Inspection equipment

Abstract

Provided is a testing device capable of identifying the position of a test region on a carrier even when there is positional displacement due to individual differences between cartridges. A testing device 110 is provided with: a loading unit 112 into which it is possible to detachably load a cartridge comprising a carrier 2 including a test region L1 having a color development state that changes depending on whether a specimen is positive or negative, and an indicator region which is disposed spaced apart from the test region L1 by a predetermined gap, and which is optically distinguishable from other regions irrespective of whether the specimen is positive or negative, and a case accommodating the carrier 2; light sources 115A, 115B for illuminating an observation region LA on the carrier 2 including the test region L1 and the indicator region; an imaging unit (sensing unit 114) for imaging the observation region LA; and a processor 120 which acquires an image including the observation region from the imaging unit, detects the position of the indicator region from the acquired image, and identifies the position of the test region relative to the detected position of the indicator region.

Description

Technical Field

[0001] The technology of the present disclosure relates to a test device used for immunochromatographic testing.

Background Art

[0002] Patent Document 1 below describes a test piece measuring device to which a test piece with a chromatographic carrier (hereinafter referred to as a carrier) attached is attached. In this test piece measuring device, the test piece is positioned in the test piece measuring device, and the irradiation light from a light source is irradiated onto the color development region on the carrier to which the sample is added. Such a color development region is called an inspection region or the like. Then, the light reflected or transmitted in the color development region is detected by a light receiving unit, and an arithmetic unit determines whether the sample is positive or negative based on the detection result. If the relative positions of the light source, the light receiving unit, and the color development region are not accurately positioned, the state of the color development region may not be accurately detected, and the inspection accuracy may decrease. In the test piece measuring device, in order to position the light source, the light receiving unit, and the color development region, such as accurately irradiating the irradiation light from the light source onto the color development region, an elastic body such as a spring is used to bias the test piece in the device to a target position.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] The test specimen described in Patent Document 1 is sometimes called a cartridge, and the test specimen measuring device is sometimes called an inspection device. The cartridge has a case that houses the carrier. In such cartridges, the position of the carrier relative to the case may be misaligned due to individual differences in the cartridge. In such cases, even if the case is biased to the target position as described in Patent Document 1, it is not possible to position the relative position of the inspection area on the carrier with respect to the light source and light receiving part. The misalignment of the carrier within the case is caused by errors during the manufacturing of the cartridge, etc.

[0005] In the case of a negative sample, the coloration of the test area does not change, making it optically indistinguishable from other areas of the carrier that forms the background of the test area. Furthermore, even if the sample is positive, the change in the coloration of the test area may be very slight. In this case, if the position of the test area cannot be determined, it is difficult to optically distinguish the change in coloration from noise present in other areas, making misrecognition likely. Therefore, if there is a misalignment in the relative positions of the test area, light source, and light receiving unit due to individual differences in the cartridge, there was a risk of misjudgment due to the misrecognition of an area other than the test area as the test area.

[0006] To suppress such misjudgments, a method was needed to reliably identify the position of the inspection area, regardless of whether there were positional deviations due to individual differences in the cartridges.

[0007] The technology disclosed herein provides an inspection device that, taking the above facts into consideration, can identify the position of the inspection area on the carrier even when there is a misalignment due to individual differences in the cartridges. [Means for solving the problem]

[0008] The inspection device of this disclosure is an inspection device used for immunochromatographic testing, and comprises a loading unit in which a cartridge having a carrier having a test area whose color development state changes depending on whether the sample is positive or negative, an indicator area which is arranged at a predetermined distance from the test area and is optically distinguishable from other areas regardless of whether the sample is positive or negative, and a case for housing the carrier is detachably loaded; a light source for illuminating an observation area on the carrier including the test area and the indicator area; an imaging unit for imaging the observation area; and a processor that acquires an image including the observation area from the imaging unit, detects the position of the indicator area from the acquired image, and identifies the position of the test area based on the position of the detected indicator area.

[0009] In the inspection apparatus of this disclosure, the indicator area is preferably an area that reacts with a reagent and changes in color.

[0010] In the inspection apparatus of this disclosure, it is preferable that the processor detects the position of the indicator region based on the optical density of the indicator region.

[0011] In the inspection apparatus of this disclosure, it is preferable to use the ΔOD value, which is the difference between the optical density of the indicator region and the optical density of the background region that serves as the background for the indicator region, as the optical density in the carrier.

[0012] In the inspection apparatus of this disclosure, it is preferable that the processor detects the position of the indicator region based on the shape of the indicator region.

[0013] In the inspection apparatus of this disclosure, the light source is preferably a white light source, the image is a color image, and the processor preferably detects the position of the indicator region based on the color of the indicator region.

[0014] In the inspection apparatus of this disclosure, when the indicator region is a first color before reacting with a reagent and changes from the first color to a second color upon reaction with the reagent, the light source comprises a first monochromatic light source that emits first monochromatic light with a greater amount of reflected light when illuminating the first color indicator region than when illuminating the second color indicator region, and a second monochromatic light source that emits second monochromatic light with a greater amount of reflected light when illuminating the second color indicator region than when illuminating the first color indicator region. Preferably, the processor uses the first monochromatic light source and an imaging unit to acquire a first image obtained by imaging the second color indicator region, uses the second monochromatic light source and an imaging unit to acquire a second image obtained by imaging the second color indicator region, and detects the position of the indicator region based on the first and second images.

[0015] In the inspection apparatus of this disclosure, the first color preferably contains a green component, the second color is orange, the first monochromatic light source is a green light source, and the second monochromatic light source is a red light source.

[0016] In the inspection apparatus of this disclosure, the reagent is an amplification solution for amplifying the change in the color development state of the inspection area, and it is preferable that the indicator area reacts with the amplification solution and changes in its color development state.

[0017] In the inspection apparatus of this disclosure, the indicator region is preferably a region in which the color development state changes upon reaction with a labeled substance.

[0018] In the inspection device of this disclosure, the inspection area and the indicator area are areas formed by coating on a carrier, and it is preferable that the carrier is assembled into a case after the inspection area and the indicator area have been formed.

[0019] The inspection device of the present disclosure has a cartridge with an observation window formed for observing an observation area from the outside. Both the outer shape of the cartridge and the observation window are rectangular. The inspection device includes biasing means for pressing the end face of the cartridge mounted on the loading part against a reference plane. The processor acquires, from the imaging unit, an image of an area that at least includes the entire observation window and a part of the outer shape line of the cartridge in a state where the cartridge is pressed against the reference plane, and performs a trimming process for cutting out the observation area from the acquired image. In the trimming process, it is preferable to execute an area specifying process for specifying the observation area by searching for the outer shape line within the image and searching for at least a part of the observation window based on the searched outer shape line.

[0020] In the inspection device of the present disclosure, the area specifying process in the trimming process may be a process of specifying the observation area by searching for the observation window of the cartridge in the image to specify the frame line of the observation window, and further searching for the boundary between the frame line and the carrier or the boundary between the margin in the area within the frame line and the carrier.

Advantages of the Invention

[0021] According to the inspection device of the present disclosure, even when there is a positional deviation due to individual differences in the cartridges, the position of the inspection area on the carrier can be specified.

Brief Description of the Drawings

[0022] [Figure 1] It is a perspective view showing the appearance of the inspection device according to the present disclosure. [Figure 2] It is a perspective view of the inspection cartridge loaded in the inspection device according to the present disclosure. [Figure 3] It is an exploded perspective view of the inspection cartridge according to the present disclosure. [Figure 4] FIG. 4A is a cross-sectional view showing a state where the first pressing operation part is operated in the inspection cartridge according to the present disclosure, and FIG. 4B is a cross-sectional view showing a state where the first pressing operation part and the second pressing operation part are operated. [Figure 5]This is a side view showing the positional relationship between the test strip, the multifunctional component, the first reagent holder, and the second reagent holder within the test cartridge related to this disclosure. [Figure 6] This is an explanatory diagram of the immunochromatography method. [Figure 7] This is a perspective view showing an example of a method for manufacturing a carrier related to this disclosure. [Figure 8] This is a partially fractured side view of the inspection device related to this disclosure. [Figure 9] This is a flowchart showing the inspection flow of the inspection device related to this disclosure. [Figure 10] This flowchart shows the process for identifying the location of the inspection area in the inspection device related to this disclosure. [Figure 11] This flowchart shows the process flow for detecting the position of the indicator area in the inspection device related to this disclosure. [Figure 12] This is a conceptual diagram showing the observation area captured by the inspection device relating to this disclosure, the captured image of the observation area, and the difference image between the two captured images. [Figure 13] This is a conceptual diagram showing the observation area, the captured image of the observation area, and the difference image between the two captured images in the presence of noise. [Figure 14] This is a conceptual diagram showing the observation region, the captured image of the observation region, and the difference image between the two captured images in the case where there is noise different from the noise shown in Figure 13. [Figure 15] This is a plan view showing the cartridge in a positioned state by the biasing means. [Figure 16] This figure shows an image captured by a detection means. [Figure 17] This diagram shows the observation area for other examples. [Figure 18] This figure shows an example where the end of the carrier is exposed in the exposed area observed through the observation window. [Figure 19] This figure shows another example where the end of the carrier is exposed in the exposed area observed through the observation window. [Figure 20] This is an explanatory diagram of the region identification process for identifying the observation area. [Modes for carrying out the invention]

[0023] Hereinafter, an inspection apparatus according to an embodiment of the present invention will be described with reference to the drawings. Components indicated by the same reference numerals in each drawing are considered to be the same component. However, unless otherwise specified in the specification, each component is not limited to one, and there may be multiple such components.

[0024] The directions indicated by arrows X and Y in each figure are along the horizontal plane and are perpendicular to each other. The direction indicated by arrow Z is along the vertical direction (up and down). In each figure, the directions indicated by arrows X, Y, and Z are assumed to be mutually coincidental.

[0025] <Overview of Immunochromatographic Testing Equipment and Testing Cartridges> Figure 1 is a perspective view showing the external appearance of an immunochromatographic inspection device 110 (hereinafter simply referred to as the inspection device 110) according to one embodiment. Figure 2 is an external view of the cartridge 100, which is an inspection cartridge mounted in the inspection device 110, and Figure 3 is an exploded perspective view of the cartridge 100. Figure 4 shows the state in which the first pressing operation part 11 and the second pressing operation part 12 provided on the cartridge 100 are operated. Figure 5 shows the main components housed inside the cartridge 100.

[0026] Cartridge 100 is a single-use type, with one cartridge used for each sample to be tested. As shown in Figure 3, cartridge 100 contains a test strip 1 containing an immunochromatographic carrier 2 (hereinafter referred to as carrier 2). The carrier 2 has a test area L1, and its color development changes depending on whether the sample contains the test substance or not, that is, whether the sample is positive or negative.

[0027] Furthermore, "change in color development state" includes any of the following: a change from a first color different from the color of carrier 2 to a different second color (i.e., discoloration); a change in the color of carrier 2 due to the development of another color in carrier 2 (i.e., color development); or a change in the density of the color (i.e., density change).

[0028] Any sample that may contain the test substance is acceptable, and the sample is not particularly limited. Examples of samples include biological samples, particularly animal (especially human) blood, serum, plasma, cerebrospinal fluid, tears, sweat, urine, pus, nasal secretions, nasal swabs, pharyngeal swabs, nasal aspirates, or other bodily fluids such as sputum, or excretions, organs, tissues, mucous membranes and skin or swabs containing them, or liquid samples containing plants and animals themselves or their dried forms. Examples of test substances include antigens, antibodies, proteins and low-molecular-weight compounds.

[0029] In this example, the testing device 110 is loaded with a cartridge 100 on which a sample has been applied. The testing device 110 then detects the color development of the test area L1 of the loaded cartridge 100 and displays a result indicating whether the sample is positive or negative. When testing multiple samples, one cartridge 100 for each sample is loaded into the testing device 110.

[0030] In the following description, the cartridge 100 is assumed to be loaded into the testing device 110. However, the cartridge 100 in this example has a configuration that allows the user to visually confirm whether the sample is positive or negative without using the testing device 110. Such a cartridge 100 is also called an immunochromatographic testing device or an immunochromatographic testing kit.

[0031] <Inspection Cartridge> As shown in Figures 2 and 3, the cartridge 100 includes, for example, a case 9 composed of a case body 20 and a cover member 10. The case 9 is made of, for example, a resin material. The case body 20 has an opening at the top and houses the test strip 1, as well as a first reagent holder 40 and a second reagent holder 45 inside. The cover member 10 is attached to the opening of the case body 20, thereby covering the opening of the case body 20. The case 9 has an overall elongated shape to match the elongated shape of the test strip 1.

[0032] In this example, the upper part of the case 9, which is formed by the cover member 10, is provided with a dropper port 16, an observation window 18, a first pressing operation part 11, and a second pressing operation part 12. These parts are integrally molded with the cover member 10 as an example. The dropper port 16 is an opening for dropping a sample into the inside of the case 9. A boss is erected on the edge of the dropper port 16, facing upwards.

[0033] (Observation window) The observation window 18 is an opening for observing the inspection area L1 from the outside, and is an opening within the inspection device 110 that is illuminated by a light source 115 (see Figure 8), which will be described later. In this example, the size of the observation window 18 is such that, in addition to the inspection area L1, the control area L2 and the color development area L3, which will be described later, can also be observed. Of the areas that can be observed from the observation window 18, including the inspection area L1, the control area L2, the color development area L3 and their surrounding areas, the area used for determining the inspection area L1 is referred to as the observation area LA in this specification. The detection unit 114 (see Figure 8), which will be described later, images the observation area LA through the observation window 18. The processor 120 then determines whether the sample is positive or negative by identifying the position of the inspection area L1 within the observation area LA and by determining the change in the color development state based on the image captured by the detection unit 114. The observation area LA may be the entire area visible from the observation window 18, i.e., the entire area exposed to the observation window 18 (hereinafter referred to as the exposed area EA), or it may be a specific area within the exposed area EA. Details of the observation area LA will be described later.

[0034] (First pressing operation section, second pressing operation section) As shown in Figures 2, 3, and 4, the first pressing operation unit 11 is an operation unit operated to supply the first reagent 41 in the first reagent holding unit 40 to the carrier 2. The second pressing operation unit 12 is an operation unit operated to supply the second reagent 46 in the second reagent holding unit 45 to the carrier 2. The first reagent 41 and the second reagent 46 are amplification solutions for amplifying the color development in the test area L1 when the sample is positive, as will be described later.

[0035] As shown in Figure 4A, when an external force is applied to the first pressing operation part 11, such as by a user's pressing operation, the first pressing operation part 11 deforms. As shown in Figure 2, for example, the first pressing operation part 11 has a square pyramidal shape, and when a pressing force is applied from above to the area including the vertex of the square pyramidal shape, as shown in Figure 4A, the vertex of the square pyramidal shape deforms so that it sinks into the inside of the case 9. When the first pressing operation part 11 deforms in this way, a pressing force is applied to the first reagent holding part 40 inside the case 9. The first reagent holding part 40 undergoes deformation due to the pressing force applied through the first pressing operation part 11. Due to this deformation, the first reagent held by the first reagent holding part 40 is supplied to the test strip 1.

[0036] Furthermore, the first pressing operation section 11 is designed to maintain its deformed state after being deformed by pressing. As a result, once the first pressing operation section 11 is pressed, the supply of the first reagent 41 to the test strip 1 continues.

[0037] Similarly, as shown in Figure 4B, when an external force is applied to the second pressing operation part 12, the second pressing operation part 12 deforms. As shown in Figure 2, the second pressing operation part 12 in this example, like the first pressing operation part 11, has a square pyramidal shape. When an external force is applied to the area including the vertex of the square pyramid from above, as shown in Figure 4B, the vertex of the square pyramid deforms so that it sinks into the inside of the case 9. When the second pressing operation part 12 deforms in this way, an external force is applied to the second reagent holding part 45 inside the case 9. The second reagent holding part 45 undergoes deformation due to the external force applied through the second pressing operation part 12. This deformation allows the second reagent 46 held by the second reagent holding part 45 to be supplied to the test strip 1. In this example, the second pressing operation part 12 is provided with a contact part 12b on the inside side of the case 9 that contacts the second reagent holding part 45.

[0038] (First reagent holding section) As shown in Figure 3, the case body 20 houses the test strip 1, which includes the carrier 2, along its longitudinal direction. As shown in Figures 3 and 4, the case body 20 has a first reagent holding section 40 located at one end in the longitudinal direction (the upstream side shown in Figure 5). In the case body 20, a first housing section 24 is formed in the area where the first reagent holding section 40 is located, with a recessed shape to match the shape of the first reagent holding section 40. One end of the test strip 1 is positioned above the first reagent holding section 40, which is housed in the first housing section 24.

[0039] As shown in Figures 4 and 5, the first reagent holder 40 holds the first reagent 41. The first reagent holder 40 is composed of, for example, a container 42 made of a resin material and having an opening on one side, and a sheet member 43 that covers the opening of the container 42 and is breakable. The container 42 is filled with the first reagent 41, and the opening of the container 42 is sealed by the sheet member 43. The first reagent holder 40 is positioned within the first storage section 24 with the sheet member 43 facing upwards.

[0040] The pressing force applied from the first pressing operation section 11 is transmitted to the sheet member 43 of the first reagent holding section 40 via the end of the test strip 1, causing the sheet member 43 to break. As a result of the sheet member 43 breaking, the first reagent 41 is supplied to the test strip 1. In this example, the first pressing operation section 11 is provided with a protruding portion 11b that contacts the sheet member 43. The protruding portion 11b has an elongated shape, for example, with its longitudinal direction extending in the width direction of the test strip 1, and its tip is pointed toward the sheet member 43, in order to facilitate the breaking of the sheet member 43.

[0041] (Multifunctional component) Furthermore, the cartridge 100 includes a multifunctional member 30 that has the function of housing the second reagent holding section 45. The multifunctional member 30 is located at the other end of the case body 20 (the downstream side shown in Figure 5) and above the test strip 1. The multifunctional member 30 is a member in which a second housing section 32 and a flow path forming section 35 are integrally formed. The second housing section 32 is the part that houses the second reagent holding section 45. The second housing section 32 has a box shape with an open top. As shown in Figures 4 and 5, the bottom of the second housing section 32 has a projection 34 for breaking the sheet member 48 of the second reagent holding section 45 (described later) and an opening 33 for allowing the second reagent 46 flowing out from the second reagent holding section 45 to flow towards the test strip 1.

[0042] Furthermore, the channel forming section 35 is provided in connection with the second housing section 32 toward the upstream side. The channel forming section 35 is flat and is positioned in the longitudinal direction of the inspection strip 1 opposite the inspection area L1, etc., and is positioned with a gap between it and the inspection strip 1. The channel forming section 35 forms a channel between itself and the inspection strip 1 that allows the second reagent 46 flowing out from the second housing section 32 to flow toward the inspection area L1, etc. The channel forming section 35 is also positioned between the observation window 18 and the inspection area L1, etc. of the inspection strip 1. For this reason, the channel forming section 35 is made of a transparent material, allowing the inspection area L1, etc. to be observed through the observation window 18.

[0043] (Second reagent holding section) The second reagent holder 45 holds the second reagent 46. The second reagent holder 45 is composed of, for example, a container 47 made of a resin material and having an opening on one side, and a sheet member 48 that covers the opening of the container 47 and is breakable. The container 47 is filled with the second reagent 46, and the opening of the container 47 is sealed by the sheet member 48. The second reagent holder 45 is positioned within the second storage section 32 with the sheet member 48 facing downwards. As a result, the sheet member 48 faces the projection 34 within the second storage section 32.

[0044] The pressing force applied from the second pressing operation section 12 to the second reagent holding section 45 acts in a direction that pushes the second reagent holding section 45 downward, thereby pressing the sheet member 43 against the projection 34. When the sheet member 48 is pressed against the projection 34, the sheet member 48 is broken. As the sheet member 48 is broken, the second reagent 46 is supplied to the test strip 1 through the flow path formed by the opening 33 at the bottom of the second housing section 32 and the flow path forming section 35.

[0045] As shown in Figure 5, a gap (clearance) D corresponding to the flow path of the second reagent 46 is formed between the back surface 36 of the flow path forming portion 35 of the multifunctional member 30 and the carrier 2 of the inspection strip 1. The gap D is, for example, in the range of 0.01 mm to 1 mm. The second reagent 46 flows out from the opening 33 at the bottom of the second containment portion 32 toward the carrier 2, and the flowed-out second reagent 46 flows through the flow path formed by the gap D and reaches at least the inspection area L1. The second reagent 46 that reaches the inspection area L1 infiltrates the inspection area L1 from the flow path.

[0046] An absorbent pad 6, described later, is positioned at the downstream end of the inspection strip 1. As shown in Figure 3, the case body 20 has a support portion 22 that supports the end of the inspection strip 1, including the absorbent pad 6, at a position opposite to the absorbent pad 6. The second housing portion 32 of the multifunctional member 30 is positioned above the absorbent pad 6. The support portion 22 also supports the multifunctional member 30 via the absorbent pad 6. In addition, the case body 20 has a support portion 21 that supports the central part of the inspection strip 1.

[0047] <Inspection strips> The inspection strip 1 comprises a carrier 2, a fluid delivery pad 4, and an absorbent pad 6. The carrier 2 is fixed and supported on a back adhesive sheet 7.

[0048] (carrier) The carrier 2 is a porous, insoluble carrier for spreading the sample, and comprises a test area L1, a control area L2, and a color development area L3. The carrier 2 also includes a label-holding pad 3. The label-holding pad 3 constitutes a dotting area where the sample is dotted from the dropper port 16. When the direction toward the test area L1 is considered the downstream side of the carrier 2 with respect to the dotting area, the color development area L3 is located downstream of the test area L1. In this example, the test area L1, the control area L2, and the color development area L3 are each line-shaped regions extending in a direction perpendicular to the direction of sample spread on the carrier 2.

[0049] Figures 3 to 5 show the state in which the test area L1, control area L2, and color-developing area L3 are expressed as lines, but these are not always expressed. As will be explained in detail later, before developing sample 50 (see Figure 6), the first reagent 41 (see Figures 4 and 5), and the second reagent 46 (see Figures 4 and 5), the colors of the test area L1 and control area L2 are almost the same as the color of the carrier 2, so at this stage, the test area L1 and control area L2 cannot be clearly seen. The test area L1 appears as a line when sample 50 is developed and the color intensity increases if the developed sample 50 is positive. In this example, the color of the carrier 2 is close to white. The color development of the test area L1 is amplified by silver amplification, which will be explained later, so the test area L1 develops to black.

[0050] When sample 50 is unfolded, the color intensity of the control region L2 increases, causing it to appear as a line. This makes the control region L2 visible. The color of the control region L2 is also amplified by silver, so the control region L2 also appears black.

[0051] On the other hand, only the color-developing region L3 appears as a dark, almost blackish-green line (hereinafter referred to as dark green) even before the first reagent 41 is developed, and is visible. However, when the first reagent 41 is developed, the dark green color in the color-developing region L3 changes to orange, causing it to appear as an orange line.

[0052] For example, a porous material such as a nitrocellulose membrane can be used as the carrier 2. The back adhesive sheet 7 to which the carrier 2 is fixed is a sheet-like substrate on which the side to which the carrier 2 is attached is the adhesive side.

[0053] (Carrier-labeling pad) As shown in Figure 6, a labeling substance 53 is fixed to the labeling pad 3. The labeling substance 53 is modified with a first binding substance 52 that specifically binds to the test substance 51 contained in the sample 50. This labeling pad 3 is fixed on the carrier 2 at a position opposite the dropper port 16 (see Figure 3) of the cover member 10. Therefore, the sample 50 is dropped onto the labeling pad 3 from the dropper port 16. Thus, the labeling pad 3 corresponds to the application area where the sample 50 is applied.

[0054] The label-holding pad 3 is fixed to approximately the center of the carrier 2 in the longitudinal direction. As the labeling substance 53, for example, gold colloid particles with a diameter of 50 nm (EM.GC50, manufactured by BBI) can be used. Note that the labeling substance 53 is not limited to gold colloid, but can also be metal sulfides that can be used in ordinary chromatography methods, colored particles used in immunoaggregation reactions, etc., and metal colloids are particularly preferred. Examples of metal colloids include gold colloid, silver colloid, platinum colloid, iron colloid, aluminum hydroxide colloid, and composite colloids thereof. Gold colloid is particularly preferred because, at an appropriate particle size, it exhibits a red color and silver colloid exhibits a yellow color, and among these, gold colloid is the most preferred.

[0055] (Carrier-inspection area) As shown in Figure 6, the test area L1 contains a second binding substance 56 that specifically binds to the test substance 51, thereby capturing the test substance 51. When the test substance 51 is captured in the test area L1 by the binding of the second binding substance 56 to the test substance 51, the first binding substance 52 and the labeling substance 53 bound to the test substance 51 are also captured. If the sample 50 contains the test substance 51, the color intensity of the test area L1 rises above a preset standard as the test substance 51 and the labeling substance 53 are captured in the test area L1. The test area L1 is a region for confirming the presence or absence of the test substance 51 by the labeling signal from the labeling substance 53 captured via the test substance 51.

[0056] (Carrier-control area) The control region L2 contains a third binding substance 58 that specifically binds to the first binding substance 52, and captures the labeled substance 53 via the first binding substance 52. When the sample 50 is applied to the label-holding pad 3, the labeled substance 53 modified with the first binding substance 52 that is not bound to the test substance 51 also spreads within the carrier 2 toward the test region L1 along with the sample 50. The labeled substance 53 that is not bound to the test substance 51 passes through the test region L1 without being captured. The labeled substance 53 that has passed through the test region L1 is captured in the control region L2 via the first binding substance 52, as the first binding substance 52 binds to the third binding substance 58. When the labeled substance 53 is captured in the control region L2, the color intensity of the control region L2 rises to a preset standard or higher. The control region L2 is a region for confirming the completion of the spread of the sample 50 by the label signal from the labeled substance 53 captured via the first binding substance 52. Therefore, the control region L2 is sometimes called the verification region.

[0057] (Carrier-Color Development Area) The color-developing region L3 contains a substance that reacts with the first reagent 41 to change its color state. The color-developing region L3 indicates that the first reagent 41 has reached that region by reacting with the first reagent 41 to develop color or by changing color. For example, when using a mixed aqueous solution of iron nitrate aqueous solution and citric acid (manufactured by Wako Pure Chemical Industries, Ltd., 038-06925) as the first reagent 41, it is preferable that the color-developing region L3 be composed of a color-developing reagent immobilization line in which bromocresol green (manufactured by Wako Pure Chemical Industries, Ltd.) is immobilized in a line. This is the embodiment of the color-developing region L3 in this example, and as described above, the color-developing region L3 in this example is dark green before reacting with the first reagent 41, and changes to orange when the first reagent 41 reaches the color-developing region L3. Furthermore, the color-developing region L3 is sometimes called the amplification indicator region because the change in color development indicates the timing for the first reagent 41 to be deployed and the supply of the second reagent 46.

[0058] Furthermore, the color-developing region L3 is positioned at a predetermined interval from the inspection region L1 (see interval T in Figures 12, 13, and 14). The color-developing region L3 is an area that is optically distinguishable from other regions, regardless of whether the sample is positive or negative. This color-developing region L3 is an example of an indicator region in this disclosure and is used as an indicator to identify the position of the inspection region L1, as will be described later.

[0059] (Method for forming the inspection area, control area, and color development area) These inspection area L1, control area L2, and color development area L3 are formed by coating during the manufacturing of the carrier 2. Specifically, as shown in Figure 7, a material containing substances for forming the inspection area L1, control area L2, and color development area L3 is applied in a line pattern to the sheet material 2A for forming the carrier 2.

[0060] In this process, the inspection area L1, control area L2, and color development area L3 are applied, for example, using a coating device (so-called dispenser) DL. The coating device DL has, for example, three outlets DL1, DL2, and DL3 arranged at predetermined intervals to dispense the coating liquid. From each of these outlets DL1, DL2, and DL3, the coating liquid is dispensed to form the inspection area L1, control area L2, and color development area L3, respectively. Furthermore, as the coating device DL dispenses these coating liquids while moving linearly in a direction intersecting the arrangement direction of the outlets DL1, DL2, and DL3, the inspection area L1, control area L2, and color development area L3 are formed in a line on the sheet material 2A. This determines the distance T between the inspection area L1 and the color development area L3.

[0061] Subsequently, the sheet material 2A is cut to a predetermined width using the cut line CT to produce strip-shaped carriers 2. In this way, the carriers 2 are assembled into the cartridge 100 after the inspection area L1, control area L2, and color development area L3 have been formed.

[0062] (binding substance) The first binding substance 52, which modifies the labeling substance 53 shown in Figure 6 and specifically binds to the test substance 51, is, for example, an antibody against the antigen if the test substance is an antigen, an antigen against the antibody if the test substance is an antibody, or an aptamer against the protein and low molecular weight compounds if the test substance is a protein and low molecular weight compounds, etc., and is a substance that specifically binds to the test substance.

[0063] The second binding substance 56, which is fixed in the test area L1 and specifically binds to the test substance 51, is a substance that specifically binds to the test substance, such as an antibody against the antigen if the test substance is an antigen, an antigen against the antibody if the test substance is an antibody, or an aptamer against the protein and low molecular weight compounds if the test substance is a protein and low molecular weight compounds. The first binding substance 52 and the second binding substance 56 may be the same or they may be different.

[0064] The third binding substance 58 that specifically binds to the first binding substance 52 may be the test substance 51 itself, or it may be a compound that has a site recognized by the first binding substance 52. For example, a compound obtained by binding a derivative of the test substance 51 to a protein may be used.

[0065] For example, if the test substance 51 is influenza A virus or its biomarker, anti-influenza A monoclonal antibody (Anti-Influenza A SPTN-5 7307, manufactured by Medix Biochemica) can be used as the first conjugate 52 and the second conjugate 56, and anti-mouse IgG antibody (anti-mouse IgG(H+L), rabbit F(ab')2, catalog number 566-70621, manufactured by Wako Pure Chemical Industries, Ltd.) can be used as the third conjugate 58.

[0066] (Fluid transfer pads) The liquid delivery pad 4 is positioned in contact with one end of the carrier 2 and delivers the first reagent 41 to the carrier 2 from upstream of the point contact area (composed of the label holding pad 3). As shown in Figure 4A, when the first pressing operation part 11 is pressed, one end of the liquid delivery pad 4 is immersed in the first reagent holding part 40. The liquid delivery pad 4 is made of a porous material and absorbs the first reagent 41, and delivers the absorbed first reagent 41 to the carrier 2 by capillary action.

[0067] (Absorbent pad) The absorbent pad 6 is positioned in contact with the other end of the carrier 2 and absorbs the sample 50, the first reagent 41, and the second reagent 46 that are spread on the carrier 2. The absorbent pad 6 is also made of a porous material.

[0068] <Amplifying solution> In this embodiment, the first reagent 41 and the second reagent 46 are amplification solutions that, by reacting together, amplify the color development in the test region L1 and the control region L2. When a metallic labeling substance such as gold colloid is used as the labeling substance 53, as in this example, silver amplification is used as a method to amplify the labeling signal of the labeling substance 53. The first reagent 41 and the second reagent 46 are amplification solutions used for silver amplification as an example, and the reaction of the first reagent 41 and the second reagent 46 with the labeling substance 53 as a catalyst is the amplification reaction. The amplification reaction generates silver particles with a particle size relatively larger than that of the labeling substance 53.

[0069] More specifically, in this example, the first reagent 41 is a reducing agent that reduces silver ions, and the second reagent 46 is silver ions. When the first reagent 41, which is silver ions, and the second reagent 46, which is a reducing agent, are brought into contact with the labeled substance 53, silver particles (see Figure 6) are generated, and these generated silver particles are deposited on the labeled substance 53, using the labeled substance 53 as a nucleus. The deposition of silver particles on the labeled substance 53 generates silver particles 60 (see Figure 6) with a particle size larger than that of the labeled substance 53. As a result, the labeling signal emitted by the labeled substance 53 is amplified, and consequently, the color development of the labeled substance 53 is amplified in the test area L1 and the control area L2.

[0070] (First reagent) As the reducing agent for the first reagent 41, any inorganic or organic material, or a mixture thereof, can be used, as long as it can reduce the silver ions used as the second reagent 46 to silver. As an inorganic reducing agent, Fe 2+ , V 2+ Or Ti 3+ Examples of preferred reducing metal salts and reducing metal complex salts are those whose valence can change with metal ions such as Fe. When using inorganic reducing agents, it is necessary to remove or detoxify the oxidized ions by forming a complex or reducing them. For example, Fe 2+ In systems using Fe as a reducing agent, citric acid or EDTA (ethylenediaminetetraacetic acid) is used to reduce the oxide Fe. 3+ It can form a complex and render harmless. In this system, it is preferable to use such an inorganic reducing agent, and more preferably Fe 2+ A metal salt is preferred.

[0071] Furthermore, developing agents used in wet silver halide photographic materials (e.g., methyl gallate, hydroquinone, substituted hydroquinone, 3-pyrazolidones, p-aminophenols, p-phenylenediamines, hindered phenols, amidoximes, azines, catechols, pyrogallols, ascorbic acid (or its derivatives), and leuco dyes), as well as other materials obvious to those skilled in the art, such as those described in U.S. Patent No. 6,020,117, can also be used.

[0072] As a reducing agent, ascorbic acid reducing agents are also preferred. Useful ascorbic acid reducing agents include ascorbic acid and its analogues, isomers and derivatives, and for example, D- or L-ascorbic acid and its sugar derivatives (e.g., γ-lactoascorbic acid, glucoascorbic acid, fucoscorbic acid, glucoheptascorbic acid, maltoascorbic acid), sodium salts of ascorbic acid, potassium salts of ascorbic acid, isoascorbic acid (or L-erythroascorbic acid), salts thereof (e.g., alkali metal salts, ammonium salts or salts known in the art), enediol-type ascorbic acid, enaminol-type ascorbic acid, thioenol-type ascorbic acid, etc., with D, L, or D,L-ascorbic acid (and its alkali metal salts) or isoascorbic acid (or its alkali metal salts) being particularly preferred, and sodium salts being preferred salts. Mixtures of these reducing agents can be used as needed.

[0073] (Second reagent) The solution containing silver ions used as the second reagent 46 is preferably one in which a silver ion-containing compound is dissolved in the solvent. The silver ion-containing compound can be an organic silver salt, an inorganic silver salt, or a silver complex. Preferably, it is an inorganic silver salt or a silver complex. As inorganic silver salts, silver ion-containing compounds with high solubility in solvents such as water can be used, including silver nitrate, silver acetate, silver lactate, silver butyrate, and silver thiosulfate. Silver nitrate is particularly preferred. As silver complexes, silver complexes coordinated to ligands having water-soluble groups such as hydroxyl groups or sulfone groups are preferred, including silver hydroxythioether.

[0074] <Immunochromatography> The immunochromatographic method will be explained with reference to Figure 6. Here, the explanation assumes that sample 50 contains the test substance 51, that is, that sample 50 is positive. In Figure 6, the side view and top view of the carrier 2 are shown in the center column, the steps in the immunochromatographic method are described in the left column, and a magnified view of the observation area LA is shown in the right column. The magnified view of the observation area LA shows how the color of the color development area L3 changes from dark green to orange before and after the development of the first reagent 41.

[0075] In the initial state before the sample 50 is applied, the colors of the test area L1 and control area L2 are almost the same as the color of the carrier 2 (which is close to white in this embodiment), so the test area L1 and control area L2 cannot be clearly seen. On the other hand, the color-developing area L3 appears as a dark green line even at this stage and is visible.

[0076] First, the sample 50 is spot-applied onto the label-holding pad 3, which is the spot-applied area (step S1). The test substance 51 in the sample 50 spot-applied onto the label-holding pad 3 specifically binds to the first binding substance 52 that modifies the label substance 53 contained in the label-holding pad 3. The sample 50 is then spread downstream from the label-holding pad 3 within the carrier 2 by capillary action. A portion of the sample 50 is also spread upstream.

[0077] If the unfolded sample 50 is positive, the test area L1 develops a black color due to the amplification effect of the first reagent 41 and the second reagent 46. As a result, the test area L1 appears as a line. However, if the sample 50 is negative, the test area L1 does not appear as a line. Similarly, if the sample 50 is unfolded, the control area L2 also develops a black color due to the amplification effect of the first reagent 41 and the second reagent 46. As a result, the control area L2 appears as a line. Furthermore, in this example, without the amplification effect of the first reagent 41 and the second reagent 46, the coloration of these areas does not change to a visible degree.

[0078] Next, the first reagent 41 is supplied (step S2). The first reagent 41 is supplied from the liquid delivery pad 4 side. The first reagent 41 is supplied to the carrier 2 via the liquid delivery pad 4 and spreads downstream.

[0079] Subsequently, the system waits until the first reagent 41 is deployed upstream (steps S3-S4). The "Wait" shown in Figure 6 indicates waiting. The first reagent 41 is gradually deployed downstream, and the sample 50 being deployed from the label-holding pad 3 and the labeled substance 53 modified with the first binding substance 52 are pushed upstream by the first reagent 41 (step S3).

[0080] The test substance 51 in the sample 50, which is deployed downstream and reaches the test area L1, is captured by the second binding substance 56 in the test area L1. That is, the labeling substance 53 that is bound to the test substance 51 via the first binding substance 52 is captured in the test area L1. On the other hand, the labeling substance 53 that is not bound to the test substance 51 passes through the test area L1 without being captured and is captured by the third binding substance 58 in the control area L2.

[0081] As the first reagent 41 expands and reaches the color-developing region L3 (step S4), the color-developing region L3 reacts with the first reagent 41 and changes color. In this example, the color-developing region L3 is dark green before reacting with the first reagent 41, and changes to orange after reacting with the first reagent 41.

[0082] After the first reagent 41 has fully expanded, the second reagent 46 is supplied to the carrier 2 (step S5). The second reagent 46 is supplied to the carrier 2 from downstream of the color development region L3 and expands upstream. Here, the first reagent 41 is a first amplification solution containing a reducing agent that reduces silver ions, and the second reagent 46 is a second amplification solution containing silver ions. The reaction between the first and second amplification solutions generates silver particles 60 using the gold colloid particles, which are the labeling substance 53, as a catalyst. This amplifies the label signal (step S6).

[0083] In the test area L1, if the sample is positive, the labeling signal is amplified by the action of the first reagent 41 and the second reagent 46, resulting in a black color. In the control area L2, the labeling signal is amplified regardless of whether the sample is positive or not, resulting in a black color.

[0084] <Immunochromatographic Inspection Equipment> As shown in Figure 1, the inspection device 110 includes a housing 111, which includes a cartridge loading section 112 into which a cartridge 100 is detachably loaded. For example, the front of the housing 111 is provided with an opening for inserting the cartridge 100 into the housing 111 and an opening / closing lid 112a for opening and closing this opening. When loading the cartridge 100, the opening / closing lid 112a is opened, the cartridge 100 is inserted into the housing, and once loaded into the cartridge loading section 112, the opening / closing lid 112a is closed. The inspection is performed with the opening / closing lid 112a closed.

[0085] Furthermore, a power switch 113 is provided on the front of the housing 111, and a monitor 119 is provided on the top surface of the housing 111. The monitor 119 displays the judgment results and error messages. The monitor 119 is, for example, a touch panel monitor, and various operation screens are displayed. The user can input operation instructions such as inputting a command to start processing and selecting an inspection procedure through the operation screen. Note that the housing 111 does not necessarily have to have a power switch 113 and a monitor 119. In this case, for example, the inspection device 110 is connected to a computer such as a personal computer, and the inspection device 110 is controlled by the computer. Then, operation instructions including turning the power of the inspection device 110 on and off are input from the computer, and the operation screen and judgment results are displayed on the computer's monitor.

[0086] As an example, the testing device 110 is loaded with a cartridge 100 in which the sample has been applied to the carrier 2 and the supply of the first reagent 41 and the second reagent 46 to the carrier 2 has begun. In this example, before loading the cartridge 100 into the testing device 110, the user presses the first pressing operation unit 11 and the second pressing operation unit 12. As a result, the cartridge 100 is in the state shown in Figure 4B, and in this state, the cartridge 100 is loaded into the testing device 110. The testing device 110 detects the color development state of the test area L1 of the loaded cartridge 100 and presents a result indicating whether the sample is positive or negative. When testing multiple samples, one cartridge 100 for each sample is loaded into the testing device 110.

[0087] As shown in Figure 8, the inspection device 110 comprises a loading unit 112, a detection unit 114, a light source 115, a processor 120, and a memory 121, all housed in a casing 111. In Figure 8, the processor 120 and memory 121 are shown outside the casing 111 of the inspection device 110, but this is a schematic diagram, and in reality they are located inside the casing 111.

[0088] (Detection unit) The detection unit 114 optically detects the color development state of the inspection area L1, the control area L2, and the color development area L3, and outputs a detection signal representing the color development state to the processor 120. The detection unit 114 is an image sensor such as a CMOS (Complementary Metal Oxide Semiconductor) image sensor or a CCD (Charge Coupled Device) image sensor, and is an imaging unit that images the observation area LA, which includes the inspection area L1, the control area L2, and the color development area L3. The image including the captured observation area LA is then output from the detection unit 114 to the processor 120. Here, "image of the observation area LA" includes not only the mode of imaging only the observation area LA, but also the mode of capturing the observation area LA and its surrounding image. The mode of capturing the observation area LA and its surrounding image will be described below. In the following description, the image captured by the detection unit 114 will be referred to as the "captured image," and the image cropped from the captured image and containing only the observation area LA will be referred to as the "observation image."

[0089] The detection unit 114 is positioned to face the observation area LA when the cartridge 100 is loaded into the inspection device 110.

[0090] (light source) To the side of the detection unit 114 is a light source 115, such as a light-emitting diode, which illuminates the observation area LA on the carrier 2, including the inspection area L1, the control area L2, and the color development area L3, when the detection unit 114 is imaging. In this example, the light source 115 comprises a first light source 115A that emits green monochromatic light and a second light source 115B that emits red monochromatic light.

[0091] The first light source 115A is positioned to the side of the detection unit 114, and the second light source 115B is positioned to the side of the detection unit 114, on the side opposite to the first light source 115A. In Figure 8, the first light source 115A, the detection unit 114, and the second light source 115B are arranged in a line along the longitudinal direction of the carrier 2, but the first light source 115A, the detection unit 114, and the second light source 115B may also be arranged in a line along the width direction perpendicular to the longitudinal direction of the carrier 2. Alternatively, one first light source 115A and one second light source 115B may be placed on each side of the detection unit 114. In the following description, the green light emitted by the first light source 115A may be referred to as G light, and the red light emitted by the second light source 115B may be referred to as R light.

[0092] As shown in Figure 6, the color-developing region L3 in this example is dark green before reacting with the first reagent 41, and changes to orange when the first reagent 41 reaches the color-developing region L3. In the art of this disclosure, dark green is an example of the first color before discoloration, and orange is an example of the second color after discoloration. The first light source 115A emits more G light when irradiated with the dark green color-developing region L3, which is an example of the first color, than when irradiated with the orange color-developing region L3, which is an example of the second color. This is because orange absorbs more G light than dark green.

[0093] On the other hand, the second light source 115B emits more red light when illuminating the orange color region L3, an example of the second color, than when illuminating the dark green color region L3, an example of the first color. This is because dark green absorbs more red light than orange.

[0094] G light is an example of first monochromatic light, and the first light source 115A is an example of a first monochromatic light source. Similarly, R light is an example of second monochromatic light, and the second light source 115B is an example of a second monochromatic light source.

[0095] (Processor) The processor 120 comprehensively controls each part of the inspection device 110. An example of the processor 120 is a CPU (Central Processing Unit) that performs various controls by executing a program. By executing the program, the CPU functions as a control unit having a detection unit control unit 122, an inspection area identification unit 123, a color development state discrimination unit 124, and a display control unit 125. Memory 121 is an example of memory connected to or built into the CPU as the processor 120. For example, a control program is stored in memory 121. The processor 120 is realized when the CPU executes the control program.

[0096] Memory 121 stores not only the control program but also setting information that is pre-configured for the processor 120 to perform various controls. The setting information includes the information necessary for the color development state determination unit 124 to determine changes in the color development state. The setting information also includes the interval T between the color development area L3 and the inspection area L1 (see Figures 12, 13, and 14).

[0097] The detection unit control unit 122 controls the timing of imaging of the observation area LA by the detection unit 114 by transmitting control signals to the detection unit 114. The detection unit control unit 122 also acquires the image captured by the detection unit 114 and outputs the image to the inspection area identification unit 123. As previously described, the image is an image that includes the observation area LA. The detection unit control unit 122 illuminates the observation area LA with G light by turning on only the first light source 115A, and operates the detection unit 114 in that state to image the observation area LA under G light illumination. As a result, the detection unit control unit 122 acquires an image that includes the observation image PG (see Figure 12) captured under G light illumination. The detection unit control unit 122 also illuminates the observation area LA with R light by turning on only the second light source 115B, and operates the detection unit 114 in that state to image the observation area LA under R light illumination. As a result, the detection unit control unit 122 acquires an image including the observation image PR (see Figure 12) captured under R-light illumination. Hereinafter, the observation image PG and observation image PR will also be referred to as the G-light observation image PG and the R-light observation image PR, respectively.

[0098] The inspection area identification unit 123 obtains observation images PG and PR, which include the observation area LA, from two captured images acquired under G-light and R-light illumination, respectively. The inspection area identification unit 123 then detects the position of the color-developed area L3, which serves as an indicator area, from the acquired observation images PG and PR, and performs a process to determine the position of the inspection area L1 based on the detected position of the color-developed area L3. In the technology of this disclosure, observation image PG is an example of the first image, and observation image PR is an example of the second image.

[0099] The color development state determination unit 124 uses at least one of the observation images PG and PR captured by the detection unit 114 to perform a color development state determination process to determine the color development state of the inspection area L1 identified by the inspection area identification unit 123.

[0100] The color development state determination process determines whether or not there is a change in the color development state of the test area L1. If sample 50 is positive, a line will appear in the test area L1, and the color development state determination process determines whether or not this line appears in the test area L1.

[0101] If the color development state determination unit 124 determines that there is a change in the color development state of the test area L1, the processor 120 determines that the sample 50 is positive. In this case, the display control unit 125 displays "positive" on the monitor 119. If the processor 120 determines that there is no change in the color development state of the test area L1, the processor 120 determines that the sample 50 is negative. In this case, the display control unit 125 displays "negative" on the monitor 119.

[0102] <Immunochromatography Test> The inspection flow of an immunochromatographic inspection using the inspection device 110 of this embodiment will now be described. As shown in Figure 9, first, the user drops the sample 50 from the dropper port 16 of the cartridge 100 onto the application area of ​​the carrier 2. This applies the sample 50 to the carrier 2 (step S100).

[0103] Next, the user presses the first pressing operation section 11 of the cartridge 100 to start supplying the first reagent 41 to the carrier 2 (step S200).

[0104] Next, after the user confirms that the color development area L3 has changed from dark green to orange, they press the second pressing operation section 12 of the cartridge 100 to start supplying the second reagent 46 to the carrier 2 (step S300).

[0105] Next, the user loads the cartridge 100 into the loading section 112 of the inspection device 110 (step S400).

[0106] Subsequently, inspection of the loaded cartridge 100 is started within the inspection device 110 (step S500).

[0107] In the inspection of cartridge 100, the processor 120 first identifies the location of inspection area L1 within observation area LA (step S600). The process of identifying the location of inspection area L1 will be described in detail later.

[0108] Next, the processor 120 determines the color development state of the inspection area L1 (step S700).

[0109] If the processor 120 determines that there is a change in the coloration of the test area L1, it determines that the sample 50 is positive and displays "positive" on the monitor 119. If the processor 120 determines that there is no change in the coloration of the test area L1, it displays "negative" on the monitor 119 (step S800) and terminates the test flow.

[0110] (Identification process for the inspection area) Next, the process of identifying the inspection area L1 in step S600 described above will be explained using Figure 10. In the process of identifying the position of the inspection area L1, the processor 120 operates the detection unit 114, the first light source 115A, and the second light source 115B to acquire the G-light observation image PG (see Figure 12) and the R-light observation image PR (see Figure 12) (step S610). As described above, the G-light observation image PG is an image of the observation area LA captured under illumination of the G-light by the first light source 115A. The R-light observation image PR is an image of the observation area LA captured under illumination of the R-light by the second light source 115B. Details of these observation images will be described later.

[0111] Next, the processor 120 performs image recognition on the observed images PG and PR to detect the position of the color-developed region L3, which serves as an indicator area (step S620). The process for detecting the position of this color-developed region L3 will be described in detail later.

[0112] Next, the processor 120 identifies the position of the inspection area L1 based on the position of the color-developing area L3 (step S630), and then terminates the process of identifying the inspection area L1. After the process of identifying the inspection area L1, the process proceeds to step S700 in Figure 9.

[0113] (Detection process of the position of the indicator area) Next, the process of detecting the position of the color-developing region L3 in the above-described process S620 will be explained using Figure 11. In the process of detecting the position of the color-developing region L3, first, the processor 120 derives a difference image ΔP (see Figure 12) between the acquired G-light observation image PG and the R-light observation image PR (process S621). Next, based on this difference image ΔP, the position of the color-developing region L3 as an indicator region is detected (process S622). After detecting the position of the color-developing region L3, the process proceeds to process S630 in Figure 10.

[0114] The process shown in Figure 11 will be conceptually explained using Figure 12. Figure 12 shows the observation area LA when the cartridge 100 is loaded into the testing device 110. In this example, the cartridge 100 is loaded into the testing device 110 after the color-developing area L3 has turned orange, so in the observation area LA, the color-developing area L3, which serves as an indicator area, is orange. On the other hand, the testing area L1 turns black if the sample 50 is positive, but does not turn color if the sample 50 is negative. Therefore, if the sample 50 is negative, the testing area L1 is almost the same color as the carrier 2. In this case, since the testing area L1 is not colored, its position cannot be determined by image recognition. Therefore, the processor 120 detects the color-developing area L3, which is an example of an indicator area, by image recognition, and determines the position of the testing area L1 based on the position of the detected color-developing area L3.

[0115] In step S610 shown in Figure 10, as shown in Figure 12, a G-light observation image PG, captured by irradiating with G-light, and a R-light observation image PR, captured by irradiating with R-light, are acquired. Both observation images PG and PR are monochrome images because they are captured with monochromatic light, either G-light or R-light. In Figure 12, in both observation image PG and observation image PR, the region corresponding to the color-developing region L3 on the observation region LA is shown as the color-developing region L3.

[0116] Since the color-developing region L3 is discolored orange, when comparing the G-light observation image PG and the R-light observation image PR, the color density of the color-developing region L3 is higher in the G-light observation image PG. This is because the amount of reflected orange light from the R-light is greater than that from the G-light. Since carrier 2 is close to white, the amount of reflected R-light is also high, similar to orange. Therefore, in the R-light observation image PR, both the near-white background of carrier 2 and the color-developing region L3 have high brightness, making it difficult to distinguish between the two. In contrast, in the G-light observation image PG, when comparing the near-white background of carrier 2 with the orange color-developing region L3, the amount of reflected G-light from the background of carrier 2 is high, resulting in a higher density of the color-developing region L3. For this reason, the color-developing region L3 is easier to identify.

[0117] The difference image ΔP between the observed image PG and the observed image PR is the difference image ΔP between the observed image PG and the observed image PR shown in Figure 12. This difference image ΔP is an image that shows the difference in density between the observed image PG and the observed image PR. In the observed image PG, the density of the colored region L3 is high, and the density of other parts is low. On the other hand, in the observed image PR, both the colored region L3 and other parts have similarly low density. Therefore, in the difference image ΔP, only the colored region L3 remains in an identifiable state.

[0118] Furthermore, the reason for using two observation images in this example, the G-light observation image PG and the R-light observation image PR, is to improve the detection accuracy of the colored region L3. That is, as shown in Figure 13, consider the case where there is a noise region L4 on the carrier 2. The noise region L4 is a line-shaped region along the X direction that has turned black due to, for example, impurities mixed into the carrier 2. Since the noise region L4 is black, it is captured in both the G-light observation image PG and the R-light observation image PR.

[0119] When the processor 120 detects the colored region L3, it searches for a predetermined position in the Y direction of the carrier 2 on the G-light observation image PG, starting from the downstream side of the carrier 2 (the end side closer to the colored region L3) and moving along the X direction. The processor 120 then detects the region with a higher density than the base of the carrier 2 as the colored region L3. In this case, as shown in Figure 13, if the position in the Y direction that the processor 120 searches is, for example, a position LY1 that does not overlap with the noise region L4, the colored region L3 can be detected based on the density difference between the base of the carrier 2 and the high-density region by searching in the X direction. However, if the position in the Y direction that the processor 120 searches overlaps with the noise region L4, the entire area of ​​the noise region L4 extending in the X direction is high density, making it difficult to distinguish it from the colored region L3 based on the density difference, and thus the colored region L3 cannot be detected.

[0120] Therefore, the colored region L3 cannot be detected using only the G-light observation image PG. Furthermore, the colored region L3 is not depicted in the R-light observation image PR, making it impossible to detect the colored region L3.

[0121] Therefore, the processor 120 uses two observation images, the G-light observation image PG and the R-light observation image PR, and uses the difference image ΔP derived from them to detect the position of the colored region L3. In the difference image ΔP, the noise region L4 depicted in both the G-light observation image PG and the R-light observation image PR is canceled out, so only the colored region L3 remains in an identifiable state.

[0122] Furthermore, as shown in Figure 14, consider the case where, for example, there is a noise region L5 on the carrier 2. Noise region L5 is a line-shaped region along the Y direction that appears black due to, for example, impurities mixed into the carrier 2. In this case, since noise region L5 is black, it is visible in both the G-light observation image PG and the R-light observation image PR. Therefore, if noise region L4 is present, the G-light observation image PG will show two lines, the colored region L3 and the noise region L4, making it impossible to determine which is the colored region L3 from the G-light observation image PG alone. Furthermore, in the R-light observation image PR, the colored region L3 is not shown, but the noise region L4 is, so the R-light observation image PR alone may misdetect the noise region L4 as the colored region L3.

[0123] Therefore, the processor 120 uses two observation images, the G-light observation image PG and the R-light observation image PR, and uses the difference image ΔP derived from them to detect the position of the colored region L3. In the difference image ΔP, the noise region L4 depicted in both the G-light observation image PG and the R-light observation image PR is canceled out, so only the colored region L3 remains in an identifiable state.

[0124] Here, the processor 120 detects the position of the color-developing region L3 based on the optical density of the color-developing region L3, which serves as an indicator region. Specifically, in the difference image ΔP, the processor 120 detects the position of the color-developing region L3 using the ΔOD (Optical Density) value, which is the difference between the optical density of the color-developing region L3, which is an example of an indicator region, and the optical density of the background region that serves as the background for the color-developing region L3, i.e., the part other than the color-developing region L3.

[0125] The processor 120 compares, for example, the ΔOD value of each pixel in the difference image ΔP with a preset threshold. It then identifies the area where the ΔOD value is greater than or equal to the preset threshold as the location of the colored region L3. The threshold is, for example, 0.015 [au]. Generally, a density difference of 0.015 [au] or more in ΔOD values ​​is a density difference that is visible to the human eye. By using the ΔOD value to detect the location of the colored region L3, the influence of individual differences in optical density between the colored region L3 and the background region can be reduced.

[0126] In this way, the processor 120 detects the position of the color-developing region L3 as an indicator region through image recognition using the observed image PG, the observed image PR, and the difference image ΔP derived from them. Then, the processor 120 identifies the position of the inspection region L1 using a predetermined interval T based on the position of the color-developing region L3. In this example, the color-developing region L3 and the inspection region L1 are arranged with an interval T along the longitudinal direction of the carrier 2. The processor 120 identifies the position of the inspection region L1 by calculating the position at an interval T along the longitudinal direction of the carrier 2 from the detected position of the color-developing region L3 in the difference image ΔP using a simple distance calculation.

[0127] <Mechanism and Effects> In the inspection device 110 of this disclosure, the detection unit 114, which serves as an imaging unit as shown in Figure 8, images the observation area LA on the carrier 2. This observation area LA includes an inspection area L1 whose coloration state changes depending on whether the sample is positive or negative, and a colored area L3 as an example of an indicator area that can be optically distinguished from other areas regardless of whether the sample is positive or negative.

[0128] In the inspection device 110 of this disclosure, the processor 120 detects the position of the color-developed region L3 as an indicator region from the observation images PG and PR shown in Figure 12, which are examples of images of the observation region LA captured by the detection unit 114. The inspection region L1 cannot be detected if the sample is negative, but the color-developed region L3 can be optically distinguished from other regions regardless of whether the sample is positive or negative, and therefore its position can be detected by comparing it with the inspection region L1.

[0129] Since the inspection area L1 is positioned with a predetermined interval T (see Figure 12) from the color development area L3, the processor 120 can determine the position of the inspection area L1 based on the detected position of the color development area L3 if it can detect the position of the color development area L3.

[0130] Since the test area L1 does not appear if sample 50 is negative, it is difficult to detect the location of the test area L1 by optical density-based image recognition when sample 50 is negative. Even in this case, however, by using the location of the color-developing area L3 as a reference, as described above, it is possible to identify the location of the test area L1 by simple distance calculation.

[0131] Furthermore, even if sample 50 is positive, the change in the coloration state of the test area L1 may be very slight. In this case, if the location of the test area L1 cannot be determined, it is difficult to optically distinguish the change in coloration state from noise present in other areas, and misrecognition is likely to occur. Even in such cases, the technology of this disclosure may be effective. That is, according to the technology of this disclosure, the coloration region L3 is detected as an indicator region by optical density-based image recognition, and the location of the test area L1 can be determined based on the detected coloration region L3 without relying on optical density-based image recognition. Therefore, according to the technology of this disclosure, the location of the test area L1 can be determined even if the change in coloration state is slight. If the location of the test area L1 can be determined, misrecognition with noise present in areas other than the test area L1 is suppressed, and the possibility of detecting slight changes in the coloration state in the test area L1 is improved.

[0132] Both the inspection area L1 and the color development area L3 are areas formed on the carrier 2. Therefore, the cartridge 100 is constructed, for example, by assembling a case body 20 and the carrier 2, which are separate parts. Compared to the individual differences in positional misalignment between the case body 20 and the carrier 2, the individual differences in positional misalignment between the inspection area L1 and the color development area L3 are far smaller.

[0133] The inspection device 110 of this disclosure determines the position of the inspection area L1 based on the position of the color-developing area L3 detected from the observation images PG and PR of the observation area LA on the carrier 2. Therefore, even if there is a misalignment between the case body 20 and the carrier 2 due to individual differences in the cartridge 100, the position of the inspection area L1 can be determined.

[0134] If it becomes possible to pinpoint the location of the inspection area L1 in this way, it will be possible to suppress misjudgments caused by mistakenly identifying areas other than the inspection area L1 as the inspection area L1.

[0135] Furthermore, in the inspection apparatus 110 of this disclosure, the processor 120 detects the position of the color-developing region L3 based on the optical density of the color-developing region L3, which serves as an indicator region. Since optical density can be measured regardless of color, such as red or green, detection is possible even if the image is monochrome. This allows the light source 115 to be not limited to a white light source, but can also be a monochromatic light source, such as a first light source 115A or a second light source 115B.

[0136] Furthermore, the inspection device 110 of this disclosure detects a color-developing region L3, which changes color state upon reaction with the first reagent 41, which is used as a reagent, as an indicator region. The first reagent 41 is an amplification solution for amplifying the change in color state of the inspection region L1. When an amplification solution is used as a reagent, the region that reacts with the amplification solution, i.e., the color-developing region L3, can be used as the indicator region.

[0137] Furthermore, it is not always necessary to use an amplification solution as a reagent. In other words, in the inspection apparatus 110 of this disclosure, if the carrier 2 has a region that reacts with some kind of labeling substance, not limited to the combination of the first reagent 41 and the color development region L3, this region can be used as an indicator region.

[0138] For example, in the inspection device 110, a control region L2 that reacts with the labeled substance 53 and changes in color development may be detected as an indicator region. In addition, if the carrier 2 has a region that reacts with some reagent other than the color development region L3 and the control region L2, this region can be used as an indicator region.

[0139] Furthermore, as described in the above embodiment, when the color-developing region L3 (an example of an indicator region) is dark green (an example of a first color) before reacting with the reagent and changes from dark green to orange (an example of a second color) upon reaction with the reagent, the inspection apparatus 110 of this disclosure comprises a first light source 115A (an example of a first monochromatic light source) and a second light source 115B (an example of a second monochromatic light source). The first light source 115A emits G light (an example of a first monochromatic light) which has a higher amount of reflected light when irradiated with the orange color-developing region L3 than when irradiated with the dark green color-developing region L3. The second light source 115B emits R light (an example of a second monochromatic light) which has a higher amount of reflected light when irradiated with the orange color-developing region L3. The processor 120 then uses the first light source 115A and the detection unit 114 (an example of an imaging unit) to capture an observation image PG of G light obtained by imaging the orange colored region L3, and further uses the second light source 115B and the detection unit 114 to capture an observation image PR of R light obtained by imaging the orange colored region L3. The processor 120 then detects the colored region L3 based on the observation image PG of G light and the observation image PR of R light. Therefore, even if there is a noise region L4 or the like within the observation region LA, the colored region L3 can be detected with high accuracy by, for example, using the difference image ΔP of the observation image PG and the observation image PR.

[0140] The first and second colors of the indicator region shown in the above embodiment are examples, and other colors may be used. In this case, the first monochromatic light and the second monochromatic light are also selected according to the first and second colors. In the above example, the first color is dark green and contains a green component, and the second color is orange. Therefore, the first light source 115A, which is an example of the first monochromatic light source, is a green light source, and the second light source 115B, which is an example of the second monochromatic light source, is a red light source.

[0141] Furthermore, in the inspection apparatus 110 of this disclosure, the light source 115A, which serves as the first monochromatic light source irradiating the color-developing region L3, is a green light source, and the light source 115B, which serves as the second monochromatic light source, is a red light source. Red light has a longer wavelength and therefore lower energy compared to blue light. As a result, it can suppress the degradation of the observation region LA. Green light also has a longer wavelength compared to blue light, for example, so it can achieve a similar effect to red light.

[0142] Furthermore, in the inspection apparatus 110 of this disclosure, in the cartridge 100, the inspection area L1 and the color development area L3 as an indicator area are areas formed by coating on the carrier 2, and the carrier 2 is assembled into the case 9 after the inspection area L1 and the color development area L3 have been formed.

[0143] When the inspection area L1 and color development area L3 are formed after the carrier 2 is assembled to case 9, individual differences in cartridge 100 are likely to occur in the spacing between the inspection area L1 and color development area L3. Therefore, compared to when the inspection area L1 and color development area L3 are formed after the carrier 2 is assembled to case 9, the positions of the inspection area L1 and color development area L3 are less likely to be misaligned. As a result, the accuracy of determining the position of the inspection area L1 based on the position of the color development area L3 (an example of an indicator area) is improved.

[0144] In the inspection apparatus 110 of this disclosure, the control region L2 is also formed on the carrier 2 by coating before being assembled to the case 9. Therefore, the same effect can be obtained even when the control region L2 is used as an indicator region.

[0145] <Other Embodiments> In the inspection apparatus 110 of this disclosure, a green light source 115A and a red light source 115B are used as light sources, but the embodiments of this disclosure are not limited to these. For example, a white light source may be used as the light source. In this case, if an imaging unit capable of capturing color images is used as the detection unit 114, the captured image and a portion thereof of the observed image captured by the detection unit 114 will be a color image. In this case, the processor 120 can detect the indicator region by identifying color in the observed image instead of or in addition to optical density. That is, the processor 120 detects the position of the indicator region based on the color of the indicator region.

[0146] For example, if noise is generated due to the presence of foreign objects, it can be difficult to distinguish between the noise and the color region L3 in a monochrome image. Therefore, color-based detection may offer higher detection accuracy, and using color images is effective in such cases.

[0147] Furthermore, in the above embodiment, the processor 120 detects the position of the indicator region based on the optical density of the indicator region, but it is not limited to this. For example, the processor 120 may detect the position of the indicator region based on the shape of the indicator region. The shape of the indicator region may be, for example, a circle, a triangle, or a striped pattern. In this way, if the shape of the color-producing region has distinctive features, it is possible to detect the color-producing region based on its shape.

[0148] In the above embodiment, the position of the indicator region is detected using two observation images acquired with two monochromatic light sources, G light and R light. However, the position of the indicator region may also be detected using one observation image acquired with a single monochromatic light source. For example, as in the above embodiment, when detecting an indicator region that emits a color other than green, such as the orange-colored region L3, the indicator region can be detected using only the G light observation image PG. This makes it possible to identify the position of the inspection region L1.

[0149] In the above embodiment, the color of the carrier 2, i.e., the background color of the inspection area L1, control area L2, and color development area L3, was described as being close to white as an example, but the color of the carrier 2 may be any other color. The color of the carrier 2 should be a color that is distinguishable from the colors of the inspection area L1, control area L2, and color development area L3 when they are developing color.

[0150] Furthermore, in the above embodiment, the color-developing region L3 is detected using only the observation image of the color-developing region L3 after discoloration, but the color-developing region L3 may also be detected using the observation image of the color-developing region L3 before discoloration. In the above embodiment, the supply of the second reagent 46 is started when the user operates the second pressing operation unit 12, and the cartridge 100 is loaded into the testing device 110 after the color-developing region L3 has turned orange. For example, some testing devices are loaded with a cartridge 100 in which only the supply of the first reagent 41 has been started, and the second pressing operation unit 12 is operated by an internal mechanism. In the case of such a testing device, the cartridge 100 is loaded when the color-developing region L3 is dark green before discoloration, so it is possible to obtain an observation image of the color-developing region L3 before discoloration. By using observation images before and after discoloration, it is possible to detect the change in color of the color-developing region L3. The position of the color-developing region L3 may also be detected based on the change in color of the color-developing region L3.

[0151] The observation image PG and observation image PR described above are images obtained by cropping a portion of the captured image taken by the detection unit 114. An example of this cropping process performed by the processor 120 is described below.

[0152] (Trimming process) The processor 120 may perform the following trimming process to trim the observed image from the captured image captured by the detection unit 114.

[0153] In order to perform this trimming process, it is preferable to provide biasing means 180 and 182 inside the inspection device 110 for pressing the cartridge 100 against the reference surfaces 112b and 112c of the cartridge loading section 112, as shown in Figure 15. The reference surfaces 112b and 112c are the surface along the insertion direction (X direction) of the cartridge 100 and the surface along the direction perpendicular to the said surface in a plan view (Y direction), respectively.

[0154] The biasing means 180 comprises a spring 180a and a pressing body 180b, and biases the cartridge 100 in the Y direction. The pressing body 180b is fixed to one end of the spring 180a. The other end of the spring 180a is fixed inside the inspection device 110.

[0155] Furthermore, the biasing means 182 comprises a spring 182a and a pressing body 182b, and biases the cartridge 100 in the X direction. The pressing body 182b is fixed to one end of the spring 182a. The other end of the spring 182a is fixed to the inside of the opening / closing lid 112a, and biases the cartridge 100 in the X direction when the cartridge 100 is loaded into the inspection device 110.

[0156] Because the cartridge 100 is rectangular in shape, when it is pressed against the reference surfaces 112b and 112c by the biasing means 180 and 182, the end face of the cartridge 100 is positioned along the reference surfaces 112b and 112c, thereby positioning the cartridge 100.

[0157] In Figure 15, the captured image PA taken by the detection unit 114 is shown by a dashed line. The captured image PA includes at least a portion of the outline of the cartridge 100. In this embodiment, a portion of the end face 100E is included. The portion of the end face 100E corresponds to a portion of the outline of the cartridge 100. The captured image PA also includes the entire observation window 18.

[0158] In Figure 16, the outer edge of the captured image PA is drawn with a dashed line. The processor 120 trims the observation area LA from this captured image PA. The observation area LA is the area inside the observation window 18. The trimming process by the processor 120 is performed between steps S500 and S600 shown in Figure 9. This trimming process is also performed by the inspection area identification unit 123 shown in Figure 8.

[0159] As shown in Figure 16, the processor 120 searches for the end face 100E within the captured image PA. For example, the processor 120 searches the captured image PA in the Y direction from a predetermined point P0 (X0, Y0) to detect the position P1 (X0, Y1) of the end face 100E in the Y direction. The processor 120 detects the portion of the captured image PA where the contrast is above a threshold as the end face 100E.

[0160] To facilitate this search, it is preferable that the cartridge 100 is made of white resin and the cartridge loading section 112 is made of a resin other than white (for example, black). Alternatively, it is preferable that the cartridge 100 and the cartridge loading section 112 are made of resins with a high contrast color.

[0161] Next, the processor 120 detects position P2(X0, Y2), which is offset by a distance H1 in the Y direction from position P1, as the center position in the Y direction of the observation area LA to be trimmed. This distance H1 is the distance from the end face 100E to the center line CL of the observation window 18.

[0162] In cartridge 100, the distance H1 from the end face 100E to the center line CL of the observation window 18 is a unique value determined by the type of cartridge. The memory 121 has the distance H1 corresponding to the type of cartridge 100 stored in advance.

[0163] Next, the processor 120 searches for the edge of the observation window 18 in the X direction within the captured image PA. At this time, the processor 120 searches within the captured image PA along the X direction from position P2 (X0, Y2) and detects point P3 (X1, Y2), which is the edge of the observation window 18 in the X direction. Since the observation window 18 is an opening formed in the case 9 of the cartridge 100, the inner circumferential wall corresponding to the edge of the observation window 18 and the carrier 2 are not coplanar, and the carrier 2 is recessed one step relative to the inner circumferential wall. Therefore, the edge of the observation window 18 appears as a shadow within the captured image PA. The processor 120 detects the edge of the observation window 18 that appears as a shadow within the captured image PA as point P3.

[0164] Next, the processor 120 trims an area with a width of H2 in the X direction from point P3 and a width of H3 in the Y direction centered on the center line CL, as the observation area LA. The shape with a width of H2 in the X direction and a width of H3 in the Y direction is the size of the observation window 18 in the cartridge 100, and these values ​​are also stored in the memory 121 in advance. Here, the center of width H3 is defined by the center line CL, but the center of width H3 does not necessarily have to be the center line CL; it is sufficient to trim an area with a width of H3 centered approximately on the center line CL (or in the vicinity of the center line CL).

[0165] Thus, in the inspection device 110 of this embodiment, the misalignment of the cartridge 100 within the cartridge loading section 112 is eliminated by pressing the cartridge 100 against the reference surfaces 112b and 112c. Therefore, the position of the outline of the end face 100E in the captured image PA is more easily determined uniquely than when there is a misalignment of the cartridge 100. As a result, searching for the outline becomes easier.

[0166] Furthermore, since the distance H1 from the outline to the center line CL of the observation window 18 can be known in advance, the observation area LA can be easily identified by searching for the observation window 18 based on the outline.

[0167] Further, by performing the trimming process on the observation area LA, the search range of the coloring area L3 as the index area becomes narrower compared to the case where the trimming process is not performed, so that the detection of the coloring area L3 can be performed simply and quickly.

[0168] In the above example, the processor 120 searches for the observation window 18 based on the end face 100E forming the outer contour line of the cartridge 100, and performs an area identification process for identifying, as the observation area LA, an area that substantially matches the size of the observation window 18, that is, an exposed area EA exposed in the observation window 18. On the other hand, as shown in FIG. 17, the processor 120 may perform an area identification process for identifying, as the observation area LA, an area whose Y-direction width is narrower than the exposed area EA exposed in the observation window 18. In the example shown in FIG. 17, an area with a width H4 (where H4 < H3) in the Y direction centered on the center line CL with respect to the Y-direction width H3 of the observation window 18 is identified as the observation area LA.

[0169] For example, when the carrier 2 is assembled to the case body 20, if the case body 20 and the carrier 2 are misaligned, the end portion 2e in the width direction of the carrier 2 may be exposed in the exposed area EA exposed in the observation window 18 provided in the cover member 10. When the case body 20 and the carrier 2 are misaligned in the width direction (Y direction) of the case body 20, as shown in FIG. 18, the end portion 2e in the width direction of the carrier 2 may be exposed in the upper end area of the exposed area EA. Depending on the direction of the misalignment, the end portion 2e in the width direction of the carrier 2 may also be exposed in the lower end area of the exposed area EA. Further, when the longitudinal direction of the carrier 2 is inclined with respect to the longitudinal direction of the case body 20, as shown in FIG. 19, the end portion 2e in the width direction of the carrier 2 may be exposed in a part of the upper end area or a part of the lower end area of the exposed area EA. As shown in FIGS. 18 and 19, when a blank area BL where the carrier 2 does not exist occurs in the exposed area EA, if the exposed area EA is identified as the observation area LA, it will prevent the determination of whether the specimen is positive or negative by detecting the coloring state of the inspection area L1. In FIGS. 18 and 19, in order to make it easy to visually recognize the carrier 2 and the blank area BL where the carrier 2 does not exist, the carrier 2 in the exposed area EA is shown in gray. The same applies to FIG. 20 to be described later.

[0170] As shown in Figure 17, by identifying an area with a narrower width in the Y direction than the exposed area EA as the observation area LA, it is possible to exclude the margin area BL that occurs when the case body 20 and the carrier 2 are misaligned within the observation area LA, thereby enabling accurate determination of the inspection area L1.

[0171] For example, the width H4 is a value predetermined as a range that does not include the margin area BL that is expected to occur when the case body 20 and the carrier 2 are misaligned, and may be stored in memory 121 in advance. In this case, the processor 120 detects a point P3 (X1, Y2) on the frame line of the observation window 18, which is the end of the observation window 18 in the X direction, and then performs a region identification process to identify an area with a width H2 in the X direction from point P3 and a width H4 in the Y direction with the center line CL as the center line, as the observation area LA.

[0172] As described above, when the processor 120 identifies an observation area LA that is narrower in the Y direction than the exposure area EA, it can identify the observation area LA using a preset width H4. Alternatively, the processor 120 may identify the observation area LA by searching for the boundary between the frame of the observation window 18 and the carrier 2, or the boundary between the margin area BL in the area within the frame (in this case, the exposure area EA) and the carrier 2. For example, the processor 120 can identify the observation area LA as follows.

[0173] The processor 120 performs the same processing as the previously described search method until it detects point P3(X1,Y2), which is the edge of the observation window 18 in the X direction. Point P3(X1,Y2) corresponds to at least a part of the observation window 18. Subsequently, as shown in Figure 20, the processor 120 identifies a frame that encloses a region with a width H2 in the X direction from point P3(X1,Y2) and a region with a width H3 in the Y direction centered on the center line CL as the frame of the observation window 18. The area inside this frame is the exposed region EA that is exposed from the observation window 18. The processor 120 detects point P4(X2,Y2) on one end in the X direction of the color-developing region L3, which serves as an indicator region, within the exposed region EA by searching for a location in the X direction where the density changes significantly from point P3(X1,Y2). Then, the processor 120 identifies point P5(X3,Y2) within the color-developing region L3, using point P4(X2,Y2) as a reference. The width of the color-developing region L3 in the X direction is known as the coating width of the color-developing region L3. Point P4(X2,Y2) is the downstream end of the color-developing region L3, so any point P5(X3,Y2) within the width of the color-developing region L3 can be identified from X2.

[0174] Subsequently, the processor 120 searches for a location where the density changes significantly in the Y direction from point P5(X3,Y2), thereby searching for the boundary between the carrier 2 and the frame line, or the boundary between the carrier 2 and the margin area BL within the frame line. In this example, the processor 120 searches for a location where the density changes significantly in the Y direction from point P5(X3,Y2). Through this search, the processor 120 detects point P6(X3,Y3) at one end (upper end in the figure) of the color development area L3 in the Y direction within the exposure area EA, and point P7(X3,Y4) at the other end (lower end in the figure) of the color development area L3 in the Y direction. Here, point P6(X3,Y3) is a point on the boundary between the carrier 2 and the margin area BL within the frame line, and point P7(X3,Y4) is a point on the boundary between the carrier 2 and the frame line.

[0175] The processor 120 then identifies the region within the range of Y3 to Y4 in the Y direction from the exposure region EA as the observation region LA.

[0176] When the processor 120 identifies an observation area LA that is narrower in the Y direction than the exposure area EA, it is preferable to identify the area where the color development area L3 exists, i.e., the area where the carrier 2 exists, in the Y direction of the exposure area EA as the observation area LA. Even if the case body 20 and the carrier 2 are misaligned more than expected and the margin area BL extends beyond what was expected, the margin area BL can be excluded by searching for the area where the carrier 2 exists and identifying the observation area LA, thereby suppressing a decrease in inspection accuracy. Furthermore, if an area with a preset width H4 is identified as the observation area LA, a large area that is not the margin area BL may be excluded. However, by searching for the area where the carrier 2 exists and identifying the observation area LA, the effective area of ​​the carrier 2 can be used for inspection without being excluded.

[0177] In the above embodiment, illumination light is irradiated onto the observation area LA from the light source 115, and the reflected light reflected from the observation area LA is received by the detection unit 114. However, it is also possible to receive transmitted light that has passed through the observation area LA, rather than reflected light, in the detection unit 114. In this case, for example, the detection unit 114 and the light source 115 are placed opposite each other, with the carrier 2 on which the observation area LA is formed in between. That is, if the surface on which the observation area LA is formed on the carrier 2 is considered the front surface, the detection unit 114 is placed facing the front surface, and the light source 115 is placed facing the back surface. As a result, the illumination light irradiated by the light source 115 enters the back surface of the carrier 2, and the transmitted light that has passed through the observation area LA from the back surface to the front surface can be received by the detection unit 114. Since the transmitted light contains information about the observation area LA, the detection unit 114 can acquire the image PA by receiving the transmitted light. The technology of this disclosure may be applied to an inspection device that receives transmitted light from the observation area LA in this manner.

[0178] Furthermore, in the above embodiment, the testing device 110 is described as an example of a device used to test a subject's specimen in a medical facility such as a hospital. However, for example, a manufacturer of cartridges 100 may use the testing device 110 to evaluate the performance of cartridges 100 during the development process of cartridges 100.

[0179] In the above embodiment, the hardware structure of the processor 120 and the processing unit (Processing Unit) that executes various processes, such as the detection unit control unit 122, inspection area identification unit 123, color development state discrimination unit 124, and display control unit 125, can be any of the following types of processors. As mentioned above, the types of processors include a CPU, which is a general-purpose processor that executes software and functions as various processing units, as well as programmable logic devices (PLDs), such as FPGAs (Field Programmable Gate Arrays), which are processors whose circuit configuration can be changed after manufacturing, and dedicated electrical circuits, such as ASICs (Application Specific Integrated Circuits), which are processors with circuit configurations specifically designed to execute specific processes.

[0180] A single processing unit may consist of one of these various processors, or it may consist of a combination of two or more processors of the same or different types (for example, a combination of multiple FPGAs, and / or a combination of a CPU and an FPGA). Alternatively, multiple processing units may be composed of a single processor.

[0181] One example of configuring multiple processing units with a single processor is a configuration where one or more CPUs and software are combined to form a single processor, and this processor functions as multiple processing units. Secondly, there is a configuration using a processor that realizes the functions of the entire system, including multiple processing units, on a single IC (Integrated Circuit) chip, as exemplified by System-on-a-Chip (SoC). Thus, various processing units are configured, in terms of hardware structure, using one or more of the above-mentioned various processors.

[0182] Furthermore, the hardware structure of these various processors can more specifically utilize electrical circuits, which are combinations of circuit elements such as semiconductor devices.

[0183] This disclosure is not limited to the embodiments described above, and may be implemented with appropriate modifications, such as omitting or replacing components, without departing from the spirit of this disclosure. [Explanation of Symbols]

[0184] 1 Inspection strip 2. Immunochromatographic carrier (carrier) 2A sheet material 3 Sign-holding pads 4 fluid transfer pads 6 absorbent pads 7 Back Adhesive Sheets 9 cases 10 Cover members 11. First pressing operation section 11b protrusion 12. Second pressing operation section 12b contact part 16 drops from the bottom 18 observation windows 20 cases 21 support part 22 support part 24. First Detention Unit 30 Multifunctional Components 32. Second Detention Unit 34 protrusions 35 Flow channel forming section 36 back side 40 First reagent holding section 41 Reagent 1 42 containers 43 Sheet members 45 Second reagent holding section 46 Reagent No. 2 47 containers 48 sheet members 50 samples 51 Test Substances 52 1st binding substance 53 labeled substances 56 Second binding substance 58 Third binding substance 60 Silver Particles 100 cartridges 100E end face 110 Immunochromatography Inspection Device (Inspection Device) 111 cabinets 112 Cartridge Loading Section (Loading Section) 112a Openable lid 112b, 112c reference plane 113 Power switch 114 detection unit 115 light source 115A light source 115B Light source 119 monitors 120 processors 121 memory 122 Detection Unit Control Unit 123 Inspection Area Identification Department 124 Color Development State Discrimination Unit 125 Display Control Unit 180 biasing means 180b Pressing body 182 biasing means 182b Pressing body ΔP difference image DLex device DL1 outlet EA exposure area L1 Examination Area L2 control area L3 color area L4 noise region L5 noise region LA observation area PA imaging images PG observation images PR observation images

Claims

1. An inspection device used for immunochromatographic testing, A loading unit in which a cartridge comprising a carrier having a test area whose color changes depending on whether the sample is positive or negative, an indicator area positioned at a predetermined distance from the test area and optically distinguishable from other areas regardless of whether the sample is positive or negative, and a case for housing the carrier is detachably loaded, A light source for illuminating the observation area on the carrier, including the inspection area and the indicator area, An imaging unit for imaging the aforementioned observation area, The system includes a processor that acquires an image including the observation area from the imaging unit, detects the position of the indicator area from the acquired image, and determines the position of the inspection area based on the detected position of the indicator area. The cartridge has an observation window formed therein for observing the observation area from the outside. The outer shape of the cartridge and the observation window are both rectangular. The loading section is equipped with a biasing means for pressing the end face of the cartridge mounted on the loading section against a reference surface. The processor acquires an image from the imaging unit of the cartridge in a state pressed against the reference surface, capturing an area that includes at least the entirety of the observation window and a portion of the outline of the cartridge. A trimming process for cutting out the observation area from the acquired image, the trimming process includes a region identification process that searches for the outline within the image and identifies the observation area by searching for at least a part of the observation window based on the searched outline, The region identification process in the trimming process is a process of identifying the observation region by searching for at least a portion of the observation window of the cartridge in the image to identify the frame of the observation window, and further searching for the boundary between the frame and the carrier, or the boundary between the margin in the region within the frame and the carrier. Inspection device.

2. The inspection apparatus according to claim 1, wherein the indicator region is a region in which the color development state changes upon reaction with a reagent.

3. The inspection apparatus according to claim 1 or 2, wherein the processor detects the position of the indicator region based on the optical density of the indicator region.

4. As the optical density, the ΔOD value, which is the difference between the optical density of the indicator region and the optical density of the background region that forms the background of the indicator region, is used in the carrier. The inspection apparatus according to claim 3.

5. The inspection apparatus according to claim 1 or 2, wherein the processor detects the position of the indicator region based on the shape of the indicator region.

6. The aforementioned light source is a white light source, The aforementioned image is a color image. The inspection apparatus according to claim 1 or 2, wherein the processor detects the position of the indicator region based on the color of the indicator region.

7. In the case where the indicator region is a first color before reacting with the reagent, and changes from the first color to a second color upon reaction with the reagent, The light source comprises a first monochromatic light source that emits first monochromatic light in which the amount of reflected light is greater when the indicator region of the first color is illuminated than when the indicator region of the second color is illuminated, and a second monochromatic light source that emits second monochromatic light in which the amount of reflected light is greater when the indicator region of the second color is illuminated than when the indicator region of the first color is illuminated. The processor uses the first monochromatic light source and the imaging unit to capture the second colored indicator region and acquire a first image. Using the second monochromatic light source and the imaging unit, a second image is obtained by imaging the indicator region of the second color, An inspection apparatus according to claim 2 and any one of claims 3 to 5 incorporating claim 2, wherein the position of the indicator region is detected based on the first image and the second image.

8. The first color contains a green component, the second color is orange, the first monochromatic light source is a green light source, and the second monochromatic light source is a red light source. The inspection apparatus according to claim 7.

9. The reagent is an amplification solution for amplifying the change in the color development state of the inspection area. The aforementioned indicator region reacts with the amplifying solution and changes in its coloration state. An inspection apparatus according to claim 2 and any one of claims 3 to 8 that references claim 2.

10. The inspection apparatus according to any one of claims 1 to 9, wherein the indicator region is a region in which the color development state changes upon reaction with a labeled substance.

11. In the cartridge, the inspection area and the indicator area are areas formed on the carrier by coating, The inspection apparatus according to any one of claims 1 to 10, wherein the carrier is assembled to the case after the inspection area and the indicator area have been formed.

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