Abstract: Electrochemical measurement techniques for measuring the concentration of an analyte in a physiological fluid sample are described. More particularly, the present invention relates to techniques for distinguishing a signal caused by an extraneous event from a desired information providing signal such as one indicative of a measurement error.

Abstract: A method for distinguishing between types of electrochemical test sensors in a meter is disclosed. The method comprises the acts of providing an electrochemical test sensor comprising an enzyme and a chemical additive, contacting the test sensor to the meter to form an electrical connection, applying a potential having a magnitude sufficient to initiate a redox reaction of the chemical additive, and determining which type of electrochemical test sensor is being used based on whether a predetermined signal has been generated after the potential has been applied. The meter is adapted to determine an analyte concentration in a fluid sample.

Abstract: The system includes: an assortment (10) of sensors (10a, 10b, 10c), wherein the working electrode (14a) of each sensor is covered with a specific reagent of a given proteolytic enzyme, including a substrate capable of releasing leaving groups (LG) via the action of the enzyme; a measuring apparatus (20) having an electronic circuit imposing a current, whose intensity or voltage may or may not be variable, between the electrodes, and for receiving in return a signal representative of the release of the LG; and an electronic apparatus (30) for processing the transmitted signal and displaying, on a display screen (32), an indication representative of the release of the LG as a function of time. The system may be used to determine, in a plasma or whole blood sample, factors responsible for a coagulation anomaly.

Abstract: Polymers for use as redox mediators in electrochemical biosensors are described. The transition metal complexes attached to polymeric backbones can be used as redox mediators in enzyme based electrochemical sensors. In such instances, transition metal complexes accept electrons from, or transfer electrons to, enzymes at a high rate and also exchange electrons rapidly with the sensor. The transition metal complexes include at least one substituted or unsubstituted biimidazole ligand and may further include a second substituted or unsubstituted biimidazole ligand or a substituted or unsubstituted bipyridine or pyridylimidazole ligand.

Abstract: This invention relates to a non-destructive means to determine electrochemical characteristics in biosensor test strips, including first applying a cyclic oxidative and reductive electric potential onto the inspection pads connecting to the reference electrode and working electrode, on which lies a drop of enzyme reagent solution, to homogenize the electrochemical characteristics of the biosensor test strips, and then applying an inspection electric potential within a short period of time over the inspection pads connecting to the reference electrode and working electrode to measure its electrical resistance to identify any abnormal biosensor test strips if present. Afterwards, embodiments of the present invention applies a reverse electric potential, having the same time interval as the inspection electric potential, onto the inspection pads connecting to the reference electrode and working electrode to prevent degradation on mediators such as potassium ferricyanide.

Abstract: Disclosed is a biosensor capable of measuring a total concentration of plural types of amino acids. An amino-acid biosensor (200) for measuring a total concentration of a plurality of specific amino acids, comprises a measuring electrode (202) which includes as components a mediator and an enzyme which selectively act on the plurality of specific amino acids each serving as a substrate, and a counter electrode (203). The enzyme has a substrate affinity to each of the plurality of specific amino acids. The enzyme is operable to catalyze a reaction in each of the plurality of specific amino acids as a substrate so as to form a reaction product, and the mediator is operable, during amino-acid concentration measurement, to carry electrons between the reaction product and the measuring electrode.

Abstract: The invention relates to sensors configured to include compositions disposed in specific regions of the sensor in order to provide the sensors with enhanced functional properties, for example faster start-up times. These compositions include, for example, hygroscopic compositions, gas generating compositions and gas solvating compositions. While typical embodiments of the invention pertain to glucose sensors, the systems, methods and materials disclosed herein can be adapted for use with a wide variety of sensors known in the art.

Abstract: The present invention relates to an analytical tool 1 which includes a flow path for moving a sample, and a working electrode 15 and a counter electrode 16 including active portions 15c, 16c, 16d for coming into contact with the sample supplied to the flow path and which is mounted in use to an analytical apparatus. The active portions 16c, 16d of the counter electrode 16 include a first active portion 16c and a second active portion 16d divided within the flow path. The working electrode 15 and the counter electrode 16 include contact ends 15a, 16a for coming into contact with terminals of an analytical apparatus when the analytical tool 1 is mounted to the analytical apparatus. At least one of the working electrode 15 and the counter electrode 16 includes a first electrode portion 16B which includes the contact end 16a and the first active portion 16c and a second electrode portion 16C which includes the second active portion 16d.

Abstract: A disposable biosensor having improved long term storage stability including a working electrode and a reference electrode formed on an insulating substrate and a dissolvable reagent layer composition disposed directly on the working electrode where the reagent layer composition contains a glucose-based enzyme, a reagent component selected from a phosphate buffer and a tris reagent, and a redox mediator.

Abstract: A sensor utilizing a non-leachable or diffusible redox mediator is described. The sensor includes a sample chamber to hold a sample in electrolytic contact with a working electrode, and in at least some instances, the sensor also contains a non-leachable or a diffusible second electron transfer agent. The sensor and/or the methods used produce a sensor signal in response to the analyte that can be distinguished from a background signal caused by the mediator. The invention can be used to determine the concentration of a biomolecule, such as glucose or lactate, in a biological fluid, such as blood or serum, using techniques such as coulometry, amperometry; and potentiometry. An enzyme capable of catalyzing the electrooxidation or electroreduction of the biomolecule is typically provided as a second electron transfer agent.

Abstract: Described herein are reagent compositions for detecting and/or measuring analytes in a test sample. In one embodiment, reagent compositions are described for detecting and/or measuring glucose in a sample.

Abstract: An electrochemical glucose biosensor comprising two electrodes with at least one of electrodes having both a metallic layer and a non-metallic layer in direct contact with the metallic layer. The metallic layer is comprised of a noble metal element. A glucose reactive strip connects the first electrode and the second electrode.

Abstract: A porous electroconductive material is provided. The electroconductive material enables efficient enzymatic metabolic reactions on electrodes and yields electrodes having immobilized enzymes thereon which remain stable in any working environment. The porous electroconductive material, which has a three-dimensional network structure, is formed from a skeleton of porous material and a carbonaceous material covering the surface of the skeleton. The porous material constituting the skeleton is foamed metal or alloy. This porous electroconductive material is made into an electrode, and enzymes are immobilized on this electrode. The resulting electrode with immobilized enzymes thereon is used as the anode of a bio-fuel cell.

Abstract: The invention relates to a biosensor comprising an electrically conductive substrate, with a first layer comprising Ruthenium Purple formed on the substrate, a second layer comprising polyaniline or a derivative thereof comprising one or more non-polar substituents formed on the first layer, and a third layer comprising one or more enzymes trapped within a matrix formed on the second layer. The biosensor is for use in the detection of analytes such as purines and derivatives thereof, particularly in the detection of hypoxanthine.

Abstract: Devices and methods for determining the concentration of an analyte in a sample of liquid are provided.

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 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 biosensor comprises a space part for sucking and housing a sample formed of two upper and lower plates, the two plates being stuck together by an adhesive layer, the space part for sucking and housing the sample being constituted so as to be partially opened in the peripheral part and partially closed by the adhesive layer, and has a working electrode having at least glucose oxidase immobilized thereon and a counter electrode on the same plane of the plate.

Abstract: The disclosure provides for reagent compositions for biosensors comprising release polymers, methods of making such biosensors and films of reagent compositions comprising release polymers. The reagent compositions comprise a release polymer and an effective analyte detecting amount of an enzyme an enzyme cofactor and a redox compound capable of acting in a biosensor as (i) a redox mediator associated with a working electrode (ii) a redox couple associated with a reference electrode or (iii) the redox mediator associated with the working electrode and the redox couple for the reference electrode.

Abstract: An electrochemical test strip, an electrochemical test system, and a measurement method using the same are provided. The electrochemical test strip includes an insulating substrate, an electrode system formed on the insulating substrate, and an insulating layer formed on the electrode system. The electrode system includes a set of measurement electrodes, a set of identifying electrodes, and a resistive path having a predetermined resistance value. The set of identifying electrodes is made of metal material, and the resistive path is made of non-metal material. The set of measurement electrodes includes a reference electrode and a working electrode insulated from each other, and the set of identifying electrodes includes a first identifying electrode and a second identifying electrode connected with each other through the resistive path.

Abstract: The invention provides an enzyme ink useful in test strips that provides a test strip bias, at the low and high glucose ends, falling within a desired target range. The ink of the invention permits an improved method for the production of single calibration code strip lots with good yields.

Abstract: A remote measurement system measures the concentrations of analytes in fluid samples. The system includes a metering device that can receive signals from a test strip or alternatively interrogate the test strip to obtain information. The test strip includes an area for receiving a fluid sample and electrochemically producing a current response that is sensed within the fluid sample. The test strip also includes an antenna and a radio frequency signal circuit for transmitting a signal indicative of the current response of a fluid sample to be analyzed. The metering device receives the signal and can convert it into a readable display in some embodiments. Remote electrochemical analysis of a fluid sample is thereby obtained.

Abstract: A biosensor includes a working electrode 101, a counter electrode 102 opposing the working electrode 101, a working electrode terminal 103 and a working electrode reference terminal 10 connected to the working electrode 101 by wires, and a counter electrode terminal 104 connected to the counter electrode 102 by a wire. By employing a structure with at least three electrodes, it is possible to assay a target substance without being influenced by the line resistance on the working electrode side.

Abstract: A method and system is provided to allow for determination of substantially Hematocrit independent analyte concentration. In one example, an analyte measurement system is provided that includes a test strip and a test meter. The test strip includes a reference electrode and a working electrode, in which the working electrode is coated with a reagent layer. The test meter includes an electronic circuit and a signal processor. The electronic circuit applies a plurality of voltages to the reference electrode and the working electrode over respective durations. The signal processor is configured to determine a substantially hematocrit-independent concentration of the analyte from a plurality of current values as measured by the processor upon application of a plurality of test voltages to the reference and working electrodes over a plurality of durations interspersed with rest voltages lower than the test voltages being applied to the electrodes.

Abstract: A sensor utilizing a non-leachable or diffusible redox mediator is described. The sensor includes a sample chamber to hold a sample in electrolytic contact with a working electrode, and in at least some instances, the sensor also contains a non-leachable or a diffusible second electron transfer agent. The sensor and/or the methods used produce a sensor signal in response to the analyte that can be distinguished from a background signal caused by the mediator. The invention can be used to determine the concentration of a biomolecule, such as glucose or lactate, in a biological fluid, such as blood or serum, using techniques such as coulometry, amperometry, and potentiometry. An enzyme capable of catalyzing the electrooxidation or electroreduction of the biomolecule is typically provided as a second electron transfer agent.

Abstract: The present invention relates to an analyzer (1) to be used with an analytical tool (2) mounted thereto and used for analyzing a particular component contained in a sample supplied to the analytical tool (2). The analyzer (1) includes at least one detection terminal pair (11, 12) including a first and a second detection terminals (11A, 11B, 12A, 12B) which are capable of selecting a mutually contacting state and a non-contacting state, a detector (15) for detecting the state of contact of the first and the second detection terminals (11A, 11B, 12A, 12B), and an abnormality detector (16) for detecting an abnormality of the at least one detection terminal pair (11, 12) based on the detection result by the detector (15).

Abstract: An electrochemical cell for detection and quantification of analytes in a liquid sample, particularly a liquid sample having a small volume. In a preferred embodiment, the electrochemical cell comprises an assembly of conducting layers and insulating layers. The electrochemical cell can be formed by depositing conducting materials and insulating materials in alternating layers on an insulating substrate. It is preferred that the layer furthest from the insulating substrate be an insulating layer to minimize the damage of the conducting layers during handling of the electrochemical cell. In another embodiment, the assembly of conducting layers and insulating layers can be formed on both major surfaces of the insulating substrate. The assembly can comprise at least one working electrode and at least one other electrode, e.g., a dual-purpose reference/counter electrode.

Abstract: Generally, embodiments of the present disclosure relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have improved uniformity of distribution of the sensing layer by inclusion of a high-boiling point solvent, where the sensing layer is disposed proximate to a working electrode of in vivo and/or in vitro analyte sensors, e.g., continuous and/or automatic in vivo monitoring using analyte sensors and/or test strips. Also provided are systems and methods of using the, for example electrochemical, analyte sensors in analyte monitoring.

Abstract: A biosensor is disclosed comprising a support; a conductive layer composed of an electrical conductive material such as a noble metal, for example gold or palladium, and carbon; slits parallel to and perpendicular to the side of the support; working, counter, and detecting electrodes; a spacer which covers the working, counter, and detecting electrodes on the support; a rectangular cutout in the spacer forming a specimen supply path; an inlet to the specimen supply path; a reagent layer formed by applying a reagent containing an enzyme to the working, counter, and detecting electrodes, which are exposed through the cutout in the spacer; and a cover over the spacer. The biosensor can be formed by a simple method, and provides a uniform reagent layer on the electrodes regardless of the reagent composition.

Abstract: Point-of-care tools for screening biological samples for markers associated with pathogenic microbial infections. In particular, devices and systems for screening cervical cells for the expression of proteins, which occur as a result of human papillomavirus infection and progression to invasive cervical cancer.

Abstract: A sample measurement device (110), in which a biosensor (30) having an electrode is mounted, voltage is applied to the electrode, and the concentration of a specific component in a sample deposited on the biosensor (30) is measured, comprises a voltage source (19) configured to apply voltage to the electrode, a time measurement component (22), and a controller (18) configured to control the voltage to be applied and measure the concentration of the specific component. The time measurement component (22) measures a detection time, which is the length of time between the mounting of the biosensor (30) and the deposition of a sample on the biosensor (30). The controller (18) changes a set value for measuring the concentration of a specific component according to the detection time. Consequently, measurement accuracy can be improved regardless of the temperature of the biosensor (30).

Abstract: Analytes in a liquid sample are determined by methods utilizing sample volumes of less than about 1.0 ?l and test times within about eight seconds. The methods are preferably performed using small test strips including a sample receiving chamber filled with the sample by capillary action.

Abstract: Analytes in a liquid sample are determined by methods utilizing sample volumes of less than about 1.0 ?l and test times within about nine seconds. The methods are preferably performed using small test strips including a sample receiving chamber filled with the sample by capillary action.

Abstract: Novel transition metal complexes of iron, cobalt, ruthenium, osmium, and vanadium are described. The transition metal complexes can be used as redox mediators in enzyme-based electrochemical sensors. The transition metal complexes include substituted or unsubstituted (pyridyl)imidazole ligands. Transition metal complexes attached to polymeric backbones are also described.

Abstract: Analytes in a liquid sample are determined by methods utilizing sample volumes of less than about 1.0 ?l and test times within about six seconds. The methods are preferably performed using small test strips including a sample receiving chamber filled with the sample by capillary action.

Abstract: Embodiments of the invention provide devices and methods for extracting nucleic acid molecules from solution using electric fields. The structures and methods of embodiments of the invention are suited to incorporation into micro and nano fluidic devices, such as lab-on-a-chip devices and micro total analysis systems.

Abstract: The present invention provides an electrochemical sensor having a sensing chemistry that operates substantially free of any “oxygen effect”. The electrochemical sensors are useful in determining the level of an analyte in a biological sample from a subject. The present invention also provides sensor assemblies including the electrochemical sensors as well as methods of using the same.

Abstract: The disclosure provides for reagent compositions for biosensors comprising release polymers, methods of making such biosensors and films of reagent compositions comprising release polymers. The reagent compositions comprise a release polymer and an effective analyte detecting amount of an enzyme an enzyme cofactor and a redox compound capable of acting in a biosensor as (i) a redox mediator associated with a working electrode (ii) a redox couple associated with a reference electrode or (iii) the redox mediator associated with the working electrode and the redox couple for the reference electrode.

Abstract: A biosensor strip having a low profile for reducing the volume of liquid sample needed to perform an assay. In one embodiment, the biosensor strip includes an electrode support; an electrode arrangement on the electrode support; a cover; a sample chamber; and an incompressible element placed between the cover and the electrode support, the incompressible element providing an opening in at least one side or in the distal end of the sample chamber to provide at least one vent in the sample chamber. In another embodiment, the biosensor strip has an electrode support; an electrode arrangement on the electrode support; a cover; and a sample chamber, the cover having a plurality of openings formed therein, at least one of the openings in register with the sample chamber. The invention further includes methods for preparing such a biosensor strips in a continuous manner.

Abstract: A method for operating a measuring meter for an electrochemical test strip is provided. The method comprises steps of applying a voltage to electrodes of the test strip at least during one of a sample presence detection period and an incubation period; and repeatedly increasing and decreasing the voltage during at least one of the sample presence detection period and the incubation period.

Abstract: The present invention is based on the discovery of NAD+ and NADP+ mediator compounds that do not bind irreversibly to thiol groups in the active sites of intracellular dehydrogenase enzymes. Such mediator compounds avoid a common mode of enzyme inhibition. The mediators can therefore increase the stability and reliability of the electrical response in amperometric electrodes constructed from NAD- or NADP-dependent enzymes.

Abstract: Devices and methods for determining the concentration of an analyte in a sample of liquid are provided.

Abstract: A method for distinguishing between types of electrochemical test sensors in a meter is disclosed. The method comprises the acts of providing an electrochemical test sensor comprising an enzyme and a chemical additive, contacting the test sensor to the meter to form an electrical connection, applying a potential having a magnitude sufficient to initiate a redox reaction of the chemical additive, and determining which type of electrochemical test sensor is being used based on whether a predetermined signal has been generated after the potential has been applied. The meter is adapted to determine an analyte concentration in a fluid sample.

Abstract: A method for the determination of the amount of cholesterol in a sample is provided. The method typically provides a breakdown of the HDL and LDL cholesterol contents of the sample.

Abstract: A BUN (blood urea nitrogen) sensor containing immobilized carbonic anhydrase and immobilized urease for the in vitro detection of urea nitrogen in blood and biological samples with improved performance and precision characteristics.

Abstract: Novel transition metal complexes of iron, cobalt, ruthenium, osmium, and vanadium are described. The transition metal complexes can be used as redox mediators in enzyme based electrochemical sensors. In such instances, transition metal complexes accept electrons from, or transfer electrons to, enzymes at a high rate and also exchange electrons rapidly with the sensor. The transition metal complexes include at least one substituted or unsubstituted biimidazole ligand and may further include a second substituted or unsubstituted biimidazole ligand or a substituted or unsubstituted bipyridine or pyridylimidazole ligand. Transition metal complexes attached to polymeric backbones are also described.

Abstract: The present invention provides reagent compositions, and analyte measuring devices and methods that utilize the reagent compositions.

Abstract: A biosensor according to the present invention comprises a support 1, a conductive layer 2 composed of an electrical conductive material such as noble metal, for example gold, palladium or the like, and carbon, slits 3a and 3b parallel to the side of the support 1, slits 4a and 4b vertical to the side of the support 1, a working electrode 5, a counter electrode 6, a detecting electrode 7, a spacer 8 which covers the working electrode 5, the counter electrode 6 and the detecting electrode 7 on the support 1, a rectangular cutout part 9 forming a specimen supply path, an inlet 9a of the specimen supply path, a reagent layer 12 formed by applying a reagent including an enzyme or the like to the working electrode 5, the counter electrode 6 and the detecting electrode 7, which is exposed from the cutout part 9 of the spacer 8, and a cover 13 which covers the spacer 8, as shown in FIG. 1.

Abstract: An integrated lancing and measurement device is provided comprising a sensor designed to determine the amount and/or concentration of analyte in a biological fluid having a volume of less than about 1 ?L. A piercing member is adapted to pierce and retract from a site on the patient to cause the fluid to flow therefrom, and the sensor is positioned adjacent to the site on the patient so as to receive the fluid flowing from the site to generate an electrical signal indicative of the concentration of the analyte in the fluid. The sensor is comprised of a working electrode comprising an analyte-responsive enzyme and a redox mediator, and a counter electrode. An analyte monitor is operatively connected to the sensor and adapted to measure the signal generated by the sensor. Also provided are analyte measuring methods that optionally employ the integrated lancing and measurement device.

Abstract: This invention relates to a biosensor and more particularly to an electrochemical biosensor for determining the concentration of an analyte in a carrier. The invention is particularly useful for determining the concentration of glucose in blood and is described herein with reference to that use but it should be understood that the invention is applicable to other analytic determinations.