Abstract: An electrochemical test sensor includes a lid and a base. The base has a length and a width. The length of the base is greater than the width of the base. The base includes at least a working electrode, a counter electrode and at least three test-sensor contacts for electrically connecting to a meter. The at least three test-sensor contacts are spaced along the length of the base from each other. The base and the lid assist in forming a fluid chamber for receiving the fluid sample. The electrochemical test sensor further includes a reagent to assist in determining the concentration of the analyte in the fluid sample.

Abstract: The present invention discloses a biosensor for quantitatively analyzing a bio-material and a manufacturing method thereof. The biosensor has an exposed conductive region of a few-nanometer scale distributed on an insulated metallic substrate in a desired pattern or randomly. The quantitative analysis of protein can be carried out by means of simplified procedures, without the necessity of rinsing out a signal-producing material, which is non-specifically bonded to the materials to be analyzed. The biosensor utilizes only the size of the molecules, and thus can be universally used for the analysis of bio-materials. A selective and separate analysis can be realized in which interference caused by other materials is significantly reduced.

Abstract: A disposable urea sensor has a laminated body having a fluid sample inlet end and an electrical contact end, a fluid sample inlet, a substantially flat sample chamber in communication between the fluid sample inlet and a vent opening, the sample chamber being adapted to collect a fluid sample through the fluid sample inlet, a working electrode and a reference electrode within the sample chamber, and a reagent matrix disposed on the working electrode wherein the reagent matrix contains urease.

Abstract: The present invention is directed to a method and apparatus for an immunoassay technique that uses amperometric measurements to rapidly analyze different pathogenic microorganisms, including bacteria, viruses, toxins, and parasites. A conductive membrane is used to provide support for antibody immobilization and serve as a working electrode. The proposed technique is adaptable for use with different materials so as to form a membrane having a pore size that is suited to the particular application. A compact and simple disposable element can be used. The immunoassay can be automated using microprocessor control so as to reduce the amount of human intervention in sample analysis.

Abstract: A test meter for use with a dual-chamber, multi-analyte test strip includes a test strip receiving module and a signal processing module. The test strip receiving module has a first electrical connector configured for contacting a first analyte contact pad of a first working electrode of the test strip; a second electrical connector configured for contacting a second analyte contact pad of a second working electrode of the test strip, a third electrical connector configured for contacting a first counter/reference contact pad of a first counter/reference electrode layer of the test strip, and a fourth electrical connector configured for contacting a second counter/reference contact pad of a second counter/reference electrode layer of the test strip.

Abstract: The present invention relates to an analytical tool (X) which includes a substrate (1), a flow path for moving a sample along the substrate (1), a reagent portion (14) provided in the flow path, and an insulating film (13) covering the substrate (1) and including an opening (15a) for defining a region for forming the reagent portion (14). The insulating film (13) further includes at least one additional opening (15b) positioned in a longitudinal direction (N1) relative to the opening (15a). For instance, the flow path is configured to move the sample by capillary force.

Abstract: An electrochemical test sensor for detecting the analyte concentration of a fluid test sample includes a base, a dielectric layer, a reagent layer and a lid. The base provides a flow path for the test sample having on its surface a counter electrode and a working electrode adapted to electrically communicate with a detector of electrical current. The dielectric layer forms a dielectric window therethrough. The reagent layer includes an enzyme that is adapted to react with the analyte. The lid is adapted to mate with the base and to assist in forming a capillary space with an opening for the introduction of the test sample thereto. At least a portion of the width of the counter electrode is greater than the width of the working electrode.

Abstract: A disposable urea sensor has a laminated body having a fluid sample inlet end and an electrical contact end, a fluid sample inlet, a substantially flat sample chamber in communication between the fluid sample inlet and a vent opening, the sample chamber being adapted to collect a fluid sample through the fluid sample inlet, a working electrode and a reference electrode within the sample chamber, and a reagent matrix disposed on the working electrode wherein the reagent matrix contains urease.

Abstract: An electrochemical test device is provided having a base layer with a first electrode thereon and a top layer with a second electrode thereon. The two electrodes are separated by a spacer layer having an opening therein, such that a sample-receiving space is defined with one electrode on the top surface, the other electrodes on the bottom surface and side walls formed from edges of the opening in the spacer. Reagents for performing the electrochemical reaction are deposited on one of the electrodes and on the side walls of the sample-receiving space.

Abstract: An electrochemical-based analytical test strip for the determination of an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) and/or a characteristic of the bodily fluid sample (for example, hematocrit) includes a first sample-receiving chamber with first and second sample-application openings, and first and second electrodes. The first and second electrodes are disposed in the first sample-receiving chamber between the first and second sample-application openings. The electrochemical-based analytical test strip also includes a second sample-receiving chamber and a plurality of electrodes disposed in the second sample-receiving chamber. In addition, the second sample-receiving chamber intersects the first sample-receiving chamber between the first and second electrodes, thereby defining a chamber intersection.

Abstract: An analytical test strip for the determination of an analyte (such as glucose) in a bodily fluid sample (e.g., a whole blood sample) includes a first and second capillary sample-receiving chambers and first and second stop junctions that are disposed between the first and second capillary sample-receiving chambers. The first stop junction defines a discontinuity boundary of the first capillary sample-receiving chamber and the second stop junction defines a discontinuity boundary of the second capillary sample-receiving chamber. In addition, the first stop junction and the second stop junction are disposed such that bodily fluid sample flow between the first capillary sample-receiving chamber and the second capillary sample-receiving chamber during use of the analytical test strip is prevented.

Abstract: An analytical test strip for the determination of an analyte (such as glucose and/or hematocrit) in a bodily fluid sample (such as a whole blood sample) includes a first capillary sample-receiving chamber, a second capillary sample-receiving chamber, and a physical barrier island disposed between the first and second capillary sample-receiving chambers. Moreover, the physical island barrier is disposed such that bodily fluid sample flow between the first capillary sample-receiving chamber and the second capillary sample-receiving chamber is prevented during use of the analytical test strip.

Abstract: Devices and methods are provided for determining the concentration of a reduced form of a redox species. For example, a device can include a working electrode and a counter electrode spaced by a predetermined distance so that reaction produces from the counter electrode arrive at the working electrode. An electric potential difference can be applied between the electrodes, and the potential of the working electrode can be selected such that the rate of electro-oxidation of the reduced form of the species is diffusion controlled. Current as a function of time can be determined, the magnitude of the steady state current can be estimated, and a value indicative of the diffusion coefficient and/or of the concentration of the reduced form of the species can be obtained from the change in current with time and the magnitude of the steady state current. Other embodiments of apparatuses, devices, and methods are also provided.

Abstract: An electrochemical detection system having a disposable cartridge capable of performing a plurality of assay protocols is disclosed. The cartridge includes a blister pack for the long-term storage and controlled release of multiple reagents. The blister pack is bonded to and operatively associated with a fluidic backbone for providing the fluid pathways, storage capacity, and fluid control functions for performing multiple assay protocols. The cartridge further includes a plurality of sensors having a multiple electrode arrangement in operative association with a respective flow cell defined by the fluidic backbone. After the user has transferred a sample into the cartridge and engaged the cartridge to the reader, the reader operatively interfaces with the cartridge such that different assay protocols may be simultaneously performed in isolation from one another inside the cartridge. The reader may be one of many readers that operatively communicate data to a remote server for processing.

Abstract: This invention relates generally to test devices and methods for performing optical and electrochemical assays and, more particularly, to test devices having the ability to perform optical and electrochemical assays on a sample and to methods of performing optical and electrochemical assays using such test devices. The present invention is particularly useful for performing immunoassays and/or electrochemical assays at the point-of-care.

Abstract: This invention relates generally to devices and methods for performing optical and electrochemical assays and, more particularly, to devices having optical and electrochemical detectors and to methods of performing optical and electrochemical assays using such devices. The present invention is particularly useful for performing immunoassays and/or electrochemical assays at the point-of-care.

Abstract: A method of determining concentrations of a plurality of analytes from a single blood sample placed in a single opening. A portion of the single blood sample is absorbed by a test matrix that includes a plurality of layers and a chromogenic agent. A colored response is generated by the test matrix. The colored response is proportional to the concentration of a first analyte. A portion of the single blood sample is drawn into a capillary tube and placed in contact with an electrode and a counter-electrode. An electrical property of the single blood sample is analyzed through the electrode and counter-electrode. The electrical property is proportional to the concentration of a second analyte in the single blood sample.

Abstract: The present invention relates to an analytical tool (X1) to be mounted to an analytical apparatus (1) which includes a plurality of terminals (11, 12) and an analysis circuit (13). The analytical tool includes a plurality of electrodes (21, 22) coming into contact with the plurality of terminals (11, 12) when mounted to the analytical apparatus (1). In the analytical tool (X1), at least one (12) of the electrodes (21, 22) serves as a disturbing-noise countermeasure electrode to which disturbing noise is more likely to come in comparison with the other electrodes (11) than the above-mentioned electrode (12).

Abstract: The present disclosure relates to an in vitro medical diagnostic device that includes a removable calibration fluid cartridge. The device also includes a removable assay cartridge containing a polymer body with channels for fluid movement.

Abstract: Electrochemical blood test strips and diagnosis systems are presented. An electrochemical blood test strip for measuring HCT % and prothrombin time includes an electrode plate having electrode circuit patterns on an insulator substrate; a separation plate disposed on the electrode plate defining a blood sample region, a channel and three reaction regions; and a cover plate disposed on the separation plate having a blood sample inlet and vents. In measuring, one of the three reaction regions is used for detecting hemoglobin and hematocrit and the other two reaction regions are biochemical reaction regions and used for detecting prothrombin time.

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 particle detection device (10) included substrates (1, 4), insulating members (2, 3), supporting member (5), and electrodes (6, 7). The insulating member (2) is provided on a principal surface of the substrate (1) and has a recess. The insulating member (3) is provided so as to make contact with the insulating member (3) and the substrate (4). The substrate (4) is formed on a principal surface of the supporting member (5). The electrode (6) is formed on a surface, which is opposite to the surface where the insulating member (2) is formed, of the substrate (1). The electrode (7) is formed on the surface (5A), the side surface (5B), and the rear surface (5C) of the supporting member (5) so as to be connected to the substrate (4). Accordingly, the detection device 10 includes a gap (8) surrounded by the insulating members (2, 3). The substrate (1) is connected to the substrate (4) with the insulating members (2, 3) and the supporting member (5) (quartz).

Abstract: This invention discloses a biosensor test strip that comprises a substrate, on which lies a conductive layer that contains a plurality of contact pads, check pads and reaction zones, which contains a plurality of working and reference electrodes, and on which the reaction reagent is deposited. The first contact pad is connected to the working electrode, while the second contact pad is connected to the reference electrode. Furthermore, this invention discloses a biosensor test strip for multiple tests on a single strip. The biosensor test strip includes a substrate with a plurality of incisions to divide the substrate into a plurality of individual test sections.

Abstract: Sensors include nano-porous alumina membranes that are sensitized by immobilization of antibodies in the nano-pores. The nano-membranes can be sensitized to respond to a single target compound, or different portions of the nano-membrane can be differently sensitized. Capture of the target compound can be detected based on a spectral signature associated with electrical conductance in the nano-pores.

Abstract: The present invention provides a class of sensors prepared from regions of conducting organic materials and conducting materials that show an increase sensitivity detection limit for amines. The present class of sensors have applications in the detection of spoiled food products and in testing for diseases, such as cholera and lung cancer, which have amines as biomarkers.

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: Multi-well plates having contoured well designs allow multi-stage high throughput parallel assaying of ion channels or ion transporters. A well of a multi-well plate has a bottom region that is sized and shaped to simultaneous accommodate a sensing electrode and a pipette for delivering, e.g., test compounds, wash fluid, and optionally ligands. Such multi-well plates may be coupled with an instrument having a pipette head and an electrode plate. Such arrangement facilitates fluidic contact between cells and fluids provided via a pipette. It also facilitates washing of wells with buffers or other wash solutions to allow serial exposure of test cells to various reagents or other stimuli. Generally, the design allows control and test experiments to be performed on the same cell (or cells) in a single well.

Abstract: A system for operating at least first and second amperometric sensors includes a cartridge and a control device. The cartridge includes a first amperometric sensor and a second amperometric sensor. The first amperometric sensor is in fluid flow communication with a liquid sample inlet and includes a first electrode. The second amperometric sensor is in fluid flow communication with a liquid sample and includes a second electrode. The control device sets the first and second electrodes to about the same potential such that the first and second amperometric sensors can be operated simultaneously.

Abstract: A dual chamber, multi-analyte test strip has a first insulating layer, a first electrically conductive layer, with a first working electrode, disposed on the first insulating layer and a first patterned spacer layer positioned above the first electrically conductive layer. The first patterned spacer layer has a first sample-receiving chamber, with first and second end openings, defined therein that overlies the first working electrode. The test strip also includes a first counter/reference electrode layer that is exposed to the first sample receiving chamber and is in an opposing relationship to the first working electrode. The test strip further includes a counter/reference insulating layer disposed over the first counter/reference electrode layer and a second counter/reference electrode layer disposed on the counter/reference substrate. Also included in the test strip is a second patterned spacer layer that is positioned above the second counter/reference electrode layer.

Abstract: Electrochemical transducer arrays are already known from the prior art. According to the invention, the transducer array is provided with at least one flexible, planar metal substrate on which at least one flexible insulator having a firm connection between the metal surface and the insulator surface is disposed. The metal substrate and the insulator disposed thereon are structured in such a manner as to give metal areas which are electrically insulated the one from the other and which serve as sensor areas. The metal substrate used is self-contained so that the structured metal areas can be contacted from the lower side.

Abstract: A liquid sample measurement apparatus of the present invention is provided with a timer for measuring the time from when a biosensor is attached to a liquid sample measurement device which measures the concentration of a specific component in a liquid sample that is applied to the biosensor to when the liquid sample is applied to the biosensor, and correction based on the time measured by the timer is performed to the measurement result of the concentration of the specific component in the liquid sample that is applied to the biosensor. Thereby, the measurement precision can be enhanced with utilizing the correction algorithm in which the ambient temperature and the temperature of the biosensor itself are considered.

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: Electrochemical test cells are made with precision and accuracy by adhering an electrically resistive sheet having a bound opening to a first electrically conductive sheet. A notching opening is then punched through the electrically resistive sheet and the first electrically conductive sheet. The notching opening intersects the first bound opening in the electrically resistive sheet, and transforms the first bound opening into a notch in the electrically resistive sheet. A second electrically conductive sheet is punched to have a notching opening corresponding to that of first electrically conductive sheet, and this is adhered to the other side of the electrically resistive sheet such that the notching openings are aligned. This structure is cleaved from surrounding material to form an electrochemical cell that has a sample space for receiving a sample defined by the first and second conductive sheets and the notch in the electrically resistive sheet.

Abstract: A blood test apparatus has a housing with an opening, and a plunger that moves back and forth inside the housing, the plunger having a projecting member. A fixing member fixes the plunger, which is provided in the housing. A blood sampling cartridge, in which a blood sensor, a puncturer, and a holder that holds the blood sensor and the puncturer, are integrated. The blood sampling cartridge is removably attached to the opening. The puncturer includes a lancet, one end of which is held by the plunger, and a blood collection needle attached to an other end of the lancet. A measuring circuit measures a signal obtained from the blood sensor to analyze components in the blood.

Abstract: A biosensor system determines an analyte concentration using one or more calibrated correlation equations for an optical and/or electrochemical analysis of a biological fluid. The biosensor system may be implemented using a measurement device and a sensor strip. The measurement device senses circuit patterns on an encoding pattern of the sensor strip. The measurement device determines calibration information in response to the circuit patterns, and uses the calibration information to calibrate one or more of the correlation equations. The measurement device uses the calibrated correlation equations to determine the analyte concentration.

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: A method of producing a biomaterial measuring device is disclosed. The method includes forming a plurality of reactions elements, to which an assay reagent is applied, on a first substrate, cutting the resulting first substrate in a unit of individual reaction element, and attaching a first substrate piece, which is formed by cutting the resulting first substrate in the unit of individual reaction element, to a predetermined portion of a second substrate. In the biomaterial measuring device, since a material cost in minimized and it is easy to automate production, it is possible to reduce a production, it is possible to reduce a production cost.

Abstract: An electrochemical sensor system that continuously monitors and calibrates the sensors included in the system. The invention also includes a method for determining failure patterns of a sensor and incorporating into an electrochemical sensor system the ability to recognize the failure pattern and initiate remedial action.

Abstract: A diagnostic multi-layer dry phase test strip with integrated biosensors for use in measuring more than one analyte in a fluid sample includes a body having a port for introducing a fluid sample. Within the body is a spreader layer configured to evenly spread the fluid sample received through the port. The test strip further includes at least one enzyme reaction layer in fluidic communication with the spreader layer. The test strip also includes a first electrode layer in fluidic communication with the at least one enzyme reaction layer. The first electrode layer includes a set of electrodes for each of the at least one enzyme reaction layer. Each set of electrodes is capable of electrically interacting with the fluid sample.

Abstract: Methods for determining a concentration of an analyte in a sample, and the devices and systems used in conjunction with the same, are provided herein. In one exemplary embodiment of a method for determining a concentration of an analyte in a sample, a sample including an analyte is provided in a sample analyzing device having a working and a counter electrode. An electric potential is applied between the electrodes and a fill time of the sample into the device is calculated. A concentration of the analyte in view of fill time can then be determined. Systems and devices that take advantage of the fill time to make analyte concentration determinations are also provided.

Abstract: A method for determining a concentration of an analyte is disclosed. The method includes applying a potential excitation to a fluid sample containing an analyte and determining if a current decay curve associated with the fluid sample has entered an analyte depletion stage. The method also includes measuring a plurality of current values associated with the fluid sample during the analyte depletion stage and calculating an analyte concentration based on at least one of the plurality of current values.

Abstract: A hollow electrochemical cell is provided. In one exemplary embodiment, a hollow electrochemical cell includes two sets of electrodes and an opening for admitting an analyte to the cell. At least one of the two sets of electrodes can be in fluid communication with the opening. Further, a first set of electrodes can include a working electrode spaced from a counter or counter/reference electrode by less than 500 ?m one embodiment the working and counter or counter/reference electrodes are not co-planer. In another embodiment the working and counter or counter/reference electrodes are of substantially corresponding area. In yet another embodiment the working and counter or counter/reference electrodes are spaced from 100 to 200 ?m apart. The first set of electrodes and the second set of electrodes can be spaced apart by greater than about 500 ?m. Other embodiments of a hollow electrochemical cell are also provided, as are several embodiments of a glucose sensor.

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: This invention is a method for determining a concentration of an analyte. The steps include applying a potential excitation to a fluid sample containing an analyte, and measuring a current associated with the potential excitation at a plurality of time-points. The method also includes calculating an analyte concentration based on the measured current and a calibration curve, wherein the calibration curve is selected from a plurality of calibration curves and each calibration curve is associated with a time-segment selected from a plurality of time-segments.

Abstract: A method of forming an electrochemical multilayer test sensor that includes a base, a second layer and a reactive layer. The reactive area includes an enzyme. The test sensor is adapted to be used in a meter and assist in determining the concentration of an analyte. A plurality of electrodes and their respective conductive leads are partially defined on the base. After partially defining the plurality of electrodes and their respective conductive leads on the base, the base is attached to a second layer to define a reaction zone in which the plurality of electrodes are fully defined. After attaching the base to the second layer, the plurality of conductive leads on the base of the test sensor are fully defined.

Abstract: Analyte meter protectors, meters that include the same, and methods. In one example, a ketone monitoring system is provided wherein a port protector is used in combination with a meter.

Abstract: A biosensor containing ruthenium, measurement using the same, and the application thereof. The biosensor comprises an extended gate field effect transistor (EGFET) structure, including a metal oxide semiconductor field effect transistor (MOSFET), a sensing unit comprising a substrate, a layer comprising ruthenium on the substrate, and a metal wire connecting the MOSFET and the sensing unit.

Abstract: Method and systems provide improved cell handling in microfluidic systems and devices using lateral cell trapping and methods of fabrication of the same that allow for selective low voltage electroporation and electrofusion.

Abstract: A blood sensor to be used in a blood test apparatus, more specifically speaking, a blood sensor which can be easily attached to a blood test apparatus and detached therefrom. Namely, a blood sensor to be detachably attached to a blood test apparatus having a plural number of connectors, which comprises: a supply channel to which blood is supplied; a detection section provided in the supply channel; an electrode system formed in an area including the detection section; a plural number of connection terminals electrically connected to each electrode of the electrode system respectively; and a standard electrode serving as a standard for differentiating these connection terminals. The connectors are connected respectively to the connection terminals and the standard electrode of the blood sensor having been attached to a definite position of the blood test apparatus.