Method and device for performing analytical measurements - Patents.com

Abstract

Disclosed are methods for assessing the suitability of a mobile device (112) for performing a color reaction-based analytical measurement, a method for calibrating a mobile device (112) for performing a color reaction-based analytical measurement, and a method for using a mobile device (112) to perform a color reaction-based analytical measurement on an optical test strip (120). Further disclosed are a suitability computer program, a calibration computer program, and a measurement computer program, as well as a mobile device (112) and a kit (110). A method for evaluating the suitability of a mobile device (112) for performing analytical measurements based on a color reaction includes: a) evaluating the capabilities of the mobile device (112) with one or more associated settings of the mobile device (112) controlled by user software running on the mobile device (112), the associated settings being related to image raw data processing steps to be performed by the mobile device (112), the associated settings including at least one of a color space conversion (132) and a tone mapping conversion (136); and b) evaluating the capabilities of the mobile device (112) with one or more associated settings of the mobile device (112) controlled by user software running on the mobile device (112), the associated settings being related to image raw data processing steps to be performed by the mobile device (112), the associated settings including at least one of a color space conversion (132) and a tone mapping conversion (136); and c) if the evaluation in step a) indicates that the mobile device (112) is not capable of having one or more associated settings controlled by the user software, providing at least one item of control information, the at least one item of control information indicating that the mobile device (112) is unsuitable for performing analytical measurements.

Description

[Technical field]

[0001] The present application refers to a method for assessing the suitability of a mobile device for performing an analytical measurement, a method for calibrating a mobile device for performing an analytical measurement, and a method for performing an analytical measurement. The invention further relates to a suitability computer program, a calibration computer program and a measurement computer program, each having program means for performing the methods according to the invention. Furthermore, the invention refers to a mobile device and a kit for performing one or more of the methods according to the invention. The methods, computer programs, mobile devices and kits according to the invention may be used in medical diagnostics, for example for qualitatively or quantitatively detecting one or more analytes in one or more body fluids. However, other fields of application of the invention are possible. [Background technology]

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

[0003] In general, devices and methods known to those skilled in the art utilize test elements that include one or more test chemistries that can exhibit one or more detectable detection reactions, such as optically detectable detection reactions, in the presence of an analyte to be detected. For these test chemistries, reference may be made, for example, to J. Hoenes et al., "The Technology Behind Glucose Meters," Test Strips, Diabetes Technology & Therapeutics, Vol. 10, Supplement 1, 2008, S-10 to S-26. Other types of test chemistries are possible and can be used to carry out the present invention.

[0004] Typically, one or more optically detectable changes in the test chemistry are monitored to extract from these changes the concentration of at least one analyte to be detected. To detect at least one change in the optical properties of the test area, various types of detectors are known in the art. Thus, various types of light sources for shining light on the test area and various types of detectors are known. In general, variable lighting conditions need to be taken into account. Thus, as an example, WO 2016 / 25935 A2 discloses a diagnostic system for biological samples. The diagnostic system includes a diagnostic instrument and a portable electronic device. The diagnostic instrument has a reference color bar and a number of chemical test pads for receiving biological samples. The portable electronic device includes a digital camera for capturing a digital image of the diagnostic instrument in an uncontrolled lighting environment, a sensor for capturing an illumination intensity of a surface of the diagnostic instrument, a processor coupled to the digital camera and the sensor for receiving the digital image and the illumination intensity, and a storage device coupled to the processor. The storage device stores instructions that are executed by the processor to process the digital images and illuminance to normalize the color of the plurality of chemical test pads and to determine a diagnostic test result in response to quantifying the color change of the chemical test pads.

[0005] In addition to using customized detectors specifically developed for optically detecting changes in the test chemistry contained in the corresponding test element, recent developments aim to use widely available devices such as smartphones, however, when using consumer electronics devices with cameras such as smartphones, the individual technical and optical characteristics may need to be taken into account, as there is a huge number of cameras available on the market that may affect the determination of the analyte concentration.

[0006] US 2014 / 072189 A1 describes a system and method for colorimetric test strip analysis and disease management. The system can include an accessory operably coupled to a mobile device, which captures and / or analyzes images of the colorimetric test strip. The light box accessory can be removably attached to the mobile device or can remain attached to the mobile device, but can be removed from the camera's field of view for general photography purposes.

[0007] The online article "Permissions overview", Android Developers, 12 October 2018 (2018-10-12), XP055586158 gives an overview of how Android permissions work, including how permissions are presented to the user, the difference between install-time and runtime permission requests, how permissions are enforced, and the types of permissions and their groups.

[0008] US Patent Application Publication No. 2016 / 080548 A1 describes a method of obtaining a collection point, selected quantitative indicia of an analyte on a test strip using a smartphone, comprising imaging the test strip where a colorimetric response of the target sample occurs due to illumination of the test strip by the smartphone, the smartphone including 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.

[0009] Thus, despite the advantages associated with using consumer electronics devices with cameras for the purpose of detecting analytes in samples or evaluating analytical measurements, some technical challenges remain. Typically, the color representation in a camera system is adapted to provide an image optimized for human color vision, for example by internal post-processing of the raw data captured by the camera. However, due to human color vision, such post-processing may not be ideal when the goal is to accurately determine the concentration of an analyte in a sample. Summary of the Invention

[0010] It is therefore desirable to provide a method and device that addresses the above technical challenges of analytical measurements using mobile devices such as consumer electronics mobile devices, in particular multi-purpose mobile devices not dedicated to analytical measurements such as smartphones or tablet computers. In particular, a method, computer program and device are proposed that are widely applicable to available mobile devices and suitable for increasing measurement accuracy and improving reliability while allowing convenient handling for users.

[0011] This problem is addressed by a method, a computer program and a device having the features of the independent claims. Advantageous embodiments which may be realized alone or in any combination are set out in the dependent claims.

[0012] As used below, the terms "have", "comprise" or "include" or any grammatical variants thereof are used in a non-exclusive manner. These terms may therefore refer both to the situation in which, in addition to the features introduced by these terms, no further features are present in the entity described in this context, and to the situation in which one or more further features are present. As an example, the expressions "A has B", "A comprises B" and "A includes B" may all refer both to the situation in which no other elements are present in A besides B (i.e., the situation in which A consists exclusively of B) and to the situation in which, in addition to B, one or more further elements are present in the entity A, such as element C, elements C and D, or even further elements.

[0013] 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.

[0014] Furthermore, as used below, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used with optional features without limiting alternative possibilities. Thus, features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. The invention may be practiced by using alternative features, as a person skilled in the art will recognize. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, without any limitations on alternative embodiments of the invention, without any limitations on the scope of the invention, and without any limitations on the possibility of combining features introduced in such a way with other optional or non-optional features of the invention.

[0015] In a first aspect, a method for evaluating the suitability of a mobile device for performing analytical measurements based on a color reaction is disclosed. The mobile device has at least one camera. The method includes the following steps, which may be performed in a given order, by way of example. It should be noted, however, that different orders are also possible. Furthermore, it is also possible to perform one or more of the method steps once or repeatedly. Furthermore, it is possible to perform two or more of the method steps simultaneously or in a time-overlapping manner. The method may include further method steps not described. In particular, the method for evaluating the suitability of a mobile device for performing analytical measurements based on a color reaction may also be referred to as a suitability method.

[0016] In general, a method for assessing the suitability of a mobile device for performing an analytical measurement based on a color reaction comprises the following steps: a) evaluating the capabilities of a mobile device and / or camera with one or more associated settings of the mobile device and / or camera controlled by a user's software running on the mobile device, the associated settings being related to image raw data processing steps performed by the mobile device and / or camera, the associated settings including at least one of color space conversion and tone mapping conversion, in particular by using a tone mapping curve; b) if the evaluation in step a) indicates that the mobile device and / or camera may have one or more associated settings controlled by user software, providing at least one item of control information to one or more of the mobile device, in particular to the user or to user software running on the mobile device, wherein the at least one item of control information indicates that the mobile device, in particular a mobile device having at least one camera, is suitable for performing analytical measurements; c) if the evaluation in step a) indicates that the mobile device and / or camera is not capable of having one or more associated settings controlled by user software, providing at least one item of control information to one or more of the mobile device, in particular to the user or to user software running on the mobile device, wherein the at least one item of control information indicates that the mobile device, in particular a mobile device having at least one camera, is unsuitable for performing analytical measurements; Includes.

[0017] The term "analytical measurement" as used herein is a broad term and should be given its ordinary and customary meaning to one of skill in the art and should not be limited to any special or customized meaning. The term may specifically, but not be limited to, refer to the quantitative and / or qualitative determination of at least one analyte in any sample. For example, the sample may include a bodily fluid, such as blood, interstitial fluid, urine, saliva, or other types of bodily fluids. As an example, the result of the analytical measurement may be the concentration of the analyte and / or the presence or absence of the analyte to be determined. Specifically, as an 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.

[0018] By way of example, the at least one analyte may be or include one or more specific chemical compounds and / or other parameters. By way of example, one or more analytes involved in metabolism, such as blood glucose, may be determined. Additionally or alternatively, other types of analytes or parameters may be determined, such as, for example, pH value. The at least one sample may be or include at least one bodily fluid, in particular, blood, interstitial fluid, urine, saliva, etc. However, additionally or alternatively, other types of samples, such as water, may be used.

[0019] 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 any special or customized meaning. The term may specifically refer to, but is not limited to, a mobile electronic device, more specifically a mobile communication device such as a mobile phone or a smartphone. Additionally or alternatively, as outlined in more detail below, a mobile device may also refer to a tablet computer or another type of portable computer having at least one camera.

[0020] The term "camera" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically, but not limited to, refer to 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. As an example, a camera may include at least one camera chip, such as at least one CCD chip and / or at least one CMOS chip configured to record an image. As used herein, but not limited to, the term "image" may specifically relate to data recorded by using a camera, such as a plurality of electronic readings from an imaging device, such as the pixels of a camera chip.

[0021] The camera may include, in addition to at least one camera or imaging chip, one or more optical elements, such as one or more lenses. As an example, the camera may be a fixed focus camera, with at least one lens that is fixedly adjusted relative to the camera. Alternatively, however, the camera may also include one or more variable lenses that may be adjusted automatically or manually. The invention shall be particularly applicable to cameras that are typically used in mobile applications, such as notebook computers, tablets, or mobile phones, particularly smartphones. Thus, in particular, the camera may be part of a mobile device that includes, in addition to at least one camera, one or more data processing devices, such as one or more data processors. However, other cameras are also possible.

[0022] The camera may be specifically a color camera. Thus, color information may be provided or generated, such as color values ​​for three colors R, G, B, etc. for each pixel. A larger number of color values ​​is also possible, such as four color values ​​per pixel, for example R, G, G, B. Color cameras are generally known to those skilled in the art. Thus, as an example, a camera chip may consist of a plurality of three or more different color sensors each, such as color recording pixels, such as one pixel for red (R), one pixel for green (G), and one pixel for blue (B). For each of the pixels, such as for R, G, B, a value may be recorded per pixel, such as a digital value ranging from 0 to 255, depending on the intensity of the respective color. As an example, instead of using a triplet of colors such as R, G, B, a quadruple of colors such as R, G, G, B may be used. The color sensitivity of the pixel may be generated by color filters or by the appropriate intrinsic sensitivity of the sensor element used in the camera pixel. These techniques are generally known to those skilled in the art.

[0023] The term "related settings" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, any configuration or adjustment deemed appropriate for a specific function or operation. Specifically, one or more related settings of a mobile device and / or a camera may specifically be or include a configuration deemed appropriate for performing an analytical measurement based on a color reaction. Thus, as an example, the related settings of a mobile device and / or a camera may refer to an image processing configuration. In particular, the related settings relate to an image raw data processing step. In particular, the related settings include at least one of color space conversion and tone mapping correction. As mentioned above, the related settings of a mobile device may specifically be controlled by a user's software running on the mobile device. In particular, as used herein, the user's software may be or include software or programs, such as software apps running on the mobile device, apps downloaded from an app store, etc.

[0024] The term "color space conversion" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically, but not limited to, refer to an algorithm or operation that changes information from one first color space, e.g., one specific mathematical representation of a color, to another color space, e.g., a second color space, such as another specific mathematical representation of a color. Any color may be represented in a first color space by a first mathematically structured information or data, e.g., by a first vector. Specifically, color space conversion may refer to changing a representation of a color in a first color space to a representation of the same color in a second color space. Thus, in particular, color space conversion may refer to changing mathematically structured data, e.g., a vector, representing a color in a first color space, to mathematically structured data or vectors representing a color in a second color space. Color space conversion may specifically, as described in further exemplary details below, be or include a matrix conversion. Further, other transformations are possible, additionally or alternatively, such as functional transformations.

[0025] As a simple example, a color space transformation may be described by changing the RGB input variables Rin, Bin, Gin to RGB output variables Rout, Bout, Gout. Specifically, the color space transformation of the input variables to the output variables may be formed by a matrix multiplication with a transformation matrix. In particular, if all off-diagonal elements of the transformation matrix are equal to 0, the RGB variables, e.g., the RGB input and output variables, remain color pure, specifically the RGB values ​​may not be mixed, but only scaled individually.

[0026] Specifically, the relationship between the RGB input variables Rin, Bin, and Gin and the RGB output variables Rout, Bout, and Gout may be described by the following equation:

number

[0027] Therefore, if all off-diagonal elements of the transformation matrix are equal to 0, the RGB output variables may be calculated by the following formula:

number

[0028] However, if the off-diagonal elements of the transformation matrix are not equal to 0, for example, RG, RB, GR, GB, BR and BG≠0, then the RGB output variables may be calculated by the following formula:

number

[0029] The term "tone mapping" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, a nonlinear compression of luminance dynamics. In particular, the tone mapping transformation may be or include an algorithm or nonlinear operation that converts pixel-related luminance values ​​of an image capture sensor or at least one camera chip, such as at least one CCD chip and / or at least one CMOS chip configured to record an image, into luminance values ​​in an image. In particular, the tone mapping transformation may use a tone mapping curve that establishes a relationship between pixel luminance values ​​(pixel luminance values ​​may be pixel luminances, which may be measured, for example, on a linear scale) and luminance values ​​stored in the image for that pixel. In particular, the tone mapping transformation may be performed in the form of a conversion function for a specific color space or specific color channel. As an example, a tone mapping curve for a standard red-green-blue color space (sRGB color space) includes gamma correction.

[0030] The term "suitability" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically, but not limited to, refer to the characteristics of an element or device to perform one or more predetermined functions. Thus, by way of example, suitability may be qualified or quantified by using one or more characteristics of the device. As outlined above or in more detail below, these one or more characteristics may be evaluated using one or more conditions, either individually or according to a predetermined combination. In particular, the device characteristic may be or include, in particular, the ability of the device to have one or more associated settings that are controlled. In particular, a characteristic such as, for example, the ability of a mobile device to have one or more associated settings that are controlled by a user's software running on the mobile device may be evaluated by attempting to control the one or more associated settings and then determining the success of the control. As a simple example, a user's software may be used to send a command to make the individual values ​​of one or more relevant settings equal to a pre-established reference value and then, for example, subsequently compare the one or more relevant settings to the one or more reference values.

[0031] The result of the comparison may be provided in at least one item of control information to indicate the suitability of the mobile device for carrying out an analytical measurement based on a chromogenic reaction.

[0032] In particular, the comparison may be a qualitative or quantitative comparison, in particular resulting in a binary or Boolean result, such as "suitable" if the respective values ​​of one or more relevant settings are equal to a reference value, or "unsuitable" / "unsuitable" if the values ​​do not match. Thus, at least one item of control information may include Boolean information regarding relevant settings of the mobile device and / or camera, in particular, being "controllable" or "uncontrollable". As a simple example, if at least one relevant setting is "uncontrollable", at least one item of control information may indicate "0" or "false", indicating that the mobile device is "unsuitable" or "unsuitable" for performing an analytical measurement. Alternatively, if the relevant setting is "controllable", the item of control information may indicate "1" or "true", indicating that the mobile device is "suitable" for performing a measurement. Different representations of the Boolean information regarding relevant settings of the mobile device that are controllable may also be possible, for example an inverted representation where "0" indicates "controllable" and "1" indicates "uncontrollable".

[0033] The term "providing at least one item of control information" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically, but not be limited to, the allocation of at least one item of control information. In particular, the at least one item of control information may be provided in electronic form, such as in analog and / or digital form. The at least one item of control information may be provided by transferring the item of control information to at least one of an interface, a data storage device, a processing device, a software component, for example, to a user's software running on a mobile device. The at least one item of control information may be provided as a data signal, specifically in the form of an electronic signal. Thus, providing at least one item of control information may refer, for example, to a process of supplying at least one item of control information, specifically, as a data signal, for example in the form of an electrical signal, for example a binary signal, to a user's software running on a mobile device.

[0034] Furthermore, as outlined in more detail below, the method of assessing the suitability of a mobile device for performing analytical measurements may be performed or supported by a computer or computer network, in particular a computer or computer network of a portable device, such as one or more of a notebook, a tablet, or a mobile phone such as a smartphone.

[0035] In a further aspect of the present invention, a method for calibrating a mobile device for performing analytical measurements based on color reactions is disclosed, the mobile device having at least one camera. The method includes the following method steps, which may be performed in a given order. However, again, different orders may be possible. Furthermore, one, two or more, or even all of the method steps may be performed once or repeatedly. Furthermore, the method steps may be performed consecutively, or two or more method steps may be performed overlapping in time or even in parallel. The method may further include additional method steps not described. In particular, the method for calibrating a mobile device for performing analytical measurements based on color reactions may also be referred to as a method of calibration.

[0036] The method of calibrating a mobile device for performing analytical measurements based on a color reaction comprises the following steps: i. assessing the suitability of the mobile device for performing analytical measurements by using a suitability method as disclosed in one or more of the embodiments above or as further disclosed in further optional details below; ii. Aborting the method if the item of control information indicates that the mobile device is unsuitable for performing analytical measurements; and iii. if the item of control information indicates that the mobile device is suitable for performing analytical measurements, then performing the following steps: (1) providing at least one object having at least one predetermined reference color characteristic; (2) capturing at least one reference image of at least a portion of the predetermined reference color characteristics using a camera; (3) extracting at least one item of reference setting information relating to a related setting of the reference image; and (4) storing at least one item of standard-setting information extracted in step (3), in particular in at least one database; and and Includes.

[0037] For further possible definitions of most of the terms used in this specification, reference may be made to the disclosure of the method for assessing the suitability of a mobile device as disclosed above or in more detail below. In particular, from step i onwards, a suitability method is used to assess the suitability of the mobile device. As an example, step i may make use of at least one item of control information, which may be or may include digital or Boolean information, in particular regarding whether the mobile device is "suitable" or "unsuitable" for performing an analytical measurement. Depending on this control information, the method may branch between steps ii and iii, and the suitability inquiry in step i may be programmed, for example, as an "if..." routine, an "if...else..." routine, etc.

[0038] The term "reference object" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to any object that includes at least one predetermined reference color characteristic, but is not limited to it. As an example, the reference object may be or include one or more of the predetermined visual reference color characteristics attached to, printed on, or incorporated into an object, such as an optical test element or optical test strip, a test strip vial, a test element container, specifically a test strip container, a package for receiving at least one optical test element or optical test strip or a portion thereof, a reference color card, etc. The term "predetermined reference color characteristic" as used herein may specifically refer to, but is not limited to it, any visual indicator whose quality or characteristics are known or predefined. As an example, the predetermined reference color characteristic may be or include a reference region or area, specifically a reference color and / or grayscale region, any region of grayscale and / or color, such as the inherent color of at least one reference object. In particular, the hue, lightness, and saturation values ​​of the reference color characteristic may be known or may be predefined.

[0039] The term "item of reference setting information" as used herein 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 any special or customized meaning. The term may specifically, but not exclusively, refer to any item of information, e.g., one or more numerical values, that quantifies at least one relevant setting of a reference image. Thus, by way of example, an item of reference information may include information that quantifies relevant settings when taking at least one reference image. In particular, an item of reference information may relate to relevant settings of a mobile device and / or camera, particularly referring to an image processing configuration of the mobile device and / or camera.

[0040] As proposed herein, the steps of assessing the suitability of the mobile device and calibrating the mobile device for performing analytical measurements may be performed separately, and once suitability is determined, any number of calibrations of the mobile device or any number of analytical measurements may be performed, as outlined in more detail below. However, alternatively, the assessment of the suitability of the mobile device in step i) may be repeated, for example after a predefined or determinable interval or if any changes are made to the mobile device. A user software, for example a software app, running on the mobile device may prompt the user to perform the method step i), for example by providing a corresponding instruction on the display and / or as an audio instruction. However, in particular, step i), if performed at all, may be performed at least once before step iii) is performed. Step i) may be performed once before step iii) is performed at least once, or step i) may be performed once before step iii) is repeatedly performed.

[0041] If at least one item of control information indicates that the mobile device is inappropriate or unsuitable for performing an analytical measurement, the method of calibrating a mobile device for performing an analytical measurement based on a color reaction may be aborted. This abort, particularly in step ii, may further include informing a user of the mobile device of the unsuitability of the mobile device for performing an analytical measurement. The information may be provided, as an example, in a normal format for providing information on the mobile device. In particular, the information may be provided by using one or more of the visual, auditory or tactile interfaces of the mobile device. For example, the unsuitability of the mobile device may be provided to the user in visual, tactile or auditory form, such as on a display of the mobile device, and / or as an auditory or tactilely receivable signal, such as at least one beep or vibration.

[0042] Additionally or alternatively, if the mobile device is determined to be unsuitable for performing analytical measurements, step ii) may also include blocking future attempts to perform analytical measurements using the mobile device. Thus, as an example, if a user attempts to launch a software app on their mobile phone, a message such as "Unfortunately, your mobile device is not suitable!" may be displayed on the display and the analytical measurement may be blocked.

[0043] Again, additionally or alternatively, step ii) may also include sending information about the mobile device being unsuitable for performing analytical measurements to the software download server, in order to inform the software download server of the unsuitability of this particular type of mobile device, more particularly to prevent future provision of software downloads of software for analytical measurements for this particular type of mobile device. Thus, by way of example, the download server may receive information about the incompatibility and may not provide the analytical software to be downloaded for this particular type of mobile device in the future.

[0044] If at least one item of control information indicates that the mobile device is suitable for performing analytical measurements, at least steps (1)-(4) of the method for calibrating the mobile device for performing analytical measurements may be performed, as shown in step iii. Furthermore, step iii may specifically include informing the user of the suitability of the mobile device for performing analytical measurements by using one or more of the visual, auditory or tactile user interfaces of the mobile device. In particular, the information of the mobile device being suitable for performing analytical measurements may be provided to the user in visual, tactile or auditory form, such as on a display of the mobile device, and / or as an auditory or tactilely receivable signal, for example at least one beep or vibration.

[0045] As an example, the at least one reference object having at least one predetermined reference color characteristic may be selected from the group consisting of a test strip, a test strip vial, a container, particularly a test strip container, a package, e.g., a package for receiving at least one test strip or a portion thereof.

[0046] Further, in particular, the at least one predetermined reference color characteristic may be one or more of a reference color area, in particular a reference color area printed or otherwise attached on the at least one object, a grayscale and / or a color, in particular an inherent color of the at least one object.

[0047] In particular, the item of criteria setting information may be or may include, for example, one or more numerical values ​​that quantify relevant settings related to the image raw data processing steps performed by the mobile device and / or camera when capturing the image in step (2).

[0048] As an example, the item of setting information may include at least one parameter relating to at least one image processing step, in particular a color space conversion and / or a tone mapping conversion, in particular by using a tone mapping curve, that is performed when capturing at least one reference image in step (2).

[0049] With regard to step (4), the at least one item of reference-setting information may in particular be stored in at least one database, e.g. a data storage device such as a memory of the mobile device and / or the camera, although the item of reference-setting information may additionally or alternatively be stored in an external database or storage medium, e.g. an online database or memory in the cloud.

[0050] In particular, in step (4), at least one item of reference setting information may be stored for use in a method of performing an analytical measurement based on a color reaction.

[0051] Furthermore, as outlined in more detail below, the method for calibrating a mobile device for performing analytical measurements may be fully or partially supported and / or performed by a computer or a computer network, in particular a computer or a computer network of a portable device, such as one or more of a notebook, a tablet, or a mobile phone such as a smartphone. In particular, at least steps i and ii, or steps i, iii, and (2) to (4) of the method for calibrating a mobile device for performing analytical measurements based on color reactions, may be performed using a computer or a computer network.

[0052] In a further aspect of the present invention, a method for performing an analytical measurement based on a color reaction in an optical test strip is disclosed, where a mobile device is used, and the mobile device has a camera. The method includes the following method steps, which may be performed in a given order. However, again, different orders may be possible. Furthermore, one, two or more, or even all method steps may be performed once or repeatedly. Furthermore, the method steps may be performed consecutively, or two or more method steps may be performed overlapping in time or even in parallel. The method may further include additional method steps not described. In particular, the method for performing an analytical measurement based on a color reaction may also be referred to as a method of measurement.

[0053] The method for performing an analytical measurement based on a color reaction in an optical test strip comprises the following steps: A) Mobile device compatibility, assessing the suitability of a mobile device by using a method for assessing the suitability of the mobile device, in particular by using a suitability method as described above or as further described below, and - checking whether at least one item of reference setting information has been stored according to a method for calibrating a mobile device, in particular according to step (4) of a method for calibrating a mobile device as described above or as further described below, and verifying by performing at least one of B) prompting the user to perform one or more of the following: applying a sample of the bodily fluid, in particular a drop, to the optical test strip and confirming said application; C) waiting a predetermined minimum time; and D) capturing at least one image of an optical test strip having a sample of bodily fluid applied thereto, wherein at least one item of configuration information is used to control at least one of one or more associated settings of the mobile device and / or camera; Includes.

[0054] The analytical measurement may specifically be an analytical measurement that includes a change in at least one optical property of the optical test strip, which may be visually measured or determined using a camera. Specifically, the analytical measurement may be or may include a color reaction in the presence of at least one analyte to be determined. The term "color reaction" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. This term may specifically refer to, but is not limited to, a chemical, biological or physical reaction in which the color, specifically the reflectance, of at least one element involved in the reaction changes as the reaction progresses.

[0055] 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 customized meaning. The term may specifically refer to, but is not limited to, any element or device configured to perform a color change detection reaction. 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 a test area that includes at least one test agent for detecting at least one analyte, among other things. As an example, an optical test strip may include at least one substrate, such as at least one carrier, to which at least one test area is attached or incorporated therein. As an 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 have a single test area or multiple test areas with the same or different test agents included therein.

[0056] As proposed herein, the actual steps of assessing the suitability of the mobile device and performing the analytical measurements may be performed separately, and once suitability has been determined, any number of analytical measurements based on color reactions may be performed using the mobile device, although alternatively, the assessment of the suitability of the mobile device may be repeated, for example after a predefined or determinable interval, or if any changes are made to the mobile device.

[0057] In particular, step A) may be performed at least once before step B) is performed. Thus, by way of example, verification of the suitability of the mobile device may be performed before performing an analytical measurement, in which the user's software, e.g. a software app, running on the mobile device may prompt the user to perform or confirm the application of the sample according to method step B), for example by providing corresponding instructions on the display and / or as voice instructions. As an example, the suitability of the mobile device may be verified by one or both of performing the suitability method or checking the execution of step (4) of the calibration method. Thus, for possible definitions of the terms and possible embodiments, reference may be made to the above description or may be described in more detail below.

[0058] As an example, when performing the method of measurement, first the suitability of the mobile device may be verified. In particular, the suitability may be verified by performing one or both of the options given above, as indicated by step A) of the method. In particular, it may be verified that the internal image processing of the mobile device is controllable. Subsequently, step B) may be performed, for example, the user may be prompted to apply a sample, in particular a drop of a body fluid, to the optical test strip. After performing step C), step D) may be performed, for example, at least one image of the optical test strip with the sample applied thereto may be captured, and at least one item of configuration information may be used to control at least one of one or more relevant settings of the mobile device. Thus, as an example, when performing step D) of the method of measurement, the item of configuration information may be equal to the item of reference configuration information extracted in step (3) of the method of calibration. In particular, at least one item of configuration information relating to the relevant settings of the mobile device when performing step D) may be set to be equal to the item of reference configuration information extracted in step (3) of the method of calibration.

[0059] The method for performing an analytical measurement based on a color reaction may further comprise a step E) of determining the concentration of at least one of the analytes in the sample of bodily fluid applied to the optical test strip. In particular, the concentration of at least one of the analytes in the sample of bodily fluid may be determined by evaluating a color reaction in the optical test strip, such as, for example, a color reaction of the optical test strip in response to the concentration of the analyte in the sample, in particular a color reaction of a test area in the optical test strip.

[0060] As an example, in step E), image data such as measurements referencing at least one color in the image may be generated by image acquisition of the optical test strip. An average of the measurements, e.g. an average color value, such as an average color value of the test areas of the optical test strip, may be determined and may further be set in relation to a reference color, such as a value for a known or predetermined color, e.g. the white color of the test strip, e.g. stripe white. In particular, to determine the analyte concentration, the average of the measurements referencing the average color of the test areas of the optical test strip, in particular the color of the test areas of the optical test strip, may be set in relation to a value referencing a reference color.

[0061] In particular, step C) of waiting a predetermined minimum time may specifically include waiting for at least 5 seconds. Thus, by way of example, a method of performing an analytical measurement based on a color reaction in an optical test strip may include waiting 5 seconds after application of a sample to the optical test strip in step B) and prior to capturing at least one image in step D) of the method.

[0062] Further, by way of example, in step D) at least one image of the optical test strip and a reference object, such as, for example, a reference color card, may be captured. In particular, the concentration of at least one analyte in the sample of bodily fluid applied to the optical test strip may be determined by using an image of the reference object, in particular the reference color card. In particular, the average of the measurements of the remaining area of ​​the optical test strip may be set in relation to the reference color characteristics of the reference object, for example, the reference color card. Thus, by way of example, in step D) a mixed image of the optical test strip and the reference object, for example, the reference color card, may be captured.

[0063] Furthermore, as outlined in more detail below, the method of performing an analytical measurement based on a color reaction in an optical test strip may be performed or supported by a computer or computer network, in particular a computer or computer network of a portable device, such as one or more of a notebook, a tablet, or a mobile phone, such as a smartphone.

[0064] In a further aspect, a compatibility computer program, in particular a smartphone app, is disclosed, comprising computer executable instructions for performing a method for assessing the suitability of a mobile device having at least one camera. The compatibility computer program is configured to perform the method for assessing the suitability of a mobile device as described above or as further described below when the program is executed on a computer or a computer network, in particular on a processor of a mobile device having at least one camera. In particular, the compatibility computer program may be configured to perform the compatibility method when executed on a computer or a computer network. Thus, the compatibility computer program may be specifically configured to perform at least steps a) and b) or steps a) and c) of the compatibility method as described above when executed on a computer or a computer network.

[0065] Again, for possible definitions of terms and possible embodiments, reference may be made to the above description or may be explained in more detail below.

[0066] In particular, the compatible computer program may be stored on a computer-readable data carrier. Thus, it is further disclosed and proposed herein to provide a data carrier having stored thereon a data structure, which, after being loaded into a computer or a computer network, such as into a working or main memory of the computer or computer network, may perform the compatible method according to one or more embodiments disclosed herein.

[0067] In a further aspect, a calibration computer program, in particular a smartphone app, is disclosed that includes computer executable instructions for performing a method of calibrating a mobile device. The calibration computer program is configured to perform the calibration method as described above or as further described below when the program is executed on a computer or a computer network, in particular on a processor of a mobile device having at least one camera. In particular, the calibration computer program may be configured to perform the calibration method when executed on a computer or a computer network. Thus, the calibration computer program may be specifically configured to perform at least steps i and ii or at least steps i and iii, in particular steps i and iii, as well as steps (2) to (4) of the calibration method as described above when executed on a computer or a computer network.

[0068] Again, for possible definitions of terms and possible embodiments, reference may be made to the above description or may be explained in more detail below.

[0069] In particular, the calibration computer program may be stored on a computer-readable data carrier. Thus, a data carrier is further disclosed and proposed, on which a data structure is stored, which, after being loaded into a computer or a computer network, such as into a working or main memory of the computer or a computer network, in particular into a processor of a mobile device having at least one camera, may execute the method of calibration according to one or more of the embodiments disclosed herein.

[0070] In a further aspect, a measurement computer program, in particular a smartphone app, is disclosed, comprising computer executable instructions for carrying out a method of performing an analytical measurement based on a color reaction. The measurement computer program is configured to carry out the method of performing an analytical measurement based on a color reaction as described above or as further described below when the program is executed on a computer or a computer network, in particular on a processor of a mobile device having at least one camera. In particular, the measurement computer program may be configured to carry out the method of measurement when executed on a computer or a computer network. Thus, the measurement computer program may be specifically configured to carry out at least steps A) to D) of the measurement method as described above when executed on a computer or a computer network.

[0071] Again, for possible definitions of terms and possible embodiments, reference may be made to the above description or may be explained in more detail below.

[0072] In particular, the computer program may be stored on a computer-readable data carrier. Thus, it is further disclosed and proposed a data carrier having stored thereon a data structure, which after being loaded into a computer or a computer network, such as into a working or main memory of the computer or a computer network, in particular into a processor of a mobile device having at least one camera, can execute the method of measurement according to one or more of the embodiments disclosed herein.

[0073] In a further aspect, a mobile device is disclosed. The mobile device includes at least one camera and - a method for assessing the suitability of a mobile device for carrying out an analytical measurement based on a chromogenic reaction, as described above or further below, - a method for calibrating a mobile device for carrying out analytical measurements based on a color reaction, as described above or further below, and - a method for performing an analytical measurement based on a color reaction in an optical test strip using a mobile device having a camera, as described above or further below, and at least one processor with software configured to execute one or more of the following:

[0074] Again, for possible definitions of terms and possible embodiments, reference may be made to the above description or may be explained in more detail below.

[0075] In a further aspect, a kit is disclosed. The kit includes a mobile device as described above or as further described below. The kit further includes at least one reference object having at least one predetermined reference color characteristic, and the kit further includes at least one optical test strip. As described above, the reference object itself can be or include an optical test strip. Thus, the at least one reference object and the at least one optical test strip included in the kit can be combined into one optical test strip having at least one predetermined reference color characteristic, for example.

[0076] Again, for possible definitions of terms and possible embodiments, reference may be made to the above description or may be explained in more detail below.

[0077] The term "kit" as used herein 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 any special or customized meaning. The term may specifically, but is not limited to, refer to an assembly of multiple components, each of which may function and be treated independently of one another, and the components of the kit may interact to perform a common function.

[0078] The methods, computer programs and devices disclosed herein may provide a number of advantages over known methods, computer programs and devices. Thus, in particular, the process of performing analytical measurements proposed in the present invention may be less time-consuming compared to other processes known in the art. In particular, the present invention may assess the general suitability of the mobile device used to perform the measurements. The established suitability or suitability of the mobile device may be valid for one, more than one, or even all subsequent measurements, and as an example, only verification of suitability may be required when performing the measurement itself. Thus, the present invention may require less time to perform analytical measurements compared to prior art approaches.

[0079] Furthermore, the present invention may simplify the process of performing analytical measurements for a user. In particular, once the general suitability of mobile devices can be established, the process of performing analytical measurements may be simpler than state-of-the-art measurements. In particular, using a suitable mobile device, the present invention may simplify the process of performing blood glucose measurements for a user. When using a suitable mobile device, the process of performing blood glucose measurements may in particular require less time than state-of-the-art processes.

[0080] The present invention may only allow a suitable mobile device to be used to perform analytical measurements based on color reactions. In particular, the present invention may only allow the use of a computer program, in particular a measurement computer program comprising computer executable instructions for performing analytical measurements based on color reactions, in conjunction with a mobile device that may have one or more of its associated settings controlled by a user's software running on the mobile device. Thereby, the present invention may improve the safety of using a mobile device to perform analytical measurements. In particular, the safety of valid results, e.g. the validity of the results of an analytical measurement, may be ensured by the present invention.

[0081] In summary, and without excluding further possible embodiments, the following embodiments can be envisaged:

[0082] EMBODIMENT 1 1. A method for assessing the suitability of a mobile device for performing an analytical measurement based on a color reaction, the mobile device having at least one camera, the method comprising: a) assessing the capabilities of a mobile device with one or more relevant settings of the mobile device controlled by a user's software running on the mobile device, the relevant settings being related to image raw data processing steps performed by the mobile device, the relevant settings including at least one of color space conversion and tone mapping conversion, in particular by using a tone mapping curve; b) if the evaluation in step a) indicates that the mobile device may have one or more associated settings controlled by user software, providing at least one item of control information to one or more of the mobile device, the user, or the user's software running on the mobile device, wherein the at least one item of control information indicates that the mobile device is suitable for performing analytical measurements; c) if the evaluation in step a) indicates that the mobile device is incapable of having one or more relevant settings controlled by the user's software, providing at least one item of control information to one or more of the mobile device, the user, or the user's software running on the mobile device, the at least one item of control information indicating that the mobile device is unsuitable for performing analytical measurements; A method comprising:

[0083] EMBODIMENT 2 2. The method of embodiment 1, wherein at least one item of control information includes Boolean information regarding relevant settings of the mobile device and / or camera being "controllable" or "uncontrollable."

[0084] EMBODIMENT 3 3. The method according to any one of embodiments 1 or 2, wherein the method for evaluating the suitability of the mobile device for performing an analytical measurement based on a color reaction is performed using a computer or a computer network.

[0085] EMBODIMENT 4 1. A method of calibrating a mobile device for performing analytical measurements based on a color reaction, the mobile device having at least one camera, the method comprising: i. assessing the suitability of a mobile device for performing analytical measurements using a method according to any one of embodiments 1 to 3; ii. Aborting the method if the item of control information indicates that the mobile device is unsuitable for performing analytical measurements; and iii. if the item of control information indicates that the mobile device is suitable for performing analytical measurements, then performing the following steps: (1) providing at least one reference object having at least one predetermined reference color characteristic; (2) capturing at least one reference image of at least a portion of the predetermined reference color characteristics using a camera; (3) extracting at least one item of reference setting information relating to a related setting of the reference image; and (4) storing at least one item of standard-setting information extracted in step (3), in particular in at least one database; and and A method comprising:

[0086] EMBODIMENT 5 5. The method of embodiment 4, wherein step ii further comprises notifying a user of the mobile device of the unsuitability of the mobile device for performing the analytical measurement, specifically by using one or more of a visual, an auditory, or a tactile user interface of the mobile device.

[0087] EMBODIMENT 6 The method of embodiment 4 or 5, wherein step iii further comprises informing the user of the suitability of the mobile device for performing the analytical measurement, specifically by using one or more of a visual, an auditory, or a tactile user interface of the mobile device.

[0088] EMBODIMENT 7 The method according to any one of embodiments 4 to 6, wherein the at least one reference object having at least one predetermined reference color characteristic is selected from the group consisting of a test strip, a test strip vial, a container, particularly a test strip container, a package, e.g., a package for receiving at least one test strip or a portion thereof, and a reference color card.

[0089] EMBODIMENT 8 The method according to any one of embodiments 4 to 7, wherein the at least one predetermined reference color characteristic is one or more of a reference color area, in particular a reference color area printed or otherwise attached on the at least one object, a grayscale and / or a color, in particular an inherent color of the at least one object.

[0090] EMBODIMENT 9 A method according to any one of embodiments 4 to 8, wherein the item of setting information includes at least one parameter relating to at least one image processing step, in particular color space conversion and tone mapping conversion, performed when capturing at least one reference image in step (2), in particular by using a tone mapping curve.

[0091] EMBODIMENT 10 10. The method according to any one of embodiments 4 to 9, wherein in step (4) at least one item of reference setting information is stored for use in a method of performing an analytical measurement based on a color reaction.

[0092] EMBODIMENT 11 The method according to any one of embodiments 4 to 10, wherein the method of calibrating a mobile device for performing analytical measurements based on a color reaction is performed using a computer or a computer network.

[0093] EMBODIMENT 12 1. A method for performing an analytical measurement based on a color reaction in an optical test strip using a mobile device having a camera, comprising: A) Mobile device compatibility, - assessing the suitability of a mobile device using the method according to any one of embodiments 1 to 11, which refers to the method for assessing the suitability of a mobile device; and - checking whether at least one item of reference setting information has been stored according to step (4) of the method for calibrating a mobile device according to any one of embodiments 1 to 11, referring to the method for calibrating a mobile device; and verifying by performing at least one of B) prompting the user to perform one or more of the following: applying a sample of the bodily fluid, particularly a droplet, to the optical test strip; and confirming the application of the sample of the bodily fluid, particularly a droplet, to the optical test strip; C) waiting a predetermined minimum time; and D) capturing at least one image of an optical test strip having a sample of the bodily fluid applied thereto, wherein at least one item of configuration information is used to control at least one of one or more associated settings of the mobile device; and A method comprising:

[0094] EMBODIMENT 13 13. The method of embodiment 12, wherein step A) is performed at least once before step B) is performed.

[0095] EMBODIMENT 14 14. The method according to embodiment 12 or 13, wherein the method further comprises a step E) of determining the concentration of at least one of the analytes in the sample of bodily fluid applied to the optical test strip.

[0096] EMBODIMENT 15 15. The method of any one of embodiments 12-14, wherein method step C) comprises waiting for at least 5 seconds.

[0097] EMBODIMENT 16 The method according to any one of embodiments 12 to 15, wherein the method of performing an analytical measurement based on a color reaction in the optical test strip is performed using a computer or a computer network.

[0098] EMBODIMENT 17 A suitability computer program, in particular a smartphone app, comprising computer executable instructions for executing the method for assessing the suitability of a mobile device having at least one camera for performing analytical measurements based on a color reaction according to any one of the embodiments 1 to 16, which refers to the method for assessing the suitability of a mobile device, when the program is executed on a computer or a computer network, in particular on a processor of a mobile device having at least one camera.

[0099] EMBODIMENT 18 A calibration computer program, in particular a smartphone app, comprising computer executable instructions for performing a method for calibrating a mobile device according to any one of the embodiments 1 to 17, when the program is executed on a computer or a computer network, in particular on a processor of a mobile device having at least one camera, the method comprising:

[0100] EMBODIMENT 19 A measurement computer program, in particular a smartphone app, comprising computer executable instructions for performing a method for performing an analytical measurement based on a color reaction according to any one of the embodiments 1 to 18, which refers to a measurement computer program, in particular a smartphone app, which, when the program is executed on a computer or a computer network, in particular on a processor of a mobile device having at least one camera, performs an analytical measurement.

[0101] EMBODIMENT 20 1. A mobile device having at least one camera, the mobile device comprising: - a method for assessing the suitability of a mobile device for carrying out an analytical measurement based on a color reaction according to any one of embodiments 1 to 19, which refers to the method for assessing the suitability of a mobile device; - a method for calibrating a mobile device for carrying out analytical measurements based on color reactions according to any one of embodiments 1 to 19, which refers to the method for calibrating a mobile device; and - a method for performing an analytical measurement based on a color reaction in an optical test strip by using a mobile device with a camera according to any one of embodiments 1 to 19, which refers to the method for performing an analytical measurement; 23. A mobile device having at least one processor with software configured to execute one or more of the following:

[0102] EMBODIMENT 21 21. A kit comprising the mobile device of embodiment 20 and further comprising at least one reference object having at least one predetermined reference color characteristic, the kit further comprising at least one optical test strip. [Brief description of the drawings]

[0103] Further optional features and embodiments are disclosed in more detail in the following description of the embodiments, preferably in conjunction with dependent embodiments. In it, each optional feature can be realized in isolation 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 identical reference numerals in these figures refer to identical or functionally comparable elements.

[0104] [Figure 1] FIG. 1 shows a perspective view of an embodiment of a kit and a mobile device. [Diagram 2] 1 illustrates an embodiment of a flow chart of an image processing chain. [Diagram 3] 1 illustrates an embodiment of a flow chart of a method for assessing suitability of a mobile device. [Figure 4] 1 illustrates an embodiment of a flowchart of a method for calibrating a mobile device. [Diagram 5] 1 illustrates an embodiment of a flowchart of a method for calibrating a mobile device. [Figure 6] 1 illustrates an embodiment of a flow chart of a method for performing an analytical measurement. [Figure 7] 1 illustrates an embodiment of a flow chart of a method for performing an analytical measurement. [Figure 8] FIG. 1 shows one embodiment of a diagram illustrating the relationship between actual and determined analyte concentrations, illustrating the difference between using typical methods and devices and using the present methods and devices to perform analytical measurements. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0105] In Fig. 1, a kit 110 for performing analytical measurements is shown in a perspective view. The kit 110 includes at least one mobile device 112 having at least one camera 114 and at least one processor 116 with software. The kit 110 further includes at least one reference object 118 having at least one predetermined reference color characteristic and at least one optical test strip 120. In particular, the reference object 118 and the optical test strip 120 may be combined into one object, and thus, as shown in the figure, the reference object 118 may be or include the optical test strip 120.

[0106] FIG. 2 shows an exemplary embodiment of a flow chart of an image processing chain of a mobile device 112. In particular, the image processing routine 116 of the mobile device may be optimized, for example, to generate an image that is as appealing as possible to the human eye. In particular, various algorithms, for example image optimization algorithms, may be used for this purpose. For example, such algorithms may include modifying image data, in particular four-dimensional image data, for example RGGB data 122, such as information about an image in the R, G, G, and B channels, into an RGGB channel vector 124, and executing a demosaicing algorithm 126 to generate three-dimensional RGB RAW data 128 of the image. Furthermore, when generating the RGB RAW data 128, various correction algorithms 130, such as hot pixel correction, noise reduction, shading correction, and geometric correction, may additionally be performed. Subsequently, for example, a color space conversion 132 may be performed to generate RGB data 134 from the RGB RAW data 128. Furthermore, a tone mapping correction 136 may be performed to generate the final RGB data 138 from the RGB data 134. However, these algorithms may modify image information, e.g., image pixel information, in a non-linear manner and thus may modify the image information to be unsuitable for a measurement task, such as performing an analyte measurement. In particular, the steps of color space conversion 132 and tone mapping correction 136 may result in, e.g., undesirable color mixing and the introduction of non-linearities into the image data. Thus, not all mobile devices 112 may be suitable for performing analyte measurements based on color reactions.

[0107] 3 illustrates an embodiment of a flow chart of a method for evaluating suitability of a mobile device 112 having at least one camera 114. The method for evaluating suitability of a mobile device 112, also referred to as a suitability method, includes a step of evaluating a) (denoted by reference numeral 140) the ability of the mobile device 112 to have one or more relevant settings of the mobile device 112 controlled by a user's software running on the mobile device 112, the relevant settings being related to image raw data processing steps performed by the mobile device 112, the relevant settings including at least one of color space conversion 132 and tone mapping correction 136. Furthermore, the suitability method may include a branch point 142 indicating a conditional query, such as deciding between a first branch 144 indicating that the relevant settings of the mobile device 112 can be controlled by a user's software running on the mobile device 112 ("y") and a second branch 146 indicating that the relevant settings of the mobile device 112 cannot be controlled ("n"). A first branch 144 indicates that the relevant settings of the mobile device 112 are controllable by the user's software, and thus if the evaluation in step a) indicates that the mobile device 112 may have one or more relevant settings controlled by the user's software, the branch may lead to step b) (denoted by reference 148) to provide at least one item of control information indicating that the mobile device 112 is suitable for performing analytical measurements. A second branch 146 indicates that the relevant settings of the mobile device 112 are not controllable by the user's software, and thus if the evaluation in step a) indicates that the mobile device may not have one or more relevant settings controlled by the user's software, the branch may lead to step c) (denoted by reference 150) to provide at least one item of control information indicating that the mobile device is unsuitable for performing analytical measurements.

[0108] In Fig. 4, an embodiment of a flow chart of a method for calibrating a mobile device 112 for performing analytical measurements based on color reactions is shown. The method for calibrating a mobile device 112 for performing analytical measurements, also referred to as a method of calibration, comprises a step i (indicated with reference 152) of evaluating the suitability of the mobile device 112 for performing analytical measurements using a suitability method as described above. Furthermore, the method of calibration may comprise a branch point 154 indicating a conditional query, such as deciding between a first branch 156 indicating that the mobile device 112 is "unsuitable" or "unsuitable" ("u") for performing analytical measurements, and a second branch 158 indicating that the mobile device 112 is "suitable" ("s") for performing analytical measurements. Thus, the first branch 156 may lead to step ii. If an item of control information (indicated with reference 160) indicates that the mobile device 112 is unsuitable for performing analytical measurements, the method is aborted. However, the second branch 158 may lead to step iii. If the item of control information (denoted 162) indicates that the mobile device is suitable for performing analytical measurements, the following steps are carried out:

[0109] (1) providing at least one reference object 118 having at least one predetermined reference color characteristic (designated 164); (2) capturing at least one reference image of at least a portion of the predetermined reference color characteristics using a camera (designated 166); (3) extracting at least one item of reference setting information relating to an associated setting of the reference image (shown at 168); and (4) storing (designated 170) at least one item of benchmarking information extracted in step (3);

[0110] 5, step ii of the method of calibration may further comprise at least one sub-step (denoted with reference 172) of informing a user of the mobile device 112 of the unsuitability of the mobile device 112 for performing analytical measurements, in particular by using one or more of the visual, auditory or tactile user interfaces of the mobile device 112. In particular, step iii of the method of calibration may further comprise at least one further sub-step (denoted with reference 174) of informing a user of the mobile device 112 of the suitability of the mobile device 112 for performing analytical measurements, in particular by using one or more of the visual, auditory or tactile user interfaces of the mobile device 112.

[0111] In Fig. 6, an embodiment of a flow chart of a method for performing an analytical measurement is shown. The method of performing an analytical measurement, also called the measurement method, comprises the following steps: A) Checking the suitability of the mobile device 112 (designated 176) - assessing the suitability of the mobile device 112, for example by using a method for assessing the suitability of the mobile device 112 as shown in FIG. 3; and - checking whether at least one item of reference setting information has been stored according to step (4) of the method for calibrating the mobile device 112, for example as shown in Figures 4 and 5; and verifying by performing at least one of B) prompting the user to perform one or more of the following: applying a sample of the bodily fluid, particularly a droplet, to the optical test strip (indicated by reference numeral 178); and / or confirming application of the sample of the bodily fluid, particularly a droplet, to the optical test strip; C) waiting a predetermined minimum time (indicated at 180); and D) capturing at least one image of an optical test strip having a sample of bodily fluid applied thereto (shown at 182), where at least one item of configuration information is used to control at least one of one or more associated settings of the mobile device.

[0112] In particular, step A) 176 may be performed at least once before step B) 178 may be performed. Further, as shown in Figure 7, the method of performing an analytical measurement, e.g., a method of measurement, may additionally include a step E) (shown at 184) of determining a concentration of at least one of the analytes in the sample of bodily fluid applied to the optical test strip.

[0113] FIG. 8 illustrates an embodiment of a diagram showing the relationship between actual and determined analyte concentrations illustrating the difference between using the general method and device and using the present method and device for performing analytical measurements. The analyte referred to in FIG. 8 is blood glucose, and thus the diagram illustrates blood glucose concentration. Specifically, the diagram illustrated in FIG. 8 illustrates the relationship between actual blood glucose levels (c) and determined blood glucose levels (dBG). Two measurement series or sequences are shown. Data points of the first measurement sequence 186 are shown in the diagram using a "*" symbol and refer to the analyte concentration determined using the general method and device. Data points of the second measurement sequence 188 are shown in the diagram using a "·" symbol and refer to the analyte concentration determined using the present method and device, specifically the method and device disclosed herein. In particular, a comparison of the data points of the first measurement sequence 186 and the data points of the second measurement sequence 188 illustrates the improved accuracy when using the present method and device as opposed to using the general approach for determining blood glucose concentration. Specifically, as shown in the figures, lower variability in determined blood glucose levels can be achieved when using the present methods and devices.

[0114] Further, FIG. 8 shows regions A-E of the error grid analysis, specifically regions A-E of the Parkes error grid, which quantifies the clinical accuracy of the determined blood glucose concentration compared to the actual blood glucose concentration. For further information on error grid analysis, Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL, "Evaluating clinical accuracy of systems for self-monitoring of blood glucose", Diabetes Care, Vol. 10, pp. 622-628, 1987, may be consulted. [Explanation of symbols]

[0115] 110 Kit 112 Mobile Devices 114 Camera 116 processors 118 Reference object 120 Optical Test Strips 122 RGGB Data 124 RGGB channel vectors 126 Demosaic 128 RGB RAW data 130 Correction Algorithm 132 Color Space Conversion 134 RGB data 136 Tone Mapping Correction 138 Final RGB data 140 Step a) 142 Branching Point 144 First Branch 146 Second Branch 148 Step b) 150 Step c) 152 Step i 154 Junction 156 First Branch 158 Second Branch 160 Step II 162 Step III 164 Steps(1) 166 Steps (2) 168 Steps(3) 170 Steps(4) 172 a substep of informing a user of the mobile device of the insuitability of the mobile device to perform analytical measurements. 174 a substep of informing a user of the mobile device of the suitability of the mobile device for performing analytical measurements. 176 Step A) 178 Step B) 180 Step C) 182 Step D) 184 Step E) 186 data points of the first measurement sequence 188 data points of the second measurement sequence

Claims

1. A method for assessing the suitability of a mobile device (112) for performing an analytical measurement based on a color reaction, said mobile device (112) having at least one camera (113), said method comprising: a) evaluating a capability of the mobile device (112) to control one or more relevant settings of the mobile device (112) by user software running on the mobile device (112), the relevant settings being related to an image raw data processing step to be performed by the mobile device (112), the relevant settings including at least one of a color space conversion (132) and a tone mapping conversion (136); b) if the evaluation in step a) indicates that the mobile device (112) is capable of controlling the one or more relevant settings by the user software, providing at least one item of control information, the at least one item of control information indicating that the mobile device (112) is suitable for performing the analytical measurement; c) if the evaluation in step a) indicates that the mobile device (112) is not capable of controlling the one or more associated settings by the user software, providing at least one item of control information, the at least one item of control information indicating that the mobile device (112) is unsuitable for performing the analytical measurement; and wherein the suitability is qualified or quantified by using one or more characteristics of the mobile device, wherein the characteristics of the mobile device are or include an ability of the mobile device to control the one or more associated settings.

2. The method of claim 1 , wherein the at least one item of control information comprises Boolean information regarding the relevant setting of the mobile device (112) being either "controllable" or "non-controllable."

3. A method of calibrating a mobile device (112) for performing analytical measurements based on a color reaction, the mobile device (112) having at least one camera (114), the method comprising: i. assessing the suitability of a mobile device (112) for performing said analytical measurement using the method of claim 1 or 2; ii. Aborting the method of calibrating the mobile device (112) if the item of control information indicates that the mobile device (112) is unsuitable for performing the analytical measurement; iii. if said item of control information indicates that said mobile device (112) is suitable to perform said analytical measurement; (1) providing at least one reference object (118) having at least one predetermined reference color characteristic; (2) capturing at least one reference image of at least a portion of the predetermined reference color characteristics using the camera (114); and (3) extracting at least one item of reference setting information related to the associated setting of the reference image; and (4) storing the at least one item of criteria setting information extracted in step (3); and and A method comprising:

4. 4. The method of claim 3, wherein the at least one reference object (118) having the at least one predetermined reference color characteristic is selected from the group consisting of a test strip (120), a test strip vial, a container, a package, and a reference color card.

5. The method according to claim 3 or 4, wherein said item of configuration information comprises at least one parameter relating to at least one of a color space transformation (132) and a tone mapping transformation, in particular by using a tone mapping curve (136).

6. 1. A method for performing an analytical measurement based on a color reaction in an optical test strip (120) using a mobile device (112) having a camera, comprising: A) checking the suitability of the mobile device (112), - assessing the suitability of the mobile device (112) using a method according to any one of claims 1 to 5, which refers to a method for assessing the suitability of the mobile device (112); and - checking whether at least one item of reference setting information is stored, according to step (4) of the method for calibrating a mobile device (112) according to any one of claims 3 to 5, which refers to the method for calibrating a mobile device (112); and verifying by performing at least one of B) prompting the user to perform one or more of: applying a sample of the bodily fluid to the optical test strip (120); and confirming application of the sample of the bodily fluid to the optical test strip (120); C) waiting a predetermined minimum time; and D) capturing at least one image of the optical test strip (120) having the sample of the bodily fluid applied thereto, wherein the at least one item of configuration information is used to control at least one of the one or more associated settings of the mobile device (112); and A method comprising:

7. The method of claim 6 , wherein step A) is performed at least once before step B) is performed.

8. The method of claim 6 or 7, further comprising the step E) of determining a concentration of at least one analyte in the sample of bodily fluid applied to the optical test strip (120).

9. The method according to any one of claims 6 to 8, wherein method step C) comprises waiting for at least 5 seconds.

10. A compatibility computer program comprising computer executable instructions for carrying out the method of claim 1 or 2, which refers to a method for assessing the compatibility of a mobile device (112), when said program is executed on a computer or a computer network.

11. A calibration computer program comprising computer executable instructions for performing the method for calibrating a mobile device (112) according to any one of claims 3 to 5, when said program is executed on a computer or a computer network.

12. A measurement computer program comprising computer executable instructions for carrying out the method for performing analytical measurements based on color reactions according to any one of claims 6 to 9, when said program is executed on a computer or a computer network.

13. A mobile device (112) having at least one camera (114), the mobile device (112) comprising: - a method for assessing the suitability of a mobile device (112) for carrying out analytical measurements based on color reactions according to claim 1 or 2, which refers to the method for assessing the suitability of a mobile device (112), - a method for calibrating a mobile device (112) for carrying out analytical measurements based on color reactions according to any one of claims 3 to 9, 11 and 12, which refers to the method for calibrating a mobile device (112), and - a method for performing an analytical measurement based on a color reaction in an optical test strip (120) by using a mobile device (112) having a camera (114) according to any one of claims 6 to 9 and 12, referring to the method for performing an analytical measurement; A mobile device (112) having at least one processor (116) with software configured to execute one or more of the following:

14. 14. A kit (110) comprising the mobile device (112) of claim 13 and further comprising at least one reference object (118) having at least one predetermined reference color characteristic, the kit further comprising at least one optical test strip (120).

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