Abstract: The present invention relates to a method for diagnosing a predisposition for diabetes, comprising determining a metabolite in a test sample of a subject suspected to have a predisposition for diabetes and comparing the metabolite to a reference to diagnose the, predisposition for diabetes. Moreover, the present invention encompasses a collection of metabolites, a data collection comprising characteristic values of metabolites and a storage medium comprising the data collection. The present invention also relates to a system comprising methods or devices for comparing characteristic values of metabolites of a sample operatively linked to a data storage medium. Additionally, diagnostic methods or devices comprising a metabolite and its use for manufacture of the diagnostic method or device for diagnosing a predisposition for diabetes are provided, along with a method for identifying diabetes-related metabolites.

Abstract: A semiconductor die includes a chemical sensor, a digital to analog converter, and microcontroller formed therein. The chemical sensor detects the presence of a chemical and outputs an analog signal to the digital to analog converter. The analog to digital converter converts the analog signal to a digital signal. The analog to digital converter outputs the digital signal to the microcontroller. Microcontroller calculates a value of the concentration of the selected chemical.

Abstract: A chemical sensor is provided on a first semiconductor die. A potentiostat is provided on a second semiconductor die. An analog to digital converter and a microcontroller are provided on a third semiconductor die. The first die is configured to be connected to the second die. The second die is configured to be connected to the third die. The chemical sensor detects a chemical in the surrounding environment and outputs a signal to the analog to digital converter. The analog to digital converter converts the signal to a digital signal and outputs the digital signal to the microcontroller. The microcontroller provides a measurement of the concentration of the chemical in the surrounding environment.

Abstract: Systems and methods are provided for monitoring a immunosuppressant drug level and renal function, hepatic function, or a combination thereof in a patient, comprising obtaining a small volume blood sample from the patient; determining the level of at least one immunosuppressant drug in the small volume blood sample and determining the level of a second immunosuppressant drug or analyzing the renal function, the hepatic function, or a combination thereof in the patient. In some embodiments, the immunosuppressant drug levels are determined using a liquid chromatography tandem mass spectrometry (LC-MS/MS) procedure. Also provided are kits for use in any of the systems and methods described herein.

Abstract: The invention provides fluorophores of formulae (I) and (II) and also fluorescent sensor compounds comprising fluorophore moieties based on such fluorophores in combination with a receptor moiety. There is further provided a method of sensing the presence of a target analyte using the fluorescent sensor compound, as well as the use of the fluorescent sensor compounds to sense a target analyte.

Abstract: Novel fluorescent dyes are disclosed for use in analyte detection. In particular, mono- and bis-substituted HPTS dyes and methods of making them are provided.

Abstract: Glucose measured in blood samples is distinguished from glucose measured in the control solutions used to test the optical instruments which make such measurements. The control solutions contain a labeling substance recognized by the optical instrument to distinguish glucose measurements made of control solutions from those made of blood samples.

Abstract: A guided structured testing kit comprising a test strip container, a test strip meter, a testing protocol advisor, and at least one of diagnostic test strip is presented. The diagnostic test strip comprising a support element, a glucose reagent provided on the support element, and a glycemic context code provided on the support element. The glycemic context code can be machine-readable. The glycemic context code signals a glycemic context to a test strip meter, either upon insertion of the diagnostic test strip or by a user manually inputting the glycemic context into the test strip meter. A method for performing a guided structured test is also provided.

Abstract: Systems and methods for detecting the presence of biomolecules in a sample using biosensors that incorporate resonators which have functionalized surfaces for reacting with target biomolecules. In one embodiment, a device includes a piezoelectric resonator having a functionalized surface configured to react with target molecules, thereby changing the mass and/or charge of the resonator which consequently changes the frequency response of the resonator. The resonator's frequency response after exposure to a sample is compared to a reference, such as the frequency response before exposure to the sample, a stored baseline frequency response or a control resonator's frequency response.

Abstract: A sensor for the detection of an analyte comprising a cis-diol moiety, which comprises a holographic element comprising a medium and a hologram disposed throughout the volume of the medium, wherein an optical characteristic of the element changes as a result of a variation of a physical property occurring throughout the volume of the medium, and wherein the medium is a polymer comprising a group of formula (i) wherein n is 0, 1, 2, 3 or 4; each X (if present) is independently is an atom or group which, via an electronic effect, promotes formation of a tetrahedral geometry about the boron atom; and Y is a spacer which, when n is 0 or otherwise optionally, is an atom or group which, via an electronic effect, promotes formation of a tetrahedral geometry about the boron atom. Such a sensor may be used for the detection of glucose.

Abstract: A biosensor system determines analyte concentration from an output signal generated by an oxidation/reduction reaction of the analyte. The biosensor system adjusts a correlation for determining analyte concentrations from output signals at one temperature to determining analyte concentrations from output signals at other temperatures. The temperature-adjusted correlation between analyte concentrations and output signals at a reference temperature may be used to determine analyte concentrations from output signals at a sample temperature.

Abstract: Analyte meter protectors, meters that include the same, and methods.

Abstract: Compounds having enhanced oxidation stability are disclosed. The compounds have an aryl boronic acid residue having one or more electron withdrawing groups on the aromatic moiety which contains the boronic acid residue, such that the molecule has enhanced oxidation resistance as compared to a corresponding molecule without the one or more electron withdrawing groups.

Abstract: An apparatus for analyzing an aqueous solution, as may be implemented with a hand-held portable electronic device (10) and test element (16). A test pad (32) of the test element responsive in color to a characteristic of an aqueous solution is interrogated by the device by measuring intensity values of an interrogating test light as reflected off of the test pad. The test pad may be supported on an opaque and non-reflective substrate (28) that cooperates with an opaque edge portion (14E) of a test element placement member (14B) and associated side walls (14W) of the device to minimize the impingement of ambient light onto the test pad during interrogation.

Abstract: The invention concerns a reagent system for the so-called on-board control of analytical elements, in particular test strips, containing an organic N-oxide or a nitroso compound. The invention also concerns analytical elements containing a reagent system for a detection reaction and a reagent system for an on-board control. Furthermore, the invention concerns a method for checking analytical elements in which a reagent system for an on-board control is examined optically or electrochemically with the aid of a measuring instrument for changes which could indicate a stress of the analytical element.

Abstract: Total analysis systems and methods for simultaneously monitoring a suite of biological and/or chemical species in water and/or other process systems are disclosed. The system provides a sample-volume controlled sensor array comprising a fluid delivery device and a plurality of optical sensor elements for determining the presence and total concentrations of multiple analytes in the process system simultaneously. Delivery means are provided to deliver a metered quantity of sample fluid to the sensor array. Image identification algorithms are provided for identifying the analytes based on image intensity, color pattern, positional arrangement, and the like. The methods incorporate multivariate optimization algorithms to analyze multiple sensor responses. This produces analytical results that are typically difficult to obtain without full system or variable compensation.

Abstract: The invention relates to a method for investigating the glucose metabolism of a human being for disease-relevant and/or disease-related particularities. The glucose concentration g(t1) to g(tn) of a body fluid is measured at time points t1 to tn that are distributed over a period of at least six hours. The data points are then determined in phase space coordinates from the glucose concentration measuring values g(t1) to g(tn). The data points are then processed to highlight disease-relevant and/or disease-related particularities of the glucose metabolism of the investigated human being. The processing of the data points can be implemented by plotting them in a phase space representation or by determining from the data points a disturbance parameter that is correlated to the severity of a disturbance of glucose metabolism.

Abstract: A test element for determining a body fluid, in particular for determining the blood glucose level, comprises a detection region which is charged with a reagent sensitive to the body fluid. A function element is arranged in and/or adjacent to the detection region for detecting at least one status parameter for the detection region, wherein said functional element can be evaluated by means of a status measurement. A method for measuring the test element is also disclosed.

Abstract: An analysis system for detecting at least one analyte in a sample is proposed, in particular for detecting glucose in a bodily fluid. The analysis system is designed to detect the analyte using at least one test element. The test element has at least one analysis zone for detecting the analyte. The test element furthermore comprises at least one coding with at least one test element specific item of information and/or at least one position specific item of information. The analysis system comprises a detector and furthermore at least one transfer device which is designed to afford the detector the possibility of acquiring the analysis zone in at least a first position and to afford the detector the possibility of acquiring the coding in at least a second position which differs from the first position.

Abstract: The application provides a laboratory. The laboratory (400) comprises a portable casing (404). The portable casing (404) comprises a tray unit (407), an actuator unit (405, 412), an analyzer unit (419), and a communication unit (402, 415, 438). The tray unit (407) is used for receiving a cartridge (409). The cartridge (409) comprises an analyte reservoir (430) for receiving an analyte fluid, one or more chemical reagent reservoirs (432) for storing one or more chemical reagent fluids, and one or more channels (434) connecting the chemical reagent reservoirs (432) with the analyte reservoir (430). The channel (434) comprises a measurement area (436) whilst the measure measurement area (436) comprises a sensor. The actuator unit (405, 412) is used for reducing the volume of the analyte reservoir (430) and for reducing the volume of the chemical reagent reservoirs (432). The analyzer unit (419) is used for measuring a physical value in the measurement area (436) using the sensor.

Abstract: Embodiments disclosed herein relate to a sensor comprising an on-board control system and a testing system. The on-board system can determine viability of the control system or the testing system. Also disclosed are methods of using such a sensor.

Abstract: A method of adjusting a final signal value measured on a lateral flow assay test strip, by: identifying a pre-determined calibration method for the test strip, wherein the pre-determined calibration method corresponds to the manufacturing lot from which the test strip has been made; measuring signal values while performing a lateral flow assay reaction on a test strip; determining a final signal value; and adjusting the final signal value based upon the identified pre-selected calibration method for the test strip.

Abstract: The present invention concerns an improved optical method and optical sensing device for determining the levels of polyhydroxyl-substituted organic molecules in vitro and/or in vivo in aqueous media. The range of detection is between about 400 and 800 nm. In particular, a sensory devise is implemented in a mammal to determine sugar levels. Specifically, a dye is combined with a conjugated nitrogen-containing heterocyclic aromatic boronic acid-substituted bis-onium compound in the presence of a sugar, such as fructose or glucose. The viologens are preferred as the aromatic conjugated nitrogen-containing boronic acid substituted compounds. The method is useful to determine sugar levels in a human being.

Abstract: An in-vitro non-invasive method for quantifying the lesions of the liver of the patient with metabolic steatosis addressing a diagnostic target, i.e. fibrosis, steatosis and/or steato-hepatitis (NASH) and measuring at least one marker selected from the group consisting of biomarkers and possibly clinical markers and possibly scores, the biomarkers being selected from the group consisting of glycemia, AST (aspartate aminotransferase), ALT (alanine aminotransferase), AST/ALT, AST.

Abstract: A test meter system for testing a characteristic of a fluid, the test meter system including a test meter having a housing with an opening adapted to accept a test strip, an interrogation coil within the housing, a pick-up coil within the housing, and a test strip including at least one magneto-electronic-resonance sensor. When the test strip is within the opening, the interrogation coil may utilize magneto-electronic-resonance technology to interrogate the magneto-electronic-resonance sensor and the pick-up coil may be used to sense a resultant oscillation frequency of the magneto-electronic-resonance sensor, the resultant oscillation frequency associated with the characteristic. The test strip may include a plurality of sensors. The sensors may be coated with a coating sensitive to a characteristic of the fluid, where the interrogation reveals information about the fluid characteristic.

Abstract: Control and calibration solutions are described that provide control and calibration data that is recognized by a test meter allowing the meter to segregate the control and calibration data from regular test data. Recognition and segregation of the control and calibration data can occur automatically with no additional input from the meter's user. Methods for use of the solutions are also provided.

Abstract: A glucose measuring system includes a glucose meter that incorporates wireless communication capabilities. The meter can advantageously be a low cost meter by eliminating expensive components, such as the display. The user nevertheless is able to retrieve and view his or her glucose values by referring to displays within the glucose measuring local area network. Feedback via these displays can advantageously be used by the diabetic to create a higher level of confidence and safety.

Abstract: A mammalian disease detecting system used to provide a visual indication of a possible disease state includes particles made of a material that is substantially clear or transparent to permit the easy visual detection of blood in urine of a mammal. The system also includes additives to permit visually detection of possible disease states or infections in mammals, such additives being of the type that are not reactive with the particular material.

Abstract: Disclosed are magnetic nanosensors or transducers that permit measurement of a physical parameter in an analyte via magnetic reasonance measurements, in particular of non-agglomerative assays. More particularly, in certain embodiments, the invention relates to designs of nanoparticle reagents and responsive polymer coated magnetic nanoparticles. Additionally provided are methods of use of nanoparticle reagents and responsive polymer coated magnetic nanoparticles for the detection of a stimulus or an analyte with NMR detectors.

Abstract: A sensor for the detection of an analyte comprising a cis-diol moiety, which comprises a holographic element comprising a medium and a hologram disposed throughout the volume of the medium, wherein an optical characteristic of the element changes as a result of a variation of a physical property occurring throughout the volume of the medium, and wherein the medium is a polymer comprising a group of formula (I): wherein n is 0, 1, 2, 3 or 4; each X (if present) is independently is an atom or group which, via an electronic effect, promotes formation of a tetrahedral geometry about the boron atom; and Y is a spacer which, when n is 0 or otherwise optionally, is an atom or group which, via an electronic effect, promotes formation of a tetrahedral geometry about the boron atom. Such a sensor may be used for the detection of glucose.

Abstract: This application is directed to methods for improving glucose control by administering metformin in combination with a DPP-IV inhibitor to a patient in need thereof, in an amount sufficient to control the glucose level over an extended period of time.

Abstract: An analytical system comprising a replaceable magazine (12) for providing a plurality of test units that react to an analyte and a measuring device (14) for processing the test units, wherein the magazine (12) is provided with a code (26) that can be registered by the measuring device (14). In order to enable the simplest possible coding, it is proposed that the code (26) comprises an unique magazine identifier (28) for the magazine (12) and that the measuring device (14) has a magazine-independent test counter (16) which registers the processing of a test unit and a counter memory (18) to store the magazine identifier (28) and a corresponding count of the test counter (16).

Abstract: Small Molecule Metabolite Reporters (SMMRs) for use as in vivo glucose biosensors, sensor compositions, and methods of use, are described. The SMMRs include boronic acid-containing xanthene, coumarin, carbostyril and phenalene-based small molecules which are used for monitoring glucose in vivo, advantageously on the skin.

Abstract: A polymeric sensing fluid for detecting the presence of glucose and systems and methods of its use are generally disclosed. The polymeric sensing fluid includes a polymer in a solvent (e.g., an aqueous solvent). The polymer has a plurality of boronic acid moieties extending from its polymeric backbone. As such, the polymeric sensing fluid is configured to increase in viscosity upon addition of glucose due to crosslinking between the boronic acid moieties of the polymer and glucose.

Abstract: A system and method for measuring substance concentrations is provided. The system has a test strip container for receiving a test strip(s). The container has a sealing device, a counter device that counts a number of opening processes of the sealing device, a data carrier that stores batch-specific data of the test strip(s), a data transmission device for wireless transmission of the data and of the number. An analysis module has a device for measuring substance concentrations by the test strip(s), and a data-receiving device for wireless reception of the data from the data transmission device and of the number. The method records the number and stores the number on the data carrier; sends data and the number by wireless transmission to the analysis module, and determines a substance concentration by the test strip(s). Also or instead, the counter device counts a time duration of the opening processes.

Abstract: A method of measuring an analyte in a biological fluid comprises applying an excitation signal having a DC component and an AC component. The AC and DC responses are measured; a corrected DC response is determined using the AC response; and a concentration of the analyte is determined based upon the corrected DC response. Other methods and devices are disclosed.

Abstract: Novel pyridinium salts functionalized with boronic acid and methods of making them are disclosed. When combined with a fluorescent dye, the compounds are useful in the detection of polyhydroxyl-substituted organic molecules.

Abstract: A method of measuring an analyte in a biological fluid comprises applying an excitation signal having a DC component and an AC component. The AC and DC responses are measured; a corrected DC response is determined using the AC response; and a concentration of the analyte is determined based upon the corrected DC response. Other methods and devices are disclosed.

Abstract: Methods and devices for performing in situ hematocrit adjustments during glucose testing using glucose-monitoring products and using those adjusted values to estimate the hematocrit value of blood samples to reduce or eliminate the assay bias caused by the different hematocrit levels of blood samples. One method involves measuring the glucose value, Glum, of the blood sample; measuring the resistance of the blood sample (Rcell) using a biosensor reagent; measuring the resistance of plasma (Rplasma) using the biosensor reagent; determining the calculated resistance of red blood cells, RRBC, of the blood sample according to the relationship RRBC=Rcell?Rplasma; calculating the percent hematocrit, % Hctc, of the blood sample; determining whether to adjust the glucose value, Glum, to an adjusted glucose value, Gluadj; and using the percent hematocrit, % Hctc, and either the glucose value, Glum, or the adjusted glucose value, Gluadj, to adjust for any bias of the biosensor reagent.

Abstract: A method of sensing glucose in subjects includes the steps of providing a sensing solution including a plurality of metal ions, introducing a bodily fluid sample from a subject into the sensing solution. An optically-based measurable derived from directing incident light on the solution is generated. The concentration of glucose in the bodily fluid using the measurable is then determined which permits the blood glucose level to be derived.

Abstract: One embodiment includes a memory unit for use in connection with a plurality of fluid sample test elements, wherein the memory unit comprises a plurality of memory portions. In one aspect of the embodiment, the memory unit comprises at least one memory portion configured to communicate calibration and expiration information relating to a lot of test elements, to a meter operably connectable with such test elements, and at least one other memory portion configured for storage and communication of data, such as measurement results, relating to the use of the test elements in analyzing a fluid sample. Further embodiments include apparatuses, systems, methods, kits and combinations of test elements and memory units.

Abstract: Molecular bioprofiles comprising biologically correlated and relevant analytes that impact the biological state of a human health condition compared to a control population are provided. These molecular bioprofiles are useful in several ways including but not limited to, monitoring a disease or condition's progression, evaluating the impact of an agent or compound on a disease or condition, evaluating the impact of a lifestyle change on a disease or condition and assessing the risk of the disease or condition to a subject. Type II diabetes molecular bioprofiles are of particular interest.

Abstract: The invention relates to devices for continuously measuring the concentrations of more than one target analyte. Specifically, the devices comprise a plurality of analyte binding domains, with each domain being capable of specifically and reversibly binding to at least one of the target analytes. The devices further comprise a membrane surrounding these binding domains that is permeable to the target analytes. The devices convey binding information to a detector. The invention also relates to methods of using the devices, including monitoring chronic disease states in an individual.

Abstract: The presently-disclosed subject matter provides biosensors for detecting molecules of interest. The biosensors comprise a polypeptide capable of selectively-binding glucose, wherein the polypeptide molecule is selected from: an unnatural analogue of wild type glucose binding protein; a fragment of wild type glucose binding protein; and an unnatural analogue fragment of wild type glucose binding protein.

Abstract: The invention relates to indicator molecules for detecting the presence or concentration of an analyte in a medium, such as a liquid, and to methods for achieving such detection. More particularly, the invention relates to copolymer macromolecules containing relatively hydrophobic indicator component monomers, and hydrophilic monomers, such that the macromolecule is capable of use in an aqueous environment.

Abstract: A sensor-dispensing instrument is adapted to determine an analyte concentration of a fluid and comprises a body, a cap, a cartridge, a test-sensor receptacle, and a sensor-advancement mechanism. The cap is adapted to move between an open position and a closed position. The cap and body are adapted to correspond with each other to form the closed position. The cartridge contains a plurality of test sensors. The cartridge is located substantially within the cap. The sensor-advancement mechanism is adapted to advance the plurality of test sensors, one at a time, to a position that allows a user to manually remove the test sensor and place the test sensor in the test-sensor receptacle. The sensor-dispensing instrument may also include a lancing device including a lancet.

Abstract: The invention provides a method for determining a suitable drug combination for the treatment of Type 2 diabetes by obtaining data from a Type 2 diabetes population in which all of the Type 2 diabetics are not taking any Type-2 diabetes drugs and obtaining reference levels of glucose supply and insulin demand parameters. Data from discrete samples of Type 2 diabetes populations in which all individuals are being treated with one or more Type 2 diabetes drugs at a therapeutic dose are also obtained, and the effects of the drugs on the glucose supply and insulin demand parameters are used to determine adjustment factors which represent the effect of each of the drugs at the therapeutic dosage, which are used to determined a ratio of a Glucose Supply Index (S) to an Insulin Demand Index (D). The ratio is further utilized in scoring cardiovascular risks for Type 2 diabetics and recommending therapeutic interventions.

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: Analyte monitoring devices and methods therefore are provided. The devices integrate various functions of analyte monitoring, e.g., sample acquisition and testing.

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.