RU2792659C2 - Methods and devices for carrying out analytical measurements - Google Patents

Abstract

FIELD: methods of analytical measurement.

SUBSTANCE: claimed group of inventions relates to a method for carrying out an analytical measurement based on the reaction of colour formation in an optical test strip using a mobile device with a camera, a computer program with software for performing this method, a mobile device and a kit for carrying out an analytical measurement that can be used in medical diagnostics, to qualitatively or quantitatively determine one or more analytes in one or more body fluids. The claimed method includes step a): providing an optical test strip (116) having a test field (118) without a sample applied to it; step b): acquisition of at least one first image of at least part of the test field (118) of the optical test strip (116) without a sample applied to it using a camera (114) with at least one camera image acquisition setting (114), in particular, with a set of camera image acquisition settings (114); step c): applying a sample, in particular a drop of physiological fluid, to the test field (118) of the optical test strip (116); step d): waiting for a predetermined minimum time; step e): obtaining at least one second image of at least a part of the test field (118) of the optical test strip (116) with a sample of physiological fluid applied to it using a camera (114) with one or more camera image acquisition settings (114), wherein the camera image acquisition settings (114) are the same as the camera image acquisition settings (114) used in step b); and step e): determining the value of the analytical measurement result using the first and second images of the optical test field (118) of the optical test strip (116), in particular by comparing at least two images.

EFFECT: increased accuracy of measurements and increased reliability, while providing ease of use for the user.

13 cl, 3 dwg

Description

FIELD OF TECHNOLOGY

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 with software for performing the method in accordance with the present invention. In addition, the present invention relates to a mobile device and a kit for performing an analytical measurement. 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 body fluids. However, other applications of the present invention are practically possible.

BACKGROUND OF THE INVENTION

In the field of medical diagnostics, it is often necessary to detect one or more analytes in bodily fluid samples such as blood, interstitial fluid, urine, saliva, or other types of bodily fluids. Examples of analytes to be determined are glucose, triglycerides, lactate, cholesterol, or other types of analytes commonly found in these body fluids. Depending on the concentration and/or presence of the analyte, an appropriate treatment can be selected if necessary. Without limiting the scope, the present invention may 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 those skilled in the art use test elements containing one or more test chemicals that, in the presence of the analyte to be determined, are capable of performing one or more detectable detection reactions, such as detection reactions determined by optically. As an example, EP 0 821 234 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 the determination of 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, to which 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 the erythrocytes contained in the sample do not reach the detection side. In addition, the test field includes a transparent film, as well as the first and second superimposed film layers deposited on it, while the first layer on the transparent film scatters light significantly less when wet than the overlying second layer.

With regard to test chemicals contained in 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 chemical that can be used to implement the present invention.

Typically, one or more optically detectable changes in the test chemical are monitored to determine the concentration of at least one analyte to be detected based on these changes. As a rule, variable lighting conditions must be taken into account. Thus, by way of example, EP 2916117 A1 discloses the quantification of the color of chemical test pads and the titration of analytes, which can be performed under various lighting conditions. In one embodiment, the lighting conditions under which the digital image is acquired are evaluated and used to select a set of reference colors for determining the titration. In another embodiment, multiple comparisons are made under different lighting conditions and the result with the highest level of confidence is selected to determine the titration.

In addition, WO 2014/037462 A1 discloses a method and apparatus for determining the application of a sample to an analytical test element in a photometric reflectance measuring device specifically for glucose measurements, which proposes the following measures: providing a disposable test element for applying a sample of physiological fluid, taking a sequence of readings reflectivity from the test element, monitor the change in reflectance readings against sample application conditions, adjust sample application conditions according to drift correction. A value for correcting for drift in reflectance readings caused by ambient measurement conditions such as humidity, temperature, or UV radiation can be taken into account in a predefined signal reduction or a predefined signal threshold to adjust sample application conditions.

For a simple and reliable control of suitability for the application of analytical elements, EP 1189064 A1 proposes to calculate the deviation of the indicator from the control value and the first standard reference value with respect to the first reference indicator, which is derived from the control reference value and the first standard reference value.

EP 0 953 149 B1 discloses a method for analyzing image data from a chemical diagnostic assay, in which an image result is obtained on a substrate. A method comprising the steps of: i) obtaining said image result on a substrate; and ii) forming an image of the image result with the image pickup device to obtain digital color image data corresponding to the color composition and distribution of the image result; and iii) applying data processing means, applying to the digital color image data the stored relationship between the color composition of the image result and the analysis calibration data to obtain a quantitative result of said analysis. In addition, said assay calibration data comprises a set of calibration values for combinations of at least two selected color parameters; and said quantitative result is obtained by interpolation between at least two of said calibration values.

US 2017/0098137 A1 describes a reagent test panel including a contamination detection medium, a color control band, at least one chemical test medium, and a unique identifier. The pollution detection medium includes a reagent that changes color in the presence of or when exposed to an aggressive or unfavorable environment. Each chemical test medium includes a reagent that is sensitive to the corresponding analyte in the biological sample. The reference color bar includes reference color swatches of different colors. The unique identifier, like the serial number, identifies a particular panel and its chemical test environment, so it can be uniquely and anonymously associated with the user.

WO 2014/025415 A2 describes a method and apparatus for testing biological materials based on a color reaction. The method includes obtaining and interpreting digital images of an unexposed and then exposed instrument in an automatically calibrated environment. This device contains a label with a unique identification (UID; Unique Identification), a reference color bar (RCB; Reference Color Bar), providing standardized color samples for image color calibration, and several test specific sequences of chemical test pads (CTP; Chemical Test Pad). In addition, the method includes locating a tool in an image, extracting a UID, extracting an RCB, and locating a plurality of CTPs in each image. In addition, the method reduces image distortion in the CTP and automatically calibrates the image according to illumination measurements made on the RCB. In addition, the method determines the test results by comparing the color of the CTP image with colors from the manufacturer's interpretation color chart (MICC; Manufacturer Interpretation Color Chart). This method shows these results in a graphical or quantitative manner.

US 2013/0267032 A1 describes a sample test strip for detecting characteristics of an analyte in a sample. The sample test strip includes a reaction zone for receiving a sample sample and a color calibration zone for determining the color or color and color intensity of the reaction zone after receiving the sample sample. The sample test strip may further include a temperature indication area to correct the analyte characterization measurement.

US 2015/0233898 A1 describes a test strip module comprising a sheath and a positioner extending down past the mating surface to the face of the mobile computing device. The position lock has a shape corresponding to the element on the front surface of the mobile computing device.

US 2012/0329170 A1 describes an analysis device comprising an image capture unit and an analysis unit. The image capturing unit contains a field of view area that covers at least the reaction area and the background area in the test area. The reaction area provides the manifestation of the color of the reaction when exposed to the test substance in the sample. The analysis unit detects the test substance by the color of the reaction and determines, at the time of detection of the test substance, whether the state of the background area is within the allowable range set for the test substance.

WO 2017/059103 A1 describes a method which includes obtaining a signal of a detection substrate exposed to a sample containing a target substance; determining that the detection substrate is in a test state; and obtaining an estimate of the presence of the target substance in the sample.

DE 102016202428 A1 describes a measuring system for carrying out colorimetric analyzes and a corresponding method with the participation of this measuring system containing at least one test strip having at least one test field for determining the concentration of at least one analyte in a test solution by changing colors of the test field, each test strip is associated with a machine-readable code with data for identifying the test strip and for evaluation by the application, a mobile device with a camera for performing a first image of at least a machine-readable code before the test strip contacts the test solution and the second image test - strips after contact with the test solution and with the application for evaluating the first and second entries installed on the mobile device, the application is at least displayed based on the reading of the first writing machine-readable code to check the applicability of the test strip for each measurement automatically and in case of acceptance The value of this test strip is associated with colorimetric analysis and the corresponding calibration data automatically to evaluate the color change of the test strip set, and only then using the second image using colorimetric analysis, automatically change the color of the test fields or and calculate the concentration of the analyte based on the calibration data.

In addition to the use of individual detectors, which are specifically designed to optically detect changes in the test chemical contained in the corresponding test elements, recent developments are directed to the use of widely available devices such as smartphones. However, when using consumer electronics with a camera, such as smartphones, individual technical and optical properties may have to be taken into account, since a huge number of cameras are available on the market, which can affect the determination of the analyte concentration.

Thus, despite the advantages associated with the use of consumer electronics having a camera for detecting an analyte in a sample or evaluating analytical measurements, several technical problems remain. In general, color representation in camera systems is adapted to provide images optimized for human color perception, such as by internally post-processing raw camera data. However, such post-processing, due to human perception of color, may not be ideal for accurately determining analyte concentrations in a sample.

PROBLEM TO BE SOLVED

Therefore, it is desirable to provide methods and devices that solve the aforementioned technical problems of analytical measurements using mobile devices such as mobile consumer electronics devices, in particular multi-purpose mobile devices that are not designed for analytical measurements, such as smartphones or tablet computers. In particular, methods, computer programs, and devices should be provided that are widely applicable to affordable mobile devices and that are suitable for improving measurement accuracy and reliability while providing ease of use for the user.

SUMMARY OF THE INVENTION

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

As used hereinafter, the terms "have", "comprise", 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 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 the situation in which, in addition to B, there are one or more additional elements in the object A, 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 only apply once when presenting the corresponding feature or element. In the following, in most cases, when talking about the corresponding feature or element, the expressions "at least one" or "one or more" will not be repeated, despite the fact that the corresponding feature or element may be present once or more than once. .

In addition, hereinafter, the terms "preferably", "more preferably", "especially", "in particular", "more specifically" or similar terms are used together with optional features, without limiting alternative possibilities. Thus, the features represented by these terms are optional features and are in no way intended to limit the scope of the claims. This invention, as will be understood by a person skilled in the art, can be implemented using alternative features. Likewise, features represented by "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 no restrictions as to the possibility of combining the features thus presented with other optional or non-optional features of the present invention.

In one aspect, a method is disclosed for making 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 also possible. In addition, it is also possible to perform one or more method steps one or more times. In addition, two or more method steps may be performed simultaneously or in an overlapping manner in time. The method may include additional method steps that are not shown.

In general, the method includes the following steps:

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

b) obtaining at least one first image of at least a portion of the test field of the optical test strip with the sample applied thereto using a camera with at least one camera image acquisition setting, in particular with a set of camera image acquisition settings;

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

d) waiting for a predetermined minimum amount of time;

e) obtaining at least one second image of at least a part of the test field of the optical test strip with a sample of physiological fluid applied to it using a camera with one or more camera image acquisition settings, and the camera image acquisition settings are the same as the acquisition settings camera images used in step b); And

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

wherein step b) further comprises locking one or more camera image acquisition settings, wherein one or more camera image acquisition settings remain locked at least until step e) is performed).

where step e) includes comparing at least two images obtained, respectively, in steps b) and e) with the detection of a difference in color and/or a difference in intensity between them,

moreover, step e) includes determining the relative value of the measurement R _rel. by the color and/or intensity of the test field of the first image I _{tf_1} and by the color and/or intensity of the test field of the second image I _{tf_2} using the following function:

and/or step e) includes determining twice the relative value of the measurement R _{dv._rel.} by the color and/or intensity of the test field of the first image I _{tf_1} , the color and/or intensity of the test field of the second image I _{tf_2} , the color and/or intensity of the control area on the optical test strip of the first image I _{Wf_2} and the color and/or intensity of the same control areas on the optical test strip of the second image I _{Wf_2} using the following functions:

As used herein, the term "analytical measurement" is a broad term, and its conventional and conventional understanding should be understood by one skilled in the art and should not be limited to special or individual understanding. This term, in particular, may refer, without limitation, to the quantitative and/or qualitative determination of at least one analyte in an arbitrary sample. For example, the sample may contain a bodily fluid such as blood, interstitial fluid, urine, saliva, or other types of bodily 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, as an example, the analytical measurement may be a blood glucose measurement, thus the result of the analytical measurement may be, for example, a blood glucose concentration. In particular, the value of the result of the analytical measurement can be determined by the analytical measurement. As used herein, the term "analytical measurement value" is a broad term, and its conventional and conventional understanding should be understood by one skilled in the art and should not be limited to special or individual understanding. The term, in particular, may refer without limitation to the numerical designation of the concentration of the analyte in the sample.

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 take part in metabolism can be defined, for example, glucose in the blood. Additionally or alternatively, other types of analytes or parameters may be determined, such as pH. In particular, at least one sample may be or may contain at least one bodily fluid such as blood, interstitial fluid, urine, saliva, and the like. However, in addition or alternatively, other types of samples, such as water, can 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, this change may be measured or determined visually with 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 forming reaction" is a broad term, and its conventional and conventional understanding should be clear to a person skilled in the art and should not be limited to a special 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 conventional and conventional understanding should be understood by one of ordinary skill in the art and should not be limited to the special or individual understanding. The specified term, in particular, may refer, without limitation, to an arbitrary element or device, made with the possibility of carrying out a reaction to determine the color change. An optical test strip may also be referred to as a test strip or a test element, and all three terms may refer to the same element. The optical test strip, in particular, may have a test field containing at least one test chemical for determining at least one analyte. The optical test strip, for example, may comprise at least one substrate, such as at least one carrier, with at least one test field applied to or integrated therein. In particular, the optical test strip may further comprise at least one white area, 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 color may be a separate field independently located on the substrate or carrier. However, additionally or alternatively, the substrate or carrier itself may be or may contain a white area. By way of example, at least one carrier may be in the form of a strip, thereby converting the test element into a test strip. These test strips are commonly used and widely available. One test strip may contain one test field or a combination of test fields containing identical or different test chemicals.

As used herein, the term "test field" is a broad term, and its conventional and conventional understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. The term particularly may refer to, without limitation, a coherent amount of a test chemical, such as a field, such as a round, polygonal or rectangular field, containing one or more layers of material, with at least one layer of the test field containing test chemical.

As used herein, the term "mobile device" is a broad term, and its conventional and conventional understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. This term may specifically refer to, without limitation, a mobile electronics device, more specifically a mobile communication device such as a cellular 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 portable computer containing at least one camera.

As used herein, the term "camera" is a broad term, and its general and understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. This term, in particular, may refer, without limitation, to a device containing at least one imaging element, configured to record or receive spatially resolved one-dimensional, two-dimensional, or even three-dimensional optical data or information. By way of example, the camera may comprise 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 image recording. 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. As an example, the camera may be a fixed focal length camera including at least one lens that is stably adjusted with respect to the camera. However, in the alternative, the camera may also include one or more adjustable lenses that can be adjusted automatically or manually. In particular, the invention should be applicable to cameras that are commonly used in mobile communication devices such as laptop computers, tablets or, in particular, cellular phones such as smartphones. Thus, in particular, the camera may 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 and generated. More color values are also practical, eg four colors for each pixel, eg R, G, G, B. Color cameras are generally known to those skilled in the art. Thus, as an example, a camera chip may be composed 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, the pixels may record values, eg numeric 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, quadruplets such as R, G, G, B can be used. camera pixels. These methods are generally known to the person skilled in the art.

Both steps b) and e) involve taking at least one image with the camera, the camera being used with at least one image acquisition setting. As used herein, the term "image acquisition setting" is a broad term, and its conventional and conventional understanding should be understood by one skilled in the art and should not be limited to a special or individual understanding. The term, in particular, may refer, without limitation, to the arbitrary configuration or setting of an object or element, in particular an imaging device, such as a camera, when the object or element is used to obtain at least one image or picture. In particular, the image acquisition settings may be camera configurations, such as the camera of a mobile device, when at least one image is acquired. For example, the image acquisition setting may be one or more of shutter speed, exposure time, lens focus, color adjustment, color saturation, pixel correction, noise reduction, or the like. Thus, when a camera is used to acquire at least one image, the camera's image acquisition settings may also simply be referred to as image acquisition settings.

In particular, the image acquisition settings may, for example, be automatically selected by a mobile device, such as a mobile device having a camera used to acquire an image. Thus, for example, a mobile device having a camera, such as a smartphone or a smartphone camera system, can automatically select or set image acquisition settings according to an external situation, such as according to ambient lighting conditions. Additionally or alternatively, one, several, or even all of the image acquisition settings may be determined or set manually or using a predetermined algorithm.

Step b) may further include locking one or more camera image acquisition settings. In particular, one or more of the camera's image acquisition settings may remain locked until at least step e), in particular, at least until the second test field image is acquired. As used herein, the term "lock" is a broad term, and its conventional and conventional understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. The term, in particular, can refer without limitation to the process of maintaining the consistency of an arbitrary configuration, for example, without changes and/or without variations. For example, a locked configuration may remain constant for a certain period of time, in particular during the time between at least two events. In particular, when the configuration is locked, starting from the first event, the configuration or setting may, for example, remain unchanged until at least one second event. Thus, blocking one or more image acquisition settings may be or may involve keeping the image acquisition settings constant or unchanged for a certain period of time, in particular during the period between the execution of step b) of the method to step e) of the method.

In particular, step b) may further include obtaining at least one parameter related to one or more image acquisition settings. For example, a parameter related to one or more image acquisition settings may be or may contain at least one numeric value related to one or more image acquisition settings.

In particular, a parameter relating to one or more image acquisition settings may, for example, be stored in a database, in particular in the memory of the mobile device and/or camera. Thus, a parameter relating to one or more image acquisition settings may be stored in the mobile device, in particular in the memory of the mobile device having the camera used to acquire images in steps b) and e). However, additionally or alternatively, a parameter relating to one or more image acquisition settings may also be stored in an external memory or database, such as in the cloud. In particular, the database may be stored in a data storage device, such as, for example, in a memory, such as volatile or non-volatile memory, for example, in the memory of a mobile device, on an external hard drive or hard drive, on an external computer, or on a computer network, on a hard drive or in the cloud.

For example, at least one parameter related to one or more image acquisition settings may be selected from the group consisting of: shutter speed, in particular exposure time; focal length; color adjustments, such as color saturation; pixel correction, in particular noise reduction.

In addition, at least one of at least one parameter related to one or more image acquisition settings can be adjusted or set by at least one algorithm, for example, to prevent overexposure, in particular white areas in the image . As an example, at least one algorithm may be configured to adjust at least one of the at least one parameter to ensure a minimum image quality, in particular the images obtained in steps b) and e). In particular, the algorithm may, for example, be stored and/or executed on a mobile device. In particular, the algorithm may be stored in the memory of the mobile device and/or may be loaded into the processor of the mobile device. Additionally or alternatively, the algorithm may be executed on a mobile device, such as on a mobile device processor.

Step c) may specifically include one or both of:

- prompting the user to apply a sample of physiological fluid, in particular a drop, to the test field of the optical test strip; or

- prompting the user to confirm the application of the physiological fluid sample to the test field of the optical test strip.

In addition, step d) may include waiting at least 5 seconds. Thus, a predetermined minimum amount of time may, for example, be at least 5 seconds.

As indicated above, step e) involves comparing at least two images obtained, respectively, in steps b) and e). In particular, when comparing at least two images, a difference in color and/or a difference in intensity is detected between them. Thus, step e) may specifically include detecting one or both of the color difference and the intensity difference, for example by comparing images, for example pixels of the images obtained in steps b) and e).

In particular, step e) includes determining the relative value of the measurement R _rel. by the color and/or intensity of the test field of the first image I _{TF_1} and the color and/or intensity of the test field of the second image I _{tf_2} using the following function:

In particular, the function may additionally contain a proportionality factor.

Additionally or alternatively, step e) includes determining twice the relative value of the measurement R _{int_rel} . by the color and/or intensity of the test field of the first image I _{tf_1} , the color and/or intensity of the test field of the second image I _{tf_2} , the color and/or intensity of the control area, for example, the white area on the optical test strip of the first image I _{WF_1} and color and/ or the intensity of the same control area on the optical test strip of the second image I _{wf_2} , using the following functions:

In particular, the function may additionally contain a proportionality factor.

The method may further include step g) evaluating at least one ambient light condition. In particular, illumination, such as the illumination of the test field, may be evaluated in step g). In particular, step g) may, for example, be performed at least once at one or more of the following times:

between step a) and step b)

- between step b) and step c),

- between steps e) and e), or

- after step e).

In particular, at least one ambient lighting condition may be specifically evaluated at least once before performing step b) and, for example, after performing step a). Additionally or alternatively, step g) may, for example, be performed at least once before step e).

In particular, step g) may further include adapting at least one ambient lighting condition by turning on or off at least one light source of the mobile device. The term "illumination source" as used herein is a broad term, and its conventional and conventional understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. The term may, in particular, without limitation, refer to an arbitrary device adapted to generate light for illuminating an object. For example, the illumination source of the mobile device may comprise at least one light emitting diode embedded in the mobile device. In particular, the light source may be the backlight of the mobile device. The mobile device may include additional lighting devices, such as at least one light source illuminating the display, and/or the display itself may be designed as an additional light source. Thus, by way of example, at least one light source may be turned on to lighten or brighten at least one ambient light condition. Thus, by way of example, at least one light source may be turned on to lighten or brighten at least one ambient light condition. Thus, by way of example, at least one light source may be turned on to lighten or brighten at least one ambient light condition.

In a further aspect, a computer program is disclosed, including computer-executable instructions for performing a method when the computer program is running on a computer or on a computer network. The computer program is configured to perform a method for making an analytical measurement based on a color forming reaction as described above or as will be described in more detail below when the computer program is executed on a computer or computer network, in particular on a processor of a mobile device. The computer program may in particular be configured to perform at least steps b), d), e), e) and optionally steps c) and/or g) of the method for performing an analytical measurement.

For possible definitions of terms and possible implementations, reference may be made to the description given above or as described in more detail below.

In particular, the computer program may be stored on a computer-readable storage medium. Thus, further described and proposed herein is a storage medium containing a data structure stored thereon, which, after being loaded into a computer or computer network, for example, into random access memory or the main storage device of a computer or computer network, can perform a method according to one or more embodiments of the invention described in this document.

In a further aspect, a mobile device for performing an analytical measurement is described. The mobile device has at least one camera. In addition, the mobile device is configured to perform at least steps b), d), e) and e) of the method for performing an analytical measurement, as described above or as will be described in more detail below.

Again, for possible definitions of terms and possible implementations, reference may be made to the description given above or as described in more detail below.

In addition, the mobile device may include at least one light source configured to adapt at least one ambient light condition.

In particular, the mobile device may comprise at least one processor programmed to control at least one of steps b), d), e) and e) and optionally steps c) and/or g). The term "processor" as used herein is a broad term, and its conventional and conventional understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. This term, in particular, can refer without limitation to an arbitrary electronic circuit made with the ability to work with data. In particular, the processor may be configured to perform operations on at least one database, such as a memory, such as the memory of a mobile device. For example, the processor may be or may comprise an integrated circuit (IC), such as an application specific integrated circuit (ASIC) or a user programmable logic array (PLA).

In a further aspect of the present invention, a kit is described for performing an analytical measurement. The set contains:

- at least one mobile device, as described above or will be described in more detail below; And

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

Again, for possible definitions of terms and possible implementations, reference may be made to the description given above or as described in more detail below.

The term "kit" as used herein is a broad term and its conventional and conventional understanding should be understood by one of ordinary skill in the art and should not be limited to the special or individual understanding. The term, in particular, can refer without limitation to an assembly of multiple components, in which each of the components can function and work independently of each other, while the components of the set can interact to perform a common function.

The methods, computer programs and devices disclosed herein can provide many advantages over prior art methods, computer programs and devices. Thus, in particular, the present invention can provide improved reliability and accuracy of analytical measurements compared to methods, computer programs and devices known in the prior art. In particular, reliability and accuracy can be improved by taking into account the image processing steps of the mobile device, in particular any image processing steps performed by software, such as by an application on a mobile device.

In addition, the present invention can make it easier for the user to make analytical measurements. In particular, the user can perform an analytical measurement using a widely available mobile device such as a smartphone instead of a customizable detector. In particular, the present invention may be suitable for a wide variety of mobile devices, such as a large number of mobile phones or smartphones, in particular because the present invention may, for example, be technically compatible with most mobile devices such that the design and/or application may be possible on a large number of mobile devices, such as mobile devices running at least one operating system, such as at least one operating system selected from Android, Windows, iOS, or Linux. Other operating systems are possible.

In addition, for the present invention, the requirements for the camera system of a mobile device can be reduced compared to methods, computer programs and devices known in the art. In particular, the requirements for absolute measurement or color detection can be reduced, for example, due to relative measurement, in particular double relative measurement, which can be used when making an analytical measurement according to the present invention. In particular, the present invention may provide for the measurement of an analyte using a relative color measurement, such as a relative intensity measurement. In particular, the first image of the optical test strip, eg the test element, may be obtained before applying the sample, in particular before applying the sample to the test area of the optical test strip. When the first image is acquired, the image acquisition options may, for example, be automatically selected by the mobile device, such as a mobile device having a camera used to acquire the image. Thus, for example, a mobile device having a camera, such as a smartphone or a smartphone camera system, can automatically select the image acquisition settings according to the external situation, for example, according to the ambient light, when the image is acquired, and overexposure, for example, of the corresponding parts of the optical test strip, such as a white field, may be suppressed. Additionally or alternatively, the image acquisition settings may be selected manually or using a predetermined algorithm. Subsequently, by way of example, the acquisition of a second image of the test element, for example after the sample has been applied to the test field, can in particular be performed using the same image acquisition settings. Thus, the image acquisition settings selected when the first image was acquired can be locked and/or stored, for example, in the mobile device, until the second image is acquired. Such a function of locking and/or storing image acquisition settings can be particularly supported by a large number of mobile devices, such as a large number of smartphones.

Summarizing and not excluding additional possible embodiments of the invention, the following embodiments of the invention 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 sample applied to it;

b) obtaining one first image of at least a portion of the test field of the optical test strip without sample applied thereto using a camera with at least one camera image acquisition setting; in particular, with a set of camera image acquisition settings;

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

d) waiting for a predetermined minimum amount of time;

e) obtaining one second image of at least a part of the test field of the optical test strip with a sample of physiological fluid applied thereto using a camera with one or more camera image acquisition settings, wherein the camera image acquisition settings are the same as the camera image acquisition settings, used in step b); And

e) determining the value of the result of the analytical measurement using the first and second images of the optical test field of the optical test strip, in particular by comparing at least two images.

Embodiment 2: The method of the previous embodiment, wherein step b) further comprises locking one or more camera image acquisition settings, wherein one or more camera image acquisition settings remain locked at least until step e) is performed. in particular, at least until the second image of the test field is obtained.

Embodiment 3. The method of any one previous embodiment, wherein step b) further comprises obtaining at least one parameter related to one or more image acquisition settings.

Embodiment 4. The method of the previous embodiment, wherein the parameter relating to one or more image acquisition settings is stored in a database, in particular in the memory of the mobile device and/or the camera.

Embodiment 5. The method of the previous embodiment, wherein at least one parameter relating to one or more image acquisition settings is selected from the group consisting of: shutter speed, in particular exposure time; focal length; color adjustments, such as color saturation; pixel correction, in particular noise reduction.

Embodiment 6. The method of the previous embodiment, wherein at least one of at least one parameter related to one or more image acquisition settings is adjusted or set by at least one algorithm, for example, to prevent overexposure, in in particular white areas in the image, the at least one algorithm being, for example, stored and/or executed on the mobile device, in particular on the processor of the mobile device.

Embodiment 7. The method of any one of the previous embodiments, wherein step c) comprises one or both of:

- prompting the user to apply a sample of physiological fluid, in particular a drop, to the test field of the optical test strip; or

- prompting the user to confirm the application of the physiological fluid sample to the test field of the optical test strip.

Embodiment 8. The method of any one of the previous embodiments, wherein step d) includes waiting for at least 5 seconds.

Embodiment 9. The method of any one of the previous embodiments wherein step e) comprises comparing at least two images obtained in steps b) and e), respectively, wherein at least one of a color difference and an intensity difference is detected.

Implementation 10. The method according to any previous implementation variant, and step e) includes determining the relative value of the measurement R _rel. one or both of the color or intensity of the test field of the first image I _{tf_1} and the color and/or intensity of the test field of the second image I _{tf_2} , using the following function:

Implementation Option 11. The method according to any one of the two previous implementation options, wherein step e) includes determining twice the relative value of the measurement R _{in._rel.} from the color and/or intensity of the test field of the first image I _{tf_1} , the color and/or intensity of the test field of the second image I _{tf_2} , the color and/or intensity of the control area, for example, the white area on the optical test strip of the first image I _{WF_1} and the color and/ or the intensity of the same control area on the optical test strip of the second image I _{wf_2} , using the following functions:

Embodiment 12. The method of any one of the preceding embodiments, the method further comprising:

g) evaluating at least one ambient lighting condition, wherein step g) is performed at least once at one or more of the following times:

between step a) and step b)

- between step b) and step c),

- between steps e) and e), or

- after step e).

Embodiment 13. The method of the previous embodiment, wherein step g) further comprises adapting at least one ambient lighting condition by turning on or off at least one light source of the mobile device.

Embodiment 14. A computer program including computer-executable instructions for performing the method of any one of the previous embodiments when the computer program is running on a computer or on a computer network, particularly on a processor of a mobile device.

Embodiment 15. A mobile device for performing an analytical measurement, a mobile device having at least one camera, a mobile device capable of performing at least steps b), d), e) and f) of the method for performing an analytical measurement according to any one from the previous implementation options relating to the method of conducting an analytical measurement.

Embodiment 16. The mobile device of the previous embodiment, wherein the mobile device further comprises at least one light source configured to adapt at least one ambient light condition.

Embodiment 17. A mobile device according to any one 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) and optionally c ) and/or e).

Embodiment 18. A kit for performing an analytical measurement, the kit comprising:

- at least one mobile device according to any one of the previous embodiments related to a mobile device; And

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

BRIEF DESCRIPTION OF THE DRAWINGS

Additional optional features and embodiments of the invention will be set forth in more detail in the following description of embodiments of the invention, 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 this invention is not limited to the preferred embodiments of the invention. Embodiments of the invention are schematically depicted in the figures. In this document, identical reference numbers in these figures refer to identical or functionally comparable elements.

Figures include the following:

in fig. 1 shows a perspective view of an embodiment of a kit and a mobile device;

in fig. 2A and 2B show block diagrams of embodiments of a method for making an analytical measurement; And

in fig. 3A and 3B show embodiments of charts representing the number of color signals recognized by the camera over time during an analyte measurement.

DETAILED DESCRIPTION OF EMBODIMENTS

In FIG. 1, an analytical measurement kit 110 is shown in perspective. The kit 110 includes at least one mobile device 112 having at least one camera 114, the kit further comprising at least one optical test strip 116 having at least one test field 118. The optical test strip 116 may further have at least one white area 119. The mobile device 112 is configured to perform a method for making an analytical measurement, such as shown in FIG. 2A and 2B. As illustrated in FIG. 1, mobile device 112 may further include at least one illumination source 120. In particular, mobile device 112 may include at least one processor 122 programmed to control the steps of the analytical measurement method.

In FIG. 2A shows an embodiment of a flowchart of a method for performing an analytical measurement based on the color formation reaction in an optical test strip 116 using a mobile device 112 having a camera 114. The method includes the following steps:

a) (indicated by reference numeral 124) providing an optical test strip 116 having a test field 118 with no sample applied thereto;

b) (indicated by reference numeral 126) obtaining at least one first image of at least part of the test field 118 of the optical test strip 116 without a sample applied to it using a camera 114 with at least one image acquisition setting of the camera 114, in particular, with a set of camera image acquisition settings 114;

c) (indicated by reference position 128) applying one or both samples, in particular a drop of physiological fluid, on the test field 118 of the optical test strip 116;

d) (indicated by reference numeral 130) waiting for a predetermined minimum amount of time;

e) (indicated by reference numeral 132) obtaining at least one second image of at least a portion of the test field of an optical test strip with a sample of physiological fluid deposited thereon using a camera with one or more image acquisition settings of the camera 114, wherein the camera image acquisition settings are the same as the image acquisition settings of the camera 114 used in step b); And

e) (indicated by numeral 134) determining the value of the result of the analytical measurement using the first and second images of the optical test field of the optical test strip, in particular by comparing at least two images.

The mobile device 112 may in particular be configured to perform at least steps b), d), e) and e) of the method for performing an analytical measurement. In particular, processor 122 may be programmed to control at least one of steps b), d), e), and f).

In FIG. 2B shows another embodiment of a flowchart for making an analytical measurement. The method may further include step g) (indicated by numeral 136) of evaluating at least one ambient lighting condition. In particular, step g) may, as shown in the figure, be performed at least once between step a) and step b). However, additionally or alternatively, step g) may be performed between steps b) and c) and/or between step e) and step e) and/or after step e). The method, in particular step b) of the method, may further include at least one substep (indicated by reference numeral 138) of locking one or more imaging settings of the camera 114. In particular, the imaging settings or set of imaging settings may remain locked until until step e) of the method is completed. In particular, the image acquisition settings may remain locked at least until the second image of the test field is acquired. Additionally or alternatively, step b) may include at least one sub-step (indicated by numeral 140) of obtaining at least one parameter related to one or more image acquisition settings. In addition, step e) may include at least one sub-step (indicated by numeral 142) of comparing at least two images obtained in steps b) and e), respectively, in particular, comparing the images with each other, and can be detected by at least one of a difference in color and a difference in intensity. As an example, in step e) the relative measured value R _rel. 144 can be determined using function (1) as described above. Additionally or alternatively, in step e) twice the relative value of the measurement R _{dv._rel.} 146 can be determined using function (2) as described above.

In FIG. 3A and 3B show embodiments of charts representing the number of color signals (C) recognized by a camera 114, such as the camera 114 of mobile device 112, over time (t) when an analyte measurement is taken. In particular, the color signal is taken into account for the color red, for example, the value of R 148 is displayed over time, measured in 150 seconds. The charts can be illustrated by the measurement of samples with a blood glucose concentration of 50 mg/dl. In particular, in the diagrams, the number of color signals or the R value for the white area 152 and the test field 154 of the optical test strip 116 are illustrated over time. In addition, the diagrams show R _rel. 144 and R _{motor_rel.} 146, and R _rel. 144 and R _{motor_rel.} 146 can be determined using functions (1) and (2) respectively.

As an example, in FIG. 3A and 3B illustrate at least steps b), c), d) and e) of a method for performing an analytical measurement based on a color formation reaction. Thus, step b), in particular the acquisition of at least one first image, can be performed within the first time interval 156, and step c), in particular the application of the physiological fluid sample to the test field 118, can be performed in the second time interval 158 In addition, the third time interval 160 may, by way of example, be equal to a predetermined minimum amount of time expected in step d) of the method. Step e), in particular the acquisition of at least one second image, may be performed in the fourth time interval 162.

In particular, in FIG. 3A, the ambient light condition is constant. Thus, for example, the R value of the white area 152 may show a constant trend over time, for example, throughout the entire measurement. As shown in FIG. 3A, for conditions of constant ambient lighting R _rel. 144 ≈ R _{motor_rel.} 146. However, in FIG. 3B, the ambient light conditions change. Thus, in particular, the R value of the white region 152 shown in FIG. 3B may change during the measurement. In addition, as shown in FIG. 3B, changing ambient light conditions can lead to R _rel. 144 F R _{motor_rel.} 146. In particular, when determining R _rel. 144, for example, the R value of the test field 154 after application of the sample can be set relative to the R value of the test field 154 without the sample applied to it, and the R value of the white area 152 may not be taken into account when determining R _rel. 144. Thus, changes in lighting conditions, as indicated, for example, by the R value of the white area 152, in particular the white field or reference field, cannot be taken into account when determining R _rel. 144. However, the R value of the white area 152 can be used to determine R _{int._rel.} 146. Thus, when determining R _{dv._rel.} 146, ambient light conditions can be taken into account. In particular, in the case of using R _{dv._rel.} 146 in step e) of the method, the determined value of the result of the analytical measurement may, for example, not even depend on changes in ambient light during the execution of the method.

List of reference positions

110 - Set

112 - mobile device

114 - Camera

116 - optical test strip

118 - test field

119 - white area

120 - light source

122 - Processor

124 - step a)

126 - step b)

128 - step c)

130 - step d)

132 - step e)

134 - step e)

136 - step g)

138 - Substep

140 - Substep

142 - Substep

144 - R _rel.

146 - R _{motor_rel.}

148 - R value

150 - Seconds

152 - R value of the white area

154 - R value of the test area

156 - first timeslot

158 - second timeslot

160 - third timeslot

162 - fourth timeslot

Claims (35)

1. A method for performing an analytical measurement based on the color formation reaction in an optical test strip (116) using a mobile device (112) having a camera (114), the method comprising: a) providing an optical test strip (116) having a test field (118) with no sample applied thereto; b) obtaining at least one first image of at least part of the test field (118) of the optical test strip (116) without a sample applied to it using a camera (114) with at least one camera image acquisition setting (114); c) applying a sample of physiological fluid to the test field (118) of the optical test strip (116); d) waiting for a predetermined minimum amount of time; e) obtaining at least one second image of at least a part of the test field (118) of the optical test strip (116) with a sample of physiological fluid applied to it using a camera (114) with one or more camera image acquisition settings (114), wherein the camera image acquisition settings (114) are the same as the camera image acquisition settings (114) used in step b); And e) determining the value of the analytical measurement result using the first and second images of the optical test field (118) of the optical test strip (116), wherein step b) further comprises locking one or more camera image acquisition settings (114), wherein one or more camera image acquisition settings (114) remain locked at least until step e) is performed). where step e) includes comparing at least two images obtained, respectively, in steps b) and e) with the detection of a difference in color and/or a difference in intensity between them, moreover, step e) includes determining the relative value of the measurement R _rel. by the color and/or intensity of the test field of the first image I _{tf_1} and by the color and/or intensity of the test field of the second image I _{TF_2} using the following function:

and/or step e) includes determining twice the relative value of the measurement R _motor. _ _rel . by the color and/or intensity of the test field of the first image I _{TF_1} , the color and/or intensity of the test field of the second image I _{tf_2} , the color and/or intensity of the control area on the optical test strip of the first image I _{Wf_1} and the color and/or intensity of the same control areas on the optical test strip of the second image I _{wf_2} using the following functions:

2. The method of claim 1, wherein step b) further comprises obtaining at least one parameter related to one or more image acquisition settings. 3. The method of claim 2, wherein the parameter relating to one or more image acquisition settings is stored in a database. 4. The method according to claim 3, wherein at least one parameter related to one or more image acquisition settings is selected from the group consisting of: shutter speed, in particular exposure time; focal length; color adjustments, such as color saturation; pixel correction, in particular noise reduction. 5. The method of claim 4, wherein at least one of the at least one parameter related to one or more image acquisition settings is adjusted or set using at least one algorithm. 6. The method according to any one of paragraphs. 1-5, wherein step c) includes one or both of: - prompting the user to apply a sample of physiological fluid to the test field (118) of the optical test strip (116); or - prompting the user to confirm application of the physiological fluid sample to the test field (118) of the optical test strip (116). 7. The method according to any one of paragraphs. 1-6, wherein the method further comprises g) evaluating at least one ambient lighting condition, wherein step g) is performed at least once at one or more of the following times: between step a) and step b) - between step b) and step c), - between steps e) and e) or - after step e). 8. The method of claim 7, wherein step g) further comprises adapting at least one ambient lighting condition by turning on or off at least one light source (120) of the mobile device (112). 9. A computer-readable storage medium stored on it with computer-executable instructions for performing the method according to any one of paragraphs. 1-8 when the instructions are executed on a computer or on a computer network. 10. Mobile device (112) for carrying out an analytical measurement, containing at least one camera (114) and configured to perform at least steps b), d), e) and f) of the method for carrying out an analytical measurement according to any of pp. 1-8. 11. The mobile device (112) of claim 10, wherein the mobile device (112) further comprises at least one light source (120) configured to adapt at least one ambient light condition. 12. Mobile device (112) according to claim 10 or 11, wherein the mobile device (112) comprises at least one processor (122) programmed to control at least one of steps b), d), e) and e) and, optionally, c) and/or g). 13. Set (110) for analytical measurement, containing: - at least one mobile device (112) according to any one of paragraphs. 10-12; And - at least one optical test strip (116) having at least one test field (118).

Images