Publication date: March 6, 2008Inventors: James P. Light, Kenny V. Nguyen
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Patent number: 7338802Abstract: A method of performing calibration and quality control of a sensor for determining a parameter in a test fluid in which method a calibration and quality control cycle is repeated. A cycle includes the steps of performing a calibration and a quality control of the sensor using independent reference materials. In the method a reference material is in one cycle used in the quality control step which in a previous cycle was used in the calibration step. The present invention further provides an apparatus for performing the method.Type: GrantFiled: October 29, 2003Date of Patent: March 4, 2008Assignee: Radiometer Medical ApSInventors: Peter Aage Frischauf, Eiler Larsen
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Patent number: 7337072Abstract: A sample testing system may include a housing, a cavity in the housing to receive a chamber, two contact members, and a sensor. The contact members may be positioned to be engageable with respective portions of the chamber inserted in the cavity, and to compress those respective portions, thereby driving fluid flow. A sample testing system may include a housing, a cavity in the housing to receive a chamber, at least one contact member, and a sensor. The at least one contact member may be positioned to be engageable with a first segment of the chamber when the chamber is in the cavity, and to compress the first segment, thereby defining a gap of the first segment of the chamber and a reservoir in at least a second segment of the chamber.Type: GrantFiled: June 8, 2004Date of Patent: February 26, 2008Assignee: Chen & Chen, LLCInventor: Shuqi Chen
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Publication number: 20080044819Abstract: The invention provides a genetic reference standard with at least one human genetic reference sequence (having a human DNA sequence containing at least one genetic variant whose presence in the DNA of a human subject is indicative of a pathological condition, a predisposition to a pathological condition, or a predisposition to an adverse reaction to external stimuli, or is indicative of a patient's likely response to a therapeutic intervention, i.e. a variant used in pharmacogenomic analysis) cloned into a non-mammalian animal cell line. There are also provided such reference standards where the human DNA is targeted to specific location in the host genome, using homologous recombination. The invention further provides a method of detecting a genetic variant using such reference standards.Type: ApplicationFiled: December 1, 2004Publication date: February 21, 2008Inventor: John Ross Hawkins
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Patent number: 7316929Abstract: An auto-calibration label for use with one or more sensing instruments. The label includes first and second encoded calibration information. The second encoded calibration information may correspond to a different instrument than the first encoded calibration information. The second encoded information may also be used to provide additional calibration information for use with the first instrument. The label may be removably attached to a sensor package including a plurality of sensors. A first conductive ink pattern is disposed on the label to define the first encoded calibration information. The first conductive ink pattern is disposed contemporaneously with or without a portion of a second conductive ink pattern defining the second encoded calibration information. An insulating layer is disposed on the first pattern. The second ink pattern is disposed on the insulating layer. The first pattern is operable with the first instrument, not the second instrument.Type: GrantFiled: August 7, 2003Date of Patent: January 8, 2008Assignee: Bayer HealthCare LLCInventor: D. Glenn Purcell
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Patent number: 7314763Abstract: A fluidics-based assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes a self-calibrated magnetic binding assay format (e.g., sandwich, competitive, etc.) that includes detection probes capable of generating a detection signal (e.g., fluorescent non-magnetic particles) and calibration probes capable of generating a calibration signal (e.g., fluorescent magnetic particles). The amount of the analyte within the test sample is proportional (e.g., directly or inversely) to the intensity of the detection signal calibrated by the intensity of the calibration signal. It has been discovered that the fluidics-based device of the present invention provides an accurate, inexpensive, and readily controllable method of determining the presence of an analyte in a test sample.Type: GrantFiled: August 27, 2002Date of Patent: January 1, 2008Assignee: Kimberly-Clark Worldwide, Inc.Inventors: Xuedong Song, Rosann Kaylor, Shawn Feaster, Kaiyuan Yang
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Patent number: 7312083Abstract: A method of assigning expected recovery values to control substances used in analytical testing is disclosed.Type: GrantFiled: June 7, 2005Date of Patent: December 25, 2007Assignee: Beckman Coulter, Inc.Inventor: John S. Middleton
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Patent number: 7306950Abstract: The invention relates to a composition for the stabilization of sulphur-containing amino acids and/or for the inhibition of the continuous formation of sulphur-containing amino acids in withdrawn blood, to the use of suitable substances and compositions therefor as well as optionally for the determination of sulphur-containing amino acids in blood, to a process for these purposes, as well as to a blood collecting device applied appropriately to these processes.Type: GrantFiled: May 15, 2002Date of Patent: December 11, 2007Assignee: Heinrich WielandInventors: Heinrich Wieland, Emanuel Bissé
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Patent number: 7303920Abstract: Automated staining equipment that can mix reagents is used to spray a Romanowsky stain onto slide mounted specimens which are then briefly centrifuged. The centrifugation step removes excess stain leaving only a thin film. Depending on the time of the centrifugation step, most of the organic solvent and part of the water in the stain are evaporated by airflow through the equipment. This greatly accelerates the staining reaction and preserves water soluble structures such as the granules in basophilic leukocytes. For optimal performance, this staining procedure requires a thiazin-eosin stain with about 90% to about 40% organic solvent, such as methanol, and only about 10% to about 60% water. This is a unique staining reagent in Romanowsky staining.Type: GrantFiled: February 18, 2005Date of Patent: December 4, 2007Assignee: Wescor, Inc.Inventors: Barry O. Stokes, Patti A. Nelson
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Patent number: 7299153Abstract: Systems and methods configured to guide and manage laboratory analytical process control operations. A Biometric quality control (QC) process application is configured to monitor bias and imprecision for each test, characterize patient population data distributions and compare, contrast, and correlate changes in patient data distributions to any change in QC data populations. The Biometric QC process monitors the analytical process using data collected from repetitive testing of quality control materials and patient data (test results). The QC process identifies the optimal combination of, for example, frequency of QC testing, number of QCs tested, and QC rules applied in order to minimize the expected number of unacceptable patient results produced due to any out-of-control error condition that might occur.Type: GrantFiled: February 1, 2006Date of Patent: November 20, 2007Assignee: Bio-Rad Laboratories, Inc.Inventors: Curtis Parvin, George S. Cembrowski, William G. Cooper
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Patent number: 7297545Abstract: A method for screening newborns using electrospray tandem mass spectrometry. The method improves the current protocols that use tandem mass spectrometry by assuring accurate and consistent results at the clinical level through enhanced quality controls and quality assurance protocols as applied to the scan profiling and sample preparation of blood spots from newborns. Specific additives are used in precise concentrations of internal standards, employing detailed controls adapted to distinguish twenty metabolites, which are scanned and vigorously compared to known spectra results. Revealing peaks, metabolite concentration, and scan intensities in the quality assurance steps are then compared to a range of thresholds to determine whether or not the sample is contaminated, drug-ridden, diagnosable, or unacceptable. All spectra results and quality assurance flags are organized in spreadsheet form and exported to a database where values are compiled and stored for daily output results and trend analysis.Type: GrantFiled: June 28, 2005Date of Patent: November 20, 2007Assignee: Pediatrix Screening, Inc.Inventor: Donald H. Chace
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Patent number: 7294307Abstract: An apparatus is provided for hematology testing, which has a sensing unit defining a counting orifice for the flow of a blood sample through the counting orifice to analyze the blood sample, and a pump unit having three syringes. A first syringe is coupled in fluid communication with the sensing unit on the inlet side of the counting orifice for injecting a stream of blood sample through the counting orifice. A second syringe is coupled in fluid communication with the sensing chamber on the inlet side of the counting orifice for simultaneously injecting a sheath of fluid surrounding the sample stream on the inlet side of the counting orifice. And a third syringe is coupled to the sensing chamber on the outlet side of the counting orifice for aspirating a sheath of fluid from the sensing chamber surrounding the sample stream on the outlet side of the counting orifice.Type: GrantFiled: October 27, 2004Date of Patent: November 13, 2007Assignee: Drew Scientific Holdings, Inc.Inventor: Edward Lawrence Carver, Jr.
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Patent number: 7294512Abstract: A multi-analyte calibration solution having known amounts of sodium carbonate, ammonium bicarbonate, and ethyl alcohol, with pH adjusted within a range between about 7.8 and 8.4.Type: GrantFiled: July 28, 2006Date of Patent: November 13, 2007Assignee: Dade Behring Inc.Inventor: Douglas Paul Clark
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Patent number: 7291501Abstract: The present invention relates to methods for making stable compositions, such as, but not limited to, test samples, that can be used in ligand-binding assays.Type: GrantFiled: November 24, 2003Date of Patent: November 6, 2007Assignee: Abbott LaboratoriesInventors: Robert G. Parsons, David J. Daghfal, Cherie A. Lipowsky, Ray A. Weigand, Judith A. Friese
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Patent number: 7287390Abstract: Hyperpolarizers for producing polarized noble gases can include: (a) a control module configured to direct the operation of a hyperpolarizer to produce polarized noble gas via spin-exchange interactions between a noble gas and an alkali metal; (b) at least one optical pumping module including an optical pumping cell operably associated with the control module; (c) a dispensing system operably associated with the control module and the optical pumping module to dispense meted volumes of polarized gas from the hyperpolarizer; and (d) a fluid distribution system operably associated with the control module, the optical pumping module, and the dispensing system, such that, in response to commands transmitted from the control module, the fluid distribution system operates to automatically direct purge gas into and out of a gas travel path that extends from the control module to the optical pumping cell prior to commencing the spin-exchange interactions in the optical pumping cell, then to receive unpolarized gas anType: GrantFiled: October 22, 2002Date of Patent: October 30, 2007Assignee: Medi-Physics, Inc.Inventor: Kenneth Bolam
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Patent number: 7287391Abstract: Modular expandable hyperpolarizers include a central control module and at least one optical pumping module that can be expandable to a plurality of optical pumping modules that can be separately operated depending on the capacity demands at the production site (hospital, clinic and the like). Methods for producing blended polarized gas products include introducing a pre-packaged pre-mixed amount of a polarizer-ready blend of unpolarized gas. Methods for producing the polarized gas can be carried out at the point of use site and the production run according to patient load. Other methods consider the patient load and automatically schedule the hyperpolarizer to yield the desired polarized gas doses to support the patient and/or MRI/NMR equipment schedule.Type: GrantFiled: October 22, 2002Date of Patent: October 30, 2007Assignee: Medi-Physics, Inc.Inventor: Kenneth Bolam
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Patent number: 7288410Abstract: Compositions, reagents, kits, systems, system components, and methods for performing assays. More particularly, the invention relates to the use of novel combinations of reagents to provide improved assay performance.Type: GrantFiled: February 9, 2005Date of Patent: October 30, 2007Assignee: Meso Scale Technologies, LLC.Inventors: Michael Tsionsky, Eli N. Glezer, Selen Altunata, George Sigal, Jonathan K. Leland, Mark A. Billadeau, Svetlana Leytner, Mark Martin, Larry Helms
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Patent number: 7285417Abstract: A method of making a reference control containing a nucleated red blood cell component includes providing a blood cell containing a nucleus; treating the blood cell with a treatment solution to alter a nucleus property from a natural value to a target value suitable for simulating nucleated red blood cells on a blood analyzer; and suspending treated blood cell in a suspension medium to form a reference control. The method also includes integrating the nucleated red blood cell component with white blood cell, red blood cell, platelet and reticulocyte components. Further disclosed is a cell treatment composition for altering a nucleus property, which includes a conditioning component, a lytic component for permeating cell membrane, and a fixing component for preserving the cell nucleus. Also disclosed is a method of using the reference control for measurement of nucleated red blood cells on a blood analyzer.Type: GrantFiled: October 30, 2006Date of Patent: October 23, 2007Assignee: Beckman Coulter Inc.Inventors: Nery Ortiz, Sandra Socarras
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Patent number: 7285426Abstract: The present invention provides methods, compositions, and kits for rapid detection of analytes in a sample. Surprisingly, it has been found that bulking materials having starch reagents effectively enhance chromatographic detection methods by providing component stability and controlled release. Thus, the novel components and methods disclosed herein provide a completely new modality of chromatographic analyte detection.Type: GrantFiled: May 5, 2005Date of Patent: October 23, 2007Assignee: Medtox Scientific, Inc.Inventors: Robert Bohannon, Glen Chapman, Alan Morris, Maria Scholz-Steele, Martin Green, Phillip Hartzog, Oluyomi Adeneye
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Patent number: 7286957Abstract: Systems and methods configured to guide and manage laboratory analytical process control operations. A Biometric quality control (QC) process application is configured to monitor bias and imprecision for each test, characterize patient population data distributions and compare, contrast, and correlate changes in patient data distributions to any change in QC data populations. The Biometric QC process monitors the analytical process using data collected from repetitive testing of quality control materials and patient data (test results). The QC process identifies the optimal combination of, for example, frequency of QC testing, number of QCs tested, and QC rules applied in order to minimize the expected number of unacceptable patient results produced due to any out-of-control error condition that might occur.Type: GrantFiled: May 2, 2005Date of Patent: October 23, 2007Assignee: Bio-Rad Laboratories, Inc.Inventors: Curtis Parvin, George Cembrowski, William G. Cooper
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Patent number: 7285418Abstract: The invention provides a method for assaying for troponin I in a sample such as serum, the method comprising a determination of the troponin I concentration in a sample using a standard preparation that comprises a complete native troponin complex. One exemplary assay for troponin I concentration according to the invention is an immunoassay. Further contemplated in the method is a step comprising contacting the sample with a Ca2+-binding agent. Another aspect of the invention is the standard preparation comprising a complete native troponin complex. Yet another aspect of the invention is a kit for use in the assay method comprising the standard preparation, a detectable label, and a troponin I binding partner, such as an anti-troponin I antibody. All aspects of the invention are usefully practiced using human materials, such as a human troponin complex, and/or human sources for samples.Type: GrantFiled: July 1, 2002Date of Patent: October 23, 2007Assignee: Hytest Ltd.Inventors: Alex G. Katrukha, Sergei Severin, Anastasia Bersenikova, Tatiana Esakova, Kim Pettersson
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Patent number: 7282346Abstract: The invention provides methods for prognosis, diagnosis, staging and disease progression in human cancer patients related to expression levels of a variety of immunohistochemical and genetic markers associated with poor cancer prognosis, and in particular those markers related to tumor invasiveness, metastasis and spread. The invention also provides methods using a predictive index for prognosis of cancer patients for metastasis, recurrence and relapse of neoplastic disease. The methods of the invention are useful for making clinical decisions on cancer treatment, surveillance and surgical intervention.Type: GrantFiled: October 16, 2001Date of Patent: October 16, 2007Assignee: Oncotech, Inc.Inventor: John Fruehauf
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Patent number: 7256048Abstract: A method of detecting parasite infection, particularly malaria, includes mixing a blood sample with a lytic reagent system to lyse red blood cells, and to form a sample mixture; performing a differential analysis of white blood cells of the sample mixture on a blood analyzer, and obtaining a cell volume distribution of a white blood cell subpopulation from a cell volume measurement used in the differential analysis; obtaining a cell volume parameter from the cell volume distribution of the white blood cell subpopulation; evaluating the cell volume parameter against a predetermined criterion, and reporting an indication of the parasite infection if the cell volume parameter meets the predetermined criterion. The method also uses a discriminant obtained from cell volume parameters of two different white blood cell subpopulations against a predetermined criterion. The method further use a cell distribution parameter of a cell distribution obtained using a RF impedance measurement.Type: GrantFiled: February 18, 2005Date of Patent: August 14, 2007Assignee: Beckman Coulter, Inc.Inventor: Ramon Simon-Lopez
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Patent number: 7247483Abstract: A method, a device, and a test kit for performing this method for determining the volume of a sample of the liquid. In the method, a specific concentration of a chromophoric indicator is provided in this liquid, a sample is separated from the liquid, the optical absorption of the separated sample is measured, and the volume of the separated sample is determined by correlation of the measured optical absorption with the concentration of indicator in this liquid. Ions that generate a color in the sample by complexing with a specific ligand are used as the indicator to stain the liquid.Type: GrantFiled: November 19, 2001Date of Patent: July 24, 2007Assignee: Tecan Trading AGInventors: Werner Halg, Nikolaus Ingenhoven, Michael Trosch
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Patent number: 7247488Abstract: A method and kit for testing a multi-channel blood-testing cartridge. In particular, blood-testing cartridges are tested with plasma samples with clotting times measured to indicate whether a batch of cartridges is suitable for testing the blood of a patient.Type: GrantFiled: May 6, 2003Date of Patent: July 24, 2007Assignee: Medtronic, Inc.Inventors: Jyotsna Ghai, Mark A. Thompson, Colleen Lutz, Narayanan Ramamurthy, Charlene X. Yuan
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Patent number: 7247498Abstract: Apparatus and methods for supplying a portion of a fluid stream and, alternately, a fluid of known composition and concentration to an analyzer are provided. The fluid stream is directed through a series of connected chambers formed in an integral housing. A sampling needle has an inlet in one of the chambers and an outlet in fluid communication with the analyzer. When desired, a tube or vial containing a known fluid may be inserted into a chamber containing the sampling needle, so that the known fluid will be supplied to the analyzer. A second needle provides ventilation to the vial to prevent the formation of a vacuum as the known fluid is drained from the vial.Type: GrantFiled: January 28, 2003Date of Patent: July 24, 2007Assignee: GE Analytical InstrumentsInventors: Richard D. Godec, Frank J. Silvester, Blaine R. Bateman
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Patent number: 7244618Abstract: The invention describes materials useful for calibrating methods, and standards, calibration verification, linearity, and quality control materials for any method used to detect lipids and/or lipoproteins. This invention describes methods for producing, and compositions produced thereby, stable lipid controls, standards, and reagents including a stabilizing amount of TDPA, and further including a known amount of a substantially pure constituent of interest, including total cholesterol (CHOL), triglycerides (TRIG), high density lipoprotein (HDL), APO lipoprotein A (APO-A), APO Lipoprotein B (APO-B), low density lipoprotein (LDL), apolipoprotein a Lp(a) and other lipoprotein moieties useful for calibrating, standardizing, verifying, quality control, and the like, relating to use of an instrument for assessing the level of such constituents in a sample.Type: GrantFiled: August 31, 2005Date of Patent: July 17, 2007Assignee: Maine Standards Company, LLCInventor: Thomas Happe
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Patent number: 7241620Abstract: Polymer fractions such as polyethylene fractions can be produced that have a PDI less than about 2.3 and a Mw greater than about 1,000,000 g/mol, 3,000,000 g/mol, or 6,000,000 g/mol. Such polyethylene fractions are separated from a UHMWPE parent polymer by first dissolving the parent polymer in a relatively good solvent. The conditions employed for such dissolution are selected to reduce the degradation of the parent polymer. The resulting parent solution is transported into a fractionation column in which a support is disposed. The fractionation column is thereafter operated at conditions effective to form a precipitate on the support comprising the desired polyethylene fraction. The polyethylene fraction may then be recovered from the fractionation column by repeatedly displacing a solvent/non-solvent mixture into the column to dissolve the polyethylene fraction. The relative concentrations of the solvent and the non-solvent are based on a solvent gradient profile of the polyethylene parent polymer.Type: GrantFiled: January 9, 2004Date of Patent: July 10, 2007Assignee: Chevron Phillips Chemical Company LPInventors: Chung C. Tso, Melvin Hildebrand, Paul J. DesLauriers, Youlu Yu
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Patent number: 7235404Abstract: A cyanide-free lytic reagent composition and method of use for measuring the total hemoglobin concentration and white blood cells in a blood sample are disclosed. The lytic reagent composition includes a quaternary ammonium surfactant to lyse red blood cells and release hemoglobin and a ligand to form a stable chromogen with the hemoglobin. The lytic reagent composition has a pH in a range of 3 to 10. The lytic reagent composition can also include a second quaternary ammonium surfactant. The ligand can be malic acid, malonic acid, ethylene diamine, N,N-diethylethylene diamine, N,N?-diethylethylene diamine, diethylene triamine, tetraethylene pentamine, 1,6-hexanediamine, 1,3-pentanediamine, 2-methylpentamethylenediamine, 1,2-diaminocyclohexane, 4-aminoacetophenone, bis-hexamethylenetriamine, pyridazine, or 3,6-dihyroxypyridazine.Type: GrantFiled: May 4, 2005Date of Patent: June 26, 2007Assignee: Beckman Coulter, Inc.Inventors: Russell F. Lang, Dennisse Parra-Diaz, Luisa Oramas, Barbara Murza, Susana Maldonado
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Patent number: 7229830Abstract: A standard sample composition containing a complexing agent and an alkali salt, mixed with a known amount of a foodstuff, the content of at least one component of which is accurately known. The mixture is dissolved in a solvent, e.g. water, and comminuted to form a dispersion. The solvent is removed e.g. by freeze-drying or other suitable method, such that the water content of the composition is <5% by weight, preferably <1% by weight, more preferably <0.1%, most preferably <0.01% by weight of the total composition.Type: GrantFiled: November 23, 2000Date of Patent: June 12, 2007Inventor: Lars-Ove Sjaunja
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Patent number: 7217531Abstract: The present invention is directed to methods and compositions for determining the presence, absence, and/or amounts of one or more membrane-associated analytes in a sample. In accordance with the invention, binding compounds derivatized with releasable molecular tags specifically bind to selected membrane-associated analytes, after which the molecular tags are released upon activation of cleavage moieties, or sensitizers, anchored in the same membrane as the membrane-associated analytes. The released molecular tags are then identified by their distinct separation and detection characteristics.Type: GrantFiled: August 27, 2005Date of Patent: May 15, 2007Assignee: Monogram BiosciencesInventors: Sharat Singh, Po-Ying Chan-Hui, Hrair Kirakossian
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Patent number: 7214481Abstract: The invention discloses methods, compositions and kits for stabilizing a solubilized phenyl phosphate, preferably paranitrophenyl phosphate (PNPP), using charcoal. Also disclosed are methods, compositions and kits for recycling solubilized phenyl phosphate, preferably PNPP, that has an absorbance of less than 0.1 when measured at 405 nm due to non-enzymatic hydrolysis.Type: GrantFiled: November 1, 2005Date of Patent: May 8, 2007Assignee: BioFX Laboratories, Inc.Inventor: Thomas M. Woerner
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Patent number: 7208166Abstract: Use of botulin toxin to obtain a product intended to be administered intramuscular with lissive effect in treating articular pathologies, particularly coxarthrosis, or arthrosis of the hip, epicondylitis of the elbow and rotator muscle cap pathology of the shoulder.Type: GrantFiled: January 4, 2002Date of Patent: April 24, 2007Assignee: Societe de Conseils de Recherches et d'Applications Scientifiques SASInventors: Corrado Marchini, Fabiano Pinat, Fabio Pinat, Francesca Zecchini
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Patent number: 7205154Abstract: A method of using a chemical array reader, chemical array readers, and computer program products for use with a chemical array reader. The chemical array reader may include a holder to mount an array and hold the array at a reading position. A light system illuminates a mounted array when at a reading position. A detection system having a focal plane, to detect light from different regions across the array emitted in response to the illumination, when at the reading position, and which generates a resulting signal for each of the regions across the array. An autofocus system which detects and reduces offset between the different regions of an array at the reading position and a determined position of the focal plane.Type: GrantFiled: January 31, 2002Date of Patent: April 17, 2007Assignee: Agilent Technologies, Inc.Inventor: John F. Corson
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Patent number: 7204960Abstract: The invention provides an apparatus and method for calibrating a dispensing system. A dispenser dispenses a controlled quantity of material into a container for receiving material. A system, preferably a vision system comprising an image capturing device and an imaging system, is adapted to capture an image of a physical dimension of a quantity of dispensed material in a given time. The physical dimension may be a width of a top surface area, a height or a cross-sectional area of the dispensed material. A calibrating system is adapted to calculate a volume of the quantity of material based upon said physical dimension.Type: GrantFiled: March 3, 2003Date of Patent: April 17, 2007Assignee: ASM Assembly Automation Ltd.Inventors: Hon Chiu Hui, Wing Fai Lam, Lim Pun Kong, Ka Yee Mak, Ka Yin Lee
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Patent number: 7203619Abstract: Systems and methods configured to guide and manage laboratory analytical process control operations. A Biometric quality control (QC) process application is configured to monitor bias and imprecision for each test, characterize patient population data distributions and compare, contrast, and correlate changes in patient data distributions to any change in QC data populations. The Biometric QC process monitors the analytical process using data collected from repetitive testing of quality control materials and patient data (test results). The QC process identifies the optimal combination of, for example, frequency of QC testing, number of QCs tested, and QC rules applied in order to minimize the expected number of unacceptable patient results produced due to any out-of-control error condition that might occur.Type: GrantFiled: June 6, 2005Date of Patent: April 10, 2007Assignee: Bio-Rad Laboratories, Inc.Inventors: Curtis Parvin, George Cembrowski, William G. Cooper
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Patent number: 7202087Abstract: A solid heparin tablet composition has a melting point of 25° C. or higher and is a continuous lipid component containing one or more polar lipids, one or more non-polar lipids, optionally one or several of water and mono- to trivalent alcohol in an amount of up to 15% by weight of the composition, and native heparin or fractionated heparin. Also described is a corresponding tablet, processes for production of the composition and the tablet, and a method of preventing or treating conditions amenable to preventive or therapeutic treatment by administration of the tablet.Type: GrantFiled: June 12, 2003Date of Patent: April 10, 2007Assignee: LTP Lipid Technologies Provider ABInventors: Bengt Herslöf, Per Tingvall
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Patent number: 7202090Abstract: To provide a hardness measurement reagent unaffected by an M alkalinity in hardness measurement. A hardness measurement reagent as a one-solution type reagent includes a dye chosen from Eriochrome Black T (EBT) and Calmagite, triethanolamine, a glycol compound, and a pH buffer, in which the pH buffer includes a combination of amines selected from primary amines and secondary amines and a salt of a weak base.Type: GrantFiled: March 29, 2005Date of Patent: April 10, 2007Assignee: Miura Co., Ltd.Inventor: Hiroyuki Mitsumoto
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Patent number: 7202091Abstract: Systems and methods for establishing and/or maintaining the accuracy of a multivariate calibration model designed for quantitative optical spectroscopic measurement of attributes or analytes in bodily tissues, bodily fluids or other biological samples, which are particularly useful when the spectral absorbance of the attribute or analyte is small relative to the background. The present invention provides an optically similar reference sample to reduce the effect of instrument or environment variation on the measurement capability of the model. The optically similar reference can be a gel composition having scattering particles suspended therein. The reference gel can be directly applied to a spectroscopic instrument sampler, or can be in a container specifically designed for optimal coupling to a spectroscopic instrument.Type: GrantFiled: October 28, 2002Date of Patent: April 10, 2007Assignee: InLight Solutions, Inc.Inventors: Howland D. T. Jones, David J. Nunez, Stephen J. Vanslyke, Robert D. Johnson, Edward L. Hull
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Patent number: 7195919Abstract: The present invention is drawn to a hematology control made from particles a particle having a biopolymer attached to a surface of the particle. The particle simulates a component of a blood sample, such as a reticulocyte or nucleated red blood cell component of a blood cell sample in a flow cytometer or hematology analysis instrument. The present invention is further drawn to methods of making and using the hematology control.Type: GrantFiled: December 19, 2003Date of Patent: March 27, 2007Assignee: Beckman Coulter, Inc.Inventors: Dana B. Jacobs, Paul W. Price, Nery Ortiz, Theodore J. Gerula
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Patent number: 7192776Abstract: A synthetic urine solution and method of its manufacture are disclosed. The solution includes water having a pH between 3 and 10. The solution further includes creatinine and means for removing bacteria from the solution so as to control or eliminate sepsis of the urine solution, preferably through the use of biocide. The solution exhibits a specific gravity of from 1.005 g/cm3 to 1.025 g/cm3. Additional compounds may also be included to further enhance the aesthetics or apparent authenticity of the synthetic urine produced according to this invention.Type: GrantFiled: January 28, 2004Date of Patent: March 20, 2007Inventor: James Matthew Stephens
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Patent number: 7176031Abstract: Reference control compositions and the method of use are disclosed for measurement of nucleated red blood cells, which includes one set of synthetic spherical particles having a mean particle diameter ranging from 6.2 ?m to 6.8 ?m and a refractive index from 1.58 to 1.62 monodispersed in an aqueous suspension medium. The synthetic spherical particles have optical properties simulating optical properties of nucleated red blood cells as measured by optical measurements. The reference control composition can further include a second set of the synthetic spherical particles having optical properties simulating optical properties of white blood cells. Further disclosed is a reference control system which includes a series of reference control compositions, each having an amount of one type of synthetic spherical particles which have optical properties simulating the optical properties of nucleated red blood cells having a specific cell maturity.Type: GrantFiled: August 1, 2005Date of Patent: February 13, 2007Assignee: Beckman Coulter, Inc.Inventors: Yi Li, Nery Ortiz, Carole J. Young, Santiago Galvez
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Patent number: 7172902Abstract: A method of monitoring calibration of a spectrophotometric apparatus that includes one or more than one calibration algorithm for one or more than one analyte, involves measuring absorbance of a quality control material with the apparatus to obtain a measurement, calculating one or more than one value from the measurement using the one or more than one calibration algorithm, and comparing the one or more than one value with an assigned value given to the quality control material for each of the one or more than one analyte. The quality control material exhibits an absorbance spectrum having a negative slope for a continuous spectral segment from about 5 nm to about 200 nm in length, and the spectral segment includes a principal calibration wavelength for the one or more than one analyte. A reagentless method for determining the concentration of one or more than one analyte in a sample in a spectrophotometric apparatus having at least one primary calibration algorithm is also disclosed.Type: GrantFiled: November 26, 2003Date of Patent: February 6, 2007Assignee: Spectromedical Inc.Inventor: James Samsoondar
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Patent number: 7163802Abstract: The present invention provides processes for determining the molecular weight of glatiramer acetate and other copolymers. The present invention further provides a plurality of molecular weight markers for determining the molecular weight of glatiramer acetate and other copolypmers which display linear relationships between molar ellipticity and molecular weight, and between retention time and the log of the molecular weight. The molecular weight markers also optimally demonstrate biological activity similar to glatiramer acetate or corresponding copolymers and can be used for treating or preventing various immune diseases. In addition, the subject invention provides pharmaceutical compositions for the treatment of immune diseases comprising a polypeptide having an identified molecular weight and an amino acid composition corresponding to glatiramer acetate or a terpolymer.Type: GrantFiled: March 25, 2005Date of Patent: January 16, 2007Assignee: Yeda Research and Development Co., Ltd.Inventors: Alexander Gad, Dora Lis
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Patent number: 7157282Abstract: A method of monitoring calibration of a spectrophotometric apparatus having one or more than one calibration algorithm for one or more than one analyte. This method involves measuring an absorbance of a quality control material to obtain a measurement, calculating one or more than one concentration value from the measurement using the one or more than one calibration algorithm, and comparing the one or more than one concentration value with an assigned value given to the quality control material for each of the one or more than one analyte. The quality control material exhibits an absorbance spectra having a negative slope for a continuous spectral segment from about 5 nm to about 400 nm in length, or a wavelength therebetween. A reagentless method for determining the concentration of one or more than one analyte in a sample in a spectrophotometric apparatus containing one or more than one primary calibration algorithm is also provided.Type: GrantFiled: March 7, 2003Date of Patent: January 2, 2007Assignee: Spectromedical Inc.Inventor: James Samsoondar
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Patent number: 7148067Abstract: A thromboplastin reagent includes tissue factor, Factor VIIa, and a net negatively charged phospholipid. The thromboplastin reagent is a synthetic thromboplastin reagent, and is in dried form.Type: GrantFiled: August 31, 2004Date of Patent: December 12, 2006Assignee: The Board of Trustees of the University of IllinoisInventors: James H. Morrissey, Stephanie A. Smith
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Patent number: 7144738Abstract: Methods for detecting biopolymers such as proteins, peptides, and nucleic acids in a matrix are provided, in which the methods include contacting the matrix with a sensitizing reagent that includes a substituted heteroaromatic compound; contacting the matrix with a reduceable metal salt to stain the biopolymer(s); and detecting the stained biopolymer(s). Compositions for performing the methods can include sensitizing agents, staining reagents, reducing agents, enhancing agents, and destaining agents. The compositions presented are compatible with mass spectrometry, and methods are provided for staining a biopolymer using the compositions of the invention and performing mass spectrometry on one or more biopolymers identified by the staining methods.Type: GrantFiled: March 31, 2005Date of Patent: December 5, 2006Inventor: Scott Whitney
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Patent number: 7141431Abstract: This invention provides a novel fluorescent particle including a core or carrier particle having on its surface a plurality of smaller polymeric particles or nanoparticles, which are stained with different fluorescent dyes. When excited by a light source they are capable of giving off multiple fluorescent emissions simultaneously, which is useful for multiplexed analysis of a plurality of analytes in a sample. The coupled complex particles carrying on their surface fluorescent nanoparticles, methods of preparing such polymer particles, and various applications and methods of using such particles are claimed.Type: GrantFiled: June 30, 2005Date of Patent: November 28, 2006Assignee: Luminex CorporationInventors: Mark B. Chandler, Don J. Chandler, Jason Bedre
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Patent number: 7135341Abstract: A method of making a reference control containing a nucleated red blood cell component includes providing a blood cell containing a nucleus; treating the blood cell with a treatment solution to alter a nucleus property from a natural value to a target value suitable for simulating nucleated red blood cells on a blood analyzer; and suspending treated blood cell in a suspension medium to form a reference control. The method also includes integrating the nucleated red blood cell component with white blood cell, red blood cell, platelet and reticulocyte components. Further disclosed is a cell treatment composition for altering a nucleus property, which includes a conditioning component, a lytic component for permeating cell membrane, and a fixing component for preserving the cell nucleus. Also disclosed is a method of using the reference control for measurement of nucleated red blood cells on a blood analyzer.Type: GrantFiled: March 30, 2005Date of Patent: November 14, 2006Assignee: Beckman Coulter, Inc.Inventors: Nery Ortiz, Sandra Socarras
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Patent number: 7129094Abstract: A composition for simulating and evaluating chemical agent contamination which can be used to safely train military personnel in handling chemical agent contamination. It has a vapor generating component having a vapor pressure of from about 0.1 to about 30 mm Hg at 25° C.; a fluorescent dye; and a solvent which uniformly disperses the vapor generating component and fluorescent dye.Type: GrantFiled: May 16, 2003Date of Patent: October 31, 2006Assignee: The United States of America as represented by the Secretary of the ArmyInventors: Alan T. Seitzinger, James A. Genovese