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

Abstract

Disclosed are a determination method for determining at least one color expectation range (128) for assessing the validity of an assumed reaction time value used in an analytical measurement based on a color-forming reaction, and a measurement method for performing an analytical measurement based on a color-forming reaction using a mobile device (112) having a camera (114) and a processor (126). Further disclosed are a determination system (110) for determining at least one color expectation range (128) for assessing the validity of an assumed reaction time value used in an analytical measurement based on a color-forming reaction, a mobile device (112) having at least one camera (114) and at least one processor (130), a kit (134) for determining the concentration of at least one analyte in a sample (128) of a body fluid comprising said mobile device (112), as well as computer programs and computer readable storage media comprising instructions that, when executed on the respective devices, cause the devices to perform the determination method and / or the measurement method.

Description

[Technical field]

[0001] Technical Field The present invention relates to a determination method for determining at least one color expectation range for evaluating the validity of an assumed reaction time value. The present invention also relates to a measurement method for performing an analytical measurement based on a color-forming reaction. Furthermore, the present invention relates to a determination system, a mobile device, as well as a computer program, a computer-readable storage medium, and a kit. The method, system, mobile device, computer program, computer-readable storage medium, and kit may be used in particular in medical diagnostics for detecting, for example quantitatively or qualitatively, one or more analytes in one or more body fluids, such as for detecting glucose in blood and / or interstitial fluid. However, other fields of application of the present invention are feasible. [Background technology]

[0002] Background technology In the field of medical diagnostics, it is often necessary to detect one or more analytes from a sample 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 that are normally present in these bodily fluids. Depending on the concentration and / or presence of the analyte, an appropriate treatment may be selected as required. Without narrowing the scope, the present invention may be specifically described with respect to blood glucose measurement. However, it should be noted that the present invention may also be used for other types of analytical measurements using test elements.

[0003] Generally, devices and methods known to those skilled in the art utilize test elements and / or strips that contain one or more test chemicals, which can carry out one or more detectable detection reactions, such as optically detectable detection reactions, in the presence of the analyte to be detected.For the test chemicals contained in the test elements and / or test strips, reference can be made, for example, to The Technology Behind Glucose Meters: Test Strips, Diabetes Technology & Therapeutics, Volume 10, Supplement 1, 2008, S-10 to S-26.Other types of test chemicals are possible and can be used to implement the present invention.

[0004] In analytical measurements, especially those based on color-forming reactions, one technical challenge lies in the evaluation of the color change resulting from the detection reaction. In addition to using dedicated analytical devices such as handheld blood glucose meters, the use of commonly available electronic devices such as smartphones and portable computers or other mobile devices has become increasingly popular in recent years. Thus, cameras included in these mobile devices may be used to measure the color change of the detection reaction of the test elements and / or test strips. In contrast to laboratory measurements, and measurements performed by dedicated analytical measurement devices and test elements and / or test strips, when using mobile computing devices such as smartphones, various influences must be taken into account. By way of example, lighting conditions, positioning, vibrations, electronic defects, or other more or less uncontrollable conditions should be taken into account. In general, procedures may be used that involve mathematically correcting and / or compensating for the results of such influences on the color change by utilizing color standards for the photometric measurements.

[0005] US Patent Application Publication No. 2020 / 0249220 describes a method for detecting a urine test strip from a captured image of the urine test strip. The disclosed method for detecting a urine test strip includes receiving an input of a urine test strip image, the urine test strip image being a captured image of a urine test strip including a first and a second marker, detecting the first and second marker images in the urine test strip image, detecting an area between the first and second marker images in the urine test strip image, and detecting the reagent pad and colorimetric table of the urine test strip image by matching an area of ​​interest representing the location of the reagent pad and colorimetric table of the urine test strip image with the area between the first and second marker images.

[0006] US Patent No. 9,787,815 describes a method of obtaining a collection point, quantitative indicia of selected analytes of a test strip using a smartphone, including imaging the test strip where a colorimetric response of the target sample occurred due to illumination of the test strip by the smartphone. The smartphone includes a smartphone app and a smartphone accessory that provides an external environment independent / internal light-free imaging environment independent of the smartphone platform being used. The results can then be presented quantitatively or converted to a more consumer-useful measurement (positive, negative, above average, etc.) and displayed to the user, stored for later use, and communicated to a location where a physician can provide additional review. Additionally, social media integration can allow the device's results to be broadcast to a specific audience, allowing users to compare their healthy lifestyles with others, compete in health-based games, create mapping, and create other applications.

[0007] EP 2916117 describes color quantification of chemical test pads and titration of analytes that can be performed under different lighting conditions. In one embodiment, a digital image is captured and an estimate of the lighting conditions is made that is utilized to select a set of reference colors against which the quantified colors are compared to determine the titration. In another embodiment, multiple comparisons are made under different lighting conditions and the result with the highest confidence level is selected to determine the titration.

[0008] EP 1963828 describes a method for determining the concentration of an analyte contained in a sample of a biological fluid. In said method, a test strip is provided, comprising at least one test point and at least one reference color section, including a white color and / or a color scale. A liquid sample is contacted with the test point and a color indicator is placed at the test point depending on the concentration of the analyte. A camera is placed on the test strip. At least one measurement value is detected for the relative position between the camera and the test strip and compared with a range of set values. If the measurement value falls outside the range of set values, the camera is moved relative to the test strip to reduce the deviation. A color image, in which at least the color indicator and the reference color section are represented, is detected with the help of the camera. An image area assigned to the color indicator and the color matching section is placed and a color value of said image area is determined. The concentration of the analyte in the sample is determined based on the color value using a predefined comparison value.

[0009] US Patent Publication No. 2015 / 0241358 describes, in one embodiment, an apparatus for automated testing diagnostics of test paddles. The apparatus comprises a personal computing device including a camera for capturing images of the test pads of the test paddles over time, a processor coupled to the camera, and a display device coupled to the processor. The processor analyzes the color change of each test pad over time to determine a color trajectory of each test pad over time. The processor compares the color development trajectory of each test pad to a color calibration curve for each test pad to determine an analyte concentration of a test biological sample, such as urine. During analysis by the processor, the display device displays a user interface including results of the analyte concentration in response to the analysis over time.

[0010] US Patent Application Publication No. 2014 / 065647 describes systems and methods for spatiotemporally resolved rapid assays.

[0011] EP 3 667 301 A1 describes a method and system for determining the concentration of an analyte in a body fluid sample, as well as a method and system for generating a software implemented module.

[0012] US Patent Application Publication No. 2021 / 299651 describes a multi-factor urine testing system that adjusts lighting and timing.

[0013] U.S. Patent Application Publication No. 2017 / 098137 describes methods, devices and systems for detecting and determining compromised reagent pads by quantifying color changes induced by exposure to a hostile environment.

[0014] US Patent Application Publication No. 2006 / 246574 describes a dispenser for the construction of a lateral flow immunoassay device that includes a fluid delivery assembly and an ejection assembly.

[0015] Despite these advantages realized by these known methods and devices, some technical challenges remain. In particular, user-dependent effects such as incorrect handling habits and / or incorrect timing of sample application or other more or less uncontrollable user-dependent handling errors can result in undetected color changes. Such undetected color changes can lead to inaccurate analytical measurements when determining the concentration of an analyte based on a color-forming reaction. Summary of the Invention [Problem to be solved by the invention]

[0016] Issues to be resolved It would therefore be desirable to provide methods and devices that at least partially address the above-mentioned technical problems, in particular to provide methods and devices that allow for detection of color changes introduced by incorrect and / or improper user handling. [Means for solving the problem]

[0017] overview This problem is addressed by a determination method for determining at least one color expectation range for evaluating the validity of an assumed reaction time value, and a measurement method for performing an analytical measurement based on a color formation reaction.Furthermore, it is addressed by a determination system, a mobile device, a computer program, a computer readable storage medium, and a kit having the features of the independent claims.Advantageous embodiments, which may be realized alone or in any combination, are described in the dependent claims as well as in the entire specification.

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

[0019] Furthermore, it should be noted that the terms "at least one," "one or more," or similar expressions indicating that a feature or element may be present one or more times are typically used only once when introducing each feature or element. In the following, in most cases, when referring to each feature or element, the expressions "at least one" or "one or more" will not be repeated, regardless of the fact that each feature or element may be present one or more times.

[0020] Furthermore, when used hereinafter, the terms "preferably", "more preferably", "particularly", "more particularly", "particularly", "more particularly" or similar terms are used in conjunction with any feature without limiting the possibilities of substitution. Thus, features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, without limitations regarding alternative embodiments of the invention, without limitations regarding the scope of the invention, and without limitations regarding the possibilities of combining the feature so introduced with other optional or non-optional features of the invention.

[0021] In a first aspect of the present invention, a determination method is disclosed for determining at least one color expectation range for evaluating the validity of the assumed reaction time value used in an analytical measurement based on a color formation reaction. The determination method includes the following steps, which can be performed in a given order as an example. However, it should be noted that a different order is generally possible. Furthermore, it may be possible to perform one or more of the method steps only once or repeatedly. Furthermore, it may also be possible to perform two or more of the method steps simultaneously or overlap in time. The determination method may include further method steps that are not listed.

[0022] The method of determination is as follows: a) providing a training set of optical test strips, each optical test strip having a reagent test area; b) providing a training set of samples of the bodily fluid and applying at least one of the samples of the bodily fluid to a reagent test area of ​​each optical test strip of the training set of optical test strips; c) capturing, by at least one mobile device having at least one camera, a training set of images, the training set of images comprising: - a training subset of first images, the training subset of first images including images of at least a portion of at least some of the reagent test areas of the training set of optical test strips to which a sample of bodily fluid is applied, the sample being captured at an in-time capture time value, the capture time value referring to the time elapsed between the application of the sample in step b) and the capture of the image; - at least one training subset of second images, the at least one training subset of second images including images of at least a portion of at least some of the reagent test areas of the training set of optical test strips to which samples of bodily fluid captured at delayed capture time values ​​are applied; To take in and d) specifically, using at least one processor, more specifically a processor of a mobile device, determining a training set of color formation values ​​from images of the training set of images, the training set of color formation values ​​including color formation values ​​of at least one color channel for color formation of the reagent test area of ​​the optical test strip of the training set of optical test strips for in-time capture time values ​​and delayed capture time values; e) deriving at least one color expectation range for at least one color channel from the training set of color formation values, the color expectation range defining an expected range of color formation values ​​for an in-time capture time value and an acceptable late capture time value, the acceptable late capture time value being determined by the delay d being greater than or equal to at least one predetermined expiration threshold d max Not exceeding, and Includes.

[0023] The term "analytical measurement based on a color-forming reaction" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or special meaning. The term may specifically, but not limited to, refer to the quantitative and / or qualitative determination of at least one analyte in any sample or aliquot of bodily fluid by using a color-forming reaction. For example, the bodily fluid may include one or more of blood, interstitial fluid, urine, saliva or other types of bodily fluid. The result of the determination of the analyte may be, by way of example, the concentration of the analyte and / or the presence or absence of the analyte to be determined. Specifically, by way of example, the analytical measurement may be a blood glucose measurement, and thus the result of the analytical measurement may be, for example, a blood glucose concentration. In particular, an analytical measurement result value, such as the concentration of an analyte of a bodily fluid, may be determined by an analytical measurement using a color-forming reaction, such as a color change reaction, depending on the quantitative and / or qualitative presence or absence of an analyte of the bodily fluid.

[0024] For example, the bodily fluid may include one or more of blood, interstitial fluid, urine, saliva, or other types of bodily fluid. Thus, the term "sample of bodily fluid" may specifically refer to any aliquot or portion of a biological fluid that is a bodily fluid directly or is derived from a bodily fluid by one or more pre-processing steps, such as centrifugation. By way of example, a sample of bodily fluid may be a drop of bodily fluid taken from a person's body, such as a drop of blood and / or interstitial fluid produced by puncturing a portion of the person's skin with a lancet, needle, or the like. A sample of bodily fluid may also be simply referred to as a sample.

[0025] In analytical measurements based on color-forming reactions, optical test strips are specifically used. The term "optical test strip" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or special meaning. The term may specifically refer to, but is not limited to, any element or device configured to perform a color change detection reaction. An optical test strip may also be referred to as a test strip or a test element, and all three terms may refer to the same element. An optical test strip may have, in particular, a reagent test area, also referred to as a test region and / or test field, which includes at least one test chemical for detecting at least one analyte. In particular, the test chemical may be configured to perform a color change, e.g., a change in its color, due to the presence of the analyte. The color change may depend, for example, on the concentration of the analyte in the body fluid sample. In particular, the reagent test area may have a visually detectable edge, such as a detectable border and / or border, in contrast to the reagent test area from the other parts of the optical test strip. By way of example, an optical test strip may include at least one substrate, such as at least one carrier, having at least one test field applied thereto or incorporated therein. In particular, an optical test strip may further include at least one white area, such as a white field, specifically adjacent to the reagent test area, for example surrounding or encircling the test area. In particular, the contrast between the reagent test area and the white area surrounding the reagent test area may be sufficient to allow visual detection of the edge and / or margin of the reagent test area. Additionally or alternatively, the substrate or carrier itself may be or comprise a white area. By way of example, the at least one carrier may be in the form of a strip, thereby making the test element a test strip. These test strips are commonly used and available. A test strip may carry a single reagent test area, or multiple test areas with the same or different test agents contained therein.

[0026] The term "assumed reaction time value used in an analytical measurement based on a color-forming reaction" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or special meaning. The term may specifically, but not exclusively, refer to a numerical representation of an estimated reaction time in an analytical measurement. In particular, the reaction time value may refer to the time taken for a color change reaction of a reagent test area of ​​an optical test strip. By way of example, the assumed reaction time value may be provided in an analytical measurement by a user, e.g., a user performing the analytical measurement. In particular, in a measurement, the user may be required to provide information such as the time of sample application to the reagent test area, allowing the user to assume and / or predict a reaction time value, also referred to as an assumed reaction time value. In particular, the assumed reaction time value may refer to an assumed and / or estimated time between the application of the sample to the reagent test area and the measurement, i.e., between the initiation of the color change reaction and the capture of an image of the reagent test area. Thus, by way of example, the assumed reaction time value may also be referred to as an assumed capture time value, such as an assumed value of the capture time value, as outlined below. As used herein, the term "expected reaction time value" or, synonymously, "expected uptake time value" is a broad term and should be given its ordinary and customary meaning to one of ordinary skill in the art and should not be limited to a special or special meaning. The term may specifically, but not limited to, refer to an expected and / or predicted numerical representation of a reaction time, i.e., the time that a chemical reaction, specifically a color change reaction, has occurred. In particular, the expected reaction time value may refer to the time that a chemical reaction has occurred and thus may also be referred to as a chemical reaction timing and / or a color change reaction timing. The expected reaction time value may specifically be a time value that is estimated and / or predicted based on, for example, instructions provided by a user. Thus, the expected reaction time value may differ from the actual reaction time that may have been required for the color change reaction of the reagent test area. The expected reaction time value may be used in an analytical measurement to determine the concentration of an analyte from the color formation value.Additionally or alternatively, the expected reaction time value may refer to a range of reaction times, i.e. an assumed and / or predicted numerical representation of the range of times for a chemical reaction, particularly a color change reaction, to occur. Thus, by way of example, instead of indicating a numerical value in time, such as, for example, "18 seconds", the expected reaction time value may additionally or alternatively indicate a numerical range of times, such as, for example, "within 1 minute" or a time range such as "between 13 and 45 seconds".

[0027] The term "color formation value" may refer to any numerical representation, such as a numerical representation, of the color of the reagent test area of ​​the test strip, particularly resulting from a color change detection reaction of the test chemicals. In particular, the color numerically indicated by the color formation value may be correlated with the analyte concentration of the sample of bodily fluid applied to the respective optical test strip. Thus, by way of example, the color, and therefore the color formation value, may be correlated with the blood glucose level and / or blood glucose concentration. Furthermore, the color of the reagent test area, and therefore the color formation value, may change over time. Thus, the correlation between the color formation value and the analyte concentration may further be time-dependent. Thus, the analytical measurement may further use an assumed reaction time value to determine the concentration of the analyte from the color formation value.

[0028] By way of example, the correlation may be represented by one or more functions, and the analyte concentration may be determined by inserting the expected reaction time value and the color formation value into the function. In particular, the expected reaction time value may be inserted as a numerical value. Additionally or alternatively, different mathematical correlation functions may be used for different expected reaction time values. Thus, for a first time range of expected reaction time values, a first mathematical correlation function may be used to determine the analyte concentration from the color formation value, and for a second time range of expected reaction time values, a second mathematical correlation function may be used. By way of example, a mathematical function "f" may be used for expected reaction time values ​​"between 13 and 45 seconds" and a mathematical function "g" may be used for expected reaction time values ​​"between 45 and 120 seconds". By way of example, if the expected reaction time value indicates "longer than 120 seconds", the analytical measurement may even be aborted, for example by displaying an error message on the display of the mobile device. Furthermore, in particular, the function "g" may be determinable from the function "f" corrected by using a predefined correction function, for example by applying a correction value. Other forms of functions may be used to represent the correlation between analyte concentration and color formation value, for example, look-up tables or interpolation may be used. By way of example, the assumed reaction time value may be used to select a function such as "f" or "g" used to determine the analyte concentration from the color formation value, but when calculating the analyte concentration itself, i.e., using and / or applying a mathematical function, i.e., "f" or "g", the assumed reaction time value may not be used or may even be irrelevant.

[0029] The term "assessing validity" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or special meaning. The term may specifically refer to, but is not limited to, a process of qualitatively and / or quantitatively determining the reliability and / or probability of an element and / or data. By way of example, validity may be assessed by using one or more characteristic parameters and / or characteristics of the element and / or data. These one or more characteristic parameters and / or characteristics may be compared to one or more conditions, either individually or according to a predetermined combination. Thus, by way of example, the validity of an expected reaction time value may be assessed by using one or more characteristic parameters and / or characteristics of the expected characteristic, specifically by using a color expectation range, as outlined in more detail below. Specifically, for an expected reaction time value, the respective color formation value may be compared to a color expectation range, such as one or more comparison values, reference values ​​or standard values, and the comparison may be a qualitative or quantitative comparison and may result in a binary result, such as "seems valid" or "not valid" / "not valid". However, additionally or alternatively, the comparison may yield a quantitative result, such as a number, that indicates some degree of validity.

[0030] The term "color expectation range" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or special meaning. The term may specifically, but not limited to, refer to a continuous and / or discrete range in color space in which colors are expected and / or predicted to be in a range of predetermined reaction time values, i.e., in a predetermined reaction time value range. Thus, by way of example, the color expectation range may be one or more of a one-dimensional, two-dimensional or three-dimensional region in color space that includes at least one of a comparison value, a reference value and / or a standard value for a predetermined reaction time value range. Thus, the color expectation range may be or include a continuous region and / or a progressive band that includes at least one expected color value. However, additionally or alternatively, the color expectation range may be or include a collection of discrete expected colors, including, for example, discrete comparison values, reference values ​​and / or standard values. In particular, the color expectation range, specifically a two-dimensional or three-dimensional color expectation range, may have any form and / or shape.

[0031] Specifically, to derive a color expectation range, the in-time capture time value and the acceptable delayed capture time value may be used to set and / or predefine a reaction time value range on which a validity assessment may be based later, i.e., in the measurement method.

[0032] As used herein, the term "determination method for determining at least one color expectation range for evaluating the validity of assumed reaction time values ​​used in analytical measurements based on color formation reactions", also referred to simply as "determination method", is a broad term and should be given its ordinary and customary meaning for those skilled in the art and should not be limited to a special or special meaning. This term may refer in particular, but not exclusively, to a method for determining the color expectation range defined above according to a given reaction time value, i.e., according to an in-time capture time value and an acceptable delayed capture time value. In particular, this term may refer to a method in which at least one range defining an expected range of color formation values ​​is determined and / or confirmed, in particular for an in-time capture time value and an acceptable delayed capture time value, as further outlined below.

[0033] The term "capture time value" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or special meaning. This term may refer in particular, but not exclusively, to a numerical representation of the time that elapses between sample application, such as sample application in step b) of the determination method, and image capture, such as image capture in step c). In particular, the capture time value may be specific to one captured image. In particular, the capture time value may refer to the actual time that elapses between sample application and image capture, and therefore may differ from the assumed reaction time value used in the analytical measurement.

[0034] As used herein, the term "in-time capture time value" is a broad term and should be given its ordinary and customary meaning to one of ordinary skill in the art and should not be limited to a special or special meaning. The term may specifically refer to, but is not limited to, a capture time value that is within a predefined time range that is considered to be "on time" and "in time". In particular, all capture time values ​​that meet a predefined punctuality requirement, i.e., are within a predefined time range, may be referred to as "in-time capture time value". In particular, an in-time capture time value may be or include a capture time value within a predefined time range, such as within a predefined and / or defined time range. By way of example, the predefined time range and / or the predefined punctuality requirement may depend on the characteristics of the color change detection reaction performed by the optical test strip, i.e., by the chemicals in the reagent test area of ​​the optical test strip. Thus, by way of example, the predefined time range may be between 5 seconds and 300 seconds. In particular, the predefined time range may be between 5 seconds and 180 seconds. More particularly, the predefined time range may be between 5 seconds and 120 seconds. More specifically, the predetermined time range may be from 10 seconds to 60 seconds. More specifically, the predetermined time range may be from 13 seconds to 45 seconds. Other predetermined time ranges for defining capture time values ​​that are within-time capture time values ​​may be possible.

[0035] As used herein, the term "delayed capture time value" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or special meaning. The term may refer in particular, but not limited to, a capture time value that includes a predetermined time lag, e.g., a predetermined delay. In particular, a delayed capture time value may refer to a capture time value that is delayed with respect to a predetermined time range that is considered to be "on time" and / or "in time". In particular, all capture time values ​​that are greater than the upper limit of the predetermined range, e.g., outside the predetermined range in the direction of increasing time, may be referred to as a "delayed capture time value". In particular, a delayed capture time value may refer to a total of delays, in particular a predefined and / or known delay, and a numerical representation of the upper limit of a predefined range of in time capture time values ​​and / or a predefined punctuality requirement. Thus, a delayed capture time value may differ from an in time capture time value by at least a delay. By way of example, throughout this specification, a delay may be referred to as d, where d may be or include a positive or negative value.

[0036] As used herein, the term "training set" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or special meaning. The term may specifically refer to, but is not limited to, a plurality of elements having known and / or predetermined differences and / or similarities. In particular, the training set may be used to train a trainable model, such as a model that may be further trained and / or updated based on additional information collected from the training set.

[0037] The term "training set of optical test strips" may particularly, but not exclusively, refer to a plurality of optical test strips as defined above. In particular, the training set of optical test strips provided in step a) includes a plurality of optical test strips, e.g., optical test strips having the same structure and / or design.

[0038] As used herein, the term "training set of samples of bodily fluid" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or special meaning. The term may refer, in particular, but is not limited to, a plurality of samples having at least one known and / or predetermined analyte concentration, for example determined in a laboratory environment. In particular, the training set of samples of bodily fluid may include a plurality of samples of bodily fluid as defined above, where for one or more of the plurality of samples, the value of a quantitative and / or qualitative analytical measurement result, such as the concentration of at least one analyte in the sample, is known. In particular, the number of samples included in the training set of samples may be different from the number of optical test strips in the training set of optical test strips. However, alternatively, the number of samples in the training set of samples may be equal to the number of optical test strips in the training set of optical test strips.

[0039] The term "mobile device" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or special meaning. The term may refer in particular, but not exclusively, to a portable electronic device, more specifically, to a mobile communication device such as a mobile phone or a smartphone. Additionally or alternatively, a mobile device may also refer to a tablet computer or another type of portable computer having at least one camera. Furthermore, as outlined below, a mobile device may optionally comprise further elements, such as, for example, one or more processors.

[0040] The term "camera" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or special meaning. The term may specifically, but not limited to, refer to a device having at least one imaging element configured to record or capture spatially resolved one-dimensional, two-dimensional, or even three-dimensional optical data or information. By way of example, a camera may comprise at least one camera chip, such as at least one CCD chip and / or at least one CMOS chip, configured to record an image. As used herein, but not limited to, the term "image" may specifically relate to data recorded using a camera, such as a plurality of electronic readings from an imaging device, such as the pixels of a camera chip.

[0041] Thus, the term "training set of images" may specifically relate to a plurality of images, i.e. a plurality of image data recorded using a camera, such as a camera as defined above. In particular, the training set of images may refer to a plurality of images, e.g. a stack of digital images, of at least a portion of one or more reagent-testing areas of a training set of optical test strips. In particular, the training set of images includes a training subset of a first image and a training subset of a second image. By way of example, the training set of images may include an image of each of the reagent-testing areas of the training set of optical test strips, where, for example, one or more samples of bodily fluid may have been applied to the reagent-testing areas, e.g., prior to image capture. In particular, the training set of images may be used to determine a training set of color formation values ​​of the reagent-testing areas of the training set of optical test strips, such as a plurality of color formation values ​​for the training set of optical test strips. The one or more images of the training set of images may be of more than one reagent-testing area. Thus, by way of example, the number of images of the training set of images may differ from the number of optical test strips of the training set of optical test strips. However, an equal number of images of the training set of images and optical test strips of the training set of optical test strips may also be possible. Specifically, by way of example, a training set of images can include a separate image for each of the reagent test areas of the training set of, eg, optical test strips.

[0042] In particular, each image of the training set of images may be captured with an in-time capture time value and / or a delayed capture time value. In particular, the images of the training set of images included in the training subset of a first image are captured with an in-time capture time value, and the in-time capture time value may differ for one or more images in the training subset of a first image. In particular, the in-time capture time value of one or more images of the training subset of a first image may be known or may be preset. Furthermore, the images of the training set of images included in the training subset of a second image are captured with a delayed capture time value, and the delayed capture time value may differ for one or more images in the training subset of a second image. In particular, the delayed capture time value of one or more images of the training subset of a second image may be known or even preset. Thus, in particular, each image of the training set of images may be assigned and / or linked to at least one in-time capture time value or a delayed capture time value.

[0043] The camera may comprise, besides at least one camera chip or imaging chip, one or more further elements such as 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 may be adjusted automatically or manually. The invention is particularly applicable to cameras that are typically used in mobile applications, such as notebook computers, tablets, or mobile phones, in particular smartphones. Thus, in particular, the camera may be part of a mobile device that, besides at least one camera, comprises one or more data processing devices, such as one or more data processors. However, other cameras are also feasible.

[0044] The camera may in particular be a color camera. Thus, for each pixel, etc., color information may be provided or generated, such as color values ​​of the three colors R, G, B, also called color channels. A larger number of color values, such as four color values ​​for each pixel, for example R, G, G, B, etc., are also feasible. Color cameras are generally known to those skilled in the art. Thus, by way of example, a camera chip may consist of three or more different color sensors, color recording pixels, such as one pixel for red (R), one pixel for green (G) and one pixel for blue (B). Depending on the intensity of the respective color, for each pixel, such as R, G, B, etc., a value may be recorded by the pixel, such as a digital value ranging from 0 to 255. By way of example, instead of using three colors, such as R, G, B, four colors, such as R, G, G, B, etc., may be used. The color sensitivity of the pixel may be generated by a color filter or by an appropriate intrinsic sensitivity of the sensor element used in the camera pixel. These techniques are generally known to those skilled in the art.

[0045] The term "processor" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or special meaning. The term may specifically, but not limited to, refer to any logic circuitry configured to perform the basic operations of a computer or system, and / or may generally refer to a device configured to perform calculations or logical operations. In particular, the processor may be configured to process the basic instructions that run the computer or system. By way of example, the processor may comprise at least one arithmetic logic unit (ALU), at least one floating point unit (FPU), such as a numeric coprocessor or numeric coprocessor, a number of registers, particularly registers configured to supply operands to the ALU and store the results of the operations, and memories, such as L1 and L2 cache memories. In particular, the processor may be a multi-core processor. In particular, the processor may be or include a central processing unit (CPU). Additionally or alternatively, the processor may be or include a microprocessor, and thus in particular, the elements of the processor may be included in a single integrated circuit (IC) chip. Additionally or alternatively, the processor may be or comprise one or more application specific integrated circuits (ASICs) and / or one or more field programmable gate arrays (FPGAs).

[0046] The processor, in particular the processor that may be used in step d) of the determination method, may be a separate processor, for example a stand-alone processor or a processor integrated in a computer or computer network separate from the mobile device. However, alternatively, the processor may be integrated in the mobile device used in step c) to capture the training set of images. Thus, in particular, the processor may be the processor of the mobile device.

[0047] Step e) of the determination method may comprise deriving at least two color expectation ranges. In particular, the at least two color expectation ranges may be complementary, for example sharing at least one border. Thus, by way of example, the determination method may be configured to determine two complementary color expectation ranges.

[0048] As an example, for a first of the complementary color expectation ranges, the delay, specifically the first delay, referred to as d1, may not exceed a predetermined tolerance threshold, which is specifically referred to as d1 throughout this specification. a The tolerance threshold d a is further set to the expiration threshold d max Therefore, specifically, d1 <d a <d max Furthermore, for the second of the complementary color expectation ranges, the delay, specifically the second delay called d2, is d a or a tolerance threshold d a and the expiration threshold d max Therefore, specifically, d a ≦d2≦d max It is.

[0049] Thus, step e) of the method may include deriving at least two complementary color expectation ranges, the first of which is a function of the actual reaction time values ​​and / or the realistic reaction time values ​​and the tolerance threshold d a In particular, the first color expectation range may be or may include colors, in particular color formation values, that are predicted for an expected reaction time value range that includes expected reaction time values ​​that differ by less than, in particular by less than an acceptable delay. In particular, the first color expectation range may be colors, in particular color formation values, that are derived and / or determined from images captured at in-time capture time values ​​and delayed capture time values, the delay of the delayed capture time values ​​being less than the acceptable delay. Furthermore, the second color expectation range, for example derived in step e), may include colors, in particular color formation values, that are derived and / or determined for an expected reaction time value range that includes expected reaction time values ​​that differ by less than, in particular by less than an acceptable delay. a only, specifically, at least the tolerable delay, but only the expiration threshold d maxThe second color expectation range may be or may include colors, specifically color formation values, that are expected for an expected reaction time value range that includes expected reaction time values ​​that differ from actual and / or real reaction time values ​​by less than or equal to the expiration delay, specifically by less than or equal to the expiration delay. In particular, the second color expectation range may be colors, specifically color formation values, that are derived and / or determined from images captured at delayed capture time values, the delay of which is greater than or equal to the acceptable delay and less than or equal to the expiration delay. In other words, the first color expectation range may include color formation values ​​that are expected for expected reaction times that differ from actual and / or real reaction times by less than the acceptable delay, and the second color expectation range may include color formation values ​​that are expected for expected reaction times that differ from actual and / or real reaction times by at least the acceptable delay but less than or equal to the expiration delay.

[0050] Step d) may further comprise labelling the colour formation values ​​of the training set of colour formation values ​​with information on the capture time values, i.e. in-time capture time values ​​or delayed capture time values. In particular, the labelling may be taken into account in step e). In particular, the information on the capture time values ​​may comprise information on whether the image was taken with an in-time capture time value or a delayed capture time value, and for delayed capture time values ​​may comprise further information in particular whether the delay is below or above at least one predefined expiration threshold and optionally below or above a tolerance threshold.

[0051] In step e), the color expectation range may include at least 80% of the color formation values ​​for color formation of the reagent test area of ​​the optical test strip of the training set of optical test strips determined from images captured at one or more of the in-time capture time values ​​and the acceptable delayed capture time values. Specifically, in step e), the color expectation range may include at least 85% of the color formation values ​​for color formation of the reagent test area of ​​the optical test strip of the training set of optical test strips determined from images captured at one or more of the in-time capture time values ​​and the acceptable delayed capture time values. More specifically, in step e), the color expectation range may include at least 90% of the color formation values ​​for color formation of the reagent test area of ​​the optical test strip of the training set of optical test strips determined from images captured at one or more of the in-time capture time values ​​and the acceptable delayed capture time values. More specifically, in step e), the color expectation range may include at least 95% of the color formation values ​​for color formation of the reagent test area of ​​the optical test strip of the training set of optical test strips determined from images captured at one or more of the in-time capture time values ​​and the acceptable delayed capture time values. More specifically, in step e), the color expectation range may include at least 97% of the color formation values ​​for color formation of the reagent test area of ​​the optical test strip of the training set of optical test strips determined from images captured at one or more of the in-time capture time values ​​and the acceptable delayed capture time values. More specifically, in step e), the color expectation range may include at least 99% of the color formation values ​​for color formation of the reagent test area of ​​the optical test strip of the training set of optical test strips determined from images captured at one or more of the in-time capture time values ​​and the acceptable delayed capture time values.

[0052] By way of example, the color expectation range may be or may comprise at least one polygon. In particular, the color expectation range may be or may include a two-dimensional polygon, the edges of which may correspond to color formation values ​​in a two-dimensional color space, such as a color plane of at least two colors. Additionally or alternatively, the color expectation range may be or may include a three-dimensional polyhedron, the edges of which may correspond to color formation values ​​in a three-dimensional color space. Additionally or alternatively, instead of edges corresponding to color formation values, the edges may be spaced apart from the color formation values ​​such that at least 80%, particularly at least 85%, more particularly at least 90%, more particularly at least 95%, more particularly at least 97%, and more particularly at least 99% of the color formation values ​​for color formation of the reagent test areas of the optical test strips of the training set of optical test strips determined from images captured at one or more of the in-time capture time values ​​and the allowable delayed capture time values ​​may be surrounded by polygons and / or polyhedrons.

[0053] In particular, the derivation in step e) may include determining an envelope that includes at least 80%, particularly at least 85%, more particularly at least 90%, more particularly at least 95%, more particularly at least 97%, and more particularly at least 99% of the color formation values ​​for color formation of the reagent test areas of the optical test strips of the training set of optical test strips determined from images captured at one or more of the in-time capture time values ​​and the acceptable delayed capture time values, and further extending the envelope by a predetermined safety factor.

[0054] As used herein, the term "envelope" is a broad term and should be given its common and ordinary meaning to those skilled in the art and should not be limited to a special or special meaning. The term may specifically, but not exclusively, refer to an element and / or entity that encompasses and / or encompasses at least one set of data. In particular, the envelope may encompass at least 80%, specifically at least 85%, more specifically at least 90%, more specifically at least 95%, more specifically at least 97%, more specifically at least 99% of the color formation values ​​for the color formation of the reagent test area of ​​the optical test strip of the training set of optical test strips determined from images captured at one or more of the in-time capture time value and the allowable delayed capture time value, i.e., in at least one color plane and / or color space, and the envelope may be determined mathematically and / or graphically.

[0055] In particular, step e) may include, in particular in a subsequent step, expanding the envelope by a predefined safety factor. The safety factor may be predetermined and / or preset, in particular a safety factor taking into account the size and / or volume of the envelope. By way of example, the safety factor may be or may include a function that depends on the envelope, i.e. the size and / or volume of the envelope. By way of example, the envelope may be expanded such that the size and / or volume of the expanded envelope may exceed the size and / or volume of the envelope by at least 1.1 times, in particular at least 1.2 times, more particularly at least 1.5 times. By way of example, the envelope may be expanded such that 99% or even 100% of the color formation values ​​determined from the images captured at one or more of the in-time capture time value and the allowable delayed capture time value are encompassed. Additionally or alternatively, the safety factor may take into account deviations in the distribution of color formation values, such as the standard deviation σ of color formation values ​​for color formation of the reagent test area determined from images captured at one or more of the in-time capture time value and the allowable delayed capture time value. Thus, by way of example, the envelope may be expanded by a factor to cover a range of at least 4σ, preferably at least 5σ, and more preferably at least 6σ.

[0056] The expansion may in particular be an evenly distributed expansion, such as a uniform and / or even expansion of the envelope. By way of example, if the color formation values ​​are equally distributed within the envelope, an even expansion of the envelope may be performed. However, a non-uniformly distributed expansion is also possible. In particular, the envelope may be non-uniformly and / or unevenly expanded, i.e. based on and / or depending on a weighted distribution of the color formation values ​​within the envelope.

[0057] Step e) may specifically include training a trainable model using at least one machine learning algorithm, specifically using a training set of color formation values. As used herein, the term "machine learning algorithm" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or special meaning. The term may specifically refer to a mathematical model that is trainable by using a record of training data, including but not limited to training input data and corresponding training output data. In particular, the training output data of a record of training data may be the expected result generated by the machine learning algorithm when given as input the training input data of the same record of training data. By way of example, the deviation between this expected result and the actual result generated by the algorithm may be observed and evaluated by a "loss function". This loss function may be used as feedback to adjust parameters of the internal processing chain of the machine learning algorithm. The machine learning algorithm may include decision trees, naive Bayes classification, nearest neighbor, neural networks, convolutional neural networks, generative adversarial networks, support vector machines, linear regression, logistic regression, random forests and / or gradient boosting algorithms. By way of example, a machine learning algorithm may be trained by using a training set of color formation values ​​as input data and corresponding information regarding in-time capture time values ​​and / or delayed capture time values ​​as output data. Specifically, the output data may be or may include information regarding whether each color formation value for color formation of a reagent test area of ​​an optical test strip of a training set of optical test strips was determined from an image captured at an in-time capture time value and an acceptable delayed capture time value or at an expired capture time, i.e., determined later than the time acceptable for safely determining an analyte concentration.In particular, the machine learning algorithm may be or may include a trainable color expectation range model, i.e. a model describing the shape and / or form of the color expectation range, and the feedback for adjusting the parameters of the model's internal processing chain may in particular be based on a quantitative or qualitative determination of whether the color formation values ​​corresponding to the in-time capture time value and / or the tolerable late capture time value, i.e. the color formation values ​​for the acceptable capture time values, are within the color expectation range. Other forms of feedback may be feasible.

[0058] In step d), color formation values ​​may be determined for at least two color channels, in particular at least two color channels selected from the group consisting of a green channel (G), a blue channel (B) and a red channel (R). In particular, in step e), a color expectation range may be derived for the at least two color channels for which color formation values ​​are determined in step d).

[0059] Furthermore, the method may include a step f) of attaching at least one optical test strip of the training set of optical test strips to a color reference card including a plurality of color reference fields having known reference color values. In particular, step f) may be performed before step c). Furthermore, at least one image of the set of images captured in step c) may further show at least a portion of the color reference card, specifically one or more of the color reference fields. The term "color reference card" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or special meaning. The term may specifically refer to, but is not limited to, any article disposed therein or thereon having a plurality of color reference fields having known color or optical characteristics, e.g., a plurality of colored fields having known reference color values, on at least one surface, etc. Furthermore, the color reference card may comprise a plurality of gray reference fields having known gray levels. As an example, the color reference card may be a flat card comprising at least one substrate having a plurality of color reference fields with known color values ​​and a plurality of gray reference fields with known gray levels disposed on and / or within at least one surface. The substrate may specifically have a flat surface with color reference fields and gray reference fields disposed thereon. As an example, the substrate may be or include one or more of a paper substrate, a cardboard substrate, a plastic substrate, a ceramic substrate or a metal substrate. Laminate substrates are also possible. The substrate may be, as an example, sheet-like or flexible. However, it should be noted that the substrate may be implemented in an article of use such as a wall of a box, a vial, a container, a medical consumable such as a test strip. The color reference card may also be fully or partially integrated into the optical test strip. At least one image of at least a portion of the reagent test area of ​​the optical test strip may fully or partially include an image of at least a portion of the color reference card.

[0060] In a further aspect of the present invention, a measurement method is disclosed, which uses a mobile device having a camera and a processor to perform an analytical measurement based on a color-forming reaction. The measurement method includes the following steps, which can be performed in a given order as an example. However, it should be noted that a different order is generally possible. Furthermore, it may be possible to perform one or more of the method steps only once or repeatedly. Furthermore, it may also be possible to perform two or more of the method steps simultaneously or overlap in time. The measurement method may include further method steps that are not listed.

[0061] The measurement method is as follows: i) providing at least one optical test strip having at least one reagent testing area; ii) applying a sample of the bodily fluid to a reagent test area of ​​the optical test strip; iii) capturing, using a camera, at least one image of at least a portion of the reagent test area to which the bodily fluid has been applied; iv) determining an assumed reaction time value corresponding to the time elapsed between the assumed time of application of the sample in step ii) and the capture of the image in step iii); v) specifically, using a processor to determine color formation values ​​of at least one color channel for color formation of the reagent test area using the image; vi) comparing, for at least one color channel, the color formation value with at least one color expectation range determined by carrying out a method according to any one of the preceding claims; vii) if the color formation values ​​are outside at least one color expectation range, deeming the expected reaction time values ​​invalid and discontinuing the measurement method; viii) validating the expected reaction time value if the colour formation value is within the colour expectation range, and determining the concentration of the analyte in the sample of the bodily fluid using the colour formation value and optionally the expected reaction time value.

[0062] The definition of the measurement method may be referred to the description of the determination method above or as outlined in more detail below. In particular, the same type of optical test strip may be used to carry out the measurement method as the determination method outlined above. Thus, by way of example, the optical test strip provided in step i) of the measurement method may be of the same or at least similar type as the multiple optical test strips of the training set of optical test strips provided in step a) of the determination method, as described above or as described in more detail below. However, the sample of bodily fluid may be a sample of bodily fluid from a user, the analyte concentration of which is to be determined and therefore may be unknown in advance.

[0063] In particular, in step vii) the expected reaction time value may differ from the actual uptake time value by more than an acceptable difference, so that in step viii) the expected reaction time value may differ from the actual uptake time value by no more than the acceptable difference.

[0064] Step vi) may include comparing the color formation value with at least one first color expectation range and at least one second color expectation range determined by performing the determination method described herein. Specifically, in step vii), if the color formation value is outside both the first color expectation range and the second color expectation range, the expected capture time may be deemed invalid and the measurement method may be aborted. Furthermore, in step viii), different algorithms may be used to determine the concentration of the analyte from the color formation value in the color formation value in the at least one first color expectation range and at least one second color expectation range. In particular, the method comprises, in step viii), if the color formation value is within the first color expectation range, the expected reaction time value is deemed valid and the color formation value and the expected reaction time value are used to determine the concentration of the analyte; if the color formation value is within the second color expectation range, the expected reaction time value is deemed valid, and the concentration of the analyte is determined using the color formation value and a predetermined delay for the second color expectation range added to the expected reaction time value.

[0065] The measurement method may further comprise an intensity check, such as checking whether the intensity of the color formation value is above or below at least one intensity threshold. In particular, if the color formation value is outside a predefined intensity range, for example below a lower intensity threshold or above a higher intensity threshold, the measurement method may be aborted.

[0066] The measurement method may further comprise step ix) of capturing, using the camera, at least one image of at least a portion of the reagent test area without the application of bodily fluid. In particular, step ix) may be performed before step ii). Thus, by way of example, the measurement method may comprise capturing at least one second image, in particular a blank image of the reagent test area without the application of a sample of bodily fluid.

[0067] Furthermore, the measurement method may include a step x) of attaching the optical test strip to a color reference card that includes a plurality of color reference fields with known reference color values. The color reference card may in particular be of the same type as the color reference card optionally used in the determination method described above. In particular, step x) may be performed before step iii) of the measurement method and optionally before step ii), in particular the image captured in step iii) may further show at least a portion of the color reference card, in particular one or more of the color reference fields.

[0068] The applying in step ii) may further include confirmation, specifically by the user, that the sample of bodily fluid has been or has been applied to the reagent-testing area of ​​the optical test strip. Thus, by way of example, the applying in step ii) may be or include a user confirmation that the sample of bodily fluid has been applied, i.e., a button press and / or other form of confirmation, for example by interacting with a mobile device. Specifically, step ii) of the measurement method may include prompting the user to perform one or more of applying the sample of bodily fluid to the reagent-testing area of ​​the optical test strip and confirming the application of the sample of bodily fluid to the reagent-testing area of ​​the optical test strip. In particular, when performing step ii), the user may be prompted to apply the sample of bodily fluid and / or the user may be prompted to confirm the sample application, for example by giving a corresponding instruction on the display of the mobile device and / or as a voice instruction.

[0069] In a further aspect of the present invention there is provided a determination system for determining at least one colour expectation range for assessing the validity of an assumed reaction time value used in an analytical measurement based on a colour forming reaction, comprising: A) at least one mobile device having at least one camera; B) a training set of optical test strips, each optical test strip having a reagent test area; and C) a training set of bodily fluid samples comprising a plurality of bodily fluid samples; D) at least one processor, - reading out a training set of images, the training set of images comprising camera-captured images of at least a portion of at least some of the reagent-testing areas of the training set of optical test strips to which a sample of bodily fluid is applied captured at an in-time capture time value, the capture time value referring to the time elapsed between the application of the sample and the capture of the image, in particular being a training subset of the first images captured in step c) of the above determining method, the training set of images further comprising camera-captured images of at least a portion of at least some of the reagent-testing areas of the training set of optical test strips to which a sample of bodily fluid is applied captured at a delayed capture time value, in particular being a training subset of the second images captured in step c) of the above determining method; - determining a training set of color formation values ​​from the images of the training set of images, the training set of images including color formation values ​​of at least one color channel for color formation of the reagent test area of ​​the optical test strip of the training set of optical test strips for in-time capture time values ​​and delayed capture time values; - deriving at least one color expectation range for at least one color channel from a training set of color formation values, the color expectation range defining an expected range of color formation values ​​for an in-time capture time value and an acceptable late capture time value, the acceptable late capture time value being determined by a delay d that is greater than or equal to at least one predetermined expiration threshold d max Not exceeding, and and a processor configured for:

[0070] In particular, the delay d is the time lag between the expiration threshold d max Therefore, for example, d≦d max Alternatively, the delay d is greater than or equal to the expiration threshold d max Therefore, an alternative option is d <d max It is.

[0071] The processor of the determination system may be a separate processor, such as a stand-alone processor separate from at least one mobile device, or a processor integrated into a computer or computer network. However, alternatively, the processor may be integrated into the mobile device.

[0072] The decision system is E) At least one color reference card configured for releasably attaching the optical test strip, the color reference card including a plurality of color reference fields having known reference color values, wherein the images of the training set of images further illustrate at least a portion of the color reference card, specifically one or more of the color reference fields.

[0073] For most of the definition of the decision system, reference may be made to the description of the decision method as above or as outlined in more detail below. In particular, the decision system may be configured to execute the decision method described herein. In particular, the decision system may be configured to execute at least steps d) and e) of the decision method described herein.

[0074] Further disclosed and proposed herein is a computer program comprising instructions that, when the program is executed by a decision system, in particular by the decision system described herein, cause the decision system to execute at least steps d) and e) of the decision method also described herein. Thus, in particular, the computer program may comprise computer executable instructions for executing the decision method according to the present invention in one or more of the embodiments attached hereto, when the instructions are executed in the decision system, i.e., in at least one processor of the decision system, for example integrated in a computer or computer network. In particular, the computer program may be stored on a computer readable data carrier and / or a computer readable storage medium.

[0075] Therefore, further disclosed and proposed herein is a computer program comprising instructions which, when executed by a decision system, in particular by the decision system described herein, cause the decision system to perform at least steps d) and e) of the decision method also described herein.

[0076] As used herein, the terms "computer-readable data carrier" and "computer-readable storage medium" may specifically refer to non-transitory data storage means such as a hardware storage medium having computer-executable instructions stored thereon. The computer-readable data carrier or storage medium may specifically be or comprise a storage medium such as a random access memory (RAM) and / or a read-only memory (ROM).

[0077] Further disclosed and proposed herein is a computer program product having program code means for executing the decision-making method according to the invention in one or more of the embodiments attached hereto when the program is executed in a decision-making system, i.e. in at least one processor of a decision-making system, for example integrated in a computer or a computer network. In particular, the program code means may be stored on a computer-readable data carrier and / or a computer-readable storage medium.

[0078] Further disclosed and proposed herein is a data carrier storing a data structure which, after being loaded into a computer or computer network, such as a working memory or main memory of the computer or computer network, is capable of executing a decision method according to one or more of the embodiments disclosed herein.

[0079] Further disclosed and proposed herein is a computer program product having program code means stored on a machine-readable carrier for executing the determination method according to one or more of the embodiments disclosed herein when the program is executed on a computer or computer network. As used herein, a computer program product refers to a program as a tradeable product. The product may generally be in any format, such as a paper format, or may be on a computer-readable data carrier and / or a computer-readable storage medium. In particular, the computer program product may be distributed over a data network.

[0080] Further disclosed and suggested herein is a modulated data signal containing instructions readable for a computer system or computer network to execute a determination method according to one or more of the embodiments disclosed herein.

[0081] In a further aspect of the present invention, a mobile device is disclosed having at least one camera and at least one processor. The mobile device is configured to perform at least steps iv) to viii) of the measurement method described herein. Therefore, for the definition of terms as described herein, reference is made to the above description, in particular with respect to the measurement method.

[0082] Further disclosed and proposed herein is a computer program comprising instructions which, when executed by a mobile device having a camera and a processor, in particular by a mobile device as described herein, cause the mobile device to perform at least steps iv) to viii) of the measurement method. Thus, in particular, the computer program may comprise computer executable instructions for performing the measurement method according to the invention in one or more of the embodiments attached hereto, when the instructions are executed on a processor of the mobile device. In particular, the computer program may be stored on a computer readable data carrier and / or a computer readable storage medium.

[0083] Therefore, further disclosed and proposed herein is a computer readable storage medium comprising instructions which, when executed by a mobile device having a camera and a processor, in particular by a mobile device as described herein, cause the mobile device to perform at least steps iv) to viii) of the measurement method as also described herein.

[0084] Further disclosed and proposed herein is a computer program product, which has program code means for executing the measurement method according to the invention in one or more of the embodiments contained herein when the program is executed on a mobile device, i.e. on at least one processor of a mobile device, for example integrated in a computer or a computer network. In particular, the program code means may be stored on a computer readable data carrier and / or a computer readable storage medium.

[0085] Further disclosed and proposed herein is a data carrier storing a data structure which, after being loaded into a computer or computer network, such as a working memory or main memory of the computer or computer network, can perform the measurement method according to one or more of the embodiments disclosed herein.

[0086] Further disclosed and proposed herein is a computer program product having program code means stored on a machine-readable carrier for executing the measurement method according to one or more of the embodiments disclosed herein when the program is executed on a computer or computer network. As used herein, a computer program product refers to a program as a tradeable product. The product may generally be present in any format, such as a paper format, or may be present on a computer-readable data carrier and / or a computer-readable storage medium. In particular, the computer program product may be distributed over a data network.

[0087] Further disclosed and proposed herein is a modulated data signal comprising instructions readable for a computer system or computer network for carrying out a measurement method according to one or more of the embodiments disclosed herein.

[0088] In a further aspect of the present invention, a kit for determining the concentration of at least one analyte in a sample of a bodily fluid, in particular in a bodily fluid sample of a user, is disclosed. The kit comprises a mobile device as described above, in particular configured to perform at least steps iv) to viii) of the measurement method described herein. The kit further comprises at least one optical test strip having at least one reagent test area.

[0089] The method and device according to the present invention provide many advantages over similar methods and devices known in the art. In particular, compared to methods and devices known in the art, the method and device described herein may increase the safety of the measurement. In particular, the method and device may increase the safety of the measurement by providing an effective fail-safe mechanism, since, for example, the color formation value must be within the color expectation range, especially when performing the measurement method, in order to determine the concentration of the analyte. Thus, in particular, the provided method and device may increase the safety of the measurement, since not all measured color values ​​are converted into analyte concentrations, for example blood glucose levels. Instead, the method and device may allow the detection of erroneous user information regarding the application time of the sample.

[0090] Furthermore, the safety and accuracy of the measurement may be improved by the proposed method and device compared to known methods and devices. The method may in particular include preventing the determination of the concentration of the analyte of the body fluid if the validity assessment cannot be met. Thus, erroneous and / or biased results of the analytical measurement may be less likely.

[0091] Furthermore, the proposed methods and devices may allow for improved user handling and / or improved user usability of analytical measurements, i.e. allowing a safe analytical measurement to be performed with only one image capture instead of at least two images, and in particular may reduce the overall time required to perform an analytical measurement compared to known methods and devices.

[0092] In summary, without excluding further embodiments, the following embodiments can be envisaged:

[0093] Embodiment 1: A method for determining at least one color expectation range for assessing the validity of an assumed reaction time value used in an analytical measurement based on a color-forming reaction, comprising: a) providing a training set of optical test strips, each optical test strip having a reagent test area; b) providing a training set of samples of the bodily fluid and applying at least one of the samples of the bodily fluid to a reagent test area of ​​each optical test strip of the training set of optical test strips; c) capturing, by at least one mobile device having at least one camera, a training set of images, the training set of images comprising: - a training subset of first images, the training subset of first images including images of at least a portion of at least some of the reagent test areas of the training set of optical test strips to which a sample of bodily fluid is applied, the sample being captured at an in-time capture time value, the capture time value referring to the time elapsed between the application of the sample in step b) and the capture of the image; - at least one training subset of second images, the at least one training subset of second images including images of at least a portion of at least some of the reagent test areas of the training set of optical test strips to which samples of bodily fluid captured at delayed capture time values ​​are applied; To take in and d) specifically, using at least one processor, more specifically a processor of a mobile device, determining a training set of color formation values ​​from images of the training set of images, the training set of color formation values ​​including color formation values ​​of at least one color channel for color formation of the reagent test area of ​​the optical test strip of the training set of optical test strips for in-time capture time values ​​and delayed capture time values; e) deriving at least one color expectation range for at least one color channel from the training set of color formation values, the color expectation range defining an expected range of color formation values ​​for an in-time capture time value and an acceptable late capture time value, the acceptable late capture time value being determined by the delay d being greater than or equal to at least one predetermined expiration threshold d max Not exceeding, and A method of determining.

[0094] Embodiment 2: The method of embodiment 1, wherein step e) includes deriving at least two complementary color expectation ranges.

[0095] Embodiment 3: For the first of the complementary color expectation ranges, the delay d1 is greater than or equal to the expiration threshold d max lower than a given tolerance threshold d a Specifically, d1 <d a <d max and for the second of the complementary color expectation ranges, the delay d2 is d a or the tolerance threshold d a and the expiration threshold d max Specifically, d a ≦d2≦d max The method of claim 2, wherein

[0096] Embodiment 4: The method according to any one of embodiments 1 to 3, wherein step d) further comprises labelling the colour formation values ​​of the training set of colour formation values ​​with information on the capture time values, i.e. in-time capture time values ​​or delayed capture time values, the labelling being specifically taken into account in step e), specifically the information on the capture time values ​​may comprise information on whether the image was captured with an in-time capture time value or a delayed capture time value, and for delayed capture time values ​​further information is included on whether the delay is below or above at least one predefined expiration threshold and optionally below or above a tolerance threshold.

[0097] Embodiment 5: A method according to any one of embodiments 1 to 4, wherein in step e), the color expectation range comprises at least 80%, particularly at least 85%, more particularly at least 90%, more particularly at least 95%, more particularly at least 97%, and more particularly at least 99% of the color formation values ​​for color formation of the reagent test area of ​​the optical test strip of the training set of optical test strips determined from images captured at one or more of the in-time capture time values ​​and the acceptable delayed capture time values.

[0098] Embodiment 6: The method of any one of embodiments 1 to 5, wherein the derivation in step e) comprises determining an envelope that includes at least 80%, particularly at least 85%, more particularly at least 90%, more particularly at least 95%, more particularly at least 97%, and more particularly at least 99% of the color formation values ​​for color formation of the reagent test area of ​​the optical test strip of the training set of optical test strips determined from images captured at one or more of the in-time capture time value and the acceptable delayed capture time value, and further extending the envelope by a predetermined safety factor.

[0099] Embodiment 7: The method of any one of embodiments 1 to 6, wherein step e) specifically comprises using at least one machine learning algorithm, specifically training a trainable model using a training set of color formation values.

[0100] Embodiment 8: A method according to any one of the preceding embodiments, wherein in step d) the color formation values ​​are determined for at least two color channels, such as at least two color channels selected from the group consisting of a green channel, a blue channel and a red channel.

[0101] Embodiment 9: A method according to embodiment 8, wherein in step e) a color expectation range is derived for at least two color channels for which color formation values ​​are determined in step d).

[0102] Embodiment 10: A determination method as described in any one of embodiments 1 to 9, wherein the method further comprises a step f) of attaching at least one optical test strip of the training set of optical test strips to a color reference card including a plurality of color reference fields having known reference color values, step f) being performed before step c), and at least one image of the training set of images captured in step c) further showing at least a portion of the color reference card, in particular one or more of the color reference fields. Embodiment 11: A method of measurement using a mobile device having a camera and a processor to perform an analytical measurement based on a color-forming reaction, comprising: i) providing at least one optical test strip having at least one reagent testing area; ii) applying a sample of the bodily fluid to a reagent test area of ​​the optical test strip; iii) capturing, using a camera, at least one image of at least a portion of the reagent test area to which the bodily fluid has been applied; iv) determining an assumed reaction time value corresponding to the time elapsed between the assumed time of application of the sample in step ii) and the capture of the image in step iii); v) specifically, using a processor to determine color formation values ​​of at least one color channel for color formation of the reagent test area using the image; vi) comparing, for at least one color channel, the color formation value with at least one color expectation range determined by performing the method according to any one of the preceding claims; vii) if the color formation values ​​are outside at least one color expectation range, deeming the expected reaction time values ​​invalid and discontinuing the measurement method; viii) validating the expected reaction time value if the colour formation value is within the colour expectation range and determining the concentration of the analyte in the sample of the body fluid using the colour formation value and optionally the expected reaction time value.

[0103] Embodiment 12: A method for measuring as described in embodiment 11, in which step vi) comprises comparing the color formation value with at least one first and at least one second color expectation range determined by performing the determination method as described in any one of embodiments 2 to 10, and in step vii) if the color formation value is outside both the first and the second color expectation ranges, the expected capture time is considered to be invalid and the measurement method is aborted, and in step viii) a different algorithm is used to determine the concentration of the analyte from the color formation value for color formation values ​​within the at least one first and at least one second color expectation range. In embodiment 13, in step viii), if the color formation value is within the first color expectation range, the expected reaction time value is deemed valid and the color formation value and the expected reaction time value are used to determine the concentration of the analyte; - If the color formation value is within the second color expectation range, the expected reaction time value is considered valid and the concentration of the analyte is determined using the color formation value and a predefined delay for the second color expectation range added to the expected reaction time value.

[0104] Embodiment 14: The measurement method of embodiment 12 or 13, further comprising step ix) of capturing at least one image of at least a portion of the reagent test area using a camera without applying a bodily fluid, wherein step ix) is performed before step ii).

[0105] Embodiment 15: A measurement method as described in embodiment 13 or 14, wherein the method further comprises a step x) of attaching the optical test strip to a color reference card including a plurality of color reference fields having known reference color values, wherein step x) is performed before step iii) and, optionally, before step ii), and wherein the image captured in step iii) further shows at least a portion of the color reference card, in particular one or more of the color reference fields.

[0106] Embodiment 16: A measurement method described in any one of embodiments 11 to 15, wherein step ii) includes prompting a user to perform one or more of applying a sample of the bodily fluid to a reagent test area of ​​the optical test strip and confirming application of the sample of the bodily fluid to the reagent test area of ​​the optical test strip. Embodiment 17: A determination system for determining at least one color expectation range for evaluating the validity of an assumed reaction time value used in an analytical measurement based on a color-forming reaction, comprising: A) at least one mobile device having at least one camera; B) a training set of optical test strips, each optical test strip having a reagent test area; and C) a training set of bodily fluid samples comprising a plurality of bodily fluid samples; D) at least one processor, - reading out a training set of images, the training set of images comprising images captured by a camera of at least a portion of at least some reagent-testing areas of the training set of optical test strips to which a sample of bodily fluid is applied captured at an in-time capture time value, the capture time value referring to the time elapsed between the application of the sample and the capture of the image, in particular being a training subset of the first images captured in step c) of the determination method according to any one of the preceding embodiments referring to the determination method, the training set of images further comprising images captured by a camera of at least a portion of at least some reagent-testing areas of the training set of optical test strips to which a sample of bodily fluid is applied captured at a delayed capture time value, in particular being a training subset of the second images captured in step c) of the determination method; - determining a training set of color formation values ​​from the images of the training set of images, the training set of images including color formation values ​​of at least one color channel for color formation of the reagent test area of ​​the optical test strip of the training set of optical test strips for in-time capture time values ​​and delayed capture time values; - deriving at least one color expectation range for at least one color channel from a training set of color formation values, the color expectation range defining an expected range of color formation values ​​for an in-time capture time value and an acceptable late capture time value, the acceptable late capture time value being determined by a delay d that is greater than or equal to at least one predetermined expiration threshold d max Not exceeding, and A decision system comprising:

[0107] Embodiment 18: A determination system comprising: E) The determination system of embodiment 17 further comprises at least one color reference card configured to releasably attach an optical test strip, the color reference card including a plurality of color reference fields having known reference color values, and the images of the training set of images further depict at least a portion of the color reference card, specifically one or more of the color reference fields.

[0108] Embodiment 19: A decision system as described in embodiment 17 or 18, wherein the decision system is configured to perform at least steps d) and e) of the decision method as described in any one of the preceding embodiments referring to the decision method.

[0109] Embodiment 20: A computer program comprising instructions that, when the program is executed by a decision system, in particular by a decision system as described in any one of the preceding embodiments referring to a decision system, cause the decision system to execute at least steps d) and e) of the decision method as described in any one of the preceding embodiments referring to the decision method.

[0110] Embodiment 21: A computer-readable storage medium comprising instructions, when executed by a decision system, in particular by the decision system described in any one of the preceding embodiments referring to the decision system, that cause the decision system to execute at least steps d) and e) of the decision method described in any one of the preceding embodiments referring to the decision method.

[0111] Embodiment 22: A mobile device having at least one camera and at least one processor, the mobile device being configured to perform at least steps iv) to viii) of the measurement method described in any one of the preceding embodiments referring to the measurement method.

[0112] Embodiment 23: A computer program comprising instructions, when executed by a mobile device having a camera and a processor, in particular by the mobile device described in embodiment 22, causing the mobile device to perform at least steps iv) to viii) of the measurement method described in any one of the preceding embodiments referring to the measurement method.

[0113] Embodiment 24: A computer-readable storage medium comprising instructions that, when executed by a mobile device having a camera and a processor, specifically by a mobile device as described in any one of the preceding embodiments referring to a mobile device, cause the mobile device to perform at least steps iv) to viii) of the measurement method as described in any one of the preceding embodiments referring to the measurement method.

[0114] Embodiment 25: A kit for determining the concentration of at least one analyte in a sample of a body fluid, the kit comprising the mobile device of embodiment 21, the kit further comprising at least one optical test strip having at least one reagent test area. [Brief description of the drawings]

[0115] Further optional features and embodiments are disclosed in more detail in the following description of the embodiments, preferably in conjunction with the dependent claims. In it, each optional feature can be realized separately and in any possible combination, as understood by a person skilled in the art. The scope of the present invention is not limited by the preferred embodiments. The embodiments are illustrated diagrammatically in the figures, in which the same reference numbers in these figures refer to the same or functionally equivalent elements.

[0116] [Figure 1] 1 illustrates an embodiment of a determination system and an embodiment of a kit. [Diagram 2] 1 shows a graphical representation of an embodiment of a determination method. [Diagram 3] 1 illustrates an embodiment of a color expectation range. [Figure 4] 1 illustrates an embodiment of a color expectation range. [Diagram 5] 1 shows graphical representations of different embodiments of the measurement method. [Figure 6] 1 shows graphical representations of different embodiments of the measurement method. [Figure 7] FIG. 13 shows a graph diagram of a diagram suggesting the relationship between actual blood glucose levels and determined blood glucose levels by using both the general method and system and by using the present method and system for determining blood glucose concentration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0117] Detailed Description of the Preferred Embodiments In Fig. 1, an embodiment of a determination system 110 is shown. The determination system 110 comprises at least one mobile device 112 having at least one camera 114. Furthermore, the determination system 110 comprises a training set of optical test strips 116. The training set of optical test strips 116 includes a plurality of optical test strips 118, each optical test strip 118 having a reagent test area 120. Furthermore, the determination system 110 comprises a training set of bodily fluid samples 122 including a plurality of bodily fluid samples 124. In particular, for each of the bodily fluid samples 124 and the training set of bodily fluid samples 122, an analyte concentration, such as, for example, a glucose concentration, may be known. Furthermore, the determination system 110 comprises at least one processor 126. The processor 126 of the determination system 110 may be, for example, a separate processor 126. However, alternatively, as shown in Fig. 1, the processor 126 may be integrated in the mobile device 112, such that the processor 126 may be the processor 126 of the mobile device 112.

[0118] In the determination system 110, the processor 126 is configured to retrieve a training set of images including images captured by the camera 114 of the mobile device 112. In particular, the training set of images includes a training subset of a first image and a training subset of a second image, where the images of the training subset of the first image are captured at an in-time capture time value, and the images of the training subset of the second image are captured at a delayed capture time value. Thus, the processor 126 is configured to retrieve both the training subset of the first image and the training subset of the second image, specifically from the camera 114. Furthermore, in the determination system 110, the processor 126 is configured to determine a training set of color formation values ​​from the images of the training set of images. The training set of color formation values ​​includes color formation values ​​of at least one color channel for color formation of each reagent test area 120 of the optical test strip 118 of the training set of optical test strips 116 for the in-time capture time value and the delayed capture time value. Further, in the determination system 110, the processor 126 is configured to derive at least one color expectation range 128 for at least one color channel from the training set of color formation values, the color expectation range 128 defining an expected range of color formation values ​​for an in-time capture time value and an acceptable late capture time value, and for the acceptable late capture time value, the delay d is greater than or equal to at least one predetermined expiration threshold d. max not exceed.

[0119] FIG. 1 also shows an embodiment of a kit 130 configured to determine the concentration of at least one analyte of a sample 124 of bodily fluid. The sample 124 of bodily fluid may specifically include a bodily fluid of a user, such as a sample with an unknown analyte concentration. In FIG. 1, such a sample is exemplarily shown at the right edge of the figure. The kit 130 includes at least one optical test strip 118 having at least one reagent test area 120. In FIG. 1, such an optical test strip 118, i.e., a single optical test strip 118, is exemplarily shown at the right edge of the figure. Furthermore, the kit 130 includes a mobile device 112 having at least one camera 114 and at least one processor 126. By way of example, the mobile device 112 of the kit 130 may be the same mobile device 112 of the determination system 110. However, alternatively, the kit 130 and the determination system 110 each comprise their own mobile device 114, i.e., their own separate mobile device 112.

[0120] The determination system 110 may in particular be configured to at least partially execute a determination method 132. An exemplary embodiment of the determination method 132 is shown in FIG. 2. The determination method 132 is configured to determine at least one color expectation range 128 for evaluating the validity of an assumed reaction time value used in an analytical measurement based on a color formation reaction. The determination method 132 comprises the following steps: a) providing a training set 116 of optical test strips (designated by reference numeral 134), each optical test strip 118 having a reagent test area 120; b) providing a training set 122 of bodily fluid samples (indicated by reference numeral 136) and applying at least one of the bodily fluid samples 124 to the reagent test area 120 of each optical test strip 118 of the training set 116 of optical test strips; c) capturing a training set of images by at least one mobile device 112 having at least one camera 114 (depicted by reference numeral 138), the training set of images comprising: a training subset of first images, the training subset of first images including images of at least a portion of at least some of the reagent test areas 120 of the training set 116 of the optical test strip to which a sample 124 of bodily fluid is applied, the sample 124 being captured at a capture time value in time, the capture time value referring to the time elapsed between the application of the sample 124 in step b) and the capture of the image; - at least one training subset of second images, the at least one training subset of second images including images of at least a portion of at least some of the reagent test areas (120) of the training set (116) of the optical test strip to which the samples 124 of bodily fluid captured at the delayed capture time values ​​are applied; To take in and d) (depicted by reference numeral 140) specifically, using at least one processor 126, more specifically the processor 126 of the mobile device 112, determining a training set of color formation values ​​from images of the training set of images, the training set of color formation values ​​including color formation values ​​of at least one color channel for color formation of the reagent test area 120 of the optical test strip 118 of the training set of optical test strips 116 for in-time capture time values ​​and delayed capture time values; e) deriving at least one color expectation range 128 for at least one color channel from a training set of color formation values ​​(indicated by reference numeral 142), the color expectation range 128 defining an expected range of color formation values ​​for an in-time capture time value and an acceptable late capture time value, the acceptable late capture time value being determined based on the delay d being within at least one predetermined expiration threshold d max Not exceeding, and Includes.

[0121] 3 and 4 show exemplary embodiments of the color expectation range 128. As shown in FIG. 3, the color expectation range 128 may be or include a polygon, such as, for example, a two-dimensional polygon of a color plane. For example, on the horizontal axis, the color plane may show color values ​​of the red channel 144, and on the vertical axis, the color plane may show color values ​​of the green channel 146. Additionally, FIG. 3 shows color formation values ​​of an exemplary training set of color formation values. By way of example, the color expectation range 128 may include at least 80% of the color formation values ​​for color formation of the reagent test areas of the optical test strips of the training set of optical test strips determined from images captured at one or more of the in-time capture time value and the allowable late capture time value, i.e., at least 80% of these color formation values ​​may be enclosed by the polygonal shape of the color expectation range 128.

[0122] Specifically, as exemplarily shown in Fig. 3, at least two complementary color expectation ranges 128 may be determined, namely a first color expectation range 148 and a second color expectation range 150. The first color expectation range 148 may be or may include colors, specifically color formation values, expected for different assumed reaction time values ​​below actual and / or realistic reaction time values ​​and an acceptable delay, where the acceptable delay is within a predetermined and / or predetermined tolerance threshold d a The second color expectation range 150 may be or may include colors, specifically color formation values, expected for assumed reaction time values ​​that differ from actual and / or real reaction time values ​​by an amount greater than the tolerable delay but less than or equal to the expiration delay, where the expiration delay is less than or equal to a predetermined and / or pre-determined expiration threshold d max In particular, in Figure 3, the first expected color range 148 may also be denoted with "I", the second expected color range 150 may also be denoted with "II", and the area outside both the first expected color range 148 and the second expected color range 150 may be denoted with "III".

[0123] 3, color formation values ​​for in-time capture time values ​​and delayed capture time values ​​are shown. In particular, the color formation value corresponding to an in-time capture time value, such as d=0 min, is shown with reference numeral 152. Similarly, the color formation value corresponding to a delayed capture time value, such as d=1 min, is shown with reference numeral 154. Also, 156 corresponds to d=2 min, 158 corresponds to d=3 min, 160 corresponds to d=4 min, 162 corresponds to d=5 min, 164 corresponds to d=7.5 min, and 166 corresponds to d=10 min.

[0124] As an example, with the illustrated color expectation ranges 148 and 150, the acceptable delay is a delay of 2 minutes, i.e., d a = 2 minutes, and the expiration delay is a delay of 6 minutes, i.e., d max = 6 minutes. Other choices of allowable delay and / or expiration delay may be possible.

[0125] Additionally or alternatively, as exemplarily shown in Fig. 4, the color expectation range 128 may be or include a three-dimensional form, such as a polyhedron. By way of example, the color expectation range 128 may be formed by a polygon in a two-dimensional color space, such as a polygon in the color plane of the red channel 144 and the green channel 146, which is extended in the third dimension, for example with reference to the blue channel 170, or with reference to intensity values, i.e. absolute intensity values ​​of the values ​​of the intensity dimension, for example the values ​​of the green channel 146. In particular, the color expectation range 128 may be limited in the direction of the blue channel 170 by an upper surface 172 and a lower surface 174. Other forms and / or geometries of the color expectation range 128 may be possible.

[0126] In particular, at least one color expectation range 128 may be used to assess the validity of expected reaction time values ​​used in analytical measurements based on color formation reactions. Such analytical measurements may be performed by a measurement method 176. An exemplary embodiment of the measurement method 176 is shown in Figures 5 and 6. The measurement method 176 includes the following steps: i) providing at least one optical test strip 118 having at least one reagent testing area 120 (designated by reference numeral 178); ii) applying a sample 124 of bodily fluid to a reagent test area 120 of an optical test strip 118 (designated by reference numeral 180); iii) using the camera 114 (designated by reference numeral 182) to capture at least one image of at least a portion of the reagent test area 120 to which the bodily fluid 124 has been applied; iv) determining (depicted by reference numeral 184) an assumed reaction time value corresponding to the time elapsed between the assumed time of application of the sample in step ii) and the capture of the image in step iii); v) (indicated by reference numeral 186) specifically, using processor 126, determining color formation values ​​of at least one color channel for color formation of reagent test area 120 using the image; vi) comparing, for at least one color channel (indicated by reference numeral 188), the color formation value with at least one color expectation range determined by executing the determination method 132; vii) (indicated by reference numeral 190) deeming the expected reaction time value invalid and aborting the measurement method 176 if the color formation value is outside at least one color expectation range 128; viii) if the color formation value (denoted by reference numeral 192) is within the color expectation range 128, then validating the expected reaction time value, and determining the concentration of the analyte in the sample of bodily fluid 124 using the color formation value and, optionally, the expected reaction time value.

[0127] Another embodiment of the measurement method 176 is shown in FIG. 6. The starting point may be indicated by a black circle at the top of the figure. By way of example, the measurement method 176 may further include an intensity check 196, such as a step of checking whether the intensity of the color formation value is above or below at least one intensity threshold. In particular, if the color formation value is outside a predefined intensity range, e.g., below a lower intensity threshold or above a higher intensity threshold, the measurement method may be aborted. In particular, if the color formation value fails the intensity check, the color formation value may be considered invalid, and therefore the measurement method 176 may be aborted.

[0128] It should be noted that the color expectation range 128 may be a variable color expectation range, such as parameters of the origin and / or definition surface of a polygon shape. For example, these origin and / or base parameters may be provided in an application (of the user's mobile device) by metadata associated with the color card, allowing the origin and / or base parameters to be changed at a later point in time if necessary. The variation of the color expectation range may be performed at any method step before starting the execution of the measurement method 176.

[0129] By way of example, if the first color expectation range 148 corresponds to the first color expectation range 148 shown in FIG. 4, step vi) 188 of the measurement method 176 may specifically include a separate step for comparing the color formation value with the first color expectation range 148. By way of example, it may be checked whether the color formation value is above the lower surface 174, as indicated by reference numeral 198. It may also be checked whether the color formation value is below the upper surface 172, as indicated by reference numeral 200. It may also be checked whether the color formation value is within the first polygon shape "I" in the color plane defined by the red channel 144 and the green channel 146, as indicated by reference numeral 202. If the color formation value fails any of the checks 198 to 202, according to step vii) 190, the color formation value is deemed invalid and the method may be aborted. Further optionally, after aborting the method, the measurement method 176 may include indicating an error message 204. A similar check may be made for the second color expectation range 150. This step is indicated in FIG. 6 by reference numeral 206. For each of the first and second color expectation ranges 148 and 150, a different post-processing code function may be used to determine the concentration of the analyte. Thus, as indicated by reference numerals 208 and 210, a flag is set if the color formation value falls within the first color expectation range 148, then the flag is set to "I" 208, or if it falls within the second color expectation range 150, the flag is set to "II" 210. By way of example, for the first color expectation range 148, i.e. "I", a first mathematical correlation function, such as mathematical function "f", may be used to determine the analyte concentration from the color formation value, and for the second color expectation range 150, i.e. "II", a second mathematical correlation function, mathematical function "g", may be used.

[0130] FIG. 7 shows a graph diagram of a diagram suggesting the relationship between actual and determined blood glucose values ​​by using the present method and system for the determination of blood glucose concentration, using both the general method and system. In particular, the diagram shown in FIG. 7 shows the relationship between actual blood glucose values ​​(mg / dl 212) and measured blood glucose values ​​(mg / dl 214). In particular, the values ​​shown with crosses show the relationship of normal measurements, i.e. measurements made without provocation and in particular without incorrect and / or improper handling procedures, and the values ​​shown with circles show the relationship of professional measurements, i.e. measurements with incorrect and / or improper user handling procedures made using the present method and device. As can be seen from the diagram, only valid results with small errors of professional measurements can be achieved.

[0131] Additionally, Figure 7 shows regions A-E of an error grid analysis, specifically regions A-E of the Parkes Error Grid, that quantify the clinical accuracy of the determined blood glucose concentration compared to the actual blood glucose concentration. For example, blood glucose values ​​within: -Area A contains values ​​within 20% of the reference sensor; -Area B includes values ​​that are outside the 20% range but would not lead to inappropriate treatment; - Area C contains values ​​that lead to unnecessary procedures; - Area D contains values ​​that indicate a potentially dangerous failure to detect hypoglycemia or hyperglycemia; -Area E contains values ​​that confound the treatment of hypoglycemia against hyperglycemia, and vice versa.

[0132] For details of error grid analysis, see Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL: Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care 10:622-628, 1987.

[0133] The measurements shown in Figure 7 are based on the same sample and assumed reaction time. In particular, the same sample and assumed reaction time were used to determine the blood glucose level for both measurements.

[0134] Table 1 shows a series of professional measurements performed using known methods and devices, as well as the number of blood glucose values ​​determined for the same measurements performed using the present methods and devices. The series of professional measurements for reference and / or control purposes further included a total of 15 "normal" measurements performed without provocation, specifically without incorrect and / or improper handling procedures, used as reference measurements. [Table 1]

[0135] Specifically, as can be seen in Table 1, measurements performed by known methods and devices provide blood glucose values ​​for nearly all measurements, while measurements according to the present invention do not provide blood glucose values ​​for the expected time spans that are considered to be invalid. In particular, when using the method and device of the present invention, blood glucose values ​​were determined for all 15 normal measurements used as references in the expert measurement set. [Explanation of symbols]

[0136] List of Reference Numbers 110 Decision System 112 Mobile Devices 114 Camera 116 Optical Test Strips Training Set 118 Optical Test Strips 120 Reagent Testing Area Training set of 122 body fluid samples 124 Body Fluid Samples 126 processors 128 color expectation range 130 Kit 132 Determination method 134 Step a) 136 Step b) 138 Step c) 140 Step d) 142 Step e) 144 Red Channel 146 Green Channel 148 First Color Expectation Range 150 Second Color Expectation Range 152 Color formation values ​​corresponding to capture time values ​​within the time (d=0 min) 154 d=1 minute 156 d=2 minutes 158 d=3 minutes 160 d=4 minutes 162 d=5 minutes 164 d=7.5 minutes 166 d=10 minutes 170 Blue Channel 172 Top surface 174 Bottom surface 176 Measurement method 178 Step i) 180 Step ii) 182 Step iii) 184 Step iv) 186 Step v) 188 Step vi) 190 Step vii) 192 Step viii) 196 Strength Check 198 Check if the color formation value is higher than the lower surface 200 Check if the color formation value is below the top 202 Check if color forming value is inside polygon 204 Error Message 206 Check whether the color formation value is within the second color expectation range 208 Set flag "I" 210 Set flag "II" 212 Actual blood glucose level (mg / dl) 214 Measured blood glucose level (mg / dl)

Claims

1. 1. A method for determining at least one color expectation range (128) for assessing the validity of an assumed reaction time value used in an analytical measurement based on a color-forming reaction, comprising: a) providing a training set (116) of optical test strips, each optical test strip (118) having a reagent test area (120); b) providing a training set of bodily fluid samples (122) and applying at least one of the bodily fluid samples (124) to the reagent test area of ​​each optical test strip (118) in the training set of optical test strips (116); c) capturing a training set of images by at least one mobile device (112) having at least one camera (114), said training set of images comprising: a training subset of first images, said training subset of first images comprising images of at least a portion of at least some of said reagent test areas (120) of said training set (116) of said optical test strip to which a sample of said body fluid is applied captured at an in-time capture time value, said capture time value referring to the time elapsed between said application of said sample in step b) and said capture of said image; - at least one training subset of second images, said training subset of at least one second image including images of at least a portion of at least some of said reagent test areas (120) of said training set (116) of said optical test strip to which said samples of said body fluid are applied, said training subset of at least one second image including images of at least a portion of said reagent test areas (120) of at least some of said training set (116) of said optical test strip to which said samples of said body fluid are applied, said images being captured at delayed capture time values; said incorporating; d) determining a training set of color formation values ​​from the images of the training set of images, the training set of color formation values ​​including color formation values ​​of at least one color channel for color formation of the reagent test area (120) of the optical test strip (118) of the training set of optical test strips (120) for in-time capture time values ​​and delayed capture time values; and e) deriving from the training set of color formation values ​​at least one color expectation range (128) for the at least one color channel, the color expectation range defining an expected range of color formation values ​​for an in-time capture time value and an acceptable late capture time value, the acceptable late capture time value being determined based on the delay d being greater than or equal to at least one predetermined expiration threshold d ｍａｘ said deriving not exceeding A method of determining.

2. The method of claim 1 , wherein step e) comprises deriving at least two complementary color expectation ranges (148, 150).

3. For the first of the complementary color expectation ranges (148), the delay d １ is the expiration threshold d ｍａｘ lower than a predetermined tolerance threshold d ａ Specifically, d １ <d ａ <d ｍａｘ and for the second of the complementary color expectation ranges (150), the delay d ２ d ａ or the tolerance threshold d ａ and the expiration threshold d ｍａｘ Specifically, d ａ ≦d ２ ≦d ｍａｘ The method of claim 2, wherein

4. The method according to claim 1 , wherein step d) further comprises labelling the colour formation values ​​of the training set of colour formation values ​​with information relating to the capture time value.

5. 5. The method of claim 1, wherein in step e), the color expectation range (128) comprises at least 80%, particularly at least 85%, more particularly at least 90%, more particularly at least 95%, more particularly at least 97%, and more particularly at least 99% of the color formation values ​​for the color formation of the reagent test area of ​​the optical test strip of the training set of optical test strips determined from images captured at one or more of the in-time capture time values ​​and the acceptable delayed capture time values.

6. 6. The method of claim 1, wherein the deriving in step e) comprises determining an envelope that includes at least 80% of the color formation values ​​for the color formation of the reagent test area (120) of the optical test strip (118) of the training set (116) of optical test strips determined from images captured at one or more of the in-time capture time values ​​and the acceptable delayed capture time values, and further extending the envelope by a predetermined safety factor.

7. The method of claim 1 , wherein step e) comprises using at least one machine learning algorithm.

8. A method of performing an analytical measurement based on a color-forming reaction by using a mobile device (112) having a camera (114) and a processor (126), comprising: i) providing at least one optical test strip (118) having at least one reagent testing area (120); ii) applying a sample (124) of bodily fluid to the reagent test area (120) of the optical test strip (118); iii) using said camera (114) to capture at least one image of at least a portion of said reagent test area (120) to which said bodily fluid has been applied; iv) determining an assumed reaction time value corresponding to the time elapsed between the assumed time of application of said sample in step ii) and said capturing of said image in step iii); v) determining color formation values ​​of at least one color channel for color formation of the reagent test area (120) using the image; vi) comparing, for said at least one color channel, said color formation value with at least one color expectation range (128) determined by executing a method according to any one of claims 1 to 7; vii) if said color formation value is outside said at least one color expectation range (128), deeming said expected reaction time value invalid and aborting said measurement method; and viii) validating said assumed reaction time value if said color formation value is within said color expectation range (128) and using said color formation value to determine an analyte concentration of said sample of bodily fluid; The measuring method comprising the steps of:

9. 9. Method according to claim 8, wherein step vi) comprises comparing said color formation value with at least one first color expectation range (148) and with at least one second color expectation range (150) determined by carrying out the method according to any one of claims 2 to 7, and wherein if in step vii) said color formation value is outside both said first color expectation range and said second color expectation range, the expected capture time is considered to be invalid and the measurement method is aborted, and in step viii) for color formation values ​​within said at least one first color expectation range and said at least one second color expectation range different algorithms are used for determining said concentration of said analyte from said color formation value.

10. In step viii), - if the color formation value is within the first color expectation range (148), the expected reaction time value is deemed valid and the concentration of the analyte is determined using the color formation value and the expected reaction time value; and if said color formation value is within said second color expectation range (150), said expected reaction time value is deemed valid and said concentration of said analyte is determined using said color formation value and a predefined delay for said second color expectation range added to said expected reaction time value; The measurement method according to claim 9.

11. 11. The method of claim 9 or 10, further comprising step ix) of capturing at least one image of at least a portion of the reagent test area (120) without applying the bodily fluid by using the camera (114), wherein step ix) is performed before step ii).

12. 12. The method of claim 10 or 11, further comprising a step x) of attaching the optical test strip (118) to a color reference card including a plurality of color reference fields having known reference color values, wherein step x) is performed before step iii), and wherein the image captured in step iii) further illustrates at least a portion of the color reference card.

13. A determination system (110) for determining at least one color expectation range (128) for assessing the validity of an assumed reaction time value used in an analytical measurement based on a color-forming reaction, comprising: A) at least one mobile device (112) having at least one camera (114); B) A training set of optical test strips (116), each optical test strip (118) having a reagent test area (120): C) a training set of bodily fluid samples (126) comprising a plurality of bodily fluid samples (128); D) at least one processor (126), - reading out a training set of images, the training set of images comprising images captured by the camera (114) of at least a portion of the reagent test areas (120) of at least some of the training set of optical test strips (116) to which a sample of the body fluid (124) is applied captured at an in-time capture time value, the capture time value referring to the time elapsed between the application of the sample and the capture of the image, the training set of images further comprising images captured by the camera (114) of at least a portion of the reagent test areas (120) of at least some of the training set of optical test strips (116) to which a sample of the body fluid (124) is applied captured at a delayed capture time value; - determining a training set of color formation values ​​from the images of the training set of images, the training set of images including color formation values ​​of at least one color channel for the color formation of the reagent test area (120) of the optical test strip (118) of the training set of optical test strips (116) for in-time capture time values ​​and delayed capture time values; and - deriving from said training set of color formation values ​​at least one color expectation range (128) for said at least one color channel, said color expectation range (128) defining an expected range of color formation values ​​for an in-time capture time value and an acceptable late capture time value, for which a delay d is greater than or equal to at least one predetermined expiration threshold d ｍａｘ said deriving not exceeding A decision system comprising: a processor (126) configured for:

14. E) at least one color reference card configured for releasably mounting said optical test strip, said color reference card including a plurality of color reference fields having known reference color values, said images of said training set of images further illustrating at least a portion of said color reference card, specifically one or more of said color reference fields; The decision system (110) of claim 13, further comprising:

15. A decision system (110) according to claim 13 or 14, configured to execute at least steps d) and e) of the decision method according to any one of claims 1 to 14, the decision method being referenced.

16. A mobile device (112) having at least one camera (114) and at least one processor (126), the mobile device (112) being configured to perform at least steps iv) to viii) of the measurement method according to any one of claims 1 to 15 referring to the measurement method.

17. 20. A kit (130) for determining a concentration of at least one analyte in a sample (124) of a bodily fluid, comprising the mobile device (112) of claim 16 and further comprising at least one optical test strip (118) having at least one reagent test area (120).

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