Improved method for determining analyte concentrations in body fluids - Patents.com

Abstract

The present invention provides an analytical method for determining a concentration of an analyte in a body 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, the at least one camera and the at least one lidar sensor having at least partially overlapping fields of view, the method comprising the steps of: a) providing at least one object, the at least one object being selected from a list comprising: an optical test element having a reagent test area; a color reference card having a reagent test area; and a color reference card adapted to be associated with an optical test element having a reagent test area, the reagent test area being adapted for application of a sample of the body fluid, the reagent test area being adapted to at least partially undergo a color development reaction when the sample of the body fluid is applied to the reagent test area; and b1) prompting a user by the display to apply a drop of the body fluid to the reagent test area and / or prompting a user by the display to confirm application of the drop of the body fluid to the reagent test area. a) prompting a user to provide at least one object within the at least partially overlapping fields of view of the at least one camera and the at least one lidar sensor by the display; b) generating, by the processor, a lidar measurement dataset of at least the object by receiving output data from the at least one lidar sensor, the lidar measurement dataset representing a three-dimensional structure of at least a part of the object; d) comparing, by the processor, the lidar measurement dataset from step c) with a pre-generated lidar dataset of the object, the pre-generated lidar dataset representing the entire three-dimensional structure of the object, thereby obtaining an item of information regarding a degree of agreement between the lidar measurement dataset and the pre-generated lidar dataset; e) if the item of information from step d) indicates a degree of agreement equal to or greater than a predetermined minimum degree of agreement, capturing, by the at least one camera, a measurement image of at least a part of the reagent test area onto which the sample of bodily fluid was applied;determining a concentration of an analyte in the body fluid based on at least the captured measurement images, or e2) if the items of information from step d) indicate a degree of match below a predefined minimum degree of match, at least temporarily not allowing the step of capturing by the at least one camera a measurement image of at least a part of the reagent test area to which the sample of the body fluid has been applied, and / or indicating by the display a warning to the user and / or instructing by the display the user to take some appropriate action to capture by the at least one camera a measurement image of at least a part of the reagent test area to which the sample of the body fluid has been applied.

Description

[Technical field]

[0001] The present invention relates to a method for determining the concentration of an analyte in a body fluid using at least one mobile device having a camera and a processor. Furthermore, the present invention relates to a mobile device having a camera and a processor for performing the method, a kit comprising a mobile device having a camera and a processor, a computer program and a computer readable storage medium. The method, the mobile device, the computer program and the storage medium may be used in medical diagnostics, in particular for qualitatively or quantitatively detecting one or more analytes in a body fluid, such as for example for detecting glucose in blood or interstitial fluid. [Background technology]

[0002] In the field of medical diagnostics, it is often necessary to detect one or more analytes from a sample of bodily fluid, such as blood, interstitial fluid, urine, saliva, or other types of bodily fluids. Examples of analytes to be detected are glucose, triglycerides, lactate, cholesterol, or other types of analytes that are typically present in these bodily fluids. Depending on the concentration and / or presence of the analytes, appropriate treatments can be selected as needed.

[0003] Generally, devices and methods known to those skilled in the art utilize a test element that contains one or more test chemicals, which can carry out one or more detectable detection reactions, such as optically detectable detection reactions, in the presence of the analyte to be detected.For information on the test chemicals contained in the test element, see, for example, J. Hoenes et al.: The Technology Behind Glucose Meters: Test Strips, Diabetes Technology & Therapeutics, Volume 10, Supplement 1, 2008, S-10 to S-26.

[0004] Specifically, in analytical measurements based on color reactions, the color change due to the detection reaction is evaluated. In addition to using dedicated analytical devices such as handheld blood glucose meters, the use of commonly available electronic devices such as smartphones and portable computers or other mobile devices has become increasingly popular in recent years. For example, methods and devices for optically measuring analytes using mobile devices with cameras that address various specific aspects considered in such measurement scenarios are described in EP 3527972, WO 2019 / 238500, EP 3650843, and EP 3651162. To enhance such measurement procedures using mobile devices, it has also been proposed to take into account additional data available from sensors present in the mobile device, such as from accelerators, gyroscopes, etc. Such data can be used for improved user guidance, for example, as described in International Patent Application No. PCT / EP2021 / 068431.

[0005] Apart from sensors currently widely used in mobile devices such as accelerators or gyroscopes, it can be expected that more and more mobile devices will be equipped with further additional sensors that are currently only available in very few mobile devices. One such example is the LIDAR sensor, the term LIDAR (or RADAR) is commonly known as "light detection and ranging" or "laser imaging, detection, and ranging" and is a method of determining distances (variable distances) using reflected laser light. Using LIDAR, it is possible to create a digital 3D representation of the surroundings or objects. LIDAR has various applications, terrestrial, airborne, and mobile, and is particularly commonly used in many applications, such as geography, topography, and atmospheric physics, to create high-resolution maps.

[0006] For example, lidars are also used in navigation or control systems of autonomous vehicles to detect obstacles. In this context, their use in combination with 3D lidar and color cameras for multiple object detection and for tracking moving objects has been described. (Hwang, Soonmin et al. (2016) "Fast Multiple Objects Detection and Tracking Fusing Color Camera and 3D LIDAR for Intelligent Vehicles", 13th Int. Conf. on Ubiquitous Robots and Ambient Intelligence (URAI), ISBN 978-1-5090-0821-6). Both inputs from the lidar and the camera are acquired in parallel and the color image from the camera is calibrated with the lidar. In the segmentation step, using statistical analysis, the 3D points are divided into several groups based on their distance from the sensor. In this way, foreground objects can be separated from background objects and object proposals in the 2D image may be used. Detection involves, on the one hand, object detection in 2D images and, on the other hand, object detection in 3D space detected by the lidar sensor, whereby local and global histograms can be extracted to represent specific objects. To merge the results from 2D images and 3D space object detection, a score calibration can be performed, whereby a single confidence score from both detectors can be obtained in the form of a probability. (Xu, Philippe et al. (2014) "Evidential combination of pedestrian detectors", Proceedings Brit. Machine Vision Conf., BMVA Press). For real tracking (e.g. of a moving vehicle), additional steps are required, such as correlating moving objects in subsequent frames over time.

[0007] Furthermore, as far as user guidance during measurements with a mobile device is concerned, WO 2021 / 105222 provides for some visual indication on the display of the mobile device, which may include the use of augmented reality, particularly in scenarios where the first and second images (such as a blank or reference image and a subsequent measurement image) should be captured in essentially the same position to minimize the influence of environmental factors such as ambient lighting conditions.

[0008] In order to properly take into account the reference color to evaluate the color development due to the detection reaction, an improvement comes from using a color reference chart together with the analytical test strip. This approach is particularly beneficial when images are captured simultaneously on both the color reference chart and the test strip. An example of such a procedure is described in the applicant's International Patent Application No. PCT / EP2021 / 065087, and an example of a suitable color reference card is disclosed in the applicant's European Patent Application No. 20190454.7.

[0009] When a color reference card is used with the test strip, various orientations of the mobile device relative to the color reference card are allowed, and can be made possible, for example, by a specific marker (e.g., ArUco code) on the top surface of the card. This improves user handling, but makes relative measurements, such as taking a first blank image and then a final measurement image, more complicated and difficult. For example, determining the distance between the camera of the mobile device and the color reference card can be made possible by considering different focal lengths, focal points, resolutions, etc., but such an approach can also be complicated and slow.

[0010] Moreover, the color reference card represents an object of a certain size, e.g. larger than a human finger. Thus, there is an increased risk that a portion of such a color reference card may be partially obscured by another object during measurement, e.g. by one or more fingers of a user. However, the covering of a portion of the color reference card by such an object or obstacle may not be distinguishable from, e.g., a shadow or some damage to the card. Thus, in such cases, it is not possible to provide an appropriate feedback to the user.

[0011] Thus, despite the advantages associated with using mobile computing devices for the purposes of performing analytical measurements, one of the technical challenges that remains is to improve the usability, and thereby the reliability, of such measurement scenarios.

[0012] Issues to be resolved It would therefore be desirable to provide an apparatus and method that at least partially addresses the above-mentioned challenges, in particular to provide an apparatus and method that allows for reliable, mobile-based determination of the concentration of an analyte in a body fluid, thereby enhancing handling efficiency, in particular with appropriate user guidance. Summary of the Invention

[0013] overview This problem is addressed by an analytical method for determining the concentration of an analyte in a body 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, with the features of the independent claims, by a kit comprising a mobile device and an object suitable for optical measurement, as well as by a computer program and a computer readable storage medium. Advantageous embodiments which may be realized alone or in any combination are recited in the dependent claims.

[0014] When used below, the terms "have", "comprise" or "include", or any grammatical variants thereof, are used in a non-exclusive manner. These terms may therefore refer both to the situation in which no further features are present in the entity described in this context, in addition to the features introduced by these terms, and to the situation in which one or more further features are present. As an example, the expressions "A has B", "A includes B" and "A includes B" may refer both to the situation in which no other elements are present in A besides B (i.e., the situation in which A consists only of B), and to the situation in which, in addition to B, one or more further elements are present in the entity A, such as element C, elements C and D, or further elements.

[0015] Furthermore, it should be noted that the terms "at least one," "one or more," or similar expressions indicating that a feature or element may be present one or more times are typically used only once when introducing each feature or element. In the following, in most cases, when referring to each feature or element, the expressions "at least one" or "one or more" will not be repeated, regardless of the fact that each feature or element may be present one or more times.

[0016] Furthermore, as used below, the terms "preferably", "more preferably", "particularly", "more particularly", "particularly", "more particularly" or similar terms are used with optional features without limiting the possibilities of substitution. Thus, features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. The invention may be implemented by using alternative features, as the skilled person will recognize. Similarly, features introduced by "in one embodiment of the invention" or similar expressions are intended to be optional features, without any limitations on alternative embodiments of the invention, without any limitations on the scope of the invention, and without any limitations on the possibilities of combining the features so introduced with other optional or non-optional features of the invention.

[0017] In a first aspect of the present invention, a method for determining a concentration of an analyte in a body fluid is disclosed, the method comprising using a mobile device having a camera and a processor. The method comprises the following steps, which may be performed in a given order, as an example. However, it should be noted that different orders are also possible. Furthermore, it is also possible to perform one or more of the method steps once or repeatedly. Furthermore, it is also possible to perform two or more of the method steps simultaneously or overlapping in time. The method may comprise additional method steps not listed. In general, the method comprises capturing at least one image of at least a portion of an optical test strip or color reference card, where a sample of the body fluid has been applied onto a reagent test area of ​​the test strip or color reference card, the capturing comprising using a camera of the mobile device. The at least one captured image comprises at least a portion of the reagent test area where the sample of the body fluid has been applied. The method further comprises determining, by the processor, the analyte concentration from the captured image based on a color reaction at the reagent test area where the sample of the body fluid has been applied.

[0018] Without narrowing the scope, the present invention will be specifically described with respect to blood glucose measurements, however, it should be noted that the present invention may also be used in other types of analytical measurements that use test elements.

[0019] The term "determining the concentration of an analyte in a bodily fluid", also referred to as "analytical measurement" as used herein, is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, the quantitative and / or qualitative determination of at least one analyte in any sample or aliquot of bodily fluid. For example, the bodily fluid may include one or more of blood, interstitial fluid, urine, saliva or other types of bodily fluid, particularly blood, and specifically, the bodily fluid may include a particular portion of blood, such as serum or plasma. The result of the concentration determination may be, by way of example, the concentration of the analyte and / or the presence or absence of the analyte to be determined. Specifically, by way of example, the analytical measurement may be a blood glucose measurement, and thus the result of the analytical measurement may be, for example, a blood glucose concentration. In particular, an analytical measurement result value may be determined by the analytical measurement.

[0020] Thus, as used herein, the term "analyte concentration value," also sometimes referred to as "analytical measurement value," is a broad term and should be given its ordinary and customary meaning to one of skill in the art and should not be limited to a special or customized meaning. The term may particularly, but not be limited to, refer to a numerical representation of the analyte concentration in a sample.

[0021] By way of example, the at least one analyte may be or may include one or more specific chemical compounds and / or other parameters. By way of example, one or more analytes involved in metabolism, such as blood glucose, may be determined. Additionally or alternatively, other types of analytes or parameters may be determined, such as pH value.

[0022] The method outlined above involves using at least one mobile device having at least one camera. The term "mobile device" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may refer in particular, but not limited to, portable electronic devices, more specifically, mobile communication devices such as mobile phones or smartphones. Additionally or alternatively, a mobile device may also refer to a tablet computer or another type of portable computer having at least one camera and at least one processor.

[0023] The term "camera" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically, but not limited to, refer to an instrument having at least one imaging element configured to record or capture spatially resolved one-dimensional, two-dimensional, or even three-dimensional optical data or information. As an example, a camera may comprise at least one camera chip, such as at least one CCD chip and / or at least one CMOS chip, configured to record an image. As used herein, but not limited to, the term "image" may specifically relate to data recorded using a camera, such as a plurality of electronic readings from an imaging device, such as the pixels of a camera chip.

[0024] The camera may comprise, besides at least one camera chip or imaging chip, one or more further elements such as one or more optical elements, for example one or more lenses. As an example, the camera may be a fixed focus camera with at least one lens that is fixedly adjusted relative to the camera. Alternatively, however, the camera may also comprise one or more variable lenses that may be adjusted automatically or manually. The invention is particularly applicable to cameras that are typically used in mobile applications such as notebook computers, tablets or mobile phones, in particular smartphones. Thus, in particular, the camera may be part of a mobile device that, besides at least one camera, comprises one or more data processing devices, such as one or more data processors. However, other cameras are also feasible.

[0025] The term "lidar" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. Lidar (or "LIDAR", "LADAR", or "3D laser scanning") is commonly known as "light detection and ranging" or "laser imaging, detection, and ranging". It is a method of determining distance (i.e., variable distance) by targeting an object with a laser, usually a pulsed laser, and measuring the time that the scattered or reflected light returns to a receiver. To create a digital 3D representation of the surroundings or any object, lidar typically relies on differences in laser return times, but may also rely on changes in laser wavelength. Traditional scanning lidars generally use a collimated laser beam that illuminates a single point at a time, and the beam is raster scanned to illuminate the field of view point by point. A time-of-flight camera with a receiver collects information about both the 3D position and the intensity of the light incident on it, which may be captured in one or more frames (also referred to herein as a "lidar image", or an "image" of the lidar sensor). For this purpose, it may be sufficient if the camera includes a point sensor. In so-called flash lidar, where the entire field of view is illuminated with a single pulse by a diverging laser beam, the camera may include a 1D or 2D sensor array, each pixel of which collects 3D position and intensity information. In both lidar and flash lidar cases, the time of flight of the laser pulse (i.e., the time it takes each laser pulse to hit the target and return to the receiver) is used to collect depth information, which is why the pulsing of the laser and the acquisition by the receiver must be synchronized. As a result, a "distance picture" (i.e., a "lidar image") can be captured in contrast to, or in addition to, images made in conventional color. The combined use of 3D lidar and color cameras for multiple object detection has been described herein above from the context of autonomous vehicle navigation or control systems for detecting obstacles.

[0026] As used herein, the terms "lidar" and "lidar sensor" are used synonymously, and both terms may particularly refer to, but are not limited to, a system, device, or one or more components thereof having a time-of-flight camera capability to record or capture spatially resolved three-dimensional data or information of one or more objects within the field of view of the time-of-flight camera. Specifically, the term "lidar" may relate to a scanning lidar system that emits multiple laser pulses at different parts of a scene within a fraction of a second, i.e., a very short period of time. This may provide real-time user guidance, such as user guidance for adjusting the orientation of a mobile device relative to an object, particularly relative to at least one object, based on data received from the lidar sensor.

[0027] For example, a lidar sensor used according to the invention may comprise at least one laser element for emitting a pulsed collimated laser beam, at least one means for raster scanning the beam to illuminate the field of view of the time-of-flight camera point-by-point (i.e., a single "lidar point" at a time), at least one receiver configured to record or capture light scattered or reflected by one or more objects in the field of view of the time-of-flight camera, including in particular recording or capturing the intensity of the scattered or reflected light, and at least one timer configured to detect or record the time it takes for a pulse of the emitted laser beam to return to the receiver. The resolution of the lidar sensor used in the invention may be selected such that a relatively large number of single "lidar points", for example at least 20, at least 30, or at least 50 multiple single "lidar points", impinge on at least one object to be detected. A lidar sensor that may be suitably used may have a resolution of 256 x 192 single "lidar points" raster scanned by a pulsed laser beam, in particular each pulse of the laser beam may raster scan a single "lidar point". Commercially available mobile devices equipped with suitable lidar sensors include, for example, tablet computers such as the Apple® iPad Pro 2020®, and smartphones such as the Apple® iPhone 12 Pro® and Pro Max®. Each of these mobile devices includes a lidar sensor that can perform time-of-flight calculations to generate a 3D map of the surrounding area using lidar scanning.

[0028] The method further includes using at least one of an optical test element having a reagent test area, a color reference card having a reagent test area, and a color reference card adapted to be associated with the optical test element having the reagent test area. The reagent test area is adapted to apply a sample of bodily fluid, and the reagent test area is adapted to undergo at least a partial color-developing reaction when the sample of bodily fluid is applied to the reagent test area. The reagent test area may also be referred to herein as a "test field." The term "optical test element" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, any element or device configured to perform a color change detection reaction. The optical test element may also be referred to as a test strip or a test element, and all three terms may refer to the same element. The optical test element and / or the color reference card may have a reagent test area that includes at least one test chemical for detecting at least one analyte, among other things. The optical test element may include at least one substrate, such as at least one carrier, on which at least one reagent test area is applied or incorporated. In particular, the optical test element may further include one or more reference areas, such as a white field and / or a black field. Additionally or alternatively, the substrate or carrier itself may be or include such a reference area. In one example, the at least one carrier may be in the form of a strip, making the test element a test strip. These test strips are commonly used and available. A test strip may carry a single test field or multiple test fields in which the same or different test agents are included. The color reference card may include features similar to those described herein above for the optical test strip. In particular, the color reference card may be provided in credit card format, i.e. in the size and shape of a conventional credit card made of plastic.Typically, such a card-sized color reference card exhibits multiple reference areas such as white, black and / or grey fields. Additionally or alternatively, the color reference card may exhibit multiple reference areas with different reference colors, said reference colors having colors other than white, black or grey.

[0029] Further, as used herein, the term "reagent test area" (also referred to herein as "test field") is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. This term may refer in particular, but not limited to, to a coherent amount of test chemical, for example, a circular, polygonal or rectangular field having one or more layers of material, at least one layer of the test field having test chemical contained therein. For test chemicals contained in optical test strips, see, for example, J. Hoenes et al.: The Technology Behind Glucose Meters: Test Strips, Diabetes Technology & Therapeutics, Volume 10, Supplement 1, 2008, S-10 to S-26. Other types of test chemicals are possible and can be used to implement the present invention.

[0030] As outlined above, the method generally involves capturing at least one image by using a camera of at least a portion of a reagent test area to which a sample of bodily fluid has been applied. The term "capturing at least one image" as used herein is a broad term and should be given its ordinary and customary meaning to one of skill in the art and should not be limited to any special or customized meaning. The term may specifically refer to, but is not limited to, one or more of imaging, image recording, image acquisition, image capture. The term "capturing at least one image" may include capturing a single image and / or multiple images, such as a series of images. For example, image capture may include recording a series of images, such as a video or movie, in succession. The capture of the at least one image may be initiated by a user action or may be initiated automatically, for example, upon automatic detection of the presence of at least one object within the field of view of the camera and / or within a predefined sector of the field of view. These automatic image capture techniques are known in the field of automatic barcode readers, for example, automatic barcode reading apps. Image capture may be by, as one example, by capturing a stream or "live stream" of images with a camera, and one or more of the images are stored and used as at least one first image or at least one second image, respectively, either automatically or by user interaction such as pressing a button. Image capture may be supported by a processor of the mobile device, and image storage may occur within a data storage device of the mobile device.

[0031] The capture of at least one image may include applying a sample of bodily fluid to the test strip and capturing at least one image, and further optionally, for example, capturing at least one image in which the sample of bodily fluid is not applied to the test strip before capturing an image in which the sample is applied to the test strip. The latter image may be specifically used for comparison purposes and may also be referred to as a "blank image" or a "dry image". The application of the sample may generally be performed, for example, directly or indirectly, for example, via at least one capillary element. The at least one image captured after sample application may typically be referred to as a "wet image", even if the sample may be dry when the image is actually captured. The wet image may typically be captured after waiting at least a predetermined waiting time, for example 5 seconds or more, to allow the detection reaction to occur. Thus, by way of example, the method may include waiting at least a predetermined minimum time between taking the optional dry image and the at least one wet image. This predetermined minimum time may specifically be sufficient for the detection reaction to occur in the test strip. By way of example, the minimum amount of waiting time may be at least 5 seconds.

[0032] The method includes determining an analyte concentration, in particular an analyte concentration value, from a color development of the test field. Thus, the method may be an analytical measurement that includes a change in at least one optical property of the optical test field, which change may be visually measured or determined using a camera. In particular, the analytical measurement may be or may include a color development reaction in the presence of at least one analyte to be determined. The term "color development reaction" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may particularly refer to, but is not limited to, a chemical, biological or physical reaction in which the color, in particular the reflectance, of at least one element involved in the reaction changes as the reaction progresses. The color development may be detected by the mobile device, such as by a processor of the mobile device, and may be quantitatively evaluated, such as by deriving from the at least one image at least one parameter that quantifies or characterizes the color development of the test field due to the presence of the analyte in the body fluid. For this purpose, one or more specific color coordinates may be used. Thus, the mobile device, and in particular the processor of the mobile device, may be configured to determine the color change by determining a change in one or more color coordinates that occurs due to the detection response.

[0033] At least one analyte concentration, in particular an analyte concentration value, is determined from the color development of the test field. For this purpose, at least one image is used. The analyte concentration value may be a numerical indication of the result of the analytical measurement, such as indicating the concentration of at least one analyte in the sample, such as, by way of example, a blood glucose concentration.

[0034] The method may further include displaying the analyte concentration values, such as on a display of the mobile device. Additionally or alternatively, the method may include storing the at least one analyte concentration value in at least one data storage device of the mobile device. Again additionally or alternatively, the method may further include transmitting the at least one analyte concentration value via the at least one interface and / or via at least one data transmission network, such as to another computer for further evaluation.

[0035] Thus, in a first aspect, the present invention relates in particular to an analytical method for determining the concentration of an analyte in a body fluid using a mobile device having at least one camera, at least one lidar sensor, at least one processor and at least one display, the at least one camera and the at least one lidar sensor comprising at least partially overlapping fields of view, the method comprising: a) providing at least one object, the at least one object being selected from a list including: an optical test element having a reagent test area; a color reference card having a reagent test area; and a color reference card adapted to be associated with an optical test element having a reagent test area, the reagent test area being adapted to apply a sample of a bodily fluid, the reagent test area being adapted to at least partially undergo a color developing reaction when the sample of the bodily fluid is applied to the reagent test area; b1) prompting a user via the display to apply a drop of the bodily fluid to the reagent-testing area and / or prompting a user via the display to confirm application of the drop of the bodily fluid to the reagent-testing area; b2) prompting a user via the display to provide at least one object within at least a partially overlapping field of view of the at least one camera and the at least one lidar sensor; c) generating, by a processor, a LIDAR measurement data set of at least 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 portion of the object; d) comparing, by a processor, the lidar measurement dataset from step c) with a pre-generated lidar dataset of the object, the pre-generated lidar dataset representing the entire three-dimensional structure of the object, thereby obtaining an item of information regarding the degree of agreement between the lidar measurement dataset and the pre-generated lidar dataset; e1) if the items of information from step d) indicate a match equal to or greater than a predetermined minimum match, capturing, by at least one camera, a measurement image of at least a portion of the reagent test area onto which the sample of bodily fluid has been applied, and determining the concentration of the analyte in the bodily fluid based on at least the captured measurement image; or e2) if the item of information from step d) shows a match below a predetermined minimum match; - at least temporarily disallowing the capture of a measurement image of at least a portion of the reagent test area to which the sample of bodily fluid has been applied by the at least one camera; and / or - indicating a warning to the user by means of a display; and / or - prompting a user, via the display, to take any appropriate action to capture, with the at least one camera, a measurement image of at least a portion of the reagent test area onto which the sample of bodily fluid has been applied; Includes.

[0036] The proposed method provides a reliable mobile-based determination of the concentration of an analyte in a body fluid, in particular by reducing the occurrence of errors due to improper user handling during the measurement procedure, thereby increasing the handling efficiency of the mobile-based determination of the concentration of an analyte in a body fluid, in particular by providing enhanced feedback to the user, such as better user guidance.

[0037] The mobile device has at least one camera, for example one, two or three cameras. The camera may be located on the rear side of the mobile device, on the front side of the mobile device, or on both sides, the front side being the side having the display and the rear side being the side opposite the side having the display. Specifically, at least one of the cameras is located on the rear side of the mobile device. The mobile device has at least one lidar sensor, for example one or two lidar sensors, the at least one lidar sensor being located on the same side of the mobile device as the at least one camera. Specifically, the at least one lidar sensor is located on the rear side of the mobile device. The at least one camera and the at least one lidar sensor may be located close to each other. Furthermore, the at least one camera and the at least one lidar sensor include at least partially overlapping fields of view. For example, the overlap of the fields of view may be at least 50%, specifically at least 75%, more specifically at least 90%. Advantageously, the fields of view of the at least one camera and the at least one lidar sensor may essentially completely overlap.

[0038] In step a), at least one object is provided, the at least one object being selected from a list comprising an optical test element having a reagent test area, a color reference card having a reagent test area, and a color reference card adapted to be associated with an optical test element having a reagent test area. The terms "optical test element", "color reference card" and "reagent test area" may specifically refer to the respective definitions of the corresponding terms given herein above. The reagent test area is adapted for application of a sample of a body fluid, such as blood, and the reagent test area is adapted to fully or at least partially undergo a color-developing reaction when the sample of the body fluid is applied to the reagent test area. A color reference card "adapted to be associated with" an optical test element having a reagent test area may refer to a color reference card that can be removably or fixedly connected to a test element, such as a test strip having a reagent test area. In particular, the test element or test strip may be attached to such a color reference card by some fixing means, such as a slot or guide rail for inserting the test strip, such that the test element remains in a fixed position relative to the color reference card. Examples of suitable color reference cards of this type are disclosed, for example, in the applicant's European Patent Application No. 20190454.7. Alternatively, the color reference card may be "adapted to be associated" with an optical test element having a reagent test area, such that the color reference card is used with the optical test element without a fastening element to hold the test element in place. In particular, the optical test element may simply be placed next to or on the color reference card, for example at a predefined edge of the color reference card or at a predefined position on the top surface of the color reference card. In this way, both the lidar sensor and the camera of the mobile device may receive input data including both the color reference card and the test element in any subsequent steps of the method.

[0039] In step b1), the user is prompted by the display to apply a drop of the body fluid to the reagent test area. Additionally or alternatively, in step b1), the user is prompted by the display to confirm the application of the drop of the body fluid to the reagent test area. In step b2), the user is prompted by the display to provide at least one object within the at least partially overlapping fields of view of the at least one camera and the at least one lidar sensor. The prompting may in each case be performed by a corresponding message, icon or other graphical representation on the display. Furthermore, other means for prompting the user may include acoustic and / or tactile signals, such as tone signals, alarms, vibrations, etc. In particular, steps b1) and b2) may be performed simultaneously or in the reverse order, for example first step b2) and then step b1).

[0040] In step c), a lidar measurement dataset is generated by the processor for the at least one object by receiving output data from the at least one lidar sensor, the generated lidar measurement dataset representing a three-dimensional structure of at least a part of the object or the entire object. In particular, if an obstacle such as a user's finger prevents the lidar sensor from detecting the complete object, the lidar measurement dataset may be generated to represent the three-dimensional structure of only a part of the object, i.e. a part of the object that is within the field of view of the lidar sensor and is not blocked by any obstacle.

[0041] In step d), the lidar measurement dataset from step c) is compared by the processor with a pre-generated lidar dataset for at least one object. The pre-generated lidar dataset represents the entire three-dimensional structure of the object. Typically, the pre-generated lidar dataset is generated in a training procedure, said training procedure may include the use of an artificial neural network. In particular, the pre-generated lidar dataset may be generated by using a lidar sensor of the same type as used in the mobile device employed in the method of the invention. However, other lidar sensors comprising different hardware and / or software components may be used as well. Furthermore, the pre-generated lidar dataset is generally generated by using one or more objects of the same type as used in the method for determining the concentration of an analyte in a body fluid. Thus, the objects used in the training procedure for generating the pre-generated lidar dataset may in particular be selected from a list comprising an optical test element having a reagent test area, a color reference card having a reagent test area, and a color reference card adapted to be associated with an optical test element having a reagent test area. As a result of such a training procedure, a pre-generated lidar dataset of at least one object is obtained, the pre-generated lidar dataset representing the entire three-dimensional structure of the object.

[0042] From the comparison in step d), an item of information is obtained regarding the degree of agreement between the lidar measurement data set and the pre-generated lidar data set. The degree of agreement thus qualitatively or quantitatively represents the degree of overlap between the lidar measurement data set on the one hand and the pre-generated lidar data set on the other hand. Thereby, the processor may determine whether the degree of overlap of both lidar data sets is low, medium or high. Alternatively, the processor may simply distinguish whether the degree of overlap of both lidar data sets is low or high. Additionally or alternatively, the processor may determine the percentage of overlap of both lidar data sets. The skilled person will understand that the determination of the degree of overlap depends on whether at least one object is fully detectable ("visible") in the field of view of the lidar sensor or whether it is only partially detectable ("visible") by the lidar sensor. For example, if an obstacle such as a user's finger prevents the lidar sensor from detecting the complete object, the object may only be partially detectable.

[0043] As indicated by the item of information from step d), the degree of match between the lidar measurement data set and the pre-generated lidar data set is compared with a minimum degree of match. Here, the minimum degree of match is selected such that at least one object is reliably identified in the lidar measurement data set. Furthermore, if at least one object is only partially detectable by the lidar sensor, the minimum degree of match is further selected such that the degree of partial overlap between the lidar measurement data set and the pre-generated lidar data set is sufficient to ensure a reliable analyte measurement according to step e1). In particular, for a reliable analyte measurement, the degree of partial overlap of the two lidar data sets includes at least the reagent test field of the optical test element and advantageously an additional part of the optical test element, such as a reference field, e.g. a black, white and / or colored reference field, in the overlapping part of the two lidar data sets.

[0044] Thus, if the items of information from step d) indicate a degree of match equal to or greater than a predetermined minimum degree of match, the method further comprises step e1), i.e. capturing by at least one camera a measurement image of the reagent test area or at least a part thereof onto which the sample of bodily fluid has been applied. The concentration of the substance to be measured in the bodily fluid is then determined by the processor based on at least the captured measurement image.

[0045] Alternatively, if the item of information from step d) shows a match below a predetermined minimum match, the method continues with step e2), namely by: - at least temporarily disallowing at least one camera from capturing measurement images of at least a portion of the reagent test area to which the sample of bodily fluid has been applied; and - indicating a warning to the user by means of a display; - prompting a user, via the display, to take any appropriate action to capture, via the at least one camera, a measurement image of at least a portion of the reagent test area onto which the sample of bodily fluid has been applied; and The method further includes performing at least one of the following:

[0046] The warning and / or instruction may be indicated to the user by a corresponding message, icon or other graphical representation on the display according to step e2. Furthermore, other means for indicating the warning and / or instruction to the user may include acoustic and / or tactile signals such as tone signals, alarms, vibrations, etc.

[0047] The appropriate action to be taken by the user in step e2) may be at least one of: removing any obstruction from the overlapping field of view between the camera and the at least one object such that the overlapping field of view between the camera and the at least one object is free of obstructions, such as, for example, a human user's finger; moving the mobile device in at least one direction relative to the at least one object; and changing an orientation angle of the mobile device relative to the at least one object.

[0048] The predetermined minimum degree of match in steps e1) and e2) represents a threshold value: only if the item of information from step d) shows a degree of match equal to or greater than said threshold value, i.e. equal to or greater than said predetermined minimum degree of match, does the method proceed further to step e1), which comprises actually determining the analyte concentration.

[0049] In particular, the predetermined minimum degree of agreement may be set as high if the items of information from step d) are selected from the group consisting of low and high degrees of agreement. In other words, in this case, the processor determines the degree of agreement between the lidar measurement data set and the pre-generated lidar data set on a binary scale, resulting in a low or high degree of agreement, and thus, depending on the case of any concrete execution of the method of the invention, either a low or a high degree of agreement is indicated by the items of information from step d). In this case, the predetermined minimum degree of agreement is set high, so that, as mentioned above, the determination of the analyte concentration in step e1) can be performed only if the items of information from step d) show a high degree of agreement (i.e. an agreement equal to or greater than the applicable threshold).

[0050] Alternatively, if the items of information from step d) are selected from the group consisting of low, medium and high degrees of agreement, the predetermined minimum degree of agreement may be set as medium or high, in particular high. In this case, the determination of the analyte concentration in step e1) may therefore only be performed if the items of information from step d) show at least a medium degree of agreement, i.e. a medium or high degree of agreement (i.e. an agreement above the applicable threshold). Alternatively, if the predetermined minimum degree of agreement is set particularly high, the determination of the analyte concentration in step e1) may only be performed if the items of information from step d) show a high degree of agreement.

[0051] Further alternatively, if the items of information from step d) are selected to express the degree of agreement in terms of a percentage value, the required predetermined minimum degree of agreement may be set to a level of agreement of at least 50%, for example at least 60%, at least 70% or at least 80%, in particular at least 75%, more particularly at least 90%, even more particularly at least 95%. In this case, the determination of the analyte concentration in step e1) may be performed only if the items of information from step d) show a percentage value of agreement equal to or greater than the percentage value selected as the predetermined minimum degree of agreement (i.e. a percentage value equal to or greater than the applicable threshold). For example, the determination of the degree of agreement in terms of a percentage value, i.e. the degree of overlap of the lidar measurement data set and the pre-generated lidar data set (at least partially), may be performed based on object detection in the lidar data set. Said object detection may be evaluated, for example by an artificial neural network, by taking into account one or more parameters, which may include accuracy, F1 score, etc. A suitable artificial neural network may be provided, for example, by a mobile device application programming interface (API), such as those provided in Apple® mobile devices, e.g. the Apple® iPad Pro 2020®, and smartphones such as the Apple® iPhone 12 Pro® and Pro Max®.

[0052] The method may further include, after step a) and before step b1), a step b2') corresponding to step b2), a step c') corresponding to step c), and a step d') corresponding to step d), and if the items of information from step d') indicate a degree of match above a predetermined minimum degree of match, the method may further include capturing by at least one camera an initial image or at least an initial image of at least a part of the reagent test area without the sample of bodily fluid being applied.

[0053] The initial image provides a blank measurement of the test element or test field, respectively. This sequence of operations makes it possible to carry out an initial check of the suitability or integrity of the test element, in particular the test field, before the application of a sample to the test field. For example, test elements, in particular test fields, that have deteriorated due to influences from environmental factors such as temperature or humidity or because their expiry date has passed may be detected.

[0054] Additionally or alternatively, the blank measurement value may in particular be used as a reference for the determination of the analyte concentration and / or to perform a relative measurement for the determination of the analyte concentration. Thus, the method may further comprise in step e1) taking into account the initial image for determining the concentration of the analyte in the body fluid.

[0055] The method generally takes into account that the chemical reactions used for color-based analyte detection may require a certain amount of time to complete or at least to proceed sufficiently toward completion of the chemical reaction. In other words, in order for the color to develop a final intensity, or at least a sufficient intensity, to be properly detected, the chemical reaction must be allowed sufficient time to occur or at least proceed sufficiently toward completion. Thus, the method includes, after step b1) and before step e1) or e2), specifically between step b1) and step b2), a predetermined minimum time, e.g.

[0056] It may further comprise the step of waiting for a period of at least 5 seconds up to several minutes, for example 5, 10, 15, 20, 25, 30, 45, 60, 90 or 120 seconds, particularly 5 to 30 seconds, more particularly 20 seconds.

[0057] Since the lidar sensor is generally adapted to detect and generate a digital 3D representation of the surroundings or objects in its field of view, the processor may distinguish foreground elements from background elements in the lidar measurement dataset. In particular, such a distinction may be achieved by evaluating a time-of-flight value, i.e. the time it takes for an emitted laser pulse to strike an object and return to the lidar sensor or its receiver. For example, an object that is farther away than the object to be detected (such as at least one object) may provide a longer time-of-flight value, and if said time-of-flight value exceeds a certain threshold, the corresponding object may be classified as a background object. Thereby, an object that is clearly identified as a background object may be removed from the lidar dataset or may not be considered for further processing of the lidar dataset. Additionally or alternatively, the distinction of the foreground elements from the background elements may be achieved by clustering one or more time-of-flight values, each of the plurality of time-of-flight values ​​may provide similar time-of-flight values, in particular time-of-flight values ​​that fall within a specified range of time-of-flight values. Further details on object detection and differentiation of foreground elements from background elements in lidar datasets, e.g., lidar measurement datasets, can be found in “Recognition and Tracking of Dynamic Objects Using Static Sensors”, Master's Thesis by R. Zille, 2019, Human-centered Assistive Robotics, Technical University Munich.

[0058] Thus, the method may further comprise identifying, by the processor in step c), at least two segments in the lidar measurement data set, relative to one another, where at least one of the segments is identified as a segment including foreground elements and at least another one of the segments is identified as a segment including background elements, whereby the foreground elements are identified as being closer in distance to the mobile device compared to the background elements, which are therefore located further away from the mobile device than the foreground elements.

[0059] Any object in the field of view of the lidar sensor may be represented in the lidar measurement data set and, accordingly, each of said objects may be identified as either a foreground element or a background element and may be assigned to a corresponding segment in the lidar measurement data set. This results in two groups of segments, the first group including all segments with foreground elements and the second group including all segments with background elements. If appropriate, an additional segment may be defined, for example including elements located at an intermediate distance from the mobile device, i.e. further from the mobile device than the foreground elements but closer to the mobile device than the background elements. Naturally, this additional distinction may depend on the relevant capabilities of any particular lidar sensor or lidar system, for example its resolution.

[0060] In particular, the method may include detecting, by the processor, at least one object in the lidar measurement data set from step c) in a segment that includes the background element, and the method may further include detecting, by the processor, at least a partial overlap of the foreground element with at least a portion of the object. Such a foreground element, e.g. a user's finger, represents an obstacle that prevents the lidar sensor from detecting the complete object. In such a case, the lidar measurement data set represents the three-dimensional structure of only a portion of the object, i.e., the portion of the object that is within the field of view of the lidar sensor and is not obstructed by the foreground element.

[0061] In particular, to improve the efficiency, reliability and / or execution speed of the method according to the invention, it may be advantageous to use image data from at least one camera in addition to data from a lidar sensor, in particular in addition to the lidar measurement data. For this purpose, it is beneficial if the additional image data corresponds to the lidar measurement data, in particular with regard to the time at which each of said data is received or recorded.

[0062] Thus, for the comparison of the LIDAR measurement dataset from step c) with a pre-generated LIDAR dataset of the object in step d), the method may further comprise overlaying, by the processor, the LIDAR measurement dataset from step c) with corresponding image data received from at least one camera, thereby obtaining a combined measurement dataset. The combined measurement dataset may be used as the LIDAR measurement dataset for the comparison in step d). It is to be noted in this context that the term "LIDAR measurement dataset" accordingly explicitly refers to data received from both the LIDAR sensor and the camera, respectively.

[0063] In particular, it is particularly advantageous if the method further comprises selecting, for overlaying by the processor in step d), the lidar measurement data set from step c) and the corresponding image data received from the at least one camera such that data relating to essentially the same point in time are overlaid.

[0064] If the LIDAR measurement dataset from step c) is superimposed with the corresponding image data from the camera in step d), it is advantageous for the comparison in step d) if the pre-generated LIDAR dataset also includes corresponding image data received from a camera, in particular from at least one camera. In other words, to generate the pre-generated LIDAR dataset, data received from a LIDAR sensor, in particular from at least one LIDAR sensor of the mobile device, may be superimposed with corresponding image data received from a camera, in particular from at least one camera of the mobile device, thereby obtaining a combined pre-generated LIDAR dataset. The combined pre-generated LIDAR dataset can then be used as the pre-generated LIDAR dataset for the comparison in step d).

[0065] As will be appreciated by those skilled in the art, the method may further include, in particular in step c) and / or step d), applying one or more image processing techniques by the processor to the LIDAR measurement data set, to the image data received from the at least one camera, to the combined measurement data set, and / or to portions of any of the foregoing. The term "image processing technique" includes any conventional technique known in the art, such as color inversion, luminance inversion, adjusting contrast, brightness, etc., thresholding, etc. Such image processing techniques may be applied, at least in part, directly, in a similar manner, or in a modified manner to the data received from the LIDAR sensor.

[0066] In another aspect of the invention, a mobile device is provided having at least one camera, at least one lidar sensor, at least one processor, and at least one display. The at least one camera and the at least one lidar sensor include fields of view that are at least partially overlapping or essentially completely overlapping. The mobile device is configured to determine a concentration of an analyte in a bodily fluid by using the camera to capture at least one image of (i) an optical test element having a reagent test area, (ii) a color reference card associated with such optical test element having a reagent test area, or (iii) at least a portion of a color reference card having a reagent test area. Furthermore, the mobile device is configured to determine a concentration of an analyte in the bodily fluid by determining at least one analyte concentration from a color reaction in the reagent test area. The mobile device is further configured to perform at least steps b1), b2), c), d), e1) and e2) of the analysis method as described herein above.

[0067] In another aspect of the invention, there is provided a kit comprising a mobile device as described hereinabove and at least one object selected from the list comprising: an optical test element having a reagent test area, a color reference card having a reagent test area, and a color reference card adapted to be associated with an optical test element having a reagent test area. The reagent test area is adapted for application of a sample of a bodily fluid. The reagent test area is further adapted to at least partially undergo a color developing reaction when the sample of the bodily fluid is applied to the reagent test area.

[0068] In another aspect of the invention there is provided a computer program comprising instructions which, when executed by a mobile device as described herein above, cause the mobile device to perform at least steps b1), b2), c), d), e1) and e2) of the analysis method as described herein above.

[0069] In another aspect of the present invention there is provided a computer readable storage medium comprising instructions which, when executed by a mobile device as described herein above, cause the mobile device to perform at least steps b1), b2), c), d), e1) and e2) of the analysis method as described herein above. [Brief description of the drawings]

[0070] Further optional features and embodiments are disclosed in more detail in the following description of the embodiments, preferably in conjunction with the dependent claims. In it, each optional feature can be realized separately as well as in any possible combination, as understood by a person skilled in the art. The scope of the present invention is not limited by the preferred embodiments. The embodiments are illustrated diagrammatically in the figures, in which the same reference numbers in these figures refer to the same or functionally equivalent elements.

[0071] In the figure, [Figure 1] 1 is a schematic perspective view of a mobile device and a color reference card associated with an optical test strip; [Diagram 2] 1 is a flow chart of one embodiment of an analytical method for determining the concentration of an analyte in a bodily fluid. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0072] Detailed Description of the Embodiments 1 shows a schematic perspective view of a mobile device (128) and a color reference card (110) associated with an optical test strip (118). The optical test strip (118) is associated with the color reference card (110) such that the reagent test field (120) of the optical test strip (118) is aligned with the cutout (116) of the color reference card (110). This allows the reagent test field (120) to be visible from above through the cutout (116). The optical test strip (118) may be removably connected to the bottom surface of the color reference card (110), for example, by some fastening element on the bottom surface that holds the optical test strip (118) in a fixed position relative to the color reference card (110). Alternatively, the optical test strip (118) may simply be placed underneath the color reference card (110) such that the reagent test field (120) is aligned with the cutout (116) and the reagent test field (120) is visible from above through the cutout (116).

[0073] The mobile device (128) is equipped with a camera (130a) and a lidar sensor (130b), both of which are shown in the sensor unit (130) in FIG. 1. Additional cameras and / or lidar sensors may be provided in the mobile device. The mobile device (128) may be or include at least one of a mobile phone, a smartphone, a tablet computer, and the like. The camera (130a) of the mobile device (128) may be configured to record an image (also referred to herein as a "captured image"), in particular a color image. Thus, the camera (130a) may be a color camera and may include at least three color sensors, such as at least one color sensor for R, G, and B colors. The lidar sensor (130a) of the mobile device (128) may be configured to provide output data to the processor (132) that may enable the processor (132) to generate a lidar data set, such as a lidar measurement data set or a pre-generated lidar data set, representing a three-dimensional structure of at least one object or a portion thereof within a field of view of the lidar sensor (130b). Additionally or alternatively, the lidar sensor (130b) may be configured to provide output data to the processor (132) that is already in the form of a complete or partial lidar data set, such as a lidar measurement data set or a pre-generated lidar data set, representing a three-dimensional structure of at least one object or a portion thereof. Additionally, the mobile device (128) has a display (not shown in FIG. 1 ) on a side of the mobile device (128) opposite the side on which the sensor unit (130) is located.

[0074] Furthermore, the mobile device (128) generally comprises at least one processor (132). The processor (132) may be configured, in particular by software programming, to execute one or more of the method steps of the method for determining the concentration of an analyte in a body fluid according to the present invention. An exemplary embodiment of said method is shown in FIG. 2 and will be described in more detail below. The processor (132) may be particularly configured to support the capture of at least one image of the color reference card (110). In particular, the processor (132) may prompt a user of the mobile device (128) to capture one or more images. Additionally or alternatively, the processor (132) may be configured to automatically capture an image of the color reference card (110), in particular when the color reference card (110) is within the field of view of the camera (130a).

[0075] The top surface of the color reference card (110) comprises a number of reference fields (color reference field 112 and gray reference field 114) having known reference color values ​​or known reference gray values. Furthermore, the color reference card (110) shown in FIG. 1 comprises a cutout portion (116). Thus, the optical test strip (118) may be visible through the cutout portion (116) such that both the top surface of the color reference card (110) and the optical test strip (118) are visible on a measurement image captured by the camera (130) of the mobile device (128), particularly when the optical test strip (118) is connected to the color reference card (110). In particular, at least one reagent test area (120) of the optical test strip (118) may be visible through the cutout portion (116) when viewed from the direction of the top surface of the color reference card (110). In such a configuration, a sample of bodily fluid is applied to the reagent test area (120) of the optical test strip (118) from the direction of the bottom surface. The color formed in the reagent test area (120) is then visible through the cutout (116). Additionally or alternatively, a sample of bodily fluid may be applied to the optical test strip prior to being connected to the color reference card (110). Further, additionally or alternatively, an optical test strip having a capillary for receiving the sample of bodily fluid and / or for transporting the sample of bodily fluid to the reagent test area (120) may be used in conjunction with the color reference card (110).

[0076] The top surface of the color reference card (110) may further comprise one or more position detection code elements (122). The position detection code elements (122) may be used to identify the orientation of the color reference card (110) and its top surface relative to the camera of the mobile device. In particular, the processor (132) of the mobile device (128) may be configured to detect the position detection code elements (122) on an image captured by the camera (130), e.g., a measurement image, and further detect information regarding the orientation of the color reference card (110) and its top surface.

[0077] 2 shows a flow chart of an exemplary embodiment of a method for determining a concentration of an analyte, such as blood glucose, in a bodily fluid, such as blood. The method includes using at least one mobile device (128) having at least one camera (130a) and at least one lidar sensor (130b), at least one processor (132), and at least one display (not shown), where the at least one camera (130a) and the at least one lidar sensor (130b) include at least partially overlapping fields of view. The method further includes using at least one object, such as a color reference card (110) associated with the optical test strip (118), as described herein above.

[0078] The method specifically includes the following steps, which may be performed in a given order. Moreover, different orders may also be possible. It may be possible to perform two or more of the method steps fully or partially simultaneously. It may further be possible to perform one, two or more, or even all of the method steps once or repeatedly. The method may include additional method steps not listed.

[0079] The method comprises the following steps: a) providing at least one object (designated by reference numeral 200), e.g., a color reference card (110) associated with an optical test element (118) having a reagent test area (120); b1) prompting a user via a display (also designated by reference numeral 200) to apply a drop of bodily fluid to a reagent test area (120); b2) prompting a user by a display (designated with reference numeral 210) to provide at least one object (110, 118) within an at least partially overlapping field of view of the at least one camera (130a) and the at least one lidar sensor (130b); c) generating, by a processor (denoted by reference numerals 230, 235), a lidar measurement data set of at least the object (110, 118) by receiving output data from at least one lidar sensor (130b), the lidar measurement data set being representative of a three-dimensional structure of at least a portion of the object (110, 118); d) comparing, by a processor (denoted by reference numeral 260), the lidar measurement dataset from step c) with a pre-generated lidar dataset of the object (110, 118), the pre-generated lidar dataset representing the three-dimensional structure of the entire object (110, 118), thereby obtaining an item of information regarding the degree of agreement between the lidar measurement dataset and the pre-generated lidar dataset; e1) (indicated by reference numeral 270) if the items of information from step d) indicate a match equal to or greater than a predetermined minimum match, capturing, by the at least one camera (130a), a measurement image of at least a portion of the reagent test area (120) onto which the sample of bodily fluid has been applied, and determining the concentration of an analyte in the bodily fluid based on at least the captured measurement image; or e2) (indicated by reference numeral 280) if the item of information from step d) shows a match below a predetermined minimum match; - at least temporarily not allowing the capture of measurement images by the at least one camera (130a) of at least a portion of the reagent test area (120) to which the sample of bodily fluid has been applied; and / or - indicating a warning to the user by means of a display; and / or - prompting a user via the display to take any appropriate action to capture, via at least one camera (130a), a measurement image of at least a portion of the reagent test area onto which the sample of bodily fluid has been applied; Includes.

[0080] In step a) (reference number 200), the at least one object may alternatively be selected to be one of an optical test element having a reagent test area or a color reference card having a reagent test area. The reagent test area (120) is adapted for application of a sample of a bodily fluid. Furthermore, the reagent test area (120) is adapted to fully or at least partially undergo a color-developing reaction when the sample of the bodily fluid is applied to the reagent test area.

[0081] Additionally or alternatively, step b1) (reference numeral 200) may include prompting the user via the display to confirm application of the droplet of bodily fluid to the reagent test area.

[0082] In step b2) (indicated by reference numeral 210), when a user provides at least one object (110, 118) within the at least partially overlapping fields of view, the at least one lidar sensor (130b) may acquire lidar input data for one or more objects, or at least a portion thereof, within the field of view. Specifically, the lidar sensor (130b) may acquire lidar input data for the at least one object (110, 118) or at least a portion thereof.

[0083] In step c), first (reference numeral 230), the processor (132) receives output data from the at least one lidar sensor (130b). The output data may include information about a three-dimensional structure of one or more objects, or at least a portion thereof, in the field of view of the lidar sensor (130b). In particular, the output data may include information about a three-dimensional structure of the at least one object (110, 118) or at least a portion thereof. Next (reference numeral 235), the processor (132) may generate a lidar measurement dataset of at least the objects (110, 118) from the output data received from the at least one lidar sensor (130b), the lidar measurement dataset being representative of the three-dimensional structure of at least a portion of the object (110, 118). Furthermore, step c) (reference number 235) may include identifying, by the processor (132), at least two segments in the lidar measurement data set, with respect to each other, at least one of the segments being identified as a segment including foreground elements and at least another of the segments being identified as a segment including background elements, such that the processor may determine background and foreground elements in the lidar measurement data set and distinguish them from each other.

[0084] For the comparison in step d) of the lidar measurement dataset from step c) with a pre-generated lidar dataset of the object (reference number 260), the method may further comprise overlaying, by the processor (132), the lidar measurement dataset from step c) with corresponding image data received from the at least one camera (130a). This may result in a combined measurement dataset being obtained. The combined measurement dataset may then be used as the lidar measurement dataset for the comparison in step d) (reference number 260).

[0085] For this purpose, in addition to the lidar data received (reference 230) by the at least one lidar sensor (130b), image data, in particular corresponding image data, is received (reference 220) by the at least one camera (130a). In this regard, it should be noted that the acquisition of the image data received by the camera (130a) on the one hand and the acquisition of the lidar data received by the lidar sensor (130b) on the other hand may be performed simultaneously, intermittently or continuously. However, this may be beneficial if the image data and the lidar data have, at least in part, essentially identical or at least overlapping time stamps, so that the processor (132) may determine which image data corresponds to which lidar data.

[0086] Thus, the lidar measurement data set from step c) may be overlaid by the processor (132) with the corresponding image data received from the at least one camera (130a). This may result in a combined measurement data set being obtained (reference number 240). It may be appropriate to perform one or more image processing methods on the combined measurement data set (reference number 250), such as color inversion, brightness inversion, adjusting contrast, brightness, etc., thresholding, etc., to improve or facilitate object detection and / or user handling.

[0087] The method may then proceed to step d) (reference number 260) as before. Depending on whether the items of information from step d) show a degree of match equal to or greater than the predetermined minimum degree of match, the processor (132) enables the capture of a measurement image according to step e1) (reference number 270) or the processor (132) instead initiates at least one of the options offered in step e2) (reference number 280). For example, the predetermined minimum degree of match may be set high. Thus, in order to proceed to step e1), the items of information from step d) must represent a high degree of match (between the LIDAR measurement dataset and the pre-generated LIDAR dataset, each of which may further include image data from at least one camera (132). In particular, if the items of information from step d) are defined to be selected from only two elements, namely a low degree of match and a high degree of match, respectively, it may be appropriate to set the predetermined minimum degree of match high (as is the case for the purposes of this example). [Explanation of symbols]

[0088] 110 Color Reference Card 112 Color Reference Field 114 Gray Reference Field 116 Cutout 118 Optical Test Strips 120 Reagent Testing Area 122 Location Detection Code Elements 128 Mobile Devices 130: Sensor unit including camera 130a and lidar sensor 130b 132 processors

Claims

1. 1. 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, comprising: the at least one camera and the at least one lidar sensor include at least partially overlapping fields of view; The method comprises: a) providing at least one object, said at least one object selected from a list comprising: an optical test element having a reagent test area; a color reference card having a reagent test area; and a color reference card adapted to be associated with an optical test element having a reagent test area, said reagent test area adapted to receive a sample of said bodily fluid, said reagent test area adapted to undergo, at least in part, a color developing reaction when said sample of said bodily fluid is applied to said reagent test area; b1) prompting a user via the display to apply a droplet of the bodily fluid to the reagent test area and / or prompting a user via the display to confirm application of the droplet of the bodily fluid to the reagent test area; b2) prompting the user via the display to provide the at least one object within the at least partially overlapping fields 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 of at least 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 portion of the object; d) comparing, by said processor, said lidar measurement dataset from step c) with a pre-generated lidar dataset of said object, said pre-generated lidar dataset representing the entire three-dimensional structure of said object, thereby obtaining an item of information regarding the degree of agreement between said lidar measurement dataset and said pre-generated lidar dataset; e1) if the items of information from step d) indicate a match that meets or exceeds a predetermined minimum match, capturing, with the at least one camera, a measurement image of at least a portion of the reagent test area onto which the sample of the bodily fluid has been applied, and determining the concentration of the analyte in the bodily fluid based at least on the captured measurement image; or e2) if the item of information from step d) shows a match below a predetermined minimum match; at least temporarily disallowing said step of capturing, by said at least one camera, a measurement image of at least a portion of said reagent test area to which said sample of said bodily fluid has been applied; and / or - indicating a warning to the user by means of said display; and / or prompting the user via the display to take any appropriate action to capture with the at least one camera a measurement image of at least a portion of the reagent test area onto which the sample of the bodily fluid has been applied; Analytical methods, including:

2. 2. The method of claim 1, further comprising, after step a) and before step b1), a step b2') corresponding to step b2), a step c') corresponding to step c), and a step d') corresponding to step d), wherein if the item of information from step d') indicates a match greater than a predetermined minimum match, the method further comprises capturing an initial image of at least a portion of the reagent test area by the at least one camera without applying the sample of the bodily fluid.

3. 3. The method of claim 2, further comprising in step e1) taking into account the initial image for said determining the concentration of the analyte in the body fluid.

4. 3. The method of claim 2, further comprising the step of waiting a predetermined minimum time after step b1) and before step e1) or e2).

5. 2. The method of claim 1, further comprising: in step c), identifying, by the processor, at least two segments in the lidar measurement data set, relative to each other, at least one of the segments being identified as a segment including foreground elements and at least another of the segments being identified as a segment including background elements.

6. 2. The method of claim 1, further comprising, for the comparison of the lidar measurement dataset from step c) with a pre-generated lidar dataset of the object in step d), overlaying by the processor the lidar measurement dataset from step c) with corresponding image data received from the at least one camera, thereby obtaining a combined measurement dataset, and using the combined measurement dataset as the lidar measurement dataset for the comparison in step d).

7. 7. The method of claim 6, further comprising selecting, for the overlaying by the processor, the lidar measurement data set from step c) and the corresponding image data received from the at least one camera such that data relating to essentially the same point in time are overlaid.

8. 6. The method of claim 5, further comprising applying, by the processor in step c) and / or step d), one or more image processing techniques to the lidar measurement dataset, the image data received from the at least one camera, the combined measurement dataset, and / or portions of any of the foregoing.

9. 6. The method of claim 5, further comprising: detecting, by the processor, the object in a segment in the lidar measurement data set from step c) that includes background elements; and detecting, by the processor, at least partial overlap between foreground elements and at least a portion of the object.

10. 2. The method of claim 1, wherein if the item of information from step d) is selected from the group consisting of low match and high match, the predetermined minimum match is set as high; or if the item of information from step d) is selected from the group consisting of low match, medium match, and high match, the predetermined minimum match is set as medium or high; or if the item of information from step d) is selected to express the match in terms of a percentage value, the predetermined minimum match required is set to a match level of at least 50%.

11. 2. The method of claim 1, wherein in step e2), the appropriate action to be taken by the user is at least one of: removing any obstructions from the overlapping field of view between the camera and the at least one object; moving the mobile device in at least one direction relative to the at least one object; and changing an orientation angle of the mobile device relative to the at least one object so that the overlapping field of view between the camera and the at least one object is clear of any obstructions.

12. 12. 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 at least partially overlapping fields of view, the mobile device being configured to determine the concentration of an analyte in a bodily fluid by using the camera to capture at least one image of: (i) an optical test element having a reagent test area, (ii) a color reference card associated with such optical test element having a reagent test area, or (iii) at least a portion of a color reference card having a reagent test area, and determining at least one analyte concentration from a color reaction at the reagent test area, the mobile device being further configured to perform at least steps b1), b2), c), d), e1), and e2) of the analytical method of any one of claims 1 to 11.

13. 13. A kit comprising the mobile device of claim 12 and at least one object selected from the list comprising an optical test element having a reagent test area, a color reference card having a reagent test area, and a color reference card adapted to be associated with an optical test element having a reagent test area, wherein the reagent test area is adapted to apply a sample of a bodily fluid, and wherein the reagent test area is adapted to at least partially undergo a color reaction when the sample of the bodily fluid is applied to the reagent test area.

14. 13. A computer program comprising instructions which, when executed by a mobile device according to claim 12, cause the mobile device to perform at least steps b1), b2), c), d), e1) and e2) of the analysis method according to any one of claims 1 to 11.

15. 13. A computer readable storage medium containing instructions that, when executed by a mobile device according to claim 12, cause the mobile device to perform at least steps b1), b2), c), d), e1) and e2) of the analysis method according to any one of claims 1 to 11.

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