Abstract: A method for generating a module configured to determine concentration of an analyte in a sample of a body fluid is disclosed. The method includes providing a first set of measurement data derived from images of one or more test strips indicating a color transformation in response to a body fluid containing an analyte. The images can be recorded by multiple devices with differing cameras, software and/or hardware device configurations for image recording and image data processing. A neural network model can be generated in a machine learning process applying an artificial neural network and a module configured to determine concentration of an analyte in a second sample of a body fluid can be generated. Further, the present disclosure includes a system for generating the module as well as a method and a system for determining concentration of an analyte in a sample of a bodily fluid.

Abstract: A method for detecting in-vivo properties of a biosensor. In the inventive method, a sensitivity-to-admittance relation is provided and a raw current in the biosensor is measured. An in-vivo current response is also measured at first and second operating points. A time constant ? is determined by the electrical capacitance C of the working electrode and the electrical resistance RM of the membrane by ?=RM·C. The first and second operating points are selected below and above ?, respectively. An analyte value in a sample of a body fluid is determined by using the raw current and compensating sensitivity drift in the biosensor, which in turn is compensated by using the measured value for the raw current and a corrected value for the sensitivity. The failsafe operation of the biosensor is monitored by using the in-vivo current response measured at the first and second operating points.

Abstract: The present invention relates to a biosensor for determining an analyte comprising a substrate, a working electrode comprising an electrically conductive pad in conductive contact with a mediator layer, and an enzyme layer in diffusion-enabling contact with said mediator layer, wherein said mediator layer is an electrodeposited mediator layer, and wherein said mediator layer comprises, in an embodiment consists of, an electrocatalytic agent. The present invention further relates to a method for manufacturing a biosensor, comprising providing a substrate having at least one conductive pad, electrodepositing a mediator layer onto at least part of said conductive pad, wherein said mediator layer comprises, in an embodiment consists of, an electrocatalytic agent, and depositing an enzyme layer onto at least part of said mediator layer. Moreover, the present invention relates to uses and methods related to the biosensor of the present invention.

Abstract: Disclosed is a method for initializing an analyte measurement system (1, 2, 3), the analyte measurement system (1, 2, 3) being designed for continuous in-vivo measurement of a body fluid analyte concentration.

Abstract: A method for detecting an interferent contribution in a biosensor is disclosed. Herein, the biosensor has a first electrode (112), a second electrode, and a third electrode (114), wherein the first electrode (112) and the second electrode are covered by a membrane, wherein the first electrode (112) further includes an enzyme or wherein the first electrode (112) is covered by an enzyme layer. Further, the first electrode (112), the second electrode, and the third electrode (114) are connected via a potentiostat, wherein, in a normal operational mode, via the potentiostat an electrical potential difference is applied between the first electrode (112) and the second electrode in a manner that the first electrode (112) allows for oxidative processes and the third electrode (114) allows for reductive processes.

Abstract: A method for generating a module configured to determine concentration of an analyte in a sample of a body fluid is disclosed. The method includes providing a first set of measurement data derived from images of one or more test strips indicating a color transformation in response to a body fluid containing an analyte. The images can be recorded by multiple devices with differing cameras, software and/or hardware device configurations for image recording and image data processing. A neural network model can be generated in a machine learning process applying an artificial neural network and a module configured to determine concentration of an analyte in a second sample of a body fluid can be generated. Further, the present disclosure includes a system for generating the module as well as a method and a system for determining concentration of an analyte in a sample of a bodily fluid.

Abstract: A method for testing enzyme based electrochemical sensors wherein an electrochemical sensor is provided. A measurement setup is provided, which is operatively coupled to the electrochemical sensor, providing an output signal Z, e.g. a measured signal current, of the electrochemical sensor; and the electrochemical sensor is suitably contacted with a test solution comprising a certain concentration of the primary analyte. The electrochemical sensor is subjected to a certain swept range of temperatures T; an output signal Z is measured for different temperature values T; a derivative Z? of the output signal Z as a function of temperature T, or inverse temperature 1/T, is determined; and a relative derivate Z?/Z at a temperature T, or inverse temperature 1/T, is determined as the ratio between derivative Z? and output signal Z.

Abstract: A method of evaluating the suitability of a mobile device for performing an analytical measurement based on a color formation reaction. The capability of the mobile device to have relevant settings of the mobile device controlled by software running on the mobile device is evaluated. The relevant settings pertain to image raw data processing steps to be carried out by the mobile device and may include a color space transformation and a tone mapping transformation. When the evaluation indicates that the mobile device is capable of having the relevant settings controlled by the software, control information indicating that the mobile device is suitable for performing the analytical measurement is provided. When the evaluation indicates that the mobile device is not capable of having the relevant settings controlled by the software, control information indicating that the mobile device is unsuitable for performing the analytical measurement is provided.

Abstract: A method for detecting in-vivo properties of a biosensor. In the inventive method, a sensitivity-to-admittance relation is provided and a raw current in the biosensor is measured. An in-vivo current response is also measured at first and second operating points. A time constant ? is determined by the electrical capacitance C of the working electrode and the electrical resistance RM of the membrane by ?=RM·C. The first and second operating points are selected below and above ?, respectively. An analyte value in a sample of a body fluid is determined by using the raw current and compensating sensitivity drift in the biosensor, which in turn is compensated by using the measured value for the raw current and a corrected value for the sensitivity. The failsafe operation of the biosensor is monitored by using the in-vivo current response measured at the first and second operating points.

Abstract: A method for testing enzyme based electrochemical sensors for quantitative detection of analytes in aqueous solutions, wherein an electrochemical sensor is provided, with a working electrode (1) and a counter electrode, the working electrode comprising an electrical conductor (3), a solid-state matrix (4) being electrically connected with said conductor and containing an immobilized enzyme able to catalytically convert a primary analyte into a secondary analyte that can be oxidised or reduced when a suitable potential is applied at the working electrode, and a membrane (5) covering said matrix and separating it from the outside. The membrane is permeable for the primary analyte, such that primary analyte molecules present in an aqueous solution with which the working electrode is contacted can pass through the membrane to the matrix, where they can be catalytically converted into second analyte molecules.

Abstract: The present invention relates to a biosensor for determining an analyte comprising a substrate, a working electrode comprising an electrically conductive pad in conductive contact with a mediator layer, and an enzyme layer in diffusion-enabling contact with said mediator layer, wherein said mediator layer is an electrodeposited mediator layer, and wherein said mediator layer comprises, in an embodiment consists of, an electrocatalytic agent. The present invention further relates to a method for manufacturing a biosensor, comprising providing a substrate having at least one conductive pad, electrodepositing a mediator layer onto at least part of said conductive pad, wherein said mediator layer comprises, in an embodiment consists of, an electrocatalytic agent, and depositing an enzyme layer onto at least part of said mediator layer. Moreover, the present invention relates to uses and methods related to the biosensor of the present invention.

Abstract: Disclosed is a method for initializing an analyte measurement system (1, 2, 3), the analyte measurement system (1, 2, 3) being designed for continuous in-vivo measurement of a body fluid analyte concentration.

Abstract: A method for detecting an interferent contribution in a biosensor is disclosed. Herein, the biosensor has a first electrode (112), a second electrode, and a third electrode (114), wherein the first electrode (112) and the second electrode are covered by a membrane, wherein the first electrode (112) further includes an enzyme or wherein the first electrode (112) is covered by an enzyme layer. Further, the first electrode (112), the second electrode, and the third electrode (114) are connected via a potentiostat, wherein, in a normal operational mode, via the potentiostat an electrical potential difference is applied between the first electrode (112) and the second electrode in a manner that the first electrode (112) allows for oxidative processes and the third electrode (114) allows for reductive processes.

Abstract: Sensor elements are provided for determining at least one analyte concentration in a body fluid. The sensor elements are at least partially implantable into a body tissue and have a substrate and at least two electrodes. One electrode is a working electrode having at least one conductive pad applied to the substrate and at least one electrically conductive sensor material is applied to the conductive pad that includes at least one detector substance adapted to perform an electrically detectable electrochemical detection reaction with the analyte. Another electrode is a counter electrode having at least one counter electrode conductive pad applied to the substrate. The sensor elements also include at least one electrically insulating material that surrounds at least the counter electrode on all sides, where a height of the electrically insulating material at least equals a height of the counter electrode conductive pad.

Abstract: A diagnostic system has a diagnostic module with an integrated lancet system and a magazine module separate from the diagnostic module. The diagnostic device also has a connecting device that is used for tensioning the lancet system.

Abstract: An analysis device for analysis of a sample on a test element is provided that comprises at least one component configured to make electrical contact with at least one other component for electrical transmission therebetween. The at least one component generally comprises an injection-molded circuit mount, also called an MID, or molded interconnect device.

Abstract: The measuring system for in vivo monitoring of an analyte concentration with malfunction detection, comprises an electrode system, a potentiostat and an evaluation unit. The electrode system has a working electrode, a reference electrode, and a counter electrode. The potentiostat is for adjusting a difference of potential between the electric potential of the working electrode and the electric potential of the reference electrode to a specified value and for measuring an electric current flowing between the working electrode and the counter electrode. The potentiostat comprises a working electrode terminal for connection to the working electrode, a reference electrode terminal for connection to the reference electrode, and a counter electrode terminal for connection to the counter electrode. The evaluation unit monitors the electric potential of the counter electrode and generates a malfunction signal when said potential is outside a specified reference range. A method of operation is also disclosed.

Abstract: An electrical connection system for an analysis system and a method for analysis of a liquid sample on an analytical test element using the described analysis system are disclosed. The analysis system provides an evaluation appliance for evaluation of electrical signals, a test element holder for holding and positioning of an analytical test element in a measurement position, and an electrical contact element which makes electrical contact with an electrical contact surface of an analytical test element to produce an electrical connection between the contact surface and the evaluation appliance. The contact element is moved by means such that contact with the electrical contact surface of the test element is made when the test element holder is in the measurement position.

Abstract: A chemistry matrix for use in determining the concentration of an analyte in a biological fluid includes a glucose dehydrogenase, nicotinamide adenine dinucleotide, an alkylphenazine quaternary salt, and/or a nitrosoaniline. The chemistry matrix is used with an electrochemical biosensor to determine the concentration of an analyte after a reaction occurs within the biosensor, at which time an analysis is completed to determine the concentration. A method of determining the concentration of an analyte using the chemistry matrix of glucose dehydrogenase, nicotinamide adenine dinucleotide, an alkylphenazine quaternary salt, and/or a nitrosoaniline is another aspect that is described. The method also further features test times of five seconds or less. Methods utilizing the new chemistry matrix can readily determine an analyte such as blood glucose at concentrations of from about 20-600 mg/dL at a pH of from about 6.5 to about 8.5.

Abstract: An analysis device for analysis of a sample on a test element is provided that comprises at least one component configured to make electrical contact with at least one other component for electrical transmission therebetween. The at least one component generally comprises an injection-molded circuit mount, also called an MID, or molded interconnect device.