Abstract: A hand-held test meter for use with an analytical test strip in the determination of an analyte in a bodily fluid sample includes a housing; a microcontroller block disposed in the housing; and a phase-shift-based hematocrit measurement block. The phase-shift-based hematocrit measurement block includes a signal generation sub-block, a low pass filter sub-block, an analytical test strip sample cell interface sub-block, a transimpedance amplifier sub-block, and a phase detector sub-block. In addition, the phase-shift-based hematocrit measurement block and microcontroller block are configured to measure the phase shift of a bodily fluid sample in a sample cell of an analytical test strip inserted in the hand-held test meter and the microcontroller block is configured to compute the hematocrit of the bodily fluid sample based on the measured phase shift.

Abstract: With this biological sample measuring device, the determination section performs measurement at specific intervals in a first measurement period from the start of measurement until a first time, and performs measurement at specific intervals in a second measurement period that comes after the first measurement period, calculates the difference between the measurement values in corresponding specific periods, and finds a plurality of first difference determination values, on the basis of a plurality of current values measured in the first measurement period and a plurality of current values measured in the second measurement period, finds a second difference determination value by finding the difference at specific intervals in the plurality of first difference determination values, and determines whether or not a reagent movement error and/or exposure error of the biological sample measurement sensor has occurred, on the basis of the first and second difference determination values.

Abstract: A portable, hand-held glucose testing device includes a housing configured to accommodate a plurality of test sensors in a stacked arrangement and having a wall with an opening defined therein. A plurality of packaged test sensors is stacked in alignment with one another within the housing. Each of the test sensors is packaged within a blister package. The blister package comprises a blister package housing and a cover foil overlying a surface of the blister package housing and the test sensor. A drive slide is configured to displace one of the plurality of packaged test sensors out of alignment with other packaged test sensors. A knife mechanism is configured to pierce through the cover foil, and to engage and urge the test sensor to extend through the opening for receiving a sample. A meter contact is configured to engage the test sensor when the test sensor extends through the opening.

Abstract: A specimen test strip is provided to detect a characteristic of an analyte in a specimen sample. The specimen test strip includes a reaction area to receive the specimen sample and a color calibration area to determine a color, or a color and a color intensity, of the reaction area after receiving the specimen sample. The specimen test strip may further include a temperature indication area to correct a measurement of the characteristic of analyte.

Abstract: Methods and devices to detect analyte in body fluid are provided. Embodiments include processing sampled data from analyte sensor, determining a single, fixed, normal sensitivity value associated with the analyte sensor, estimating a windowed offset value associated with the analyte sensor for each available sampled data cluster, computing a time varying offset based on the estimated windowed offset value, and applying the time varying offset and the determined normal sensitivity value to the processed sampled data to estimate an analyte level for the sensor.

Abstract: Disclosed is an improved post-column fluorimetric determination-boric acid complex anion exchange method which allows analysis of mannose-6-phosphate. The disclosed method is a method for separation analysis of reducing sugars using column chromatography, comprising loading a sample onto an anion exchange column, washing the column by allowing to flow a sufficient volume of a first mobile phase consisting of an aqueous solution of a predetermined concentration of boric acid containing a predetermined concentration of a water-soluble inorganic salt through the column, supplying a second mobile phase with an elevated concentration of the salt to elute the reducing sugars, adding to the eluate a basic amino acid, heating, and continuously measuring and recording the intensity of fluorescent light emitted under irradiation with excitation light.

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

Abstract: Quaternary nitrogen heterocyclic boronic acid-containing compounds are described, which are sensitive to glucose and fructose, as well as a variety of other physiologically important analytes, such as aqueous chloride and iodide, and a method of using the compounds. Also disclosed is a contact lens doped with the quaternary nitrogen heterocyclic boronic acid-containing compound, and a method of using the doped contact lens to measure the concentration of analyte in tears under physiological conditions.

Abstract: This invention provides devices, compositions and methods for determining the concentration of one or more metabolites or analytes in a biological sample, including cells, tissues, organs, organisms, and biological fluids. In particular, this invention provides materials, apparatuses, and methods for several non-invasive techniques for the determination of in vivo blood glucose concentration levels based upon the in vivo measurement of one or more biologically active molecules found in skin.

Abstract: An optic light guide test sensor comprises a light guide, a reagent-coated membrane, and a mesh layer. The reagent-coated membrane and the mesh layer are attached to the light guide at an output end of the light guide. The light guide test sensor is adapted to be used to test the level of an analyte in a biological fluid sample when used with a readhead. A method of manufacturing the light guide test sensor involves providing a plurality of light guides, providing a strip of reagent-coated membrane, and providing a strip of mesh layer. The reagent-coated membrane and mesh layer are attached to the light guides by ultrasonic welding. The reagent-coated membrane and mesh layer may also be attached to the light guides by adhesive.

Abstract: The presently-disclosed subject matter provides biosensors for detecting molecules of interest. The biosensors include 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: A test strip with a sample chamber is secured to a meter. The sample chamber in the portion of the test strip that extends out of the meter is illuminated by transmitting light from a light source inside the meter internally through the test strip towards the sample chamber. By way of analogy, the test strip acts in a fashion similar to a fiber optic cable or optical wave guide by transmitting the light from the meter to the remotely located sample chamber that extends outside the meter. The user is then able to easily see the sample chamber of the test strip in dark conditions so that the user is able to readily align the sample chamber with the drop of fluid on the skin as well as view the sample chamber in order to ensure proper filling. The light also illuminates a test strip slot into which the test strip is inserted.

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 surface grafted conjugated polyelectrolyte (CPE) is formed by coupling a CPE by a coupling moiety to the surface of a substrate. The substrate can be of any shape and size, and for many uses of the surface grafted CPE, it is advantageous that the substrate is a nanoparticle or microparticle. Surface grafted CPEs are presented that use silica particles as the substrate, where a modified silane coupling agent connects the surface to the CPE by a series of covalent bonds. Two methods of preparing the surface grafted CPEs are presented. One method involves the inclusion of the surface being modified by the coupling agent and condensed with monomers that form the CPE in a grafted state to the substrate. A second method involves the formation of a CPE with terminal groups that are complimentary to functionality that has been placed on the surface of the substrate by reaction with a coupling agent. The surface grafted CPEs are also described for use as biosensors and biocides.

Abstract: Medical devices are typically sterilized in processes used to manufacture such products and their sterilization by exposure to radiation is a common practice. Radiation has a number of advantages over other sterilization processes including a high penetrating ability, relatively low chemical reactivity, and instantaneous effects without the need to control temperature, pressure, vacuum, or humidity. Unfortunately, radiation sterilization can compromise the function of certain components of medical devices. For example, radiation sterilization can lead to loss of protein activity and/or lead to bleaching of various dye compounds. Embodiments of the invention provide methods and materials that can be used to protect medical devices from unwanted effects of radiation sterilization.

Abstract: The present invention relates to a novel method for analysing carbohydrates. The invention is in particular useful in detecting a terminal monosaccharide which may be released from a glycosylated substrate for example using an exoglucosidase. After relase from the glycosylated substrate the terminal monosaccharide may be captured on a solid support, incubated with a boronate detection agent and detected by aid of the boronate detection agent. The methods of the invention are useful for a variety of purposes including sequencing of carbohydrates, wherein exoglycosidases with predetermined specificity are employed for the release.

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: The present invention discloses a biological measuring device with auto coding capabilities. In accordance with one embodiment of the present invention, the biological measuring device with auto coding capabilities may include a test strip associated with a code pattern; and a code reader electrically coupled to the test strip to read the code pattern, wherein the code reader is configured to read an output from the code pattern consisted of a first logical value, a second logical value, and a third logical value.

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

Abstract: Devices, methods and systems effective to evaluate a physical or chemical property of an ion exchange resin-treated biological fluid sample are provided.

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 glucose tolerance test device comprising: a test zone having a means to receive at least first and second blood test samples spaced apart by a predetermined time interval; a timer to measure such a time interval, and for example to measure elapsed time after collection of a said first sample; an indicator to indicate at least that a second test is due, operatively Jinked to the timer so as to make such indication after lapse of a predetermined time interval; a data collector to collect data from the lest zone in relation to each test sample; a data register to store data in relation to each test sample, in data communication with said data collector. A method of use is also described.

Abstract: Described is a method for analyzing the metabolites of a biological sample which comprises quantitatively determining one or more metabolites in said sample in a way that said quantitative determination resolves isotopic mass differences within one metabolite, said method being characterized in that the sample comprises or is derived from a cell which has been maintained under conditions allowing the uptake of an isotopically labeled metabolizable compound so that the metabolites in said cell are saturated with the isotope with which said metabolizable compound is labeled. This method may further comprise, prior to quantitative determining the metabolites, combining the biological sample (i.e. the first biological sample) with a second biological sample in which the metabolites are not isotopically labeled or are isotopically labeled differently from the first biological sample; and determining in said biological samples the relative quantity of metabolites which differ by their isotopical label.

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

Abstract: The invention provides an optical sensor, e.g a fibre optic sensor, for determining the presence or amount of an analyte in a medium, the sensor having an indicator provided in the form of a fluid. In one aspect, the sensor contains either a solution of the indicator itself, or a solution of a support material which is bonded to the indicator. Dendrimers are examples of suitable support materials.

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: 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: Devices, methods and systems effective to evaluate a physical or chemical property of a surfactant-treated biological fluid sample are provided.

Abstract: A guided structured testing kit which may include 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 includes 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: A device for detecting an analyte in a sample is provided, which comprises: a collecting chamber containing an opening for collecting a liquid sample; a detecting element for detecting an analyte in the liquid sample; and a lid for covering the opening of the collecting chamber. The device further comprises an indicating device thereon to indicate whether or not the lid covers at an appointed position. The operation of the device is very simple.

Abstract: Biological fluid samples are deposited by methods that produce a uniform layer of the sample over a reagent-containing surface. In one embodiment, a nozzle having multiple openings is used to deposit a sample over the reagent-containing surface simultaneously. In an alternative embodiment, single droplets of the sample are deposited in a pattern on the surface, preferably in a sequence of parallel lines. The reaction between the biological sample and the reagents is read from a spectrographic image of the reagent-containing surface obtained by optical methods.

Abstract: A test unit cartridge for holding a plurality of test units includes a first test unit that contains a first analyte sensor and a second test unit that contains a second analyte sensor. The first and second analyte sensors use first and second reagents to detect first and second analytes, respectively. The first analyte is different from the second analyte and the first and second test units are functionally non-fungible. The plurality of test units can also include a third test unit that contains two analyte sensors having two reagents for detecting two different analytes using one fluid sample. A method of using the test unit cartridge is also described, which comprises loading the cartridge into an analyte testing device and cocking an actuator of the device that is configured to (i) expose an analyte sensor of a test unit, (ii) ready a lancet, and (iii) advance a lancet cartridge.

Abstract: A sensor comprises respective acceptor and donor compounds immobilised in or on a matrix including a glucose-binding boronate and a cationic species, whereby the spacing between the acceptor and donor compounds is reduced in the presence of glucose. For example a holographic sensor comprises a glucose-binding boronate and a cationic species held within the sensor.

Abstract: A sensor system, and a method of detecting a target analyte, comprises a chemically functionalized block copolymer, and a target analyte. The block copolymer exhibits a color change in the visible spectrum upon exposure to the target analyte.

Abstract: A method of preparing a dry stick test device for determining an analyte in a milk sample by chemical assay. At least one reagent pad is provided by impregnating a first porous material with an aqueous solution including a reagent capable of reacting with the analyte, a derivative of the analyte or an indicator compound for the analyte to provide a detectable signal when in a moistened state. The reagent pad is dried. A development pad is provided by impregnating a second porous material with an aqueous solution including at least one controlling compound which, when in a moistened state, is capable of providing a condition required for the reagent to react with the analyte to provide the detectable signal. The impregnated second porous material is dried. The first porous material is immobilized with the second porous material, on a solid support, to obtain the dry stick test device.

Abstract: A blood glucose measurement system in which a blood glucose level measured with an invasive blood glucose measurement apparatus 101 is used to calibrate a blood glucose level measured with a non-invasive blood glucose measurement apparatus 102, comprising a controller that outputs an invasive actuation signal that starts the detection of a characteristic quantity in the body with the invasive blood glucose measurement apparatus, and a blood sampling component for collecting blood from the body on the basis of the invasive actuation signal, wherein measurement with the invasive blood glucose measurement apparatus is begun when the amount of change in the estimated blood glucose level has reached or exceeded a non-invasive blood glucose threshold.

Abstract: A process is described for the preparation of modified electrodes useful for the measurement of analytes in biological fluids, comprising the deposition of Prussian blue on screen printed electrodes, and the modified electrodes prepared via said process; the enzymatic electrodes and the biosensors comprising said modified electrodes and the method for the determination of analytes in biological fluids which uses said modified electrodes are also described.

Abstract: A method for the prevention or treatment of a condition selected from type 2 diabetes, obesity and metabolic syndrome comprising activating a GITRL pathway. Methods for screening for substances to treat these conditions, diagnosing or predicting these conditions and selecting and monitoring therapies.

Abstract: A method of detecting the presence or absence of saccharide or saccharide level in a biological or artificial sample comprising contacting the sample with a water-soluble tetraphenylethene-cored probe having multiple functionalities of boronic acid and aggregation induced emission (AIE) characteristics, and detecting fluorescence. A method for detecting pH in a sample solution with a certain pH value comprising contacting the sample solution with a water-soluble tetraphenylethene-cored probe having multiple functionalities of boronic acid and aggregation induced emission (AIE) characteristics, and detecting fluorescence.

Abstract: An analytical test element for determining an analyte in a body fluid comprises a detection area in which the analyte is detected and an application site at which the body fluid can be applied to the test element. The application site is spaced apart from the detection area, wherein at least some of the body fluid applied to the application site moves from the application site to the detection area. The test element also comprises a contamination area which at least partially adjoins the application site, wherein an adhesive substance is applied to at least part of the contamination area of the test element. The adhesive substance adheres to the contamination area of the test element and is able to interact with an excess amount of applied body fluid such that at least some of the body fluid adheres to the test element and thereby an excess amount of body fluid remains in the contamination area. An additional embodiment provides for test elements which, after use, can be stored in a storage container.

Abstract: Assays in which samples of biological fluids are dispensed onto reagent-containing porous substrates are improved in the accuracy and repeatability by dispensing the biological fluids in two or more fractions thereof, separated by intervals in which the biological fluid is not dispensed. Reagents and other fluids may be dispensed during the intervals when the biological fluid is not dispensed. Alternatively, reagents and other fluids may be dispensed in a similar manner onto substrates already containing biological fluids.

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 includes 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 includes 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: Methods, devices and a system for disease management are provided that employ diagnostic testing devices (e.g., blood glucose meters) and medication delivery devices (e.g., insulin delivery devices) for providing data to a repository in real-time and automatically. Repository data can be analyzed to determine such information as actual test strip use, patient health parameters to outside prescribed ranges, testing and medication delivery compliance, patient profiles or stakeholders to receive promotional items or incentives, and so on. Connected meters and medication delivery devices and repository data analysis are also employed to associate a diagnostic test to a mealtime based on timing of a therapeutic intervention performed by an individual.

Abstract: A test device for determining the concentration of at least one analyte in a sample using a element is proposed. The test device can be used particularly for glucose measurement, in particular blood glucose measurement, cholesterol measurement and/or coagulation measurement. The test device according to the invention comprises a housing with a closed state and an opened state, and a storage device for receiving at least one test element. The at least one test element is typically designed as a strip-shaped test element, and the storage device typically comprises a magazine. The magazine comprises a plurality of cavities, and the test elements are received substantially parallel to one another in the cavities. A measuring device and a dispensing device are also provided. The dispensing device comprises means for conveying the at least one test element from at least one storage position of the storage device during opening of the housing.

Abstract: An exemplary test strip reading and analyzing system includes a test strip unit, a mobile device and a remote computing apparatus. The test strip unit includes at least one tested-object reacting region. The mobile device includes an image capture module for capturing a test-strip image of the test strip unit and a transmission module electrically coupled to the image capture module. The remote computing apparatus, installed with a test strip analyzing system, is for analyzing the test-strip image and accordingly generating an test report. The test-strip image captured by the image capture module is transmitted to the remote computing apparatus through the transmission module; and the test report generated by the remote computing apparatus is consequently transmitted to the mobile device.

Abstract: An integrated meter system for determining information related to an analyte of a fluid sample includes a meter including a housing and a plurality of test sensors. Each of the plurality of test sensors includes a penetrating member, a testing portion, and a channel. The channel is adapted to receive the fluid sample. The test sensors are removably located within the housing. At least one of the test sensors is removably connected to an adjacent test sensor. The integrated meter system also includes a test-sensor advancement mechanism that is configured to advance the test sensors.

Abstract: A method of detecting an analyte in a fluid includes the step of positioning a sensor probe in the fluid. The sensor probe includes a sensing element which absorbs in the infrared region of the spectrum in response to the analyte. The change is then detected with a detection system.

Abstract: A medical device includes a connector which contacts a sensor to electrically connect the sensor with a measurement circuit in a medical device, a contact terminal which constitutes the connector, and a slide pin which ejects the sensor out of the medical device. The slide pin performs the operation of pushing up the contact terminal contacting the sensor as well as the operation of pushing the sensor out of the medical device. Since the contact terminal is completely lifted up by the inclined surface of the upper end part of the slide pin before the sensor is discarded, there occurs no reaction due to rebound of the contact terminal which might occur at the moment when the contact terminal of the connector is separated from the sensor, and thereby the sensor can be discarded so as to fall freely.

Abstract: The present invention relates to a method for diagnosing diabetes or a predisposition thereof, comprising determining at least one metabolite in a test sample of a subject suspected to suffer from diabetes or to have a predisposition therefor and comparing the metabolite to a reference to diagnose diabetes or a predisposition therefor. The present invention further 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. The present invention also encompasses diagnostic methods or devices comprising at least one metabolite and use of the metabolite for the manufacture of diagnostic methods and devices for diagnosing diabetes; and a method for identifying diabetes-related metabolites.