RU2823570C1 - Analytical measurement method - Google Patents

Abstract

FIELD: chemistry.

SUBSTANCE: group of inventions relates to an analytical measurement method based on a colour formation reaction in an optical test strip using a mobile device having a camera. Method of analytical measurement includes the following stages: a) providing an optical test strip having a test field without a physiological fluid sample applied thereon; b) obtaining, using the camera, at least one first image of at least a portion of the test field of the optical test strip without a physiological fluid sample applied thereon; c) applying a sample of physiological fluid to the test field of the optical test strip; d) obtaining, using the camera, at least one second image of at least part of the test field of the optical test strip with the sample applied thereon; and e) determining the value of the analytical measurement result using the first image and the second image of the optical test field of the optical test strip, e) wherein the mobile device provides an indication of where to obtain the second image so that the first and second images are obtained in similar local positions relative to at least one environmental object, wherein the environmental object is an object which has a fixed and/or unchanged position between obtaining the first and second images.

EFFECT: higher accuracy of measurements.

15 cl, 5 dwg

Description

Technical field

The present application relates to a method for performing an analytical measurement based on a color formation reaction in an optical test strip using a mobile device having a camera. The present invention also relates to a computer program and a computer readable storage medium with software for performing the method in accordance with the present invention. Furthermore, the present invention relates to a mobile device and an analytical measurement kit. The methods, computer programs, mobile devices and kits in accordance with the present invention can be used in medical diagnostics to, for example, qualitatively or quantitatively determine one or more analytes in one or more physiological fluids. However, other areas of application of the present invention are practically possible.

State of the art

In the field of medical diagnostics, in many cases it is necessary to detect one or more analytes in samples of physiological fluid, such as blood, interstitial fluid, urine, saliva or other types of physiological fluids. Examples of analytes to be determined are glucose, triglycerides, lactate, cholesterol, or other types of analytes typically present in these body fluids. Depending on the concentration and/or presence of the analyte, appropriate treatment can be selected if necessary. Without limiting the scope, the present invention can be specifically described in relation to blood glucose measurements. However, it should be noted that the present invention can also be applied to other types of analytical measurements using test elements.

Typically, devices and methods known to one skilled in the art employ test cells containing one or more test chemicals that, in the presence of the analyte to be determined, are capable of performing one or more detectable determination reactions, such as determination reactions determined by optically. By way of example, EP 0821234 A2 describes a diagnostic test carrier for the determination of an analyte in whole blood using a reagent system contained in the carrier, and a method for determining an analyte from whole blood using the diagnostic test carrier. The diagnostic test carrier includes a color forming reagent. The test field has a sample application side, where the blood sample is delivered, and a detection side, where an optically detectable change occurs as a result of the reaction of the analyte with the reagent system. In addition, the test field is designed in such a way that red blood cells contained in the sample do not reach the detection side. In addition, the test field includes a transparent film and first and second superimposed film layers deposited thereon, wherein the first layer on the transparent film scatters light significantly less when wet than the overlying second layer.

Regarding the test chemicals contained in the test elements, reference may be made to, 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. There are other types of test chemicals that can be used to practice the present invention.

In the case of analytical measurements, especially analytical measurements based on color reactions, one of the technical problems is to evaluate the color change that occurs as a result of the determination reaction. In addition to the use of specialized analytical devices such as portable glucose meters, the use of commonly available electronic devices such as smartphones and laptop computers has become increasingly popular in recent years. WO 2012/131386 A1 describes a testing device for performing an analysis, the testing device comprising: a container containing a reagent, the reagent reacting with an applied test sample by exhibiting a color or pattern change; a portable device, such as a mobile phone or laptop computer, comprising a processor and an imaging device, wherein the processor is configured to process data received by the imaging device and output a test result for the applied test sample. In addition, software applications for use with smartphones are available for download, such as ACCU-CHEK® SugarView App from Roche Diabetes Care GmbH, Germany, available at https://www.accu-chek-sugarview.com.

Unlike laboratory measurements and measurements made using dedicated analytical measurement devices, when using mobile computing devices such as smartphones, various influences must be taken into account. By way of example, lighting conditions, location, vibration or other more or less uncontrollable conditions should be taken into account. In the field of mobile computing device technology, various technical approaches have been developed in recent years to improve image recognition and obtain additional information, for example, about unknown geometric parameters of the installation.

Thus, by way of example, US Pat. No. 9,691,152 B1 discloses ways to minimize variations in the height of a camera of a computing device when estimating the distance to objects represented in image data captured by the camera. For example, the front-facing camera of a computing device can be used to capture a real-time image of the user. The application can analyze image data to find the user's facial features in order to match the user with the computing device. As the position and/orientation of the device changes relative to the user, the image data can be analyzed to determine whether the location of the user's feature representation matches the matched element. Once the feature is aligned with the matched element, the rear camera or another camera can obtain the second image data of the object. The second image data can be analyzed to determine a geometric relationship between the rear camera and the object, and the geometric relationship can be used to determine the distance of the object relative to the computing device.

Further, US 9,934,612 B2 discloses a method for determining the position of a camera relative to a real-world object for use in a generated/augmented reality application, which includes generating a first image using a camera capturing a real-world object, generating first orientation data from at least one orientation sensor associated with the camera, or from an algorithm that analyzes the first image with respect to finding and determining features indicating the orientation of the camera, extracting the distance of the camera from the real object, generating distance data indicating the extracted distance, determining the position of the camera relative to the system coordinates associated with a real object in a real environment, using distance data and first orientation data. The method can be implemented with lower processing requirements and/or higher processing speed in a mobile device, such as mobile phones having a display, a camera, and an orientation sensor.

US Pat. No. 9,667,860 B2 discloses a method, computer-readable medium, and apparatus for providing arrangement and position control of a camera. One method involves detecting an image captured on a capture device. The image is analyzed to identify objects and determine object attributes. Suggestions are provided for adjusting at least one position or setting the capture device according to rules based on image analysis. The adjustment of the capture device based on the provided suggestions is detected and used to obtain an adjusted image. The adjusted image is captured by the capture device.

Moreover, US 20110254860 A1 discloses a mobile device including a visual input device for receiving external visual information containing actual visual background information, and a processing device. The processing device is configured to associate the selected application with external visual information and to execute the selected application based on the external visual information and input information related to the user. A processing device for generating a visual output related to at least one virtual visual object in response to an application is further configured to provide the visual output to a projection device included in the mobile device such that the projection device will be configured to project said output. a visual signal relating to at least one virtual visual object on the visual background, thereby modifying said external visual information.

WO 2013103912 A1 discloses devices, methods and systems for visual transaction capture (“TVC”) that convert communication of mobile device location coordinates, real-time visual capture of reality, and capture of mixed gestures using TVC components into information related to the purchase of a product. real-time behavior-based purchasing notifications and electronic receipts. In one embodiment, the TVC receives user registration information from the user's mobile device when the user enters the store. The TVC retrieves the user ID based on the user's registration information and provides database access for the user's profile. The TVC determines the user's previous behavior pattern from the user's profile that is being accessed and receives real-time data about the user's in-store behavior from the user's mobile device.

US 2018/024049 A1 describes a method and colorimetric apparatus for performing a colorimetric analysis of a test fluid to assess associated physiological parameters. Images of the test strip at different heights are obtained using a calorimetric device, and based on the analysis of the resulting images, many geometric parameters corresponding to the test strip are determined. Based on a plurality of geometric parameters, an image resizing factor is determined, and resized images are generated based on the image resizing factor. After generating the resized images, calorimetric values corresponding to the resized images are determined, based on which the physiological parameters associated with the test fluid are estimated.

EP 1801568 A1 describes a method that involves placing a camera near a test strip to graphically determine a color indicator and a reference color area. The measured value is determined for the relative position between the camera and the strip and compared with the required value range. The camera is moved to reduce the deviation relative to the strip during the deviation between the measured value and the desired value. The image area assigned to the indicator is localized in the color image determined by the camera. The concentration of the analyte in the sample is determined using the reference value.

Despite the benefits associated with using mobile computing devices for analytical measurement, a number of technical challenges remain. In particular, it is necessary to improve and ensure the reliability and accuracy of measurements. The main challenge remains the presence and influence of changing environmental conditions, such as lighting conditions. Thus, measurement results may be highly dependent on installation conditions and/or background lighting and thus may vary from measurement to measurement, even under identical chemical or biochemical conditions. Additionally, measurement results may depend on the relative positioning of the lighting device and the camera of the mobile device, which, due to the vast number of different mobile devices available on the market, may vary between different types or models of mobile devices. These technical difficulties are further compounded by the fact that, typically, when performing an analytical measurement with optical test strips, at least two images must be taken and analyzed, with one image showing at least part of the test field without the sample applied to it, while at least one second image is obtained with the sample applied thereto, the acquisition of the second image typically occurring after a certain waiting time until the color formation reaction occurs. Since at least two images must be compared, and the test strip is typically processed and moved between the two images, measurement uncertainty increases further.

Problem to be solved

It is therefore desirable to provide methods and apparatuses that solve the aforementioned technical problems of analytical measurements using mobile devices, such as consumer electronics mobile devices, in particular, multifunctional mobile devices that are not designed for analytical measurements, such as smartphones or tablet computers. In particular, methods and devices must be proposed to ensure reliability and accuracy of measurements. The essence of the invention

This problem is solved by methods, computer programs, computer-readable storage media and devices with the features of independent claims. Advantageous embodiments, which can be implemented separately or in any arbitrary combinations, are given in the dependent claims.

Hereinafter, as used herein, the terms “have,” “contain,” or “include,” or any arbitrary grammatical variations thereof, are used in a non-exclusive manner. Thus, these terms can refer both to a situation in which, in addition to the feature represented by these terms, there are no other features in the object 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 contains B,” and “A includes B” can refer to both a situation in which, in addition to B, there is no other element in A (i.e., a situation in which A consists only and exclusively from B), and to a situation in which, in addition to B, object A contains one or more additional elements, such as element C, elements C and D, or even other elements.

In addition, 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 once or more than once will generally be used only once when presenting the corresponding feature or element. In the following, in most cases, when referring to a corresponding feature or element, the expressions “at least one” or “one or more” will not be repeated, although the corresponding feature or element may be present once or more than once .

Additionally, as used hereinafter, the terms “preferably”, “more preferably”, “especially”, “in particular”, “more particularly” or similar terms are used in conjunction with optional features, without limiting alternative possibilities. Accordingly, the features represented by these terms are optional features and are in no way intended to limit the scope of the claims. The present invention, as will be understood by one skilled in the art, can be implemented using alternative features. Likewise, the features represented by the expression “in an embodiment of the present invention” or similar expressions are intended to be used as optional features, without any limitation as to alternative embodiments of the present invention, without any limitation as to the scope of the present invention, and without any restrictions on the ability to combine the features so presented with other optional or optional features of the present invention.

A first aspect discloses a method for performing an analytical measurement based on a color formation reaction in an optical test strip using a mobile device having a camera. The method includes the following steps, which, for example, can be performed in this order. However, it should be noted that another order is possible. In addition, it is also possible to perform one or more steps of the method one or more times. In addition, it is possible to perform two or more steps of the method simultaneously or in an overlapping manner. The method may include additional method steps that are not shown.

Typically, the method includes the following steps:

a) providing an optical test strip having a test field without a sample applied to it;

b) obtaining, using the camera, at least one first image of at least a portion of the test field of the optical test strip without a sample applied thereto;

c) applying a sample of physiological fluid to the test field of the optical test strip;

d) obtaining, using the camera, at least one second image of at least part of the test field of the optical test strip with a sample of physiological fluid applied to it; And

e) determining the value of the analytical measurement result using the first and second images of the optical test field of the optical test strip,

f) wherein the mobile device provides an indication of where to obtain the second image such that the first and second images are obtained at similar local positions relative to the at least one environmental object.

Herein, in particular, method step e) can be performed before or during method step d) and the remaining method steps, in particular, can be performed in this order. However, as indicated above, a different order is also possible, in particular for steps a) to e) of the method.

As used herein, the term “analytical measurement” is a broad term and its common and traditional understanding should be understood by one skilled in the art and should not be limited to a specialized or individual understanding. The term may specifically refer, without limitation, to the quantitative and/or qualitative determination of at least one analyte in an arbitrary sample. The sample contains a body fluid such as blood, interstitial fluid, urine, saliva, or other types of body fluids. The result of an analytical measurement, for example, may be the concentration of the analyte and/or the presence or absence of the analyte to be determined. Specifically, by way of example, the analytical measurement may be a blood glucose measurement, so the result of the analytical measurement may be, for example, a blood glucose concentration. In particular, the value of an analytical measurement result can be determined by the analytical measurement. As used herein, the term “analytical measurement result value” is a broad term and its common and traditional understanding should be understood by one skilled in the art and should not be limited to special or individual understanding. The term may specifically refer, without limitation, to a numerical designation of the concentration of an analyte in a sample.

The at least one analyte, for example, may be or may contain one or more specific chemical compounds and/or other parameters. As an example, one or more analytes that are involved in metabolism, such as blood glucose, can be determined. Additionally or alternatively, other types of analytes or parameters, such as pH value, may be determined. In particular, the at least one sample may be or may contain at least one physiological fluid, such as blood, interstitial fluid, urine, saliva, or the like. However, other types of samples, such as water, may additionally or alternatively be used.

The analytical measurement may in particular be an analytical measurement involving a change in at least one optical property of the optical test strip, which change may be measured or determined visually using a camera. In particular, the analytical measurement may be or may include a color formation reaction in the presence of at least one analyte to be determined. As used herein, the term “color formation reaction” is a broad term and its common and conventional understanding should be understood by one skilled in the art and should not be limited to a specialized or individual understanding. The term in particular may refer, without limitation, to a chemical, biological or physical reaction during which the color, in particular the reflectance of at least one element involved in the reaction, changes as the reaction proceeds.

As used herein, the term “optical test strip” is a broad term and its common and traditional understanding should be understood by one skilled in the art and should not be limited to a specialized or individual understanding. In particular, the term may refer, without limitation, to an arbitrary element or device comprising at least one strip-shaped carrier with at least one test field applied thereto or integrated therein, the element being configured to conduct a change detection reaction colors. An optical test strip may also be called a test strip or test cell. The optical test strip, in particular, may have a test field containing at least one test chemical for determining at least one analyte. An optical test strip, for example, may comprise at least one substrate, such as at least one carrier, with at least one test field applied or integrated therein. In particular, the optical test strip may further comprise at least one white region, such as a white field, in particular in the immediate vicinity of the test field, for example, enclosing or surrounding the test field. The white area may be a separate field independently located on the substrate or media. However, additionally or alternatively, the substrate or carrier itself may be or may contain a white area. These test strips are generally widely used and available. One test strip may contain one test field or a combination of test fields containing identical or different test chemicals.

As used hereinafter, the term “test field” is a broad term and its common and conventional understanding should be understood by one skilled in the art and should not be limited to a specialized or individual understanding. The term may specifically refer to, without limitation, a coherent amount of a test chemical, such as a field, such as a circular, polygonal or rectangular shaped field, containing one or more layers of material, with at least one test field layer containing a test chemical. Chemical substance.

As used herein, the term “mobile device” is a broad term and its common and traditional understanding should be understood by one skilled in the art and should not be limited to a specialized or individual understanding. The term may specifically refer, without limitation, to a mobile electronics device, more particularly to a mobile communications device such as a cell phone or smartphone. Additionally or alternatively, as will be described in more detail below, a mobile device may also refer to a tablet computer or other type of laptop computer comprising at least one camera.

As used herein, the term “camera” is a broad term and its common and traditional understanding should be understood by one skilled in the art and should not be limited to a specialized or individual understanding. The term may specifically refer, without limitation, to a device comprising at least one imaging element configured to record or obtain spatially resolved one-dimensional, two-dimensional or even three-dimensional optical data or information. As an example, the camera may include at least one camera chip, such as at least one charge-coupled device (CCD) chip and/or at least one complementary metal oxide semiconductor (CMOS) chip, configured to recording images. As used herein, without limitation, the term "image" may specifically refer to data recorded by a camera, such as a collection of electronic readings from an imaging device, such as pixels on a camera chip.

Said camera, in addition to at least one camera chip or imaging chip, may contain additional elements, such as one or more optical elements, such as one or more lenses. By way of example, the camera may be a fixed focal length camera including at least one lens that is steadily adjusted relative to the camera. However, as an alternative, the camera may also include one or more adjustable lenses, which can be adjusted automatically or manually. In particular, the invention should be applicable to cameras that are typically used in mobile communication devices, such as portable computers such as laptops, tablets or, in particular, cell phones such as smartphones. Thus, in particular, the camera can be part of a mobile device which, in addition to at least one camera, contains one or more data processing devices, such as one or more data processors. However, it is practically possible to use other cameras.

In particular, the camera may be a color camera. Thus, for example, for each pixel, color information, such as color values for the three colors of the red, green, blue (R, G, B) palette, can be provided or generated. It is also practicable to have a larger number of color values, for example four colors for each pixel, for example R, G, G, B. Color cameras are generally known to one 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 ( IN). For each of the pixels, eg R, G, B, values may be recorded by the pixels, eg digital values ranging from 0 to 255, depending on the intensity of the corresponding color. Instead of using color triplets such as R, G, B as an example, quadruples such as R, G, G, B can be used. The color sensitivity of the pixels can be generated using color filters or the corresponding native sensitivity of the sensor elements used in camera pixels. These methods are generally known to one skilled in the art.

Each of steps b) and d) involves obtaining at least one image using a camera. The term “acquiring at least one image” refers to one or more of image formation, image recording, image reception, image acquisition. The term "acquiring at least one image" may include obtaining a single image and/or a collection of images, such as a sequence of images. For example, image acquisition may involve continuously recording a sequence of images, such as a video or film. Acquisition of the at least one image may be initiated by a user action or may be initiated automatically, for example, as soon as the presence of at least one object in the field of view and/or within a specified sector of the camera's field of view is automatically determined. These automatic image acquisition methods are known, for example, in the field of automatic barcode readers, for example from applications for automatic barcode reading. Acquisition of images may occur, for example, by receiving a stream or "live stream" of images using a camera, where one or more images, automatically or as a result of user interaction such as a button press, are stored and used as at least one first image or at least one second image, respectively. Reception of the images may be supported by a processor of the mobile device, and storage of the images may occur in a storage device of the mobile device.

In each of steps b) and d) at least one image of at least part of the test field is obtained using the camera. These images are referred to as "at least one first image" and "at least one second image", where the terms "first" and "second" are used for nomenclature purposes only, without ranking or numbering these images and without providing any advantage. The term "at least a portion of a test field" or "at least a portion of a given test field" in both cases refers to the fact that at least one portion of at least one test field must be visible in each of the images, the first and the second image may show different parts of at least one test field. In addition to at least one portion of the test field, in each case additional portions of the optical test strip may be visible, such as at least one portion of the test strip substrate.

In step b) at least one first image is obtained without a sample applied to the test field. This at least one first image is typically also called a "blank image", and in typical evaluation methods this image is used for reference purposes to account for color changes or other optical properties of the test field that are not associated with the sample or the analyte itself. The application of the sample in step c) can take place, for example, directly or indirectly, for example using at least one capillary element. At least one second image taken after the sample has been applied is generally also referred to as a "wet image", even though the sample may have already dried when the image is actually taken. The second image is typically obtained after waiting for at least a predetermined wait time, for example five seconds or more, to allow the detection reaction to occur.

Thus, for example, the method may include, between steps c) and d), waiting for at least a predetermined minimum amount of time. This predetermined minimum amount of time may in particular be sufficient for the detection reaction in the test strip to proceed. For example, the minimum amount of wait time may be at least 5 seconds.

In step c), the value of the analytical measurement result is determined using the first and second images of the optical test field of the optical test strip. The analytical measurement result value, for example, may be an indicator of the numerical value of the analytical measurement result, such as an indicator of the concentration of at least one analyte in the sample, such as a blood glucose concentration. To determine the value of an analytical measurement result from the at least one first image and the at least one second image, for example, a predetermined or determined relationship between information obtained from the first and second images, such as color information or color change information, and may at least one analytical measurement result value is obtained. This predetermined or definable relationship may, for example, be stored in a storage device of the mobile device and/or in a processor of the mobile device. For example, the processor may be configured in software to obtain at least one element of information from the first and second images, such as at least one chromaticity coordinate, and to apply a specified or definable relationship to the at least one element of information. Said correlation, for example a lookup function, lookup table or lookup table, can be determined, for example, empirically and can, for example, be stored in at least one storage device of the mobile device, for example by software, in particular an application downloaded from an application store , or the like For example, to obtain at least one piece of information, the processor may be programmed to recognize, preferably automatically, such as through pattern recognition and/or other algorithms, a test field or at least one portion of a test field in the images. Therefore, the processor may be programmed to determine at least one element of information, such as one or more chromaticity coordinates. The corresponding at least one information element obtained from the blank image can be used for normalization, for example, by dividing the at least one information element obtained from the wet image by at least one information element obtained from the corresponding blank image, or by subtracting at least one information element obtained from the wet image from at least one information element obtained from the blank image, or vice versa. It is practically possible to use other normalization methods. Said correlation, for example a lookup function, lookup table or lookup table, can be determined, for example, empirically and can, for example, be stored in at least one storage device of the mobile device, for example by software, in particular an application downloaded from an application store , or the like

The method may further include the step of displaying the value of the analytical measurement result, for example, on the display of a mobile device. In this case, one or more numerical values indicating the value of the result of the analytical measurement can be indicated, for example on a display. Additionally or alternatively, a range of indications related to the analytical measurement result value may be specified, for example by indicating whether the analytical measurement result value is within or outside one or more specified ranges. For example, ranges such as high range, target range, or low range can be displayed without necessarily specifying a numerical value of the analytical measurement result value. Thus, the display does not have to be a numeric value display. It is practical to employ other means of displaying the value of the analytical measurement result, which display may be one or more of a visual display, an audio display, or a tactile display. Additionally or alternatively, the method may include storing the value of the analytical measurement result in at least one storage device of the mobile device. Again, additionally and alternatively, the method may further include transmitting the analytical measurement result value through at least one interface and/or through at least one data network, for example, to another computer, for example, for further evaluation.

As stated above, the method is performed such that an indication is provided by the mobile device where to obtain a second image such that the first and second images are acquired at similar local positions relative to the at least one environmental object.

As used herein, the term “environmental object,” as will also be explained in more detail below, can generally refer to any reference element and/or reference feature in the camera's field of view. The environmental object in particular may be suitable for defining a location and/or coordinate system in space and/or may be used as a location marker in the camera's field of view. The environmental object may in particular be an object which has a fixed and/or unchanging position between the acquisition of the first and second images. A fixed and/or unchanging position of an environmental object may particularly refer to a fixed and/or unchanging absolute position in space. The environmental object, in particular, may be an object that is not likely to change position between the acquisition of the first and second images. The environmental object may be or may contain the product or part thereof, such as a table on which the test strip is placed during measurement, or a part of a table, such as the surface structure of a table. The at least one environmental object may in particular comprise at least one of an article in the camera's field of view or a structural feature of the article in the camera's field of view. An environmental object or product may be tangible. The environmental object may be different from the test strip or parts of the test strip and from the camera mobile device or parts thereof.

To determine at least one environmental object, the method may include determining at least one environmental object in one or both of the first and second images. To this end, for example, the method may use image recognition, for example software automatic image recognition and/or image recognition using machine learning processes.

Therefore, the partial feature of feature e), indicating that the first and second images are acquired at the same local positions relative to the at least one environmental object, generally may refer to the fact that the at least one environmental object provides a system coordinates defining the first and/or second local positions. Thus, the local acquisition position of the first image may be determined and/or tracked relative to at least one environmental object, or the local acquisition position of the second image may be determined and/or tracked relative to at least one environmental object, or both. Additional illustrative embodiments will be described in more detail below.

Providing an indication is typically determined by method step e), wherein method step e) can typically be performed before or during method step d). In fact, method step e) may also be part of method step d), for example by acquiring or recording a real-time image or image stream using the camera of a mobile device and displaying this image stream or real-time image on the display of the mobile device wherein the mobile device provides an indication of where to acquire the second image such that the first and second images are acquired at the same local positions relative to the at least one environmental object. By way of example, and as will be discussed in more detail below, augmented reality can be used, for example, by adding guidance regarding where to obtain a second image to an image stream or real-time image displayed on a display.

As will be discussed in more detail below, the term "local position" as used herein and specifically used in the context of acquiring the first and second images, hereinafter also simply referred to as "position", is a broad term and its common and traditional understanding should be understood one skilled in the art and should not be limited to specialist or individual understanding. In particular, the term may refer, without limitation, to at least one piece of spatial parameter information related to one or more of a camera or test field at the time of image acquisition, for example, at and/or during image acquisition, wherein information about the at least one spatial parameter takes into account at least one environmental object, for example, by determining the position of the at least one environmental object in the camera's field of view. The at least one spatial parameter information element may relate to at least one of a spatial coordinate and/or a spatial orientation, for example, at least one spatial coordinate and/or at least one spatial orientation in at least one coordinate system, determined by at least one environmental object. The at least one spatial information element may refer to at least one of an absolute spatial information element or a relative spatial information element, for example, a relative spatial information element relating to a spatial relationship between the camera and the test field. Thus, for example, an absolute element of spatial information may be defined for a camera or test field in a coordinate system defined by at least one environmental object, and a relative element of spatial information may be defined for another one of the camera or test field. Alternatively, absolute elements of spatial parameter information may be determined for both of the camera and the test field in a coordinate system defined by at least one environmental object.

For example, local positions may include at least one of: an absolute position of the camera in space relative to at least one environmental object; the absolute position of the test field in space relative to at least one environmental object; a relative position between the camera and the test field in a coordinate system defined by at least one environmental object in the camera's field of view; orientation of the camera in space relative to at least one environmental object; orientation of the test field in space relative to at least one environmental object; a relative angular orientation between the camera and the test field in a coordinate system defined by at least one environmental object; a relative angular orientation between the camera and at least one environmental object in the camera's field of view; relative angular orientation between the test field and at least one environmental object in the camera's field of view; the relative angular orientation between the camera and the test field in a coordinate system defined by at least one environmental object in the camera's field of view.

As will also be set forth below in further illustrative detail, the term “same” as used herein and specifically used in the context of the local positions of the first and second images is a broad term and its common and conventional understanding will be understood by one skilled in the art and should not be limited to special or individual understanding. In particular, the term may refer, without limitation, to the fact that the first and second images are obtained at local positions that satisfy at least one predetermined or definable similarity criterion. Thus, for example, the local positions of the first and second images may be identical at least within a predetermined range of valid values, for example, a predetermined range of valid values stored in at least one storage device of the mobile device.

Thus, step e), i.e. providing an indication of where to obtain the second image such that the first and second images are acquired at the same local positions relative to the at least one environmental object may include providing at least one similarity criterion for the local positions when the first and second images are acquired. For example, the similarity criterion may be provided by a storage device of a mobile device having at least one similarity criterion stored therein.

The method may further include assessing whether the similarity criterion is satisfied. Thus, for example, the processor may be configured to estimate local positions at which the first and second images are acquired, wherein the position of the second image may be a current position in a method for acquiring the second image, for example, by obtaining a sequence of images or a stream of images in a mode real time, and the processor may be configured to determine whether the at least one similarity criterion is satisfied or not.

The at least one similarity criterion may particularly include at least one of an illumination similarity criterion and a local similarity criterion. Thus, for example, position similarity may refer to illumination similarity and/or local similarity similarity.

Evaluating whether the at least one similarity criterion is satisfied may in particular include comparing local positions when acquiring the first and second images, in particular comparing the deviation between the local positions with at least one tolerance threshold. Thus, for example, the processor may be configured to determine a deviation between a second local position and a first local position and may be configured to compare the deviation with at least one tolerance threshold, such as at least one tolerance threshold stored in at least one storage device of the mobile device.

The method may include determining a first local position when acquiring a first image and determining at least one second local position before or when acquiring a second image. Herein, one or both of the first and second local positions may be defined relative to at least one environmental object as set forth above, for example, in at least one coordinate system defined by the at least one environmental object. The method may include comparing the first and second local positions to determine whether the first and second images are acquired at the same local positions relative to the at least one environmental object. Thus, as set forth above, the processor may be configured to determine first and second local positions and compare the first and second local positions and/or their deviation with at least one threshold of acceptable values to determine whether a similarity criterion is satisfied or No.

The indication provided in step e), i.e. the indication provided by the mobile device of where to obtain the second image such that the first and second images are acquired at the same local positions relative to the at least one environmental object may particularly include a visual indication, more particularly a visual indication on the display of the mobile device. In particular, the guidance may be provided at least in part in the form of augmented reality on the display of a mobile device. The term "augmented reality" as used herein is a broad term and its common and traditional understanding should be understood by one skilled in the art and should not be limited to a specialized or individual understanding. In particular, the term may refer, without limitation, to a method of overlaying on a display a current image, a real-time image, or a stream of images of a subject with one or more elements of additional information, such as one or more visual indicators or the like. Thus, for example, the augmented reality in step e) can be provided by providing one or more arrows, frames or lines on the display indicating the preferred location of the camera and test strip. Additionally or alternatively, text may be displayed indicating in which direction the camera and/or test strip should be moved. Another augmented reality is possible.

In particular, the method may include determining and optionally storing at least one first element of location information relative to one or both of a camera position and a test field position when the first image is acquired. Thus, the position of the camera and/or test field at at least one time when the at least one first image is acquired can be determined and optionally stored. Various means are possible for determining the position in practice, which will be explained in more detail below. The at least one first element of location information may specifically include at least one of: an absolute position of the test field; absolute camera position. Herein, at least one first element of position information, for example, one or more of the absolute positions listed previously, may be defined relative to at least one environmental object, for example, in at least one coordinate system defined by at least at least one environmental object.

Determining the at least one first location information item may include analyzing an image of the at least one first image to detect at least one environmental object in the at least one first image. However, additionally or alternatively, other means of determining the at least one first element of location information may be used. Thus, for example, the at least one determination of the at least one first location information element may include the use of at least one mobile device sensor, in particular at least one of a location sensor, a gyro sensor, an optical sensor, an inclination sensor . Thus, one or more sensors of the mobile device itself may be used to determine the at least one first piece of location information.

As set forth above, visual means, such as image recognition means, can be used to determine at least one first element of location information. Thus, determining the at least one first element of location information, alternatively or in addition to using the at least one sensor of the mobile device, may include detecting at least one environmental object in the local environment.

The at least one first location information element may comprise information about the location of one or both of the camera and the test field relative to the at least one environmental object. Thus, for example, at least one environmental object may be used by the processor to define a coordinate system in space, and camera and/or test field location information may be defined in that coordinate system. Additionally or alternatively, the at least one first element of location information may simply relate to a spatial distance between one or more of the camera and test field and an environmental object.

Detecting at least one environmental object may in particular include image recognition on at least one image provided by the camera, more particularly on a still image during acquisition of the at least one first image and/or on a real-time image and /or image stream. Thus, for example, the first image itself may be used and may be subjected to image recognition, thereby recognizing at least one environmental object. Thus, for example, the processor may be configured to perform a histogram analysis of an image, such as a first image, to determine a characteristic element of an environmental object that can be used as a spatial reference.

The indication provided in step e), i.e. An indication provided by the mobile device of where to obtain the second image such that the first and second images are acquired at the same local positions relative to the at least one environmental object may in particular be provided based on the first location information element. Thus, the mobile device may be configured to record the position of the camera and/or test field when the first image is acquired, particularly in relation to at least one environmental object, to provide the user with directions as to where to obtain the second image. This indication may include visual indication, in particular visual indication on the display of a mobile device, more particularly visual indication at least in part using augmented reality on the display of a mobile device.

To enable the indication to be provided in step e), the method may include determining, in particular determining in real time, and optionally storing in a storage device of the mobile device, at least one second element of location information relative to one or both of the camera position and position test field and comparing the second location information item with the first location information item. Providing instructions at step e), i.e. indicating where to obtain the second image such that the first and second images are acquired at the same local positions relative to at least one environmental object may include providing an indication such that the second element of location information when acquiring the second image is, at least within a specified range of acceptable values, identical to the first element of location information.

Like the at least one first location information element, the at least one second location information element may include at least one of: an absolute position of the test field; absolute camera position; relative position between the camera and the test field, in particular at the time the second image is acquired and/or before the second image is acquired. Thus, the second position information element may be particularly defined as a flow of information prior to acquisition of the second image to provide guidance continuously or repeatedly so that the user can adjust the position of the test field and/or camera, respectively, prior to acquisition of the second image. Again, the at least one second element of location information may be defined relative to the at least one environmental object, for example, in at least one coordinate system defined by the at least one environmental object.

For determining the at least one second location information element, substantially the same options exist as for determining the at least one first location information element. Thus, for example, at least one internal sensor and/or image recognition means may be used, as explained above with respect to the at least one first element of location information. Thus, determining the at least one second location information item may include analyzing an image of the at least one second image to detect the at least one environmental object in the at least one second image. However, additionally or alternatively, other means of determining the at least one second element of location information may be used. Thus, for example, the at least one determination of the at least one second location information element may include the use of at least one mobile device sensor, in particular at least one of a location sensor, a gyro sensor, an optical sensor, an inclination sensor . Additionally or alternatively, as set forth above, determining the at least one second element of location information may include detecting at least one environmental object in the local environment, for example, the same environmental object as used to determine the at least one first location information element. The at least one second location information element may comprise information about the location of one or both of the camera and the test field relative to the at least one environmental object. Detecting the at least one environmental object may include recognizing an image from an image provided by the camera, more specifically from a real-time image. Thus, as set forth above, the at least one second element of position information may be determined continuously and/or repeatedly before and/or during acquisition of the at least one second image to allow a user to adjust the local position of one or both of the camera and the test image. fields. As set forth above, the at least one environmental object may contain at least one of an article in the camera's field of view or a structural feature of the article in the camera's field of view. Other options are also possible.

In the event that at least one environmental object is not in the camera's field of view in preparation for acquiring the at least one second image, the mobile device may provide the user with guidance, such as visual guidance, in particular using augmented reality, regarding how to move and/or reorient the mobile device to bring at least one environmental object into view. Thus, for example, upon acquiring a first image, the mobile device may determine at least one first local position relative to at least one environmental object visible in the camera's field of view. To obtain at least one second image, when the mobile phone detects that an environmental object is not visible, the user may be provided with an instruction indicating where to move and/or how to reorient the mobile device to, again, move the same at least one environmental object in the camera's field of view. Since in this case the environmental object is, firstly, inaccessible for determining the second local position, one or more internal and/or external sensors may be used to provide an indication. Thus, for example, one or more internal or external sensors may be used to detect whether the mobile device, after receiving the first image, has been moved and/or reoriented to provide an indication, for example, by indicating to the user that the mobile device should be moved back and/or reoriented to bring an environmental object into view. Once the at least one environmental object is in the camera's field of view, for example, image analysis may be applied to determine a second local position relative to the at least one environmental object.

The acquisition of the at least one second image may be one or both of user initiated or automatically initiated. In particular, acquisition may be automatically triggered as soon as the mobile device recognizes that the condition for acquiring a second image at the same local location as previously acquired for the first image is met. Thus, step d) can be initiated automatically when at least one of the camera and the test field is at a predetermined position, such that the first and second images are acquired at the same local positions relative to the at least one environmental object.

To obtain at least one first image, basically two options can be considered. Thus, the first image can be obtained at a generally arbitrary and not predetermined local position. As stated above, the local position when the first image is acquired may be determined and/or stored in a storage device. The acquisition of the first image, for example, can be initiated by the user, for example once the user has placed the test strip in a suitable location, for example on a table. As a second option, the local position of one or both of the test field and the camera when acquiring at least one first image may be determined by the mobile device, wherein an indication may be provided to the user in the same manner as in step e) as to where to obtain the first image. For possible variations of this indication, reference may be made to the description of step e). Thus, before performing step b), an indication may be provided by the mobile device where to obtain the first image. For example, the mobile device may detect a suitable environmental object in an image, such as in an image stream and/or in a real-time image, prior to acquiring the first image, and, when a suitable object is detected, may suggest a position close to that object to the user by providing appropriate instructions. This indication includes visual indication, in particular visual indication on the display of a mobile device, more particularly visual indication at least in part using augmented reality on the display of a mobile device.

The above mentioned options can also be used as possible alternatives, at the discretion of the user. Thus, for example, the user may override the suggestion provided by the mobile device and may apply a different local setting to obtain the first image.

The mobile device may be further configured to provide guidance to the user through one or more steps of a procedure. Thus, for example, instructions may be provided on the display to perform one or more actions. For example, user guidance for one or more of steps a) through d) may be provided in a visual format and/or through other means, such as audio narration.

For example, when applying the sample in step c) a user manual may be provided. Thus, step c) may include at least one of:

a mobile device prompting the user to apply a sample, in particular a drop, of physiological fluid onto the test field of the optical test strip;

mobile device prompting the user to confirm the application of a sample of physiological fluid to the test field of the optical test strip. As discussed above, the guidance may be provided by a mobile device providing appropriate guidance to the user in a visual format and/or through other means, such as acoustic means. For example, a user manual may be provided on the display.

Similarly, a user guide may be provided by the mobile device for performing step a). Thus, step a) may include at least one of:

a mobile device prompting the user to provide an optical test strip having a test field without a sample applied thereto;

a mobile device prompting the user to confirm the provision of an optical test strip having a test field without a sample applied thereto;

a mobile device that automatically detects, in particular by image recognition, whether a test strip is provided.

For hint options, you can refer to the description above. Thus, even the steps of providing an optical test strip and applying a sample to the test strip can be at least partially supported by the mobile device.

As set forth above, the method in one or more of the disclosed embodiments may be fully or partially computerized. Thus, in a further aspect, there is provided a computer program comprising instructions that, when executed by a mobile device having a camera, particularly a processor of the mobile device, cause the mobile device to perform a method described herein, more specifically at least steps b), d ), e) and f) of the method, wherein also steps a) and c) can be at least partially computerized or computer-assisted.

In particular, a computer program may be developed as an application. The application, for example, can be downloaded from a download server.

As commonly used herein, "computer" may refer to a device having at least one processor and optionally additional elements, such as one or more interfaces, one or more storage devices, one or more user interfaces, and the like. The term “processor” as used herein is a broad term and its common and traditional understanding should be understood by one skilled in the art and should not be limited to a specialized or individual understanding. In particular, the term may refer, without limitation, to arbitrary logic circuits configured to perform basic computer or system operations, and/or generally to a device that is configured to perform calculations or logical operations. In particular, the processor may be configured to process basic instructions that control a computer or system. For example, the processor may comprise at least one arithmetic logic unit (ALU), at least one floating point unit (FPU), such as a coprocessor or math coprocessor, a plurality of registers, in particular registers configured to providing operands to the ALU and storing the results of operations, and memory, such as L1 and L2 cache. In particular, the processor may be a multi-core processor. In particular, the processor may be or may comprise a central processing unit (CPU). Additionally or alternatively, the processor may be or may comprise a microprocessor, such that, in particular, elements of the processor may be contained in one discrete integrated circuit (IC). Additionally or alternatively, the processor may be or may include one or more application-specific integrated circuits (ASICs) and/or one or more field programmable gate arrays (FPGAs) or the like.

The computer program may further comprise instructions that, when executed by the mobile device, may further prompt the user to perform steps a) and/or c) or to confirm completion of steps a) and/or c). Regarding possible options, you can refer to the above description of the method.

In a further aspect, a computer-readable storage medium is disclosed, in particular a medium intended for non-transitory storage of data, comprising instructions that, when executed by a mobile device having a camera, in particular a processor of the mobile device, cause the mobile device to perform a method in accordance with the present invention, e.g. , in accordance with any of the embodiments disclosed above and/or in accordance with any of the embodiments disclosed in detail below. In particular, as set out above, at least steps b), d), e) and f) may be performed, wherein also one or both of steps a) and c) may be at least partially computerized or at least with computer support as outlined above. Thus, as discussed above, the computer-readable storage medium may further comprise instructions that, when executed by the mobile device, further prompt the user to perform steps a) and/or c) or to confirm completion of steps a) and/or c).

As used herein, the terms “computer-readable storage medium” and “computer-readable storage medium” may specifically refer to media intended for long-term storage of data, such as hardware storage media containing computer-executable instructions stored thereon. The computer-readable storage medium or data storage medium may in particular be or contain a data storage medium such as a random access memory (RAM) and/or a read only memory (ROM).

The computer program may also be implemented as a computer software product. As used herein, the term “computer software product” may refer to the program as a marketable product. The product typically may exist in any format, such as a paper format or a computer-readable storage medium and/or a computer-readable storage medium. In particular, the computer program product may be transmitted over a data network.

In a further aspect, a mobile device for performing an analytical measurement is described. For definitions and embodiments of a mobile device, reference may be made to the above description of the method. The mobile device includes at least one camera and may include one or more processors. The mobile device is configured to perform at least steps b), d), e) and f) of a method for performing an analytical measurement in accordance with the present invention, for example, in accordance with any of the embodiments disclosed above and/or in accordance with any of embodiments disclosed in detail below. Thus, the processor of the mobile device may be software configurable to perform and/or control execution of the method of at least steps b), d), e) and f) of the method, wherein also steps a) and/or c) may at least at least partially controlled and/or supported by the processor as described above.

The mobile device may contain additional elements. Thus, for example, the mobile device may further comprise at least one illumination source configured to illuminate the test field. For example, the mobile device may include at least one LED. The processor may also be configured to control the light source, for example, during steps b) and/or d) of image acquisition.

As discussed above, the mobile device may include at least one processor programmed to control at least one of steps b), d), e) and f). For definitions and options related to processor design, reference may be made to the above description.

In a further aspect, a kit for performing an analytical measurement is disclosed. Set contains:

- at least one mobile device in accordance with any of the previous paragraphs relating to a mobile device; And

- at least one optical test strip having at least one test field.

The term “kit” as used herein is a broad term and its common and traditional understanding should be understood by one skilled in the art and should not be limited to a specialized or individual understanding. The term may specifically refer, without limitation, to an assembly of multiple components in which each of the components can function and be handled independently of each other, but the components of the assembly can interact to perform a common function.

The present invention, in any of the aspects described herein, may provide many advantages over known methods and devices of this type. Thus, in particular, the present invention can solve the above-mentioned technical problems. As stated above, smartphone-based methods typically require at least two images to be acquired, with at least one image acquired before sample application and at least one image acquired thereafter, which may be referred to as a "wet" or final image. . The present invention may enable the use of augmented reality to improve positioning during acquisition of the first and second images. In this way, the same or at least similar positioning of the test strip can be ensured during the acquisition of the first or blank image and the acquisition of at least one second or final image after application of the sample.

Generally, the present invention can greatly improve the measurement efficiency of analytical measurements. Thus, the optical analysis measurement performance of smartphone-based test strips can generally be highly dependent on the conditions under which images are acquired before and after sample application. Ideally, the conditions are the same for both images. Augmented reality can be used to guide the user to obtain both images under very similar conditions. In relation to positioning, mobile phone position sensors and/or image recognition techniques can be used to determine conditions to improve measurement efficiency.

There are several options. Thus, a predetermined position can be applied to obtain both a blank image and a final image. Additionally or alternatively, the blank image may be acquired generally at an arbitrary first local position, wherein the mobile device may determine and/or indicate the first local position and may later use the first local position to provide user guidance so as to guide the user to the correct position to obtain a second image.

To summarize and not exclude additional possible embodiments, the following embodiments can be envisaged:

Embodiment 1: A method for performing an analytical measurement based on a color formation reaction in an optical test strip using a mobile device having a camera, the method comprising:

a) providing an optical test strip having a test field without a physiological fluid sample applied to it;

b) obtaining, using the camera, at least one first image of at least a portion of the test field of the optical test strip without a physiological fluid sample applied to it;

c) applying a sample of physiological fluid to the test field of the optical test strip;

d) obtaining, using the camera, at least one second image of at least part of the test field of the optical test strip with a sample of physiological fluid applied to it; And

e) determining the value of the analytical measurement result using the first image (214) and the second image (222) of the optical test field of the optical test strip,

f) wherein the mobile device provides an indication of where to obtain the second image such that the first and second images are obtained at similar local positions relative to the at least one environmental object.

Embodiment 2: The method according to the previous embodiment, the method further comprising between steps c) and d) waiting for at least a predetermined minimum period of time.

Embodiment 3: The method according to the previous embodiment, wherein the minimum waiting time period is at least 5 seconds.

Embodiment 4: The method according to any of the previous embodiments, wherein the local positions include at least one of: an absolute position of the camera in space relative to at least one environmental object; the absolute position of the test field in space relative to at least one environmental object; a relative position between the camera and the test field in a coordinate system defined by at least one environmental object in the camera's field of view; orientation of the camera in space relative to at least one environmental object; orientation of the test field in space relative to at least one environmental object; a relative angular orientation between the camera and the test field in a coordinate system defined by at least one environmental object; a relative angular orientation between the camera and at least one environmental object in the camera's field of view; relative angular orientation between the test field and at least one environmental object in the camera's field of view; the relative angular orientation between the camera and the test field in a coordinate system defined by at least one environmental object in the camera's field of view.

Embodiment 5: A method according to any of the previous embodiments, wherein indicating where to obtain a second image such that the first and second images are obtained at the same local positions relative to at least one environmental object includes providing at least one similarity criterion for local positions when obtaining the first and second images.

Embodiment 6: A method according to the previous embodiment, the method including judging whether a similarity criterion is satisfied.

Embodiment 7: The method according to any of the previous two embodiments, wherein the at least one similarity criterion includes at least one of an illumination similarity criterion and a local similarity criterion.

Embodiment 8: Method according to any of the previous three embodiments, wherein the at least one similarity criterion includes a comparison of local positions when acquiring the first and second images, in particular, a comparison of the deviation between local positions with at least one threshold of acceptable values .

Embodiment 9: A method according to any of the previous embodiments, wherein the method includes determining a first local position when acquiring a first image and determining at least one second local position before or during acquisition of a second image, wherein the method includes comparing the first and second local positions to determine whether the first and second images are obtained at similar local positions relative to the at least one environmental object.

Embodiment 10: The method according to any of the previous embodiments, wherein the indication provided by the mobile device where to obtain the second image such that the first and second images are acquired at the same local positions relative to the at least one environmental object includes visual indication, in particular visual indication on the display of a mobile device.

Embodiment 11: A method according to any of the previous embodiments, wherein an indication provided by the mobile device where to obtain a second image such that the first and second images are acquired at similar local positions relative to the at least one environmental object is provided at least partially in the form of augmented reality on the display of a mobile device.

Embodiment 12: A method according to any of the previous embodiments, wherein the method includes determining and optionally storing at least one first element of position information relative to one or both of a camera position and a test field position when the first image is acquired.

Embodiment 13: The method according to the previous embodiment, wherein the at least one first position information element includes at least one of: an absolute position of the test field; absolute camera position.

Embodiment 14: Method according to any of the previous two embodiments, wherein determining at least one first element of location information includes using at least one mobile device sensor, in particular at least one of a location sensor, a gyro sensor , optical sensor, tilt angle sensor.

Embodiment 15: The method according to any of the previous three embodiments, wherein determining the at least one first location information element includes detecting at least one environmental object in the local environment, wherein the at least one first location information element contains information about the location of one or both of the camera and the test field relative to at least one environmental object.

Embodiment 16: The method according to the previous embodiment, wherein detecting at least one environmental object includes recognizing an image in an image provided by a camera, more specifically in a real-time image.

Embodiment 17: The method according to any of the previous two embodiments, wherein the at least one environmental object includes at least one of an article in the camera's field of view or a structural feature of the article in the camera's field of view.

Embodiment 18: The method according to any of the previous six embodiments, wherein an indication provided by the mobile device where to obtain a second image such that the first and second images are acquired at the same local positions relative to the at least one environmental object, provided based on the first element of location information.

Embodiment 19: The method according to the previous embodiment, wherein the guidance includes visual guidance, in particular visual guidance on the display of a mobile device, more particularly visual guidance at least in part using augmented reality on the display of a mobile device.

Embodiment 20: A method according to any of the previous two embodiments, wherein the method includes determining, in particular real-time determining, and optionally storing at least one second element of position information relative to one or both of a camera position and a test position fields and comparing the second location information item with the first location information item.

Embodiment 21: The method according to the previous embodiment, wherein providing an indication of where to obtain a second image such that the first and second images are obtained at the same local positions relative to at least one environmental object includes providing an indication in this manner such that the second location information element when acquiring the second image is, at least within a predetermined range of acceptable values, identical to the first location information element.

Embodiment 22: The method according to any of the previous two embodiments, wherein the at least one second position information element includes at least one of: an absolute position of the test field; absolute camera position.

Embodiment 23: A method according to any of the three previous embodiments, wherein determining the at least one second element of location information includes using at least one mobile device sensor, in particular at least one of a location sensor, a gyro sensor , optical sensor, tilt angle sensor.

Embodiment 24: A method according to any of the previous four embodiments, wherein determining the at least one second location information element includes detecting at least one environmental object in the local environment, in particular, the same environmental object as and used to determine at least one first element of location information, wherein the at least one second element of location information comprises information about the location of one or both of the camera and the test field relative to the at least one environmental object.

Embodiment 25: The method according to the previous embodiment, wherein detecting at least one environmental object includes recognizing an image in an image provided by a camera, more specifically in a real-time image.

Embodiment 26: The method according to any of the previous two embodiments, wherein the at least one environmental object includes at least one of an article in the camera's field of view or a structural feature of the article in the camera's field of view.

Embodiment 27: The method according to any of the previous six embodiments, wherein step d) is initiated automatically when at least one of the camera and the test field is at a predetermined position, such that the first and second images are obtained in the same local positions relative to at least one environmental object.

Embodiment 28: A method according to any of the previous embodiments, the method further comprising, before performing step b), providing the mobile device with an indication of where to obtain the first image.

Embodiment 29: The method according to the previous embodiment, wherein the guidance includes visual guidance, in particular visual guidance on the display of a mobile device, more particularly visual guidance at least in part using augmented reality on the display of a mobile device.

Embodiment 30: The method according to any of the previous embodiments, wherein step c) includes at least one of:

- a mobile device that prompts the user to apply a sample, in particular a drop, of physiological fluid onto the test field of the optical test strip;

- a mobile device that prompts the user to confirm the application of a sample of physiological fluid to the test field of the optical test strip.

Embodiment 31: The method according to any of the previous embodiments, wherein step c) includes at least one of:

- a mobile device prompting the user to provide an optical test strip having a test field without a sample applied to it;

- a mobile device prompting the user to confirm the provision of an optical test strip having a test field without a sample applied to it;

- a mobile device that automatically detects, in particular by image recognition, whether a test strip is provided.

Embodiment 32: A computer program comprising instructions that, when executed by a mobile device having a camera, particularly a processor of the mobile device, cause the mobile device to execute a method in accordance with any of the previous embodiments, more specifically at least steps b), d ), e) and f) the method in accordance with any of the previous embodiments.

Embodiment 33: A computer program according to the previous embodiment, wherein the computer program further comprises instructions that, upon execution of the program by the mobile device, further prompt the user to perform steps a) and/or c) or to confirm execution of steps a) and/or c).

Embodiment 34: A computer-readable storage medium, in particular a medium intended for long-term storage of data, comprising instructions that, when executed by a mobile device having a camera, in particular a processor of the mobile device, cause the mobile device to perform a method in accordance with any of the previous embodiments implementing the method, more specifically at least steps b), d), e) and f) of the method in accordance with any of the previous embodiments of the method.

Embodiment 35: The computer-readable data storage medium according to the previous embodiment, wherein the data storage medium further comprises instructions that, when executed by the mobile device, further prompt the user to perform steps a) and/or c) or confirm execution of steps a) and /or in).

Embodiment 36: A mobile device for performing an analytical measurement, wherein the mobile device has at least one camera, wherein the mobile device is configured to perform at least steps b), d), e) and f) of a method for performing an analytical measurement according to with any of the previous embodiments relating to a method for performing an analytical measurement.

Embodiment 37: The mobile device according to the previous embodiment, wherein the mobile device further comprises at least one illumination source configured to illuminate the test field.

Embodiment 38: A mobile device in accordance with any of the previous two embodiments, wherein the mobile device comprises at least one processor programmed to control at least one of steps b), d), e) and f).

Embodiment 39: An analytical measurement kit, the kit comprising:

- at least one mobile device in accordance with any of the previous embodiments relating to a mobile device; And

- at least one optical test strip having at least one test field.

Brief description of graphic materials

Additional optional features and embodiments will be set forth in more detail in the following description of embodiments, preferably in conjunction with dependent claims. In this case, the corresponding optional features can be implemented separately, as well as in any arbitrary possible combination, which will be clear to a person skilled in the art. The scope of the present invention is not limited to the preferred embodiments. Embodiments are shown schematically in the figures. As used herein, identical reference numerals in these figures refer to identical or functionally comparable elements.

The figures show the following:

FIG. 1 is a perspective view of an embodiment of a kit and mobile device for performing an analytical measurement;

FIG. 2 is a flowchart of an embodiment of a method for performing an analytical measurement; FIG.

FIGS. 3 and 4 show by way of example the first and second images taken before and after application of the sample; And

Figure 5 shows comparative glucose measurements in

blood.

Detailed Description of Embodiments of the Invention

1 is a perspective view of an exemplary embodiment of an analytical measurement kit 110. Kit 110 includes a mobile device 112, such as a smartphone, and, in addition, at least one optical test strip 114, in this installation placed within the field of view 116 of the camera 118 of the mobile device 112.

Mobile device 112 may include, in addition to at least one camera 118, at least one processor 120 and at least one storage device 122. The mobile device 112 may further include at least one display 124, for example, for displaying a real-time image captured by the camera 118 and/or for displaying information to the user. Mobile device 112 may further include at least one lighting source 123, such as an LED or the like.

The optical test strip 114 may include at least one substrate 126, such as a flexible strip-shaped substrate. The optical test strip 114 further comprises at least one test field 128 deposited on a substrate, a test field 128 containing at least one test chemical for conducting a determination reaction with at least one analyte contained in the sample 130. The sample 130 may directly or indirectly applied to the test field 128, such as by applying a drop of physiological fluid to the test field 128 and/or to a capillary element to conduct sample 130 to the test field 128.

The mobile device 112 is configured, by appropriately programming the processor 120, to perform and/or support the method in accordance with the present invention, which will be described with reference to the exemplary embodiment shown in the block diagram of FIG. 2.

In the first step (step a)), indicated by reference numeral 210, an optical test strip 114 is provided. For example, the user may take an optical test strip from a test strip container. Step 210 may be supported by mobile device 112, for example, by prompting the user to provide optical test strip 114, such as by displaying a corresponding message on display 124. Additionally or alternatively, mobile device 112 may also prompt the user to confirm that optical test strip 114 is provided. , for example, in the field of view of 116 cameras. Again, additionally or alternatively, the mobile device 112 may also be configured to automatically detect, for example through image recognition means, that the optical test strip 114 is provided.

In an additional step (step b)), indicated by the reference numeral 212, the mobile device 112 obtains, using the camera 118, at least one first image 214 of at least a portion of the test field 128 of the optical test strip 114 without the sample 130 applied thereto. as symbolically depicted in Fig. 2. The first image 214 may be stored in the storage device 122 of the mobile device 112. The first image 214 may also be referred to as a “idle image,” and the first image 214 may comprise a single image or a series of images, such as a stream of images. The acquisition of the first image 214 may be initiated by the user and/or may be supported in whole or in part by the mobile device 112, for example, by automatically initiating an image acquisition upon recognition of the optical test strip 114 and/or the test field 128. For the acquisition of the first image 214, the optical test strip 114 can be placed by the user in an arbitrary position relative to the camera 118 and/or relative to at least one environmental object 132 in the field of view 116, which is symbolically depicted in FIG. Here, mobile device 112 may particularly be configured to determine a first local position upon acquisition of the first image 214, and optionally store the first local position in storage device 122. Additionally or alternatively, the mobile device 112 may also be configured to provide guidance to the user as to where to obtain the first image 214 by indicating, for example, a corresponding location on the display 124.

In an additional step (step c)), indicated by reference numeral 216, the body fluid sample 130 is directly or indirectly applied to the test field 128 of the optical test strip 114. Again, as in step 210, this sample application may not necessarily be supported by the mobile device 112. for example, by prompting the user to apply pattern 130 and/or by prompting the user to confirm that pattern 130 has been applied. Again, for example, appropriate instructions may be displayed on display 124. Additionally or alternatively, mobile device 112 may also be configured to automatically detect application of a sample.

After applying the sample at step 216, the method may include an appropriate wait time. For example, the wait time may be at least 5 seconds to allow the detection reaction to proceed. The timeout may be displayed on the display 124, and/or the mobile device 112 may be configured to prevent additional steps until the timeout has expired.

In an additional step (step e)), indicated by reference numeral 218, the mobile device 112 provides an indication to the user where to obtain or capture a second image of at least a portion of the test field 128 of the optical test strip 114 with the body fluid sample 130 applied thereto, such that such that the first and second images are acquired at the same local positions relative to at least one environmental object 132. Herein, for example, local positions may be determined using a coordinate system 134 defined by at least one environmental object 132 in FIG. 1. Local positions may include one or more of absolute positions of optical test strip 114, camera 118, or both, or relative positions. The term "position", as set forth above, can also include orientations, such as angular orientations. To perform step e), the mobile device 112, for example, may record and/or display in real time a stream of images of the field of view 116 and may provide, also on the display 124, augmented reality with instructions to the user as to where to position one or both of test field 128 and chamber 118. Exemplary embodiments will be shown below.

In an additional step (step d)), indicated by reference numeral 220 in FIG. 2, at least one second image, indicated by reference numeral 222, is obtained of at least a portion of the test field 128 of the optical test strip 114, with sample 130 applied thereto. physiological fluid. Again, this acquisition may be triggered automatically, for example, when mobile device 112 recognizes that camera 118 and/or test field 128 are correctly positioned such that, at least within a predetermined tolerance range, the first and second images 214, 222 were obtained in identical positions, i.e. in identical local positions relative to at least one environmental object 132, satisfying one or more specified similarity criteria.

In an additional step (step e)), indicated by the reference numeral 224, the mobile device 112 is configured to determine at least one analytical measurement result value using the first and second images 214 and 222 of the optical test field 128 of the optical test strip 114. In this document, one or more estimation algorithms may be applied by processor 120 to images 214 and 222. For example, processor 120 may obtain at least one chromaticity coordinate from each of images 214 and 222 to determine the color change between blank image 214 and final image 222. reaction-induced determination. Because of the color change, for example, using a predetermined correlation or calibration function or lookup table, the value of the analytical measurement result, for example, the concentration of at least one analyte of interest, can be determined. For example, the concentration of glucose in blood or interstitial fluid can be determined as the value of an analytical measurement result. There are other possibilities.

FIGS. 3 and 4 show real-time images displayed on the display 124 of the mobile device 112, including augmented reality. Herein, for example, FIG. 3 shows the situation when the first image 214 is acquired, while FIG. 4 shows a real-time image before the second image 222 is acquired. As can be seen, a plurality of environmental objects 132 are detected in the field of view 116 cameras 118, such as a computer keyboard on a table, a cube, a computer mouse, or just a table template, such as a wood texture. Environmental objects 132 may be used, as in FIG. 1, to determine local positions of test field 128 and/or camera 118, for example, using image recognition techniques. Additionally or alternatively, one or more sensors 136 of the mobile device 112 may be used to determine the first and/or second local positions.

As can be seen in FIG. 4, augmented reality may be used to provide an indication of where to obtain a second image 222 such that the first and second images 214, 222 are acquired at the same local positions relative to at least one environmental object 132. The augmented reality may include symbols, such as a "no parking" sign and arrow, as well as text, such as text containing instructions regarding necessary positional adjustments to test field 128 and/or camera 118.

Generally, as outlined above, two options can be considered. Thus, as a first option, the first image 214 may be acquired at an arbitrary first local position. The mobile device 112 may be configured to determine a first local position and store the first local position, for example, in a storage device 122. When the second image 222 is received by the mobile device 112, an indication is provided, for example using augmented reality as shown in FIG. 4, where to obtain the second image 222 such that the first and second images 214, 222 are acquired at the same local positions relative to at least one object 132 environment. As a second option, the mobile device 112 may already provide an indication of where to obtain the first image 214, for example using augmented reality shown in FIG. 4, and similarly also in relation to obtaining the second image 222.

Figure 5 shows measurement results that demonstrate the effect of controlling local positions to obtain a blank image and a final image. For these experiments, blood glucose measurements were made using optical test strip 114 and sample 130. Two different setups were used: In the first setup, designated by reference numeral 310, blank images or first images 214 and final images or second images 222 were acquired in identical local provisions. In the second setting, indicated by reference numeral 312, blank images or first images 214 were acquired at a common first local position, and final images or second images 222 were acquired at a common second local position, wherein the second local position was different from the first local position. For each setup, 10 measurements were taken, with blank images using a fresh 114 optical test strip (no sample applied), while for final images, a 114 optical test strip was used 3 days after application of the sample for demonstration purposes (test field of this strip had permanent optical properties different from a fresh optical test strip).

The measurement results are shown in Fig.5. In this case, the horizontal axis shows two different settings 310, 312. The vertical axis shows a specific analytical measurement result, in this case the blood glucose concentration c in mg/dL. The results are shown as boxplots for both setups 310, 312. As can be seen, a significant difference is observed between the correct or controlled setup 310 and the uncontrolled setup 312. This difference is believed to be mainly due to different lighting conditions at the first and second local positions. However, other impacts may also occur. This difference clearly demonstrates the advantage of the present invention, since acquiring the first and second images 214, 222 at the same local positions relative to at least one environmental object provides increased measurement reproducibility.

List of reference items

110 analytical measurement set

112 mobile device

114 optical test strip

116 field of view

118 Camera

120 Processor

122 storage device

123 light source

124 Display

126 Substrate

128 test field

130 Sample

132 environmental object

134 coordinate system

136 Sensor

210 optical test strip provision

212 obtaining the first image of the test field without a sample applied to it

214 first image

216 applying a sample of physiological fluid to the test field of an optical test strip

218 providing the mobile device with an indication of where to obtain a second image such that the first and second images are acquired at similar local positions relative to at least one environmental object

220 obtaining a second image of the test field with a sample of physiological fluid applied to it

222 second image

224 determination of the value of the result of an analytical measurement

310 first setting: blank image and final image obtained at identical local positions

312 second setting: blank image and final image obtained at different local positions

Claims (30)

1. A method of performing an analytical measurement based on a color formation reaction in an optical test strip (114), using a mobile device (112) having a camera (118), the method comprising: a) providing an optical test strip (114) having a test field (128) without a physiological fluid sample (130) applied thereto; b) obtaining, using a camera (118), at least one first image (214) of at least a part of the test field (128) of the optical test strip (114) without a physiological fluid sample (130) applied to it; c) applying a sample (130) of physiological fluid to the test field (128) of the optical test strip (114); d) obtaining, using a camera (118), at least one second image (222) of at least part of the test field (128) of the optical test strip (114) with the sample (130) applied thereto; And e) determining the value of the analytical measurement result using the first image (214) and the second image (222) of the optical test field (128) of the optical test strip (114), e) wherein the mobile device (112) provides an indication of where to obtain the second image (222) such that the first and second images (214, 222) are obtained at similar local positions relative to the at least one environmental object (132), wherein In this case, the environmental object (132) is an object that between the acquisition of the first (214) and second (222) images has a fixed and/or unchanging position. 2. The method of the previous claim, the method further comprising between steps c) and d) waiting for at least a predetermined minimum period of time. 3. The method according to any of the previous paragraphs, wherein the local positions include at least one of: an absolute position of the camera (118) in space relative to at least one environmental object (132); the absolute position of the test field (128) in space relative to at least one environmental object (132); a relative position between the camera (118) and the test field (128) in a coordinate system defined by at least one environmental object (132) in the field of view of the camera (118); orientation of the camera (118) in space relative to at least one environmental object (132); orientation of the test field (128) in space relative to at least one environmental object (132); relative angular orientation between the camera (118) and the test field (128) in a coordinate system defined by at least one environmental object (132); the relative angular orientation between the camera (118) and at least one environmental object (132) in the field of view of the camera (118); the relative angular orientation between the test field (128) and at least one environmental object (132) in the field of view of the camera (118); relative angular orientation between the camera (118) and the test field (128) in a coordinate system defined by at least one environmental object (132) in the field of view of the camera (118). 4. A method as claimed in any one of the preceding claims, wherein the method includes determining a first local position when acquiring a first image (214) and determining at least one second local position before or during acquisition of a second image (222), wherein the method includes comparing the first and second local positions to determine whether the first and second images (214, 222) are obtained at similar local positions relative to the at least one environmental object. 5. The method as claimed in any one of the preceding claims, wherein an indication provided by the mobile device (112) of where to obtain the second image (222) such that the first and second images (214, 222) are obtained at similar local positions relative to at least one environmental object is provided at least in part as augmented reality on the display of a mobile device (112). 6. A method as claimed in any one of the preceding claims, wherein the method includes determining at least one first element of position information relative to one or both of a camera position (118) and a test field position (128) when the first image (214) is acquired. 7. The method of the preceding claim, wherein the determination of the at least one first location information element includes at least one of: - using at least one sensor (136) of the mobile device (112); - determining at least one environmental object (132) from the local environment, wherein the at least one first element of location information includes information about the location of one or both of the camera (118) and the test field (128) relative to the at least one object (132) of the environment. 8. The method according to any of the previous two claims, wherein the method includes determining at least one second element of location information relative to one or both of the position of the camera (118) and the position of the test field (128) and comparing the second element of location information with the first element location information, wherein providing an indication of where to obtain a second image (222) such that the first and second images (214, 222) are acquired at similar local positions relative to the at least one environmental object includes providing an indication in such a manner that such that the second location information element upon acquisition of the second image (222) is, at least within a predetermined range of acceptable values, identical to the first location information element. 9. The method as claimed in any one of the preceding claims, wherein the method further includes, before performing step b), providing the mobile device (112) with an indication of where to obtain the first image (214). 10. The method according to any of the previous claims, wherein step c) includes at least one of: - a mobile device (112) prompting the user to apply a sample (130) of physiological fluid onto the test field (128) of the optical test strip (114); - a mobile device (112) prompting the user to confirm the application of a sample (130) of physiological fluid to the test field (128) of the optical test strip (114). 11. The method according to any of the previous paragraphs, in which the environmental object (132) includes a product or part thereof. 12. The method according to any of the previous claims, wherein step a) includes at least one of: - a mobile device (112) prompting the user to provide an optical test strip (114) having a test field (128) without a sample (130) applied to it; - a mobile device (112) prompting the user to confirm the provision of an optical test strip (114) having a test field (128) without a sample applied to it (130); - a mobile device (112) automatically determining whether an optical test strip (114) has been provided. 13. A computer-readable storage medium containing instructions that, when executed by a mobile device (112) having a camera (118), cause the mobile device (112) to perform at least steps b), d), e) and f) of the method of any of the previous points related to the method. 14. Mobile device (112) for performing an analytical measurement, wherein the mobile device (112) has at least one camera (118), wherein the mobile device (112) is configured to perform at least steps b), d), e ) and e) the method of carrying out the analytical measurement according to any of the previous paragraphs relating to the method of carrying out the analytical measurement. 15. A set (110) for performing an analytical measurement, wherein the set (110) contains: - at least one mobile device (112) according to any of the previous paragraphs relating to a mobile device (112); And - at least one optical test strip (114) having at least one test field (128).