Method for determining numerical analyte result values

Abstract

A computer-implemented method for determining a numerical analyte result value corresponding to the concentration of an analyte in a sample of a subject's body fluid applied to a reagent test area includes: (a) determining the numerical analyte result value based on an image of the reagent test area by using an algorithm that takes into account one or more parameters, each parameter adapted to take two or more values; (b) displaying the numerical analyte result value, and / or the corresponding analyte value range, and / or a corresponding message on a display device; and (c) automatically checking for available updated values ​​for one or more parameters on a remote server before performing step (a), and updating the corresponding parameter value taken into account in step (a) for each available updated value.

Description

[Technical Field]

[0001] The present application relates to a computer-implemented method for determining a numerical analyte result value corresponding to the concentration of an analyte in a sample of a subject's bodily fluid applied to a reagent test area, the method comprising the steps of: determining a numerical analyte result value based on an image of the reagent test area by using an algorithm that takes into account one or more parameters, each parameter adapted to take on two or more values; and displaying the numerical analyte result value, and / or an analyte value range of a preset analyte value range group corresponding to the numerical analyte result value, and / or a message corresponding to the corresponding numerical analyte result value or analyte value range on a display device. [Background technology]

[0002] In the field of medical diagnostics, one or more analytes must often be detected in a sample of bodily fluid, such as blood, interstitial fluid, urine, saliva, or other types of bodily fluid. Examples of analytes to be detected are glucose, triglycerides, lactate, cholesterol, or other types of analytes typically present in these bodily fluids. Depending on the concentration and / or presence of the analyte, appropriate processing may be selected as needed. Without narrowing the scope, the present invention will be specifically described with reference to blood glucose measurement. However, it should be noted that the present invention may also be used for other types of analytical measurements that use test elements with reagent test areas. In general, devices and methods known to those skilled in the art utilize test elements containing one or more test chemistries that can exhibit one or more detectable detection responses, such as optically detectable detection responses, in the presence of the analyte to be detected. For more information regarding these test chemistries, see, for example, J. Hoenes et al.: The Technology Behind Glucose Meters: Test Strips, Diabetes Technology & Therapeutics, Volume 10, Supplement 1, 2008, S-10 to S-26. Other types of test chemistries are possible and may be used to practice the present invention.

[0003] Typically, one or more optically detectable changes in the test chemistry, such as a color change in the reagent test area, are monitored. In analytical measurements based on such color reactions, one technical challenge is the evaluation of the color change that occurs. In addition to using dedicated analytical devices such as portable blood glucose meters, the use of commonly available electronic devices such as smartphones and portable computers has become increasingly common in recent years. Such a method for detecting analyte concentrations using an image of the reagent test area generated by a mobile device is known from EP 3,591,385. Another method for analyte concentration detection using a mobile device is disclosed in EP 3,978,909, in which the reagent test area is combined with a color reference card containing multiple different color reference fields with known reference color values ​​and / or gray fields within the field of view of the mobile device's camera, and the known reference values ​​are taken into account when determining the analyte concentration in the applied sample. The determination of the analyte concentration may be performed by the mobile device, and the necessary parameters, such as reference values, may be stored in the mobile device's internal data storage and / or received from a remote server prior to the determination process.

[0004] Alternatively, as disclosed in Chinese Patent Application Publication No. 113569678, for an automatic biochemical indicator detection method for pet urine using urine test strips, only image acquisition and result presentation are performed by a mobile device, and image processing and result value determination are performed by a remote server.

[0005] For the accuracy of image processing and determination of result values, it is important that all parameters used are up to date.

[0006] Therefore, it is desirable to provide a method and a device that addresses the above-mentioned technical challenges of analytical measurements using mobile devices. In particular, a method, a computer program, and a device should be proposed that are widely applicable to available mobile devices and are suitable for improving reliability and safety while allowing convenient handling for users. Summary of the Invention

[0007] 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. One aspect of the invention is to automatically check for available updated values ​​for one or more parameters before using said one or more parameters when determining a numerical analyte result value via an algorithm.

[0008] When used below, the terms "have," "comprise," or "include," or any grammatical variations thereof, are used in a non-exclusive manner. Thus, these terms may refer both to a 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 a situation in which one or more additional features are present. For example, the expressions "A has B," "A comprises B," and "A includes B" may both refer to a situation in which, apart from B, no other elements are present in A (i.e., a situation in which A consists solely and exclusively of B), and to a situation in which, apart from B, one or more further elements are present in entity A, such as element C, elements C and D, and even further elements.

[0009] Furthermore, it should be noted that the terms "at least one" or "one or more," or similar expressions, indicating that a feature or element may be present more than once, are typically used only once when introducing each feature or element. In the following, in most cases, when referring to each feature or element, the expressions "at least one" or "one or more" will not be repeated, despite the fact that each feature or element may be present more than once.

[0010] Furthermore, when used hereinafter, the terms "preferably," "more preferably," "particularly," "more particularly," "particularly," "more particularly," or similar terms are used in conjunction with optional features without limiting alternative possibilities. Features introduced by these terms are therefore optional features and are not intended to limit the scope of the claims in any way. The present invention may be implemented by using alternative features, as would be understood by one skilled in the art. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features without any limitations regarding alternative embodiments of the invention, without any limitations regarding the scope of the invention, and without any limitations regarding the possibility of combining the feature introduced in this manner with other optional or non-optional features of the invention.

[0011] In one aspect, a computer-implemented method for determining a numerical analyte result value corresponding to a concentration of an analyte in a sample of a subject's bodily fluid applied to a reagent test area includes: (a) determining the numerical analyte result value based on an image of the reagent test area by using an algorithm that considers one or more parameters, each parameter adapted to take on two or more values; (b) displaying the numerical analyte result value and / or an analyte value range of a pre-set analyte value range group corresponding to the numerical analyte result value, and / or a message corresponding to the numerical analyte result value or analyte value range; and (c) automatically checking for available updated values ​​for one or more parameters on a remote server before performing step (a), and for each available updated value, updating the corresponding parameter value considered in step (a).

[0012] In another aspect, a method for determining a numerical analyte result value corresponding to a concentration of an analyte in a sample of a subject's bodily fluid, applied to a reagent test area and determined using a mobile device having a processor, a communications interface, and a display device, further includes: (a) determining, by the processor, the numerical analyte result value based on an image of the reagent test area by using an algorithm that considers one or more parameters, where each parameter is adapted to take on two or more values; (b) displaying, by the display device, the numerical analyte result value and / or an analyte value range of a preset analyte value range group that corresponds to the numerical analyte result value and / or a message corresponding to the corresponding numerical analyte result value or analyte value range; and (c) automatically checking, by the processor via the communications interface, for available updated values ​​for one or more parameters on a remote server before performing step (a), and for each available updated value, updating, by the processor, the corresponding parameter value considered in step (a).

[0013] In another aspect, a non-transitory computer-readable storage medium includes instructions that, when processed by a computing device including a processor and a display device, configure the computing device to perform one or both of the aforementioned methods.

[0014] In another aspect, the computing device includes a processor, a display device, and a communications interface. The computing device also includes memory storing instructions that, when executed by the processor, configure the computing device to: determine, by the processor, a numerical analyte result value based on the image of the reagent test area by using an algorithm that considers one or more parameters, each parameter adapted to take on two or more values; display, by the display device, the numerical analyte result value and / or an analyte value range of a preset analyte value range group corresponding to the numerical analyte result value and / or a message corresponding to the corresponding numerical analyte result value or analyte value range; and automatically check, by the processor, for available updated values ​​for the one or more parameters on a remote server before performing step (a), and for each available updated value, update the corresponding parameter value considered in step (a).

[0015] Here, the term "computing device" refers to any electronic machine or data apparatus on which a program, such as a computer-implemented method, can be programmed or executed. In particular, a computing device may be a personal computer or a mobile device, such as a mobile phone or tablet, that includes one or more data processing devices, such as one or more data processors.

[0016] An "analyte" refers to a substance or chemical component of interest in an analytical procedure, also referred to as a constituent or chemical species. As an example, one or more analytes involved in metabolism, such as blood glucose, may be determined. Additionally or alternatively, other types of analytes or parameters, such as pH, may be determined. The analyte is contained in at least one sample of the subject's, i.e., patient's, bodily fluid and induces a color-developing reaction in test chemicals, also referred to as test reagents. To induce the reaction, the bodily fluid is applied to a reagent test area, which may be part of a test element, such as, but not limited to, a test strip, capable of undergoing a color-developing reaction upon contact with the respective analyte.

[0017] "Sample" refers to a limited quantity of something and is intended to represent a larger quantity similar to itself. "Body fluid" refers to any fluid in the body, such as blood, interstitial fluid, urine, or saliva. "Color development" refers to the color of a reagent test area resulting from a color reaction, i.e., a chemical, biological, or physical reaction in which the color, specifically the reflectance, of at least one element involved in the reaction changes depending on the concentration of an analyte involved in the reaction. As used herein, the term "color" is a broad term and can refer to any form of light reflected from a reagent test area, including color. In particular, the term "color" also refers to black, white, or gray, as well as red, green, or blue, etc. By color development, the concentration of an analyte in a body fluid may be determined by evaluating the color development, i.e., the color change due to the reaction.

[0018] The analyte concentration in the form of a numerical analyte result value is determined based on an image of the reagent test area, particularly the reagent test area, after the sample has been applied and a color reaction has occurred. In one embodiment, the image may be recorded by a camera, for example, by a camera provided on a mobile device. "Mobile device" refers to a mobile electronic device, such as a consumer electronics device, and specifically refers to a multi-purpose mobile device not dedicated to analytical measurements. A mobile device may also refer to a portable device having at least one processor, at least one display device, and optionally a camera. A mobile device may specifically refer to a mobile communication device, such as a mobile phone or smartphone. Additionally or alternatively, a mobile device may refer to a tablet computer or another type of portable computing device having a display device and optionally a camera. A "processor" refers to any device or combination of machines capable of processing data, i.e., generating a defined set of outputs for a set of inputs. For example, a processor may be a central processing unit (CPU), e.g., a microprocessor, and / or a multi-core processor.

[0019] A "camera" refers to a device having at least one imaging element configured to record or capture spatially resolved one-, two-, 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. An "image" refers to a set of spatially resolved optical data. Specifically, the term may relate to data recorded using a camera, such as multiple electronic readouts from an imaging device, such as the pixels of a camera chip. Furthermore, the term may refer to a color digital image, consisting of pixels containing color information, such as, but not limited to, at least three different colors, i.e., color values ​​for at least three different wavelengths of light. More color values, such as four color values ​​per pixel, e.g., R, G, G, B, are also possible.

[0020] Color cameras and images, particularly color digital images, are commonly known to those skilled in the art. Thus, as an example, a camera chip may be configured with three or more different color sensors, each with a plurality of color recording pixels, such as one pixel for red (R), one pixel for green (G), and one pixel for blue (B). For each R, G, B, etc. pixel, a value, such as a digital value ranging from 0 to 255, may be recorded depending on the intensity of the respective color, and the plurality of recorded pixels results in an image. For example, instead of using three colors, such as R, G, and B, four may be used, such as R, G, G, and B. The color sensitivity of a pixel may be generated by a color filter or by the appropriate inherent sensitivity of the sensor element used in the camera pixel. Those skilled in the art are generally familiar with these techniques.

[0021] The determined numerical analyte result value is then communicated to the user by displaying the numerical analyte result value itself, and / or the analyte value range, and / or a message corresponding to the determined numerical analyte result value. A corresponding or associated "message" refers to any displayable symbol capable of informing the user of the status of the analyte concentration, i.e., the determined numerical analyte result value. The message may include one or more of a range name, a corresponding value such as a range limit, a corresponding recommendation, an alarm, a symbol, etc. Communication may be achieved via a display device, where "display device" refers to any output device for communicating information to a user in visual or tactile form, such as, but not limited to, an LCD display, an LED display, or a tactile electronic display, which may be useful in communicating a result such as a numerical analyte result value.

[0022] Numerical analyte result values ​​corresponding to concentrations are determined based on the image using an algorithm, which typically considers several parameters. An "algorithm" generally refers to a finite sequence of precise instructions typically used to solve a specific class of problems or perform a calculation. Here, an algorithm is a sequence of instructions for processing an image and calculating a numerical analyte result value based on the image processing. Here, a "parameter" refers to a value used by the algorithm that can take on more than one value, i.e., can change over time. Changes may occur periodically, e.g., to adapt the components used to a particular production lot, or non-periodically, e.g., in a product care context to improve the method. For example, one or more parameters may each represent one or similar characteristics of the components used, such as the correlation between the color of the reagent test area and the concentration or concentration range of the analyte, or a safety margin value for reducing the area of ​​the reagent test area in the image considered for analyte concentration determination, or a reference color value of a color reference device, if used, or a fail-safe threshold. For example, if one of the components is changed, it may be beneficial or necessary to update the corresponding parameter, i.e., the parameter should take on a new value that is different from its previous value. It may also be advantageous to change the parameter based on knowledge from analysis of past numerical analyte result values ​​determined by the method and / or other user data. Updating generally allows for continuous improvement of the method.

[0023] The parameters are stored in a data storage, where "data storage" or memory refers to any type of digital data storage technology, such as, for example, random access memory, hard disk mass storage device, or removable media via a corresponding drive or the like, or any combination thereof. In one embodiment, a computing device, e.g., a mobile device, comprises the data storage.

[0024] An aspect of the invention is to automatically check whether updated values ​​of one or more parameters are available on the remote server, i.e., whether the remote server is reachable and whether any of the values ​​provided by the remote server are different from the current parameter values ​​described by the algorithm. If the remote server cannot be reached, i.e., if communication is not established and / or the remote server does not respond to the request sent under method step (c), no updated values ​​of any of the parameters are available and the current parameter values ​​are used in step (a).

[0025] A "remote server" refers to a piece of computer hardware or software that provides functionality to other programs or devices, often referred to as clients. For example, the remote server may be or include at least one cloud-based server, also referred to as a cloud-based server device. Other embodiments are possible. The remote server may communicate directly or indirectly with clients via a wireless network, e.g., the Internet or a local network, and / or via a wired connection. Additionally, the remote server may provide one or more functions, such as sharing data and / or performing computations for clients. In one embodiment, a connection to the remote server is established via a communications interface provided on a device executing a mobile device method, e.g., via an internal antenna or wireless access point. A "communications interface" or port for communications refers to any wired or wireless connection for exchanging data between two or more separate components, i.e., for sending and receiving data. The term communications interface may refer to any device configured to at least receive data, particularly, but not limited to, a wireless or wired interface for receiving data. The two-way communication interface may be established by any device configured to transmit and receive data, such as a transmitter, or by a receiving device and a transmitting device that are wholly or partially separate devices.

[0026] For each available update value, the value of the corresponding parameter is updated, i.e., the previous value is replaced with the available update value. The automatic checking and updating of parameters in step (c) is performed before step (a), and therefore before using one or more parameters when determining the numerical analyte result value via the algorithm.

[0027] The method ensures that all parameters used to determine the analyte concentration, i.e., the numerical analyte result value, have the most up-to-date values ​​possible, while also ensuring that the method is adapted to run on a local device without a network connection, if necessary. If a connection to a remote server can be established, updating the entire algorithm (e.g., the entire application or program, including the parameters) is avoided, resulting in resource-efficient updates. In particular, updates are limited to parameters for which updates are available.

[0028] For example, the method allows for reliable updating of one or more parameters provided by the remote server based on the determined numerical analyte result value, e.g., based on data analysis of multiple numerical analyte result values. The multiple values ​​may be selected based on a particular time, a particular user or group of users, etc. Alternatively or additionally, the one or more parameters on the remote server are updated based on information related to the color reference device, e.g., taking into account lot-specific variations in the color reference device.

[0029] The method may also include checking for available update values ​​by checking, for each parameter, a flag associated with the parameter on the remote server; checking at least one status change flag on the remote server, such as a single flag indicating any status changes for all parameters or a group of parameters; checking a status or flag register on the remote server, such as a list of all status changes; or comparing each parameter to a corresponding parameter on the remote server. Checking may also include any combination of the foregoing alternatives, for example, without limiting scope, where, for a first group of parameters, a status change flag associated with the group of parameters is checked and, for a second group of parameters, each parameter is compared to a corresponding parameter on the remote server. Checking may be performed by a processor, for example, by a processor of the mobile device.

[0030] "Flag" refers to a bit field or fields used to control or indicate the result of a particular operation. For example, a hash function may be used, which refers to any function that can be used to map data of any size to a fixed-size value, a so-called hash value, hash code, digest, hash flag, or simply a hash that is typically used to index a fixed-size hash table. Hashing is a computationally and space-efficient example of data access that can be used to check for available updated values.

[0031] The method may also include checking for available updates by automatically identifying an identification code of the color reference device in the image of the reagent test area and checking for available updates of one or more parameters linked to the identification code, thereby ensuring that all linked parameters, i.e., associated with the color reference device, are up to date. For example, the color reference device may include a color field with known reference color values, which may be slightly different or change, for example, for different production lots, thereby necessitating adaptation of the associated or linked parameters when a new or different color reference device is used. The automatic identification, like the checking, may be performed by a processor, the same processor, or a different processor, e.g., a processor of a mobile device.

[0032] A "color reference device" refers to any item having, disposed within, or disposed on at least one surface, such as having one or more fields with defined color levels, e.g., known reference color values. As an example, a color reference device may be a flat card comprising at least one substrate having one or more color reference fields disposed on and / or within at least one surface, each having known color coordinates or values. The fields may be two-dimensional structures, such as rectangles, squares, polygons, circles, and / or ellipses, with uniform color values, e.g., uniform gray values. The color values ​​of the fields may be known, for example, in terms of an RGB color model or an additive color model, i.e., with known values ​​of red, green, and blue. Specifically, the color values ​​may be one or more of predetermined, known, or determinable. For example, a gray value occurs when the red, green, and blue color values ​​or color channels of an image point / pixel have equal values. When a color reference device is used, the image forming the basis of step (a) of the method includes, i.e., encompasses, at least a portion of the reagent test area and at least a portion of the color reference device. Additionally, the known reference color values ​​are parameters used by the algorithm to increase the reliability of the determination of the color of the reagent test area within the image.

[0033] "Identification code" refers to an optical marker that identifies a color reference device, for example, uniquely or as part of a group, for example, a production lot, thereby making it possible to distinguish between different devices or groups of devices. The identification code may be, for example, a QR code or the like. The code may or may not include further information.

[0034] The method may also include the at least one parameter being a reference color value of a color field of a color reference device, a failsafe threshold, or a region of interest margin value.

[0035] "Region of interest margin value" or ROI margin value or test field margin refers to the value of a safety margin for reducing the region of interest in an image that is taken into account for determining analyte concentration. The region of interest may be, for example, the area of ​​the reagent test area or the area of ​​the color reference device, if used.

[0036] The method may also include, in step (c), if the connection to the remote server fails, displaying a message indicating that step (a) was performed using the current parameter values ​​and that the establishment of the connection to the remote server failed. The message may be displayed via any display device, for example, via a display device of the mobile device.

[0037] The method may also include that the method includes the step of capturing an image for step (a).

[0038] The computing device may also include a camera mounted on the computing device to record an image of the reagent testing area. Other technical features will be readily apparent to those skilled in the art from the following drawings, specifications, and claims.

[0039] The non-transitory computer-readable storage medium may also include steps (a) and (c) being performed by a processor and step (b) being performed by a display device.

[0040] The non-transitory computer-readable storage medium may also include an image of the reagent testing area recorded by a camera provided on the computing device. Other technical features will be readily apparent to those skilled in the art from the following drawings, specification, and claims. [Brief explanation of the drawings]

[0041] Further optional features and embodiments are disclosed in more detail in the following description of the embodiments, preferably in conjunction with the dependent claims, wherein 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 schematically in the figures.

[0042] To easily identify the description of any particular element or act, the most significant digit(s) of a reference number refers to the figure number in which that element is first introduced.

[0043] [Figure 1] 1 illustrates an aspect of the subject matter according to one embodiment. [Figure 2] 1 illustrates an aspect of the subject matter according to a further embodiment. [Figure 3] 1 illustrates an aspect of the subject matter according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0044] 1 illustrates a computer-implemented method 102 for determining a numerical analyte result value corresponding to the concentration of an analyte in a sample of a subject's bodily fluid. The determination of the numerical analyte result value corresponding to the analyte concentration is based on an image of a color reaction of a reagent test area to which the analyte sample has been applied. In one embodiment, the reagent test area is positioned adjacent to a color reference device, and images are taken from both the reagent test area and the color reference device, the color reference device including at least one area, field, etc., having a color with a known reference color value.

[0045] The numerical analyte result value is determined by using an algorithm that considers one or more parameters, and for each parameter, a value is locally stored and provided by local data storage. The parameters, all parameters, or some of the parameters may be specific to one or more components used in performing method 102, such as characteristics of the reagent in the reagent testing area or characteristics of the camera used to capture images of the reagent testing area. The parameters may be grouped into different groups, such as a group of periodically changing parameters and / or a group of component-specific parameters, particularly parameters specific to a particular production lot of a component(s). Another group may include parameters that do not periodically change, e.g., parameters of a more general nature. The other group may include parameters that are not dependent on any component or that do not change at an associated rate between production units of a component.

[0046] Method 102 may be triggered on a computing device, such as a mobile device, by a measurement request 104, for example, by a user initiating method 102 via an input device, such as a touch display of the mobile device, or by a user taking a photograph with a camera on the mobile device of a test element, such as a test strip, including a reagent test area and a one- or two-dimensional computer-readable code, such as a QR code or ArUco code, that includes a trigger message, such as a measurement request 104, to initiate method 102.

[0047] Method step (c) may be performed as a first step that includes establishing 106 communication with the remote server 108 and checking 110 whether there are updated values ​​for one or more of the parameters available on the remote server 108. Establishing 106 communication may include one-way or two-way communication via a communication interface of the mobile device, such as a transmitter. Establishing 106 communication may further include downloading information from the remote server 108, such as updated values ​​for the parameters, the availability of all updated parameters, or all available parameters.

[0048] Checking 110 for the availability of updated parameter values ​​may include comparing a group or all of the locally stored parameters with corresponding parameters on the remote server 108. Alternatively, the remote server 108 provides a register, list, or the like indicating some, group, or all parameters that have changed. In a further embodiment, the remote server 108 provides a list of one, more, or all parameters indicating the date the current parameter value was stored for the parameter on the remote server.

[0049] Method step (c) further includes updating 112 the locally stored values ​​of parameters for which updated parameter values ​​are available. After updating 112, or if checking 110 did not reveal updated parameter values ​​available on the remote server 108, after checking 110 at the step of performing the requested measurement 114, the numerical analyte result value is determined according to method steps (a) and (b), i.e., determining a numerical analyte result value based on an image of the reagent test area after application of the analyte sample by using an algorithm that takes into account one or more of the locally stored parameters, and displaying the numerical analyte result value and / or an analyte value range of a preset analyte value range group corresponding to the numerical analyte result value and / or a message corresponding to the corresponding numerical analyte result value or analyte value range on a display device.

[0050] In the illustrated embodiment, on the remote server 108, the parameters of the algorithm are stored in a current parameter group 116. In the illustrated embodiment, the current parameter group 116 includes the current values ​​of all parameters, i.e., all parameters considered by the method 102. Furthermore, the current parameter group 116 includes a subgroup of component-independent parameters 118. For parameters included in the current parameter group 116 but not the subgroup of component-independent parameters 118, checking 110 includes comparing each locally stored parameter value with the corresponding parameter value on the server. The subgroup of component-independent parameters 118 includes parameters that are independent, or at least largely independent, of any used components and therefore do not change regularly, such as due to component variations, at least within production tolerances. For the subgroup of component-independent parameters 118, a change flag indicates whether any of the parameters in the subgroup of component-independent parameters 118 have changed, and checking 110 includes checking the change flag. The parameter values ​​of the subgroup of constituent-independent parameters 118 are compared to the locally stored parameter values ​​only if the change flag indicates that at least one parameter value of the subgroup of constituent-independent parameters 118 has changed.

[0051] It is understood that in other embodiments, the parameters considered by the algorithm may similarly be grouped on the remote server 108 into a single group with no subgroups, or into a single group with two or more subgroups, or into two or more separate groups, etc. Furthermore, it is understood that in other embodiments, checking 110 may include identical steps for all parameters, or similarly may include any combination of the steps described for checking 110.

[0052] The values ​​of one or more of the subgroup of component-independent parameters 118 are changed based on, for example, efforts in the context of maintenance and product care 120. In the illustrated embodiment, maintenance and product care 120 includes data analysis 122, e.g., analysis of all or some of the numerical analyte result values ​​previously determined via method 102 by one, some, or all users. Additionally, maintenance and product care 120 includes user feedback 124. Based on maintenance and product care 120 and / or user feedback 124, one or more of the parameters of the subgroup of component-independent parameters 118 are improved in a step of parameter improvement 126; thus, based on analysis of the result data and / or feedback from users, etc., new values ​​are determined for one or more parameter(s) of the subgroup of component-independent parameters 118. In the illustrated embodiment, parameter values ​​are not directly and / or automatically updated within the subgroup of component-independent parameters 118 on the remote server 108, but a decision step 128 is incorporated that allows timing or other aspects, such as safety or approval issues, to be taken into account. If no safety or authorization or timing issues exist and a positive determination is provided in decision step 128, the corresponding parameter value or values ​​on the remote server 108 are updated with the improved parameter value(s) resulting from parameter improvement 126.

[0053] In FIG. 2, examples of parameters of a subgroup of component-independent parameters 118 and exemplary parameter refinements 126 are shown.

[0054] 2A shows an image portion 202a including a reagent test area 204a. In a first step, an area of ​​the image that will form the basis for the determination of a numerical analyte result value in step (a) of method 102 is determined as a region of interest 206a. In the embodiment shown, the region of interest 206a is circular and may be determined by image processing such as, for example, test field detection, using, for example, a circle detection algorithm.

[0055] In a next step, as shown in FIG. 2B , the region of interest 206b is reduced to exclude all areas surrounding the reagent test area 204a to increase the reliability of the method 102. As a result, the region of interest 206b includes, or covers, only the portion of the image portion 202b that shows the reagent test area 204b, and does not include, or does not cover, surrounding areas, such as portions of a color reference device. The region of interest 206 determined in the first step, indicated by the dotted line in FIG. 2B , is reduced by a region of interest margin 208 having a region of interest margin value to form a reduced region of interest 206b. The region of interest margin 208 is a parameter of a subgroup of component-independent parameters 118. The region of interest margin 208, i.e., the region of interest margin value, is, for example, an absolute or relative value that reduces the diameter of the region of interest 206b.

[0056] The region of interest margin 208 is a tool for reducing the image to an area within the boundary of the test field margin that contains color development information and is suitable for forming the basis for determining a numerical analyte result value. In the embodiment shown in FIG. 2B, the reduction also includes the boundary area of ​​the reagent test area 204b. This can be advantageous because the boundary area of ​​the reagent test area 204b may be shaded by surrounding components such as a color reference device, may not be completely wetted by the analyte, or may otherwise be affected. The resulting reduced region of interest 206b covers only a portion of the reagent test area 204b that can form a reliable basis for determining color development in step (a) of method 102 and therefore may be a good choice as a starting point. Therefore, the corresponding region of interest margin 208 can be used as the current parameter value for the region of interest margin 208 to reliably exclude any surrounding areas as well as the boundary area of ​​the reagent test area 204b.

[0057] 2C, for example, analysis of several images taken by one or different users during the data analysis 122 step may reveal, for example, that a reduced region of interest margin 210, i.e., reducing the current region of interest margin 208, still reliably excludes the shaded or otherwise affected border area and surroundings of the reagent test area 204c. Thus, a correspondingly increased region of interest 206c may be achieved without any adverse effects. In this case, the region of interest margin value on the remote server may be updated to correspond to the new reduced region of interest margin 210 and increased region of interest 206c.

[0058] In FIG. 3, an example of a parameter of the subgroup of component-independent parameters 118 and an exemplary parameter improvement 126 is shown, where the parameter is maximum tilt angle.

[0059] In the illustrated embodiment, a test strip 302 having a reagent test area 304 is provided surrounded by a color reference device 306. The reagent test area 304 is disposed within a window 308 of the color reference device 306. The color reference device 306 comprises position markers 310a-310d, a first type of color reference field 312 (e.g., a reference field having a different type of green reference color value), and a second type of color reference field 314 (e.g., a reference field having a different type of gray reference color value). In one embodiment, the position markers 310a-310d, one of the position markers 310a-310d, or more than one of the position markers 310a-310d also function as an identification code, i.e., additionally provide information regarding the location of the color reference device 306, and also include information for identifying the color reference device 306, such as information regarding the production lot, type, etc.

[0060] A computing device 316 including a camera 318 with a light source 320 and a processor 322 is provided to generate an image of the reagent test area 304 surrounded by the color reference device 306. The computing device may be a mobile device such as a mobile phone or tablet. The quality and / or reliability of the determination method 102 may be enhanced if the camera 318, i.e., the computing device 316, is aligned parallel to the test strip 302 and / or the color reference device 306 when the user positions the camera 318, i.e., the computing device 316, to capture the image. Thus, in the illustrated embodiment, for each image captured by the camera 318, a tilt angle 326 of the camera 318 of the computing device 316 about a longitudinal axis 324 of the computing device 316 is determined and compared to a maximum tilt angle as a predetermined threshold before the image is used in step (a) of the method 102. The tilt angle 326 is measured with respect to a plane parallel to the plane of the test strip 302 and / or the color reference device 306. If the determined tilt angle 326 exceeds the maximum tilt angle, the captured image is not used and the user is prompted to capture a new image.

[0061] The described safety / quality measures may result in an undesirable number of error messages, i.e., requests to take a new image, for some users who struggle to align and / or stabilize the camera 318 while recording an image. For these users, it may be beneficial to analyze, in a step such as data analysis 122, whether the determined tilt angles 326 that do not comply with the threshold for that user or a group of users or all users are typically close to a threshold, i.e., close to the maximum tilt angle. In that case, adapting the maximum tilt angle specifically for that user, i.e., slightly increasing the parameter value for the maximum tilt angle, may significantly reduce the number of error messages received by that user without significantly reducing the safety and / or quality of method 102. [Explanation of symbols]

[0062] 102 Method 104 Measurement request 106 Establishing Communications 108 Remote Server 110 Things to check 112 Update 114 Carrying out the required measurements 116 Current Parameter Group 118 Subgroup of Component-Independent Parameters 120 Maintenance and Product Care 122 Data Analysis 124 User Feedback 126 Parameter Improvement 128 Decision Steps 202a Image section 202b Image section 202c Image section 204a Reagent testing area 204b Reagent testing area 204c Reagent testing area 206a Area of ​​Interest 206b Area of ​​Interest 206c Area of ​​Interest 208 Region of Interest Margin 210 Reduced Region of Interest Margin 302 Test Strips 304 Reagent testing area 306 Color Reference Device 308 Window 310a Position Marker 310b Position marker 310c Position Marker 310d position marker 312 First type color reference field 314 Second type color reference field 316 Computing Devices 318 Camera 320 light source 322 processors 324 Longitudinal Axis 326 Tilt Angle

Claims

1. 1. A computer-implemented method for determining a numerical analyte result value corresponding to a concentration of an analyte in a sample of a subject's bodily fluid applied to a reagent test area (204a-204c, 304), comprising: (a) determining (114) a numerical analyte result value based on an image of said reagent test area (204a-204c, 304) by using an algorithm that takes into account one or more parameters, each parameter adapted to take on two or more values; (b) displaying the numerical analyte result value and / or an analyte value range of a preset analyte value range group corresponding to the numerical analyte result value and / or a message corresponding to the corresponding numerical analyte result value or analyte value range; (c) before performing step (a), automatically checking (110) for available updated values ​​for one or more of said parameters on a remote server (108), and for each available updated value, updating (112) the corresponding parameter value considered in step (a); 11. A computer-implemented method comprising:

2. Checking for available updated values ​​(110) checking, on the remote server for each parameter, a flag associated with the parameter; or checking at least one status change flag on said remote server; or Checking a status / flag register on the remote server; or comparing each parameter to a corresponding parameter on the remote server; The method of claim 1 , comprising:

3. 3. The method of claim 1, wherein checking for available updates (110) comprises automatically identifying an identification code of a color reference device (306) in the image of the reagent test area (204a-204c, 304) and checking for available updates of one or more parameters linked to the identification code.

4. The method of claim 1 , wherein the at least one parameter is a reference color value of a color field of a color reference device (306), a fail-safe threshold, or a region of interest margin value.

5. 5. The method of claim 1, wherein if in step (c) the connection to the remote server fails, step (a) is performed using current parameter values ​​and a message indicating the failure to establish a connection to the remote server (108) is displayed.

6. The method of claim 1 , wherein the method includes capturing the image for step (a).

7. 10. A non-transitory computer-readable storage medium comprising instructions that, when processed by a computing device (316) comprising a processor (322) and a display device, configure the computing device (316) to perform the method of any one of claims 1 to 6.

8. 8. The non-transitory computer-readable storage medium of claim 7, wherein steps (a) and (c) are performed by the processor (322) and step (b) is performed by the display device.

9. 9. The non-transitory computer-readable storage medium of claim 7 or 8, wherein the image of the reagent testing area (204a-204c, 304) is recorded by a camera (318) included in the computing device (316).

10. A computing device (316), a processor (322), a display device, and a communication interface; a memory that, when executed by the processor, (a) determining (114) by said processor (322) a numerical analyte result value based on the image of the reagent test area (204a-204c, 304) by using an algorithm that takes into account one or more parameters, each parameter adapted to take on two or more values; (b) displaying, by the display device, the numerical analyte result value and / or an analyte value range of a preset analyte value range group corresponding to the numerical analyte result value and / or a message corresponding to the corresponding numerical analyte result value or analyte value range on the display device; (c) before performing step (a), automatically checking (110) by said processor (322) for available updated values ​​for one or more of said parameters on a remote server (108), and for each available updated value, updating (112) the corresponding parameter value considered in step (a); a memory storing instructions for configuring the computing device (316) to: A computing device comprising:

11. The computing device of claim 10, wherein the computing device (316) comprises a camera (318) adapted to record the image of the reagent testing area (204a-204c, 304).

Images