Method for determining the concentration of at least one analyte in a body fluid - Patents.com

Abstract

A method for determining a concentration of at least one analyte in a bodily fluid by using a mobile device (112), the mobile device (112) having at least one camera (114) and at least one ambient light detector (122), the ambient light detector (122) comprising at least one of an ambient light sensor (124) and an additional camera (126), the method comprising: i. performing at least one ambient light check (178), the ambient light check (178) including: i.1 using the ambient light detector (122) to determine at least one item of ambient light information; and i.2 determining whether at least one validity criterion for the item of ambient light information is met; and ii. If the validity criteria are met, determining the concentration of the analyte in the bodily fluid by evaluating at least one image captured by a camera of the mobile device of at least a portion of at least one reagent test area of ​​the optical test strip to which the sample of the bodily fluid has been applied. Further disclosed are a mobile device, a kit, a computer program, and a computer-readable storage medium.

Description

[Technical Field]

[0001] The present invention relates to a method for determining the concentration of at least one analyte in a body fluid. The invention further relates to a mobile device having at least one camera, a kit comprising said mobile device, a computer program, and a computer-readable storage medium. The method, mobile device, kit, computer program, and computer-readable storage medium may be used in particular in medical diagnostics for quantitatively or qualitatively detecting one or more analytes in one or more body fluids, such as for detecting glucose in blood and / or interstitial fluid. However, other fields of application of the invention are possible. [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 fluid. Examples of analytes to be detected are glucose, triglycerides, lactate, cholesterol, or other types of analytes typically present in these bodily fluids. Depending on the concentration and / or presence of the analyte, appropriate treatment may be selected as needed. Without narrowing the scope, the present invention may be specifically described with respect to blood glucose measurement. However, it should be noted that the present invention may also be used for other types of analytical measurements using test elements.

[0003] Generally, devices and methods known to those skilled in the art utilize test elements containing one or more test chemicals, which may perform one or more detectable detection reactions, such as optically detectable detection reactions, in the presence of the analyte to be detected. For test chemicals contained in test elements, 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.

[0004] In analytical measurements, especially those based on color reactions, one technical challenge is the evaluation of the color change resulting from the detection reaction. 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, WO 2012 / 131386 discloses a test device for performing an assay, the test device comprising: a container containing a reagent that reacts to an applied test sample by exhibiting a color or pattern change; and a portable device, such as a mobile phone or laptop, equipped with a processor and an image capture device, the processor being configured to process data captured by the image capture device and output a test result for the applied test sample.

[0005] In contrast to laboratory measurements and measurements performed using dedicated analytical measurement equipment, various influences must be taken into account when using mobile computing devices such as smartphones. For example, lighting conditions, positioning, vibrations, or other more or less uncontrollable conditions must be taken into account. Generally, procedures can be used that involve determining these influences under laboratory conditions.

[0006] For example, U.S. Patent No. 9,185,764 discloses a driver device including a current regulator to which at least one light-emitting diode can be connected, and a driver circuit coupled to the current regulator and characterized by a measurement input for receiving a measurement signal dependent on the operation of the at least one light-emitting diode, the driver circuit being designed to adjust the current level of the current regulator current of the current regulator in response to the measurement signal so that the amount of light emitted by the at least one light-emitting diode has a constant brightness value.

[0007] Chinese Patent Application Publication No. 105744067 describes a method for adjusting the brightness of a flashlight of a mobile terminal, including the steps of: determining whether the flashlight of the mobile terminal is in an automatic brightness adjustment mode when the flashlight is opened; if the flashlight is in the automatic brightness adjustment mode, obtaining the brightness of the current environment in which the mobile terminal is located; obtaining a flashlight driving current setting value corresponding to the brightness of the current environment; and adjusting the driving current of the flashlight to be equal to the driving current setting value, thereby driving the flashlight to adjust the illumination brightness. Furthermore, a flashlight adjustment device for a mobile terminal and a mobile terminal are also described. According to the method for adjusting the brightness of a flashlight of a mobile terminal, the flashlight may be automatically adjusted according to the brightness of the environment.

[0008] U.S. Patent No. 10,219,709 discloses an optical proximity sensor assembly including an IR LED emitting light having an infrared wavelength, an IR photodetector sensitive to infrared wavelengths, an optical barrier blocking direct light from the LED to the IR photodetector and allowing reflected light to reach at least one photodetector, and an electronic integrated circuit having an amplifier for amplifying the signal detected by the photodetector, an analog-to-digital converter, an LED driver, noise reduction and ambient light cancellation circuitry, and a digital interface for communicating with a microcontroller. The optical proximity sensor is housed in a wearable carrier. A single sensor may include multiple identical or different LEDs, multiple photodiodes, or both. Additionally, several sensors may be placed on a person's skin along a vascular pathway to obtain data on blood flow and arterial stiffness.

[0009] U.S. Patent No. 9,241,663 describes a system and method for analyzing colorimetric test strips and disease management. The system can include an accessory operably coupled to a mobile device, which acquires and / or analyzes images of the colorimetric test strips. The light box accessory can be removably attached to the mobile device or can remain attached to the mobile device, with the ability to remove the light box accessory from the camera's field of view for general photographic purposes. In other embodiments, images containing known calibration colors and reagent areas are acquired without the light box for comparison with previous calibration images to model changes in ambient lighting conditions and determine a color correction function. A correction can be applied to the detected color of the reagent area to match it to a reference color on a reference chart. If necessary, the information can be processed and displayed to provide feedback and sent to a healthcare provider for analysis.

[0010] U.S. Patent Application Publication No. 2017 / 0219569 discloses a method for a mobile computing device having a camera and a screen for measuring a test strip in a test strip module, the method including detecting ambient light effects by the camera when the test strip module is attached to a surface of the mobile computing device during a calibration phase before a sample is introduced into the reaction area on the test strip. During a measurement phase after the sample is introduced into the reaction area on the test strip, the method also includes illuminating the test strip with light provided by a light source area on the screen, detecting one or more colors of the reaction area with the camera, correcting the detected one or more colors for ambient light effects, correlating the corrected one or more colors with an analyte characteristic, and displaying the value of the analyte characteristic on the screen.

[0011] U.S. Pat. No. 9,506,855 describes a method, system, and computer program for analyzing a colorimetric assay, including obtaining an image of the assay, optionally correcting for ambient light conditions in the image, converting intensity data of at least one of the red, green, or blue channels into a first data point, invoking a predetermined standardization curve, comparing the first data point to the standardization curve, and identifying a value of an assay parameter from the standardization curve.

[0012] US Pat. No. 10,299,674 discloses a mobile computing device, a front-mounted optical system, and a computer program product that enables perimetry.

[0013] WO 2020 / 094594 describes a method for performing an analytical measurement based on a color-forming reaction in an optical test strip by using a mobile device with a camera, as well as a computer program containing computer-executable instructions for performing the method. Mobile devices and kits for performing the analytical measurement are further disclosed. The method includes step a): providing an optical test strip having a test field on which no sample has been applied; step b): capturing at least one first image of at least a portion of the test field of the optical test strip on which no sample has been applied by using a camera with at least one image acquisition setting of the camera, specifically a set of acquisition settings of the camera; step c): applying a sample of bodily fluid, specifically a droplet, to the test field of the optical test strip; step d): waiting for a predetermined minimum amount of time; step e): capturing at least one second image of at least a portion of the test field of the optical test strip on which the sample of bodily fluid has been applied by using a camera with one or more image acquisition settings of the camera, wherein the image acquisition settings of the camera are the same image acquisition settings of the camera used in step b); and step f): determining an analytical measurement result value using the first and second images of the optical test field of the optical test strip, specifically by comparing the at least two images.

[0014] U.S. Patent Application Publication No. 2018 / 143179 discloses a mobile device configured to detect sickle cell trait in a blood sample. The device includes a mobile device having a camera operably coupled to a microscope lens and an image converter configured to receive an image from the camera and perform a noise reduction procedure. The noise reduction procedure manipulates the image to a black and white image and applies a Gaussian filter. A contour detector detects contours in the image. An image analysis tool is configured to analyze the contours to identify individual and clustered blood cells. A user is then notified of whether sickle cell trait is present based on at least the shape of the individual blood cells.

[0015] Despite the advantages achieved by methods and devices known in the art, several technical challenges remain. Specifically, methods known in the art generally require capturing images in manual mode on a mobile computing device. Automatic detection of the test element may be impossible when ambient light is low. Therefore, automatic detection of the test element may be turned off. Checking ambient light conditions may produce erroneous results if the user of the mobile computing device does not accurately align the mobile computing device with the test element. Further checking of ambient light after measurement may detect unacceptable ambient light conditions. However, this may only be determined after measurement and application of blood to the test element. Furthermore, the settings of the mobile computing device's camera in automatic mode are generally unknown. Therefore, checking ambient light conditions using the mobile computing device's camera is generally not possible with methods and devices known in the art.

[0016] Issues to be resolved It would therefore be desirable to provide methods and apparatus that at least partially address the above-mentioned technical challenges, particularly methods and apparatus that enable user-friendly, mobile-based determination of the concentration of at least one analyte in a bodily fluid and that take ambient light conditions into account for the determination. Summary of the Invention

[0017] overview This problem is addressed by a method for determining the concentration of at least one analyte in a body fluid by a mobile device and a kit, by a computer program and a computer-readable storage medium having the features of the independent claims. Advantageous embodiments, which may be realized alone or in any combination, are set out in the dependent claims as well as in the entire specification.

[0018] When used below, the terms "have," "comprise," or "include," or any grammatical variations thereof, are used in a non-exclusive manner. Thus, these terms may refer both to the situation in which, in addition to the features introduced by these terms, no further features are present in the entity described in this context, and to the situation in which one or more additional features are present. For example, the expressions "A has B," "A comprises B," and "A includes B" may both refer to the situation in which, apart from B, no other elements are present in A (i.e., the situation in which A consists solely and exclusively of B), and to the situation in which, apart from B, one or more further elements are present in entity A, such as element C, elements C and D, and even further elements.

[0019] 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, despite the fact that each feature or element may be present one or more than one time.

[0020] Furthermore, when used hereinafter, the terms "preferably," "more preferably," "particularly," "more particularly," "particularly," "more particularly," or similar terms are used in conjunction with any feature without limiting the possibility of substitution. Therefore, features introduced by these terms are optional features and are not intended to constrain the scope of the claims in any way. The present invention may also be implemented by using alternative features, as recognized by those skilled in the art. Similarly, features introduced by "in an embodiment of the present invention" or similar expressions are intended to be optional features without any limitation regarding alternative embodiments of the invention, without any limitation regarding the scope of the invention, and without any limitation regarding the possibility of combining the feature introduced in such a way with other optional or non-optional features of the invention.

[0021] In a first aspect of the present invention, a method for determining a concentration of at least one analyte in a body fluid by using a mobile device is disclosed, the mobile device comprising at least one camera and at least one ambient light detector, wherein the ambient light detector comprises at least one of an ambient light sensor and an additional camera.

[0022] The method specifically includes the following steps, which may be performed in a given order. However, specifically, step i. may be performed at least once before step ii. is performed, as described below. Thus, steps i. and ii. may specifically be implemented as separate method steps, with step i. being performed at least once before step ii. is performed. Furthermore, it is also possible to perform one or more of the method steps once or repeatedly. Furthermore, it is possible to perform two or more of the method steps simultaneously or with overlapping times. The method may include additional method steps not described.

[0023] The method comprises: i. performing at least one ambient light check, said ambient light check comprising: i.1 using an ambient light detector to determine at least one item of ambient light information; i.2 Determining whether at least one validity criterion for an item of ambient light information is met; performing at least one ambient light check, including ii. if the validity criteria are met, determining the concentration of the analyte in the bodily fluid by evaluating at least one image captured by a camera of the mobile device of at least a portion of at least one reagent test area of ​​the optical test strip to which the sample of the bodily fluid has been applied; Includes:

[0024] As used herein, the term "determining the concentration of at least one analyte in a bodily fluid," also referred to as "analytical measurement," 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. This 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. The result of the concentration determination may be, for example, the concentration of the analyte and / or the presence or absence of the determined analyte. Specifically, for 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.

[0025] Thus, the term "analyte concentration value," often also referred to as "analytical measurement value," as used herein, is a broad term and should be given its ordinary and customary meaning to those of skill in the art and should not be limited to any special or customized meaning. The term may specifically, but is not limited to, refer to a numerical representation of the analyte concentration in a sample.

[0026] By way of example, the at least one analyte may be or 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, for example, pH value.

[0027] As described above, the method includes using a mobile device, the mobile device having at least one camera and at least one ambient light detector. As used herein, the term "mobile device" 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. The term may specifically refer to, but is not limited to, a portable electronic device, more specifically a portable communication device such as a mobile phone or smartphone. Additionally or alternatively, as outlined in more detail below, a mobile device may also refer to a tablet computer or another type of portable computer having at least one camera.

[0028] 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 any special or customized meaning. The term may specifically, but not exclusively, refer to a device having at least one imaging element configured to record or capture spatially resolved one-, two-, or three-dimensional optical data or information. By way of example, a camera may include 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 by using a camera, such as multiple electronic readings from an imaging element, such as pixels of a camera chip.

[0029] In addition to at least one camera chip or imaging chip, the camera may also include one or more optical elements, such as one or more lenses. For 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 include one or more variable lenses that can be adjusted automatically or manually. The present invention should be particularly applicable to cameras typically used in mobile applications, such as notebook computers, tablets, or mobile phones, particularly smartphones. Thus, specifically, the camera may be part of a mobile device that includes, in addition to at least one camera, one or more data processing devices, such as one or more data processors. However, other cameras may also be used.

[0030] The camera may specifically be a color camera. Therefore, color information such as three-color R, G, and B color values ​​may be provided or generated for each pixel. More color values, such as four color values ​​per pixel, for example, R, G, G, and B, are also possible. Color cameras are commonly known to those skilled in the art. Thus, for example, a camera chip may each comprise three or more different color sensors, such as color recording pixels, one pixel for red (R), one pixel for green (G), and one pixel for blue (B). For each R, G, B, etc. pixel, a value may be recorded by the pixel, such as a digital value ranging from 0 to 255, depending on the intensity of each color. For example, instead of using a color triplet, such as R, G, and B, a quadruple, such as R, G, G, and B, may be used. The color sensitivity of a pixel may be generated by a color filter or by the appropriate inherent sensitivity of the sensor element used in the camera pixel. These techniques are commonly known to those skilled in the art.

[0031] The term "ambient light detector" 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. The term may specifically refer to, but is not limited to, a device comprising at least one element sensitive to light and / or other electromagnetic radiation. The ambient light detector may specifically be configured to generate at least one item of information indicative of ambient light, such as a measurement signal and / or digital value indicative of the brightness and / or illuminance of the ambient light. The ambient light detector may be directly or indirectly coupled to a processor of the mobile device and configured to provide the item of information to the processor. The ambient light detector may specifically be separate from the camera of the mobile device. Thus, as outlined in more detail below, the ambient light sensor and camera may be located on opposite sides of the mobile device. For example, the ambient light sensor may be located on the front side of the mobile device facing the user, the front side having, for example, a display and / or one or more operating elements, and the camera may be located on the back side of the mobile device, the side facing an object, such as an optical test strip.

[0032] The ambient light detector is configured to detect ambient light, as outlined above. The term "ambient light," 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. The term may specifically, but not be limited to, light present in the environment of a mobile device. Specifically, ambient light may refer to light that is ambient to one or more of a mobile device, an optical test strip, or a color reference card. Ambient light may be the result of a superposition of light originating from any natural light source, such as sunlight, and / or any artificial light source, such as artificial lighting. The ambient light detector may be configured to convert the ambient light into an electronic signal, such as an analog and / or digital electronic signal, e.g., a voltage signal and / or a current signal, that qualitatively and / or quantitatively indicates the intensity of the ambient light. The ambient light detector may be specifically configured to detect the intensity of ambient light.

[0033] As mentioned above, the ambient light detector comprises at least one of an ambient light sensor and an additional camera. Thus, an entity called an "ambient light detector" includes at least one light-sensitive element called an "ambient light sensor," or at least one additional camera separate from the camera, or both.

[0034] As used herein, the term "ambient light sensor" 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. This term may specifically refer to, but is not limited to, a device having at least one light-receiving element configured to detect light and / or other electromagnetic radiation. Specifically, the light-receiving element of the ambient light sensor may be configured to detect light in the visible spectral range and / or the infrared spectral range. The visible spectral range may refer to the wavelength interval of light having wavelengths from 380 nm to 760 nm. The infrared spectral range may refer to the wavelength interval of light having wavelengths from 760 nm to 1 mm. For example, the light-receiving element may include at least one interface of a semiconductor material, such as a p-n junction. The photosensitive element may specifically include at least one of a photodiode, a phototransistor, a photoconductor, and a semiconductor element, specifically a photosensitive semiconductor element. The ambient light sensor may form part of a mobile device. Specifically, the ambient light sensor may be included in one or more components of the mobile device. For example, the ambient light sensor may be included in at least one display of the mobile device. Therefore, many displays include an ambient light sensor to adapt the brightness of the display to ambient lighting conditions. An ambient light sensor, particularly in a display on the front of the mobile device, may also be dual-purposed to perform step i.1. Additionally or alternatively, a further ambient light sensor may be incorporated into the mobile device, such as one separate from the display. The ambient light sensor and camera may be located, as outlined above, on opposing sides of the mobile device, in particular.

[0035] Additionally or alternatively, the ambient light detector may be or may include at least one additional camera. The term "additional 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 any special or customized meaning. Specifically, the term may refer to, but is not limited to, an additional device related to the term "camera" above. Thus, in this option, the mobile device includes at least two cameras, at least one of which, referred to herein simply as "camera," is used in step ii., and at least another camera, referred to herein as "additional camera," is used for the ambient light check in step i.1. Specifically, the additional camera may be a camera device physically separated from the camera of the mobile device. For example, the camera of the mobile device may be the main camera of the mobile device or may include the main camera of the mobile device, while the additional camera may be the front camera of the mobile device or may include the front camera of the mobile device. The camera and the additional camera may be located on opposite sides of the mobile device. For example, the additional camera, specifically the front camera, may be located on the front of the mobile device. The term "front side" 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. This term may specifically, but is not limited to, refer to the side of a mobile device that faces a user of the mobile device. Specifically, the front side of a mobile device may include at least one operating element of the mobile device, specifically at least one display and / or at least one touchscreen. A camera of the mobile device, such as a main camera, may be located on the back side of the mobile device. The term "back side" 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. This term may specifically, but is not limited to, refer to the side opposite the front side of a mobile device.Specifically, the back surface of the mobile device faces one or more of the optical test strip or color reference card when at least one image of at least a portion of at least one reagent test area is captured.

[0036] As outlined above, the method includes, in step i., performing at least one ambient light check. The term "ambient light check," 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. This term may specifically refer to, but is not limited to, a process of qualitative and / or quantitative evaluation of ambient light as defined above. Specifically, the ambient light check may include quantifying the ambient light and checking whether the ambient light meets one or more conditions, as outlined in more detail below. The ambient light check may specifically include evaluating the suitability of the ambient light for analytical measurements. For example, the ambient light check may evaluate whether the ambient light is suitable for performing analytical measurements. In particular, the ambient light check may ensure that the ambient light intensity is appropriate for performing analytical measurements. In particular, the ambient light check may ensure that the ambient light intensity is not below and / or above a predetermined threshold. Thus, typically, strong ambient light can result in unwanted reflections or other disturbances that can abort analytical measurements and / or reduce the accuracy of the remission measurements used to determine the concentration of at least one analyte in a bodily fluid. For example, strong ambient light can be reflected by the optical test strip, the color reference card, or both. By using an ambient light check, these uncertainties can be avoided or at least reduced. An ambient light check can also be advantageous when the mobile device includes a light source or illumination source for illuminating the optical test strip and / or the reagent test area. Thus, for example, the mobile device can include at least one light-emitting diode (LED) that can be used to illuminate the optical test strip and / or the reagent test area. The light source may define illumination at a location within the area that undergoes a detection reaction, such as a color change reaction, in the presence of the analyte to be detected. In this case, the ambient light check can specifically ensure, via illumination by the light source, that color values ​​resulting from the combination of ambient light and illumination by the light source are not altered such that they are outside the tolerance range or color gamut of the mobile device's camera.

[0037] For example, if the ambient light intensity exceeds at least one threshold, the analytical measurement may determine a biased analyte concentration value. Thus, the ambient light check may ensure an accurate determination of the analyte concentration in the bodily fluid. The ambient light check may be performed automatically by the mobile device, i.e., without user interaction or triggering, such as when launching a software app that controls the method.

[0038] The ambient light check utilizes at least one ambient light detector, as outlined above, which may be separate from the camera used to capture an image of the optical test strip. Thus, the ambient light detector and the camera may be located on opposite sides of a mobile device, such as a smartphone. For example, the ambient light detector may directly detect ambient light from artificial light sources, such as ceiling lamps, and / or natural light sources, such as the sun. Conversely, the detector on the same side as the camera may not be able to detect ambient light because the mobile device itself may block the ambient light. Additionally or alternatively, the ambient light check may be performed without using a light source or illumination source on the mobile device. Thus, the mobile device may include at least one light source for capturing at least one image of at least a portion of at least one reagent test area in step ii. For example, a light source on the mobile device, such as at least one light-emitting diode (LED), may be used to illuminate the reagent test area and measure reflected and / or returned light. However, for the ambient light check in step i., the light source on the mobile device may be kept off and / or not used. This represents an advantage in that it does not confuse the user as may occur when the light source is repeatedly switched on, for example at least once for an ambient light check and at least once to capture an image of the reagent test area.

[0039] As further outlined above, the ambient light check includes, in step i.1, using an ambient light detector to determine at least one item of ambient light information, and, in step i.2, determining whether at least one validity criterion for the item of ambient light information is met. As used herein, the term “item of ambient light information” 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. The term may specifically refer to an item of information that qualifies and / or quantifies ambient light, such as, but not limited to, an item of information indicating the intensity of ambient light. The item of ambient light information may specifically indicate the intensity of ambient light qualitatively and / or quantitatively. The item of ambient light information may be or include at least one radiometric quantity and / or at least one photometric quantity. Alternatively and / or additionally, the item of ambient light information may include at least one dimensionless quantity, such as bit information. The item of ambient light information may be determined using at least one of an ambient light sensor and / or an additional camera. Radiometric and / or photometric quantities may be determined by using an additional camera on the mobile device. Dimensionless quantities such as bit information may be determined by using an ambient light sensor.

[0040] The term "validity criterion" 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. Specifically, the term can refer, without limitation, to any item of information that qualifies and / or quantifies at least one item of ambient light information. Thus, by way of example, a validity criterion may be met if an item of ambient light information has at least one predetermined value or is within at least one predetermined value range, but may not be met if an item of ambient light information does not have at least one predetermined value or is not within at least one predetermined value range. The validity criterion may indicate the validity of an item of ambient light information by using one or more numeric values ​​and / or by using one or more Boolean values ​​and / or one or more digital values, such as "met" and "not met." By way of example, as outlined in more detail below, a validity criterion may be set to a particular value if an item of ambient light information is above or below a predetermined threshold. For example, one or more thresholds may be used, and if an item of ambient light information exceeds the threshold, the validity criterion may be set to "not met," otherwise it may be set to "met," or vice versa.

[0041] As outlined above, in step ii., if the validity criteria are met, the method includes determining the concentration of the analyte in the bodily fluid by evaluating at least one image captured by a camera of the mobile device of at least a portion of at least one reagent test area of ​​the optical test strip to which a sample of the bodily fluid has been applied.

[0042] The term "optical test strip" 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. This term can specifically, but not exclusively, refer to any element or device configured to perform a colorimetric reaction. Optical test strips can also be referred to as test strips or test elements, and all three terms can refer to the same element. Optical test strips may have, among other things, a reagent test area containing at least one test chemical for detecting at least one analyte. By way of example, an optical test strip may comprise at least one substrate, such as at least one carrier, to which at least one reagent test area is applied or incorporated. In particular, an optical test strip may further include at least one white area, such as a white field, particularly adjacent to, e.g., surrounding or enclosing, the reagent test area. The white area may be a separate field independently disposed on the substrate or carrier. Additionally or alternatively, however, the substrate or carrier itself may be or include a white area. For example, at least one carrier can be strip-shaped, thereby making the test element a test strip. These test strips are commonly used and available. An optical test strip can carry a single reagent test area or multiple reagent test areas with the same or different test agents contained therein.

[0043] The term "reagent test area" 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. This term can specifically refer to, but is not limited to, a concentrated amount of test chemical, such as a circular, polygonal, or rectangular shaped field having one or more layers of material with at least one layer of reagent test area containing the test chemical.

[0044] The term "capturing an image" 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. This term may specifically refer to, but is not limited to, one or more of imaging, image recording, image acquisition, and 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, capturing an image may include continuously recording a series of images, such as a video or motion picture. Capturing at least one image may be initiated by a user action or may be initiated automatically, for example, upon automatically detecting the presence of at least one object within the camera's field of view and / or within a predetermined sector of the field of view. These automatic image capture techniques are known, for example, in the field of automated barcode readers, such as automated barcode reading apps. Capturing an image may be performed, for example, by a camera capturing a stream or "lifestream" of images, one or more of which are stored and used automatically or through user interaction, such as pressing a button, as at least one first image or at least one second image, respectively. 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. Alternatively or additionally, captured images may be transferred, in whole or in part, to a cloud system, and image storage may occur, in whole or in part, within a data storage device of the cloud system.

[0045] The at least one image of at least a portion of the optical test strip may specifically include an image of at least a portion of the reagent test area. Additionally, the image may include an image of other portions of the optical test strip, such as a white reference portion of the optical test strip.

[0046] Capturing at least one image may include applying a sample of bodily fluid to the test strip and capturing at least one image, and optionally, for example, capturing at least one image without applying a sample of bodily fluid to the test strip before applying the sample to the test strip and capturing an image. The latter image may be specifically used for comparison purposes and may also be referred to as a "blank image" or "dry image." Sample application 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 also 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 a color reaction to occur. Thus, for example, the method may include waiting at least a predetermined minimum amount of time between capturing at least one optional dry image and at least one wet image. This predetermined minimum time may specifically be sufficient for a color reaction to occur within the optical test strip. By way of example, the minimum amount of waiting time may be at least 5 seconds.

[0047] The term "sample of bodily fluid," also referred to as "sample," 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. The term can specifically refer to, but is not limited to, any aliquot portion or aliquot portion of a bodily fluid. Specifically, a sample of a bodily fluid can refer to an optical test strip, more specifically, a portion of a bodily fluid that has been applied to a reagent test area of ​​an optical test strip.

[0048] As outlined above, the method, specifically step i.2, may further include comparing at least one item of ambient light information with at least one threshold value. The term "threshold value" 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. This term may specifically refer to, but is not limited to, any numerical value that may be used in an ambient light check. Specifically, the item of ambient light information may be compared with at least one threshold value. The validity criterion may be determined based on the comparison of the item of ambient light information with the threshold value. The validity criterion may be met if one of the following conditions is met: at least one item of ambient light information has a value below the threshold value; or at least one item of ambient light information has a value not exceeding the threshold value. Alternatively or additionally, at least one first threshold value may be used in the ambient light check, and the validity criterion may be met if at least one item of ambient light information has a value equal to or less than the first threshold value. Additionally, the ambient light check may use at least one second threshold, and if at least one item of ambient light information has a value equal to or greater than the second threshold, the validity criterion may not be met. If the item of ambient light information falls within an intermediate range between the first and second thresholds, the validity criterion may be set to "potentially insecure." In this case, the user may proceed with the analytical measurement, and the analyte concentration may be labeled with a warning notice that it is potentially inaccurate.

[0049] The threshold may be a predetermined threshold, such as a threshold that is the same for all mobile devices and / or a mobile device-specific threshold. It may be possible to adapt the threshold based on the analyte concentration determined by the method of the present invention, such as by using one or more machine learning algorithms. As an example, for high analyte concentration values ​​that may result in particularly dark color values, the threshold may be adapted to allow for higher ambient light intensities. The threshold may also be determined empirically or semi-empirically, such as by determining ambient light conditions under which the determination of the concentration of at least one analyte in the bodily fluid is still possible, and determining ambient light conditions under which the determination of the concentration of at least one analyte in the bodily fluid is hindered or obstructed by ambient light, such that the accuracy of the measurement falls below a predetermined accuracy threshold.

[0050] As noted above, the at least one item of ambient light information may include at least one radiometric and / or at least one photometric quantity. Specifically, the at least one item of ambient light information may include at least one of an irradiance measurement, a relative irradiance measurement, a luminance measurement, a relative luminance measurement, an exposure measurement, or a relative exposure measurement.

[0051] The method comprises: iii. may further include at least partially automatically ceasing the determination of the concentration of the analyte in the bodily fluid if the validity criteria are not met.

[0052] Specifically, step iii. may include ceasing, specifically automatically ceasing, at least one of capturing an image of the reagent test area; requesting a user to position the optical test strip within the camera's field of view; requesting a user to apply a sample of bodily fluid to the reagent test area of ​​the optical test strip; pricking the user's finger to apply the sample of bodily fluid to the reagent test area of ​​the optical test strip; and evaluating a color reaction in the reagent test area.

[0053] Step ii. of the method comprises: ii.1 capturing at least one image of at least a portion of at least one reagent test area to which a sample of bodily fluid has been applied; ii.2 determining at least one item of optical information indicative of a color reaction of the reagent test area; and ii.3 Deriving the concentration of an analyte by using the items of optical information; It may further include:

[0054] The term "color 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 any special or customized meaning. This term can specifically, but not exclusively, refer to a chemical, biological, or physical reaction in which the color, specifically the reflectance, of at least one element involved in the reaction changes as the reaction progresses. The color change can be detected by a mobile device, such as by a processor of the mobile device, and quantitatively evaluated, such as by deriving from at least one image at least one parameter that quantifies or characterizes the color change in the reagent test area due to the presence of an analyte in the bodily fluid. By way of example, one or more of the color values ​​described above, such as at least one color value for one or more of the three colors R, G, and B, may be used. Thus, the mobile device, specifically the processor of the mobile device, may be configured to determine the color change by determining the change in one or more color values ​​resulting from the color reaction.

[0055] The term "item of optical information," 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. This term can specifically refer to, but is not limited to, an item of information that includes at least one parameter that quantifies or characterizes color formation in a reagent test area due to the presence of an analyte in a bodily fluid. By way of example, an item of optical information may be or include the value of at least one color value derived from an image, such as an R, G, or B value.

[0056] At least one analyte concentration value may be determined from the color reaction of the reagent test area, specifically by using an item of optical information. At least one image may be used for this purpose. The analyte concentration value may be a numerical indicator of the result of an analytical measurement, such as indicating the concentration of at least one analyte in the sample, e.g., blood glucose concentration.

[0057] Method step ii. ii.4. may further include prompting the user to apply a sample of the bodily fluid to the reagent test area.

[0058] The term "prompting," 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, providing instructions by one or more of visual, auditory, and / or tactile means, requesting a user to perform one or more specific actions. Instructions may specifically be provided by the mobile device via a display of the mobile device, via a speaker of the mobile device, via haptic feedback of the mobile device, etc. For example, verbal and / or pictographic instructions may be prompted to the user on a display of the mobile device. Additionally or alternatively, the notification may include playing audio and / or spoken instructions via a speaker of the mobile device.

[0059] Step ii. ii.5. The method may further include prompting the user to place the optical test strip within the field of view of the camera before performing step ii.1.

[0060] Method step ii. ii.6. Prior to performing step ii.1, the method may further include prompting the user to place at least one color reference card within the field of view of the camera, the color reference card including a plurality of color reference fields having known reference color values.

[0061] Steps ii.5 and ii.6 may be performed as separate steps, or may be combined in whole or in part, such as in a single step, such as alternative step ii.5, which includes prompting the user to place the optical test strip and color reference card within the field of view of the camera before performing step ii.1.

[0062] The term "color reference card" 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. This term can specifically, but not exclusively, refer to any article having, disposed within, or on at least one surface, a plurality of color reference fields having known color or optical characteristics, e.g., a plurality of colored fields having known reference color values. Furthermore, the color reference card can include a plurality of gray reference fields having known gray levels. For example, the color reference card can be a flat card including at least one substrate having, disposed on and / or within at least one surface, a plurality of color reference fields having known color values ​​and a plurality of gray reference fields having known gray levels. The substrate can specifically have a flat surface having a color reference field and a gray reference field disposed thereon. For example, the substrate can be or include one or more of a paper substrate, a cardboard substrate, a plastic substrate, a ceramic substrate, or a metal substrate. Laminate substrates are also possible. For example, the substrate can be sheet-like or flexible. It should be noted, however, that the substrate may be implemented in an article of use such as a wall of a box, a vial, a container, a medical consumable such as a test strip, etc. The color reference card may also be fully or partially integrated into the optical test strip. At least one image of at least a portion of the reagent test area of ​​the optical test strip may fully or partially include an image of at least a portion of the color reference card.

[0063] Specifically, step ii.3 may be performed by using at least one measured reference color value derived from the image. For example, the color correction may be derived by using at least one measured reference color value of one or more color reference fields. The color correction may convert the measured reference color value to a known reference color value. Thus, the color correction may be configured to correct the measured color value in the image. The color correction may also be applied to the color value of the reagent test area, specifically, the optical information of the color reaction of the reagent test area.

[0064] The camera and the ambient light detector may be located on opposite sides of the mobile device. The ambient light sensor may be included in at least one display of the mobile device. The ambient light sensor may include at least one light-sensitive element, specifically at least one of a photodiode, a phototransistor, a photoconductor, and a semiconductor element.

[0065] As mentioned above, the additional camera may comprise at least one front camera arranged on the front side of the mobile device, the front side of the mobile device comprising at least one operating element of the mobile device, in particular at least one touchscreen, which operating element of the mobile device, in particular the touchscreen, may also form part of the display of the mobile device.

[0066] The method may be specifically computer-implemented. The computer implementation may include a software application running on a mobile device, which may include guiding a user through a measurement sequence after launching the software application, which may include at least step ii., and step i. may be performed fully or partially before and / or during the measurement sequence. Specifically, the software application may be configured to prompt the user, such as to provide instructions via the mobile device.

[0067] In a further aspect of the present invention, a mobile device is disclosed having at least one camera, wherein the mobile device further comprises at least one processor, wherein the mobile device further comprises at least one ambient light detector, wherein the ambient light detector comprises at least one of an ambient light sensor and an additional camera, and wherein the mobile device is configured to perform a 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 disclosed in more detail below.

[0068] The term "processor" 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. The term can refer specifically, but not limited to, to any logic circuit configured to perform the basic operations of a computer or system, and / or generally to any device configured to perform calculations or logical operations. In particular, a processor may be configured to process the basic instructions that drive a computer or system. By way of example, a processor may include at least one arithmetic logic unit (ALU), at least one floating-point unit (FPU), such as a math coprocessor or numeric coprocessor, multiple registers, specifically registers configured to provide operands to the ALU and store operation results, and memory, such as L1 and L2 cache memories. In particular, a processor may be a multi-core processor. In particular, a processor may be or include a central processing unit (CPU). Additionally or alternatively, a processor may be or include a microprocessor; thus, in particular, elements of a processor may be included on one single integrated circuit (IC) chip. Additionally or alternatively, the processor may be or include one or more application specific integrated circuits (ASICs) and / or one or more field programmable gate arrays (FPGAs), or the like.

[0069] The processor may be specifically configured to perform and / or support the method steps of the method, such as by software programming. Specifically, the processor may be configured to support capturing at least one image of at least a portion of at least one reagent test area of ​​the optical test strip by using a camera. The processor may be further configured to determine at least one analyte concentration value from the color formation of the reagent test area, such as by evaluating the image, deriving at least one item of optical information from the image, and converting the at least one item of optical information to at least one analyte concentration value. The processor may be specifically configured to support one or more or all of steps i. and ii., and optionally step iii., of the method, such as performing an ambient light check, determining the item of ambient light information, determining validity criteria for the ambient light information, evaluating the image of the portion of the reagent test area of ​​the optical test strip, and aborting the determination of the analyte concentration if the validity criteria may not be met. The processor may be further configured to support sample application to the optical test strip, such as by providing user guidance in visual or audible form. The processor may be further configured to support capturing at least one image, for example, by automatically detecting the optical test strip or a portion thereof within the field of view and / or by prompting a user to capture an image.

[0070] In a further aspect of the present invention, a kit is disclosed comprising a mobile device 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 disclosed in more detail below, further comprising at least one optical test strip having at least one reagent test area.

[0071] The kit may further comprise at least one color reference card, the color reference card comprising a plurality of color reference fields having known reference color values.

[0072] In a further aspect of the present invention, a computer program is disclosed comprising instructions which, when executed by a mobile device according to the present invention, such as according to any one of the embodiments disclosed above and / or as disclosed in more detail below, cause the mobile device, and in particular a processor of the mobile device, to perform a method according to the present invention, such as according to any one of the embodiments disclosed above and / or as disclosed in more detail below.

[0073] A computer program may also be embodied as a computer program product. As used herein, a computer program product may refer to a program as a tradeable product. The product generally exists in any format, such as a paper format, or on a computer-readable data carrier and / or computer-readable storage medium. In particular, the computer program product may be distributed over a data network.

[0074] In a further aspect of the present invention, a computer-readable storage medium is disclosed that includes instructions that, when executed by a mobile device according to the present invention, such as according to any one of the embodiments disclosed above and / or as disclosed in more detail below, cause the mobile device, and in particular a processor of the mobile device, to perform a method according to the present invention, such as according to any one of the embodiments disclosed above and / or as disclosed in more detail below.

[0075] As used herein, the term "computer-readable storage medium" may specifically refer to a non-transitory data storage means such as a hardware storage medium having computer-executable instructions stored thereon. A computer-readable data carrier or storage medium may specifically be or include a storage medium such as a random access memory (RAM) and / or a read-only memory (ROM).

[0076] The method and apparatus of the present invention offer many advantages over similar methods and apparatus known in the art. Specifically, compared to methods and apparatus known in the art, the method and apparatus described herein may increase analytical measurement flexibility. In particular, by performing an ambient light check using an ambient light detector, it may be possible to perform the method for determining the concentration of at least one analyte in a bodily fluid on a large number of different mobile devices. Specifically, by alternatively or additionally using one or more of an ambient light sensor and an additional camera, the method may be performed on a wide variety of different mobile devices.

[0077] Additionally, the present methods and devices may improve the ease of use of analytical measurements. The present methods may specifically include discontinuing the determination of the concentration of an analyte in a bodily fluid if validity criteria may not be met. Thus, the present methods may provide a means for a user to discontinue unnecessarily applying a sample of bodily fluid onto the reagent test area of ​​an optical test strip. Furthermore, the present methods may also conserve resources if the optical test strip is not used when a user discontinues applying a sample of bodily fluid onto the optical test strip.

[0078] Furthermore, the method and apparatus of the present invention can improve the accuracy and safety of analytical measurements. By using an ambient light check in conjunction with a color reference card, determination of the concentration of at least one analyte in a bodily fluid can be more reliable and accurate. Because proper lighting conditions can be ensured by the ambient light check, erroneous and / or biased results of analytical measurements can be less likely. Furthermore, the method can enable use of a mobile device camera in an automatic mode to determine the concentration of an analyte in a bodily fluid, while the ambient light check can use an ambient light detector, such as one or more of an ambient light sensor and an additional camera. Thus, the ambient light check can be performed before and / or during a measurement sequence that can use the mobile device camera in an automatic mode.

[0079] The method and apparatus of the present invention may enable performing an ambient light check when determining the concentration of at least one analyte in a bodily fluid when a color reference card is required to be used with an optical test strip. The method may enable applying the ambient light check while using an automatic mode of a camera to capture at least one image of a portion of a reagent test area of ​​the optical test strip. Specifically, the method may enable performing an ambient light check while capturing an image of the optical test strip using a fully automatic mode of a camera on a mobile device.

[0080] Instead of using the mobile device's camera, the method and apparatus according to the present invention may provide an alternative for ambient light checks by using an ambient light sensor and / or an additional camera, which may be used in parallel with the mobile device's camera, thus allowing ambient light checks to be performed before and / or during a measurement sequence.

[0081] The ambient light check may be performed in parallel with the capture of at least one image of a portion of the reagent test area of ​​the optical test strip. Thus, prompting the user, specifically providing instructions to the user, may be performed simultaneously to ensure the ability to perform an analytical measurement. Additionally, the ambient light check may be provided for analytical measurements that require the use of a color reference card with the optical test strip, since these methods generally require capturing images in the camera's automatic mode. Alternatively or additionally, the ambient light check may also be used for analytical measurements performed on a mobile device using, at least in part, the camera's manual mode.

[0082] If an optical test strip without a color reference card is used, an ambient light sensor and / or an additional camera may be used in addition to the mobile device camera for the ambient light check. By doing so, data regarding the ambient light may be collected and analyzed via at least one cloud computing system to further improve the ambient light check. If a color reference card is used with the optical test strip, the ambient light check may be performed directly, as no alternative methods are known in the art.

[0083] As is evident from any one of the above embodiments and / or any one of the embodiments disclosed in more detail below, the method and apparatus of the present invention may provide an ambient light check where a color reference card may be used with an optical test strip and an image of the reagent test area of ​​the optical test strip may be captured in an automatic mode of the camera. Although the method may involve some uncertainty regarding the ambient light check, it may be considered to date as the best alternative for checking ambient light conditions using an automatic mode of the camera.

[0084] As outlined above, the method may be fully or partially computer-implemented and / or computer-controlled. Specifically, steps i. and ii. may be computer-implemented, e.g., performed by software running on a processor of a mobile device, such as a software application. Furthermore, one or more or all of any additional method steps may be computer-implemented by software running on a processor, such as step iii. Furthermore, the capture of at least one image in step ii.1 may be computer-controlled by software running on a processor, and any one or even all of steps ii.2 to ii.3, and optionally steps ii.4 to ii.5, may be computer-implemented by the same software. Software running on a processor may also be referred to as a software application or software app and may include one or more software components. As outlined above, the software may also guide a user through a measurement sequence.

[0085] The software or computer program may generally include computer-executable instructions for carrying out the method according to the present invention in one or more of the embodiments attached hereto when the program is run on a computer or a computer network. In particular, the computer program may be stored on a computer-readable data carrier and / or a computer-readable storage medium.

[0086] As used herein, the terms "computer-readable data carrier" and "computer-readable storage medium" may specifically refer to non-transitory data storage means such as a hardware storage medium on which computer-executable instructions are stored. A computer-readable data carrier or storage medium may specifically be or include a storage medium such as a random access memory (RAM) and / or a read-only memory (ROM).

[0087] In summary, without excluding further embodiments, the following embodiments can be envisaged:

[0088] Embodiment 1: A method of determining a concentration of at least one analyte in a bodily fluid by using a mobile device, wherein the mobile device has at least one camera and at least one ambient light detector, the ambient light detector comprising at least one of an ambient light sensor and an additional camera, and the method comprises: i. performing at least one ambient light check, the ambient light check comprising: i.1 using an ambient light detector to determine at least one item of ambient light information; i.2 Determining whether at least one validity criterion for an item of ambient light information is met; performing at least one ambient light check, including: ii. if the validity criteria are met, determining the concentration of the analyte in the bodily fluid by evaluating at least one image captured by a camera of the mobile device of at least a portion of at least one reagent test area of ​​the optical test strip to which the sample of the bodily fluid has been applied; A method comprising:

[0089] Embodiment 2: The method of embodiment 1, wherein step i.2 includes comparing at least one item of ambient light information to at least one threshold value.

[0090] Embodiment 3: The method of embodiment 2, wherein the validity criterion is met if one of the following conditions is met: at least one item of ambient light information has a value below a threshold; at least one item of ambient light information has a value not exceeding a threshold.

[0091] Embodiment 4: A method according to any one of embodiments 1 to 3, wherein at least one item of ambient light information includes at least one of an irradiance measurement; a relative irradiance measurement; a luminance measurement; a relative luminance measurement; an exposure measurement; or a relative exposure measurement.

[0092] Embodiment 5: The method comprises: iii. The method of any one of embodiments 1 to 4, further comprising at least partially automatically ceasing the determination of the concentration of the analyte in the bodily fluid if the validity criteria are not met.

[0093] Embodiment 6: The method of embodiment 5, wherein step iii. includes aborting at least one of capturing an image of the reagent test area, requesting the user to position the optical test strip within the camera's field of view, requesting the user to apply a sample of bodily fluid to the reagent test area of ​​the optical test strip, pricking the user's finger to apply a sample of bodily fluid to the reagent test area of ​​the optical test strip, and evaluating a color reaction of the reagent test area.

[0094] Embodiment 7: Step ii. ii.1 capturing at least one image of at least a portion of at least one reagent test area to which a sample of bodily fluid has been applied; ii.2 determining at least one item of optical information indicative of a color reaction of the reagent test area; and ii.3 Deriving the concentration of an analyte by using the items of optical information; 7. The method of any one of embodiments 1 to 6, comprising:

[0095] Embodiment 8: Step ii. ii.4 The method of embodiment 7, further comprising prompting the user to apply a sample of the bodily fluid to the reagent test area.

[0096] Embodiment 9: Step ii. ii.5 The method of embodiment 7 or 8, further comprising prompting the user to place the optical test strip within the field of view of the camera before performing step ii.1.

[0097] Embodiment 10: Step ii. ii.6 The method of any one of embodiments 7 to 9, further comprising prompting the user to place at least one color reference card within the field of view of the camera before performing step ii.1, wherein the color reference card includes a plurality of color reference fields having known reference color values.

[0098] Embodiment 11: The method of embodiment 10, wherein step ii.3 is performed by using at least one measured reference color value derived from the image.

[0099] Embodiment 12: The method of any one of embodiments 1 to 11, wherein the camera and the ambient light detector are located on opposite sides of the mobile device.

[0100] Embodiment 13: The method of any one of embodiments 1 to 12, wherein the ambient light sensor is included in at least one display of the mobile device.

[0101] Embodiment 14: The method of any one of embodiments 1 to 13, wherein the ambient light sensor comprises at least one photosensitive element, specifically at least one of a photodiode, a phototransistor, a photoconductor, and a semiconductor element.

[0102] Embodiment 15: A method according to any one of embodiments 1 to 14, wherein the additional camera comprises at least one front camera arranged on the front side of the mobile device, and the front side of the mobile device comprises at least one operating element of the mobile device, in particular at least one touch screen.

[0103] Embodiment 16: The method of any one of embodiments 1 to 15, wherein the method is computer-implemented.

[0104] Embodiment 17: The method of embodiment 16, wherein the computer implementation comprises a software application running on the mobile device, the software application including guiding a user through a measurement sequence after launching the software application, the measurement sequence including at least step ii., and step i. being performed fully or partially before and / or during the measurement sequence.

[0105] Embodiment 18: A mobile device having at least one camera, wherein the mobile device further comprises at least one processor, and the mobile device further comprises at least one ambient light detector, the ambient light detector comprising at least one of an ambient light sensor and an additional camera, and the mobile device is configured to perform the method described in any one of embodiments 1 to 17.

[0106] Embodiment 19: A kit comprising the mobile device of embodiment 18, further comprising at least one optical test strip having at least one reagent test area.

[0107] Embodiment 20: The kit of embodiment 19, wherein the kit further comprises at least one color reference card, the color reference card comprising a plurality of color reference fields having known reference color values.

[0108] Embodiment 21: A computer program comprising instructions, which when executed by a mobile device as described in embodiment 18, cause the mobile device, and in particular a processor of the mobile device, to perform the method as described in any one of embodiments 1 to 17.

[0109] Embodiment 22: A computer-readable storage medium containing instructions, which, when executed by a mobile device as described in embodiment 18, cause the mobile device, specifically a processor of the mobile device, to perform a method as described in any one of embodiments 1 to 17. [Brief explanation of the drawings]

[0110] Further optional features and embodiments are disclosed in more detail in the subsequent description of the embodiments, preferably in conjunction with the dependent claims. Here, each optional feature may be realized independently 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 schematically in the figures, where the same reference numerals in these figures refer to identical or functionally comparable elements.

[0111] The diagram is as follows: [Figure 1] 1A and 1B show perspective views of an embodiment of a kit and a mobile device configured to perform a method for determining the concentration of at least one analyte in a body fluid. [Figure 2] 1 shows a flowchart of an embodiment of a method for determining the concentration of at least one analyte in a bodily fluid by using a mobile device. [Figure 3] 10 shows a flow chart of an embodiment of an ambient light check. DETAILED DESCRIPTION OF THE INVENTION

[0112] Detailed Description of the Embodiments 1 illustrates a perspective view of an exemplary embodiment of a kit 110. The kit 110 includes a mobile device 112 having at least one camera 114. The kit 110 further includes at least one optical test strip 116 having at least one reagent test area 118. The kit 110 may include at least one color reference card 120.

[0113] The mobile device 112 further comprises at least one ambient light detector 122. The ambient light detector 122 comprises at least one of an ambient light sensor 124 and an additional camera 126. The mobile device 112 is configured to perform a method for determining the concentration of at least one analyte in a bodily fluid. The method will be described with reference to an exemplary embodiment illustrated in the flowchart shown in FIG. 2. Therefore, reference may be made to the description of FIG. 2. As seen in FIG. 1, the camera 114 and the ambient light detector 122 may be located on opposite sides of the mobile device 112. For example, the camera 114 may be located on a back surface 128 of the mobile device 112. The back surface 128 may refer to the side of the mobile device 112 that faces one or more of the optical test strip 116, the reagent test area 118, and the color reference card 120. The ambient light detector 122 may be located on a front surface 130 of the mobile device 112. The front surface 130 of the mobile device 112 may face a user of the mobile device 112.

[0114] Additionally, the mobile device 112 may include at least one display 132. The ambient light sensor 124 may be included in the display 132 of the mobile device 112. The ambient light sensor 124 may include at least one light-receiving element, specifically at least one of a photodiode, a phototransistor, a photoconductor, or a semiconductor element. The display 132, and therefore the ambient light sensor 124, may be disposed on the front surface 130 of the mobile device 112.

[0115] The additional camera 126 may comprise at least one front camera 134. The front camera 134 may be located on a front surface 130 of the mobile device 112. The front surface 130 of the mobile device 112 may comprise at least one operating element 136 of the mobile device 112. In particular, the operating element 136 may be at least one touchscreen 138. The operating element 136, in particular the touchscreen 138, may form part of the display 132 of the mobile device 112.

[0116] The mobile device 112 may further comprise at least one processor 140. The processor 140 may be configured, such as by software programming, to perform and / or support one or more, or even all, of the method steps of a method for determining the concentration of at least one analyte in a bodily fluid. Specifically, the processor 140 may be configured to support the capture of at least one image of at least a portion of at least one reagent test area 118 of the optical test strip 116 by using the camera 114. The processor 140 may further be configured to determine at least one analyte concentration value from a color formation in the reagent test area 118. The processor 140 may further be configured to perform an ambient light check 178 and abort the determination of the analyte concentration if a validity criterion may not be met. The processor 140 may be configured to support sample application to the optical test strip 116, such as by providing user guidance in visual form and material or in audible form. For example, user guidance may be provided in visual form via the display 132 of the mobile device 112.

[0117] Color reference card 120 may include a plurality of color reference fields 142 having known reference color values. Color reference card 120 may further include a plurality of gray reference fields 144 having known gray levels. The plurality of color reference fields 142 and the plurality of gray reference fields 144 may be specifically arranged on the surface of color reference card 120 such that the plurality of color reference fields 142 and the plurality of gray reference fields 144 are visible when an image of optical test strip 116 is captured.

[0118] The color reference card 120 may be fully or partially integrated with the optical test strip 116. Alternatively or additionally, the color reference card 120 may include at least one window element 146, which may be configured to receive the optical test strip 116. The optical test strip 116 may be visible to the camera 114 of the mobile device 112 when the optical test strip 116 is received by the window element 146 of the color reference card 120.

[0119] The color reference card 120 may further comprise at least one position marker 148. The mobile device 112, and more particularly the processor 140 of the mobile device 112, may be configured to identify the position and / or orientation of the color reference card 120 by recognizing the position marker 148 in at least one image captured by the camera 114.

[0120] FIG. 2 shows a flowchart of an exemplary embodiment of a method for determining the concentration of at least one analyte in a bodily fluid by using a mobile device 112 having at least one camera 114 and at least one ambient light detector 122, which comprises an ambient light sensor 124 and at least one of an additional camera 126.

[0121] The method specifically includes the following steps, which may be performed in a given order. Furthermore, different orders may be possible. Two or more method steps may be performed fully or partially simultaneously. Furthermore, one, more than one, or all method steps may be performed once or repeatedly. The method may include additional method steps not listed.

[0122] The method comprises: i. performing at least one ambient light check 178 (indicated by reference numeral 150), the ambient light check 178 comprising: i.1 using an ambient light detector 122 to determine at least one item of ambient light information (indicated by reference numeral 152); i.2 (indicated by reference numeral 154) determining whether at least one validity criterion for an item of ambient light information is met; performing at least one ambient light check 178, including: ii. if the validity criteria are met (indicated by reference numeral 156), determining the concentration of the analyte in the bodily fluid by evaluating at least one image captured by the camera 114 of the mobile device 112 of at least a portion of at least one reagent test area 118 of the optical test strip 116 to which the sample of the bodily fluid has been applied; Includes:

[0123] The items of ambient light information determined in step i.2 may in particular include one or more of the following: irradiance measurements; relative irradiance measurements; luminance measurements; relative luminance measurements; exposure measurements; relative exposure measurements.

[0124] Specifically, step i.2 may include comparing at least one item of ambient light information with at least one threshold. Based on the comparison of the item of ambient light information with the at least one threshold, at least one validity criterion may be determined. The validity criterion may be met if one of the following conditions is met: at least one item of ambient light information has a value below the threshold; at least one item of ambient light information has a value not exceeding the threshold.

[0125] As shown in FIG. 2 , step i.2 (indicated by reference numeral 154) may be a branching point of the method. The branching point may indicate a conditional query, such as deciding between a first branch 158 and a second branch 160. The conditional query of step i.2 may use a validity criterion. The validity criterion may include a numerical value indicating the validity of an item of ambient light information. For example, the validity criterion may include a Boolean value, such as “met” (“y”) or “not met” (“n”). As an example, if an item of ambient light information may be below and / or not exceed a threshold, the validity criterion may be set to “met,” and the first branch 158 may lead to step ii. of the method. The second branch 160 may indicate an invalid item of ambient light information, such as an item of ambient light information exceeding a threshold, and the validity criterion may be set to “not met.” Thus, the second branch 160 may lead to any step iii. of the method.

[0126] The method comprises: iii. (Indicated by reference numeral 162) may further include automatically at least partially ceasing to determine the concentration of the analyte in the bodily fluid if the validity criteria are not met.

[0127] Specifically, step iii. may include stopping at least one of capturing an image of the reagent test area 118, requesting the user to position the optical test strip 116 within the field of view of the camera 114, requesting the user to apply a sample of bodily fluid to the reagent test area 118 of the optical test strip 116, pricking the user's finger to apply a sample of bodily fluid to the reagent test area 118 of the optical test strip 116, and evaluating a color reaction in the reagent test area 118.

[0128] Step ii. of the method comprises: ii.1 capturing at least one image of at least a portion of at least one reagent test area 118 to which a sample of bodily fluid has been applied (indicated by reference numeral 164); ii.2 determining at least one item of optical information indicative of a color reaction of the reagent test area 118 (indicated by reference numeral 166); and ii.3 (designated by reference numeral 168) deriving the concentration of the analyte by using the item of optical information; It may further include:

[0129] Step ii.3 may be performed, specifically, by using at least one measured reference color value derived from the image. For example, color correction may be derived by using at least one measured reference color value of one or more color reference fields 142. Color correction may convert the measured reference color value to a known reference color value. Thus, color correction may be configured to correct the measured color value in the image. Color correction may also be applied to the color value of reagent test area 118, specifically, to the optical information of the color reaction of reagent test area 118.

[0130] Step ii. consists of the following steps: ii.4 prompting the user to apply a sample of bodily fluid to the reagent test area 118 (indicated by reference numeral 170); ii.5 (indicated by reference numeral 172) prompting the user to place the optical test strip 116 within the field of view of the camera 114 before performing step ii.1; ii.6 (indicated by reference numeral 174) prompting the user to place at least one color reference card 120 within the field of view of the camera 114 before performing step ii.1, the color reference card 120 including a plurality of color reference fields 142 having known reference color values; may further include one or more of:

[0131] Prompting may specifically include providing instructions by the mobile device 112 via the display 132 of the mobile device 112, via a speaker of the mobile device 112, via haptic feedback of the mobile device 112, etc. For example, verbal instructions and / or pictographic instructions such as pictures may be prompted to the user on the display 132 of the mobile device 112. Additionally or alternatively, the notification may include playing audio and / or spoken instructions via the speaker of the mobile device 112.

[0132] Additionally, the method may be computer-implemented. The computer implementation may include a software application running on the mobile device 112. The software application may include guiding a user through a measurement sequence 176 after launching the software application, where the measurement sequence 176 may include at least step ii. The measurement sequence 176 may further include one or more of steps ii.1, ii.2, ii.3, ii.4, ii.5, and / or ii.6. Step i. may be performed completely and / or partially before and / or during the measurement sequence 176.

[0133] 3 illustrates a flow chart of an exemplary embodiment of an ambient light check 178. The ambient light check 178 may be initiated by a user request 180, such as a user request 180 for a measurement sequence 176, e.g., a measurement sequence 176 that includes determining the concentration of an analyte in a bodily fluid. The ambient light check 178 may specifically be performed before the measurement sequence 176 is initiated. Additionally and / or alternatively, the check of ambient light 178 may also be performed during the measurement sequence 176.

[0134] Following user request 180, ambient light check 178 may include checking whether information is available from ambient light sensor 124 (indicated by reference numeral 182) and additional camera 126 (indicated by reference numeral 184). If at least one of this information is available, ambient light check 178 may include reading information from ambient light sensor 124 (indicated by reference numeral 186) and additional camera 126 (indicated by reference numeral 188). By way of example, the information may include sensor information from ambient light sensor 124 and pixel information from additional camera 126, respectively.

[0135] In a further step, the ambient light check 178 may include determining an item of ambient light information by using the ambient light sensor 124 (indicated by reference numeral 190) and the additional camera 126 (indicated by reference numeral 192). With respect to the additional camera 126, the item of ambient light information may take into account meta-information from the image capture (indicated by reference numeral 194), such as the ISO value, the aperture of the additional camera 126, and / or the exposure time. For example, the pixel information from the additional camera 126 may include an exposure value, which may be used to derive a relative brightness using the meta-information from the additional camera 126.

[0136] Ambient light 176 may further include comparing the items of ambient light information to at least one threshold for each item of ambient light information determined by using ambient light sensor 124 (indicated by reference numeral 196) and additional camera 126 (indicated by reference numeral 198). The threshold may be a predetermined threshold, such as a threshold predetermined by laboratory measurements. At least one validity criterion may be determined based on the comparison of the items of ambient light information with the threshold.

[0137] If the validity criteria can indicate an invalid item of ambient light information (“N”), such as an item of ambient light information that exceeds a threshold, the ambient light check 178 can abort the measurement sequence 176 and prompt the user to change the ambient light conditions (indicated by reference numeral 200).

[0138] Additionally and / or alternatively, the ambient light check 178 may further include combining the independent ambient light assessments from the ambient light sensor 124 and the additional camera 126 to determine at least one validity criterion (indicated by reference numeral 202). For example, if both assessments of the validity criterion for an item of ambient light information match ("Y"), the ambient light check 178 may allow the measurement sequence 176 to be performed. If the assessments of the validity criterion for an item of ambient light information do not match ("N"), the ambient light check 178 may abort the measurement sequence 176 and prompt the user to change the ambient light conditions (indicated by reference numeral 200). Combining ambient light assessments may be possible when both the ambient light sensor 124 and the additional camera 126 can determine an item of ambient light conditions.

[0139] If only one of the ambient light sensor 124 and the additional camera 126 is available, the ambient light check 178 may use only one of the validity criteria determined by using one of the ambient light sensor 124 and the additional camera 126. If the validity criteria can indicate a valid item of ambient light information (“Y”), such as an item of ambient light information being below or not exceeding a threshold, the ambient light check 178 may enable the measurement sequence 176. [Explanation of symbols]

[0140] 110 kits 112 Mobile Devices 114 Camera 116 Optical Test Strips 118 Reagent Testing Area 120 Color Reference Cards 12 Ambient Light Detector 124 Ambient Light Sensor 126 additional cameras 128 Back 130 Front 132 Display 134 Front Camera 136 Operational Elements 138 Touchscreen 140 processors 142 Color Reference Field 144 Gray Reference Field 146 Window Elements 148 Position Marker 150 Perform at least one ambient light check 152 Using an ambient light detector to determine at least one item of ambient light information 154 Determine whether at least one validity criterion for an item of ambient light information is met 156 Determine the concentration of an analyte in a body fluid 158 First Branch 160 Second Branch 162 Abort determination of analyte concentration in body fluids 164 Capture at least one image 166 Determine at least one item of optical information 168 Deriving Analyte Concentration 170 Prompt the user to apply a sample of body fluid 172 Prompt User to Place Optical Test Strip 174 Prompt user to place at least one color reference card 176 Measurement Sequence 178 Ambient Light Check 180 User Request 182 Check if information from ambient light sensor is available 184 Check if information from additional cameras is available 186 Read information from the ambient light sensor 188 Read information from additional cameras 190 Determine an item of ambient light information by using an ambient light sensor 192 Determining Ambient Light Information Items by Using Additional Cameras 194 Considering Meta Information from Image Capture 196 Comparing an item of ambient light information determined by using an ambient light sensor to a threshold value 198 Comparing items of ambient light information determined by using an additional camera to a threshold value 200 Prompt user to change ambient light conditions 202 Combining Independent Ambient Light Assessments

Claims

1. 1. A method for determining a concentration of at least one analyte in a body fluid by using a mobile device (112), the mobile device (112) having at least one camera (114) and at least one ambient light detector (122), the ambient light detector (122) comprising at least one of an ambient light sensor (124) and an additional camera (126), the method comprising: i. performing at least one ambient light check (178), said ambient light check (178) comprising: i.

1. using said ambient light detector (122) to determine at least one item of ambient light information; i.2 determining whether at least one validity criterion for said item of ambient light information is met; performing at least one ambient light check (178), including: ii. if the validity criteria are met, determining the concentration of the analyte in the bodily fluid by evaluating at least one image captured by the camera of the mobile device of at least a portion of at least one reagent test area of ​​an optical test strip to which a sample of the bodily fluid has been applied; Including, wherein the method further comprises: iii. automatically preventing the determination of the concentration of said analyte in said bodily fluid if said validity criteria are not met. The method comprising:

2. 2. The method of claim 1, wherein step i.2 comprises comparing the at least one item of ambient light information to at least one threshold value.

3. 3. The method of claim 2, wherein the validity criterion is met if one of the following conditions is met: at least one item of ambient light information has a value below the threshold; at least one item of ambient light information has a value not exceeding the threshold.

4. 4. The method of claim 1, wherein step iii. comprises aborting at least one of capturing the image of the reagent test area (118), requesting a user to position the optical test strip (116) within a field of view of the camera (114), requesting a user to apply the sample of the bodily fluid to the reagent test area (118) of the optical test strip (116), pricking a user's finger to apply the sample of the bodily fluid to the reagent test area (118) of the optical test strip (116), or evaluating a color reaction in the reagent test area (118).

5. Step ii. ii.1 capturing the at least one image of the at least a portion of the at least one reagent test area (118) to which the sample of the bodily fluid has been applied; ii.2 Determining at least one item of optical information indicative of a color reaction of said reagent test area (118); ii.

3. deriving said concentration of said analyte by using said items of optical information; and The method according to any one of claims 1 to 4, comprising:

6. Step ii. ii.4 prompting a user to apply the sample of the bodily fluid to the reagent test area (118); ii.

5. prompting a user to place the optical test strip (116) within the field of view of the camera (114) before performing step ii.1; ii.

6. before performing step ii.1, prompting a user to place at least one color reference card (120) within the field of view of said camera (114), said color reference card (120) including a plurality of color reference fields (142) having known reference color values; The method of claim 5 , further comprising at least one of:

7. The method of any one of claims 1 to 6, wherein the camera (114) and the ambient light detector (122) are located on opposite sides of the mobile device (112).

8. The method of any one of claims 1 to 7, wherein the ambient light sensor (124) is included in at least one display (132) of the mobile device (112).

9. The method according to any one of claims 1 to 8, wherein the additional camera (126) comprises at least one front camera (134) arranged on a front surface (130) of the mobile device (112), and the front surface (130) of the mobile device (112) comprises at least one operating element (136).

10. 10. The method of claim 1, wherein the method is computer-implemented, the computer implementation comprising a software application running on the mobile device (112), the software application including guiding a user through a measurement sequence (176) after launching the software application, the measurement sequence (176) including at least step ii., and step i. being performed fully or partially before and / or during the measurement sequence (176).

11. A mobile device (112) having at least one camera (114), the mobile device (112) further comprising at least one ambient light detector (122), the ambient light detector (122) comprising at least one of an ambient light sensor (124) and an additional camera (126), the mobile device (112) being configured to perform the method of any one of claims 1 to 10.

12. 12. A kit (110) comprising the mobile device (112) of claim 11, further comprising at least one optical test strip (116) having at least one reagent test area (118).

13. A computer program comprising instructions, when said program is executed by a mobile device (112) according to claim 11, said instructions causing said mobile device (112) to perform the method according to any one of claims 1 to 10.

14. 12. A computer-readable storage medium comprising instructions that, when executed by a mobile device (112) according to claim 11, cause the mobile device (112) to perform the method according to any one of claims 1 to 10.

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