BR112021000111B1 - DETECTION METHOD, NON-TRANSIENT COMPUTER READABLE MEDIUM, MOBILE DEVICE AND KIT FOR DETECTING AT LEAST ONE ANALYTE IN AT LEAST ONE SAMPLE - Google Patents

Abstract

DETECTION METHOD, COMPUTER PROGRAM, MOBILE DEVICE AND KIT. A method, a computer program, and devices for detecting at least one analyte in at least one sample (114) are disclosed. The method comprising: a) providing at least one mobile device (112) having at least one camera (118) and at least one lighting source (120); b) providing at least one test strip (116) having at least one test field (124), the test field comprising at least one test chemical (126) for carrying out an optical detection reaction in the presence of the analyte ; c) applying at least one sample (114) to the test field (124); d) capturing a plurality of images (142) of at least one region (144) of the test strip (116), the region (144) comprising at least a portion of the test field (124) to which the sample (114) is applied, comprising d1) capturing at least one image (142) before applying the sample (114) to the test field (124), with the lighting source (120) turned off; d2) capturing at least one image (142) before applying the sample (114) to the test field (124), with the lighting source (120) turned on; and d3) capturing at least one image (142) after applying the sample (114) to the test field (124); e) determine a concentration of (...).

Description

FIELD OF INVENTION

[0001] The present invention relates to a detection method for detecting an analyte in a sample. The invention also relates to a computer program with program means for carrying out the method according to the invention. Furthermore, the invention relates to a mobile device and a kit. Method, computer program, mobile device and kit according to the present invention can be used in medical diagnostics in order to qualitatively and/or quantitatively detect one or more analytes in one or more body fluids. Other fields of application of the present invention, however, are possible.

BACKGROUND OF THE INVENTION

[0002] In the field of medical diagnosis, in many cases, one or more analytes must be detected in samples of a bodily fluid, such as blood, interstitial fluid, urine, saliva or other types of bodily fluids. Examples of analytes to be detected are glucose, triglycerides, lactate, cholesterol, or other types of analytes typically present in these body fluids. According to the concentration and/or presence of the analyte, an appropriate treatment can be chosen, if necessary.

[0003] Generally, devices and methods known to those skilled in the art make use of test elements comprising one or more test chemistries, which, in the presence of the analyte to be detected, are capable of carrying out one or more detectable detection reactions, such as optically detectable detection reactions. With respect to these test chemistries, reference may be made, for example, to J. Hoenes et al.: The Technology Behind Glucose Meters: Test Strips, Diabetes Technology & Therapeutics, Volume 10, Supplement 1, 2008, S-10 a S-26. Other types of chemical testing are possible and can be used to carry out the present invention.

[0004] In analytical measurements, specifically analytical measurements based on color formation reactions, a technical challenge lies in evaluating the color change that is due to the detection reaction. In addition to using dedicated analytical devices such as portable blood glucose meters, the use of commonly available electronics such as smartphones and portable computers has become increasingly popular in recent years. WO 2012/131386 A1 discloses a testing apparatus for carrying out an assay, the testing apparatus comprising: a receptacle containing a reagent, the reagent being reactive to an applied test sample, developing a color or pattern variation; a portable device, e.g., a mobile phone or a laptop, comprising a processor and an image capture device, wherein the processor is configured to process data captured by the image capture device and output a test result for the sample test applied.

[0005] WO 2015/078954 A1 discloses a method, an analytical device and an analytical system for determining a concentration of at least one analyte in a bodily fluid is disclosed. The method comprises: a) applying a sample of the body fluid to a test carrier; b) illuminate the test carrier by at least one light source; c) receiving light sent by the test carrier using at least one detector; d) determining the concentration of the analyte by evaluating at least one detector signal generated by the detector. The at least one light source is modulated using at least two modulation frequencies. The detector signal is demodulated with the at least two modulation frequencies to generate at least two demodulated detector signals, each demodulated detector signal corresponding to one of the modulation frequencies. The method comprises a fault detection based on a comparison of the at least two demodulated detector signals.

[0006] US 2017/0343480 A1 is provided which describes a method for measuring blood glucose levels by a portable terminal using a strip module. The strip module includes a dye pad with a color that changes in response to a sample applied to the dye pad. The strip module also includes a transparent strip with a first side and a second side. The first side is opposite the second side. The ink pad is mounted on the first side of the transparent strip and the transparent strip reflects light supplied from a light source of a portable terminal located adjacent to the second side and transmits the light to the ink pad.

[0007] US 2015/233898 A1 describes a test strip module including a case, a test strip in the case, and a position anchor extending downwardly through a mating surface to a face of a computing device mobile. The positioning anchor has a shape that corresponds to a feature on the face of the mobile computing device.

[0008] US 6 267 722 B1 describes systems and methods for medical diagnosis or risk assessment for a patient. These systems and methods are designed to be employed at the point of care, such as in emergency rooms and operating rooms, or in any situation where a quick and accurate result is desired. The systems and methods process patient data, particularly data from point-of-care diagnostic tests or assays, including immunoassays, electrocardiograms, X-rays, and other tests, and provide an indication of a medical condition or risk or lack thereof. The systems include an instrument for reading or evaluating the test data and software for converting the data into diagnostic or risk assessment information.

[0009] The reliability and accuracy of analytical measurement using mobile computing devices generally depend on a large number of technical factors. Specifically, a large number of mobile devices with cameras are available on the market, all with different technical and optical properties that must be considered for analytical measurement. For example, the measurement of physical and biochemical parameters with mobile devices is disclosed in EP 3 108 244 A1 and WO 2015/120819 A1 describing a test strip module including a case, a test strip in the case and a position anchor that extends downward past a mating surface to a face of a mobile computing device. The position anchor has a shape that corresponds to a feature on the face of the mobile computing device.

[00010] Furthermore, the reliability and accuracy of analytical measurement using mobile computing devices generally depend to a large extent on the lighting and lighting conditions during the measurement. For example, in US 6,574,425 B1, a modulated light source emits light to illuminate a target surface that has a certain color and color tone. The light that is reflected from the target surface is detected by an optical detector. The output from the optical detector is processed and fed back to the optical detector to compensate for any changes caused by ambient light, temperature or other external factors, and is differentially amplified to generate an output signal indicative of the color and hue of the target surface. The differential amplifier output signal is then demodulated by a synchronous detector to produce a substantially stable DC voltage that is indicative of the color or shade of color on the surface of the target. Where the color hue of the target surface is indicative of a certain measurable quantity or quality (such as an analyte concentration), the stable DC voltage is converted using a look-up table or mathematical formula into a corresponding quality or quantity measurement. When performing this conversion, compensation is made for any variations in the intensity of the modulated light source due to the change in temperature.

[00011] US 4,553,848 A discloses a method and device for detecting and evaluating the optical properties of a specimen, using a light source that has alternating light and dark phases, a detector that captures light from the light source by means of the specimen being examined, and a circuit that integrates and digitizes the signals received from the detector, which includes an integrator and which can be connected to the detector. The signals emitted by the detector are integrated both during at least part of the light phase and during at least part of the dark phase. The integral obtained during the dark phase is subtracted from that obtained during the light phase to determine the results. The integrator used to integrate the signals is used as a double integration type analog-to-digital converter to convert the integral into a digital signal. To achieve maximum accuracy and simplicity in the integration and digitization phase, each part of the light or dark phase is followed by a voltage measurement period during which the signals coming from the detector are applied in sequence and with mathematical signs opposite to a single integrator. Integration is performed over an integer number of voltage measurement periods to form a total integral.

[00012] EP 1 912 058 A1 discloses an apparatus and method for detecting and evaluating optical signals. The arrangement has a mixing unit that produces a light control signal from two different control signals (AN1, AN2) and a light source controlled by the light control signal. A signal source produces one of the control signals with frequency and intensity. A measurement signal and control signal are supplied to a frequency selective amplifier. The output signals (A1, A2) are fed to an evaluation unit, which compares the output signals. An external light determines information about a measurement interference from the comparison result. An independent claim is also included for a method for detecting and analyzing an optical signal to detect an analyte in an analytical fluid.

[00013] Despite the advantages involved in using a mobile computing device to perform an analytical measurement, several technical challenges remain. Specifically, the reliability and accuracy of measurements need to be improved and guaranteed. A major difficulty is the presence and impact of ambient light. The reliability and accuracy of analytical measurement may depend significantly on lighting conditions when capturing images of a test strip for analytical measurement when using a mobile phone camera. Specifically, ambient light can have a significant impact on lighting conditions, for example, due to various lighting media being present in different specific locations and/or depending on where the image is captured and at what time of day or night the image is taken. is captured. In particular, ambient light can interfere with the evaluation of the color formed in a reagent field of a test strip.

PROBLEM TO BE SOLVED

[00014] It is therefore desirable to provide methods and devices that address the aforementioned technical challenges of analytical measurements using mobile devices, such as mobile consumer electronic devices, specifically multi-purpose mobile devices that are not dedicated to analytical measurements, such as smart phones or tablets . Specifically, methods and devices must be proposed that guarantee the reliability and accuracy of measurements.

DESCRIPTION OF THE INVENTION

[00015] This problem is addressed by a detection method for detecting at least one analyte in at least one sample, a computer program, a mobile device and a kit with the characteristics of the independent claims. Advantageous embodiments that can be realized alone or in any arbitrary combinations are listed in the dependent claims.

[00016] As used below, the terms "has", "comprises" or "includes" or any arbitrary grammatical variations thereof are used non-exclusively. Thus, these terms may refer to a situation in which, in addition to the characteristic introduced by these terms, no other characteristic is present in the entity described in this context and to a situation in which one or more additional characteristics are present. For example, the expressions "A has B", "A comprises B", and "A includes B" may both refer to a situation in which, apart from B, no other element is present in A (i.e., a situation in which that A consists solely and exclusively of B) and a situation in which, in addition to B, one or more other elements are present in entity A, such as element C, elements C and D or other elements.

[00017] Furthermore, it should be noted that the terms "at least one", "one or more" or similar expressions indicating that a characteristic or element may be present one or more than once will normally be used only once when introducing the respective characteristic or element. In the following, in most cases, when referring to the respective characteristic or element, the expressions "at least one" or "one or more" will not be repeated, notwithstanding the fact that the respective characteristic or element may be present once or more than once.

[00018] Furthermore, as used below, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features, without restricting alternative possibilities. Accordingly, the features introduced by these terms are optional features and are not intended to restrict the scope of the claims in any way. The invention may, as one skilled in the art will recognize, be carried out using alternative features. Likewise, the features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, without any restriction as to alternative embodiments of the invention, without any restrictions as to the scope of the invention, and without any restriction as to to the possibility of combining the features introduced in such a way with other optional or non-optional features of the invention.

[00019] In a first embodiment, a detection method for detecting at least one analyte in at least one sample is disclosed. The method comprises the following steps which, by way of example, can be carried out in the given order. It should be noted, however, that a different order is also possible. Furthermore, it is possible to perform one or more of the method steps once or several times. Furthermore, it is also possible to perform two or more of the method steps simultaneously or overlapping in a timely manner. The method may also comprise steps that are not listed.

[00020] The detection method comprises the following steps: a) providing at least one mobile device with at least one camera and at least one lighting source; b) providing at least one test strip with at least one test field, the test field comprising at least one test chemical for carrying out an optical detection reaction in the presence of the analyte; c) apply at least one sample to the test field; d) capturing a plurality of images of at least one region of the test strip, the region comprising at least a portion of the test field to which the sample is applied, comprising: d1) capturing at least one image before applying the sample to the test field, with the lighting source turned off; d2) capture at least one image before applying the sample to the test field, with the lighting source turned on; d3) capture at least one image after applying the sample to the test field; and e) determining a concentration of the analyte in the sample using the images captured in step d).

[00021] The term "detecting an analyte in a sample", as used herein, is a broad term and should be given its common and customary meaning to one skilled in the art and should not be limited to a special or personalized meaning. The term may specifically refer, without limitation, to a quantitative and/or qualitative determination of at least one analyte in an arbitrary sample. For example, the sample may comprise a bodily fluid, such as blood, interstitial fluid, urine, saliva, or other types of bodily fluids. The result of the analytical measurement, for example, may be a concentration of the analyte and/or the presence or absence of the analyte to be determined. Specifically, by way of example, the analytical measurement may be a blood glucose measurement, therefore, the result of the analytical measurement may be, for example, a blood glucose concentration.

[00022] For example, in step a), a mobile device with at least one camera and at least one lighting source can be provided. The term "mobile device" as used herein is a broad term and should be given its ordinary and customary meaning by one skilled in the art and should not be limited to a special or personalized meaning. The term may refer specifically, without limitation, to a mobile electronic device, more specifically to a mobile communication device, such as a cell phone or smartphone. Additionally or alternatively, as will be described in more detail below, mobile device may also refer to a tablet, a laptop or any other type of portable computer with at least one camera and at least one lighting source.

[00023] The term "camera", as used herein, is a broad term and should be given its common and customary meaning to one skilled in the art and should not be limited to a special or personalized meaning. The term may specifically refer, without limitation, to a device with at least one imaging element configured to record or capture spatially resolved one-dimensional, two-dimensional, or even three-dimensional optical information. As an example, the camera may comprise at least one camera chip, such as at least one CCD chip and/or at least one CMOS chip configured to record images. For example, the camera may be a color camera comprising at least 3-color pixels. The camera may be a color CMOS camera. For example, the camera may comprise black and white pixels and colored pixels. Color pixels and black and white pixels can be combined internally in the camera. The camera may comprise at least one color camera and at least one black and white camera, such as a black and white CMOS. The camera may comprise at least one black and white CMOS chip. The camera may generally comprise a one-dimensional or two-dimensional array of image sensors, such as pixels. By way of example, the camera may comprise at least 10 pixels in at least one dimension, such as at least 10 pixels in each dimension. It should be noted, however, that other cameras are also viable. The camera may be a camera of a mobile communication device. The invention must be specifically applicable to cameras typically used in mobile applications such as notebooks, tablets or, specifically, cell phones such as smartphones. Thus, specifically, the camera may be part of a mobile device which, in addition to at least one camera, comprises one or more data processing devices, such as one or more data processors. Other cameras, however, are viable. The camera, in addition to at least one camera chip or imaging chip, may comprise other elements, such as one or more optical elements, for example, one or more lenses. By way of example, the camera may be a fixed focus camera, with at least one lens that is fixedly adjusted relative to the camera. Alternatively, however, the camera may also comprise one or more variable lenses that can be adjusted, automatically or manually.

[00024] The camera may specifically be a color camera. Thus, as for each pixel, color information such as color values for three colors R, G, B can be provided or generated. A larger number of color values is also feasible, such as four colors for each pixel. Color cameras are generally known to those skilled in the art. So, as an example, each pixel on the camera chip may have three or more different color sensors, such as color recording pixels such as a pixel for red (R), a pixel for green (G), and a pixel for blue (B). ). For each of the pixels, such as for R, G, B, values can be recorded by the pixels as digital values in the range 0 to 255, depending on the intensity of the respective color. Instead of using triples of colors such as R, G, B, for example, quadruples such as C, M, Y, K or similar can be used.

[00025] As used herein, the term "the lighting source of the mobile device" refers to an arbitrary light source of the mobile device. The term "lighting source" refers to at least one device adapted to generate light to illuminate an object. As used herein, the term "light" generally refers to electromagnetic radiation in one or more of the visible spectral range, the ultraviolet spectral range, and the infrared spectral range. The term "visible spectral range" generally refers to a spectral range of 380 nm to 780 nm. Preferably, the light as used in the present invention is light in the visual spectral range. The lighting source may comprise at least one light-emitting diode integrated into the mobile device. In particular, the lighting source may be a backlight of the mobile device, in particular the mobile phone. The mobile device may comprise other lighting devices, such as at least one lighting source illuminating the display and/or the display may be designed as another lighting source itself.

[00026] The illumination source may have two states, an on state in which it generates a beam of light to illuminate the test strip and an off state in which the illumination source is turned off. As used herein, the term "turns on" refers to the lighting source being activated and/or turned on to illuminate the test strip. The term “is off” refers to the lighting source being in an off state or actively off. As described above, in step d1), at least one image is captured in which the lighting source of the mobile device is turned off. This may enable the capture of an image comprising light intensities from ambient light sources only and independent of the illumination provided by the mobile device's illumination source. In step d2), the illumination source is turned on, so that it may be possible to capture the second image comprising illumination intensities of both ambient light and illumination by the illumination source of the mobile device.

[00027] The lighting source may comprise at least one light-emitting diode (LED) integrated into the mobile device. The lighting source may comprise at least one white light LED. The white light LED can be controlled using a short current pulse, so the white light LED can be adapted to generate a bright flash of light. The illumination source can be adapted to illuminate the test strip at all times during image capture. In contrast to electron flashes, the white light LED flash duration may take several 100 ms, this may allow the illumination source to illuminate the test strip at all times during image capture in a flash mode. LED. Alternatively, the LED can be adapted to permanently illuminate the test strip in a flash-free mode.

[00028] In step b), at least one test strip with at least one test field can be provided. As used herein, the term "test strip" is a broad term and should be given its ordinary and customary meaning to one skilled in the art and should not be limited to a special or personalized meaning. The term may specifically refer, without limitation, to an arbitrary element or device configured to carry out a color change detection reaction. The test strip may particularly have a test field comprising at least one test chemical for carrying out an optical detection reaction in the presence of the analyte in order to detect the at least one analyte. The test element, by way of example, may comprise at least one substrate, such as at least one carrier, with the at least one test field applied thereto or integrated therein. As an example, the at least one carrier may be strip-shaped, thereby making the test element a test strip. These test strips are generally widely used and available. A test strip may contain a single test field or a plurality of test fields with identical or different test chemicals comprised therein. The test strip may have at least one sample applied to it. In particular, the test strip may be a higher dosage test strip, such as a test strip configured to have at least one sample applied to it on a second side and further configured to perform the color change detection reaction. so that the color change can be identified on a first side of the test strip, specifically the first side being disposed opposite the second side of the test strip.

[00029] The term "test field", as used herein, is a broad term and should be given its ordinary and customary meaning to one skilled in the art and should not be limited to a special or personalized meaning. The term may specifically refer, without limitation, to a coherent amount of the test chemical, such as a field, e.g., a field of round, polygonal or rectangular shape, with one or more layers of material, with at least least one test field layer that contains the test chemical. Other layers may be present providing specific optical properties, such as reflective properties, providing scattering properties for spreading the sample, or providing separation properties, such as for separating particulate components of the sample, such as cellular components.

[00030] The term "test chemical", as used herein, is a broad term and should be given its ordinary and customary meaning to one skilled in the art and should not be limited to a special or personalized meaning. The term may specifically refer, without limitation, to a chemical compound or a plurality of chemical compounds, such as a mixture of chemical compounds suitable for carrying out a detection reaction in the presence of the analyte, wherein the detection reaction is detectable by means specific, such as optically. The detection reaction can be specifically analyte specific. The test chemical in the present case may specifically be an optical test chemical, such as a color change test chemical that changes color in the presence of the analyte. The color change may depend specifically on the amount of analyte present in the sample. The test chemical, for example, may comprise at least one enzyme, such as glucose oxidase and/or glucose dehydrogenase. Furthermore, other components may be present, such as one or more dyes, mediators and the like. The test chemicals are generally known to the person skilled in the art and reference may be made to J. Hoenes et al.: Diabetes Technology and Therapeutics, vol. 10, Supplement 1, 2008, pp.10-26. Other testing chemicals, however, are also viable.

[00031] The term "analyte", as used herein, is a broad term and should be given its common and usual meaning for one skilled in the art and should not be limited to a special or personalized meaning. The term may specifically refer, without limitation, to one or more specific chemical compounds and/or other parameters to be detected and/or measured. By way of example, the at least one analyte may be a chemical compound that participates in metabolism, such as one or more of glucose, cholesterol or triglycerides. Additionally or alternatively, other types of analytes or parameters can be determined, for example a pH value.

[00032] As used herein, without limitation, the term "image" may refer specifically to data recorded using a camera, such as a plurality of electronic readouts from an imaging device, such as the pixels of the camera chip. The image itself therefore may comprise pixels, the image pixels correlating with the camera chip pixels. Consequently, when referring to “pixels”, reference is made to the units of image information generated by the single pixels of the camera chip or to the single pixels of the camera chip directly. The image may comprise raw pixel data. For example, the image may comprise data in RGGB space, single color data from one of R, G or B pixels, a Bayer pattern image or the like. The image can include evaluated pixel data, such as a color image or an RGB image. The raw pixel data can be evaluated, for example, using demosaicing algorithms and/or filtering algorithms. These techniques are generally known to those skilled in the art.

[00033] The term "capturing at least one image" refers to one or more of image generation, image recording, image acquisition, image capture. The term "capturing at least one image" may comprise capturing a single image and/or a plurality of images, such as a sequence of images. The capture of at least one image may be initiated by user action or may be initiated automatically, for example, once the presence of at least one object within a field of view and/or within a predetermined sector of the field of view The camera's view is automatically detected. Such automatic image acquisition techniques are known, for example, in the field of automatic barcode readers, e.g., automatic barcode reading applications.

[00034] For example, in step d) a plurality of images of at least one region of the test strip can be captured. The at least one region of the test strip may comprise at least part of the test field to which the sample may be applied. In particular, as described above, images captured in step d) can, for example, be used to determine the concentration of the analyte in the sample in step e).

[00035] Furthermore, the detection method may further comprise step f) of comparing the corresponding images captured in step d) with the lighting source turned on and off and determining a difference in light intensities. Specifically, the term "corresponding images" may refer, without limitation, to at least two images of an object, such as the test strip, wherein one of the at least two images is captured with the illumination source turned on and wherein the other one of at least two images is captured with the lighting source turned off, preferably with the other conditions of the situation unchanged. For example, the at least one image captured in step d1) can be compared with the at least one image captured in step d2). Additionally or alternatively, the at least one image captured in step d3) can, for example, be compared with one of the images captured in step d1) and/or step d2). In particular, step f) may comprise determining information about differences in light intensities between corresponding images captured in step d).

[00036] Furthermore, step e) may, for example, comprise using the result of step f) to determine the concentration of the analyte in the sample. Specifically, differences in light intensities determined in step f) can be used to determine the concentration of the analyte in the sample. Thus, information about differences in light intensities can, for example, be taken into account when determining the concentration of the analyte in the sample.

[00037] Furthermore, step f) may, for example, comprise: f1) deriving at least one item of color information from the part of the test field to which the sample is applied for each image to be compared; f2) transforming the color information item into at least one light intensity information item using at least one camera-specific transmission function; and f3) determining differences in light intensities using light intensity information items from corresponding images with the lighting source on and off.

[00038] The term "color information item" as used herein is a broad term and should be given its ordinary and customary meaning to one skilled in the art and should not be limited to a special or personalized meaning. The term may specifically refer, without limitation, to an indication or information about the color of an arbitrary object, such as, in the present case, the color of at least that part of the test field to which the sample can be applied. . As an example, the color information item may indicate the color of part of the test field using coordinates to describe the color in an arbitrary color coordinate system. Thus, the at least one color information item specifically may imply at least one photometric information item indicating an illumination light intensity weighted with one or more spectral sensitivity functions, such as one or more sensitivity functions. spectral characteristics determined by the spectral sensitivity of the camera or a component thereof, e.g., a camera chip and/or one or more spectral filters, e.g., R, G, B filters. Various color coordinate systems are generally known to the technical in the subject and can also be used in the context of the present invention. In particular, the color information item may comprise information about one, more than one, or even all of the color coordinates of several or even all of the pixels of at least one image showing at least that part of the test field for which the sample can be applied. The color information item, for example, may be digital information. In particular, the color information item may be or may comprise, for example, at least one digital value in the range of 0 to 255 for one or more color coordinates, such as, for example, for one or more of R, G and B.

[00039] By way of example, the color information item may, in particular, comprise information about an intensity, specifically in the case where only one color coordinate is evaluated. Thus, by way of example, specifically in the case where a color coordinate is considered and/or evaluated, the color information may be or may comprise a value of a color channel or color coordinate, wherein, by way of example , a high value can also correspond to a high intensity and a low value can correspond to a low intensity. In general, a change in color can also be accompanied by a change in intensity. Specifically, in this case, steps f1) and f2) listed above do not necessarily need to be separate method steps. Thus, steps f1) and f2) can be combined, at least partially.

[00040] In a simple case, by way of example, the color information item may be or may comprise the value for a color coordinate that is known to undergo a more significant or profound change during the color change or color reaction. color formation of the test chemical. For example, in the event that a specific test chemical is known to change its hue deeper into the blue spectral range during the color change reaction used to detect the analyte, a blue color coordinate may be used and the test item Color information may be or may comprise the blue color coordinate values determined for all pixels or for at least a group of pixels of at least part of the test field within the image to which the sample may be applied.

[00041] As indicated above, the color information item can be transformed into at least one light intensity information item, in substep f2), using at least one camera-specific transmission function. As used herein, the term "light intensity information item" is a broad term and should be given its ordinary and customary meaning to one skilled in the art and should not be limited to a special or personalized meaning. The term may specifically refer, without limitation, to an indication of information about the intensity of light, specifically the illumination intensity or exposure level, of an arbitrary object, as for example, in the present case of at least a portion of the test field to which the sample can be applied. As an example, the light intensity information item may indicate the light intensity of part of the test field in terms of an exposure value (EV), such as an exposure level. The at least one light intensity information item, specifically, may imply at least one information item indicating a radiometric power of the illumination per unit area, such as in W/m2 or similar units. In particular, the light intensity information item may be derived using at least one camera-specific transmission function.

[00042] The term "camera specific transmission function" as used herein is a broad term and should be given its ordinary and customary meaning to one skilled in the art and should not be limited to a special or personalized meaning. The term may specifically refer, without limitation, to a mathematical operation to describe an arbitrary action or behavior of the camera in transferring illumination or light intensity from at least one object, specifically from at least part of the test field to which the sample is placed. can be applied, in color information, as in at least one color information item. The camera-specific transmission function may be particularly dependent on the technical characteristics of the camera, such as the image chip or one or more sensors, the data processing device, such as the processor, the optical elements, such as one or more lenses, or any other technical characteristics of the camera.

[00043] The camera-specific transmission function, for example, may be determined by empirical or semi-empirical means and, by way of example, may be predetermined or may be determined by one or more calibration processes, which may also do part of the method. Thus, by way of example, the camera-specific transmission function may be fully or partially determined using one or more reference fields with known color coordinates or known color properties. To determine the camera-specific transmission function, one or more reference fields, by way of example, may be illuminated under one or more known lighting conditions, e.g., with known intensity or intensities and color information, such as at least An item's color information, can be measured using the camera. In this way, a relationship between the at least one color information item and the intensity can be determined. The camera-specific transmission function may, for example, be determined or stored using one or more of a curve, a graph, an analytical transformation function, a table, a matrix, or any other means that indicates an intensity value for a specific color information item or vice versa. The camera-specific transmission function, by way of example, may be stored in a data storage device, such as a volatile or non-volatile data storage device. The camera-specific streaming function, for example, can be predetermined for a specific type of camera. Thus, by way of example, a plurality of camera-specific transmission functions may be predetermined, for example, for a plurality of specific mobile devices, and the method may entail selecting an appropriate camera-specific transmission function from the plurality of camera-specific transmission functions in accordance with the type of mobile device.

[00044] Furthermore, for step e), differences in light intensities can be transformed into differences in color information items for corresponding images. In particular, differences in light intensities can be transformed into differences in color information items for corresponding images using an inverted function of the camera-specific transmission function.

[00045] In particular, the camera-specific transformation function may be a non-linear function. The camera-specific transformation function can, for example, allow the transformation of light intensity, for example measured in exposure value (EV), into color information, such as an RGB value. Thus, the camera-specific transformation function can, for example, be a non-linear light intensity transmission function. Additionally or alternatively, the camera-specific transformation function may, for example, allow the transformation of light intensity or exposure level, for example, measured in exposure value (EV), into color information, such as in JPEG brightness. Thus, the camera-specific transformation function could be, for example, a non-linear exposure level sensitivity function. In particular, the camera-specific transformation function may be, for example, one or more of a non-linear light intensity transmission function and a non-linear exposure level sensitivity function.

[00046] Furthermore, substep or step d3) may comprise at least two other substeps. In particular, d3) may comprise: d3i) capturing at least one image with the lighting source turned off; and d3ii) capture at least one image with the lighting source turned on.

[00047] In particular, step e) may further comprise using a difference in light intensities between the images captured in d31) and d3ii). Thus, step e) of the detection method may further comprise using the difference in light intensities between the images captured in d3i) and d3ii) to determine the concentration of the analyte in the sample.

[00048] Furthermore, one or more of steps d1) to d3) can be performed repeatedly. In particular, carrying out one or more of steps d1), d2) and/or d3) repeatedly, may, for example, allow monitoring of a kinetic measurement curve of the optical detection reaction. Thus, the detection method may further comprise monitoring a kinetic measurement curve of the optical detection reaction.

[00049] In step c) of the detection method, the sample can be specifically applied to the test field on a side opposite the camera. The test strip, specifically the top dose test strip, may be positioned relative to the camera so that one side of the test field may face the camera, wherein the other side of the test field may be turned away or facing away from the camera. In particular, the sample can be applied to the side of the test field opposite or away from the camera.

[00050] Specifically, a holder can be used to position the test strip relative to the mobile device. In particular, the test strip may be positioned with the test field at a distance from the camera, in particular the camera of the mobile device. By way of example, the mobile device may be arranged so that the camera may face in a first direction, e.g., upward, facing specifically a first side of the test field and the sample may be applied to a second side. of the testing ground opposing the first side. Thus, the detection method may comprise using the holder to position the test strip relative to the mobile device, wherein the test strip may be positioned with the test field at a distance from the camera, wherein the camera may be on the first side of the test field and where the sample can be applied to the second side opposite the first side.

[00051] The support can specifically be opened to the second side so that the test field can be uncovered on the second side. In particular, the holder cannot cover the test field on the second side so that the holder does not interfere or get in the way when applying the sample to the second side of the test field. Furthermore, the support may comprise an opening so that the test field can also be uncovered on the first side.

[00052] Furthermore, the test field may be, for example, at least partially translucent. In particular, in step e) of the detection method, a contribution from ambient light shining through the test field to the camera can be determined. The term "translucent" as used herein is a broad term and should be given its ordinary and customary meaning by one skilled in the art and should not be limited to a special or personalized meaning. The term may specifically refer, without limitation, to a characteristic or property of an arbitrary object allowing light, specifically incident light, to pass through the object. Where a translucent object can generally transmit light, thus allowing more than 0% of the light to pass through, the translucent object may still not transmit incident or ambient light completely, thus allowing less than 100% of the light to pass through. As an example, the translucent test field may allow a restricted amount of light to pass through the test field. Specifically, incident or ambient light, e.g., light falling on the test field, may be at least partially transmitted by the test field. In particular, the test field can, for example, transmit up to 60% of the incident light. Preferably, the test field can transmit up to 40% of the incident light. More preferably, the test field can transmit up to 30% of the incident light. Specifically, the test field may, for example, transmit from 1% to 60% of the incident light, preferably from 1% to 40% of the incident light, more preferably from 1% to 30% of the incident light. Transmission, however, may depend on the spectral properties of the incident light. Furthermore, transmission may specifically depend on a state or condition of the test field, such as, for example, on a dry or wet state of the test field. Thus, transmission may be particularly dependent on a wetting condition, a damp condition or a wet condition of the test field, specifically a wetting of the test field by the sample. By way of example, the test field in a dry condition may specifically show a higher transmittance of incident light than, for example, the same test field in a damp or wet condition, such as the test field with the sample. applied to it. The aforementioned transmission values, by way of example, can be given for at least one wavelength within the visible spectral range.

[00053] The test strip may, for example, further comprise a reference field. In particular, at least part of the reference field may, for example, be comprised by the region of the test strip, specifically the region of the test strip comprising at least part of the test field. Thus, the reference field and the test field can be specifically arranged at a close distance, such as next to each other.

[00054] Furthermore, the reference field may be opaque. Specifically, the term "opaque" may, without limitation, refer to a characteristic or property of an arbitrary object that does not allow light to pass through the object. In particular, the opaque reference field may be configured not to transmit incident or ambient light through the reference field. By way of example, the reference field may transmit less than 3%, preferably less than 2%, more preferably less than 1% of the ambient light through the reference field. Specifically, the reference field may, for example, be 100% opaque, thus the reference field by way of example may transmit 0% of incident or ambient light through the reference field.

[00055] Step d) of the detection method may further comprise substep d4) of capturing at least one image of the reference field. Furthermore, the image of the reference field can, for example, be taken into account for step e).

[00056] The reference field, for example, may contain at least one white field. In particular, the white field, specifically the white field comprised by the reference field, may, for example, be used to calibrate the camera, such as to set a white balance of the camera.

[00057] The detection method may further comprise at least one step of checking specific properties of the camera. For example, the camera-specific transformation function can be determined in the camera-specific properties checking step. Other camera-specific properties, such as color authenticity, can also be checked at this step.

[00058] In a further embodiment, a computer program is disclosed that comprises program means for fully or partially carrying out the detection method. Thus, specifically, step d), step e) and, optionally, step f) of the detection method can be performed by the computer program. In particular, the computer program comprises program means such as computer-executable instructions for fully or partially carrying out the detection method while the computer program is being executed on a computer or on a computer network, such as in a mobile device processor. Specifically, the computer may be fully or partially integrated with the mobile device and the computer program may be specifically incorporated as a software application. In particular, the computer program may be stored on a computer-readable data carrier, such as, for example, in a memory or data store of the mobile device. Alternatively, however, at least part of the computer may also be located outside the mobile device.

[00059] Further disclosed and proposed herein is a data carrier with a data structure stored therein, which, upon loading into a computer or computer network, such as into a working memory or main memory of the computer or network, computers, may perform the detection method in accordance with one or more of the embodiments disclosed herein, for example, steps d) and e) and, optionally, f), including possible substeps.

[00060] Further disclosed and proposed herein is a computer program product with program code means stored on a machine-readable carrier in order to perform the method in accordance with one or more of the embodiments disclosed herein, when the program is executed on a computer or computer network, for example, steps d) and e) and, optionally, f), including possible substeps. As used herein, a computer program product refers to the program as a tradable product. The product may generally exist in an arbitrary format, such as in paper format or on a computer-readable medium. Specifically, the computer program product may be distributed over a data network.

[00061] Finally, disclosed and proposed herein is a modulated data signal that contains instructions readable by a computer system or computer network, to perform the detection method in accordance with one or more of the embodiments disclosed herein, specifically one or more steps of the detection method as mentioned above or as further described below, for example, steps d) and e) and, optionally, f), including possible substeps.

[00062] Specifically, disclosed herein are: - a computer or computer network comprising at least one processor, wherein the processor is adapted to perform the detection method according to one of the embodiments described in this description, for example, the steps d) and e) and, optionally, f), including possible substeps, - a computer-loadable data structure that is adapted to perform the detection method according to one of the embodiments described in this description, while the data structure is being executed on a computer, for example steps d) and e) and optionally f), including possible substeps, - a computer program, wherein the computer program is adapted to perform the detection method in accordance with one of the described embodiments In this description, while the program is running on a computer, for example, steps d) and e) and, optionally, f), including possible substeps, - a computer program comprising program means for carrying out the detection method in accordance with with one of the embodiments described in this description, while the computer program is running on a computer or on a computer network, for example, steps d) and e) and, optionally, f), including possible substeps, - a computer program computer comprising program means according to the previous embodiment, wherein the program means is stored on a computer-readable storage medium, e.g., steps d) and e) and, optionally, f), including possible substeps , - a storage medium, in which a data structure is stored in the storage medium and in which the data structure is adapted to carry out the detection method, according to one of the embodiments described in this description, after being loaded into a main and/or working storage of a computer or a computer network, for example, steps d) and e) and, optionally, f), including possible substeps, and - a computer program product with code means of program, wherein the program code means can be stored or is stored on a storage medium, for carrying out the detection method, according to one of the embodiments described in this description, if the program code means is executed in a computer or on a computer network, for example, steps d) and e) and, optionally, f), including possible substeps.

[00063] In another embodiment of the present invention, a mobile device is disclosed. The mobile device comprises: I) at least one camera; II) at least one lighting source; and III) at least one processor.

[00064] The mobile device is configured to perform the detection method as described herein, for example, according to any of the embodiments described above and/or described in more detail below, together with a test strip with at least a test field, wherein the test field comprises at least one test chemical for carrying out an optical detection reaction in the presence of the analyte.

[00065] For most terms used in this document and for possible definitions, reference may be made to the description of the detection method given above or as described below.

[00066] By way of example, the processor may comprise program means for fully or partially carrying out the detection method as disclosed above or as disclosed later. Specifically, the program means may be configured to perform steps d), e) and, optionally, f) of the detection method.

[00067] In a further embodiment, a kit for detecting at least one analyte in at least one sample is disclosed. The kit comprises the mobile device according to the present invention and at least one test strip with at least one test field, the test field comprising at least one test chemical for carrying out an optical detection reaction in the presence of the analyte. .

[00068] For most terms used in this document and for possible definitions, reference may be made to the description of the detection method and/or the description of the mobile device provided above or as described below.

[00069] Additionally, the kit may comprise at least one holder for positioning the test strip relative to the mobile device, wherein the test strip may be positioned by the holder with the test field at a distance from the camera, wherein the camera may be on a first side of the test field and the sample may be applicable from a second side opposite the first side.

[00070] Furthermore, the support can be opened to the second side so that the test field can be uncovered on the second side. Specifically, the holder may be configured to leave the second side of the test field uncovered so that the sample is applicable to the second side of the test field without interference from the holder.

[00071] In particular, the holder with the test strip and the mobile device can constitute an internal space. The space, for example, can be enclosed by the mobile device, the holder and the test strip. Specifically, the holder, the test strip and the movable device can be arranged so that the internal space can be formed. Furthermore, the camera and lighting source can face the internal space. In particular, the holder may position the test strip so that the illumination source is capable of illuminating the test field.

[00072] The method and devices according to the present invention can provide a large number of advantages over known methods and devices for analytical measurements. The present invention can improve the reliability and ease of use of the process for detecting an analyte in a sample, compared to processes known in the art. Specifically, the present invention can improve the reliability and ease of use of an application, e.g., an application including computer-executable instructions for detecting an analyte in a sample, compared to known computer applications or programs. In particular, the present invention may make it possible to ensure robust detection of the analyte in variable or unstable imaging conditions. Specifically, the invention can provide improved reliability and accuracy of applications or computer programs using images from the mobile device's camera because an impact of ambient light is taken into account when determining the result, specifically when detecting the analyte in the sample.

[00073] Summarizing and without excluding other possible embodiments, the following embodiments may be considered: Embodiment 1. Detection method for detecting at least one analyte in at least one sample, the method comprising: a) providing at least one mobile device with at least at least one camera and at least one lighting source; b) providing at least one test strip with at least one test field, the test field comprising at least one test chemical for carrying out an optical detection reaction in the presence of the analyte; c) apply at least one sample to the test field; d) capturing a plurality of images of at least one region of the test strip, the region comprising at least a portion of the test field to which the sample is applied, comprising: d1) capturing at least one image before applying the sample to the test field, with the lighting source turned off; d2) capture at least one image before applying the sample to the test field, with the lighting source turned on; d3) capture at least one image after applying the sample to the test field; and e) determining a concentration of the analyte in the sample using the images captured in step d); Embodiment 2. Method, according to the previous embodiment, further comprising: f) comparing the corresponding images captured in step d) with the lighting source turned on and off and determining the differences in light intensities; Embodiment 3. Method, according to the previous embodiment, wherein step e) comprises using the result of step f) to determine the concentration of the analyte in the sample; Embodiment 4. Method according to either of the two previous embodiments, wherein step f) comprises: f1) deriving at least one item of color information from the part of the test field to which the sample is applied for each image to be compared; f2) transforming the color information item into at least one light intensity information item using at least one camera-specific transmission function; and f3) determine differences in light intensities using light intensity information items from corresponding images with the lighting source on and off; Embodiment 5. Method, in accordance with the two previous embodiments, wherein, for step e), differences in light intensities are transformed into differences in color information items for corresponding images using an inverted function of the specific transmission function camera; Embodiment 6. Method according to either of the two previous embodiments, wherein the camera-specific transmission function is a non-linear function that transforms the color information item into the light intensity information item; Embodiment 7. Method, according to any of the three previous embodiments, wherein the camera-specific transformation function is one or more of a non-linear light intensity transmission function and a non-linear exposure level sensitivity function ; Embodiment 8. Method, according to any of the previous embodiments, wherein step d3 comprises: d3i) capturing at least one image with the lighting source turned off; and d3ii) capture at least one image with the lighting source turned on; Embodiment 9. Method, according to the previous embodiment, wherein step e) further comprises using a difference in light intensities between the images captured in d3i) and d3ii); Embodiment 10. Method, according to any of the previous embodiments, wherein one or more of steps d1) to d3) are performed repeatedly; Embodiment 11. Method, according to the previous embodiment, in which a kinetic measurement curve of the optical detection reaction is monitored; Embodiment 12. Method, according to any of the previous embodiments, wherein, in step c), the sample is applied to the test field on a side opposite the camera; Embodiment 13. Method, according to the previous embodiment, wherein a holder is used to position the test strip relative to the mobile device, wherein the test strip is positioned with the test field at a distance from the camera, in that the camera is on a first side of the test field and that the sample is applied from a second side opposite the first side; Embodiment 14. Method, according to the previous embodiment, in which the support is opened to the second side, so that the test field is uncovered on the second side; Embodiment 15. Method according to either of the two previous embodiments, wherein the support comprises an opening so that the test field is uncovered on the first side; Embodiment 16. Method, according to any of the previous embodiments, wherein the test field is at least partially translucent, wherein, in step e), a contribution of ambient light shining through the test field to the camera; Embodiment 17. The method of any of the preceding embodiments, wherein the test strip further comprises a reference field, wherein the region of the test strip further comprises at least a portion of the reference field; Embodiment 18. Method, according to the previous embodiment, in which the reference field is opaque; Embodiment 19. Method, according to either of the two previous embodiments, wherein step d) of the method further comprises: d4) capturing at least one image of the reference field; Modality 20. Method, according to the previous embodiment, in which the image of the reference field is taken into consideration for step e); Embodiment 21. Method, according to any of the three previous embodiments, wherein the reference field contains at least one white field; Embodiment 22. Method, according to any of the previous embodiments, wherein the method further comprises at least one step of verifying specific properties of the camera; Embodiment 23. Computer program, comprising program means for fully or partially carrying out the method as defined in any of the preceding embodiments, specifically for carrying out steps d), e) and, optionally, f) of the method, while the computer program is running on a computer or a computer network, specifically on a processor of the mobile device; Modality 24. Mobile device, comprising: I) at least one camera; II) at least one lighting source; and III) at least one processor, wherein the mobile device is configured to perform the detection method for detecting the at least one analyte in at least one sample, as defined in any of the previous embodiments, together with a test strip with at least one test field, the test field comprising at least one test chemical for carrying out an optical detection reaction in the presence of the analyte; Embodiment 25. Mobile device, according to the previous embodiment, wherein the processor comprises program means for carrying out in whole or in part the method, as defined in any of the previous embodiments that relate to a method, specifically for carrying out the steps of ), e) and, optionally, f) of the method; Embodiment 26. Kit for detecting at least one analyte in at least one sample, the kit comprising the mobile device as defined in any of the preceding embodiments that refer to a mobile device, the kit further comprising at least one test strip with at least one test field, the test field comprising at least one test chemical for carrying out an optical detection reaction in the presence of the analyte; Embodiment 27. Kit, according to the previous embodiment, the kit further comprising at least one holder for positioning the test strip relative to the mobile device, wherein the test strip is positioned by the holder with the test field at a distance of the camera, wherein the camera is on a first side of the test field and wherein the sample is applied from a second side opposite the first side; Embodiment 28. Kit, according to the previous embodiment, in which the support is opened to the second side, so that the test field is uncovered on the second side; Embodiment 29. Kit, according to either of the two previous embodiments, wherein the holder with the test strip and the mobile device constitutes an internal space, the space being enclosed by the mobile device, the holder and the test strip; Modality 30. Kit, according to the previous embodiment, in which the camera and the lighting source are facing the internal space; and Embodiment 31. Kit, according to any of the previous embodiments that refer to a kit, wherein the holder positions the test strip so that the illumination source is capable of illuminating the test field.

BRIEF DESCRIPTION OF THE DRAWINGS

[00074] Other optional features and embodiments will be disclosed in more detail in the subsequent description of the embodiments, preferably in conjunction with the dependent embodiments. In it, the respective optional features can be realized in isolation, as well as in any viable arbitrary combination, as the person skilled in the art will understand. The scope of the invention is not restricted by preferred embodiments. The realizations are represented schematically in the Figures. In this sense, identical reference numbers in these Figures refer to identical or functionally comparable elements.

[00075] In the Figures: Figure 1 shows a side view of an embodiment of a kit comprising a mobile device for carrying out a detection method, in accordance with the present invention; Figure 2 shows an enlarged sectional view of the embodiment of the kit illustrated in Figure 1; Figure 3 shows a realization of an image captured by the mobile device camera; Figures 4A and B show graphs of an influence of ambient light on a color of a test field and a reference field; Figures 5A and B show graph realizations of a camera-specific transmission function; and Figures 6 and 7 show flowchart realizations of an embodiment of a detection method.

DESCRIPTION OF ACHIEVEMENTS

[00076] In Figure 1, there is illustrated a side view of an embodiment of a kit 110 for detecting at least one analyte in at least one sample 114 comprising a mobile device 112 and a test strip 116. The mobile device 112, as shown in Figure 1, comprises at least one camera 118, at least one lighting source 120, and at least one processor 122. The test strip 116 comprises at least one test field 124, comprising at least one test chemical 126 for perform an optical detection reaction in the presence of the analyte. Furthermore, three examples of light rays can be illustrated in Figure 1 by three dashed arrows. A first dashed arrow may indicate ambient or incident light shining from an arbitrary ambient light source 128, such as the sun, a lamp, or any other light source, on a test field 124. A second dashed arrow may indicate light emitted by the lighting source 120 when the lighting source 120 is turned on. Thus, the second dashed arrow may indicate light present only if the lighting source 120 is turned on. In the event that the lighting source 120 is turned off, no light may be emitted from the lighting source 120 of the mobile device 112. A third dashed arrow may indicate light shining on the camera 118. Specifically, in the event that the lighting source 120 is turned off , the light shining into the camera 118, e.g., the light indicated by the third dashed arrow, may comprise ambient or incident light transmitted through the test strip 116, e.g., through the test field 124, to the camera 118. Alternatively , in the event that the illumination source 120 is turned on, the light shining into the camera 118, e.g., the light indicated by the third dashed arrow, may comprise ambient or incident light transmitted through the test strip 116, as well as light emitted by the lighting source 120. In particular, in case the lighting source 120 is turned on, the light shining on the camera 118 may, for example, be reflected by the test strip 116, such as, for example, by the test field 124 and/or by a support 130, wherein the support 130 may be comprised by the kit 110.

[00077] In Figure 2, an enlarged sectional view of the embodiment of the kit 110, as illustrated in Figure 1, is shown. In particular, the test strip 116 with the test field 124 is shown, the test field 124 comprising at least least one test chemical 126. By way of example, the test strip 116 may comprise a substrate or carrier 132, wherein the test field 124, by way of example, may be applied to the carrier 132. The test field 124, as illustrated in Figure 2, may, for example, comprise multiple layers, such as, for example, a wetting layer 134 to evenly spread the sample 114, a filter layer 136 to filter or separate the components of the sample 114 to a subsequent color change detection reaction that may be carried out by the test chemical 126. Other structures or layer accumulation may be viable. As an example, the test chemical 126 may be arranged such that the color change may be identifiable on a first side 138 of the test field 124. In particular, the first side 138 may be disposed opposite a second side 140 of the test field 124, wherein the sample 114 may be applied to the second side 140 of the test field 124. Specifically, the camera 118 may be arranged to face the first side 138 of the test field 124.

[00078] Figure 3 illustrates an embodiment of an image 142 captured by the camera 118 of the mobile device 112. The image 142, by way of example, may be of at least one region 144 of the test strip 116 comprising at least a portion of the test field 124, wherein the test field 124 may, for example, be translucent. By way of example, region 144 may further fully or partially comprise a reference field 146, wherein the reference field 146, by way of example, may be opaque and may contain at least one white field.

[00079] In Figures 4A and B, graphs of an influence of ambient light on a color of the test field 124 and the reference field 146 are illustrated. In graphs, the x-axis may indicate time t, for example, measured in seconds, and the y-axis may indicate a color or reflectivity R. The graph in Figure 4A illustrates an influence of ambient light on a given color or reflectivity of the field. of test field 124 and in a determined color of the reference field 146. In particular, determined colors or reflectivities R of the test field 124, illustrated in a solid line, and the reference field 146, illustrated in a dotted line, are shown to three different lighting conditions over time. For example, in a first lighting condition, the ambient light source 128 may be turned off and the lighting source 120 of the mobile device 112 may be turned on. Specifically, in the graph, the first lighting condition can be used at the time intervals ti, t3, ts, and t7, where ti = 0 < t < 2 s, t3 = 11 < t < 18 s, ts = 32 < t < 34 and t7 = 39 < t < 41 s. In a second and third lighting condition, both the mobile device lighting source i20 and the ambient light source i28 can be turned on. However, in the third lighting condition, the ambient light may have a higher brightness level than in the second lighting condition. Specifically, in the graph, the second lighting condition can be used at time interval t2, where t2 = 2 < t < 11 s, and the third lighting condition can be used at time intervals t4 and t6, where t4 = 18 < t < 32 and t6 = 34 < t < 39 s. In the graph, as illustrated in Figure 4A, the i24 test field shows a different color, for example, a different color coordinate value, a different specific color intensity, or a different intensity in a specific spectral color range, or reflectivity for each of the three lighting conditions. In particular, the first determined color 148 of the test field 124 for the first lighting condition may be less bright than the second determined color 150 of the test field 124 for the second lighting condition and the third determined color 152 of the test 124 for the third lighting condition. Furthermore, the third determined color 152 of the test field 124 may be brighter than the second determined color 150. Thus, the lighting condition may have a direct impact on the determined color of the test field 124. However, a color determined 154 of the reference field 126 may be independent of the lighting condition, as can be seen in the graph illustrated in Figure 4A.

[00080] It may be noted that given time specifications, such as, for example, the specific times of the time intervals, as stated in the description of the figures, are provided for exemplary purposes and therefore serve to illustrate possible realizations and should not be interpreted as limiting its scope.

[00081] The graph in Figure 4B illustrates an influence of a combination of ambient light and the lighting source 120 being turned on or off and the sample 114 being or not being applied to the test field 124, on a given color of the test field 124 and in a determined color of the reference field 146. In particular, determined colors or reflectivities R of the test field 124, illustrated in the solid line, and of the reference field 146, illustrated in the dotted line, are shown for different lighting conditions and of sample 114, whether or not it is applied to test field 124. Specifically, in the graph, sample 114 is not applied to test field 124 during time 0 < t < 32 s. Subsequently, during the time 32 < t < 38 s, the sample 114 is being applied to the test field 124 and the color change detection reaction can be carried out by the test chemical 126. During the subsequent time 38 < t < 86 s, the sample is applied to the test field 124 and the color change detection reaction may already be completed. As an example, sample application may occur within an interval of one second or less. The sample may penetrate the test chemical 126 and the color change detection reaction, with its characteristic reaction kinetics, may occur. In Figure 4B, once again, three different lighting conditions can be used, where the lighting conditions used in Figure 4B differ from the lighting conditions used in Figure 4A.

[00082] In particular, in the first lighting condition used in Figure 4B, the lighting source 120 of the mobile device 112 is turned on and the ambient light source 128 is also turned on, wherein in this graph the ambient light source 128 can only be able to adapt the two stages “on” and “off”. The first lighting condition used in Figure 4B can be used in the time intervals ti', t4 and t?', where ti = 0 < t < 5 s, t4 = 16 < t < 58 s and t?' = 75 < t < 82 s. In the second lighting condition, the lighting source 120 is turned off while the ambient light source i28 is turned on. The second lighting condition can be used specifically in the time intervals t2', t5' and t8', where t2' = 5 < t < 13 s, t5' = 58 < t < 68 s and t7' = 75 < t < 82 s. In the third lighting condition, the i20 lighting source is turned on, while the i28 ambient light source is turned off. The third lighting condition can be used specifically in the time intervals t3' and t6', where t3' = 13 < t < 16 s and t6' = 68 < t < 75 s.

[00083] As can be seen in Figure 4B, the first determined color i56, such as a first color coordinate value, a first specific color intensity, or an intensity in a first specific spectral color range, of the reference field i46 may be essentially the same for the first lighting condition and the third lighting condition. Thus, for example, only the lighting source i20, for example, being turned on or off, can have an impact on the determined color of the reference field 146. Specifically, as illustrated in Figure 4B, the second determined color 158 of the reference field 146, for example, determined at the time intervals during which the lighting source 120 is turned off, may, for example, show a color or reflectivity of R = 0. However, the determined color of the test field 124, as illustrated on the graph, may show a significant dependence on the lighting condition as well as the application of the sample 114. Specifically, the determined colors of the test field 124 may differ from each other for each lighting condition. Furthermore, the determined color of the test field 124 may be different whether the sample 114 is applied to the test field 124 or not, even for the same lighting condition. In particular, a determined first color 160 of test field 124 for the first lighting condition may be brighter before applying sample 114 to test field 124 than after applying sample 114. By way of example, a translucency of the test field 124 may be decreased due to the sample 114 being applied to the test field 124, thus a smaller amount of light may be transmitted through the test field 124 to the camera 118, which may result in a color transition 159. Specifically, the color transition 159 may lead to a less bright first determined color 160 of the test field 124 under the same first lighting condition after the sample 114 is applied to the test field 124 as before. Furthermore, as illustrated in Figure 4B, the second determined color 162 as well as the third determined color 164 of the test field 124 differ from each other and from the first color 160 and, furthermore, the second color 162 and the third color 164 also changes in brightness due to application of sample 114 to test field 124.

[00084] In Figures 5A and B, realizations of a graph of a camera-specific transmission function 165 are shown. Specifically, in graphs, an exposure level or light intensity I, specifically an incoming light intensity, may be illustrated on the x-axis and a corresponding color or reflectivity R, specifically a color channel value of a given color, e.g. example of one or more of R, G and B, can be illustrated on the y-axis. As an example, Figures 5A and B may show the same camera-specific transmission function 165. However, in Figure 5A, the x-axis may show a light intensity I on a linear scale of light intensity values in one unit arbitrary, wherein in Figure 5B a logarithmic scale can be used to illustrate the light intensity I. In particular, by way of example, the camera-specific transmission function 165 illustrated in the graphs can be mathematically described as: R(I) = 62.5 log2 I - 165.24.

[00085] By way of example, an inverse function of the non-linear function (2) can be mathematically described as:

[00086] In Figures 6 and 7, flowcharts of a detection method for detecting at least one analyte in at least one sample 114 are illustrated. The detection method comprises step a) (denoted with reference numeral 166) of providing at least one mobile device 112 with at least one camera 118 and at least one lighting source 120. By way of example, the mobile device 112 as illustrated in Figure 1 can be provided. Further, the detection method comprises step b) (denoted with reference numeral 168) of providing at least one test strip 116 with at least one test field 124, the test field 124 comprising at least one chemical. test 126 to perform an optical detection reaction in the presence of the analyte. In particular, by way of example, the test strip 116 illustrated in Figure 1 may be provided. Furthermore, the detection method may comprise step c) (denoted with reference numeral 170) of applying the at least one sample 114 to the test field 124. By way of example, step c) may be performed by means of dripping of sample 114 into test field 124, as illustrated in Figures 1 and 2.

[00087] Furthermore, the detection method comprises step d) (denoted with reference number 172) of capturing a plurality of images 142 of at least one region 144 of the test strip 116, the region 144 comprising at least a portion of the test field 124 to which the sample 114 is applied. Step d) of the method further comprises at least the following substeps: d1) (denoted with reference number 174) capturing at least one image 142 before applying the sample 114 to the test field 124, with the illumination source 120 off; d2) (denoted with reference number 176) capturing at least one image 142 before applying the sample 114 to the test field 124, with the lighting source 120 turned on; and d3) (denoted with reference number 178) capturing at least one image 142 after applying the sample 114 to the test field 124.

[00088] In particular, substep d1) can, for example, be carried out in the time interval t2' of the graph illustrated in Figure 4B. Furthermore, substep d2) can, by way of example, be carried out in one or both of intervals t1' and t3'. It may also be possible to perform substep d2) at the beginning of the time interval t4', for example, for 16 < t < 32 s, for example, before performing step e) of applying the sample 114 to the test field 124, for example, during 32 < t < 38 s. Furthermore, substep d3) may be carried out specifically after applying the sample 114 to the test field 124, such as, for example, at the end of the time interval t4', for example, during 38 < t < 58 s, and/or or time intervals t5', t6', t7' and t8'.

[00089] The detection method further comprises step e) (denoted with reference number 180) of determining a concentration of the analyte in sample 114 using images 142 captured in step d). As illustrated in Figure 7, the detection method may further comprise step f) (denoted with reference numeral 182) of comparing corresponding images captured in step d) with the lighting source 120 on and off and determining differences in intensities. of light. The result of step f) can, for example, be used to determine the concentration of the analyte in sample 114, thus, by way of example, step e) can comprise step f), as illustrated in Figure 7.

[00090] As illustrated in Figure 7, step f) may, for example, comprise the following substeps: f1) (denoted with reference number 184) deriving at least one item of color information from the portion of the test field to the which sample is applied to each image to be compared; f2) (denoted with reference number 186) transforming the color information item into at least one light intensity information item using at least one camera-specific transmission function 165; and f3) (denoted with reference numeral 188) determining differences in light intensities using light intensity information items from corresponding images with the lighting source on and off.

[00091] By way of example, the camera-specific transmission function 165, which can be used in substep f2) can, for example, be illustrated in Figures 5A and B. Thus, in the following, an exemplary calculation is shown, which can be carried out in the detection method. The image 142 captured in step d1) may, for example, show a color or reflectivity of Rd1 = 230 and the image 142 captured in step d2) may, for example, show a color or reflectivity of Rd2 = 80. By way of example , Rd1 and Rd2 can be understood by the color information item derived in step f1). By way of example, in step f2), the inverse camera specific transmission function (2) can be used to transform Rd1 and Rd2 into light intensities Id1 = 80 and Id2 = 15. Subsequently, a difference in light intensities can be determined in step f3), such as Idi2 = 80 - 15 = 65. In particular, for step e), differences in light intensities, for example, can be transformed into differences in color information items for images corresponding using the inverted function (2) of the camera-specific transmission function (1). Thus, as an example, Rd12 (Id12 = 65) = 211 can be calculated. In particular, differences in color information items, e.g. Rd12, may, for example, comprise information about a true color of the test field, such as the color of the reference field without interference from external or ambient light. , before the sample 114 can be applied to the test field 124.

[00092] After applying the sample 114 to the test field, for example, after performing step c), step d3) can be performed. In particular, step d3) may, for example, comprise substep d3i) (denoted with reference numeral 190) of capturing at least one image 142 with the lighting source 120 turned off; and substep d3ii) (denoted with reference number 192) of capturing at least one image 142 with the lighting source 120 turned on. By way of example, images 142 captured in step d3) may show a color or reflectivity of Rd3i = 190 and Rd3ii = 15. By way of example, Rd3i and Rd3ii may be understood by the color information item derived in step f1) . Again, by way of example, using the inverted function (2) of the camera-specific transmission function (1), the corresponding light intensities Id3i = 51 and Id3ii = 7, can be determined, for example, in step f2), leading to a difference in light intensities Id3 = 44. Subsequently, by way of example, Rd3 (Id3 = 44) = 176 can be calculated. Rd3 may, for example, comprise information about a true color of the test field 124, after the color change detection reaction is carried out by the test chemical 126. Thus, a color change, specifically a difference in color due to analyte concentration in sample 114 independent of incident or ambient light, can, for example, be determined from a difference between Rd12 and Rd3.

[00093] List of reference numbers: 110 Kit; 112 Sample; 114 mobile device; 116 test strip; 118 Camera; 120 lighting source; 122 Processor; 124 test field; 126 test chemical; 128 ambient light source; 130 Support; 132 Conveyor; 134 moistening layer; 136 filter layer; 138 first side; 140 second side; 142 Image; 144 Region; 146 reference field; 148 first color of the test field; 150 second test field color; 152 third color of the test field; 154 reference field color; 156 first color of the reference field; 158 second color of the reference field; 159 color transition; 160 first color of the test field; 162 second color of the test field; 110 Kit; 164 third test field color; 165 camera-specific transmission function; 166 step a); 168 step b); 170 step c); 172 step d); 174 step d1); 176 step d2); 178 step d3); 180 step e); 182 step f); 184 step f1); 186 step f2); 188 step f3); 190 step d3i); and 192 step d3ii).

Claims (11)

1. DETECTION METHOD for detecting at least one analyte in at least one sample (114), the method comprising: a) providing at least one mobile device (112) having at least one camera (118) and at least one source of lighting (120); b) providing at least one test strip (116) having at least one test field (124), the test field comprising at least one test chemical (126) for carrying out an optical detection reaction in the presence of the analyte ; c) applying at least one sample (114) to the test field (124); d) capturing a plurality of images (142) of at least one region (144) of the test strip (116), the region (144) comprising at least a portion of the test field (124) to which the sample (114) is applied, comprising: d1) capturing at least one image (142) before applying the sample (114) to the test field (124), with the lighting source (120) turned off; d2) capturing at least one image (142) before applying the sample (114) to the test field (124), with the lighting source (120) turned on; and d3) capturing at least one image (142) after applying the sample (114) to the test field (124), wherein step d3) comprises d3i) capturing at least one image (142) with the illumination source ( 120) off; and d3ii) capturing at least one image (142) with the lighting source (120) turned on; e) determining a concentration of the analyte in the sample (114) using the images (142) captured in step d); the method being characterized by further comprising: f) comparing the corresponding images captured in step d) with the lighting source turned on and off (120) and determining differences in light intensities, wherein step f) comprises: g) ) deriving at least one item of color information from the part of the test field (124) to which the sample (114) is applied for each image (142) to be compared; h) ) transforming the color information item into at least one light intensity information item using at least one camera-specific transmission function (165); i) ) determining differences in light intensities using light intensity information items from corresponding images with the lighting source (120) turned on and off; wherein step e) comprises using the result of step f) to determine the concentration of the analyte in the sample (114). 2. METHOD according to claim 1, characterized in that, for step e), differences in light intensities are transformed into differences in color information items for corresponding images using an inverted function of the camera-specific transmission function (165), wherein the camera-specific transmission function (165) is a nonlinear function that transforms the color information item into the light intensity information item. 3. METHOD, according to any one of claims 1 to 2, characterized by step e) further comprising using a difference in light intensities between the images (142) captured in d3i) and d3ii). 4. METHOD, according to any one of claims 1 to 3, characterized in that, in step c), the sample (114) is applied to the test field (124) on a side opposite to the camera (118). 5. METHOD according to claim 4, characterized in that a support (130) is used to position the test strip (116) relative to the mobile device (112), wherein the test strip (116) is positioned with the test field (124) at a distance from the camera (118), wherein the camera (118) is on a first side (138) of the test field (124) and wherein the sample (114) is applied from on a second side (140), opposite the first side (138). 6. METHOD, according to claim 5, characterized in that the support (130) is open towards the second side (140), so that the test field (124) is uncovered on the second side (140), in which the support (130) comprises an opening, so that the test field (124) is uncovered on the first side (138). 7. METHOD according to any one of claims 1 to 6, characterized in that the test field (124) is at least partially translucent, wherein, in step e), a contribution from ambient light shining through the test field (124 ) for the camera (118) is determined. 8. METHOD according to any one of claims 1 to 7, characterized in that the test strip (116) further comprises a reference field (146), wherein the region (144) of the test strip (124) further comprises at least at least one part of the reference field (146), wherein the reference field (146) is opaque, wherein step d) of the method further comprises: step d4) capturing at least one image (142) of the reference field ( 146), and in which the image (142) of the reference field (146) is taken into account for step e). 9. COMPUTER READABLE NON-TRANSITIONAL MEDIUM, characterized by implementing a method for carrying out at least step d), step e) and step f) of the method, as defined in any one of claims 1 to 8, while the non-transitory readable medium per computer is being read on a computer or a computer network. 10. MOBILE DEVICE (112), comprising: I) at least one camera (118); II) at least one lighting source (120); and III) at least one processor (122), characterized in that the mobile device (112) is configured to perform the detection method for detecting the at least one analyte in the at least one sample (114), as defined in any one of claims 1 to 8, together with a test strip (116) having at least one test field (124), the test field (124) comprising at least one test chemical (126) for carrying out an optical detection reaction in the presence of the analyte. 11. KIT (110) FOR DETECTING AT LEAST ONE ANALYTE IN AT LEAST ONE SAMPLE (114), the kit (110) being characterized by comprising the mobile device (112), as defined in claim 10, the kit (110) further comprising at least one test strip (116) having at least one test field (124), the test field (124) comprising at least one test chemical (126) for carrying out an optical detection reaction in the presence of the analyte .