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    • 10. 发明申请
    • ENHANCED METHOD FOR THE DETERMINATION OF AN ANALYTE CONCENTRATION IN BODILY FLUID
    • WO2023062123A1
    • 2023-04-20
    • PCT/EP2022/078495
    • 2022-10-13
    • F. HOFFMANN-LA ROCHE AGROCHE DIABETES CARE GMBHROCHE DIABETES CARE, INC.
    • LIMBURG, BerndBERG, MaxHAILER, FredrikALPEROWITZ, LukasBODLÉE, Florian
    • G01N21/78G01S17/88
    • The present invention relates to an analytical method for determining a concentration of an analyte in a bodily fluid by using a mobile device having at least one camera, at least one lidar sensor, at least one processor, and at least one display, wherein the at least one camera and the at least one lidar sensor comprise an at least partially overlapping field of view, the method comprising the following steps: a) providing at least one object, the at least one object being selected from the list comprising: an optical test element having a reagent test region, a color reference card having a reagent test region, a color reference card adapted to be associated with an optical test element having a reagent test region; wherein the reagent test region is adapted for application of a sample of the bodily fluid, and wherein the reagent test region is adapted to undergo, at least partially, a color formation reaction when the sample of the bodily fluid is applied to the reagent test region; b1) prompting, by the display, a user to apply a drop of the bodily fluid to the reagent test region and/or prompting, by the display, a user to confirm application of a drop of the bodily fluid to the reagent test region; b2) prompting, by the display, the user to provide the at least one object within the at least partially overlapping field of view of the at least one camera and the at least one lidar sensor; c) generating, by the processor, a lidar measurement data set at least for the object by receiving output data from the at least one lidar sensor, the lidar measurement data set representing a three-dimensional structure of at least a part of the object; d) comparing, by the processor, the lidar measurement data set from step c) to a pre-generated lidar data set for the object, the pre-generated lidar data set representing a three-dimensional structure of the entire object, thereby obtaining an item of information on a degree of congruence of the lidar measurement data set and the pre-generated lidar data set; and e1) if the item of information from step d) indicates a degree of congruence equal to or above a pre-determined minimum degree of congruence: capturing, by the at least one camera, a measurement image of at least a part of the reagent test region having the sample of the bodily fluid applied thereto, and determining the concentration of the analyte in the bodily fluid based at least on the measurement image captured; or e2) if the item of information from step d) indicates a degree of congruence below a pre-determined minimum degree of congruence: - at least temporarily not allowing the capturing, by the at least one camera, of a measurement image of at least a part of the reagent test region having the sample of the bodily fluid applied thereto; and/or - indicating, by the display, a warning to the user; and/or - indicating, by the display, instractions to the user to take some appropriate action in order to capture, by the at least one camera, a measurement image of at least a part of the reagent test region having the sample of the bodily fluid applied thereto.