Inspection device, inspection system, inspection method, and storage medium

Abstract

This inspection device comprises: a data acquisition device that acquires image data and includes a first color development unit that reacts with a specific substance in a specimen and develops a color, and a reference unit that displays a sample color used to determine the color of the first color development unit and a reference color used in the correction of variation caused by an arrangement; and a determination device that determines the amount of the specific substance on the basis of the color information about the first color development unit, the color information about the sample color, and the color information about the reference color.

Description

Inspection device, inspection system, inspection method, and storage medium

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

[0002] Immunochromatography-based testing instruments for antibody and antigen tests have been disclosed (see, for example, Patent Documents 1 and 2). The test instruments of Patent Documents 1 and 2 include, for example, a case having a sample drop window and a detection window for visually observing the state of the test strip, in which a test strip with a labeled antigen or antibody and a capture antigen or antibody immobilized thereon is enclosed. Specifically, in the test strip, the labeled antigen or antibody is immobilized at the drop window, and the capture antigen or antibody is immobilized in a line at the detection window. The labeled antigen or antibody is labeled with, for example, a metal colloid. When a sample is dropped onto the drop window, the antibody or antigen in the sample forms a complex with the labeled antigen or antibody. The complex migrates the test strip toward the detection window and is captured by the capture antigen or antibody. This capture causes the test strip to develop a color at the location where the labeled antigen or antibody is fixed, resulting in the appearance of a line in the detection window. The appearance of this line determines the presence or absence of an antibody or antigen in the sample.

[0003] The level of antibodies, etc., can also be determined according to the color tone of the line by comparing it with a judgment card with an arrangement of color samples. When the judgment using the above-mentioned test device is performed automatically rather than visually, it is possible to perform the judgment by image analysis of the line. However, depending on the photography technique and photography environment (lighting conditions at the time of photography, photography situation, etc.) when taking the image, the color tone of the image may differ from the actual color tone. Therefore, depending on the photography environment, etc., the color tone of the line in the image may vary greatly, resulting in variation in the test judgment.

[0004] Here, a technology has been disclosed in which image data of a patient's face taken on a patient's terminal is sent to a medical institution and various medical diagnoses are performed based on the image data (Patent Document 3). Also, a technology has been disclosed in which image data of a specimen taken together with a predetermined color sample or color grid is analyzed (Patent Documents 4 and 5). However, the technologies of Patent Documents 3 to 5 do not solve the variation in judgment caused by variations in color tone of the captured image due to the imaging technique or imaging environment.

[0005] Japanese Patent Application Laid-Open No. 2022-119435 Japanese Patent Application Laid-Open No. 2016-102790 Japanese Patent Application Laid-Open No. 10-165375 Japanese Patent Application Laid-Open No. 2016-161301 Special Publication No. 2017-515106

[0006] In view of the above problems, an object of the present invention is to provide a testing device, a testing system, a testing method, and a storage medium that can appropriately determine the amount of a specific substance in a sample.

[0007] According to one embodiment, the testing device comprises a data acquisition device that acquires image data including a color-developing section that reacts with a specific substance in a sample and develops color, and a reference section that displays a sample color used to determine the color of the color-developing section and a reference color used to correct for variations due to placement, and a determination device that determines the amount of the specific substance based on the color information of the color-developing section, the color information of the sample color, and the color information of the reference color obtained from the image data.

[0008] According to one embodiment, the testing system comprises a data acquisition device that acquires image data including a color-developing section that reacts with a specific substance in a sample to develop a color, and a reference section that displays a sample color used to determine the color of the color-developing section and a standard color used to correct for variations due to placement, and a determination device that determines the amount of the specific substance based on the color information of the color-developing section, the color information of the sample color, and the color information of the standard color obtained from the image data.

[0009] According to one embodiment, the testing method comprises acquiring image data including a color-producing section that reacts with a specific substance in a sample and produces a color, and a reference section that displays a sample color used to determine the color of the color-producing section and a standard color used to correct for variations due to placement, and determining the amount of the specific substance based on the color information of the color-producing section, the color information of the sample color, and the color information of the standard color obtained from the image data.

[0010] According to one embodiment, a non-transitory storage medium storing a program causes a control device to acquire image data including a color-producing section that reacts with a specific substance in a sample and produces a color, and a reference section that displays a sample color used to determine the color of the color-producing section and a standard color used to correct for variations due to placement, and to determine the amount of the specific substance based on the color information of the color-producing section, the color information of the sample color, and the color information of the standard color obtained from the image data.

[0011] FIG. 1 is a block diagram showing an outline of a testing system according to one embodiment. FIG. 2 is a block diagram showing the configuration of a user terminal according to one embodiment. FIG. 3 is a block diagram showing the configuration of a testing device according to one embodiment. FIG. 4 is a front view showing an example of the configuration of a testing kit. FIG. 5 is a front view showing a testing instrument included in the testing kit. FIG. 6 is a front view showing a mount included in the testing kit. FIG. 7 is a diagram explaining an example of image data. FIG. 8 is a flowchart showing automatic determination among the operations of the testing system. FIG. 9 is a diagram showing the relationship between an estimated value of saturation and the amount of a specific substance among the color information at the position of the first color-developing unit. FIG. 10 is a flowchart showing the operations of the testing system. FIG. 11 is a front view showing a modified example of the testing kit or image data. FIG. 12 is a front view showing a modified example of the testing kit or image data. FIG. 13 is a front view showing a modified example of the testing kit or image data. FIG. 14 is a front view showing a modified example of the testing kit or image data.

[0012] [Embodiment] An inspection system according to an embodiment will be described below with reference to the drawings.

[0013] An example of the configuration of the testing system 1 will be described with reference to Figures 1 to 3. Figure 1 is a block diagram showing an outline of the testing system 1. The testing system of this embodiment acquires image data of a testing instrument placed on a predetermined mount, and performs image processing on the image data to correct color information of the image data, thereby determining the amount of a specific substance in a sample.

[0014] 1, the inspection system 1 includes an inspection device 4. The inspection device 4 is connected to user terminals 2 (2a, 2b, ..., 2n) via a communication line 3. Note that the inspection system 1 may include both the inspection device 4 and the user terminals 2.

[0015] 2 is a block diagram showing the configuration of the user terminal 2. The user terminal 2 is, for example, an information terminal operated by a user. The user terminal 2 photographs an inspection instrument 5 (described later) used in an inspection, and transmits the image data from the user terminal 2 to the inspection device 4. The user is a person who provides image data for inspection to the inspection device 4, and may be the subject who provides the specimen, or may be a person different from the subject.

[0016] Examples of the user terminal 2 include various types of computers such as personal computers, smartphones, and tablet terminals.

[0017] The user terminal 2 includes a control device 21 , a main memory device 22 , a communication interface 23 , an input / output interface 24 , an auxiliary memory device 25 , and an image capturing device 26 .

[0018] The control device 21 includes a processing unit such as a CPU, reads out the computer program P1 and data stored in the auxiliary storage device 25, and executes predetermined information processing (specifically, various processes executed by the user terminal 2). The main storage device 22 includes a memory device such as a DRAM, and temporarily stores data required for the control device 21 to execute the processing.

[0019] The communication interface 23 is an interface for communicating with the inspection device 4. The communication interface 23 serves as a data transmission device IT and transmits image data acquired by the imaging device 26 to the inspection device 4. The communication interface 23 also transmits various data required for inspection to the inspection device 4. The communication interface 23 also receives inspection result data from the inspection device 4.

[0020] The input / output interface 24 is an interface for receiving input signals from a keyboard, mouse, touch panel, etc., and for outputting various output signals to a display, etc.

[0021] The auxiliary storage device 25 is a non-volatile storage medium or non-transitory storage medium NM such as a hard disk or flash memory, and stores the computer program P1 and data used by the control device 21 to execute various information processes. The auxiliary storage device 25 stores data necessary for testing, test result data received from the testing device 4 (described below), and the like. The computer program P1 and the above data may be stored and provided in a storage medium other than the auxiliary storage device 25. Examples of storage media include a flexible disk, a hard disk, a CD-ROM, an MO (magnetic disk), a DVD-ROM, and a memory card. The computer program P1 can also be transmitted to the user terminal 2 via the communication line 3 and installed.

[0022] Data required for testing includes, for example, image data, vaccination history, PCR test history, antibody test history, antigen test history, negative certificate issuance history, etc. Test result data includes, for example, the amount of a specific substance, etc.

[0023] The photographing device 26 is, for example, a camera, and photographs the inspection tool 5 (described later) and the like to obtain image data.

[0024] 3 is a block diagram showing the configuration of the inspection device 4. The inspection device 4 is, for example, an information terminal of an inspection institution that performs inspections based on image data of the inspection instrument 5 acquired from the user terminal 2. The inspection device 4 performs automatic inspections, automatic judgments, etc. based on the image data acquired from the user terminal 2, and transmits the inspection results to the user terminal 2.

[0025] The inspection device 4 may be a general-purpose computer or a multi-computer consisting of multiple computers. The inspection device 4 may also utilize cloud computing.

[0026] The inspection device 4 includes a control device 41 , a main memory device 42 , a communication interface 43 , an input / output interface 44 , and an auxiliary memory device 45 .

[0027] The control device 41 includes a processing unit such as a CPU, reads out the computer program P2 and data stored in the auxiliary storage device 45, and executes predetermined information processing (specifically, various processes executed by the inspection device 4, which will be described later). The main storage device 42 includes a memory device such as a DRAM, and temporarily stores data required for the control device 41 to execute the processing.

[0028] The control device 41 includes a determination device 41a that analyzes image data acquired from the user terminal 2 and outputs test results. The control device 41 implements the determination device 41a by reading and executing a computer program P2. The determination device 41a determines the amount of a specific substance in a sample based on color information of the first color generating unit 55, color information of the sample color SC, and color information of the reference color BC obtained from the image data 20 (described later) (see FIG. 7). Specifically, the determination device 41a estimates corrected color information of at least one of the first color generating unit 55 and the color sample 64 using gradient information calculated from the color information of the reference display unit 62 obtained from the image data 20, thereby determining the amount of the specific substance. The operation of the determination device 41a will be described later.

[0029] The communication interface 43 is, for example, an interface for communicating with the user terminal 2. As a data acquisition device IG, the communication interface 43 receives image data of the inspection instrument 5 and the like from the user terminal 2. The communication interface 43 also receives various data necessary for the inspection from the user terminal 2. The communication interface 43 also transmits inspection result data to the user terminal 2.

[0030] The input / output interface 44 is an interface for receiving input signals from a keyboard, a mouse, etc., and for outputting various output signals to a display, etc.

[0031] The auxiliary storage device 45 is a non-volatile storage medium or non-transitory storage medium NM such as a hard disk or flash memory, and stores the computer program P2 and data used by the control device 41 to execute various information processes described below. The auxiliary storage device 45 stores data required for the inspection received from the user terminal 2, inspection result data, etc. The computer program P2 and the above data may be provided by being stored in a storage medium other than the auxiliary storage device 45. Examples of storage media include a flexible disk, a hard disk, a CD-ROM, an MO (magnetic disk), a DVD-ROM, and a memory card. The computer program P2 can also be transmitted to the inspection device 4 via the communication line 3 and installed.

[0032] The test kit and the like used for the test will be described below with reference to Figures 4 to 6. In this embodiment, a test for a neutralizing antibody will be described as an example, but the test target of the test system 1 according to this embodiment is not limited to this.

[0033] 4 is a front view showing an example of the configuration of the test kit 10. The test kit 10 includes a test device 5 and a mount 6 on which the test device 5 is placed. The test device 5 and the mount 6 are test devices provided in advance to the subject by a testing institution.

[0034] 5 is a front view showing the test instrument 5 of the test kit 10. The test instrument 5 has a sample receiving section 51, a buffer receiving section 52, and a result display section 53. The sample receiving section 51, the buffer receiving section 52, and the result display section 53 are connected via filter paper PF housed in a cassette section 54 of the test instrument 5. In the cassette section 54, the filter paper PF is exposed in the areas corresponding to the sample receiving section 51, the buffer receiving section 52, and the result display section 53.

[0035] The sample receiving section 51 is the section that receives the sample. The sample is the test material, such as blood in the case of a neutralizing antibody test. The sample can be changed depending on the test, and in addition to blood, for example, saliva, nasopharyngeal swab, nasal swab, cerebrospinal fluid, urine, tears, other secretions, tissue parts, etc. can be used. The sample contains a specific substance to be tested. The specific substance is, for example, an antibody or antigen. A labeled substance that reacts with the specific substance to form a complex is immobilized on the filter paper portion corresponding to the sample receiving section 51. The labeled substance is, for example, a labeled antigen or labeled antibody. In the sample receiving section 51, the specific substance and the labeled substance combine to form a complex, which moves toward the result display section 53. The labeled substance may also be immobilized on the filter paper portion corresponding to the result display section 53.

[0036] The buffer receiving section 52 is a section that receives a buffer solution. The buffer dropped into the buffer receiving section 52 moves toward the result display section 53 and assists the movement of the composite substance.

[0037] The result display unit 53 displays test results regarding the presence or absence of a specific substance in the sample and the amount of the specific substance. The filter paper portion corresponding to the result display unit 53 has a capture line TL and a control line CL. A capture substance that specifically binds to the complex substance is adsorbed or immobilized linearly on the upstream capture line TL. Examples of the capture substance include a capture antigen and a capture antibody. Examples of the control substance that specifically binds to the labeled substance are immobilized linearly on the downstream control line CL. Examples of the control substance include a control antigen and a control antibody.

[0038] In the result display unit 53, the complex substance binds to the capture substance, resulting in a concentrated state of colored particles derived from the labeling substance, and the capture line TL changes color. As a result, a band-shaped first color-forming portion 55 appears in the capture line TL. Furthermore, in the result display unit 53, the labeling substance binds to the control substance, resulting in a concentrated state of colored particles derived from the labeling substance, and the control line CL changes color. As a result, a band-shaped second color-forming portion 56 appears in the control line CL. The second color-forming portion 56 changes color when the buffer is properly dispensed. If both the first color-forming portion 55 and the second color-forming portion 56 change color, it is determined that the sample contains a specific substance. Furthermore, the amount of the specific substance is determined based on the color tone (e.g., the shade of color) of the first color-forming portion 55. In the case of a neutralizing antibody test, the amount of the specific substance is, for example, the antibody titer.

[0039] FIG. 6 is a front view showing the mount 6 of the test kit 10. FIG. 6 shows the mount 6 without the test device 5 placed on it. The mount 6 has a placement area 61, a reference display section 62, and a chart section 63. The reference display section 62 and the chart section 63 form a reference section 69 used in processing image data, which will be described later. The reference section 69 displays a sample color SC used to determine the color of the first color-producing section 55 and a reference color BC used to correct for variations due to placement. The sample color SC is the display color of a color sample 64 of the chart section 63, which will be described later. The reference color BC is the display color of the reference display section 62, which will be described later.

[0040] The placement area 61 is an area where the test instrument 5 is placed. The placement area 61 is disposed approximately in the center of the mount 6.

[0041] The reference display unit 62 is used for calibration and serves as a reference for calculating the amount of correction required to correct color unevenness due to illumination light resulting from the photography technique or photography environment (e.g., lighting conditions during photography, photography situation, etc.). The reference display unit 62 is disposed to surround the mounting area 61 and the chart unit 63. The reference display unit 62 displays a reference color BC for estimating corrected color information that compensates for positional differences for at least one of the first color development unit 55 and the color sample 64 of the chart unit 63. Because a gradient occurs in the image data 20 due to the photography environment, etc., the control device 41 of the inspection device 4 functions as a judgment device 41a to compensate for positional differences based on the gradient information of the reference color BC and estimate corrected color information for the color sample 64 or the first color development unit 55 assuming that it is located at the position of the first color development unit 55 or the color sample 64. The reference display unit 62 is displayed, for example, as a single reference color BC. Specifically, the reference display unit 62 is colored with a color corresponding to predetermined color information (for example, color components such as red, green, and blue in the RGB color space, or hue, saturation, and brightness in the HSV (HSB) color space). The color information is obtained directly from the image data 20. The color information is information that constitutes the image data 20 or the camera image, and includes hue, saturation, brightness, and the like. The corrected color information is color information that allows comparison by offsetting the influence of gradients due to differences in the arrangement of the first color development unit 55 and the chart unit 63 (color sample 64).

[0042] The chart section 63 is an index that is compared with the color or color information of the first color-forming section 55 to determine the amount of a specific substance. The chart section 63 is arranged in two locations on both sides of the mounting area 61 in the left-right direction, i.e., the X direction. That is, the chart section 63 has a first chart section 63a on the left side and a second chart section 63b on the right side. The chart section 63 has a color sample 64 that displays a sample color SC to be compared with the color of the first color-forming section 55. The first chart section 63a and the second chart section 63b each have a plurality of color samples 64 with different gradations.

[0043] The color sample 64 is a sample of a color corresponding to the amount of a specific substance. The color sample 64 has predetermined color information (for example, color components such as red, green, and blue in the RGB color space, or hue, saturation, and brightness in the HSV (HSB) color space). In the first chart portion 63a and the second chart portion 63b, the color samples 64 are arranged line-symmetrically. That is, in the first chart portion 63a and the second chart portion 63b, the color samples 64 have the same color and arrangement.

[0044] In the illustrated example, the color sample 64 includes a first color sample 64a, a second color sample 64b, and a third color sample 64c. The first color sample 64a, the second color sample 64b, and the third color sample 64c each have a different gradation. For example, the saturation of the first color sample 64a is higher than that of the second color sample 64b and lower than that of the third color sample 64c. That is, the colors become darker in the order of the second color sample 64b (light color), the first color sample 64a (medium color), and the third color sample 64c (dark color). Here, the color of the reference display portion 62 (reference color) is the same as the medium color among the multiple color samples 64. That is, the first color sample 64a has the same color as the reference display portion 62, but is not limited to this. Furthermore, the position and number of each color sample 64 are not limited to this.

[0045] The mount 6 preferably has an identification section 67 that includes individual information (lot information, serial information, etc.) of the inspection tool 5 and can be read by any reader terminal (including a smartphone or computer). The identification section 67 is, for example, a two-dimensional barcode. However, the form of the identification section 67 is not limited to this. The identification section 67 may also be provided on the inspection tool 5.

[0046] The identification unit 67 can confirm that the test tool 5 displayed in the image data 20 (described later) is being used for the first time in this test. This makes it possible to prevent, for example, the image data 20 of a test tool 5 that was previously positive (having antibodies) from being used again.

[0047] According to the test kit 10 or test instrument 5 described above, the process for obtaining test results is simple, and the amount of the specific substance can be visually determined based on the color tone of the first color-producing portion 55 .

[0048] Image data acquired from the user terminal will be described with reference to Fig. 7. Fig. 7 is a diagram illustrating an example of image data 20.

[0049] The image data 20 is obtained by photographing the mount 6 on which the inspection tool 5 is placed. That is, the image data 20 is an image including the inspection tool 5 and the mount 6. Specifically, the image data 20 includes the first color-forming portion 55, the reference display portion 62, and the chart portion 63 of the inspection tool 5. In other words, the image data 20 includes the first color-forming portion 55 and the reference portion 69.

[0050] The color information (color components) of pixels displayed in the image data 20 is usually based on the RGB color space. In this embodiment, the control device 41 of the inspection device 4 preferably converts the RGB color components of each pixel of the acquired image data 20 into color information (hue, saturation, and brightness) in the HSV (HSB) color space, which is easier to analyze. However, the control device 41 does not have to convert the color information, and even if it does convert the color information, it may convert it into color information in another color space. Furthermore, the control device 41 may convert the color information of all pixels in the image data 20, or may convert the color information of only pixels located in a specific location.

[0051] In the image data 20, if both the first color forming section 55 and the second color forming section 56 of the result display section 53 are colored, it is determined that the sample contains a specific substance. In addition, the amount of the specific substance is determined based on the color tone of the first color forming section 55. The color tone is the shade of the color, and is indicated, for example, by the level of saturation. If only the second color forming section 56 is colored, it is determined that the sample does not contain the specific substance. If only the first color forming section 55 is colored, it is determined that there is an inspection error.

[0052] The first coloring section 55 changes its color density depending on the amount of the specific substance. For example, the saturation of the color information in the first coloring section 55 changes. When a light color appears in the first coloring section 55, the first coloring section 55 indicates that the amount of the specific substance is low. On the other hand, when a dark color appears in the first coloring section 55, the first coloring section 55 indicates that the amount of the specific substance is high.

[0053] Hereinafter, automatic determination using image data in the testing device 4 will be described with reference to Fig. 8 etc. Here, automatic determination means determining the amount of a specific substance in a sample by determining the color of the first color developing unit 55. Fig. 8 is a flowchart showing automatic determination, which is one of the operations of the testing system 1.

[0054] As described above, in the test tool 5, the color tone of the first color-forming portion 55 serves as an index for determining the amount of a specific substance. When performing a test using image data 20 of the test tool 5 captured by the user terminal 2, the color tone of the first color-forming portion 55 displayed in the acquired image may differ from the actual color tone depending on the capture technique and capture environment. Capture techniques and capture environments vary from user to user. Therefore, the color tone of the first color-forming portion 55 in the image data 20 is expected to vary significantly. Furthermore, the illuminance distribution of the illumination light illuminating the test tool 5 and the distribution of reflected light from the test tool 5 differ depending on the test tool 5. Therefore, the color tone (color information) of the first color-forming portion 55 displayed in the image data 20 may be affected not only by the capture angle but also by the relative position of the test tool 5 with respect to the illumination.

[0055] Furthermore, the illuminance distribution of the light illuminating the mount 6 and the distribution of the light reflected from the mount 6 also differ depending on the position on the mount 6. Therefore, the color information of the reference display section 62 and the chart section 63 (color sample 64) displayed in the image data 20 may differ from the actual color information.

[0056] In consideration of the above, the control device 41 of the inspection device 4 performs a correction process on the image data 20 based on the correction value of the reference display section 62, and corrects variations in the color information of the first color forming section 55 and the chart section 63.

[0057] In advance, the control device 41 of the inspection device 4, as the determination device 41a, specifies color information and positions of each part in the image data 20 acquired from the user terminal 2 (step S1). Note that, when determining the presence or absence of a specific substance (inspection determination) described below, it is preferable that these specifications be performed after acquiring the image data 20 and before the inspection determination.

[0058] The control device 41 of the inspection device 4, functioning as the determination device 41a, calculates gradient information of the reference display section 62 from the image data 20 (step S2). Here, gradient information refers to the amount of change in color information per unit pixel or unit length. Specifically, the control device 41 calculates gradient information of color information (e.g., saturation) corresponding to the reference display section 62 from an arbitrary position to another position on the reference display section 62. For example, the control device 41 calculates gradient information L1 (gradient information along the X direction) from point A to point C on the reference display section 62 shown in FIG. 7 and gradient information L2 (gradient information along the Y direction) from point A to point B on the reference display section 62. Note that the method of calculating the gradient information can be changed as appropriate.

[0059] Next, the control device 41 of the inspection device 4, functioning as the determination device 41a, calculates the gradient between the color sample 64 and the first coloring unit 55 (step S3). Here, the gradient refers to the amount of change in color information corresponding to the color sample 64 between the color sample 64 and the first coloring unit 55. The gradient is a difference correction value in a specific direction and corresponds to the correction value of the color sample 64. Specifically, the control device 41 calculates a gradient V1 of color information (saturation) corresponding to the first color sample 64a between the first coloring unit 55 and the first coloring unit 55 based on the gradient information L1, gradient information L2, the position of the first color sample 64a, and the position of the first coloring unit 55. This makes it possible to estimate, for example, the gradient V1 in the direction from the first coloring unit 55 to the first color sample 64a shown in FIG. 7.

[0060] For example, when the gradient information is L1, the gradient information is L2, the position (coordinates) of the first color sample 64a is (Xa, Ya), and the position (coordinates) of the first color forming unit 55 is (Xs, Ys), the gradient V1 is calculated by the following formula: V1=(Xs-Xa)×L1+(Ys-Ya)×L2 Here, the value (Xs-Xa)×L1 is the gradient of the color information along the X direction, and the value (Ys-Ya)×L2 is the gradient of the color information along the Y direction.

[0061] The control device 41 of the inspection device 4, functioning as the determination device 41a, calculates an estimated value (corrected color information) of the color information of the color sample 64 at the position of the first color developing unit 55 (step S4). Specifically, the control device 41 estimates the corrected color information of the first color sample 64a at the position of the first color developing unit 55 from the gradient V1. When the color information of the first color sample 64a is Cs, the corrected color information Ca of the first color sample 64a at the position of the first color developing unit 55 is calculated by the following formula. In step S5, which will be described later, the estimated values ​​calculated for each pair of first color samples 64a are averaged. Note that similar calculations can be made for color samples 64 at other positions, but it is preferable to unify the positive and negative values ​​of the color information. Ca = Cs + V1

[0062] Consider the case where, for example, in image data 20, gradient information L1 = 1, gradient information L2 = 2, the position of the first color sample 64a (Xa, Ya) = (20, 20), and the position of the first color forming unit 55 (Xs, Ys) = (30, 25). In this case, if the color information Cs (saturation) of the first color sample 64a is 40, the corrected color information Ca of the first color sample 64a at the position of the first color forming unit 55 is calculated as 60 using the above formula. Specifically, the gradient of the color information along the X direction from X = 20 to X = 30 is (Xs - Xa) x L1 = (30 - 20) x 1 = 10. The gradient of the color information along the Y direction from Y = 20 to Y = 25 is (Ys - Ya) x L2 = (25 - 20) x 2 = 10. That is, the gradient V1 of the color information corresponding to the first color sample 64a between the first color sample 64a and the first color forming unit 55 is 20. As a result, the corrected color information Ca of the first color sample 64a at the position of the first color forming unit 55 is estimated to be Cs+V1=40+20=60. Note that the methods for calculating the gradient, estimated values ​​of color information, etc. are merely examples and can be changed as appropriate.

[0063] The control device 41 of the inspection device 4, as a judgment device 41a, similarly calculates the gradients V2 and V3 of the color information corresponding to the second color sample 64b (or the third color sample 64c) between the second color sample 64b (or the third color sample 64c) and the first color-developing section 55 for the second color sample 64b and the third color sample 64c, and estimates the corrected color information of the second color sample 64b (or the third color sample 64c) at the position of the first color-developing section 55.

[0064] Next, the control device 41 of the inspection device 4, as the determination device 41a, determines the amount of the specific substance from the estimated value (corrected color information) of the color information of the color sample 64 and the color information of the first color developing unit 55 (step S5). Specifically, the control device 41 determines the amount of the specific substance corresponding to the first color developing unit 55 based on the estimated value (estimated value of saturation) of the color information of each color sample 64 at the position of the first color developing unit 55 and the color information (saturation) of the first color developing unit 55.

[0065] FIG. 9 is a diagram showing the relationship between the estimated saturation value of the corrected color information at the position of the first coloring unit 55 and the amount of a specific substance. The horizontal axis of FIG. 9 represents the estimated saturation value at the position of the first coloring unit 55 obtained based on the estimated saturation values ​​of each color sample 64a to 64c calculated in step S4. The vertical axis of FIG. 9 represents the antibody titer, which is an example of the amount of a specific substance. The first color sample 64a corresponds to an antibody titer of 50 BAU / mL, for example. The second color sample 64b corresponds to an antibody titer of 15 BAU / mL, for example. The third color sample 64c corresponds to an antibody titer of 100 BAU / mL, for example.

[0066] The amount of the specific substance is determined, for example, by using an estimated value of the saturation of the color sample 64 that is close to the saturation of the first coloring unit 55. It is preferable that the amount of the specific substance is determined under the condition that the saturation of the first coloring unit 55 is included between the estimated values ​​of the saturations of two different color samples 64.

[0067] For example, consider a case where the color information (saturation) of the first coloring unit 55 is 70. In step S4, the corrected color information (saturation) of the first color sample 64a at the position of the first coloring unit 55 is estimated to be 60, and the corrected color information (saturation) of the third color sample 64c is estimated to be 80. Therefore, the antibody titer is determined based on the amount of change from the estimated saturation of the first color sample 64a to the estimated saturation of the third color sample 64c. When the color information (saturation) of the first coloring unit 55 is 70, the antibody titer increases by 2.5 for every 1 increase in saturation. Meanwhile, the difference between the saturation of the first color sample 64a at the position of the first coloring unit 55 and the saturation of the first coloring unit 55 is 10. As a result, the antibody titer corresponding to the color information of the first color-forming portion 55 can be calculated as 50 + 2.5 × 10 = 75 BAU / mL, assuming that the antibody titer corresponding to the first color sample 64a is 50 BAU / mL. Therefore, the antibody titer determined from the color information of the first color-forming portion 55 is 75 BAU / mL.

[0068] The estimated value (corrected color information) of the color sample 64 may be one or more. That is, as long as the amount of change in the amount of the specific substance relative to the saturation is known, a single estimated value may be used. Even if the saturation of the first color forming unit 55 is outside the calculated estimated value, the amount of the specific substance can be determined by predicting the amount of change.

[0069] In the above, an estimated value is calculated for saturation among color information, but an estimated value may also be calculated for lightness or hue. Also, an estimated value may be calculated by combining saturation, lightness, and hue.

[0070] The operation of the inspection system according to the embodiment will be described below with reference to Fig. 10. Fig. 10 is a flowchart showing the operation of the inspection system 1.

[0071] First, the control device 21 of the user terminal 2 controls the operation of the photographing device 26 to acquire image data 20 (step S11). Specifically, the control device 21 controls the operation of the photographing device 26 to photograph the inspection device 5 on which the first coloring portion 55 and the second coloring portion 56 appear on the result display section 53, and the mount 6 on which the inspection device 5 is placed in the placement area 61. As a result, image data 20 including the inspection device 5, the reference display section 62, and the chart section 63 is obtained.

[0072] Next, the control device 21 of the user terminal 2 transmits the image data 20 to the inspection device 4 via the communication interface 23 (step S12). At this time, the control device 41 also transmits data necessary for the inspection to the inspection device 4.

[0073] Next, the control device 41 of the inspection device 4 receives or acquires the image data 20 from the user terminal 2 via the communication interface 43 (step S21).

[0074] Next, the control device 41 of the inspection device 4, as the determination device 41a, specifies the color information and position of each part in the image data 20 (step S22). Specifically, the control device 41 specifies the color information and position of the first color generating part 55, the color information and position of the reference display part 62, and the color information and position of the chart part 63 (each color sample 64) displayed in the image data 20.

[0075] Next, the control device 41 of the testing device 4 functions as the determination device 41a to determine whether or not the specific substance is present in the sample (step S23). Specifically, if both the first color forming section 55 and the second color forming section 56 of the result display section 53 develop a color in the image data 20, it is determined that the specific substance is contained in the sample. If only the second color forming section 56 develops a color, it is determined that the specific substance is not contained in the sample. If only the first color forming section 55 develops a color, it is determined that a test error has occurred.

[0076] Next, the control device 41 of the testing device 4, functioning as the determination device 41a, determines the amount of the specific substance in the sample (step S24). In step S24, the control device 41 performs the processes of steps S2 to S5 described above, and determines the amount of the specific substance based on various information obtained regarding the first color generating unit 55, the reference display unit 62, and the chart unit 63 (for example, color information and position information of each unit).

[0077] Next, the control device 41 of the testing device 4 transmits the test results to the user terminal 2 via the communication interface 43 (step S25). The test results include, for example, information regarding the presence or absence of a specific substance and the amount of the specific substance. This allows the user to confirm the amount of the specific substance contained in the sample, etc. The control device 41 stores the test results in the auxiliary storage device 45 together with data necessary for the test.

[0078] Next, the control device 21 of the user terminal 2 receives the test results from the test device 4 via the communication interface 23 (step S16). The control device 21 stores the test results in the auxiliary storage device 25.

[0079] After step S16, the control device 21 of the user terminal 2 displays the test results on a display or the like via the input / output interface 24 (step S17).

[0080] As described above, according to one embodiment, the inspection device 4 obtains image data 20 including the first color development unit 55 and the reference unit 69 displaying the sample color SC and the reference color BC. This allows the color of the first color development unit 55 to be determined based on the sample color SC, reflecting the results of correcting for variations due to positioning. The inspection device 4 corrects the color information of the image data 20 by estimating corrected color information that compensates for positioning differences for at least one of the first color development unit 55 and the color sample 64 based on the color information of the reference display unit 62. Specifically, the determination device 41a estimates corrected color information for the color sample 64 of the chart unit 63 at the position of the first color development unit 55 from the gradient information L1 and L2 of the reference display unit 62. Based on this corrected color information, the amount of a specific substance corresponding to the color information of the first color development unit 55 is determined. As a result, the amount of a specific substance in a sample can be appropriately determined without being affected by the user's imaging technique or the imaging environment.

[0081] Although the present invention has been specifically described based on the embodiments, the present invention is not limited to the embodiments and can be modified in various ways without departing from the spirit of the present invention. Furthermore, the features described in the embodiments can be freely combined within the scope of technical compatibility.

[0082] The present invention is not limited to the above embodiment and includes the following modifications. For example, in the above embodiment, the control device 41 of the inspection device 4, as the determination device 41a, references the color information of the first coloring unit 55 and estimates the corrected color information of each color sample 64 at the position of the first coloring unit 55 based on the gradient information L1 and L2 obtained from the color information of the reference display unit 62. However, the control device 41 may also estimate the corrected color information of the first coloring unit 55 at the position of each color sample 64 based on the gradient information L1 and L2. In this case, the control device 41 determines the amount of the specific substance based on the estimated corrected color information of the first coloring unit 55 and the color information of each color sample 64. Alternatively, the control device 41 may estimate the corrected color information at specific positions for both the first coloring unit 55 and each color sample 64 and determine the amount of the specific substance.

[0083] In the above embodiment, the control device 41 calculates two pieces of gradient information L1 and L2 from the color information of the reference display unit 62. However, the control device 41 may also calculate gradient information at other positions, such as gradient information L3 and L4 shown in FIG. 7 . That is, the control device 41 calculates gradient information L3 (gradient information along the X direction) from point B to point D on the reference display unit 62, and gradient information L4 (gradient information along the Y direction) from point C to point D on the reference display unit 62. In this case, more detailed change information regarding the color information of the reference display unit 62 can be obtained based on the gradient information L1 to L4. As a result, the control device 41 can more accurately estimate the corrected color information of each color sample 64 at, for example, the position of the first coloring unit 55. Note that the control device 41 may also estimate the corrected color information using one of the gradient information L1 to L4. Furthermore, the range for calculating the gradient information may be divided into multiple ranges. For example, when calculating gradient information along the X direction, the control device 41 divides the calculation range into two at the midpoint between point A and point C on the reference display unit 62. That is, the control device 41 calculates gradient information from point A to the midpoint and gradient information from the midpoint to point C.

[0084] The control device 41 may also calculate gradient information on a line connecting any position on the reference display unit 62 or the pair of color samples 64 across the inspection instrument 5, the chart unit 63, etc. In this case, the control device 41 can calculate gradient information within the area surrounded by the reference display unit 62. Specifically, the control device 41 calculates gradient information from point A to point D on the reference display unit 62 as an example of gradient information in a diagonal direction. As another example of gradient information in a diagonal direction, the control device 41 calculates gradient information on a line connecting the midpoint between points A and B on the reference display unit 62 and the midpoint between points B and D. As an example of gradient information along the X direction, the control device 41 calculates gradient information on a line connecting the midpoint between points A and B on the reference display unit 62 and the midpoint between points C and D. As an example of gradient information along the Y direction, the control device 41 calculates gradient information on a line connecting the midpoint between points A and C on the reference display unit 62 and the midpoint between points B and D. In the above, the calculation range of the gradient information can be changed or combined as appropriate.

[0085] In the above embodiment, the reference display unit 62 has a frame-like shape surrounding the test instrument 5 and the chart unit 63, but is not limited to this. As shown in Fig. 11 , for example, the reference display unit 62 may be discretely arranged at the four corners of a frame surrounding the test instrument 5 and the chart unit 63. Furthermore, as shown in Fig. 12 , when the chart unit 63 also serves as the reference display unit 62, the reference display unit 62 may have, for example, a strip-like shape extending in the vertical direction (Y direction) of the image data 20.

[0086] In the above embodiment, the control device 41 calculated the gradient information L1 and L2 from the color information of the reference display unit 62. However, the chart unit 63 may also serve as the reference display unit 62 by setting the layout and color scheme. In this case, the control device 41 calculates the gradient information from the color information of the chart unit 63. For example, the control device 41 calculates the Y-direction gradient information L2 from the color information of the reference display unit 62 shown in FIG. 12 , while calculating the X-direction gradient information L5 from the color information of the two first color samples 64a of the chart unit 63.

[0087] In the above embodiment, the mount 6 may not include the reference display unit 62. As shown in FIG. 13 , the mount 6 may include chart units 63, each serving as the reference display unit 62, arranged above, below, left, and right of the mounting area 61. The pair of upper and lower or left and right chart units 63 have the same color information. In this case, the control device 41 calculates the Y-axis gradient information L6 and L7 using the two fourth color samples 64d of the upper and lower chart units 63, and calculates the X-axis gradient information L5 using the two first color samples 64a of the left and right chart units 63. While it is preferable that the first color sample 64a and the fourth color sample 64d have the same color information, they do not have to have the same color information. Furthermore, the upper and lower fourth color samples 64d may be any pair of color samples from the first chart unit 63a and the second chart unit 63b. The control device 41 may also calculate the gradient information using another pair of color samples 64.

[0088] In the above embodiment, the mount 6 does not need to have the chart portion 63. As shown in Fig. 14, the reference display portion 62 serving as the reference portion 69 displays the sample color SC and the reference color BC. In Fig. 14, the area AR1 representing the sample color SC and the area AR2 representing the reference color BC are merely examples and can be changed as appropriate.

[0089] In the modified example of Figure 14, the control device 41 can estimate the correction color information of the sample color SC at the position corresponding to the first color generating unit 55 using gradient information based on the reference color BC of the reference display unit 62.

[0090] In another variation of FIG. 14 , the control device 41 may convert the sample color SC using a standard conversion formula assuming standard illumination and reflect the converted color information of the first color generating unit 55. Specifically, the control device 41 performs gradient correction on the color information of the sample color SC based on the color information of the reference color BC to calculate color information of the corrected sample color. The control device 41 then restores the color of the first color generating unit 55 from the corrected sample color. Here, the color information of the sample color SC and the reference color BC is converted using, for example, the stimulus values ​​and brightness of the three primary colors as elements. The stimulus values ​​and brightness of the three primary colors are expressed, for example, in the XYZ (Yxy) color system (x and y correspond to red and green). The control device 41 determines a conversion formula that provides a deviation from the standard illumination color under standard conditions for the color information of the corrected sample color. The control device 41 then restores the standard illumination color of the first color generating unit 55 by applying an inverse conversion formula of the above conversion formula to the color information of the first color generating unit 55. This allows the control device 41 to estimate color information of the first color forming unit 55 in the standard state. The amount of the specific substance in the sample is calculated from a relational expression between the color information of the standard illumination color of the first color forming unit 55 and the amount of the specific substance, which is stored in the auxiliary storage device 45, based on the restored standard illumination color of the first color forming unit 55. In this modified example, the color of the first color forming unit 55 can be accurately reproduced using the XYZ color system or the like, and numerical information corresponding to these can be obtained, even if it is not the same as hue, saturation, and lightness. Therefore, the color state of the first color forming unit 55 can be accurately grasped and determined.

[0091] In the above embodiment, the gradient is not limited to a linear change, but may also be a curved change.

[0092] In the above embodiment, the control device 41 determines the amount of the specific substance as a predetermined amount, but may determine the amount as an amount within a predetermined range. Also, the control device 41 may determine the amount of the specific substance as a level.

[0093] In the above embodiment, the cassette unit 54 of the test instrument 5 may be provided with a component corresponding to the reference display unit 62 or the chart unit 63. In this case, the test kit 10 may not have the mount 6.

[0094] In the above embodiment, the configuration of the test device 5 may be modified as appropriate. For example, the test device 5 may not have the buffer receiving section 52. In this case, a mixture of a sample and a buffer is dropped into the sample receiving section 51.

[0095] Examples of the test instrument 5 include an antibody test instrument, an antigen test instrument, and a biomarker test instrument. For example, in the case of an antigen test that tests for an antigen as a specific substance in a sample, the test instrument 5 as an antigen test instrument does not need to have a buffer receptacle 52, and the shade of the first color-forming unit 55 of the test instrument 5 changes depending on the amount of antigen contained in the sample. In the case of an antigen test, similar to the case of an antibody test, for example, the test instrument 5 is placed on the mounting area 61 of the mount 6 on which the chart unit 63 and the reference display unit 62 are provided, and image data 20 of the test instrument 5 placed on the mount 6 is acquired. The image data 20 is then analyzed, and the amount of antigen in the sample is determined based on the color information of the first color-forming unit 55 of the test instrument 5, the color information of the chart unit 63, and the color information of the reference display unit 62. In the case of a biomarker test that tests for a biomarker as a specific substance in a sample, the shade of the first color-forming unit 55 of the test instrument 5 changes depending on the amount of biomarker contained in the sample. In the case of biomarker testing, as in the case of antibody testing, image data 20 of the test instrument 5 placed on the backing sheet 6 is acquired, and the amount of biomarker in the sample is determined based on the color information of the first color-producing section 55, the color information of the chart section 63, and the color information of the reference display section 62.

[0096] In the above embodiment, the inspection tool 5 and the mount 6, particularly the reference display portion 62 and the chart portion 63, are preferably made of a material with low reflection.

[0097] In the above embodiment, the capture lines TL may be provided in two or more locations, so that the first color forming portions 55 appear in two or more locations. In this case, the first color forming portions 55 in two or more locations may be the same color or different colors.

[0098] In the above embodiment, the shapes of the first coloring portion 55 and the second coloring portion 56 are not limited to lines. For example, the shapes of the first coloring portion 55 and the second coloring portion 56 may be circles or dots.

[0099] In the above embodiment, the test device 5 is not limited to a lateral flow type in which the sample moves in one direction along the filter paper, but may use other immunochromatography methods such as a vertical flow type. Furthermore, for example, the test device 5 may be configured so that the sample moves by spreading out in a circular shape from the spot where the sample was dropped. In this case, the areas spreading out in the same shape from the spot where the sample was dropped are designated as the first color-forming portion and the second color-forming portion.

[0100] In the above embodiment, the labeling substance that reacts with a specific substance is not limited to gold colloid particles modified with specific binding molecules, etc. The labeling substance may be any substance capable of specific binding, such as fluorescent particles, Qdot (registered trademark), aptamers, etc. Fluorescent particles and Qdots adsorb to gold colloid particles and emit a red color. An aptamer is a molecule that specifically binds to a target molecule. Examples of aptamers include nucleic acid aptamers and peptide aptamers. In particular, peptide aptamers have a structural characteristic of binding at two points, and therefore have a stronger binding strength than antibodies. An example of a peptide aptamer is BEF peptide (binding enhanced fluorogenic peptide), which emits fluorescence when bound to a target.

[0101] In the above embodiment, the amount of a specific substance is determined by the inspection device 4 connected to the user terminal 2 via the communication line 3. However, if the computer program P2 is installed on the user terminal 2, the user terminal 2 can function as the inspection device 4. In this case, the photographing device 26 provided on the user terminal 2 functions as the data acquisition device IG to acquire image data 20 including the inspection tool 5 and the mount 6, and the control device 21 of the user terminal 2 functions as the determination device to determine the amount of a specific substance from the image data 20. Note that the inspection device 4 may acquire the image data 20 using a photographing device such as a camera and perform automatic determination without using the user terminal 2. In this case, the inspection results may be transmitted to the user terminal 2 via the communication line 3 or may be notified by mail, etc.

[0102] The present invention is not limited to the above-described embodiments, and it is clear that each embodiment can be appropriately modified or changed within the scope of the technical concept of the present invention. The technology of each embodiment can be used in other embodiments as long as no technical contradiction occurs.

Claims

1. a data acquisition device for acquiring image data including a color-developing portion that reacts with a specific substance in a sample to develop a color, and a reference portion that displays a sample color used to determine the color of the color-developing portion and a reference color used to correct for variations due to placement; a determination device that determines the amount of a specific substance based on color information of the color-developing portion, color information of the sample color, and color information of the reference color obtained from the image data; An inspection device comprising:

2. 2. The inspection device according to claim 1, wherein the reference unit includes a chart unit having a color sample that displays the sample color to be compared with the color of the color-developing unit, and a reference display unit that displays the reference color for estimating corrected color information that compensates for placement differences for at least one of the color-developing unit and the color sample.

3. The inspection device according to claim 2 , wherein the determination device estimates the corrected color information of at least one of the color-producing portion and the color sample using gradient information calculated from the color information of the reference display portion to determine the amount of the specific substance.

4. the chart section includes a plurality of color samples with different gradations, 4. The inspection device according to claim 2, wherein the reference color is the same as a neutral color among the plurality of color samples.

5. 4. The inspection device according to claim 2, wherein the chart section also serves as the reference display section by setting the layout and color scheme.

6. The testing device according to claim 1 , wherein the color-developing unit is provided in a testing tool into which the sample is introduced.

7. The testing device according to claim 6 , wherein the testing tool is any one of an antibody testing tool, an antigen testing tool, and a biomarker testing tool.

8. The inspection device according to claim 6 , wherein the reference portion is provided on a mount having a mounting area on which the inspection instrument is placed.

9. a data acquisition device for acquiring image data including a color-developing portion that reacts with a specific substance in a sample to develop a color, and a reference portion that displays a sample color used to determine the color of the color-developing portion and a reference color used to correct for variations due to placement; a determination device that determines the amount of a specific substance based on color information of the color-developing portion, color information of the sample color, and color information of the reference color obtained from the image data; An inspection system comprising:

10. The inspection system according to claim 9 , further comprising a user terminal that transmits the image data to the data acquisition device.

11. acquiring image data including a color-developing portion that develops color in response to a specific substance in a sample, and a reference portion that displays a sample color used to determine the color of the color-developing portion and a reference color used to correct for variations due to placement; determining the amount of the specific substance based on color information of the color-developing portion, color information of the sample color, and color information of the reference color obtained from the image data; An inspection method comprising:

12. acquiring image data including a color-developing portion that develops color in response to a specific substance in a sample, and a reference portion that displays a sample color used to determine the color of the color-developing portion and a reference color used to correct for variations due to placement; determining the amount of the specific substance based on color information of the color-developing portion, color information of the sample color, and color information of the reference color obtained from the image data; A non-transitory storage medium that stores a program that causes a control device to execute the above.