Method of detecting an analyte in a sample of bodily fluid

Abstract

A method of detecting at least one analyte in a sample of bodily fluid by using a mobile device (112) having at least one camera (114) is disclosed. The method comprises: a) prompting a user to confirm an application of a sample of bodily fluid to at least one test field (118) of an optical test element (116), wherein the test field (118) of the optical test element (116) is configured for performing at least one optical detection reaction in the presence of the analyte in the sample of the bodily fluid, wherein the optical detection reaction is observable at least one predetermined position on the test field (118); b) receiving, from at least one sensor, at least one item of user response information about a user response, wherein the sensor is one or more of a sensor of the mobile device (112) and a sensor of a connected device connected to the mobile device (112), wherein the user response comprises one or more of - a gesture, and - an eye movement; c) deriving, from the item of user response information, at least one item of control information about the status of the application of the sample of bodily fluid; d) if the item of control information indicates that the sample of bodily fluid is applied to the test field (118) of the optical test element (116), receiving at least one image of at least a part of the test field (118) from the camera (114); and e) detecting the analyte by evaluating the at least one image. Further, a mobile device (112) having at least one camera (114) and being configured for detecting at least one analyte in a sample of bodily fluid is disclosed. Further disclosed are a kit (110), a computer program and a computer-readable storage medium.

Description

[0001] Method of detecting an analyte in a sample of bodily fluid

[0002] Technical Field

[0003] The present invention relates to a method of detecting at least one analyte in a sample of bodily fluid by using a mobile device having at least one camera. The invention further relates to a mobile device having at least one camera and to a kit comprising the mobile device. Further, the invention relates to a corresponding computer program and a computer readable storage medium. The invention specifically may be used in medical diagnostics in order to quantitatively or qualitatively detect one or more properties of a sample of a bodily fluid. As an example, the methods and devices may be used for qualitatively and or quantitatively detecting the presence of one or more analytes in a sample of bodily fluid, such as for detecting blood glucose. Additionally or alternatively, as an example, the invention may be used for detecting the presence of the SARS-CoV-2 coronavirus in the sample of the bodily fluid. Other fields of application of the present invention, however, are also feasible.

[0004] Background art

[0005] In the field of medical diagnostics, in many cases, one or more analytes have to be detected in samples of a bodily fluid, such as blood, interstitial fluid, urine, saliva or other types of body fluids. Examples of analytes to be detected are glucose, triglycerides, lactate, cholesterol or other types of analytes, that, typically, are present in these body fluids. Additional or alternative analytes to be detected are viruses, such as the SARS-CoV-2 coronavirus. According to the concentration and / or the presence of the analyte, an appropriate treatment may be chosen, if necessary.

[0006] Generally, devices and methods known to the skilled person make use of test elements comprising one or more test chemicals, which, in presence of an analytes to be detected, are capable of performing one or more optically detectable reactions, such as optical detection reactions. As an example, in the field of glucose detection, with regard to the test chemicals comprised in test elements, reference may be made e.g. to 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 chemistry are possible and may be used for performing the present invention.

[0007] Typically, the detection of the analyte may rely on an optical detection reaction that becomes visible on the optical test element to indicate the presence of the analyte. When using a mobile device for detecting the analyte, particularly in home-testing scenarios, images of the optical test element may be captured by a camera comprised by the mobile device. For the purpose of taking these images, typically, the test element is placed on a surface available nearby, such as a desk and / or chair, such that both hands of the user can be used to handle the image acquisition. Typically, in these scenarios, the user uses one hand for holding the mobile device and the other hand for pressing buttons to follow a measurement sequence guide on the mobile device. However, in case a nearby surface is not available and / or placing the test element on the chair or desk is inappropriate for contamination and / or hygiene reasons, keeping the test element in the user‘s hand is typically more convenient. In the latter case, the mobile device would have to be operated by the user using one hand only. Depending on the type and / or model of mobile device that is used, this can be particularly challenging. Specifically, the one-handed operation of the mobile device might increase the risk of errors occurring due to the user unintendedly selecting and / or pressing the mobile device’s display, e.g. a touch display, and / or buttons.

[0008] In general, means for controlling electronic devices, which do not require a user to touch the electronic device, such as voice control or by using external devices, e.g. augmented reality goggles, are known.

[0009] US 2022 / 0108694 Al describes a method of supporting voice instructions for executing an application. The method includes obtaining a sequence for operating an application based on a user interaction, receiving a voice instruction with respect to the application from a user, extracting at least one keyword included in the voice instruction, comparing the at least one keyword with pre-stored keywords in a device, and executing the application to perform an action corresponding to the voice instruction.

[0010] US 11, 340, 708 B2 describes a computer-implemented medical method, a computer program and a system for controlling a display in a medical environment based a user's viewing direction and gestures performed by the user, particularly involving the use of AR-goggles. US 2022 / 0291134 Al describes a method of performing an analytical measurement based on a color formation reaction in an optical test strip by using a mobile device having a camera. An optical test strip having a test field is provided. The camera captures a first image of at least part of the test field before a sample is applied and a second image after the sample is applied. The mobile device indicates where to take the second image so that the first and second images are taken at similar local positions with respect to at least one environmental feature that has a fixed and / or unchanged position between the capturing of the first and second images. An analytical measurement result value is then determined by using the first and second images. A computer program, a computer-readable storage medium, a mobile device and a kit for performing an analytical measurement are also disclosed.

[0011] Despite the advantages involved in using voice control or external devices in the context of controlling displays and electronic device, several technical challenges remain. Specifically, a technical challenge may lie in the circumstance that the detection of the analyte in a bodily fluid is a medical detection reaction and thus, strict requirements are to be upheld in order not to compromise safety and / or accuracy of the detection. Further, specifically in cases where the detection is to be performed while on the road or when travelling, the user may not always be in an environment where using voice control is comfortable and / or appropriate, e.g. in a busy public restroom. Furthermore, in known methods or devices, the hand not holding the electronic device is usually free for intervening in exceptional situations, for example if an incorrect entry has been made. Further, the use of external devices, may decrease reliability or may even hinder the user from performing the detection at all, specifically in case the specific external device is not readily available, e.g. when having been forgotten at home and / or run out of battery.

[0012] Problem to be solved

[0013] It is therefore desirable to provide a method of detecting at least one analyte in a sample of bodily fluid by using a mobile device having at least one camera, a mobile device having at least one camera and a kit comprising the mobile device, which at least partially address the above-mentioned challenges. Specifically, methods and devices shall be proposed, which facilitate performing the detection reaction while one of the user’s hands is busy holding the test element. Summary

[0014] This problem is addressed by a method of detecting at least one analyte in a sample of bodily fluid by using a mobile device having at least one camera, a mobile device having at least one camera, a kit comprising the mobile device, a corresponding computer program and a computer readable storage medium with the features of the independent claims. Advantageous embodiments, which might be realized in an isolated fashion or in any arbitrary combinations, are listed in the dependent claims as well as throughout the specification.

[0015] As used in the following, the terms “have”, “comprise” or “include” or any arbitrary grammatical variations thereof are used in a non-exclusive way. Thus, these terms may both refer to a situation in which, besides the feature introduced by these terms, no further features are present in the entity described in this context and to a situation in which one or more further features are present. As an example, the expressions “A has B”, “A comprises B” and “A includes B” may both refer to a situation in which, besides B, no other element is present in A (i.e. a situation in which A solely and exclusively consists of B) and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D or even further elements.

[0016] Further, it shall be noted that the terms “at least one”, “one or more” or similar expressions indicating that a feature or element may be present once or more than once typically will be used only once when introducing the respective feature or element. In the following, in most cases, when referring to the respective feature or element, the expressions “at least one” or “one or more” will not be repeated, non-withstanding the fact that the respective feature or element may be present once or more than once.

[0017] Further, as used in the following, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features, without restricting alternative possibilities. Thus, features introduced by these terms are optional features and are not intended to restrict the scope of the claims in any way. The invention may, as the skilled person will recognize, be performed by using alternative features. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, without any restriction regarding alternative embodiments of the invention, without any restrictions regarding the scope of the invention and without any restriction regarding the possibility of combining the features introduced in such way with other optional or non-optional features of the invention. In a first aspect of the present invention, a method of detecting at least one analyte in a sample of bodily fluid by using a mobile device having at least one camera is disclosed. The method may also be referred to as “detection method”, “analytical method”, “analytical measurement” and / or simply as “method”. The method comprises the following steps, which specifically may be performed in the given order. However, a different order may also be possible. It is further possible to perform more than one of the method steps in a timely overlapping fashion and / or fully or partially simultaneously. The method may comprise additional method steps, which are not listed. Further, it is possible to perform one, more than one or even all of the method steps repeatedly.

[0018] The method comprises the following steps: a) prompting a user to confirm an application of a sample of bodily fluid to at least one test field of an optical test element, wherein the test field of the optical test element is configured for performing at least one optical detection reaction in the presence of the analyte in the sample of the bodily fluid, wherein the optical detection reaction is observable at at least one predetermined position on the test field; b) receiving, from at least one sensor, at least one item of user response information about a user response, wherein the sensor is one or more of a sensor of the mobile device and a sensor of a connected device connected to the mobile device, e.g. via Bluetooth, wherein the user response comprises one or more of

[0019] - a gesture, and

[0020] - an eye movement; c) deriving, from the item of user response information, at least one item of control information about the status of the application of the sample of bodily fluid; d) if the item of control information indicates that the sample of bodily fluid is applied to the test field of the optical test element, receiving at least one image of at least a part of the test field from the camera, e.g. capturing the image by using the camera; and e) detecting the analyte by evaluating the at least one image.

[0021] The term “detecting an analyte in a sample” as used herein is a broad term and is to be given its ordinary and customary meaning to person of ordinary skill in the art and is not to be limited to a special customized meaning. The term specifically may refer, without limitation, to a quantitative and / or qualitative determination of at least one analyte in an arbitrary sample. For example, the sample may comprise a body fluid, such as blood, interstitial fluid, urine, saliva or other types of body fluids. The result of the analytical method, as an example, may be a concentration of the analyte and / or the presence or absence of the analyte to be determined. Specifically, as an example, the analytical method may be a blood glucose measurement, thus the result of the analytical method may for example be a blood glucose concentration. Additionally or alternatively, as an example, the analytical method may be a urine test, thus the result of the analytical method may for example be on may comprise information on the presence or absence of one of my analytes in the urine sample. In particular, an analytical measurement result value may be determined by the analytical method. Thus, as an example, specifically step e) of the method, may comprise determining the analytical measurement result value, indicating one or more of the concentration of the analyte and / or the presence or absence of the analyte in the sample of bodily fluid.

[0022] The term “sample of bodily fluid” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special customized meaning. The term specifically may refer, without limitation, to an arbitrary aliquot part or aliquant part of a biological fluid, such as a droplet of biological fluid, which directly is a bodily fluid or, which is derived from a bodily fluid, such as by one or more pre-processing steps, e.g. by transferring a bodily fluid to at least one sampling fluid, by diluting a bodily fluid, by centrifugation of the body fluid or the like. The bodily fluid may comprise one or more of saliva, blood, interstitial fluid, urine or other types of body fluids. The sample of bodily fluid may specifically comprise at least one preparation of the bodily fluid, such as a cell preparation of the bodily fluid, e.g. a stain cell preparation of the bodily fluid. The sample of bodily fluid may also be referred to as a “drop of bodily fluid”, a “droplet of bodily fluid” or simply as “sample”.

[0023] The term “mobile device” as used herein is a broad term it is to be given its ordinary and customary meaning to person of ordinary skill in the art and is not to be limited to a special customized meaning. The term specifically may refer, without limitation, to a mobile electronics device, more specifically to a mobile communication device, such as a cell phone and / or a smart phone. Additionally or alternatively, the mobile device may also refer to a notebook, a tablet computer or another type of portable computer having at least one camera. Thus, generally, the mobile device may be selected from the group consisting of a cell phone having at least one camera, specifically a smart phone; a portable computer having at least one camera, specifically at least one of a notebook and a tablet computer. The mobile device may specifically be used for the analytical method, particularly for performing the analytical method, as will be outlined in further detail below. The mobile device, besides the at least one camera, may comprise further elements, such as a processor and one or more displays or screens. As an example, the mobile device may comprise more than one camera, such as a front camera, e.g. arranged on the same side as the one or more displays or screens, and a back camera, e.g. arranged on a side opposing the side on which the front camera is arranged.

[0024] The term “camera” as used herein is a broad term and is to be given its ordinary and customary meaning to the person of ordinary skill in the art and is not to be limited to a special customized meaning. The term specifically may refer, without limitation, to a device having at least one imaging element configured for recording or capturing spatially resolved one dimensional, two-dimensional or even three-dimensional optical data or information. As an example, the camera may comprise at least one camera chip, such as at least one CCD chip and / or at least one CMOS chip configured for recording images. As used herein, without limitation, the term “image” specifically may relates to data recorded by using the camera, such as a plurality of electronic readings from the imaging device, such as the pixels of the camera chip.

[0025] The camera, besides the at least one camera chip or imaging chip, may comprise further elements, such as one or more optical elements, e.g. one or more lenses. As an example, the camera may be a fixed focus camera, having at least one lens, which is fixedly adjusted with respect to the camera. Alternatively, however, the camera may also comprise one or more variable lenses, which may be adjusted, automatically or manually. The invention specifically shall be applicable to cameras as usually used in mobile applications, such as notebook computers, tablets or, specifically, cell phones, such as smart phones. Thus, specifically, the camera may be part of the mobile device which, besides the at least one camera, comprises one or more data processing devices such as one or more data processors. Other cameras, however, a feasible.

[0026] The camera specifically may be a color camera. Thus, such as for each pixel, color in-for- mation may be provided or generated, such as color values for three colors R, G, B. A larger number of color values is also feasible, such as four colors for each pixel, for ex-ample R, G, G, B. Color cameras are generally known to the skilled person. Thus, as an example, each pixel of the camera chip may have three or more different color sensors, such as color recording pixels like one pixel for red (R), one pixel for green (G) and one pixel for blue (B). For each of the pixels, such as for R, G, B, values may be recorded by the pixels, such as digital values in the range of 0 to 255, depending on the intensity of the respective color. Instead of using color triples such as R, G, B, as an example, quadruples may be used, such as R, G, G, B or C, M, Y, K or the like. The color sensitivities of the pixels may be generated by color filters or by appropriate intrinsic sensitivities of the sensor elements used in the camera pixels. These techniques are generally known to the skilled person.

[0027] The mobile device may further comprise at least one processor. The term “processor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary logic circuitry configured for performing basic operations of a computer or system, and / or, generally, to a device which is configured for performing calculations or logic operations. In particular, the processor may be configured for processing basic instructions that drive the computer or system. As an example, the processor may comprise at least one arithmetic logic unit (ALU), at least one floating-point unit (FPU), such as a math co-processor or a numeric co-processor, a plurality of registers, specifically registers configured for supplying operands to the ALU and storing results of operations, and a memory, such as an LI and L2 cache memory. In particular, the processor may be a multi-core processor. Specifically, the processor may be or may comprise a central processing unit (CPU). Additionally or alternatively, the processor may be or may comprise a microprocessor, thus specifically the processor’s elements may be contained in one single integrated circuitry (IC) chip. Additionally or alternatively, the processor may be or may comprise one or more application-specific integrated circuits (ASICs) and / or one or more field-programmable gate arrays (FPGAs) and / or one or more tensor processing unit (TPU) and / or one or more chip, such as a dedicated machine learning optimized chip, or the like. The processor specifically may be configured, such as by software programming, for performing one or more analyte detection operations as will be outlined in further detail below.

[0028] The term “optical test element” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary element or device configured for performing an optical detection reaction, for example a color change detection reaction and / or a reaction during which one or more optically detectable features on or within the test element become observable and / or discernable, such as one or more markings, such as linear markings known from rapid CO VID testing. The optical test element may also simply be referred to as “test element”. The optical test element may be embodied as a test strip, a test card, a test paper, a test tape or as a test stick. The optical test element may particularly have the at least one test field containing at least one test chemical being sensitive for the property of the sample, such as for detecting the at least one analyte. In particular, the test field may be or may comprise a coherent amount of the test chemical and may be a field of round, polygonal or rectangular shape, e.g. having one or more layers of material, with at least one layer of the test field having the test chemical comprised therein. The optical test element may, as an example, comprise one or more application sites for applying the at least one sample of bodily fluid. The application side may be different from the position of the test field and may be fluidically connected to the test field, such as by one or more capillary elements, such as one or more porous elements capable of transporting liquid. The optical test element, as an example, may comprise at least one substrate, such as at least one carrier, with the at least one test field applied thereto or integrated therein. Additionally or alternatively, the optical test element may be embodied as a stick, such as a dip-stick, configured for applying the sample of bodily fluid to the test field by being dipped into the sample of bodily fluid. These test elements are generally widely in use and available. One optical test element may carry a single test field or a plurality of test fields having identical or different test chemicals comprised therein. For example, the optical test element may be configured for performing at least one color change detection reaction for detecting blood glucose in the sample of bodily fluid, such as a blood glucose test. Alternatively or additionally, as another example, the test element may comprise at least one lateral flow essay, specifically at least one lateral flow essay configured for performing at least one reaction during which one or more optically detectable features on or within the test element become observable, e.g. visible, for detecting a presence of an analyte in the sample of the body fluid, such as in a urine sample. Various further options may also be feasible.

[0029] The term “sensor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary element configured for one or more of detecting, measuring or monitoring at least one measurement variable or measurement property. Specifically, the sensor may be capable of generating at least one signal, such as a measurement signal, e.g. an electrical signal, which is a qualitative or quantitative indicator of the measurement variable and / or measurement property. In particular, the sensor may be capable of generating at least one signal in reaction to a user response, such as to a response of the user in reaction to being prompted to perform a specific action.

[0030] The term “connected device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary gadget and / or wearable connected to the mobile device. In particular, the connected device may be connected to the mobile device, such that information may be transferrable from the connected device to the mobile device and optionally vice versa. Specifically, the connected device may be connected to the mobile device by means for transferring or exchanging information from the connected device to the mobile device or between the connected device and the mobile device. As an example, the connected device may be connected to the mobile device by one or more wire bound connections and / or wireless connections, such as via Bluetooth, NFC, inductive coupling or the like. The connected device, as an example, may be or may comprise at least one gadget and / or wearable selected from the group consisting of an augmented reality headset, a virtual reality headset, a pair of smart glasses, and a hearable, such as smart ear- or headphones. Other wearables or gadgets, such as smart watches, however, are also feasible.

[0031] The term “prompting as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to at least one of requesting, asking, suggesting and inviting the user to perform a specific action. Specifically, the prompting may comprise providing a notification to the user, such as one or more of a visual notification, and acoustic modification and a haptic notification, the notification specifically requesting the user to perform the specific action.

[0032] The term “item of user response information” as used herein is a broad term it is to be given its ordinary and customary meaning to person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to at least one item of information indicating a user response, such as an item of information on and / or about a user response. In particular, the item of user response information may comprise information on the user response, such as to the response of the user in reaction to being prompted to perform a specific action. The item of user response information may be or may comprise at least one numerical and / or alphanumerical item of information, configured for indicating the user response. As an example, the item of user response information may be or may comprise at least one indicator and / or pointer and / or reference to at least one user response, such as to a user response listed in a predefined and / or predetermined list of identifiable user responses. Thus, as a simple example, the item of user response information may comprise a pointer to a specific entry within the list of identifiable user responses, such as to a shaking or nodding of the user’s head and / or to and up-and-down or right-left movement of the user’s eyes. Additionally or alternatively, however, item of user response information may comprise information on and / or about a more complex user response, such as to a gesture, e.g. a heads gesture, and / or an eye movement, for example following a predefined and / or predetermined pattern, when reacting to being prompted to perform a specific action.

[0033] The term “item of control information” as used herein is a broad term and is to be given its ordinary and customary meaning to a person skilled in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to at least one item of information, e.g. one or more numerical values, which indicate the status of the application of the sample of bodily fluids to the optical test element. In particular, the item of control information may be or may comprise at least one item information on and / or about the status of the sample application. As an example, the item of control information may be or may comprise information indicating that the sample of bodily fluid has not yet been applied to the test field, is currently being applied to the test field or has already been applied to the test field.

[0034] The item of control information may for example comprise Boolean information, such as “applied” or “not applied”. Specifically, the item of control information may comprise Boolean information indicating one of

[0035] - the sample of bodily fluid is applied to the test field; and

[0036] - the sample of bodily fluid is not (yet) applied to the test field and / or the application of the sample of bodily fluid is still in process.

[0037] Thus, the item of control information may, for example, indicate that the sample of bodily fluid applied and / or has been applied to the test field. Alternatively, the item of control information may, for example, indicate that the sample of bodily fluid is not applied to the test field, is not yet applied to the test field and / or that the application of the sample to the test field is still in process.

[0038] The sensor, specifically the sensor used in step b), may specifically be one or more of a camera and an accelerometer. In particular, the sensor may be one or more of the at least one camera, e.g. at least one back camera, of the mobile device, at least one second camera of the mobile device, e.g. at least one front camera of the mobile device, and an accelerometer of the mobile device. Additionally or alternatively, the sensor may be one or more of a camera and an accelerometer of the connected device. For example, the sensor may be at least one camera of an augmented reality headset, of a virtual reality headset, of a pair of smart glasses, and / or of one or more hearables. Further, as an additional or alternative example, the sensor may be at least at least one accelerometer of an augmented reality headset, of a virtual reality headset, of a pair of smart glasses, and / or of one or more hearables. Specifi cally , in case the sensor is or comprises the camera of the mobile device, such as the front camera of the mobile device, step b) may comprise receiving from the camera the at least one item of user response information. As an example, in case the sensor is or comprises the camera of the mobile device, such as the front camera of the mobile device, step b) may comprise capturing the at least one user response by using the camera, e.g. the front camera, of the mobile device.

[0039] The gesture may be one or more of a head gesture and a hand gesture, such as a gesture performed by the user with one or more of (i) the head of the user and (ii) the hand of the user holding the mobile device. In particular, the head gesture may be one or more of shaking and nodding, wherein the hand gesture may be one or more of shaking and rotating the mobile device. Thus, as an example, the gesture may be a head gesture performed by the user’s head, for example one or more of a nodding, such as an up-down movement of the user’s head, and a shaking, such as a right-left and / or turning movement of the user’s head. Additionally or alternatively, the gesture may be a hand gesture performed by the user’s hand, which is holding the mobile device, for example one or more of a shaking movement, e.g. an up-down, back and forth, and / or right-left movement, of the mobile device, and / or a turning movement, e.g. a rotating movement, of the mobile device.

[0040] The user response in step b) may additionally comprise a sound, such as a vocal command, generated by the user. Thus, an additional user response may for example be or may comprise a spoken word and / or phrase. Specifically, in case the user response additionally comprises the sound, the sensor from which the at least one item of user response information about the sound may be received, may be a microphone, particularly a microphone of one of more of the mobile device and the connected device.

[0041] In particular, for deriving the item of control information from the item of user response information, two or more of the user responses may be used. In other words, in step b), two or more of the user responses may be used for generating two or more items of user response information, which may then, particularly in step c), be used for deriving the item of control information. Thus, as an example, one, more than one or even all of the user responses may be taken into account for deriving the at least one item of control information. For example, in step b), at least one item of user response information may be received from the at least one sensor for each of the user responses, e.g. resulting in exactly one item of user response information about and / or on exactly one user response. Step c) may further comprise deriving the item of control information about the status of the application of the sample of bodily fluid, based on more than one item of user response information, e.g. on the plurality of items of user response information. In particular, as an example, the item of control information may indicate that the sample of bodily fluid has been applied to the test field, in case a majority of the items of user response information indicate that the application has already happened. Similarly, as an example, the item of control information may indicate that the sample of bodily fluid has not been applied to the test field, in case a majority of the items of user response information indicates that the application has not happened. Additionally or alternatively, step c) may further comprise a plausibility check based on the consensus of the items of user response information, e.g. only deriving the item of control information in case all the items of user response information indicate the same status of the application of the sample of bodily fluid. Specifically, the plausibility check may indicate an error in case the items of user response information indicate that there is no consensus on the status of the sample application, e.g. resulting in a repetition of steps b) and c) of the method.

[0042] In case in step b) the user response comprises the eye movement, in step c) the captured eye movement may be compared to a predefined eye movement pattern, such as to a line of sight tracking pattern, for deriving the item of control information. For example, in case the captured eye movement corresponds to one of the predefined patterns, the item of control information may indicate that the drop of bodily fluid is applied and / or has been applied. Alternatively, for example, in case the captured eye movement does not correspond to one of the predefined patterns, the item of control information may indicate that the drop of bodily fluid is not applied and / or has not been applied yet.

[0043] The method, specifically before performing step a), e.g. in an initial set-up run, may further comprise f) prompting the user to one or more of

[0044] - indicate whether or not the user has at least one vision condition, specifically a vision condition preventing a standard line of sight, such as a vision condition from a predefined list of vision conditions, and

[0045] - select none, one or more than one vision conditions that apply to the user from a predefined list of vision conditions.

[0046] The predefined list of vision conditions may specifically comprise one or more of: nystagmus, amblyopia, strabism, anisocoria, and ocular prosthesis. The method may further comprise: g) automatically detecting whether or not a vision condition applies to the user from the item of user response information received in step b), by evaluating the user’s eye movement.

[0047] In particular, evaluating the user’s eye movement may be or may comprise a comparison of the captured user’s eye movement to a predefined pattern of eye movements typical for vision conditions. Alternatively however, evaluating the user’s eye movement may be or may comprise simply registering a varying and / or implausible item of user response information about the eye movement, e.g. the result of an eye tracking, for example based on an error in tracking and / or capturing of the eye movement or movements as the user response. In particular, the tracking and / or capturing of the eye movement or movements may also be referred to as line of sight control and / or line of sight tracking. These tracking techniques are generally known to the skilled person. Thus, in step g), it may be detected that a vision condition applies to the user in case an error occurs during one or steps b) and c), e.g. indicating that the eye tracking and / or capturing the user’s eye movement, i.e. the deriving of the item of control information from the item of user response information about the user’s eye movement, is faulty.

[0048] In step g), in case a standard line of sight is not detectable within a predefined amount of time, a vision condition may be detected. As an example, in step g), it may be considered that a vision condition applies to the user, if a standard line of sight is not detectable within a predefined amount of time.

[0049] Specifically, in case a vision condition is detected, e.g. in case it is considered that a vision condition applies to the user, the method may further comprise one or more of:

[0050] - cancelling the eye movement from the possible user response in step b), and

[0051] - taking the vision condition into account when performing step c), e.g. by comparing the user’ s eye movements to one or more of a predefined adapted set of eye movements, such as an adapted eye movement pattern.

[0052] As an example, one or both of the limitations referred to in the previous paragraph may also be accompanied by an information and / or a confirmation request to the user. Such an information and / or confirmation request may specifically be provided to the user visually and / or auditory. For example, visually via the display and / or screen of the mobile device, e.g. by showing an error message, and / or auditory via one or more speakers of the mobile device, e.g. by generating at least one error indicating sound. Step c) may be adapted according to a user’s experience level, wherein the user’s experience level may be set automatically based on a number of performed analyte detections by the user. As an example, the deriving of the item of control information in step c) may take into account an amount of time the user watched the display and / or screen after the prompting in step a), such as the amount of time the user required to respond to the prompting of step a), e.g. the amount of time that has passed between the prompting in step a) and the receiving of the item of user response information in step b). Based on the user’s experience level, the amount of time considered “norma in step c) may be adapted and / or set automatically based on the number of performed analyte detections by the user. For example, in step c), a minimum amount of time for watching the screen may be reduced based on a user’s experience level, before deriving that the drop of bodily fluid is applied.

[0053] The method may further comprise one or more of the following steps: h) prompting a user to confirm the user’s readiness for sample application; i) receiving at least one further item of user response information on a further user response from the at least one sensor, wherein the further user response comprises one or more of

[0054] - a gesture, and

[0055] - an eye movement; j) deriving, from the further item of user response information, at least one further item of control information on the user’s readiness for sample application.

[0056] In particular, the method may be fully or partially computer-implemented. Specifically, at least steps a) to e), and optionally one or more of steps f) to j), of the method may be computer-implemented, e.g. performed by the mobile device.

[0057] The term “computer-implemented” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a method involving at least one computer and / or at least one computer network, such as the mobile device. The computer and / or computer network, e.g. the mobile device as defined above, may comprise at least one processor which is configured for performing at least one of the method steps of the method according to the present invention, such as of the analytical method. Preferably, each of the method steps may be performed by the mobile device. In a further aspect of the present invention, a mobile device having at least one camera is disclosed. The mobile device is configured for detecting at least one analyte in a sample of bodily fluid by using the following steps:

[0058] A) prompting a user to confirm an application of a sample of bodily fluid to at least one test field of an optical test element, wherein the test field of the optical test element is configured for performing at least one optical detection reaction in the presence of the analyte in the sample of the bodily fluid, wherein the optical detection reaction is observable at at least one predetermined position on the test field;

[0059] B) receiving, from at least one sensor of one or more of the mobile device and a connected device connected to the mobile device, e.g. via Bluetooth, at least one item of user response information on a user response, wherein the user response comprises one or more of

[0060] - a gesture, and

[0061] - an eye movement;

[0062] C) deriving, from the item of user response information, at least one item of control information about the status of the application of the sample of bodily fluid;

[0063] D) if the item of control information indicates that the sample of bodily fluid is applied to the test field of the optical test element, receiving at least one image of at least a part of the test field from the camera, e.g. by capturing at least one image of at least a part of the test field by using the camera;

[0064] E) detecting the analyte by evaluating the at least one image.

[0065] The mobile device may specifically be configured for performing the method as outlined herein, e.g. the analytical method. Thus, for definitions and options of the mobile device, reference may be made to the description of the method given above or as further outlined below. The mobile device may specifically be configured for performing at least steps a) to e), and optionally one or more of steps f) to j), of the method according to the present invention, such as according to any one of the embodiments disclosed above and / or according to any one of the embodiments described in further detail below. Thus, the processor of the mobile device may be software-configured for performing and / or controlling the execution of the method, e.g. at least one of steps a) to e) of the analytical method, wherein optionally also steps f) to j) may at least partially be controlled and / or supported by the processor.

[0066] As outlined above, the mobile device may comprise at least one processor being programmed for controlling at least steps a) to e), and optionally at least one of steps f) to j), of the analytical method. For definitions and options regarding the design of the processor, reference may be made to the description given above. In a further aspect of the present invention, a kit is described. The kit comprises the mobile device as described herein above or as described in further detail below. The kit further comprises at least one optical test element having at least one test field configured for performing at least one optical detection reaction in the presence of the analyte in the sample of the bodily fluid, wherein the optical detection reaction is observable at at least one predetermined position on the test field. For definitions and options of the mobile device and of the optical test element, reference may be made to the description of the method given above or as further outlined below.

[0067] The term “kit” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an assembly of a plurality of components, wherein the components each may function and may be handled independently from each other, wherein the components of the kit may interact to perform a common function.

[0068] In a further aspect of the present invention, a computer program is disclosed. The computer program comprises instructions which, when the program is executed by the mobile device as described herein, cause the mobile device to perform the method as also described herein, e.g. the analytical method. In particular, the computer program may include computer-executable instructions for performing the analytical method in one or more of the embodiments enclosed herein when the instructions are executed on the mobile device. Specifically, the computer program may be stored on a computer-readable data carrier and / or on a computer- readable storage medium.

[0069] In a further aspect of the present invention, a computer-readable storage medium is disclosed. The computer-readable storage medium comprising instructions, which, when the instructions are executed by the mobile device as described herein, cause the mobile device to perform the method as also described herein, e.g. the analytical method.

[0070] As used herein, the terms “computer-readable data carrier” and “computer-readable storage medium” specifically may refer to non-transitory data storage means, such as a hardware storage medium having stored thereon computer-executable instructions. The computer- readable data carrier or storage medium specifically may be or may comprise a storage medium such as a random-access memory (RAM) and / or a read-only memory (ROM). Thus, specifically, one, more than one or even all of method steps a) to e), and optionally steps f) to j), as indicated above, may be performed by using a computer or a computer network, e.g. the mobile device, preferably by using the computer program.

[0071] The invention in any one of the aspects described herein may provide for a large number of advantages over known methods and devices of this kind. Thus, specifically, the invention may address the technical challenges referred to above. As outlined above, smart phonebased methods typically require both hands for handling and operating the smart phone, wherein one hand is holding the smart phone, while the other hand is used for pressing in app buttons while performing the method, i.e. to follow the measurement sequence.

[0072] The present invention may allow for an improved and / or more user friendly handling of the mobile device, e.g. the smart phone, for performing analytical measurements. Thus, performing the analytical measurement may be more comfortable by allowing the user to keep holding the optical test element in one hand, without require requiring it to be placed on a surface, such as on a desk and / or chair. In particular, the proposed methods and devices may simplify and analyte detection by allowing the performance of the analytical measurement while only using one hand for holding and operating the mobile device, e.g. the smart phone.

[0073] Further, a measurement safety may be significantly improved by the proposed methods and devices. In particular, by the user being able to keep holding the optical test element in one hand without having to place it on a surface, the risk of contamination of the surface with the sample of bodily fluid may be minimized, thereby increasing the user’s safety during and after performing the analytical method, e.g. the analytical measurement. Furthermore, due to a plausibility test taking into account more than one user response, incorrect entries and / or unintended selections during the performance of the analytical measurement may be minimized and / or even eradicated, thereby further increasing measurement safety.

[0074] Summarizing and without excluding further possible embodiments, the following embodiments may be envisaged:

[0075] Embodiment 1. A method of detecting at least one analyte in a sample of bodily fluid by using a mobile device having at least one camera, the method comprising: a) prompting a user to confirm an application of a sample of bodily fluid to at least one test field of an optical test element, wherein the test field of the optical test element is configured for performing at least one optical detection reaction in the presence of the analyte in the sample of the bodily fluid, wherein the optical detection reaction is observable at at least one predetermined position on the test field; b) receiving, from at least one sensor, at least one item of user response information about a user response, wherein the sensor is one or more of a sensor of the mobile device and a sensor of a connected device connected to the mobile device, e.g. via Bluetooth, wherein the user response comprises one or more of

[0076] - a gesture, and

[0077] - an eye movement; c) deriving, from the item of user response information, at least one item of control information about the status of the application of the sample of bodily fluid; d) if the item of control information indicates that the sample of bodily fluid is applied to the test field of the optical test element, receiving at least one image of at least a part of the test field from the camera, e.g. capturing the image by using the camera; and e) detecting the analyte by evaluating the at least one image.

[0078] Embodiment 2. The method according to the preceding embodiment, wherein the item of control information comprises Boolean information, such as “applied” or “not applied”, specifically indicating one of

[0079] - the sample of bodily fluid is applied to the test field; and

[0080] - the sample of bodily fluid is not (yet) applied to the test field and / or the application of the sample of bodily fluid is still in process.

[0081] Embodiment s. The method according to any one of the preceding embodiments, wherein the sensor is one or more of the at least one camera, e.g. at least one back camera, of the mobile device, at least one second camera of the mobile device, e.g. at least one front camera of the mobile device, at least one accelerometer of the mobile device, at least one camera of the connected device, such as at least one camera of an augmented reality headset, of a virtual reality headset, of a pair of smart glasses, and / or of one or more hearables, and at least one accelerometer of the connected device, such as at least one accelerometer of an augmented reality headset, of a virtual reality headset, of a pair of smart glasses, and / or of one or more hearables.

[0082] Embodiment 4. The method according to the preceding embodiment, wherein the connected device is one or more of an augmented reality headset, a virtual reality headset, a pair of smart glasses, and one or more hearables. Embodiment 5. The method according to any one of the two preceding embodiments, wherein in case the sensor is the camera of the mobile device, specifically the front camera of the mobile device, step b) comprises receiving from the camera the at least one item of user response information, e.g. capturing the at least one user response by using the camera.

[0083] Embodiment 6. The method according to any one of the preceding embodiments, wherein the gesture is one or more of a head gesture and a hand gesture, such as a gesture performed by the user with one or more of (i) the head of the user and (ii) the hand of the user holding the mobile device.

[0084] Embodiment 7. The method according to the preceding embodiment, wherein the head gesture is one or more of shaking and nodding, and / or wherein the hand gesture is one or more of shaking and rotating the mobile device.

[0085] Embodiment 8. The method according to any one of the preceding embodiments, wherein the user response in step b) additionally comprises a sound, such as a vocal command, generated by the user.

[0086] Embodiment 9. The method according to any one of the preceding embodiments, wherein in case in step b) the user response comprises the eye movement, in step c) the captured eye movement is compared to a predefined eye movement pattern, such as a line of sight tracking pattern, for deriving the item of control information.

[0087] Embodiment 10. The method according to any one of the preceding embodiments, wherein the method, specifically before performing step a), e.g. in an initial set-up run, comprises f) prompting the user to one or more of

[0088] - indicate whether or not the user has at least one vision condition, specifically a vision condition preventing a standard line of sight, such as a vision condition from a predefined list of vision conditions, and

[0089] - select none, one or more than one vision conditions that apply to the user from a predefined list of vision conditions.

[0090] Embodiment 11. The method according to the preceding embodiment, wherein the predefined list of vision conditions comprises one or more of nystagmus, amblyopia, strabism, anisocoria, and ocular prosthesis. Embodiment 12. The method according to any one of the preceding embodiments, wherein the method comprises g) automatically detecting whether or not a vision condition applies to the user from the item of user response information received in step b), by evaluating the user’s eye movement.

[0091] Embodiment 13. The method according to the preceding embodiment, wherein in step g), in case a standard line of sight is not detectable within a predefined amount of time, a vision condition is detected.

[0092] Embodiment 14. The method according to any one of the four preceding embodiments, wherein in case a vision condition is detected, the method comprises one or more of

[0093] - cancelling the eye movement from the possible user response in step b), and

[0094] - taking the vision condition into account when performing step c), e.g. by comparing the user’ s eye movements to one or more of a predefined adapted set of eye movements, such as an adapted eye movement pattern.

[0095] Embodiment 15. The method according to any one of the preceding embodiments, wherein step c) is adapted according to a user’s experience level, wherein the user’s experience level is set automatically based on a number of performed analyte detections by the user.

[0096] Embodiment 16. The method according to any one of the preceding embodiments, wherein the method further comprises: h) prompting a user to confirm the user’s readiness for sample application; i) receiving at least one further item of user response information on a further user response from the at least one sensor, wherein the further user response comprises one or more of

[0097] - a gesture, and

[0098] - an eye movement; j) deriving, from the further item of user response information, at least one further item of control information on the user’s readiness for sample application.

[0099] Embodiment 17. The method according to any one of the preceding embodiments, wherein the method is computer-implemented, specifically steps a) to e), and optionally one or more of steps f) to j), are computer-implemented. Embodiment 18. A mobile device having at least one camera, the mobile device being configured for detecting at least one analyte in a sample of bodily fluid by using the following steps:

[0100] A) prompting a user to confirm an application of a sample of bodily fluid to at least one test field of an optical test element, wherein the test field of the optical test element is configured for performing at least one optical detection reaction in the presence of the analyte in the sample of the bodily fluid, wherein the optical detection reaction is observable at at least one predetermined position on the test field;

[0101] B) receiving, from at least one sensor of one or more of the mobile device and a connected device connected to the mobile device, e.g. via Bluetooth, at least one item of user response information on a user response, wherein the user response comprises one or more of

[0102] - a gesture, and

[0103] - an eye movement;

[0104] C) deriving, from the item of user response information, at least one item of control information about the status of the application of the sample of bodily fluid;

[0105] D) if the item of control information indicates that the sample of bodily fluid is applied to the test field of the optical test element, receiving at least one image of at least a part of the test field from the camera, e.g. by capturing at least one image of at least a part of the test field by using the camera;

[0106] E) detecting the analyte by evaluating the at least one image.

[0107] Embodiment 19. The mobile device according to the preceding embodiment, wherein the mobile device is configured for performing the method according to any one of the preceding embodiments referring to a method.

[0108] Embodiment 20. A kit comprising the mobile device according to any one of the preceding embodiments referring to a mobile device, the kit further comprising at least one optical test element having at least one test field configured for performing at least one optical detection reaction in the presence of the analyte in the sample of the bodily fluid, wherein the optical detection reaction is observable at at least one predetermined position on the test field.

[0109] Embodiment 21. A computer program comprising instructions which, when the program is executed by the mobile device according to any one of the preceding embodiments referring to a mobile device, cause the mobile device to perform the method according to any one of the preceding embodiments referring to a method. Embodiment 22. A computer-readable storage medium comprising instructions, which, when the instructions are executed by the mobile device according to any one of the preceding embodiments referring to a mobile device, cause the mobile device to perform the method according to any one of the preceding embodiments referring to a method.

[0110] Short description of the Figures

[0111] Further optional features and embodiments will be disclosed in more detail in the subsequent description of embodiments, preferably in conjunction with the dependent claims. Therein, the respective optional features may be realized in an isolated fashion as well as in any arbitrary feasible combination, as the skilled person will realize. The scope of the invention is not restricted by the preferred embodiments. The embodiments are schematically depicted in the Figures. Therein, identical reference numbers in these Figures refer to identical or functionally comparable elements.

[0112] In the Figures:

[0113] Figure 1 shows an embodiment of a kit and a mobile device configured for detecting at least one analyte in a sample of bodily fluid; and

[0114] Figures 3 to 6 show different flowcharts of a method of detecting at least one analyte in a sample of bodily fluid by using a mobile device having at least one camera.

[0115] Detailed description of the embodiments

[0116] In Figure 1, an exemplary embodiment of a kit 110 is shown in a perspective view. The kit 110 comprises a mobile device 112, such as for example a smart phone, having at least one camera 114 and being configured for detecting at least one analyte in a sample of bodily fluid. The kit 110 further comprises at least one optical test element 116 having at least one test field 118 configured for performing at least one optical detection reaction in the presence of the analyte in the sample of the bodily fluid. The optical detection reaction is observable at at least one predetermined position on the test field 118. The mobile device 112, besides the camera 114, further comprises at least one processor 120 and at least one display 122. As an example, the mobile device 112 may comprise more than one camera 114, such as a front camera 124 and a back camera 126. In particular, the mobile device 112 is configured for detecting the at least one analyte in the sample of bodily fluid by using the following steps:

[0117] A) prompting a user to confirm an application of a sample of bodily fluid to at least one test field of an optical test element, wherein the test field of the optical test element is configured for performing at least one optical detection reaction in the presence of the analyte in the sample of the bodily fluid, wherein the optical detection reaction is observable at at least one predetermined position on the test field;

[0118] B) receiving, from at least one sensor of one or more of the mobile device and a connected device connected to the mobile device, e.g. via Bluetooth, at least one item of user response information on a user response, wherein the user response comprises one or more of

[0119] - a gesture, and

[0120] - an eye movement;

[0121] C) deriving, from the item of user response information, at least one item of control information about the status of the application of the sample of bodily fluid;

[0122] D) if the item of control information indicates that the sample of bodily fluid is applied to the test field of the optical test element, receiving at least one image of at least a part of the test field from the camera, e.g. by capturing at least one image of at least a part of the test field by using the camera;

[0123] E) detecting the analyte by evaluating the at least one image.

[0124] Specifically, the mobile device 112 may be configured, for example by appropriate programming of the processor 120 of the mobile device 112, for performing at least steps a) to e) of a method 127 of detecting at least one analyte in a sample of bodily fluid. The method 127 will be described with reference to exemplary embodiments shown in flowcharts illustrated in Figures 2 to 6.

[0125] The method 127 of detecting at least one analyte in a sample of bodily fluid by using a mobile device 112 having at least one camera 114 comprises the following steps, which may specifically be performed in the given order. Still, a different order 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, more than one or even all of the method steps once or repeatedly. The method may comprise additional method steps, which are not listed. The method steps of the method 127 are the following: a) (denoted by reference number 128) prompting a user to confirm an application of a sample of bodily fluid to at least one test field 118 of an optical test element 116, wherein the test field 118 of the optical test element 116 is configured for performing at least one optical detection reaction in the presence of the analyte in the sample of the bodily fluid, wherein the optical detection reaction is observable at at least one predetermined position on the test field 118; b) (denoted by reference number 130) receiving, from at least one sensor, at least one item of user response information about a user response, wherein the sensor is one or more of a sensor of the mobile device 112 and a sensor of a connected device connected to the mobile device 112, e.g. via Bluetooth, wherein the user response comprises one or more of

[0126] - a gesture, and

[0127] - an eye movement; c) (denoted by reference number 132) deriving, from the item of user response information, at least one item of control information about the status of the application of the sample of bodily fluid; d) (denoted by reference number 134) if the item of control information indicates that the sample of bodily fluid is applied to the test field 118 of the optical test element 116, receiving at least one image of at least a part of the test field 118 from the camera 114, e.g. capturing the image by using the camera 114; and e) (denoted by reference number 136) detecting the analyte by evaluating the at least one image.

[0128] Further, as an example, step d), i.e. the branching point 134, may indicate a condition query, such as deciding between a first branch 138 and a second branch 140. For example, the condition query may make use of the item of control information. The item of control information may comprise Boolean information, such as “applied” or “not applied”. As an example, the first branch 138 indicates that the sample of bodily fluid is applied to the test field 118. Thus, the first branch 138 leads to step e) 136, wherein an analytical measurement result value indicating one or more of the concentration of the analyte and / or the presence or absence of the analyte in the sample of bodily fluid may be determined. The second branch 140 may indicate that the sample of bodily fluid is not (yet) applied to the test field 118 and thus, may lead to step b) 130, as exemplarily illustrated in Figures 2 to 4. Additionally or alternatively, specifically in case a predefined amount of time may be exceeded, the method 127 may be aborted (not illustrated in the Figures) or a warning and / or error message may be illustrated on the display (denoted by reference number 141).

[0129] As exemplarily illustrated in Figure 3, the method 127 may further, for example in an initial set-up run, such as only in a first performance of the method, comprise step f) (denoted by reference number 142) of prompting the user to one or more of indicating whether or not the user has at least one vision condition and selecting none, one or more than one vision conditions that apply to the user from a predefined list of vision conditions. Such a predefined list of vision conditions may comprise one or more of nystagmus, amblyopia, strabism, an- isocoria, and ocular prosthesis and the like.

[0130] As exemplarily illustrated in Figure 4, the method 127 may further comprise step g) (denoted by reference number 144) of automatically detecting whether or not a vision condition applies to the user from the item of user response information received in step b), by evaluating the user’s eye movement. In particular, a vision condition may be detected in step g) in case a standard line of sight of the user may not be detectable within a predefined amount of time.

[0131] As an example, step g) may specifically be part of the method 127 if the method has been run at least once before or in case the user, e.g. during performing step f), selected none of the vision conditions.

[0132] Further, but not illustrated in the Figures, specifically before performing step a), the method 127 may comprise the following steps: h) prompting a user to confirm the user’s readiness for sample application; i) receiving at least one further item of user response information on a further user response from the at least one sensor, wherein the further user response comprises one or more of

[0133] - a gesture, and

[0134] - an eye movement; j) deriving, from the further item of user response information, at least one further item of control information on the user’s readiness for sample application.

[0135] Additionally or alternatively, the method 127 may comprise further steps. As shown in Figure 5, the method 127 of detecting at least one analyte in a sample of bodily fluid by using a mobile device 112 having at least one camera 114 may be initiated by starting the method sequence (denoted by reference number 146). Further, information may be illustrated (denoted by reference number 148) on the display 122 of the mobile device 112, e.g. informing the user about the progress of performing the method 127, this may also simply be referred to as “default operation” of the method 127. Then, in case a user interaction is required (denoted by reference number 150), one of steps a) 128 or h) may be performed. In case no user interaction is required, the method may continue with the default operation 148. After steps a) 128 or h) are performed, steps b) 130 or i) may be performed respectively. As an example, the item of user response information about the user response may be received, e.g. a gesture detection may be performed. In the subsequent steps c) 134 or j), a condition query 152 may decide whether a defined gesture was detected, i.e. by the first branch 154, or not, e.g. by the second branch 156. In case one or more of the defined gestures, for example indicating that the sample was applied to the test field 118 or that the user is ready for sample application, was detected, i.e. following the first branch 154, the item of control information may be set to “applied” or “ready”, respectively. If, however, none of the defined gestures was detected or the detected gesture indicates that the sample has not (yet) been applied, e.g. “not applied”, or the user is “not ready”, it may be checked whether a defined timeout has been reached. If the time out has been reached, an error message may be illustrated 141. If the time out has not been reached, the method 127 may be reset to steps b) 130 or i) respectively.

[0136] As an example, the optical test element 116 may be a urine dip stick. An example of the method 127 performed with the urine dip stick is exemplarily illustrated in Figure 6. After starting the method sequence 146, information may be illustrated 148 on the display 122 of the mobile device 112, such as instructing the user to prepare the urine dip stick, e.g. a urine dip stick test (denoted by reference number 162). For this purpose, as an example, instructions may be provided in form of one or more of text, an animation, a video or the like (denoted by reference number 164). This step may require a user confirmation to proceed (denoted by reference number 166). Further, optionally, a blank scan (denoted by reference number 168) of the optical test element may be performed, such as by capturing an image of the optical test element without having the sample applied to the test field 118. Then, the user may be instructed to run the urine dip stick test (denoted by reference number 170). For this purpose, again, as an example, instructions may be provided in form of one or more of text, an animation, a video or the like (denoted by reference number 164). Then, steps a) 128 to d) 134, at least partially, may be performed subsequently or at least partially in a timely overlapping fashion. In case the item of control information indicates that the urine sample is applied to the dip stick test, according to step d) 134 of the method 127, at least one image of the urine dip stick may be captured (denoted by reference number 172) by using the camera 114. This step 172 may also be referred to as “final scan”. Then, from the “final scan”, in the method 127, it may be continued to perform step e) 136, which may comprise calculating and displaying the analytical measurement result value indicating the presence or absence of one or more analyte in the urine sample (denoted by reference number 174). Further, step e) may comprise one or more of instructing the user to discard the urine dip stick (denoted by reference number 176) and asking the user to confirm receiving the measurement result (denoted by reference number 178). List of reference numbers

[0137] 110 kit

[0138] 112 mobile device

[0139] 114 camera

[0140] 116 optical test element

[0141] 118 test field

[0142] 120 processor

[0143] 122 display

[0144] 124 front camera

[0145] 126 back camera

[0146] 127 analytical method

[0147] 128 step a)

[0148] 130 step b)

[0149] 132 step c)

[0150] 134 step d)

[0151] 136 step e)

[0152] 138 first branch

[0153] 140 second branch

[0154] 141 illustrate error message

[0155] 142 step f)

[0156] 144 step g)

[0157] 146 starting the method sequence

[0158] 148 illustrating information

[0159] 150 check whether user interaction is required

[0160] 152 condition query

[0161] 154 first branch

[0162] 156 second branch

[0163] 158 set item of control information to “applied” or “ready”

[0164] 160 check whether timeout has been reached

[0165] 162 instructing the user to prepare a urine dip stick

[0166] 164 providing instructions

[0167] 166 user confirmation to proceed

[0168] 168 blank scan

[0169] 170 instructing user to run the urine dip stick test

[0170] 172 final scan

[0171] 174 calculating and displaying the analytical measurement result value 176 instructing the user to discard the urine dip stick

[0172] 178 asking the user to confirm receiving the measurement result

Claims

Claims1. A method of detecting at least one analyte in a sample of bodily fluid by using a mobile device (112) having at least one camera (114), the method comprising: a) prompting a user to confirm an application of a sample of bodily fluid to at least one test field (118) of an optical test element (116), wherein the test field (118) of the optical test element (116) is configured for performing at least one optical detection reaction in the presence of the analyte in the sample of the bodily fluid, wherein the optical detection reaction is observable at at least one predetermined position on the test field (118); b) receiving, from at least one sensor, at least one item of user response information about a user response, wherein the sensor is one or more of a sensor of the mobile device (112) and a sensor of a connected device connected to the mobile device (112), wherein the user response comprises one or more of- a gesture, and- an eye movement; c) deriving, from the item of user response information, at least one item of control information about the status of the application of the sample of bodily fluid; d) if the item of control information indicates that the sample of bodily fluid is applied to the test field (118) of the optical test element (116), receiving at least one image of at least a part of the test field (118) from the camera (114); and e) detecting the analyte by evaluating the at least one image.

2. The method according to the preceding claim, wherein the item of control information comprises Boolean information, such as “applied” or “not applied”.

3. The method according to any one of the preceding claims, wherein the sensor is one or more of the at least one camera (114) of the mobile device (112), at least one second camera of the mobile device (112), at least one accelerometer of the mobile device (112), at least one camera of the connected device, and at least one accelerometer of the connected device.

4. The method according to any one of the preceding claims, wherein the gesture is one or more of a head gesture and a hand gesture, such as a gesture performed by the user with one or more of (i) the head of the user and (ii) the hand of the user holding the mobile device (112).

5. The method according to any one of the preceding claims, wherein the user response in step b) additionally comprises a sound generated by the user.

6. The method according to any one of the preceding claims, wherein in case in step b) the user response comprises the eye movement, in step c) the captured eye movement is compared to a predefined eye movement pattern.

7. The method according to any one of the preceding claims, wherein the method comprises f) prompting the user to one or more of- indicate whether or not the user has at least one vision condition, and- select none, one or more than one vision conditions that apply to the user from a predefined list of vision conditions; wherein the predefined list of vision conditions comprises one or more of nystagmus, amblyopia, strabism, anisocoria, and ocular prosthesis.

8. The method according to any one of the preceding claims, wherein the method comprises g) automatically detecting whether or not a vision condition applies to the user from the item of user response information received in step b), by evaluating the user’ s eye movement.

9. The method according to any one of the two preceding claims, wherein in case a vision condition is detected, the method comprises one or more of cancelling the eye movement from the possible user response in step b), and- taking the vision condition into account when performing step c).

10. The method according to any one of the preceding claims, wherein step c) is adapted according to a user’s experience level, wherein the user’s experience level is set automatically based on a number of performed analyte detections by the user.

11. The method according to any one of the preceding claims, wherein the method further comprises: h) prompting a user to confirm the user’s readiness for sample application; i) receiving at least one further item of user response information on a further user response from the at least one sensor, wherein the further user response comprises one or more of- a gesture, and- an eye movement; j) deriving, from the further item of user response information, at least one further item of control information on the user’s readiness for sample application.

12. A mobile device (112) having at least one camera (114), the mobile device (112) being configured for detecting at least one analyte in a sample of bodily fluid by using the following steps:A) Prompting a user to one or more of:- apply a sample of bodily fluid to at least one test field (118) of an optical test element (116), and- confirm an application of a sample of bodily fluid to at least one test field (118) of an optical test element (116);B) receiving, from at least one sensor of one or more of the mobile device (112) and a connected device connected to the mobile device (112), at least one item of user response information on a user response, wherein the user response comprises one or more of- a gesture, and- an eye movement;C) deriving, from the item of user response information, at least one item of control information about the status of the application of the sample of bodily fluid;D) if the item of control information indicates that the sample of bodily fluid is applied to the test field (118) of the optical test element (116), receiving at least one image of at least a part of the test field (118) from the camera (114);E) detecting the analyte by evaluating the at least one image.

13. A kit (110) comprising the mobile device (112) according to any one of the preceding claims referring to a mobile device (112), the kit (110) further comprising at least one optical test element (116) having at least one test field (118) configured for performing at least one optical detection reaction in the presence of the analyte in the sample ofthe bodily fluid, wherein the optical detection reaction is observable at at least one predetermined position on the test field (118).

14. A computer program comprising instructions which, when the program is executed by the mobile device (112) according to any one of the preceding claims referring to a mobile device (112), cause the mobile device (112) to perform the method according to any one of the preceding claims referring to a method.

15. A computer-readable storage medium comprising instructions, which, when the instructions are executed by the mobile device (112) according to any one of the preceding claims referring to a mobile device (112), cause the mobile device (112) to perform the method according to any one of the preceding claims referring to a method.

Images