Abstract: An analyte test element for determining the concentration of at least one analyte in a physiological sample fluid having a first and a second surface in a predetermined distance opposite from each other, said both surfaces are provided with two substantially equivalent patterns forming areas of high and low surface energy which are aligned mostly congruent, whereby the areas with high surface energy create a sample distribution system with at least two detection areas, characterized in that the detection areas of first and second surface are also provided with two corresponding patterns of working and reference electrodes of electrochemical detection means.

Abstract: An analyte test element for determining the concentration of at least one analyte in a physiological sample fluid having a first and a second surface in a predetermined distance opposite from each other, said both surfaces are provided with two substantially equivalent patterns forming areas of high and low surface energy which are aligned mostly congruent, whereby the areas with high surface energy create a sample distribution system with at least two detection areas, characterized in that the detection areas of first and second surface are also provided with two corresponding patterns of working and reference electrodes of electrochemical detection means.

Abstract: This invention provides a device for determining the concentration of an analyte like glucose, cholesterol, free fatty acids, triglycerides, proteins, ketones, phenylalanine or enzymes, in a physiological or aqueous fluid like blood, serum, plasma, saliva, urine, interstitial and/or intra-cellular fluid, the device having an integrated calibration and quality control system suitable for dry reagent test strips with a very small sample volume of about 0.5 ?L based on to a new sample distribution system. The production of the inventive analyte test element involves only a small number of uncomplicated production steps enabling an inexpensive production of the strips.

Abstract: This invention provides a device for determining the concentration of an analyte like glucose, cholesterol, free fatty acids, triglycerides, proteins, ketones, phenylalanine or enzymes, in a physiological or aqueous fluid like blood, serum, plasma, saliva, urine, interstitial and/or intra-cellular fluid, the device having an integrated calibration and quality control system suitable for dry reagent test strips with a very small sample volume of about 0.5 ?L based on to a new sample distribution system. The production of the inventive analyte test element involves only a small number of uncomplicated production steps enabling an inexpensive production of the strips.

Abstract: A container for moisture sensitive test elements comprising a container body (2, 102, 202), an insert (22, 122, 220) fitting in container body, whereby a cavity (18, 118) is created between outer surface of insert wall (24, 124, 240) and inner surface of container body wall (4, 104, 204), and a lid (50, 150, 250) dimensioned to seal container open end when in a closed position, wherein a desiccant material is contained within the cavity (18, 118) between container body wall and insert wall. Insert wall defines a hollow channel (29, 129, 229) which is dimensioned that at least one test element ex-tents from the insert channel facilitating accessibility to an individual test element for the testing of an analyte of interest. Desiccant material includes an indicator whose colour changes when exposed to moisture indicating to a user whether contents therein, i.e. test elements, have been compromised by environmental factors.

Abstract: An analyte test element for the qualitative and/or quantitative determination of at least one analyte in a physiological or aqueous sample fluid having a first surface (2a) and a second surface (4a) in a predetermined distance opposite from each other, said both surfaces are provided with two substantially equivalent patterns forming areas of high and low surface energy which are aligned mostly congruent, whereby the areas of high surface energy (6, 6?) create a sample distribution system with at least two detection areas (6a, 6?a), said at least one of the detection areas (6a, 6?a) of the first and second surfaces (2a, 4a) is provided with at least one non-enzymatic recognition element (32).

Abstract: A test element for the determination of coagulation in a plasma or whole blood sample having a first surface (2a) and a second surface (4a) in a predetermined distance opposite from each other, said both surfaces being provided with two substantially equivalent patterns forming areas of high and low surface energy which are aligned mostly congruent, whereby the areas of high surface energy create a sample distribution system (6) with at least one detection area (6a), wherein the detection area(s) (6a, 6?a) of the first and second surfaces (2a, 4a) is/are provided with at least one coagulation stimulation reagent. The coagulation test element is provided with an integrated quality control system suitable for dry reagent test strip format with a very small sample volume of about 0.5 ?L. The production of the inventive coagulation test element involves only a small number of uncomplicated production steps enabling an inexpensive production of the element.

Abstract: An apparatus for detection and quantitation of an electrochemically-detectable analyte, such as glucose, in blood or interstitial fluid includes a meter unit, a lancet and an electrochemical sensor. Of these components, the meter is preferably reusable, while the lancet and the electrochemical sensor are preferably incorporated in assemblies intended for single-use. The meter unit has a housing, within which a lancet is engaged with a mechanism for moving then lancet; a connector disposed within the housing for engaging an electrochemical sensor specific for the analyte and transmitting a signal indicative of the amount of analyte, and a display operatively-associated with a connector for displaying the amount of the analyte to user. The electrochemical sensor is adapted for detection of a particular analyte. In addition, the electrochemical sensor has an absorptive member for uptake of a sample of blood or interstitial fluid.

Abstract: An analyte test element for determining the concentration of at least one analyte in a physiological sample fluid having a first and a second surface in a predetermined distance opposite from each other, said both surfaces are provided with two substantially equivalent patterns forming areas of high and low surface energy which are aligned mostly congruent, whereby the areas with high surface energy create a sample distribution system with at least two detection areas, characterized in that the detection areas of first and second surface are also provided with two corresponding patterns of working and reference electrodes of electrochemical detection means.

Abstract: A microfluidic analytical system for monitoring an analyte (such as glucose) in a fluid sample (e.g., blood or ISF) includes an analysis module and an electrical device (for example, a meter or power supply). The analysis module includes an insulating substrate and a microchannel(s) within the insulating substrate's upper surface. The analysis module also includes a conductive contact pad(s) disposed on the upper surface of the insulating substrate and an electrode(s), with the electrode(s) being disposed over the microchannel. In addition, the analysis module includes an electrically conductive trace(s) that electrically connects the electrode to at least one electrically conductive contact pad. The analysis module also has a laminate layer disposed over the electrode, the electrically conductive trace, the microchannel and a portion of the upper surface of the insulating substrate.

Abstract: A method for manufacturing an analysis module with accessible electrically conductive contact pads includes forming an insulating substrate with an upper surface, a microchannel(s) within the upper surface, and electrically conductive contact pad(s) disposed on the upper surface. The method also includes producing a laminate layer with a bottom surface, electrode(s) on the laminate layer bottom surface, and electrically conductive trace(s) on the laminate layer bottom surface. The method further includes adhering the laminate layer to the insulating substrate such that a portion of the bottom surface of the laminate layer is adhered to a portion of the upper surface of the insulating substrate, each electrode is exposed to at least one microchannel; and each electrically conductive trace is electrically contacted to at least one electrically conductive contact pad.

Abstract: A device and method for measuring clotting times in a fluid, typically blood, within a microchannel, with the onset of clotting being determined by measurement of the rate of change, or the value, of capacitance or impedance between two electrodes situated on either side of the microchannel. The device includes an upper support member and a lower support member with a microchannel formed therein. The device also includes electrodes situated along the length of the microchannel.

Abstract: A microfluidic analytical system for monitoring an analyte (for example, glucose) in a liquid sample (e.g., ISF) includes an analysis module with at least one micro-channel for receiving and transporting a liquid sample, at least one analyte sensor for measuring an analyte in the liquid sample and at least one position electrode. The analyte sensor(s) and position electrode(s) are in operative communication with the micro-channel. The microfluidic system also includes a meter configured for measuring an electrical characteristic (such as impedance or resistance) of the position electrode(s). Moreover, the measured electrical characteristic is dependent on the position of the liquid sample in the micro-channel that is in operative communication with the position electrode for which an electrical characteristic is measured.

Abstract: Methods are disclosed for remotely monitoring an analyte concentration of an individual by one or more other individuals.

Abstract: Systems are disclosed for remotely monitoring an analyte concentration of an individual by one or more other individuals.

Abstract: A microfluidic analytical system for monitoring an analyte (for example, glucose) in a liquid sample (e.g., ISF) includes an analysis module with at least one micro-channel for receiving and transporting a liquid sample, at least one analyte sensor for measuring an analyte in the liquid sample and at least one position electrode. The analyte sensor(s) and position electrode(s) are in operative communication with the micro-channel. The microfluidic system also includes a meter configured for measuring an electrical characteristic (such as impedance or resistance) of the position electrode(s). Moreover, the measured electrical characteristic is dependent on the position of the liquid sample in the micro-channel that is in operative communication with the position electrode for which an electrical characteristic is measured.

Abstract: This invention provides a device for determining the concentration of an analyte like glucose, cholesterol, free fatty acids, triglycerides, proteins, ketones, phenylalanine or enzymes, in a physiological or aqueous fluid like blood, serum, plasma, saliva, urine, interstitial and/or intra-cellular fluid, the device having an integrated calibration and quality control system suitable for dry reagent test strips with a very small sample volume of about 0.5 ?L based on to a new sample distribution system. The production of the inventive analyte test element involves only a small number of uncomplicated production steps enabling an inexpensive production of the strips.

Abstract: A device for extracting bodily fluid (such as an ISF sample) includes a penetration member with a channel (e.g., a hollow needle) and a fluid flow regulator (for example, a narrow-bore cylinder) disposed within the channel. The penetration member is configured for penetrating a target site (such as a dermal tissue target site) and subsequently residing within the target site and extracting a bodily fluid sample therefrom. The fluid flow regulator is adapted to control (e.g., reduce or minimize variation in) bodily fluid flow rate through the penetration member. In addition, the presence of the fluid flow regulator in the channel of the penetration member serves to reduce sensor lag by reducing the dead volume of the penetration member. A method for extracting bodily fluid from a target site includes providing the aforementioned device. Next, the target site is penetrated with the penetration member of the device.

Abstract: An apparatus for detection and quantitation of an electrochemically-detectable analyte, such as glucose, in blood or interstitial fluid includes a meter unit, a lancet and an electrochemical sensor. Of these components, the meter is preferably reusable, while the lancet and the electrochemical sensor are preferably incorporated in assemblies intended for single-use. The meter unit has a housing, within which a lancet is engaged with a mechanism for moving then lancet; a connector disposed within the housing for engaging an electrochemical sensor specific for the analyte and transmitting a signal indicative of the amount of analyte, and a display operatively-associated with a connector for displaying the amount of the analyte to user. The electrochemical sensor is adapted for detection of a particular analyte. In addition, the electrochemical sensor has an absorptive member for uptake of a sample of blood or interstitial fluid.

Abstract: A glucose sensor in the form of a skin patch 2 has a microneedle 4 which painlessly penetrates the skin to draw out interstitial fluid. The interstitial fluid passes to a common entrance port 7. A series of microchannels 8 is provided on the skin patch. The fluid drawn onto the patch is selectively switched between a number of microchannels 8 by means of electro-osmotic pumps 10 and hydrophobic gates 12. Each microchannel 8 has an electrochemical detector 11 for sensing gluocse concentration.