Abstract: A test strip or electrochemical sensor for measuring the amount of an analyte in a hiological fluid, e.g., the glucose content of whole blood, includes a size self-limiting reagent formulation employing an enzyme system for reaction with the analyte, the reactive system mixed into a water-soluble swellable polymer matrix containing small water-insoluble particles having a nominal size of about 0.05 to 20 ?m, preferably about 1 to 10 ?m. The weight ratio of the water-insoluble particles to the water-soluble swellable polymer matrix is about 1/2 to 2/1. The reagent formulation is deposited onto a non-porous substrate to form a thin layer about 6-16 ?m thick, providing a rapid and stable response to application of a sample, while being insensitive to the amount of the sample.

Abstract: A method for diagnosing a body weight condition or predisposition to a body weight condition in an animal by determining observed level(s) of at least one biomarker in a tissue or biofluid sample from the animal and comparing the observed level(s) to reference level(s) for the biomarker; wherein the observed level(s) relative to the reference level(s) are individually or collectively indicative of the body weight condition or predisposition.

Abstract: Assay systems and methods are provided for detecting a target antigen in a physiological fluid (e.g., blood, serum, or urine). The method includes linking via a first antibody a magnetic microparticle to the target antigen in the physiological fluid; linking via a second antibody a glucose molecule to the target antigen; utilizing a magnetic field to separate the magnetic microparticle-linked antigen from the physiological fluid to form a test sample; and detecting the glucose in the test sample to determine the concentration of target antigen in the physiological fluid. The target antigen can be a protein or marker resulting from cardiac tissue injury, which can be used to assess acute myocardial infarction. An exemplary target antigen is myoglobin. The glucose detection preferably is one that can be done rapidly, e.g., with a conventional glucometer, and may include measuring the electrical resistance, color, or pH of the test sample.

Abstract: Provided are methods and compositions for assaying for ubiquitin agents that are enzymatic components of ubiquitin-mediated proteolysis and, more particularly, methods and compositions for assaying for agents that modulate the activity of such ubiquitin agents.

Abstract: Disclosed herein is a dry fluorescence biosensor strip for rapid detection of a target analyte present in bodily fluids. The dry fluorescence biosensor strip comprises a sample receptacle and a dry detection membrane. The sample receptacle receives a sample of one of the bodily fluids. The dry detection membrane detects presence of the target analyte in the received sample based on fluorescence induced on the dry detection membrane. Fluorescent signals are emitted from the dry detection membrane on induction of fluorescence. A fluorometer quantifies measurable properties of the target analyte based on the emitted fluorescent signals. The dry fluorescence biosensor strip may further comprise a filtration membrane for filtering the received sample. The filtered sample migrates from the filtration membrane to the dry detection membrane. The dry detection membrane may then detect presence of the target analyte in the filtered sample.

Abstract: Standard reference materials and related methods are described for quality testing and calibration of instruments used for the qualitative and quantitative determination of hemoglobin and glycated hemoglobin as well as other analytes of interest in animal tissue samples. The reference solutions of the disclosure utilize a synthetic cruor in combination with an Hb peptide chain.

Abstract: The invention provides an assay kit for the measurement of free D-galactose and/or Larabinose in a sample, the kit comprising galactose mutarotase and (3-galactose dehydrogenase. The kit may further comprise a reagent capable of hydrolysing molecules containing D-galactose and/or L-arabinose, to yield the free mono- or disaccharide so that the kit finds use for determination of not just of free D-galactose and/or L-arabinosebut also those molecules as released (or synthesized) from other molecules, including lactose, D-galacose-1-phosphate, galactosyl-sucrose oligosaccharides (such as raffinose), galactan, galactomannan, arabinan and arabinogalactan.

Abstract: A method of screening for disorders of glucose metabolism such as impaired glucose tolerance and diabetes allows prevention, or early detection and treatment of diabetic complications such as cardiovascular disease, retinopathy, and other disorders of the major organs and systems. A mathematical algorithm evaluates the shape of a subject's glucose profile and classifies the profile into one of several predefined clusters, each cluster corresponding either to a normal condition or one of several abnormal conditions. The series of blood glucose values making up the glucose tolerance curve may be measured using any glucose analyzer including: invasive, minimally invasive and noninvasive types. The method is executed on a processing device programmed to perform the steps of the method. Depending on the outcome of the screening, a subject may be provided with additional information concerning their condition and/or counseled to consult further with their health care provider.

Abstract: The present invention relates to oxidoreductase apoenzyme variants which are enzymatically inactive but have coenzyme-binding properties. Further, the present invention relates to DNA sequences encoding these oxidoreductase apoenzyme variants, expression vectors containing such DNA sequences and the use of these oxidoreductase apoenzyme variants in diagnostic applications.

Abstract: The present invention provides a microorganism-derived soluble coenzyme-binding glucose dehydrogenase which catalyzes a reaction for oxidizing glucose in the presence of an electron acceptor, has an activity to maltose as low as 5% or less, and is inhibited by 1,10-phenanthroline. The invention also provides a method for producing the coenzyme-binding glucose dehydrogenase, and a method and a reagent for measuring employing the coenzyme-binding glucose dehydrogenase. According to the invention, the coenzyme-binding glucose dehydrogenase can be applied to an industrial field, and a use becomes possible also in a material production or analysis including a method for measuring or eliminating glucose in a sample using the coenzyme-binding glucose dehydrogenase as well as a method for producing an organic compound. It became also possible to provide a glucose sensor capable of accurately measuring a blood sugar level.

Abstract: This invention relates to a method of diagnosing or treating a biological subject, such as a person or animal, comprising the steps of subjecting at least a microsample of the subject's tissue to a physiological perturbation and measuring the response of the microsample to the perturbation using optical coherence tomography (OCT). In an exemplary embodiment, the concentration of glucose in the microsample is perturbed, as by providing the subject with a high glucose drink, and subsequently monitoring at a high sample rate in a microsample by OCT. Pathology, such as diabetes, can be diagnosed by deviation of the concentration vs. time response over several cells (micro-oscillation) from the micro-oscillation in the cells of a healthy subject. Other applications include diagnosing or treating de-hydration and diseases that cause changes in the osmolyte concentrations and thus the osmotic pressure in the cells in tissue.

Abstract: A reagent strip for measuring the concentration of glucose in whole blood has a polymer on at least one side thereof to increase the opacity thereof, thereby reducing the effect of hematocrit on the glucose determination.

Abstract: Provided herein are methods for determining the metabolism of one or more sugars and/or fatty acids, and applications thereof. Such applications include determining the rate of glycogen synthesis and glycolysis, which are believed to be early markers for predicting elevated risk of diabetes and cardiovascular disease. Other applications include methods for screening drugs that effect sugar and/or fatty acid metabolism. The methods are useful for at least partially characterizing drugs for desirable or undesirable (toxic) characteristics. Drugs that are at least partially characterized using the methods of the invention can then be further developed in pre-clinical testing and clinical trials. Such drugs may be found to be useful in treating obesity, diabetes, cardiovascular disease, and other disorders of metabolism.

Abstract: Embodiments of the present invention provide a method for detecting a composition comprising (a) providing a first composition which reacts with an oxidase to generate a second composition; (b) providing nitrogen-doped nanocarbons; and (c) detecting the first composition with the nanocarbons. Devices and systems containing such nitrogen-doped nanocarbons are also provided.

Abstract: Method and apparatus for channeling fluid away from an insertion site having a channel guiding the fluid flow from the insertion site, and a channeling compartment containing absorbent material to wick the fluid such as blood away from the insertion site is provided.

Abstract: The present invention is directed to methods which can be used to test agents for their ability 5 to modulate cell proliferation, differentiation and other biological activities of target cells such as stem cells. In addition, the invention is also directed to methods for modulating a biological activity of target cells in vitro, to the cells whose biological activity is modulated by such methods, to the cells that may be produced from target cells by such methods, and to the use of such cells for transplantation, transfusion and other purposes.

Abstract: Membrane containing microneedles, microneedle arrays, and needles, and systems and methods relating to same are disclosed.

Abstract: A method of reducing thickness non-uniformity in a microjet-deposited solids layer is disclosed which comprises depositing onto a substrate by microjet deposition a composition containing a liquid vehicle, at least one reagent; and a polyol which is present at a concentration that enhances thickness uniformity of a solids layer, containing the reagent(s), which is formed when the microjet-deposited composition is dried.

Abstract: The present invention relates to an analytical instrument (1) which includes a flow path (5) for moving a sample containing blood cells, an introduction port (50) for introducing the sample into the flow path (5), a reagent portion (51) arranged in the flow path (5), and an electron detection medium (52) for obtaining information necessary for analyzing an analysis target component contained in the sample in relation with an amount of electrons transferred. The reagent portion (51) contains an electron mediator for supplying an electron taken from the analysis target component in the sample to the electron detection medium (52), and at least part of the reagent portion is positioned adjacent to the introduction port (50).

Abstract: A meter and sensors, for use in combination, where no calibration code has to be entered by the user or is read by the meter. The meter is configured with a predetermined slope and y-intercept built into the meter. If the slope and y-intercept of the sensor are within a predetermined area or grid, or otherwise close to the slope and y-intercept of the meter, the batch of sensors is acceptable for use with that meter for providing accurate analyte concentration results.

Abstract: The objective of the present invention is to provide a method and instrument for measuring glucose concentration in blood using infrared spectroscopy. Glucose concentration in blood is measured based on an integrated value obtained by measuring an absorption spectrum that includes the wavelength range of 1020-1040 cm?1, and by integrating the intensity of absorption of the wavelength range of 1020-1040 cm?1 within the absorption spectrum. Alternatively, a glucose concentration in blood is measured based on an integrated value through measuring an absorption spectrum including the wavelength range of 1010-1050 cm?1; obtaining a second-derivative spectrum by calculating a second derivative of the absorption spectrum that includes the wavelength range of 1010-1050 cm?1 in the absorption spectrum; determining an integration range based on the second derivative spectrum; and then obtaining the integrated value by integrating the intensity of absorption based on this determined integration range.

Abstract: The present invention provides a method of modulating appetite and/or body weight in a subject, said method comprising administering to said subject an effective amount of a MIC-1 modulating agent, wherein said agent increases or decreases the amount of MIC-1 present in said subject, or inhibits or enhances the biological activity of present in said subject.

Abstract: A protein is provided, including a glucose binding site, cyan fluorescent protein (CFP), and yellow fluorescent protein (YFP). The protein is configured such that binding of glucose to the glucose binding site causes a reduction in a distance between the CFP and the YFP. Substance monitoring apparatus (210) is also provided, including a semi-permeable barrier (212), adapted to be implanted in a body of a subject and to allow passage therethrough of a substance, while inhibiting passage therethrough of immune cells; and microorganisms (214), disposed within the semi-permeable barrier (212) so as to produce a measurable response to a level of the substance. A sensor (220) is adapted to measure the measurable response and not to measure a response of any mammalian cells that may be disposed within the semi-permeable barrier (212).

Abstract: Non-invasive methods for detecting non-alcoholic fatty liver disease (NAFLD) and identifying the presence or absence of non-alcoholic steatohepatitis (NASH) in a subject utilize one or more biomarkers. The methods can differentiate between subjects with NASH and those with simple steatosis. Kits containing one or more agents for measuring the level of the biomarkers can be utilized to perform the described methods.

Abstract: A novel class of compounds that includes HPTS-Cys-MA, and methods of making them are disclosed herein. The class of compounds including HPTS-Cys-MA are useful as fluorescent dyes for analyte detection.

Abstract: A small diameter flexible electrode designed for subcutaneous in vivo amperometric monitoring of glucose is described. The electrode is designed to allow “one-point” in vivo calibration, i.e., to have zero output current at zero glucose concentration, even in the presence of other electroreactive species of serum or blood. The electrode is preferably layered, with the layers serially deposited within a recess upon the tip of a polyamide insulated gold wire. A first glucose concentration-to-current transducing layer can be overcoated with an electrically insulating and glucose flux limiting layer (second layer) on which, optionally, an immobilized interference-eliminating horseradish peroxidase based film is deposited. An outer layer is preferably biocompatible.

Abstract: A method and apparatus for performing a first measurement on a biological fluid or control, which first measurement varies with both the concentration of a first component and at least one of the presence and concentration of a second component. The method and apparatus perform a second measurement on the biological fluid or control, which second measurement varies primarily only with the at least one of the presence and concentration of the second component to develop an indication of the at least one of the presence and concentration of the second component. The first and second measurements may be made sequentially or simultaneously. The method and apparatus then remove an amount representative of the indicated presence or concentration of the second component from the concentration of the first component indicated by the first measurement.

Abstract: Methods and reagents are provided for measuring protease activity. The reagent comprises a surface to which is linked an enzyme donor fragment through a protease recognition sequence, where the enzyme donor fragment complexes with an enzyme acceptor fragment to form an active indicator enzyme when the enzyme donor fragment is cleaved from said surface. Conveniently, the surface is a cell membrane surface where the reagent is expressed in the cell. The method comprises bringing together the reagent, the protease, the enzyme acceptor and substrate for the indicator enzyme and measuring the indicator enzyme activity as a measure of the protease activity. The method finds application in screening for compounds modulating the activity of the protease.

Abstract: Substrate specificity for glucose of a glucose dehydrogenase having the amino acid sequence of SEQ ID NO: 13 is improved by substituting another amino acid residue for the amino acid residue at position 472 and/or 475.

Abstract: Disclosed are various preferred embodiments for dynamic transfer of information from a test sensor to an analyte medical test device. Exemplary embodiments include various containers, systems and methods.

Abstract: This invention relates to an iconic display of pre-event or post-event iconic markers for a meter and a method for marking an analyte concentration with a pre-event or post-event iconic marker. The meter includes at least one segment on a display adapted to show a pre-event or post-event iconic marker. The user can interact with the meter via a button on the meter. The button allows the user to scroll from pre-event, post-event, and neither iconic marker, and it also allows the user to select one or neither of the iconic markers. A memory device located within the meter stores the analyte concentration with the corresponding pre-event, post-event, or neither iconic marker.

Abstract: An analyte detection system is configured to measure concentrations of at least first and second analytes in a single material sample supported by a sample element. The measurement of a second analyte can be conditioned on a quantitative or qualitative result of the first measurement. In one embodiment, the first analyte is glucose and the second analyte is a ketone. According to such an embodiment the ketone is measured if the result of the glucose measurement exceeds a previously-specified value or falls outside of a previously-specified range.

Abstract: A method is provided to identify a modulator of ?Klotho-dependant glucose transporter-1 (GLUT-1) upregulation that specifically modulates interaction of ?Klotho and an FGFR.

Abstract: A reagent strip for measuring the concentration of glucose in whole blood has a polymer on at least one side thereof to increase the opacity thereof, thereby reducing the effect of hematocrit on the glucose determination.

Abstract: A method for formulating and immobilizing a protein and a protein matrix formed by the method. The protein matrix preparation method results in a physically and chemically stable protein matrix that has low swelling, non-leaching, high activity, and high mechanical strength properties. The method includes cross-linking and hardening the protein mixture and using a mold to form a protein into a desired shape and size.

Abstract: The invention provides novel methods and compositions for modulating gluconeogenesis through modulation of PGC-1 activity or expression. Also provided are methods for identifying compounds that modulate gluconeogenesis through modulation of PGC-1 activity or expression, as well as methods for identifying compounds that modulate the interaction of PGC-1 with PGC-1 target molecules. Further provided are methods for treating disorders characterized by aberrant gluconeogenesis.

Abstract: An hydrogel incorporating a biologically active component is provided that is useful as an interface material for transdermal sensing applications. Specifically, the hydrogel has a crosslinked gel structure and a biologically active component incorporated into the crosslinked gel structure, the biologically active component being capable of converting glucose into a compound having potentiometric activity.

Abstract: A protein biosensor having increased signal intensity to sugar concentration and the use thereof. A fluorescent indicator protein is described, in which fluorescent proteins of different emission ranges are fused to both ends of a binding protein undergoing a conformational change due to binding of sugars, such that a change in the concentration of various sugars involved in intracellular metabolism, e.g., maltose, can be detected by measuring a change in emission intensities, caused by FRET (fluorescence resonance energy transfer). A method for detecting a change in the concentration of sugars using such fluorescent indicator protein is also described. The fluorescent indicator protein has excellent signal intensity enabling precision measurement of intracellular concentration of various sugars. In one implementation, high signal intensity fluorescent indicator proteins can be prepared from proteins otherwise used as biosensors, to enable them to be more widely useful.

Abstract: The invention relates to novel PQQ-dependent soluble glucose dehydrogenases (sPQQGDH) from Acinetobacter and to a process for their preparation by overexpression in suitable microbial expression systems.

Abstract: A redox polymer for use in an electrochemical-based sensor includes a hydrophobic polymer backbone (e.g., a hydrophobic poly(methyl methacrylate) polymer backbone) and at least one hydrophilic polymer arm (such as a hydrophilic oligo(N-vinylpyrrolidinone) polymer arm) attached to the hydrophobic polymer backbone. The redox polymer also includes a plurality of redox mediators (e.g., ferrocene-based redox mediators) attached to the at least one hydrophilic polymer arm.

Abstract: The invention provides an in vivo screening assay and an in vitro screening assay for rapid screening of diabetes. A method of the invention includes determining a first glucose concentration in an ocular fluid of a patient; administering orally a load of carbohydrate to the patient; determining a second glucose concentration in an ocular fluid of the patient at a period of time of less than 50 minutes after orally administering of the load of carbohydrate; comparing the second glucose concentration with the first glucose concentration to determine if the patient is likely to be a diabetic. The method of the invention is performed by using a kit of the invention. The kit comprises: (1) a glucose-sensing ophthalmic device and instructions for using the glucose-sensing ophthalmic device to screen for diabetes; or (2) two or more tear-collecting devices, and a testing agent composition which specifically reacts with glucose to form a detectable signal.

Abstract: The present invention concerns a polymer layer for a sensor, wherein the polymer layer has nanoparticles embedded therein which impart to the polymer layer recognizing properties as well as transducer properties, a sensor comprising such layer and the use of the sensor for detecting and/or quantifying a target analyte.

Abstract: A method for detecting exposure to ionizing radiation. An HbA1c test is performed on blood extracted from an animal at a first time, to establish a baseline glycosylated hemoglobin score, and a second HbA1c test is performed on blood extracted from the animal at a second time, to establish a test glycosylated hemoglobin score. The test and baseline scores are compared to determine any difference, and an inference is drawn as to whether the animal has or has not been exposed to ionizing radiation between the first and second times based, at least in part, on the amount of the difference.

Abstract: Object: An object of the present invention is to provide a more practically advantageous enzyme usable as a reagent for measuring blood glucose than the known enzymes used as blood glucose sensors. Method for Achieving the Object: A modified flavin adenine dinucleotide dependent glucose dehydrogenase (FADGDH) with more improved heat stability than FADGDH derived from wild-type FADGDH, the modified FADGDH being derived from preferably a eukaryote, more preferably a filamentous fungus, and furthermore preferably an Aspergillus fungus, and, for example, those having a primary structure with at least one amino acid substituted, deleted, inserted or added to FADGDH having an amino acid sequence represented by SEQ ID Nos. 2 or 46 in the sequence table.

Abstract: A test strip for use of the determination of an analyte in a fluid sample according to one embodiment of the present invention is disclosed. The test strip comprises a base having a top and a bottom, a collection chamber that extends between the top and the bottom of the base, a containing ring that is disposed on the bottom of the base and surrounds the collection chamber, and a capillary channel formed in top of the base that has an inlet fluidly coupled to the collection chamber, a test element disposed within the capillary channel. A lid is attached to the top of the base and covers the collection chamber, the test membrane, and at least a portion of the capillary channel.

Abstract: Embodiments of a detection reagent, as well as test elements and analytical kits including such reagent, and methods for using such reagent, are disclosed herein for optical detection and/or measurement of an analyte in a fluid sample.

Abstract: The present invention provides for stable nicotinamide adenine dinucleotide (NAD/NADH) and nicotinamide adenine dinucleotide phosphate (NADP/NADPH) derivatives of formula (I), enzyme complexes of these derivatives and their use in biochemical detection methods and reagent kits.

Abstract: An apparatus comprising a user interface configured to generate an electrical signal to begin a carbohydrate ratio test when prompted by a user, an input configured to receive sampled blood glucose data of a patient that is obtained during a specified time duration (including a time duration after delivery of an initial carbohydrate insulin bolus), and a controller in electrical communication with the input and the user interface. The controller includes a carbohydrate ratio module configured to establish a blood glucose baseline from a measure of an initial blood glucose level of the patient, and determine a carbohydrate ratio according to a difference between a blood glucose level of the patient at the end of the specified time duration and the blood glucose baseline. Other systems and methods are disclosed.

Abstract: The present invention concerns compositions and methods of extracting infectious pathogens from a volume of blood. In one embodiment, the method includes the steps of creating a fibrin aggregate confining the pathogens and introducing a fibrin lysis reagent to expose the pathogens for analysis. The present invention also concerns materials and methods for removing aurintricarboxylic acid (ATA) from a sample.

Abstract: The present invention relates to a health monitoring device for measuring blood or tissue indicators and a strip cassette suitable for use in connection with the device. The device comprises a body (6) having a first opening (5) and a second opening (4), a piercing means (7) having a piercing head and connected to the body, the piercing means being arranged to extend from the first opening of the body and being cockable and further releasable for piercing the skin with the piercing head, and a space (17) arranged in connection with the body, into which space a number of sensor strips (12) can be arranged so that the strips can be brought out from the body one at a time.