Test device, test system, and method

Abstract

The present invention enables accurate performance of a test. A method according to one embodiment of the present invention comprises: acquiring an image in which an indication of a reaction between an object under test and a reagent is captured; and determining the amount of a substance in the object under test, or the quality of the object under test based on the amount of said substance, on the basis of a relative value between pixels in a region indicating a normally performed test in the image and pixels in a region indicating the state of the reaction in the image.

Description

Inspection Device, Inspection System, and Method

[0001] The present invention relates to an inspection device, an inspection system, and a method.

[0002] Conventionally, when inspecting a substance in a test object such as a human specimen, a method is known in which the substance is reacted with a reagent on a test strip, and the determination is made based on the color reaction in a region (also called a test line) indicating the state of the reaction between the substance and the reagent.

[0003] When determining positive and negative, the presence or absence of the color reaction in the test line can be visually confirmed. However, when determining the density of the test line, dedicated equipment must be used for analysis.

[0004] Japanese Patent Application Laid-Open No. 2024-012250, Japanese Patent Application Laid-Open No. 2013-096726

[0005] However, when time elapses after the substance in the test object reacts with the reagent on the test strip (for example, when the test strip is sent to a place where dedicated equipment is installed, or when there are many inspection items and it takes a long time), the density of the test line increases over time (that is, the determination result changes), and an accurate determination result cannot be obtained.

[0006] Therefore, a method of taking a picture of the test strip and making a determination using the photographed data is known (Patent Document 1, Patent Document 2). However, the determination result changes depending on the imaging conditions such as lighting, and it is not easy to perform the inspection accurately.

[0007] An object of the present invention is to perform inspection accurately.

[0008] A method according to an embodiment of the present invention includes obtaining an image in which an object indicating the reaction between a test object and a reagent is photographed, and based on the relative value between the pixels in a region indicating that the inspection has been normally performed in the image and the pixels in a region indicating the state of the reaction in the image, determining the amount of the substance in the test object or the quality of the test object based on the amount of the substance.

[0009] According to the present invention, inspection can be performed accurately.

[0010] This is a diagram illustrating an example of an inspection kit according to one embodiment of the present invention. This is a diagram illustrating the calculation of the detection amount of a test line according to one embodiment of the present invention. This is a diagram illustrating the target area for imaging according to one embodiment of the present invention. This is a diagram illustrating the imaging conditions according to one embodiment of the present invention. This is an example of the overall configuration according to one embodiment of the present invention. This is a functional block diagram of an inspection system according to one embodiment of the present invention. This is a functional block diagram of an inspection device according to one embodiment of the present invention. This is a flowchart of the overall processing flow according to one embodiment of the present invention. This is a flowchart of the imaging process according to one embodiment of the present invention. This is a flowchart of the test line detection calculation process according to one embodiment of the present invention. This is an example of a screen that displays the target area for imaging and a screen that displays the result of the judgment according to one embodiment of the present invention. This is a diagram illustrating the focus according to one embodiment of the present invention. This is a diagram illustrating illumination detection according to one embodiment of the present invention. This is a diagram illustrating shadow detection according to one embodiment of the present invention. This is a hardware configuration diagram of a user terminal, server, and inspection device according to one embodiment of the present invention.

[0011] Embodiments of the present invention will be described below with reference to the drawings.

[0012] <Explanation of Terms> ・"Tested object" refers to the object being tested. For example, a tested object can be a human specimen, food, or a specimen derived from the living environment. For example, human specimens include the stratum corneum (e.g., scrapes of skin), skin, urine, saliva, etc. ・"Substance" refers to any substance within the tested object. For example, substances include proteins such as SCCA (squamous cell carcinoma antigen) 1, components of food ingredients, components of mold, hormones, proteins, viral antigens, bacterial antigens, mycotoxins, DNA (deoxyribonucleic acid), RNA (ribonucleic acid), etc. ・"Object showing reaction between substance and reagent" refers to a test strip coated with a reagent. The test strip has an area indicating that the test was performed normally (hereinafter also called the control line) and an area indicating the state of the reaction between the substance in the tested object and the reagent (hereinafter called the test line). Whether the test was performed normally and the state of the reaction between the substance in the tested object and the reagent are indicated by a color reaction. Furthermore, it may be indicated that the test was performed correctly by the absence of color development or discoloration. ・"Quality of the object under test" is any quality based on the amount of substance in the object under test. For example, the quality of the object under test may be the degree of skin inflammation. ・"Image target area" is the area of ​​the image used to determine the amount of substance or the quality of the object under test based on the amount of that substance. Specifically, the image target area is the area of ​​the image in which an object showing the reaction between the substance in the object under test and the reagent (e.g., a test strip) is photographed, including the control line and the test line. The image target area may be part of or all of the image in which an object showing the reaction between the substance in the object under test and the reagent (e.g., a test strip) is photographed (for example, if the entire test kit case is photographed, the image target area is part of the image; if only the test strip is photographed, the image target area is the entire image (the photographed image itself)). For example, the image target area is a rectangular area.

[0013] <Overview> In this invention, the amount of a substance in the substance to be tested or the quality of the substance based on that amount is determined by using the area of ​​the image captured from a test strip or the like on which the substance to be tested has been dropped (i.e., the area including the area indicating that the test was performed normally (control line) and the area indicating the reaction state between the substance in the substance to be tested and the reagent (test line)).

[0014] [Overview of the Test Kit] Figure 1 is a diagram illustrating an example of a test kit according to one embodiment of the present invention. For example, after performing an inspection using a test kit like the one in Figure 1, the amount of substance in the object being inspected or the quality of the object being inspected based on the amount of that substance can be determined by taking a photograph of the test strip or the like.

[0015] The test kit contains a test strip coated with reagents inside a case. The case has an opening through which the test strip can be observed. The test strip has a control line and a test line. The test strip may have multiple test lines, each indicating a reaction state with a different substance. The substance to be tested is dropped onto the test strip, and the test is performed using immunochromatography.

[0016] [Calculation of the detection amount of the test line] Figure 2 is a diagram illustrating the calculation of the detection amount of the test line according to one embodiment of the present invention. The line perpendicular to the control line and the test line is defined as the X-axis, and the line parallel to the control line and the test line is defined as the Y-axis.

[0017] The upper part of Figure 2 shows the area to be scanned. The area to be scanned includes the control line, test line, and the shadowed area caused by the test kit case. The lower part of Figure 2 is a histogram generated based on the pixel values ​​of the area to be scanned in the upper part of Figure 2. The calculation of the detection amount of the test line will be described in detail below.

[0018] 1. Generating a histogram showing the sum of pixel values ​​in the Y-axis direction of the target area First, as shown at the bottom of Figure 2, a histogram is generated that shows the sum of pixel values ​​in the Y-axis direction of the target area (also called the total value or cumulative value). The X-axis of the histogram indicates which pixel is from the left edge of the target area (i.e., X=1 indicates the leftmost pixel in the target area). The Y-axis of the histogram shows the sum of the pixel values ​​of all pixels that have a value on the X-axis. Note that in Figure 2, the histogram is the sum of inverted pixel values ​​(the pixel values ​​of the image are inverted).

[0019] For example, a pixel value is one of the R (Red), G (Green), or B (Blue) values ​​of the RGB spectrum (for example, the R value (a value between 0 and 255)).

[0020] 2. In the calculation histograms for regions A, B, and C, the following are calculated: region A, which is the region obtained by excluding the shaded area from the target area; region B, which includes the control line when region A is divided into two regions; and region C, which includes the test line when region A is divided into two regions.

[0021] - Exclusion of shaded areas: The exclusion of shaded areas will be explained. For example, the average value of the Y-axis values ​​can be calculated, and a predetermined value can be added to this average value to obtain a threshold. Area A can be calculated by excluding the parts that are above the threshold from both ends of the histogram.

[0022] • Dividing into two areas The division into two areas will be explained. For example, the area may be divided into two areas at a predetermined ratio depending on where the control line and the test line are indicated.

[0023] 3. Calculate Peak B, which is the peak value (the largest Y-axis value) in region B, and Peak C, which is the peak value (the largest Y-axis value) in region C. Note that the peak value may be a predetermined value of the largest Y-axis value (for example, 90% of the largest Y-axis value). Also, if the image pixel values ​​have not been inverted, the peak value will be the smallest Y-axis value (that is, in this invention, the peak value may be the maximum value or the minimum value).

[0024] 4. Calculation of the Test Line Detection Amount: The value of Peak C / Peak B is calculated as the detection amount of the test line (i.e., the result of detecting the color of the test line).

[0025] - Determining the quality of the object being inspected The quality of the object being inspected can be determined by predicting its quality from the amount detected by the test line calculated above. Specifically, a correspondence between the amount detected by the test line and the quality of the object being inspected (for example, the degree of skin inflammation) can be created in advance (for example, a machine learning model that is trained to output the quality of the object being inspected when the amount detected by the test line is input), and the quality of the object being inspected can be predicted from the amount detected by the test line using this correspondence.

[0026] - Prediction of the specific amount of substance The amount detected by the test line calculated above may be determined as the amount of substance in the object being tested, or the specific amount of substance predicted from the amount detected by the test line may be determined as the amount of substance in the object being tested. Specifically, a correspondence between the amount detected by the test line and the amount of substance measured by ELISA (enzyme-linked immunosorbent assay), etc. (for example, a machine learning model trained to output the amount of substance when the amount detected by the test line is input) may be created in advance, and the specific amount of substance (i.e., the amount of substance measured by ELISA, etc.) may be predicted from the amount detected by the test line using this correspondence.

[0027] - Prediction using images or histograms of the target area. Alternatively, the amount of a specific substance predicted from the image of the target area, or the amount of a specific substance predicted from the histogram generated from the image of the target area, may be determined as the amount of substance in the object being inspected. Specifically, a correspondence between the image or histogram of the target area and the amount of substance measured by ELISA or the like (for example, a machine learning model trained to output the amount of substance when an image or histogram of the target area is input) may be created in advance, and the amount of a specific substance (i.e., the amount of substance measured by ELISA or the like) may be predicted from the image or histogram of the target area using this correspondence.

[0028] [Shooting Target Area] Figure 3 is a diagram illustrating the shooting target area according to one embodiment of the present invention. The user terminal 11 or inspection device 10 (described later) extracts the shooting target area (specifically, an area including an area indicating that the inspection was performed normally (i.e., a control line) and an area indicating the reaction state between the substance in the object under inspection and the reagent (i.e., a test line)) and acquires an image of the shooting target area (specifically, the image of the shooting target area is stored in the storage unit of the user terminal 11 or inspection device 10).

[0029] As shown in [Example 1], if the shape of the opening of the test kit case (i.e., the part where the test strip is observed) is rectangular, the user terminal 11 or the testing device 10 can extract the opening as the area to be photographed.

[0030] As shown in [Example 2] and [Example 3], if the shape of the opening of the test kit case (i.e., the part where the test strip is observed) is not rectangular, the user terminal 11 or the testing device 10 can extract the rectangular area inside the opening as the area to be photographed.

[0031] [Shooting Conditions] Figure 4 is a diagram illustrating the shooting conditions according to one embodiment of the present invention. The rectangle in Figure 4 indicates the area to be photographed.

[0032] The user terminal 11 or inspection device 10 (described later) issues a warning if the area to be photographed does not meet the shooting conditions (for example, it outputs text, audio, etc., warning the user to change the shooting environment). The area to be photographed is made available to acquire an image of the area to be photographed that meets the shooting conditions (specifically, the image of the area to be photographed is stored in the storage unit of the user terminal 11 or inspection device 10).

[0033] For example, the shooting conditions are at least one of the following: the difference or ratio of opposite sides of the rectangular target area is less than a threshold, and the number of pixels in the target area is greater than or equal to a threshold.

[0034] This section describes the shooting condition where the difference or ratio of opposite sides of the rectangular target area is less than a threshold. If the difference or ratio of opposite sides of the target area in Figure 4 (for example, a and its opposite side) is greater than or equal to the threshold (i.e., the rectangle is distorted into a trapezoid or other shape instead of a rectangle), the control line and test line are distorted, and a warning will be issued to change the camera orientation. Note that b and its opposite side may also be used.

[0035] The shooting condition where the number of pixels in the target area is above a threshold is explained below. If the number of pixels in the target area in Figure 4 is below the threshold, a precise histogram cannot be generated, and a warning will be issued to bring the camera closer to the test paper or similar object.

[0036] <Overall Configuration Example> Figure 5 shows an overall configuration example according to one embodiment of the present invention.

[0037] [Example 1] The inspection system 1 includes a user terminal 11 and a server 12. The user terminal 11 and the server 12 can send and receive data from each other.

[0038] In Example 1, the server 12 determines the amount of substance in the object being inspected or the quality of the object based on the amount of that substance, and the user terminal 11 displays the result of the determination.

[0039] <<User Terminal>> The user terminal 11 is a terminal operated by the person who provides the object to be tested (for example, a human specimen). For example, the user terminal 11 may be a personal computer, tablet, smartphone, etc.

[0040] <<Server>> Server 12 is a server that can connect to one or more user terminals 11. Server 12 consists of one or more computers.

[0041] [Example 2] In Example 2, the inspection device 10 determines the amount of substance in the object to be inspected or the quality of the object to be inspected based on the amount of substance, and displays the result of the determination.

[0042] <<Inspection Device>> The inspection device 10 is a terminal operated by the person providing the object to be inspected (for example, a human specimen). For example, the inspection device 10 is a personal computer, tablet terminal, smartphone, etc.

[0043] <Functional blocks> The functional configuration of the inspection system 1 will be described below while referring to FIG. 6, and the functional configuration of the inspection device 10 will be described while referring to FIG. 7.

[0044] FIG. 6 is a functional block diagram of the inspection system 1 according to an embodiment of the present invention.

[0045] <<Server>> The server 12 can include an image acquisition unit 102, a determination unit 103, and a determination result output unit 104. The server 12 can function as the image acquisition unit 102, the determination unit 103, and the determination result output unit 104 by executing a program.

[0046] The image acquisition unit 102 acquires an image of an object (e.g., a test strip) showing the reaction between the substance and the reagent in the test object. For example, the image acquisition unit 102 receives, from the user terminal 11, an image of the imaging target area acquired by the user terminal 11.

[0047] The determination unit 103 determines the amount of the substance in the test object or the quality of the test object based on the amount of the substance, based on an area (control line) indicating that the inspection has been normally performed in the image acquired by the image acquisition unit 102 and an area (test line) indicating the state of the reaction (i.e., the reaction between the substance and the reagent in the test object) in the image acquired by the image acquisition unit 102 (e.g., based on the relative value of the pixels of both). Specifically, the determination unit 103 determines based on the sum of the pixel values of the area indicating that the inspection has been normally performed and the sum of the pixel values of the area indicating the state of the reaction (i.e., the reaction between the substance and the reagent in the test object) (e.g., based on the ratio of the sum of the pixel values of the area indicating that the inspection has been normally performed to the sum of the pixel values of the area indicating the state of the reaction (i.e., the reaction between the substance and the reagent in the test object)).

[0048] The determination result output unit 104 outputs (e.g., transmits to the user terminal 11) the result determined by the determination unit 103. 7>

[0049] <<User Terminal>> The user terminal 11 may include a shooting unit 201, a transmitting unit 202, a receiving unit 203, and a display unit 204. The user terminal 11 can function as the shooting unit 201, the transmitting unit 202, the receiving unit 203, and the display unit 204 by executing a program.

[0050] The imaging unit 201 photographs an object (for example, a test strip) that shows the reaction between a substance in the object being tested and the reagent.

[0051] For example, the imaging unit 201 extracts an area to be imaged that includes a control line indicating that the inspection was performed correctly, and a test line indicating the state of the reaction (i.e., the reaction between the substance in the object being inspected and the reagent). The imaging unit 201 issues a warning if the area to be imaged does not meet the imaging conditions, and acquires an image of the area to be imaged if the conditions are met (specifically, it stores the image of the area to be imaged in the user terminal 11 or the storage unit of the inspection device 10).

[0052] The transmission unit 202 transmits the image captured by the imaging unit 201 to the server 12.

[0053] The receiving unit 203 receives the result of the determination (i.e., the amount of substance in the object being inspected or the quality of the object being inspected based on the amount of that substance) from the server 12.

[0054] The display unit 204 displays the result of the judgment (i.e., the amount of substance in the object being inspected or the quality of the object being inspected based on the amount of that substance) received by the receiving unit 203 on the user terminal 11.

[0055] <<Inspection Device>> Figure 7 is a functional block diagram of an inspection device 10 according to one embodiment of the present invention. The inspection device 10 may include an imaging unit 101, an image acquisition unit 102, a determination unit 103, and a determination result output unit 104. The inspection device 10 can function as the imaging unit 101, the image acquisition unit 102, the determination unit 103, and the determination result output unit 104 by executing a program.

[0056] The imaging unit 101 photographs an object (for example, a test strip) that shows a reaction between a substance in the object being tested and a reagent.

[0057] For example, the imaging unit 101 extracts an area to be imaged that includes a control line indicating that the inspection was performed correctly, and a test line indicating the state of the reaction (i.e., the reaction between the substance in the object being inspected and the reagent). The imaging unit 101 issues a warning if the area to be imaged does not meet the imaging conditions, and acquires an image of the area to be imaged if the conditions are met (specifically, it stores the image of the area to be imaged in the user terminal 11 or the storage unit of the inspection device 10).

[0058] The image acquisition unit 102 acquires images of an object (for example, a test strip) that shows the reaction between a substance in the object being tested and a reagent. For example, the image acquisition unit 102 receives an image of the target area acquired by the imaging unit 101.

[0059] The determination unit 103 determines the amount of substance in the object being tested or the quality of the object being tested based on the amount of substance, based on the area in the image acquired by the image acquisition unit 102 that indicates that the inspection was performed normally (control line) and the area in the image acquired by the image acquisition unit 102 that indicates the state of the reaction (i.e., the reaction between the substance in the object being tested and the reagent) (test line). Specifically, the determination unit 103 makes the determination based on the sum of the pixel values ​​of the area indicating that the inspection was performed normally and the sum of the pixel values ​​of the area indicating the state of the reaction (i.e., the reaction between the substance in the object being tested and the reagent) (for example, based on the ratio of the sum of the pixel values ​​of the area indicating that the inspection was performed normally to the sum of the pixel values ​​of the area indicating the state of the reaction (i.e., the reaction between the substance in the object being tested and the reagent)).

[0060] The judgment result output unit 104 outputs the result determined by the judgment unit 103 (for example, displayed on the inspection device 10).

[0061] <Method> Figure 8 is a flowchart showing the overall processing flow according to one embodiment of the present invention.

[0062] In step 11 (S11), the imaging unit 201 of the user terminal 11 or the imaging unit 101 of the inspection device 10 photographs an object (for example, a test strip) that shows the reaction between the substance in the object to be tested and the reagent. The imaging process will be described in detail with reference to Figure 9. Images taken by terminals or devices other than the user terminal 11, or terminals or devices other than the inspection device 10, may also be used.

[0063] In step 12 (S12), the image acquisition unit 102 of the server 12 or the image acquisition unit 102 of the inspection device 10 acquires the image taken in S11 (that is, an image showing the reaction between the substance in the object being inspected and the reagent). For example, the image acquisition unit 102 of the server 12 or the image acquisition unit 102 of the inspection device 10 acquires an image of the target area extracted from the image showing the reaction between the substance in the object being inspected and the reagent.

[0064] In step 13 (S13), the determination unit 103 of the server 12 or the determination unit 103 of the inspection device 10 determines the amount of substance in the object being inspected or the quality of the object being inspected based on the amount of substance, based on the area in the image acquired in S12 that indicates that the inspection was performed normally (control line) and the area in the image acquired in S12 that indicates the state of the reaction (i.e., the reaction between the substance in the object being inspected and the reagent) (test line).

[0065] Figure 9 is a flowchart of the image capture process according to one embodiment of the present invention.

[0066] In step 21 (S21), the imaging unit 201 of the user terminal 11 or the imaging unit 101 of the inspection device 10 reads the image captured by the camera lens of the user terminal or the inspection device 10 (for example, by continuously reading a video, or by acquiring an image (still image) while recording a video).

[0067] In step 22 (S22), the imaging unit 201 of the user terminal 11 or the imaging unit 101 of the inspection device 10 extracts the target area from the image captured by the lens in S21 by pattern matching or the like.

[0068] In step 23 (S23), the imaging unit 201 of the user terminal 11 or the imaging unit 101 of the inspection device 10 rotates the area to be photographed extracted in S21. For example, the imaging unit 201 of the user terminal 11 or the imaging unit 101 of the inspection device 10 rotates so that the line perpendicular to the control line is parallel to the X-axis, and the line parallel to the control line is parallel to the Y-axis (the Y-axis is assumed to be perpendicular to the X-axis).

[0069] The imaging unit 101 may extract a straight line (either on the outside or at the opening) of the inspection kit case and rotate it so that the longer side is parallel to the X-axis, or it may extract characteristic points of the case (corners of the case or opening) and rotate it so that the straight line connecting the corners is parallel to the X-axis.

[0070] In step 24 (S24), the imaging unit 201 of the user terminal 11 or the imaging unit 101 of the inspection device 10 determines whether the area to be photographed in S23 meets the shooting conditions. If the area to be photographed in S23 does not meet the shooting conditions, the imaging unit 201 of the user terminal 11 or the imaging unit 101 of the inspection device 10 issues a warning.

[0071] In step 25 (S25), the imaging unit 201 of the user terminal 11 or the imaging unit 101 of the inspection device 10 displays the target area if the target area satisfies the imaging conditions in S24 (for example, the screen shown in S1001 of Figure 11 is displayed). Alternatively, the system may divide the system into items to be determined during imaging (i.e., whether the imaging conditions are met during imaging) and items to be determined after imaging (i.e., whether the imaging conditions are met after imaging). After the imaging conditions determined during imaging are met, the target area may be displayed, and a screen may be shown to the user to confirm whether the imaging conditions are met.

[0072] In step 26 (S26), the imaging unit 201 of the user terminal 11 or the imaging unit 101 of the inspection device 10 acquires an image of the target area displayed in S25 (specifically, the image of the target area is stored in the storage unit of the user terminal 11 or the inspection device 10). Alternatively, the image of the target area may be acquired when the operator instructs the system to proceed with the judgment process on the screen shown in S1001 of Figure 11.

[0073] Figure 10 is a flowchart of the process for calculating the detection amount of a test line according to one embodiment of the present invention.

[0074] In step 31 (S31), the determination unit 103 of the user terminal 11 or the determination unit 103 of the inspection device 10 generates a histogram showing the sum of the pixel values ​​in the Y-axis direction of the area to be photographed as described in Figure 2.

[0075] In step 32 (S32), the determination unit 103 of the user terminal 11 or the determination unit 103 of the inspection device 10 calculates, in the histogram of S31, the region obtained by excluding the shaded area from the area to be photographed (region A), the region containing the control line when region A is divided into two regions (region B), and the region containing the test line when region A is divided into two regions (region C). The region containing the control line (region B) is determined by either defining region B as the region containing the largest Y-axis value in region A (for example, 80% of the largest Y-axis value) when region A is divided into two regions, or by defining region B as a predetermined position relative to the opening into which the object to be inspected is dropped, which in Figure 1 is the region to the right of region A.

[0076] In step 33 (S33), the determination unit 103 of the user terminal 11 or the determination unit 103 of the inspection device 10 calculates Peak B, which is the peak value (largest Y-axis value) of region B in S31, and Peak C, which is the peak value (largest Y-axis value) of region C in S31. The peak value may be a predetermined value of the largest Y-axis value (for example, 90% of the largest Y-axis value). Also, if the pixel values ​​of the image have not been inverted, the peak value will be the smallest Y-axis value.

[0077] In step 34 (S34), the determination unit 103 of the user terminal 11 or the determination unit 103 of the inspection device 10 calculates the value of peak C / peak B as the detected amount of the test line (i.e., the result of detecting the color change of the test line).

[0078] <User Interface> Figure 11 is an example of a screen that displays the area to be photographed and a screen that displays the result of the determination according to one embodiment of the present invention.

[0079] As shown in step 1001 (S1001), a preview of the area to be photographed is displayed on the user terminal 11 or the inspection device 10. When the operator instructs the system on the screen to proceed with the judgment process, the screen shown in step 1002 is displayed. If the operator instructs the system on the screen to preview a different area to be photographed, a preview of the other area to be photographed is displayed. In this way, the operator inputs whether the image to be judged (i.e., the area to be photographed) is acceptable or not, thus preventing misjudgments due to shooting errors. Furthermore, if the operator instructs the system to retake the image, the system returns to the screen for taking the image and allows the system to retake the image.

[0080] As shown in step 1002 (S1002), the amount of substance in the object under inspection (e.g., expressed as a level, numerical value, or body or skin condition) or the quality of the object under inspection based on the amount of substance is displayed on the user terminal 11 or inspection device 10. Along with the amount of substance in the object under inspection or the quality of the object under inspection based on the amount of substance, an image of the area to be photographed may also be displayed. If the operator instructs the system to save the data on the screen, the result of the judgment is stored. In this way, data indicating the state at the time of inspection can be saved.

[0081] [Shooting Method] In one embodiment of the present invention, images are captured in the following manner.

[0082] When photographing the target area, if there are problems with the shooting conditions or environment, it may not be possible to make an accurate judgment, so a warning will be presented to the user. The content of the warning may include, for example, the focus of the target area, control line, test line, illumination of the shooting environment, and the reflection of shadows on the target area. The timing of the warning may be during image loading (i.e., during image loading in step 21) or after image loading (between step 21 and step 22). The timing of the warning may be changed depending on the content of the warning. For example, if the target area is distorted, the processing load for distortion detection is high, so it is more efficient to perform distortion detection and issue a warning after the image has been loaded once. For illumination of the shooting environment and reflection of shadows, the processing load for illumination and shadow detection may be low, so a warning may be issued while the image is being loaded.

[0083] (1) Detect whether the control line and test line are in focus and instruct the user to change the shooting conditions. Take a picture of the test paper, etc., and determine that the image is out of focus if the peak of the control line histogram is blunted. If the image is out of focus, instruct the user to take the picture again.

[0084] Focusing Instructions: Focus on the case or edge of the test kit's opening, where the brightness is above the threshold relative to the test strip (usually white). For example, making the case or edge of the test kit black will increase the contrast with the test strip, making focusing easier. If the image size of the target area is too large, i.e., the camera and test strip are too close, assume that focusing will not be possible and instruct the user to move the camera and test strip further apart.

[0085] (2) Detect the shadow of the device taking the picture, such as a smartphone, that is reflected on the test paper. - If there is a peak other than the peak of the control line and the peak of the test line in the histogram (histogram in Figure 2) which shows the sum of the pixel values ​​in the Y axis direction of the area to be photographed, it is determined that there is a shadow. - A histogram which shows the sum of the pixel values ​​in the X axis direction of the area to be photographed is generated and it is determined whether or not there is a shadow orthogonal to the control line and the test line.

[0086] (3) If the illuminance detection and color histogram are below a predetermined value, the system will determine that the illuminance of the shooting environment is low and issue a warning to move to a brighter location. - The system will move the camera while pointing it at a test paper or similar object and displaying it on the screen, detecting focus and shadows, and when the optimal position is reached with focus and no shadows, it will prompt the user to take a picture and then take the picture.

[0087] (4) If the area to be photographed is trapezoidal or the like, the image processing may be performed without issuing a warning to correct the image of the trapezoidal or the like area to a rectangular image.

[0088] [Focus] Figure 12 is a diagram illustrating focus according to one embodiment of the present invention. The upper part of Figure 12 shows the case when the image is in focus, and the lower part of Figure 12 shows the case when the image is out of focus. Whether the image is in focus is detected from the cumulative pixel value of the control line. If the width in the Y-axis direction where the cumulative pixel value is equal to or greater than a reference value (average value of cumulative pixel values) near the maximum value of the control line is equal to or greater than a predetermined value (e.g., 10%) of the Y-axis width of the entire extracted area (test paper), the image is considered out of focus. If it is determined that the image is out of focus, and the size of the long side of the test paper is equal to or greater than a predetermined value relative to the number of pixels in the captured image, the user is instructed to move the test kit away. If it is within the predetermined value, the user is instructed to touch the area of ​​the test paper on the screen during capture. In addition, to make focusing easier, the case of the test kit may be set to a predetermined value or less that makes it easier to focus with respect to the brightness or RGB value of the test paper.

[0089] [Illuminance Detection] Figure 13 is a diagram illustrating illumination detection according to one embodiment of the present invention. The upper part of Figure 13 shows the case of low illumination, and the lower part of Figure 13 shows the case of high illumination (i.e., good illumination). The system estimates whether the shooting environment has sufficient illumination for shooting from the color histogram of the area on the test paper. The system acquires a color histogram of one of the following: R, G, or B in an RGB image, L in a Lab image, V in an HSV image, Y in a YIQ image, or V in an HSV image. If the distribution of the color histogram, such as the peak or mean of the colors, is below a predetermined value, the system warns that the illumination is low and advises the user to avoid casting shadows on the test paper or to move to a brighter location. In the case of Figure 13, the peak value is around 128.

[0090] [Shadow Detection] Figure 14 is a diagram illustrating shadow detection according to one embodiment of the present invention. If the test paper is partially shadowed, it may not be judged correctly. Therefore, after detecting the case of the test kit or the test paper area, the cumulative pixel value in the Y-axis direction is obtained with the long side of the test paper parallel to the X-axis, and if there is a difference in the average value of a predetermined range in the Y-axis direction other than the test paper (case area 1 and case area 2 in Figure 14), it is determined that there is a shadow, and instructions are given to hold the test paper in your hand to avoid shadowing or to take a picture in a way that avoids shadowing. If only the test paper is used, the average value of a predetermined range other than the test line and control line area is compared.

[0091] <Effect> In one embodiment of the present invention, by using not only the pixel values ​​of the test line region in the image but also the pixel values ​​of the control line region, it is possible to accurately determine the density of the test line without being affected by lighting or other factors.

[0092] <Hardware Configuration> Figure 15 is a hardware configuration diagram of a user terminal 11, a server 12, and a testing device 10 according to one embodiment of the present invention. The user terminal 11, server 12, and testing device 10 may include a control unit 1001, a main memory unit 1002, an auxiliary memory unit 1003, an input unit 1004, an output unit 1005, and an interface unit 1006. Each of these will be described below.

[0093] The control unit 1001 is a processor (for example, a CPU (Central Processing Unit), a GPU (Graphics Processing Unit), etc.) that executes various programs installed in the auxiliary storage unit 1003.

[0094] The main memory unit 1002 includes non-volatile memory (ROM (Read Only Memory)) and volatile memory (RAM (Random Access Memory)). The ROM stores various programs, data, etc. necessary for the control unit 1001 to execute various programs installed in the auxiliary memory unit 1003. The RAM provides a work area that is expanded when various programs installed in the auxiliary memory unit 1003 are executed by the control unit 1001.

[0095] The auxiliary storage unit 1003 is an auxiliary storage device that stores various programs and information used when various programs are executed.

[0096] The input unit 1004 is an input device that allows operators of the user terminal 11, server 12, and inspection device 10 to input various instructions to the user terminal 11, server 12, and inspection device 10.

[0097] The output unit 1005 is an output device that outputs the internal status of the user terminal 11, server 12, inspection device 10, etc.

[0098] The interface unit 1006 is a communication device for connecting to a network and communicating with other devices.

[0099] Although embodiments of the present invention have been described in detail above, the present invention is not limited to the specific embodiments described above, and various modifications and changes are possible within the scope of the gist of the present invention as described in the claims.

[0100] This international application claims priority under Japanese Patent Application No. 2025-003793, filed on 9 January 2025, and the entire contents of No. 2025-003793 are incorporated herein by reference.

[0101] 1 Inspection System 11 User Terminal 12 Server 10 Inspection Device 101 Imaging Unit 102 Image Acquisition Unit 103 Judgment Unit 104 Judgment Result Output Unit 201 Imaging Unit 202 Transmission Unit 203 Receiving Unit 204 Display Unit 1001 Control Unit 1002 Main Memory Unit 1003 Auxiliary Memory Unit 1004 Input Unit 1005 Output Unit 1006 Interface Unit

Claims

1. A method comprising: acquiring an image of an object showing a reaction between an object to be tested and a reagent; and determining the amount of substance in the object to be tested or the quality of the object to be tested based on the amount of substance, based on the relative values ​​of pixels in the image that indicate that the test was performed normally and pixels in the image that indicate the state of the reaction.

2. The method according to claim 1, wherein the fact that the inspection was performed normally and the state of the reaction are indicated by a color reaction, and the pixels are the cumulative value of the pixel values ​​in the region indicating that the inspection was performed normally and the cumulative value of the pixel values ​​in the region indicating the state of the reaction.

3. The method according to claim 2, wherein the determination is made based on the ratio of the cumulative value of pixel values ​​in the region indicating that the inspection was performed normally to the cumulative value of pixel values ​​in the region indicating the state of the reaction.

4. The method according to claim 1, further comprising taking the image, wherein, at the time of taking the image, a warning is issued if the difference or ratio of opposite sides of a rectangular region including the region indicating that the inspection was performed normally and the region indicating the state of the reaction is greater than or equal to a threshold.

5. The method according to claim 1, further comprising capturing the image, wherein, at the time of capturing the image, a warning is issued if the number of pixels in the region including the region indicating that the inspection was performed normally and the region indicating the state of the reaction is less than a threshold.

6. The method according to claim 1, wherein the object to be tested is a human specimen, food, or a specimen derived from the living environment.

7. The method according to claim 1, wherein the substance is one of the following: a component of a food ingredient, a component of a mold, a hormone, a protein, a viral antigen, a bacterial antigen, a mycotoxin, DNA, or RNA.

8. The method according to claim 7, wherein the protein is SCCA1.

9. The method according to claim 1, wherein the amount of the substance is the amount of SCCA1, and the quality of the object to be examined is the degree of skin inflammation.

10. An inspection apparatus comprising: an image acquisition unit that acquires an image of an object showing a reaction between a substance and a reagent in the object to be inspected; and a determination unit that determines the amount of the substance or the quality of the object to be inspected based on the amount of the substance, based on the relative value between the pixels in the image that indicate that the inspection was performed normally and the pixels in the image that indicate the state of the reaction.

11. A program that causes an inspection device to perform the following actions: acquire an image of an object being inspected that shows a reaction between a substance and a reagent; and determine the amount of the substance or the quality of the object being inspected based on the amount of the substance, based on the relative values ​​between the pixels in the image that indicate that the inspection was performed normally and the pixels in the image that indicate the state of the reaction.

12. An inspection system including a server and a user terminal, wherein the server includes an image acquisition unit that acquires an image of an object showing a reaction between a substance and a reagent in the object to be inspected, and a determination unit that determines the amount of the substance or the quality of the object to be inspected based on the amount of the substance, based on the relative value between pixels in the image indicating that the inspection was performed normally and pixels in the image indicating the state of the reaction, and the user terminal transmits the image to the server and acquires and displays the result of the determination from the server.

13. A method for photographing an object that shows a reaction between a substance and a reagent within an object to be inspected, comprising: extracting a target area that includes at least an area indicating that the inspection was performed normally and an area indicating the state of the reaction; issuing a warning if the target area does not meet the shooting conditions while the image is being loaded or after the image has been loaded, and acquiring an image of the target area if the target area meets the shooting conditions.

14. The imaging method according to claim 13, wherein the imaging target area is a rectangular area, and the imaging condition is not met if the difference or ratio of opposite sides of the rectangular area is greater than or equal to a threshold.

15. The shooting method according to claim 13, wherein if the shooting conditions are not met, the number of pixels in the area to be shot may be less than a threshold.

Images