JP7625240B2 - REAGENT REACTION EVALUATION DEVICE, REAGENT REACTION EVALUATION SYSTEM, REAGENT REACTION EVALUATION METHOD, AND REAGENT REACTION EVALUATION PROGRAM - Google Patents

Description

The present invention relates to a reagent reaction evaluation device, a reagent reaction evaluation system, a reagent reaction evaluation method, and a reagent reaction evaluation program for evaluating the reaction results when a reagent is reacted with a test object.

2. Description of the Related Art Conventionally, in medical testing, etc., testing tools have been known that are used to help obtain information about a test subject, such as the presence or absence of a disease, by reacting the test subject, such as a body fluid or blood, with a test reagent (diagnostic agent).
The evaluation of the reagent reaction results is often performed by the tester visually observing the reaction. However, this type of method evaluation requires that the individual tester has a certain level of experience and skill, so it is not easy for everyone to do it. The risk of inaccurate evaluation cannot be overlooked, and the cost of training the tester is also a burden that cannot be ignored.
In response to this, Patent Document 1 discloses a component analysis device that includes a test body in which multiple reagent parts each having a reagent are arranged two-dimensionally. The test body is intended to impregnate the reagent parts with substances contained in the material to be measured, such as water quality, soil quality, metals, and body fluids, and cause a reaction to generate color information. By capturing an image of the multiple reagent parts after the reaction using a digital camera, image sensor, or the like, the color-developing areas of the reagent parts arranged on a two-dimensional surface are detected as a two-dimensional image, and each reagent part is identified from this two-dimensional image. The color-developing state or color-developing information of each reagent part is separated into luminance information, and the concentration is calculated based on the luminance information, and the component amount of the substance to be analyzed can be obtained from the concentration.
Furthermore, Patent Document 2 discloses a diagnostic test unit that includes a reagent disposed in at least one separate analysis area on a substrate, and a color legend on the substrate.
When an analyte (blood, water, saliva) is placed on an analysis area, the analyte reacts with the reagent and changes color. An imaging device, such as a smartphone or tablet, captures an image of at least one analysis area after the reaction and compares the color of the analysis area to a color legend in the captured image to determine the value (e.g., concentration) or property (e.g., pH) of the analyte.

JP 2004-144672 A JP2017-053849A

The component analysis device of Patent Document 1 analyzes an image of the reaction of a reagent with an analysis target, and automatically analyzes the amount of components in the target based on brightness.
Patent Document 2 describes a method of automatically obtaining information about an analyte by capturing an image of a reaction of a reagent with the analyte.
According to the techniques disclosed in these patent documents, the reaction of the reagent with the analyte is imaged and the device automatically analyzes it, so that information about the analyte can be determined with a certain degree of accuracy regardless of the skill or experience of the person analyzing it.
However, even in these patent documents, the images of the reagent reaction results are simply analyzed, and in order to more accurately determine the reagent reaction results from the images, new methods that differ from conventional methods are required.
The present invention has been made in consideration of the above problems, and has an object to perform more accurate reagent reaction evaluation based on an image of the reagent reaction result.

In order to solve the above problems, the present invention provides a reagent reaction evaluation device for evaluating a reagent reaction result for a test object placed on a test kit, the test kit comprising a test area in which the test object is placed, the reagent reaction evaluation device comprising: an imaging control unit that causes an imaging means to image the test kit after a reagent is applied to the test object on the test area; and a concentration calculation processing unit that calculates a grayscale concentration value corresponding to the reagent reaction result in an area of the imaging data captured by the imaging means that corresponds to the test area, the imaging control unit causes the imaging means to image the test kit twice at a predetermined time interval, the concentration calculation processing unit calculates the grayscale concentration value corresponding to the reagent reaction result from values of RGB components in first imaging data captured by the imaging means the first time and values of RGB components in second imaging data captured by the imaging means the second time, and the reagent reaction evaluation device comprises an evaluation value determination processing unit that determines an evaluation value of the reagent reaction result based on an amount of change between the grayscale concentration value in the first imaging data and the grayscale concentration value in the second imaging data.

As configured as described above, the present invention makes it possible to achieve more accurate reagent reaction evaluation based on images of the reagent reaction results.

FIG. 2 is a diagram outlining a procedure for evaluating the results of a reagent reaction in this embodiment. FIG. 4 is a diagram showing a menu screen displayed on a display screen provided in the reagent reaction evaluation device. FIG. 11 is a diagram (part 1) for explaining the calibration operation of the reagent reaction evaluation device. FIG. 13 is a diagram (part 2) for explaining the calibration operation of the reagent reaction evaluation device. FIG. 11 is a diagram (part 3) for explaining the calibration operation of the reagent reaction evaluation device. 11A and 11B are diagrams for explaining the imaging and calculation operations of the reagent reaction evaluation device. 1 is a diagram showing a configuration of a reagent reaction evaluation device according to an embodiment of the present invention. 4 is a flowchart illustrating a calibration process according to the present embodiment. 4 is a flowchart illustrating a reagent reaction evaluation process according to the present embodiment. FIG. 11 is a system configuration diagram for explaining another example of the present embodiment. FIG. 13 is a block diagram illustrating a hardware configuration of a server device according to another embodiment. FIG. 13 is a block diagram illustrating the functional configuration of a server device and a reagent reaction evaluation device in another embodiment.

Hereinafter, an embodiment of the present invention will be described in detail with reference to the drawings.
The reagent reaction evaluation device of this embodiment is, for example, a smartphone, and determines the reaction result of a reagent (diagnostic agent) to a test object such as blood or body fluid by capturing an image with a camera provided in the reagent reaction evaluation device.
The reagent reaction evaluation device captures an image of the reagent reaction and outputs information for evaluating the result of the reagent reaction expressed as a change in brightness (grayscale density). Note that it is a medical professional such as a doctor who judges the possibility of the presence or absence of a disease based on the outputted evaluation result of the reagent reaction, and the reagent reaction evaluation device is a device that presents the evaluation result to the medical professional as a basis for judgment.

The tester visually checks the reagent reaction (change in grayscale density) to the test object. Therefore, the evaluation of the extent to which the reagent reacted to the test object due to time variation is largely dependent on the tester's own experience and ability. The evaluation of the reagent reaction cannot completely eliminate ambiguity due to human evaluation.
In contrast, the reagent reaction evaluation device of the present embodiment digitizes and quantifies the evaluation of the reagent reaction due to time-dependent variations, thereby eliminating ambiguity in the evaluation.
The reagent reaction evaluation device takes images of the reaction results when different reagents are reacted with the test object placed on the test kit multiple times, for example twice, calculates the concentration change between the first and second images which serve as a reference (the concentration change between the initial concentration and the concentration after the reaction), and outputs an evaluation of the reaction result as a numerical value on a five-point scale, for example.
Since the reaction time for the test object differs depending on the reagent, the time interval between the first and second imaging is set so that the reaction can be evaluated after all the reagents have reacted sufficiently.
In this embodiment, the number of test objects arranged in the test kit and used to evaluate the reagent reaction results may be one or more.
Instead of capturing images of the reaction results multiple times, a reference concentration value may be prepared in advance, and the amount of change in concentration between the reference concentration value and the concentration value of the reaction result in an image captured at least once may be calculated, and an evaluation of the reaction result may be output.

Below, we will explain in detail the case where the reaction results when different reagents are reacted with the test object placed on a test kit are imaged multiple times, for example twice, and the amount of concentration change is calculated based on the difference between the concentration value obtained by the first image taken as a reference and the concentration value obtained by the second image taken, and an evaluation of the reaction results is output.
FIG. 1 is a diagram outlining the procedure for evaluating the results of a reagent reaction in this embodiment.
1(a), a test kit 20 is prepared that includes multiple (e.g., four) test areas such as recesses (first test area 21, second test area 22, third test area 23, fourth test area 24) in which test objects such as blood or body fluids can be placed, and the test objects are placed in the first test area 21 to fourth test area 24. Then, different reagents are applied (dropped) to the test objects on the test areas.
Then, as shown in FIG. 1(b), an image of the test kit 20 is captured using a smartphone as the reagent reaction evaluation device 10, and the concentration (brightness) of the areas in the captured image corresponding to the first test area 21 to the fourth test area 24 is calculated.
After that, when the set time has elapsed, as shown in Figure 1 (c), the reagent reaction evaluation device 10 takes a second image of the test kit 20 and calculates the concentration (brightness) of the areas in the image data corresponding to the first test area 21 to the fourth test area 24.
After completing two imaging operations, the reagent reaction evaluation device 10 calculates the concentration difference between the first and second images for the first inspection area 21 to the fourth inspection area 24, and determines an evaluation value, for example on a five-level scale, based on the calculated concentration difference.
As shown in FIG. 1(d), the reagent reaction evaluation device 10 displays the evaluation value as the judgment result, for example, with the same number of stars.

FIG. 2 is a diagram showing a menu screen displayed on a display screen provided in the reagent reaction evaluation device.
The operation of the reagent reaction evaluation device 10 is roughly divided into two stages: "calibration" and "imaging and calculation".
The menu screen of the reagent reaction evaluation device 10 shown in FIG. 2 includes a "calibration" button 60 for executing calibration, and a "start" button 70 for starting imaging and calculation of the reagent reaction.
In the "calibration" operation, the reagent reaction evaluation device 10 adjusts the camera focus and exposure, the image capture interval, the image capture position, and calibrates the brightness (black and white calibration).
In the "imaging/calculation" operation, the reagent reaction evaluation device 10 performs two imaging operations as described above, calculates the amount of concentration change due to the reagent reaction in the areas corresponding to the first inspection area 21 to the fourth inspection area 24 in the first imaging data and the second imaging data, and determines an evaluation value.

3 to 5 are diagrams for explaining the calibration operation of the reagent reaction evaluation device.
When the "Calibration" button 60 is selected to instruct the start of a calibration operation, the reagent reaction evaluation device 10 starts focus setting of the camera provided in the reagent reaction evaluation device 10, as shown in Fig. 3(a). The focal length is determined based on a distance measured in advance, and the reagent reaction evaluation device 10 performs focus setting based on the focal length determined in advance.
It is also possible to use an imaging kit that can capture an image while fixing the distance between the reagent reaction evaluation device 10 and the test kit.

When the user operates the "Next" button 65, the reagent reaction evaluation device 10 starts setting the predetermined focal length and the exposure (brightness) of the camera as shown in Fig. 3(b). The user adjusts the exposure (brightness) using the exposure function provided in the application.
When the user operates the "Next" button 65, the reagent reaction evaluation device 10 stores the exposure setting value, and as shown in FIG. 3(c), the reagent reaction evaluation device 10 allows the user to set the image capture interval of the camera.
The initial setting is, for example, 180 seconds, and the displayed number (number of seconds) can be increased or decreased by swiping the touch panel, etc. When the "Next" button 65 is operated, the displayed number of seconds is set as the image capture interval.

4, the reagent reaction evaluation device 10 allows the user to set the image capturing position within the angle of view. The reagent reaction evaluation device 10 does not capture all images within the angle of view, but captures only the areas within the angle of view that correspond to the first inspection area 21 to the fourth inspection area 24, thereby enabling accurate evaluation of the reagent reaction and reducing the processing load.
4(a), the reagent reaction evaluation device 10 allows the user to set an area within the angle of view corresponding to the first test area 21 of the test kit 20. First, the user operates the "+" button 61a and the "-" button 61b to set the size of the area.
Next, the reagent reaction evaluation device 10 has the user operate the "up" button 62a, the "down" button 62b, the "left" button 62c, and the "right" button 62d to move the area and set the location of the area corresponding to the first testing area 21.

When the user operates the "Next" button 65, the reagent reaction evaluation device 10 stores the setting values (the coordinate values of the area corresponding to the first test area 21) and sets an area within the angle of view corresponding to the second test area 22 of the test kit 20 in Fig. 4(b) . The setting method is the same as for the first test area 21.
When the user operates the "Next" button 65, the reagent reaction evaluation device 10 stores the setting values (the coordinate values of the area corresponding to the second inspection area 22) and sets an area within the angle of view corresponding to the third inspection area 23 of the test kit 20 in Fig. 4(c) . The setting method is the same as for the first inspection area 21 and the second inspection area 22.
When the user operates the "Next" button 65, the reagent reaction evaluation device 10 stores the setting values (coordinate values of the area corresponding to the third inspection area 23) and sets an area within the angle of view corresponding to the fourth inspection area 24 of the test kit 20 in Fig. 4(d) . The setting method is the same as for the first inspection area 21, the second inspection area 22, and the third inspection area 23.
When the user operates the "Next" button 65, the reagent reaction evaluation device 10 stores the setting values (the coordinate values of the area corresponding to the fourth inspection area 24), and the setting of the imaging position is completed.
In this embodiment, the test kit 20 is described as having four test areas (first test area 21 to fourth test area 24), but the number of test areas in which the reagent reacts may be one to three, or five or more.

Next, the reagent reaction evaluation device 10 performs a black and white calibration process for the camera as shown in FIG.
5(a), the reagent reaction evaluation device 10 captures an image of a white sample with a camera and stores white calibration information based on the density (brightness) information of the captured data. The white sample can be, for example, a white part on the exterior of a test kit.
5B, the reagent reaction evaluation device 10 captures an image of a black sample with a camera and stores black calibration information based on the density (brightness) information of the captured data. The black sample can be, for example, a black part on the exterior of a test kit.
The white calibration information and the black calibration information are white density information and black density information that serve as the reference for calculating the brightness (grayscale density value) of the reagent reaction result.
More specifically, the reagent reaction evaluation device 10 calculates the gray value _YB of black by the formula _YB = 0.299 x R + 0.587 x G + 0.114 x B based on the R, G, and B density information in the image data obtained by imaging a black sample with a camera.
The reagent reaction evaluation device 10 sets this value _YB to "0" (reference black density information) and calculates the difference between this value and the original black density value "0" on the grayscale.
For example, if the calculated value for the imaging data is "4", the difference value "4" is calculated.

The reagent reaction evaluation device 10 also obtains the white gray value (density value) _Yw from the formula _Yw = 0.299 x R + 0.587 x G + 0.114 x B based on the R, G, and B density information in the image data obtained by capturing an image of a white sample with a camera. The reagent reaction evaluation device 10 sets this value _Yw to "99" (standard white density information) and calculates the difference between this value and the original white density value "255" in the grayscale.
For example, if the calculated value for the imaging data is "250", the calculated difference value is "5".
Normally, the grayscale density value is 256 levels (8 bits) from 0 (black) to white (255), but by setting the black gray value and the white gray value when the sample is imaged to "0" and "99", respectively, the gray value when the inspection area is actually imaged falls within the range of "0" to "99".
In addition, the difference value between the density value when a black sample is imaged and the original black density value of "0" (the above "4"), and the difference value between the density value when a white sample is imaged and the original white density value of "255" (the above "5") are stored in the setting memory unit 55 as calibration data (referred to as the black calibration value and the white calibration value, respectively).
In FIG. 5C, the message "calibration complete" is displayed on the display screen, and the calibration operation ends.

FIG. 6 is a diagram for explaining the imaging and calculation operations of the reagent reaction evaluation device.
In FIG. 6, the display device 37 of the reagent reaction evaluation device 10 displays the first test area 21 to the fourth test area 24 of the test kit 20 photographed by the camera and an evaluation result screen.
As shown in Figure 6 (a), in a first run, the reagent reaction evaluation device 10 uses a camera to capture an image of the test kit 20 having the first test area 21 to the fourth test area 24, and calculates the concentration (brightness) of the areas corresponding to the first test area 21 to the fourth test area 24 in the resulting image data.
At this time, the reagent reaction evaluation device 10 calculates the above-mentioned formula Y = 0.299 x R + 0.587 x G + 0.114 x B for the concentration values of the RGB components in the areas corresponding to the first inspection area 21 to the fourth inspection area 24 contained in the image data, and converts them to grayscale (calculates grayscale concentration values).
As shown in Figure 6 (b), after a set time has elapsed, the reagent reaction evaluation device 10 uses a camera to capture an image of the test kit 20 having the first test area to the fourth test area for the second time, and calculates the concentration values of the areas corresponding to the first test area 21 to the fourth test area 24 from the resulting image data.
At this time, the reagent reaction evaluation device 10 calculates the above-mentioned formula Y = 0.299 x R + 0.587 x G + 0.114 x B for the concentration values of the RGB components in the areas corresponding to the first inspection area 21 to the fourth inspection area 24 contained in the image data, and converts them to grayscale (calculates grayscale concentration values).

As shown in Figure 6 (c), the reagent reaction evaluation device 10 shifts (fits) the grayscale values (256 gradations) calculated in Figure 6 (a) obtained by capturing the first image of the first inspection area 21 to the fourth inspection area 24 into the range of "0" to "99" set during calibration.
In addition, the reagent reaction evaluation device 10 shifts (fits) the grayscale values (256 gradations) calculated in Figure 6 (b) from the second image of the first inspection area 21 to the fourth inspection area 24 within the range of "0" to "99" set during calibration.
For example, the grayscale density value (after shift) that is to be kept within the range of "0" to "99" is
Grayscale density value (after shift) = 256-level grayscale value x 100/256
This can be obtained by the calculation:
At this time, it is more preferable that the reagent reaction evaluation device 10 take into consideration the black calibration value and the white calibration value (in the above explanation, "4" and "5", respectively) stored in the setting storage unit 55.
When considering calibration values, for example,
The grayscale density value after the shift is calculated as follows: grayscale density value after the shift (after the shift)=grayscale value of 256 gradations×100/256−black calibration value−white calibration value.
By confining the 256-level gray scale to 100 levels from "0" to "99," the amount of change in density due to the reagent reaction can be clearly represented, making evaluation easier.

The reagent reaction evaluation device 10 calculates the amount of concentration change based on the shifted concentration values obtained in the first and second photographing. The amount of concentration change is, for example, the difference between the grayscale concentration value (reference concentration value) obtained in the first photographing and the grayscale concentration value obtained in the second photographing.
As mentioned above, when a predetermined initial value is used as the reference density value, the amount of density change is, for example, the difference between the grayscale density value obtained in the first shooting (reference density value) or the grayscale density value obtained in the second shooting and the predetermined initial value.
Then, an evaluation value of the amount of density change is determined for each inspection region based on the amount of density change.
As an example, in one inspection area, if the amount of density change is in the range of "0" to "19", the evaluation value is set to "1", if the amount of density change is in the range of "20" to "39", the evaluation value is set to "2", if the amount of density change is in the range of "40" to "59", the evaluation value is set to "3", if the amount of density change is between "60" and "79", the evaluation value is set to "4", and if the amount of density change is in the range of "80" to "99", the evaluation value is set to "5".

It should be noted that some reagents react immediately after being added to the test object, and the change in concentration is completed by the time the first image is taken.
In order to accommodate such reagents, the initial value of the grayscale density value may be set within the range of "0" to "99" as a reference density value.
In this case, the amount of density change may be calculated from the difference between the grayscale density value obtained in the first shooting and the above-mentioned initial value.
Depending on the reaction speed of the reagent, the amount of change in concentration may be calculated from the difference between the concentration value (from "0" to "99") obtained in the second image capture and the initial value.
When an initial value is used as the reference concentration value, the reagent reaction evaluation device 10 may be photographed only once.

As shown in FIG. 6(d), the reagent reaction evaluation device 10 displays the determined evaluation value for each test area (each reagent) on the display screen.
According to the reagent reaction evaluation device 10, it is possible to easily and objectively evaluate how the reagent has reacted to the test object based on the change in brightness in the imaging data that captures the reagent reaction result.

7A and 7B are diagrams showing the configuration of the reagent reaction evaluation device 10 of this embodiment, where FIG. 7A is a diagram showing the functional configuration by hardware, and FIG. 7B is a diagram showing the functional configuration by software.
As shown in Figure 7 (a), the reagent reaction evaluation device 10 is equipped with a CPU (Central Processing Unit) 31 that executes a general-purpose operating system that controls the entire device and also executes programs that realize the functions of the reagent reaction evaluation device 10, a RAM (Random Access Memory) 32 in which various programs, temporary data, and variables are expanded for processing by the CPU 31, and a storage device 33 such as a flash memory or HDD (Hard Disk Drive) in which programs and data are stored, or a ROM (Read Only Memory) not shown.
The reagent reaction evaluation device 10 also includes an I/O interface 34, and is connected to a camera 100 (imaging means) via the I/O interface 34 to input imaging data.
The reagent reaction evaluation device 10 includes a network I/F 36 and is connectable to the Internet. The reagent reaction evaluation device 10 includes a display device 37 and displays various information including a menu screen, a setting screen, and evaluation values.

The CPU 31 is an example of a control circuit that is equipped in the reagent reaction evaluation device 10 and realizes the control unit, and other processors such as a multi-core CPU, an FPGA (Field Programmable Gate Array), or a PLD (Programmable Logic Device) can also be used as the control circuit.
The HDD serving as the storage device 33 is a drive device that drives a built-in hard disk, and the HDD reads out programs and data stored in the hard disk serving as a storage medium, and writes data to the hard disk.
The flash memory serving as the storage device 33 is a non-volatile memory that records data by injecting hot electrons into a floating gate of an FET. The flash memory is used as a recording medium in smartphones and the like to replace HDDs.

The reagent reaction evaluation device 10 may also include a reading/writing device 35 that reads and writes programs and data from a removable storage medium 200 such as an optical disk, such as a floppy disk (FD), a compact disk (CD), a digital versatile disk (DVD), or a Blu-ray (registered trademark) disk (BD), or a flash memory.
The reading/writing device 35 may be a floppy disk drive (FDD), a compact disk drive (CDD), a digital versatile disk drive (DVDD), a Blu-ray (registered trademark) disk drive (BDD), a universal serial bus (USB), or the like.
The CPU 31, the RAM 32, the storage device 33, the I/O interface 34, the reading/writing device 35, and the network I/F 36 are connected via an internal bus, for example.

As shown in FIG. 4(b), the CPU 31 executes, as the control unit 30A, an imaging control unit 41, a concentration calculation processing unit 42, a concentration change amount calculation processing unit 43, a score (evaluation value) calculation processing unit 44, a display control unit 45, a setting reception processing unit 46, a calibration processing unit 47, and a communication control unit 48.
These processing units are programs that realize the functions of the control unit 30A of the reagent reaction evaluation device 10, and the programs can be stored in a hard disk or storage medium 200 included in the HDD serving as the storage device 33. The programs are read from the hard disk or storage medium 200 to the RAM 32 by the HDD or reading/writing device 35 and executed by the CPU 31.
A program for implementing the functions of the control unit 30 A of the reagent reaction evaluation device 10 can be stored in a flash memory serving as the storage device 33 , and the program is read from the flash memory to the RAM 32 and executed by the CPU 31 .
The storage device 33 and the RAM 32 constitute a storage unit 30B of the reagent reaction evaluation device 10.
The storage unit 30B includes an imaging data storage unit 51 , a calculated concentration storage unit 52 , a calculated change amount storage unit 53 , a decision score storage unit 54 , and a setting storage unit 55 .

The imaging control unit 41 controls the camera 100 in accordance with the setting values stored in the setting memory unit 55 to capture images of the test kit 20 twice, and stores the first imaging data (first imaging data) and the second imaging data (second imaging data) in the imaging data memory unit 51.
The concentration calculation processing unit 42 calculates the grayscale concentration values ("0" to "99") of the areas corresponding to the first inspection area 21 to the fourth inspection area 24 in the first imaging data and the second imaging data stored in the imaging data memory unit 51 using the method described above, and stores the values in the calculated concentration memory unit 52.
The density change amount calculation processing unit 43 calculates the difference between the grayscale density values for each inspection area based on the first grayscale density value and the second grayscale density value stored in the calculated density memory unit 52, and stores the calculated density change amount in the calculated change amount memory unit 53.
The density change amount calculation section 43 may calculate the density change amount based on the difference between the first or second grayscale density value and a predetermined initial value.
The score determination processing unit 44 determines a score for each test area (each reagent) according to the amount of change in concentration for each test area stored in the calculated amount of change storage unit 53, and stores the score in the determined score storage unit 54.
The display control unit 45 controls the display of the scores stored in the determined score storage unit 54 on the display device 37 .

The setting reception processing unit 46 receives settings for the focus of the camera 100, the brightness (exposure) of the camera 100, the imaging time interval of the camera 100, and the coordinates corresponding to the inspection area within the angle of view of the camera 100, and performs processing to store the setting information in the setting memory unit 55.
The calibration processing unit 47 controls the camera 100 to capture an image, performs black calibration and white calibration, and stores the calibration information in the setting storage unit 55 .
The communication control unit 48 controls the network I/F 36 to connect the reagent reaction evaluation device 10 to a network, thereby enabling communication with an external device.

FIG. 8 is a flowchart illustrating the calibration process of this embodiment.
In step S101, the CPU 31 (setting reception processing unit 46) determines whether or not a calibration start operation has been performed.
If it is determined that a calibration start operation has been performed (Yes in step S101), the CPU 31 (setting reception processing unit 46) sets the focus of the camera 100 in accordance with the user's operation in step S102, and stores the setting information in the setting memory unit 55.

Next, in step S<b>103 , CPU 31 (setting reception processing unit 46 ) sets the brightness (exposure) of camera 100 in response to the user's operation, and stores the setting information in setting storage unit 55 .
Next, in step S<b>104 , the CPU 31 (setting reception processing unit 46 ) sets the image capture time interval in response to the user's operation, and stores the setting information in the setting storage unit 55 .
Next, in step S105, the CPU 31 (setting reception processing unit 46) receives the setting of an area corresponding to the inspection area within the angle of view of the camera 100 in response to the user's operation, and stores the setting information (coordinates of the area) in the setting memory unit 55.
Next, in step S106, CPU 31 (calibration processing unit 47) performs white calibration and black calibration of camera 100, stores the calibration information in setting storage unit 55, and ends the current calibration process.

FIG. 9 is a flowchart illustrating the reagent reaction evaluation process of this embodiment.
In step S201, the CPU 31 (imaging control unit 41) determines whether or not an evaluation start operation has been performed.
When it is determined that the evaluation start operation has been performed (Yes in step S201), the CPU 31 (imaging control unit 41) determines in step S202 whether or not calibration has been completed.
If it is determined that calibration has not been completed (setting information and calibration information are not stored in the setting memory unit 55) (No in step S202), the CPU 31 (imaging control unit 41) does nothing and terminates the current reagent reaction evaluation process.
If it is determined that calibration has been completed (setting information and calibration information are stored in the setting storage unit 55) (Yes in step S202), the CPU 31 (imaging control unit 41) executes a first imaging in step S203.
In step S204, the CPU 31 (imaging control unit 41) stores the imaging data in the imaging data storage unit 51, and in step S205, starts measuring the set imaging time interval, and ends this processing.

In step S201, when it is determined that the evaluation start operation has not been performed (No in step S201), the CPU 31 (imaging control unit 41) determines in step S211 whether or not the imaging time interval has elapsed since the start of timing.
When it is determined that the set time has not elapsed (No in step S211), the CPU 31 (imaging control unit 41) does nothing and ends the current reagent reaction evaluation process.
When it is determined that the set time has elapsed (Yes in step S211), the CPU 31 (imaging control unit 41) executes a second imaging operation in step S212, and stores the imaging data in the imaging data storage unit 51 in step S213.

When the two imaging operations are completed, in step S214, the CPU 31 (density calculation processing unit 42) calculates the grayscale density values ("0" to "99") of the areas in the first imaging data corresponding to the first inspection region 21 to the fourth inspection region 24 by the method described above, and stores the grayscale density values in the memory unit 30 B. Next, in step S215, the CPU 31 (density calculation processing unit 42) calculates the grayscale density values ("0" to "99") of the areas in the second imaging data corresponding to the first inspection region 21 to the fourth inspection region 24, and stores the grayscale density values in the calculated density memory unit 52.
In step S216, the CPU 31 (density change amount calculation unit 43) calculates the density change amount based on the difference between the first and second grayscale density values for each inspection area, and stores it in the memory unit 30B (calculated change amount memory unit 53).
In step S216, the CPU 31 (density change amount calculation section 43) may calculate the amount of density change for each inspection region based on the difference between the first or second grayscale density value and a predetermined initial value.
In step S217, the CPU 31 (score determination processing unit 44) determines an evaluation value based on the amount of change in concentration for each test area (each reagent), and stores the evaluation value in the determined score storage unit 54.
In step S218, the CPU 31 (display control unit 45) causes the display device 37 to display the determined evaluation value for each test area (each reagent), and ends the current reagent reaction evaluation process.
After the judgment start operation in step S201, the reagent reaction evaluation device 10 may input information (ID information) identifying the test subject to whom the test object is provided, and store the information in association with the evaluation value.

FIG. 10 is a system configuration diagram for explaining another example of this embodiment.
In this embodiment, the reagent reaction evaluation device 10 serving as a terminal device (smartphone) transmits captured image data and the like via a network NW to a server device 300 providing a service on the cloud.
The server device 300 performs calculations and evaluations based on the transmitted imaging data, etc., and the reagent reaction evaluation device 10 displays the evaluation results.

FIG. 11 is a block diagram illustrating the hardware configuration of the server device.
11A, the server device 300 includes a CPU (Central Processing Unit) 301 that executes a general-purpose operating system that controls the entire device and executes programs that realize the functions of the server device 300, a RAM (Random Access Memory) 302 in which various programs, temporary data, and variables are expanded for processing by the CPU 301, and a HDD (Hard Disk Drive) 303 and a ROM (Read Only Memory) (not shown) in which programs and data are stored. Instead of the HDD 303, a SSD (Solid State Drive) may be used.
The server device 300 includes a network I/F 305 and is connectable to the Internet.

The CPU 301 is an example of a control circuit that is provided in the server device 300 and realizes the control unit. Other processors that can be used as the control circuit include a multi-core CPU, a Field Programmable Gate Array (FPGA), and a Programmable Logic Device (PLD).
The HDD 303 is a drive device that drives a built-in hard disk. The HDD 303 reads out programs and data stored on the hard disk as a storage medium, and writes data to the hard disk.

The server device 300 may also be provided with a reading/writing device 304 that reads and writes programs and data from a removable storage medium 310 such as an optical disk, such as a floppy disk (FD), a compact disk (CD), a digital versatile disk (DVD), or a Blu-ray (registered trademark) disk (BD), or a flash memory.
The reading/writing device 304 may be a floppy disk drive (FDD), a compact disk drive (CDD), a digital versatile disk drive (DVDD), a Blu-ray (registered trademark) disk drive (BDD), a universal serial bus (USB), or the like.
The CPU 301, the RAM 302, the HDD 303, the reading/writing device 304, and the network I/F 305 are connected via an internal bus, for example.

FIG. 12 is a block diagram for explaining the functional configuration of a server device in an embodiment in which calculations and evaluations are performed by the server device.
In the case of FIG. 12, the reagent reaction evaluation device 10 serving as the terminal device executes an imaging control unit 41, a setting reception processing unit 46, a calibration processing unit 47, and a communication control unit 48 as the control unit 30A.
The storage unit 30B includes an imaging data storage unit 51 , a decision score storage unit 54 , and a setting storage unit 55 .
The imaging control unit 41 controls the camera 100 in accordance with the setting values stored in the setting memory unit 55 to capture images of the test kit 20 twice, and stores the first and second imaging data in the imaging data memory unit 51.
The display control unit 45 controls the display of the score that the communication control unit 48 receives from the server device 300 and stores in the determined score storage unit 54 on the display device 37 .

The setting reception processing unit 46 receives settings for the focus of the camera 100, the brightness (exposure) of the camera 100, the imaging time interval of the camera 100, and the coordinates corresponding to the inspection area within the angle of view of the camera 100, and performs processing to store the setting information in the setting memory unit 55.
The reagent reaction evaluation device 10 may allow the user to input information (ID information) for identifying the test subject to whom the test object is provided, and may retain the information in association with the evaluation value.
The calibration processing unit 47 controls the camera 100 to capture an image, performs black calibration and white calibration, and stores the calibration information in the setting storage unit 55 .
The communication control unit 48 controls the network I/F 36 to connect the reagent reaction evaluation device 10 to the network, enabling communication with the server device 300. The communication control unit 48 transmits imaging data and setting information (which may include the above-mentioned ID information) to the server device 300, and receives the calculated score from the server device 300.

The CPU 301 of the server device 300 executes a concentration calculation processing unit 311 , a concentration change amount calculation processing unit 312 , a score determination processing unit 313 , and a communication control unit 314 as a control unit 300</b>A.
These processing units are programs that realize the functions of the control unit 300A of the server device 300, and the programs can be stored in the hard disk included in the HDD 303 or the storage medium 200. The programs are read from the hard disk or storage medium 310 to the RAM 302 by the HDD 303 or the reading/writing device 304 and executed by the CPU 301.
The HDD 303 and the RAM 302 constitute a storage unit 300B of the server device 300.
The storage unit 300B includes an imaging data storage unit 321 , a calculated concentration storage unit 322 , a calculated change amount storage unit 323 , a decision score storage unit 324 , and a setting storage unit 325 .

The concentration calculation processing unit 311 calculates the grayscale concentration values ("0" to "99") of the areas corresponding to the first inspection area 21 to the fourth inspection area 24 in the first imaging data and the second imaging data received by the communication control unit 314 from the terminal device 10 and stored in the imaging data memory unit 321 using the method described above, and stores the values in the calculated concentration memory unit 322.
The density change amount calculation processing unit 312 calculates the difference between the first grayscale density value and the second grayscale density value stored in the calculated density memory unit 322 as a density change amount for each inspection area, and stores the calculated change amount in the calculated change amount memory unit 323.
The density change amount calculation section 312 may calculate the density change amount for each inspection region based on the difference between the first or second grayscale density value and a predetermined initial value.
The score determination processing unit 313 performs a process of determining a score for each test area (each reagent) according to the amount of change in concentration stored in the calculated amount of change storage unit 323 , and storing the score in a determined score storage unit 324 .
The communication control unit 314 controls the network I/F 305 to connect the server device 300 to the network, enabling communication with the reagent reaction evaluation device 10. The communication control unit 314 transmits a calculated score to the reagent reaction evaluation device 10, and receives imaging data and setting information from the reagent reaction evaluation device 10.

Evaluation value data for each reagent is stored in a database provided in the server device 300 in a manner that allows identification of individuals, and when new imaging data is transmitted and an evaluation value is determined, the data is managed so that it is combined with past evaluation value data.
The evaluation data accumulated on the server device 300 may be graphed for each reagent (product) and displayed on a smartphone. The reagent reaction evaluation device 10 or other smartphone apps may determine the evaluation results using, for example, AI, and may recommend a medical examination to the user depending on the results. It is also possible to transmit the evaluation results to a terminal of a doctor at a hospital, for example, to use in diagnosis.
As configured as described above, according to this embodiment, the reagent reaction can be easily and accurately evaluated by capturing an image of the reagent reaction result using a smartphone or the like.

[First aspect]
A first aspect of this embodiment is a reagent reaction evaluation device 10 that evaluates a reagent reaction result for a test object placed on a test kit 20, and includes an imaging control unit 41 that causes the imaging means 100 to image the test kit 20 after applying a reagent to the test object, a concentration calculation processing unit 42 that calculates a concentration value corresponding to the reagent reaction result in the imaging data captured by the imaging means 100, and an evaluation value determination processing unit 43 that determines an evaluation value of the reagent reaction result based on the concentration calculated by the concentration calculation processing unit 42 and the amount of concentration change based on the reference concentration value. According to this embodiment, the reagent reaction can be easily and accurately evaluated by imaging the reagent reaction result with a smartphone or the like.

[Second aspect]
In the reagent reaction evaluation device 10 of the first aspect, the test kit 20 includes a plurality of test areas in which test objects are provided, and the imaging control unit 41 is capable of capturing imaging data for each test area when different reagents are applied to the test objects placed in each test area. According to this aspect, it is possible to easily and accurately evaluate the reagent reaction for a plurality of reagents.

[Third aspect]
In the reagent reaction evaluation device 10 of the first or second aspect, the imaging control unit 41 causes the imaging means 100 to image the test kit 20 twice at a predetermined time interval, the concentration calculation processing unit 42 calculates a concentration value corresponding to the reagent reaction result in the first imaging data captured by the imaging means 100 the first time and the second imaging data captured the second time, and the evaluation value determination processing unit 43 determines an evaluation value using the concentration corresponding to the reagent reaction result in the first imaging data as a reference concentration. According to this embodiment, it is possible to easily and accurately evaluate the reagent reaction for a plurality of reagents.

[Fourth aspect]
The reagent reaction evaluation device 10 of the third aspect described above is provided with a setting means 46 that allows a user to set the time interval. According to this aspect, the reagent reaction result is imaged in accordance with the reaction time of the reagent, making it possible to easily and accurately evaluate the reagent reaction.

10 Reagent reaction evaluation device (terminal device), 20 Test kit, 21 First test area, 22 Second test area, 23 Third test area, 24 Fourth test area, 30A Control unit, 30B Memory unit, 31 CPU, 32 RAM, 33 HDD, 34 I/O interface, 35 Reading/writing device, 36 Network I/F, 37 Display device, 41 Imaging control unit, 42 Concentration calculation processing unit, 43 Concentration change amount calculation processing unit, 44 Score determination processing unit, 45 Display control unit, 46 Setting reception processing unit, 47 Calibration processing unit, 48 Communication control unit, 51 Imaging data storage unit, 52 Calculated concentration storage unit, 53 Calculated change amount storage unit, 54 Determined score storage unit, 55 Setting storage unit, 100 Camera, 200 Storage medium, 300 Server device, 300A Control unit, 300B Memory unit, 301 CPU, 302 RAM, 303 HDD, 304 reading device, 305 network I/F, 310 storage medium, 311 density calculation processing unit, 312 density change amount calculation processing unit, 313 score determination processing unit, 314 communication control unit, 321 imaging data storage unit, 322 calculated density storage unit, 323 calculated change amount storage unit, 324 determined score storage unit, 325 setting storage unit

Claims (6)

A reagent reaction evaluation device for evaluating a reagent reaction result for a test object placed on a test kit,
The test kit includes a test area in which the test object is placed,
The reagent reaction evaluation device includes:
an imaging control unit that causes an imaging means to capture an image of the test kit after a reagent is applied to the test object on the test area;
a concentration calculation processing unit that calculates a grayscale concentration value corresponding to a reagent reaction result in a region of the image data captured by the imaging means, the region corresponding to the test region;
Equipped with
The imaging control unit causes the imaging means to image the test kit twice at a predetermined time interval,
the concentration calculation processing unit calculates the grayscale concentration value according to the reagent reaction result from the values of RGB components in first imaging data captured by the imaging means for the first time and the values of RGB components in second imaging data captured by the imaging means for the second time,
the reagent reaction evaluation device includes an evaluation value determination processing unit that determines an evaluation value of a reagent reaction result based on an amount of change between a grayscale density value in the first imaging data and a grayscale density value in the second imaging data;
A reagent reaction evaluation device comprising: 2. The reagent reaction evaluation device according to claim 1, further comprising a setting means for allowing a user to set the time interval. 3. The reagent reaction evaluation device according to claim 1,
The test kit includes a plurality of the test areas,
The reagent reaction evaluation device, wherein the imaging control unit is capable of capturing the imaging data for each test area when a different reagent is applied to a test object placed in each test area. A reagent reaction evaluation system comprising a terminal device and a server device capable of communicating with the terminal device and for evaluating a reagent reaction result for a test object placed in a test area of a test kit,
The test kit includes a test area in which the test object is placed,
the terminal device applies a reagent to the test object on the test area, and then causes an image capturing means to capture an image of the test kit twice at a predetermined time interval;
The server device includes:
calculating grayscale density values according to a reagent reaction result from the RGB component values of the first imaging data captured by the imaging means for the first time and the RGB component values of the second imaging data captured by the imaging means for the second time;
determining an evaluation value of a reagent reaction result based on an amount of change between the grayscale density value in the first imaging data and the grayscale density value in the second imaging data;
A reagent reaction evaluation system comprising: A reagent reaction evaluation method executed by a processor included in a reagent reaction evaluation device that evaluates a reagent reaction result for a test object placed in a test area of a test kit, comprising:
After applying a reagent to the test object, the test kit is imaged twice at a predetermined time interval by an image capturing means;
calculating grayscale density values according to a reagent reaction result from the RGB component values of the first imaging data captured by the imaging means for the first time and the RGB component values of the second imaging data captured by the imaging means for the second time;
determining an evaluation value of a reagent reaction result based on an amount of change between the grayscale density value in the first imaging data and the grayscale density value in the second imaging data;
A method for evaluating a reagent reaction. A reagent reaction evaluation program executed by a processor included in a reagent reaction evaluation device that evaluates a reagent reaction result for a test object placed in a test area of a test kit,
After applying a reagent to the test object, the test kit is imaged twice at a predetermined time interval by an image capturing means;
calculating grayscale density values according to a reagent reaction result from the RGB component values of the first imaging data captured by the imaging means for the first time and the RGB component values of the second imaging data captured by the imaging means for the second time;
determining an evaluation value of a reagent reaction result based on an amount of change between the grayscale density value in the first imaging data and the grayscale density value in the second imaging data;
A reagent reaction evaluation program that causes the processor to execute a process.

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