Abstract: The present invention relates to providing improved hydrogen peroxide assays, as well as droplet actuators for conducting such assays. The droplet actuators of the invention may be used to conduct droplet-based hydrogen peroxide assays. They may also be associated with detectors for analyzing the results of the hydrogen peroxide assays of the invention. They may be provided as components of systems which control droplet operations and/or detection for conducting the hydrogen peroxide assays. Measurement by the detector may be used to quantify the presence of an analyte in a sample.

Abstract: A method for performing an assay to determine the presence or concentration of an analyte contained in a sample of body fluid by using a device comprising at least one analyte quantification member and a sensor associated therewith, the method includes: applying a first sample to the analyte quantification member; and detecting the presence or absence of an adequate sample volume; wherein upon detection of the absence of an adequate sample volume, initiating a finite timed period, and signaling the user to introduce a second sample of body fluid to the analyte quantification member. Associated arrangements and devices are also disclosed.

Abstract: A medical diagnostic device includes a wirelessly transmitted time data receiver and processor. Associated devices, methods and functionality are also described.

Abstract: A computer implemented method and associated apparatus for the combined control of insulin bolus dosing and basal delivery for the goal of achieving normal glycemic response to meals, exercise, stressors, and other perturbations to blood glucose levels. A run-to-run algorithm is used to monitor blood glucose levels and adjust insulin delivery as conditions are varied.

Abstract: The invention is directed to enhanced methods for detecting an analyte of interest in situ, by immunoassay, or by hybridization comprising binding an enzyme-labeled conjugate molecule to an analyte of interest in the presence of a redox-inactive reductive species and a soluble metal ion. The enzyme catalyzes the conversion of the inactive reductive species to an active reducing agent, which in turn reduces the metal ion to a metal atom thereby providing an enhanced means of detecting the analyte via metal deposition.

Abstract: A polymer matrix that may coated on an electrode is created by co-crosslinking (1) an adduct of a polyaniline formed by templated oxidative polymerization on a polymer acid; (2) a water-soluble crosslinker; and (3) a redox enzyme. The polymer matrix may be hydrated, and the absorbed water may make it permeable to, for example, glucose. The polyaniline may be polyaniline itself or a substituted polyaniline; the water-soluble crosslinker may be poly(ethylene glycol) diglycidyl ether, and the redox enzyme may be glucose oxidase. The polymer matrix may be produced by co-crosslinking (1) an adduct of an electrically conductive polymer and a polymer acid; (2) a water-soluble crosslinker; and (3) a redox enzyme in a single step at an about neutral pH, curing by drying. After hydration, the crosslinked polymer matrix may form a 3-dimensional glucose-permeable bioelectrocatalyst, catalyzing the electrooxidation of glucose.

Abstract: A biosensor 1 comprises a cavity 17 for holding a sample, an electrode system 14 for measuring the sample concentration in the cavity 17, and a thermocouple 16 for obtaining temperature information during measurement. A measurement device 2 comprises a reference temperature junction sensor 33 or an environmental temperature sensor 22 for measuring the temperature of reference temperature junctions 42 and 43 of the thermocouple. A temperature compensation step S9 involves measuring the temperature difference between a measuring junction 41 and a reference temperature junctions 42 and 43 of the thermocouple 16, specifying the temperature of a reference temperature junction, thereby using these temperature information as the temperature of a measurement component 18 and performing accurate temperature compensation from the measuring junction temperature information and the environmental temperature information with respect to the measured values.

Abstract: The present invention relates to a method for identifying compounds that act as insulin-sensitizers. The method can include screening of test compounds in two assays of insulin sensitivity. This method can identify lead compounds for the treatment of disorders caused by insulin resistance to glucose uptake. This invention also includes methods for treating insulin resistance and related disorders.

Abstract: The invention provides a modified flavin adenine dinucleotide dependent glucose dehydrogenase (FADGDH), as well as a glucose sensor comprising the modified FADGDH and a method for measuring glucose comprising using the glucose sensor to measure glucose of a sample

Abstract: Physiological protein and enzyme complex having active Trimethylglycine, active amylases, active lipases, and active proteases, of human (saliva enzymes), yeast, plant, fungi, and or microbial origin, preferably digestive enzyme complex such as, Trimethylglycine, 4-?-D-glucan glucanohydrolase; Exo-1,4-?-glucosidase; Beta-fructofuranosidase; Protease (3.0); Pectinase; Lipase; Cellulase; Lactase; Malt Diastase, or digestive enzyme complex containing proteins and enzymes for the treatment of high levels of saccharides and correction of amylases malfunctioning activity or inactivity in the body. The invention also relates to the production of pharmaceutical compositions suitable for such treatment.

Abstract: A method for determining (e.g., detecting and/or measuring the concentration of) an analyte in a bodily fluid sample includes obtaining a bodily fluid sample, applying the bodily fluid sample to an analyte test strip, transferring the applied bodily fluid sample to a sample-receiving chamber of the analyte test strip, and determining an analyte in the bodily fluid sample. The analyte test strip employed in the method includes a first port in fluidic communication with the sample-receiving chamber and proximate a platform portion of the analyte test strip. Moreover, the platform portion is configured to receive a first (relatively large) bodily fluid sample of at least 5 micro-liters and transfer at least a portion of the first bodily fluid sample to the sample-receiving chamber via the first port.

Abstract: An apparatus and method for detecting the presence and measuring the concentrations of molecules through a barrier and/or at a distance utilizes the principle of chemical/electrostatic attraction (hereinafter “affinity”), i.e., the affinity between charged atoms and molecules that cause their chemical interactions and reactions, to infer, based on the behavior of molecules on one side of the barrier, the presence and concentration of corresponding molecules on the other side of the barrier. The invention is useful, by way of example and not limitation, in non-invasively measuring glucose levels of diabetic patients.

Abstract: The invention is directed to novel compositions of matter and methods of detecting in situ an immunohistochemical epitope or nucleic acid sequence of interest in a biological sample comprising binding an enzyme-labeled conjugate molecule to the epitope or sequence of interest in the presence of a redox-inactive reductive species and a soluble metal ion, thereby facilitating the reduction of the metal ion to a metal atom at or about the point where the enzyme is anchored. Novel phosphate derivatives of reducing agents are described that when exposed to a phosphatase are activated to their reducing form, thereby reducing metal ions to insoluble metal.

Abstract: An electrochemical sensor system and membrane and method thereof for increased accuracy and effective life of electrochemical and enzyme sensors.

Abstract: The present invention relates to a mutant protein of PQQ-dependent s-GDH characterized in that in at least one of the positions 122 and 124 the amino acid lysine is present, wherein these positions correspond to the amino acid positions known from the A. calcoaceticus s-GDH wild-type sequence (SEQ ID NO: 2), it also discloses genes encoding such mutant s-GDH, and different applications of these s-GDH mutants, particularly for determining the concentration of glucose in a sample.

Abstract: The present invention relates to the identification of a series of biomarkers, the detection of which is prognostic for women at risk of becoming hyperglycemic during pregnancy and/or fetuses at risk of developing congenital anomalies as a result of maternal hyperglycemia.

Abstract: A testing system for testing an analyte in a fluid sample includes a user interface including a display for displaying information relating to measurements of health data and an input device for receiving information from a user relating to the health data. The testing system further includes an automarking feature adapted to identify a testing result of a control solution, the testing of the control solution being distinguishable from the testing of the fluid sample. The testing result of the control solution is not included in the information relating to the measurements of health data that is displayed to a user via the user interface.

Abstract: The invention concerns test elements and methods for the optical detection of an analyte in a sample. The test element includes a support having at least one transparent portion, and a one-layer film positioned on the support. The film has a thickness when dry of less than about 10 ?m. The method includes contacting the sample with the test element and determining the analyte concentration in the sample.

Abstract: The invention is directed to entrapped mutated binding proteins, mutated binding proteins containing reporter groups, compositions of mutated binding proteins containing reporter groups in analyte permeable matrixes, and their use as analyte biosensors both in vitro and in vivo.

Abstract: The present application provides Ag/AgCl based reference electrodes having an extended lifetime that are suitable for use in long term amperometric sensors. Electrochemical sensors equipped with reference electrodes described herein demonstrate considerable stability and extended lifetime in a variety of conditions.

Abstract: The invention provides a method for diagnosing a disorder or disease associated with an imbalance of monoamines in a subject, or of diagnosing susceptibility of the subject to the same, wherein the method comprising (a) providing a sample from a subject to be tested, (b) measuring the levels of dopamine, melatonin and/or serotonin in the sample; and (c) comparing the levels measured in step (b) with levels of dopamine, melatonin and/or serotonin associated with a reference population of subjects, wherein a difference in one or more of the levels measured in step (b) with the levels of dopamine, melatonin and serotonin associated with the reference population of subjects is indicative of a positive diagnosis. The invention further provides a method of prevention or treatment of a disorder or disease associated with an imbalance of monoamines, and kits for the same.

Abstract: Methods and compositions for detection of microbial contaminants in peritoneal dialysis solutions are provided. The methods and compositions employ modified bioburden testing and the detection of peptidoglycan. A novel cause of aseptic peritonitis is provided—aseptic peritonitis associated with gram positive microbial contamination of a dialysis solution. Peptidoglycan is a major component of a gram positive bacterial cell wall and thus can serve as a marker for gram positive bacteria. In this regard, testing for peptidoglycans can be utilized to effectively prevent peritonitis in patients that use the peritoneal dialysis solutions, such as peritoneal dialysis solutions that contain a glucose polymer including an icodextrin and the like.

Abstract: The invention relates to yeast strains in which a human GLUT4 transport or a human GLUT1 transporter can be functionally expressed and to particular GLUT4 transport proteins which can be functionally expressed particularly readily in yeast strains.

Abstract: The invention relates to a method for improving the heat stability of glucose dehydrogenase (GDH), comprising a step of combining, in a composition comprising soluble coenzyme-bound glucose dehydrogenase (GDH), the enzyme with any one or more selected from the group consisting of sugar alcohols, carboxyl group-containing compounds, alkali metal-containing compounds, alkali earth metal compounds, ammonium salts, sulfate salts and proteins, thereby improving the heat stability of GDH over that achieved without the inclusion of the compounds.

Abstract: The Cellular GPRS system includes a cellular-based Glucometer (CBG) for blood glucose monitoring, a pedometer for exertion measurement, combined with user-entered dietary or other diabetes-relevant information. Data from all inputs is transmitted over a cellular network, using a GPRS or other wireless link. The data is preferably stored in the device prior to being transmitted wirelessly over the cellular airway to a central computer server. The remote computer server will evaluate the data received and respond with a data packet (making recommendations on further glucose measurement, exercise, diet, insulin requirements or other).

Abstract: The present invention relates to a predictive-kinetic method for use with data processing of a sensor-generated signal, as well as, microprocessors and monitoring systems employing such a predictive-kinetic method. Data from a transient region of a signal is used with suitable models and curve-fitting methods to predict the signal that would be measured for the system at the completion of the reaction. The values resulting from data processing of sensor response using the methods of the present invention are less sensitive to measurement variables.

Abstract: A chemistry matrix for use in determining the concentration of an analyte in a biological fluid includes a glucose dehydrogenase, nicotinamide adenine dinucleotide, an alkylphenazine quaternary salt, and/or a nitrosoaniline. The chemistry matrix is used with an electrochemical biosensor to determine the concentration of an analyte after a reaction occurs within the biosensor, at which time an analysis is completed to determine the concentration. A method of determining the concentration of an analyte using the chemistry matrix of glucose dehydrogenase, nicotinamide adenine dinucleotide, an alkylphenazine quaternary salt, and/or a nitrosoaniline is another aspect that is described. The method also further features test times of five seconds or less. Methods utilizing the new chemistry matrix can readily determine an analyte such as blood glucose at concentrations of from about 20-600 mg/dL at a pH of from about 6.5 to about 8.5.

Abstract: An apparatus and method for detecting the presence and measuring the concentrations of molecules through a barrier and/or at a distance utilizes the principle of chemical/electrostatic attraction (hereinafter “affinity”), i.e., the affinity between charged atoms and molecules that cause their chemical interactions and reactions, to infer, based on the behavior of molecules on one side of the barrier, the presence and concentration of corresponding molecules on the other side of the barrier. The invention is useful, by way of example and not limitation, in non-invasively measuring glucose levels of diabetic patients.

Abstract: A method of testing a glucose polymer or a glucose polymer derivative includes providing a sample of the glucose polymer or glucose polymer derivative. The sample is filtered at a specified molecular weight cutoff to obtain a retentate portion and a filtrate portion. The retentate portion is added to a first assay. The filtrate portion is added to a second assay. A reagent is added to each of the first assay and the second assay. The reagent produces a proinflammatory response. The proinflammatory response of each of the first assay and the second assay is measured. The proinflammatory response of the first assay is compared to the proinflammatory response of the second assay to determine if the glucose polymer or glucose polymer derivative is suitable for use in a patient.

Abstract: Various systems and methods of operating an analyte measurement device is provided. The device has a display, user interface, processor, memory and user interface buttons. In one example, one of the methods can be achieved by measuring an analyte with the analyte measurement device; displaying a value representative of the analyte; prompting a user to activate a test reminder; and activating the test reminder to remind a user to conduct a test measurement at a different time. Other methods and systems are also described and illustrated.

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 methods and compositions for modulating the expression, processing, post-translational modification, stability and/or activity of XBP-1 protein, or a protein in a signal transduction pathway involving XBP-1 to treat dyslipidemias and steatosis disorders. The present invention also pertains to methods for identifying compounds that modulate the expression, processing, post-translational modification, and/or activity of XBP-1 protein or a molecule in a signal transduction pathway involving XBP-1.

Abstract: The present invention relates to a diabetes animal model. Specifically, the present invention relates to a transgenic nonhuman animal, into which recombinant DNA comprising a gene encoding a diphtheria toxin receptor and an insulin promoter for regulating expression of the above gene has been introduced.

Abstract: The invention relates to processes and devices for detecting an analyte in a sample by fluorescence measurement.

Abstract: The invention provides methods for the determination of insulin sensitivity, insulin resistance, and non-insulin dependent Diabetes mellitus based on oral glucose tolerance test data and lipid ratios from reference populations that define an insulin resistance index. The invention also provides methods for using the IR index to determine disease progression and to evaluate the efficacy of therapeutic agents. The invention further provides an IR calculator for automating diagnosis, producing and storing patient medical records.

Abstract: An electrically non-conductive, nanoparticulate membrane comprising nanoparticles of at least one inorganic oxide of an element selected from Group IA, IIA, IIIA, IVA, IB, IIB, IIIB, IVAB, VB, VIB, VIIB or VIIIB of the Periodic Table, and wherein an oxidoreductase enzyme and a polymeric redox mediator capable of transferring electrons are diffusibly dispersed in said nanoparticulate membrane.

Abstract: Provided is a method of storing a reagent in a microfluidic device. The reagent, in a liquid form, is loaded into reaction chambers arranged on the microfluidic device; followed by lyophilization as being contained in the microfluidic device.

Abstract: An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing.

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: A biosensor system determines analyte concentration from an output signal generated from a light-identifiable species or a redox reaction of the analyte. The biosensor system adjusts a correlation for determining analyte concentrations from output signals with one or more index functions extracted from the output signals. The index functions determine at least one slope deviation value, ?S, or normalized slope deviation from one or more error parameters. The slope-adjusted correlation between analyte concentrations and output signals may be used to determine analyte concentrations having improved accuracy and/or precision from output signals including components attributable to bias.

Abstract: Methods of using alpha-1-acid glycoprotein, or an active derivative, to modulate the blood glucose level in mammals, particularly humans, is described. A therapeutically effective amount of alpha-1-acid glycoprotein is administered to a patient afflicted with Type 1 or Type 2 diabetes to lower the blood glucose level. An anti-diabetic medicament, particularly insulin, may also be administered in combination with alpha-1-acid glycoprotein. The invention also provides a treatment regimen by periodically administering alpha-1-acid glycoprotein and further provides a method of mitigating the inhibitory effect of an acute phase protein on the action of insulin.

Abstract: A sensor and method for measuring the concentration of one or more chemical substances within a solution. The sensor including a body of saturated hydrogel held within a sensor body. A window to allow flow through of the chemical substance to be measured. The hydrogel is held under a predetermined compressive force within the sensor body such that the hydrogel exerts a base pressure. A pressure sensor such as a strain gauge senses the pressure exerted by the hydrogel within the sensor body. The sensed pressure is stored or displayed. The hydrogel is reactive to the one or more chemical substances so that contact causes the hydrogel to either increase the pressure above the base pressure under which the hydrogel is held or to decrease the pressure relative to the base pressure of the hydrogel.

Abstract: Spectrophotometric assays are rendered more sensitive by adding to the assay mixture a light-emitting moiety. The decrease in intensity of light emitted due to the presence of a light-absorbing moiety associated with the photometric assay is much more sensitive to analyte than the absorbance of the light-absorbing moiety itself.

Abstract: Biomarkers relating to insulin resistance, pre-diabetes, type-2 diabetes, metabolic syndrome, atherosclerosis, and cardiomyopathy are provided, as well as methods for using such biomarkers as biomarkers for insulin resistance, pre-diabetes, type-2 diabetes, metabolic syndrome, atherosclerosis, and cardiomyopathy. In addition, methods for modulating the respective disorders or conditions of a subject are also provided. Also provided are suites of small molecule entities as biomarkers for insulin resistance, pre-diabetes, type-2 diabetes, metabolic syndrome, atherosclerosis, and cardiomyopathy.

Abstract: The systems and methods disclosed herein include a sensor particle for detecting the presence of a chelatable analyte, such as glucose, wherein the sensor comprises a chromophore and a fluorescent component, such as a quantum dot. The sensor particle further comprises moieties that bind both a clelatable analyte and chromophore reversibly and competitively. In the presence of the chelatable analyte, the moieties bind the analyte, and release the chromophore. The chromophore absorbs photons of one wavelength in a free state but of a different wavelength in a bound state, and is selected to operate with the fluorescent component such that the chromophore absorbs emissions of the fluorescent substance in only one of the bound and unbound states. In certain aspects, the invention comprises methods for detecting the presence of a chelatable analyte in a medium such as water, blood plasma and urine, using the sensor particles of the invention.

Abstract: A mutant of PQQ-dependent soluble glucose dehydrogenase (s-GDH; EC 1.1.5.2) is provided with improved specificity for glucose as compared to maltose, having a substitution of threonine at position 348 by either glycine, alamine or serine, wherein said mutant additionally comprises, at least one mutation for improving the stability of the mutant and one or more mutation(s) for improving the affinity of the mutant to glucose, and/or one or more mutation(s) for further improving the specificity of the mutant for glucose as compared to maltose, and wherein position 348 correspond to the amino acid positions known from the A. calcoaceticus s-GDH wild-type sequence. Also disclosed are genes encoding such mutant s-GDH, and different applications of these s-GDH mutants, particularly for determining the concentration of glucose in a sample.

Abstract: A method of distinguishing a control solution from a sample in an electrochemical test sensor is performed. The method includes adding a control marker to the control solution. The control solution includes the control marker and analyte. The test sensor includes working and counter electrodes, and a reagent. A potential is applied to the test sensor to oxidize the control marker and the analyte. The resulting electrical current is measured. A potential is applied to the test sensor lower than the other potential in which the potential is sufficient to oxidize the analyte and not the control marker. The resulting electrical current is measured. Determining whether a control solution or a sample is present based on the measured electrical currents. To increase the measured current, a salt may be added to the control solution in an amount sufficient to increase the electrical current by at least 5% as compared to a control solution in the absence of a salt.

Abstract: An amplifiable ?-lactamase substrate is provided comprising an enzyme donor fragment of ?-galactosidase linked to form a ring to a ?-lactam ring that is a substrate for lactamase and upon opening of the ?-lactam ring the enzyme donor fragment becomes linearized. The cyclic substrate only weakly binds to the enzyme acceptor fragment of ?-galactosidase. The substrate finds application for the sensitive detection of ?-lactamase for direct detection of the enzyme or when the enzyme is used as a label.

Abstract: An enzymatic process to obtain 4-O-?-D-galactopyranosyl-D-xylose useful in compositions or solutions in the in vivo evaluation of intestinal lactose activity in humans, that comprises the steps of preparing a reaction mixture of D-xylose, a ?-D-galactopyranoside and a reaction medium that comprises water buffered to a pH between 5.0 and 9.0; adding 10 to 1,000 units of ?-D-galactosidase per gram of ?-D-galactopyranoside; subjecting the reaction mixture to a reaction or a temperature between a temperature higher than the freezing point of the reaction mixture and 45° C., for 2 to 48 hours; for the reaction by deactivation of the ?-D-galactosidase; and to isolate and crystallize the fractions that contain 4-O-?-D-galactopyranosyl-D-xylose from a crystallization mixture selected between mixtures of acetone/methanol in a ratio between 5/1 to 20/1 and mixtures of acetone/water in a ratio between 5/1 to 20/1.

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.