Inspection equipment and cartridges

Abstract

Provided is a test device that is used in immunochromatographic testing and is provided with: a loading section for loading a cartridge that comprises a carrier which has a test region where the state of color development changes according to whether a sample is positive or negative, and a case which accommodates the carrier in an internal space that is defined by an outer shell formed from a translucent material, and in which an opening for observing an observation region that includes the test region is formed in a portion of the outer shell; an illumination section that has a light-emitting end that emits light for illuminating the observation region, and that can be disposed in a state in which there is contact with at least a portion of the light-emitting end at a position which is separated from the opening in the outer surface of the outer shell of the loaded cartridge and which is capable of guiding light to the inner edge of the opening by allowing light incident from the light-emitting end to the inside of the outer shell to be transmitted inside the outer shell; and a detection section that is disposed at a position that opposes the opening of the loaded cartridge, is for detecting the state of color development in the test region, and optically detects the state of color development by receiving reflected light that has been emitted from the inner edge of the opening and reflected by the surface of the observation region.

Description

[Technical Field]

[0001] The technology of the present disclosure relates to a testing device and a cartridge used in immunochromatographic testing. [Background Art]

[0002] Japanese Patent Application Publication No. 2013-238543 describes a testing device (referred to as a test strip in Japanese Patent Application Publication No. 2013-238543) for performing a test by immunochromatography to determine whether a sample is positive or negative, that is, whether the sample contains a test substance. Such a testing device is called a testing cartridge or the like. The testing cartridge includes a carrier having a testing region for testing whether a sample is positive or negative, and a case that accommodates the carrier. An antibody that reacts with the test substance is immobilized in the testing region, and the color development state of the testing region changes when the antibody reacts with the test substance. An opening for externally observing the color development state of the testing region is formed in the case.

[0003] On the other hand, Japanese Patent Application Publication No. 2002-267664 describes a measuring apparatus for an immunochromatographic test strip. This measuring apparatus is loaded with an immunochromatographic test tool, that is, a case, that accommodates an immunochromatographic test strip serving as a carrier. Light from a light-emitting element enters the case loaded in the measuring apparatus from the back side of the case via a light guide portion. Further, on the front side of the case, a linear image sensor is provided as a detection unit that measures a change in a sample on the surface of the carrier. The light from the light-emitting element enters the carrier from the back side of the carrier, and the light that has entered the carrier transmits through the testing region. The detection unit receives transmitted light that has passed through the carrier including the testing region. [Summary of Invention] [Problem to be Solved by the Invention]

[0004] In the inspection cartridge shown in Japanese Patent Publication No. 2013-238543, the side wall of the opening is a tapered inclined surface. When the inspection cartridge is loaded into the inspection device, a detection unit is positioned directly opposite the opening to detect reflected light from the inspection area. A light source is positioned to the side of the detection unit, and the light source is positioned diagonally above the opening. Light from the light source is shone onto the opening from diagonally above.

[0005] As described in Japanese Patent Publication No. 2013-238543, when the detection unit is positioned directly opposite the aperture, it is necessary to illuminate the aperture from an oblique direction. When illuminating from an oblique direction in this way, there is a problem that the light intensity distribution in the observation area tends to become uneven due to differences in distance from the light source within the observation area, including the inspection area and its surrounding area, and vignetting of the light around the aperture. The configuration of the inspection device described in Japanese Patent Publication No. 2013-238543 was not sufficient to solve these problems.

[0006] On the other hand, as described in Japanese Patent Publication No. 2002-267664, if light is irradiated from the back side opposite to the surface where the opening is located toward the inspection area of ​​the carrier, the light-emitting element can be positioned directly opposite the inspection area. Therefore, the problems of the inspection device described in Japanese Patent Publication No. 2013-238543 are less likely to occur.

[0007] However, when irradiating from the back side of the carrier, the detection unit receives transmitted light that has passed through the carrier, which presents a problem as it is susceptible to adverse effects due to individual differences in the carrier. For example, if there is dirt and impurities inside the carrier deeper than the inspection area formed on the surface, when light is transmitted from the back side of the carrier, the transmitted light received by the detection unit will contain unwanted information other than the inspection area, such as dirt and impurities.

[0008] The technology disclosed herein provides an inspection device and cartridge that, taking the above facts into consideration, is less susceptible to adverse effects due to individual differences in carriers and can suppress non-uniformity of the light intensity distribution in the observation area. [Means for solving the problem]

[0009] The inspection device of this disclosure is an inspection device used for immunochromatographic testing, and comprises a loading section into which a cartridge is loaded, the cartridge having a carrier having an inspection area whose coloration state changes depending on whether the sample is positive or negative, and a case that houses the carrier in an internal space defined by an outer shell made of a light-transmitting material, the case having an opening formed in a part of the outer shell for observing an observation area including the inspection area; an illumination section having an emission end that emits light to illuminate the observation area, the illumination section being positioned on the outer surface of the outer shell of the loaded cartridge at a position separated from the opening, and in a position where at least a part of the emission end is in contact with the position in which light incident into the outer shell from the emission end can be guided to the inner edge of the opening by passing through the inside of the outer shell; and a detection section positioned opposite the opening of the loaded cartridge and detecting the coloration state of the inspection area, the detection section optically detects the coloration state by receiving reflected light emitted from the inner edge of the opening and reflected off the surface of the observation area.

[0010] The inspection apparatus of the present disclosure is preferably provided with a suppression unit that suppresses light leakage that leaks out around the exit end without entering the outer shell of the light emitted from the exit end.

[0011] The inspection apparatus of this disclosure preferably has an emission end that includes an emission window for emitting light and a window frame surrounding the emission window, and the suppression part is provided on the window frame and is a light-shielding elastic member that elastically deforms when pressed against the outer surface of the outer shell.

[0012] In the inspection device of this disclosure, it is preferable that the contact position of the ejection end is on the outer surface of the outer shell facing the detection unit.

[0013] The inspection device of this disclosure preferably has at least two illumination units, one on each side of the opening in the outer shell.

[0014] In the inspection apparatus of this disclosure, the light source of the illumination unit is preferably a semiconductor light source.

[0015] In the cartridge of this disclosure, it is preferable that a light-transmitting material having diffusive properties that diffuse light is used as the light-transmitting material.

[0016] In the cartridge of this disclosure, the diffuse light transmittance of the light-transmitting material is preferably 0.1% or more and 50% or less for at least specific wavelengths of light when the transmission distance is 2 mm.

[0017] In the cartridge of this disclosure, the diffuse light transmittance of the light-transmitting material is preferably 1% to 40% for light with a wavelength of 420 nm to 680 nm when the transmission distance is 2 mm.

[0018] The cartridge of this disclosure preferably includes a case which is a light guide member made of a light-transmitting material that has a higher light transmittance than the light-transmitting material forming the outer shell, and which guides light incident from the exit end to the inner edge of the opening.

[0019] In the cartridge of this disclosure, the light guide member is preferably arranged on the outer surface of the outer shell and is in contact with at least a portion of the emission end of the illumination section, and further preferably the area of ​​the light guide member other than the contact portion in which the emission end contacts is shielded from light. [Effects of the Invention]

[0020] The inspection apparatus and cartridge of this disclosure are less susceptible to adverse effects due to individual differences in the carrier, and can suppress non-uniformity of the light intensity distribution in the observation area. [Brief explanation of the drawing]

[0021] [Figure 1]It is a perspective view showing the appearance of an inspection device according to the present disclosure. [Figure 2] It is a perspective view of an inspection cartridge to be loaded into an inspection device according to the present disclosure. [Figure 3] It is an exploded perspective view of an inspection cartridge according to the present disclosure. [Figure 4] Fig. 4A is a cross-sectional view showing a state where a first pressing operation portion is operated in an inspection cartridge according to the present disclosure, and Fig. 4B is a cross-sectional view showing a state where both the first pressing operation portion and a second pressing operation portion are operated. [Figure 5] It is a side view showing the positional relationship among an inspection strip, a multifunctional member, a first reagent holding portion and a second reagent holding portion in an inspection cartridge according to the present disclosure. [Figure 6] It is an explanatory diagram of an immunochromatography method. [Figure 7] It is a partially broken side view of an inspection device in a state where an inspection cartridge according to the present disclosure is loaded therein. [Figure 8] It is a cross-sectional view showing the positional relationship between an inspection cartridge according to the present disclosure and an illumination unit in an inspection device. [Figure 9] It is a cross-sectional view showing an illumination unit in an inspection device according to the present disclosure. [Figure 10] It is a cross-sectional view showing a light path within an outer shell of a case forming an inspection cartridge according to the present disclosure. [Figure 11] It is a cross-sectional view showing a comparative example. [Figure 12] Fig. 12A is a graph showing an example of diffuse light transmittance of a light-transmitting material forming a cover member that forms an inspection cartridge according to the present disclosure, and Fig. 12B is a graph showing another different example. [Figure 13] It is a cross-sectional view showing a modified example in which an illumination unit is disposed on an inclined portion. [Figure 14] Fig. 14A is a cross-sectional view showing a modified example in which a light guide member is provided on an inspection cartridge according to the present disclosure, and Fig. 14B is a cross-sectional view showing a variation in the position of the light guide member. [Figure 15]Figure 15A is a cross-sectional view showing a modified example in which a light-reducing section is formed by a screen to suppress light leakage from the lighting section; Figure 15B is a cross-sectional view showing a modified example in which a recess is formed in the case to create a light-reducing section; and Figure 15C is a cross-sectional view showing a modified example in which no light-reducing section is formed. [Modes for carrying out the invention]

[0022] Hereinafter, an inspection cartridge 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.

[0023] Furthermore, explanations of redundant components and reference numerals in each drawing may be omitted. It should be noted that the present invention is not limited to the following embodiments, and can be implemented with appropriate modifications, such as omitting components or replacing them with different components, within the scope of the objectives of the present invention.

[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> Embodiments of the immunochromatographic inspection apparatus of this disclosure will be described with reference to the drawings. Figure 1 is a perspective view showing the external appearance of an immunochromatographic inspection apparatus 110 (hereinafter simply referred to as the inspection apparatus 110) according to one embodiment. Figure 2 is an external view of a cartridge 100 mounted in the inspection apparatus 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 positional relationship of the main housing components 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] The specimen can be any sample that may contain the test substance, and is not particularly limited. Examples of specimens 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 will be explained assuming that it is 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. In the following, the configuration and function of the cartridge 100 will be explained first, followed by a description of the testing device 110.

[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 has an overall elongated shape to match the elongated shape of the inspection strip 1.

[0032] As will be described later, the cover member 10 is used as a light guide member to guide illumination light irradiated onto the cartridge 100 when inspection is performed with the inspection device 110. For this reason, the cover member 10 is made of a light-transmitting material that diffuses light. The diffuse light transmittance of the light-transmitting material used for the cover member 10 is, as an example, 1% to 40% for visible light with wavelengths from 420 nm to 680 nm when the transmission distance is 2 mm, as shown in Figure 12A.

[0033] The "diffuse light transmittance" of a translucent material is the proportion of incident light rays entering the translucent material from a light source that diffuse within the material and then exit. Note that a portion of the incident light rays travel in a straight line through the translucent material. The proportion of this straight-traveling component that exits the translucent material is called the "parallel light transmittance." For example, the parallel light transmittance of the translucent material forming the cover member 10 is 0.1% or less for visible light with wavelengths from 420nm to 680nm. In Figure 12A, the diffuse light transmittance in the wavelength range of 420nm to 680nm is at least 10% across the entire range. Therefore, a parallel light transmittance of 0.1% or less means that, across the entire wavelength range of 420nm to 680nm, most of the light rays transmitted through the translucent material are diffuse components.

[0034] Furthermore, the sum of "diffuse light transmittance" and "parallel light transmittance" is called "total light transmittance." In other words, the "total light transmittance" of a translucent material is the proportion of incident light rays that enter the translucent material from a light source and are transmitted through the material before being emitted.

[0035] Total light transmittance can be measured, for example, using an integrating sphere. As is well known, an integrating sphere is a hollow sphere whose inner wall surface is composed of reflective surfaces, and it is a measuring instrument for spatially integrating the directional and diffusive components of light rays passing through a translucent material by reflection from the inner wall surface. By measuring the amount of light integrated within the integrating sphere, the amount of light rays passing through the translucent material can be measured.

[0036] The total light transmittance is measured while varying the wavelength of the light being measured, for example, within a range of approximately 400 nm to 800 nm. On the other hand, the parallel light transmittance is measured without using an integrating sphere, by measuring only the straight-traveling component of the incident light rays that travels in a straight line through the translucent material. For example, in a measuring device that measures the amount of light, it is possible to measure the straight-traveling component by applying a mask to the light-receiving surface of the light-receiving part so that only the straight-traveling component of the transmitted light rays is incident on the light-receiving part. Naturally, the parallel light transmittance is also measured while varying the wavelength of the light being measured within a range of approximately 400 nm to 800 nm. The diffuse light transmittance is the value obtained by subtracting the parallel light transmittance from the total light transmittance measured in this way. The graph shown in Figure 12A shows the diffuse light transmittance calculated in this way. The transmission distance is the distance that the incident light rays travel through the translucent material, and as an example, if the translucent material is in the form of a plate, it is the thickness of the plate-shaped translucent material. A transmission distance of 2 mm means that the thickness of the translucent material used to measure the total light transmittance is 2 mm. Translucent materials include, for example, resin materials.

[0037] The light transmission characteristics shown in Figure 12A are those of a resin material known as milky white. A resin material having the light transmission characteristics shown in Figure 12A can be used as illumination light, green light with a central wavelength of approximately 550 nm, or red light with a central wavelength of approximately 650 nm.

[0038] The case body 20 is made of, for example, a resin material and has an opening at the top. Inside, it houses the test strip 1, as well as the first reagent holder 40 and the second reagent holder 45. The cover member 10 is attached to the opening of the case body 20, thereby covering the opening of the case body 20. As a result, the test strip 1 with the carrier 2 is housed in the internal space of the case 9.

[0039] In case 9, the "outer shell" refers to the case body 20 and cover member 10 themselves, and is used to distinguish them from the internal space of case 9. In other words, "inside case 9" refers to the internal space, but "inside the outer shell of case 9" refers to the inside of the components that make up case 9, namely the inside of the cover member 10 and the case body 20. The cover member 10, like the case body 20, is the outer shell of case 9 and together with the case body 20 defines the internal space of case 9. As described above, the cover member 10 is made of a translucent material. Therefore, case 9 is a case that houses the carrier 2 in an internal space defined by the cover member 10, which is an outer shell made of a translucent material.

[0040] In this example, the cover member 10 that constitutes the upper part of case 9 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 case 9. A boss is erected on the edge of the dropper port 16, facing upwards.

[0041] (Observation window) The observation window 18 is an opening for observing the inspection area L1 from the outside. 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. The area 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, is referred to as the observation area LA in this specification.

[0042] The cover member 10 is provided with inclined portions 10B around the observation window 18, forming recesses that drop down from the flat portion 10A of the cover member 10. The inclined portions 10B are portions that are inclined diagonally downward with respect to the flat portion 10A, which is a surface parallel to the surface of the observation area LA of the inspection strip 1. The inclined portions 10B are formed on both sides of the observation window 18. The cover member 10 is the outer shell of the case 9, and the flat portion 10A and the inclined portions 10B are the outer surfaces of the outer shell of the case 9.

[0043] (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.

[0044] 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 an external 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, an external 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 external force applied through the first pressing operation part 11. Due to this deformation, the first reagent 41 held by the first reagent holding part 40 is supplied to the test strip 1.

[0045] 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.

[0046] Similarly, as shown in Figure 4B, when an external pressing force is applied to the second pressing operation part 12, the second pressing operation part 12 deforms. The second pressing operation part 12 in this example, like 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 pyramid, 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, a pressing 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 pressing force applied through the second pressing operation part 12. Due to this deformation, the second reagent 46 held by the second reagent holding part 45 is supplied to the test strip 1. The second pressing operation part 12 in this example is provided with a contact part 12b that contacts the second reagent holding part 45.

[0047] (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.

[0048] 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.

[0049] 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 the sheet member 43 breaks and the end of the test strip 1 is immersed in the container 42, 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.

[0050] (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-like shape with an open top. As shown in Figure 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 for allowing the second reagent 46 flowing out of the second reagent holding section 45 to flow towards the test strip 1.

[0051] 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.

[0052] (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.

[0053] 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 48 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 opening at the bottom of the second storage section 32 and the flow path formed by the flow path forming section 35.

[0054] 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 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.

[0055] An absorbent pad 6 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.

[0056] <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.

[0057] (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.

[0058] 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 color of the test area L1 and control area L2 is almost the same as the color of carrier 2 (e.g., white), 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. 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 a black color.

[0059] 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.

[0060] 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.

[0061] 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 to which the side to which the carrier 2 is attached is an adhesive surface.

[0062] (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.

[0063] 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.

[0064] (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.

[0065] (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 unfolds 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 unfolding of the sample 50 by the labeling signal from the labeled substance 53 captured via the first binding substance 52. Therefore, the control region L2 is sometimes called the verification region.

[0066] (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., product code 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 at which the first reagent 41 is unfolded and the second reagent 46 is supplied.

[0067] (binding substance) The first binding substance 52, which modifies the labeling substance 53 and specifically binds to the test substance 51, is, for example, an antibody against the antigen if the test substance is an antigen, or an antigen against the antibody if the test substance is an antibody. Furthermore, if the test substance is a protein or low-molecular-weight compound, the first binding substance 52 is a substance that specifically binds to the test substance, such as an aptamer for proteins and low-molecular-weight compounds.

[0068] The second binding substance 56, which is fixed in the test area L1 and specifically binds to the test substance 51, is, for example, an antibody against the antigen if the test substance is an antigen, or an antigen against the antibody if the test substance is an antibody. Furthermore, if the test substance is a protein or low-molecular-weight compound, the second binding substance 56 is a substance that specifically binds to the test substance, such as an aptamer for proteins and low-molecular-weight compounds. The first binding substance 52 and the second binding substance 56 may be the same or different.

[0069] 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. Examples include compounds obtained by binding a derivative of the test substance 51 to a protein.

[0070] For example, if the test substance 51 is influenza A virus or its biomarker, anti-influenza A monoclonal antibody (product name 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.

[0071] (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 formed by 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.

[0072] (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.

[0073] <Amplifying solution> In this embodiment, the first reagent 41 and the second reagent 46 are amplification solutions that, through their reaction, 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 60 (see Figure 6) with a particle size relatively larger than that of the labeling substance 53.

[0074] 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 a reducing agent, and the second reagent 46, which is silver ions, are brought into contact with the labeled substance 53, silver particles 60 are generated, and the generated silver particles 60 are deposited on the labeled substance 53, using the labeled substance 53 as a nucleus. The deposition of silver particles 60 on the labeled substance 53 generates silver particles 60 with a larger particle size than the labeled substance 53 (see Figure 6). As a result, the labeling signal emitted by the labeled substance 53 is amplified, and consequently, the color development of the labeled substance 53 in the test area L1 and the control area L2 is amplified.

[0075] (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 whose valence can be changed by metal ions such as the following. 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 ethylenediaminetetraacetic acid (EDTA) 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.

[0076] In addition, as reducing agents, developer mains used in wet silver halide photographic photosensitive 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, may also be used.

[0077] 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-ascorbic acid, L-ascorbic acid or D,L-ascorbic acid (and their alkali metal salts) or isoascorbic acid (or their alkali metal salts) being particularly preferred, and sodium salts being preferred salts. Mixtures of these reducing agents can be used as needed.

[0078] (Second reagent) The silver ion-containing solution used as the second reagent 46 is preferably one in which a silver ion-containing compound is dissolved in a solvent. As the silver ion-containing compound, an organic silver salt, an inorganic silver salt, or a silver complex can be used. Preferably, an inorganic silver salt or a silver complex is used. As the inorganic silver salt, a silver ion-containing compound with high solubility in a solvent such as water can be used, such as silver nitrate, silver acetate, silver lactate, silver butyrate, and silver thiosulfate. Silver nitrate is particularly preferred. As the silver complex, a silver complex coordinated to a ligand having a water-soluble group such as a hydroxyl group or a sulfone group is preferred, such as silver hydroxythioether.

[0079] <Immunochromatography> Referring to Figure 6, the immunochromatographic method will be explained. Here, the explanation assumes that sample 50 contains the test substance 51, that is, that sample 50 is positive.

[0080] 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. Within the carrier 2, the sample 50 spreads downstream from the label-holding pad 3 by capillary action in the carrier 2. Some of the sample 50 also spreads upstream. Arrow S indicates the spreading of the sample 50.

[0081] 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.

[0082] Subsequently, the system waits until the first reagent 41 is deployed downstream (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 downstream by the first reagent 41 (step S3).

[0083] 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.

[0084] 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.

[0085] 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).

[0086] Having described the configuration and functions of cartridge 100, the following will explain the general configuration and inspection procedure of inspection device 110, followed by a description of the characteristic configuration of inspection device 110.

[0087] <Immunochromatographic Inspection Equipment> Returning to Figure 1, the inspection device 110 comprises 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 and the cartridge 100 is inserted into the housing 111. Once the cartridge 100 is 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.

[0088] 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, etc. The monitor 119 is, for example, a touch panel monitor, and various operation screens are displayed. Through the operation screen, the user can input operation instructions such as inputting a command to start processing and selecting an inspection procedure.

[0089] 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.

[0090] As shown in Figure 7, the inspection device 110 includes, in addition to the cartridge loading unit 112, a detection unit 114, an illumination unit 115, a lifting device 125, a processor 120, and a memory 121 within the housing 111. In Figure 7, the processor 120 and memory 121 are shown outside the housing 111 of the inspection device 110, but this is a schematic diagram, and in reality they are located inside the housing 111.

[0091] The detection unit 114 is positioned opposite the observation window 18 of the cartridge 100 when it is loaded into the inspection device 110, and detects the color development state of the inspection area L1 included in the observation area LA. The detection unit 114 optically detects the color development state of the inspection area L1 by emitting light from the inner edge 18A of the observation window 18, which is an opening, and receiving reflected light reflected from the surface of the observation area LA.

[0092] 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 captures an observation area LA that includes an inspection area L1, a control area L2, and a color development area L3. The captured image is then output from the detection unit 114 to the processor 120.

[0093] The illumination unit 115 illuminates the observation area LA, which includes the inspection area L1, the control area L2, and the color development area L3, when the detection unit 114 is capturing images.

[0094] The lifting device 125 is an example of a moving mechanism for moving the lighting unit 115. The lighting unit 115 uses the cover member 10 of the cartridge 100 as a light guide member for illumination light. The lifting device 125 moves the lighting unit 115 between a contact position (see the position shown by the solid line in Figure 8) where it is in contact with the outer surface of the cover member 10 which acts as a light guide member, and a retracted position (see the position shown by the dashed line in Figure 8) where it is retracted from the contact position. The lifting device 125 is composed of a motor and an actuator, etc. When loading and removing the cartridge 100, the lighting unit 115 is moved to the retracted position by the lifting device 125.

[0095] 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, a color development state discrimination unit 123, and a display control unit 124. 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. This setting information includes information necessary for the color state determination unit 123 to determine changes in the color state.

[0097] The detection unit control unit 122 controls the imaging timing of the observation area LA by the detection unit 114. The detection unit control unit 122 also controls the operation of the lifting device 125.

[0098] The color development state determination unit 123 performs inspection area determination processing based on the detection signal output by the detection unit 114.

[0099] The inspection area discrimination process determines whether or not there is a change in the color development state of the inspection area L1 based on the detection signal output by the detection unit 114. In this example, a line appears in the inspection area L1 when the labeling substance 53 is captured in the inspection area L1, or when it is amplified by silver after being captured. Therefore, the inspection area discrimination process determines whether or not a line appears in this inspection area L1.

[0100] If the color development state determination unit 123 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 124 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 124 displays "negative" on the monitor 119.

[0101] <Immunochromatography Test> The procedure for immunochromatographic testing using the testing device 110 of this embodiment will be briefly described. As described above, before loading the cartridge 100 into the testing device 110, the user performs pre-treatment by applying the sample 50, supplying the first reagent 41, and supplying the second reagent 46. Applying the sample 50 is done by dropping the sample 50 from the dropper port 16 of the cartridge 100 onto the application area of ​​the carrier 2. Supplying the first reagent 41 is done by the user pressing the first pressing operation part 11 of the cartridge 100. Supplying the second reagent 46 is done by the user pressing the second pressing operation part 12 of the cartridge 100 after confirming that the color development area L3 has changed from dark green to orange.

[0102] After these pre-processing steps are taken, the cartridge 100 is loaded into the inspection device 110. Once the cartridge 100 is loaded into the inspection device 110, the processor 120 moves the illumination unit 115 to the contact position using the lifting device 125 and turns on the illumination unit 115. This illuminates the observation area LA of the cartridge 100. In this state, the processor 120 instructs the detection unit 114 to take an image of the observation area LA. The processor 120 then determines the color state of the inspection area L1 based on the captured image of the observation area LA.

[0103] If the processor 120 determines that there is a change in the coloration of the test area L1, it displays on the monitor 119 that the test result is "positive". If it determines that there is no change in the coloration of the test area L1, it displays on the monitor 119 that the test result is "negative".

[0104] <Method of illumination> In the following, the illumination method of the inspection device 110, which is a feature of the inspection device 110, will be explained with reference to Figures 8 to 10 as appropriate. As described above, the detection unit 114 is positioned opposite the observation window 18 of the cartridge 100 when it is loaded into the inspection device 110. More precisely, as shown in Figure 8, the detection unit 114 is positioned directly opposite the observation area LA. In addition, there are two illumination units 115, one on each side of the detection unit 114 in the width direction of the cartridge 100. The two illumination units 115 move up and down at their respective positions on either side of the detection unit 114. The illumination units 115 move from the retracted position shown by the dashed line toward the outer surface of the cover member 10, thereby moving to a contact position where they come into contact with the outer surface of the cover member 10.

[0105] As shown in Figure 9, the illumination unit 115 comprises a light source 115A and a case 115B. The light source 115A is a semiconductor light source such as a light-emitting diode. The case 115B is a cylindrical container that holds the light source 115A inside, and an opening for emitting light is formed at one end in the axial direction of the cylinder. The light emitted by the light source 115A is emitted from this opening. In the illumination unit 115, the end of the case 115B on the side where the opening is formed is the emission end 115BE that emits light to illuminate the observation area LA.

[0106] The emission end 115BE has an emission window 115C that emits light and a window frame that surrounds the emission window 115C. The emission window 115C is, for example, a transparent cover that protects the light source 115A while transmitting light from the light source 115A. The emission window 115C is made of, for example, acrylic resin or glass. The emission window 115C is fitted into an opening edge formed in the case 115B. The opening edge is formed in a circular shape so that it can surround the circular emission window 115C, and this opening edge functions as a window frame.

[0107] Light emitted from the light source 115A is emitted to the outside of the case 115B through the emission window 115C. In this example, the emission end 115BE is described as having an emission window 115C made of a transparent cover and a window frame, but it is not limited to this. An emission window 115C made of a transparent cover is not required, and the emission end 115BE may simply have an emission opening that can emit illumination light.

[0108] A light-shielding member 115D is attached to the exit end 115BE. The light-shielding member 115D is formed in an annular shape from an elastic material with light-shielding properties, such as black rubber, and is provided around the entire circumference of the window frame of the exit end 115BE. The light-shielding member 115D functions as a suppression part to suppress light leakage, as will be described later.

[0109] As shown in Figure 8, the illumination unit 115 is positioned at a contact point with the cartridge 100 (shown by a solid line) with its output end 115BE in contact with the outer surface of the outer shell of the case 9 of the loaded cartridge 100. The contact point is located on the outer surface of the cover member 10, which is the outer shell of the case 9, at a position away from the observation window 18, and is also a position where light incident from the output end 115BE into the interior of the cover member 10 can be guided to the inner edge 18A of the observation window 18 by passing through the interior of the cover member 10.

[0110] In this example, the contact position of the ejection end 115BE is set on the flat portion 10A of the cover member 10. The flat portion 10A, together with the inclined portion 10B, constitutes the upper surface of the case 9, and both face the detection unit 114. That is, the contact position of the ejection end 115BE is the outer surface of the case 9's outer shell that faces the detection unit 114. One of the requirements for the contact position is "a position away from the observation window 18," which is a position on the flat portion 10A that is away from the observation window 18. Since the detection unit 114 is located in front of the observation window 18, the illumination unit 115 needs to be located outside the field of view of the detection unit 114. Therefore, the contact position needs to be away from the observation window 18.

[0111] When the illumination unit 115 is in contact position, the light emitted from the emission end 115BE enters the interior of the cover member 10. This light, as an example, as shown by arrow E1, passes through the interior of the outer shell, the cover member 10, and is guided to the inner edge 18A of the observation window 18. As described above, since the cover member 10 is a light-transmitting material with diffusivity, the light that enters the interior of the cover member 10 is guided while diffusing inside. Furthermore, the guided light exits from the inner edge 18A of the opening, the observation window 18, and illuminates the observation area LA.

[0112] Here, Figure 10 shows an example of the path of light incident inside the cover member 10. As indicated by arrow K1, the light incident inside the cover member 10 diffuses in various directions inside the cover member 10, as indicated by arrows K2, K3 and straight line K4.

[0113] The diffused light, indicated by the straight line K4, is reflected on the inner surface of the cover member 10 and transmitted through the interior of the cover member 10. Here, if the angle of incidence of the diffused light incident on the inner surface of the cover member 10 is greater than or equal to the critical angle θE, as indicated by angle θ1, this diffused light undergoes total internal reflection on the inner surface of the cover member 10. On the other hand, if the angle of incidence is smaller than the critical angle θE, as indicated by angle θ2, part of this diffused light is reflected on the inner surface of the cover member 10 as indicated by arrow K5, and the remainder is emitted outwards from the cover member 10 as indicated by arrow K6. This critical angle θE is determined according to the refractive index of the translucent material constituting the cover member 10. The shape of the cover member 10 and the translucent material are selected so that the amount of emitted light emitted from the inner edge 18A of the observation window 18 is increased.

[0114] Furthermore, since the light transmitted through the inside of the cover member 10 is diffused internally, it may be emitted from parts other than the inner edge 18A of the observation window 18, as indicated by arrows K7 and K8. Even in this case, as indicated by arrow K7, some of the light emitted from the peripheral part of the observation window 18 can be used as illumination light to light up the observation area LA.

[0115] On the other hand, as indicated by arrow K8, light emitted to the outside of the cover member 10 at a position relatively far from the observation window 18 cannot be used as illumination light for the observation area LA. Furthermore, such light may directly enter the detection unit 114. Light that directly enters the detection unit 114 is unwanted light that becomes noise for the detection unit 114. In order to block such unwanted light, it is preferable to place a light-shielding material such as light-shielding paint on the outer surface of the cover member 10, except for the area around the observation window 18, including the inner edge 18A.

[0116] Furthermore, at the emission end 115BE, the emission window 115C is positioned one step further inward toward the light source 115A than the light shielding member 115D. Therefore, when the emission end 115BE is in contact position, the light shielding member 115D, which is part of the emission end 115BE, comes into contact with the flat portion 10A of the cover member 10. When the light shielding member 115D is pressed against the flat portion 10A of the cover member 10, it elastically deforms to adhere closely to the flat portion 10A. As a result, the light shielding member 115D functions as a suppression unit that suppresses light leakage that escapes from the emission end 115BE and does not enter the outer shell of the case 9 but leaks out around the emission end 115BE. <Mechanism of action, effect> The inspection device 110 of this disclosure is loaded with a cartridge 100 containing a carrier 2 having an inspection area L1. The inspection area L1 of the carrier 2 changes color depending on whether the sample is positive or negative, and this color state is detected by the detection unit 114.

[0117] To accurately detect the coloration state of the inspection area L1, it is necessary to illuminate the observation area LA, which includes the inspection area L1, with the illumination unit 115 and accurately grasp the coloration state, such as the optical density and color of the inspection area L1 in the observation area LA. For this purpose, it is undesirable for the light intensity distribution within the observation area LA to become uneven due to the partial occurrence of shadows and high-luminance areas in the observation area LA when illuminated by the illumination light. Therefore, it is preferable for the light intensity distribution in the observation area LA to be as uniform as possible.

[0118] In the inspection device 110 of this example, as shown in Figure 8, the illumination unit 115 is positioned such that at least a portion of the light-emitting end 115BE is in contact with the flat surface 10A, which is the outer surface of the cover member 10, which is the outer shell of the loaded cartridge 100, at a position separated from the observation window 18. The contact position of the illumination unit 115 is such that light incident from the light-emitting end 115BE into the interior of the cover member 10 can be guided to the inner edge 18A of the observation window 18, which is the opening, by passing through the interior of the cover member 10, as indicated by arrow E1. Therefore, the inspection device 110 guides the light from the illumination unit 115 to the inner edge 18A by passing it through the interior of the cover member 10, and irradiates the observation area LA with the light emitted from the inner edge 18A as illumination light.

[0119] As a result, shadows from the cover member 10 are less likely to be cast in the observation area LA. Therefore, the uniformity of the light intensity distribution in the observation area LA can be improved.

[0120] The reason is as follows. For example, consider the conventional technology shown in Figure 11 as a comparative example. In the comparative example, the illumination unit 800, like the detection unit 114, is positioned with a gap between it and the cover member 10 of the cartridge 100, without contact with it. In this configuration, when the observation area LA is illuminated from the illumination unit 800, there is a possibility that the shadow of the observation window 18 will be cast on the observation area LA. This is because the detection unit 114 is often positioned directly facing the observation area LA in order to accurately detect the color development state of the inspection area L1 in the observation area LA. Therefore, the illumination unit 800 has no choice but to be positioned to avoid the detection unit 114, and for example, as shown in Figure 11, the illumination unit 800 will be positioned diagonally above the observation window 18. When the observation area LA is illuminated from such a position, the observation area LA is illuminated from diagonally above the observation window 18, so the illumination light is vignetted by the inner edge 18A of the observation window 18. Consequently, the shadow of the observation window 18 is cast on the observation area LA, and unevenness in the light distribution is likely to occur in the observation area LA.

[0121] In this example, the inspection device 110 is positioned so that the emission end 115BE of the illumination unit 115 is in contact with the outer surface of the cover member 10. The light from the illumination unit 115 is then guided to the inner edge 18A by passing it through the inside of the cover member 10, and the light emitted from the inner edge 18A is used as illumination light to irradiate the observation area LA. Therefore, as shown in Figure 11, there is little concern that the illumination light will be vignetted by the inner edge 18A. Consequently, shadows from the cover member 10 are less likely to occur in the observation area LA, and the uniformity of the light intensity distribution in the observation area LA can be improved.

[0122] Furthermore, in the inspection apparatus 110 of this disclosure, as shown in Figure 9, the emission end 115BE of the illumination unit 115 is provided with a light-shielding member 115D as a suppression part that suppresses light leakage that leaks out around the emission end 115BE without entering the interior of the outer shell, the cover member 10. As a result, the light utilization efficiency of the illumination unit 115 (amount of light reaching the observation area LA / amount of light emitted) is increased compared to when the light-shielding member 115D is not present.

[0123] Furthermore, if there is light leakage, some of it may directly enter the detection unit 114 without illuminating the observation area LA. This light that directly enters the detection unit 114 is unwanted light that becomes noise for the detection unit 114. By providing the light-shielding member 115D, this unwanted light can be reduced.

[0124] Furthermore, the light-shielding member 115D in the inspection apparatus 110 of this disclosure is a light-shielding elastic member that is provided around the entire circumference of the light-emitting end 115BE and elastically deforms when pressed against the flat portion 10A, which is the outer surface of the cover member 10, which is the outer shell of the case 9. In this way, the deformation of the elastic member can fill the gap between the light-emitting end 115BE and the flat portion 10A of the cover member 10. This enhances the effect of suppressing light emitted from the light-emitting end 115BE from leaking to the outside of the cover member 10.

[0125] Furthermore, the illumination unit 115 in the inspection apparatus 110 of this disclosure is arranged on both sides (both sides in the X direction in Figure 8) of the observation window 18 on the flat surface 10A of the outer shell of the cover member 10. This enhances the effect of suppressing non-uniformity of the light intensity distribution in the observation area LA compared to the case where illumination is only from one side.

[0126] Furthermore, the illumination unit 115 does not necessarily need to be placed on both sides of the observation window 18; it may be placed on only one side. Even when the illumination unit 115 is placed on one side of the observation window 18, shadows from the cover member 10 are less likely to occur in the observation area LA. As a result, compared to the conventional technology shown in Figure 11, vignetting of light occurring in the observation window 18 is suppressed, and an effect of improving the uniformity of the light intensity distribution in the observation area LA can be expected.

[0127] Furthermore, the illumination unit 115 in the inspection apparatus 110 of this disclosure uses a light-emitting diode as the light source 115A. In addition to a light-emitting diode, it is preferable to use a semiconductor light source such as a semiconductor laser as the light source 115A. A semiconductor light source can be miniaturized compared to a light source that combines, for example, a xenon lamp and a fiber optic light guide. Therefore, the inspection apparatus 110 can be miniaturized. The light source 115A may also be an organic EL (electroluminescence) element. Even if an organic EL element is used, it can be miniaturized compared to a light source that combines, for example, a xenon lamp and a fiber optic light guide, so the inspection apparatus 110 can be miniaturized.

[0128] Furthermore, in the cartridge 100 of this disclosure, a light-transmitting material having diffusive properties that diffuse light is used as the light-transmitting material forming the cover member 10. As the light-transmitting material diffuses light, the observation area LA is illuminated by diffused light. Therefore, compared to light with strong directivity, the effect of suppressing the non-uniformity of the light intensity distribution incident on the observation area LA can be enhanced.

[0129] Furthermore, in the cartridge 100 of this disclosure, as shown in Figure 12A, the diffuse light transmittance of the translucent material forming the cover member 10 is set to 1% or more and 40% or less in visible light with wavelengths of 420 nm to 680 nm when the transmission distance is 2 mm.

[0130] This allows the use of various colors of light as illumination, including white light, red light with a central wavelength of approximately 650 nm, and green light with a central wavelength of approximately 550 nm. This increases the range of illumination color options, making it easier to select the appropriate color of illumination depending on the color emitted by, for example, the inspection area L1 included in the observation area LA.

[0131] If the diffuse light transmittance of the translucent material is less than 1%, the amount of illumination light is insufficient, and the necessary amount of light for detecting the color development state of the observation area LA cannot be secured. On the other hand, if the diffuse light transmittance of the translucent material is greater than 40%, a large amount of light is emitted to the outside of the cover member 10 without total internal reflection on the inner surface of the cover member 10, as shown by the light indicated by arrow K8 in Figure 10. This light becomes leaked light that does not contribute to the illumination of the observation area LA. This leaked light becomes unwanted light that directly enters the detection unit 114 without passing through the observation area LA. Thus, when the diffuse light transmittance exceeds 40%, there is a large amount of unwanted light due to leaked light. In this example, since the diffuse light transmittance of the translucent material is 40% or less, unwanted light due to leaked light can be reduced.

[0132] Furthermore, in the cartridge 100 of this disclosure, the parallel light transmittance of the translucent material forming the cover member 10 is set to 0.1% or less. The lower the parallel light transmittance is relative to the diffuse light transmittance, the better the diffuseness of the translucent material. Also, the higher the parallel light transmittance, the more light travels straight through the interior of the translucent material and is emitted to the outside of the cover member 10. As in this example, it is preferable that the parallel light transmittance of the translucent material be 0.1% or less. If the diffuse light transmittance of the translucent material is set to 40% or less and the parallel light transmittance is set to 0.1% or less, the straight-traveling component can be almost eliminated while ensuring the diffuseness of the translucent material, thereby further reducing unwanted light caused by light leakage.

[0133] Furthermore, the light transmission characteristics of the translucent material of the cover member 10 may be as shown in Figure 12B. As shown in Figure 12B, the diffuse light transmittance of the translucent material is preferably 0.1% to 50% for at least a specific wavelength of light when the transmission distance is 2 mm. This specific wavelength is not particularly limited, but in Figure 12B, as an example, the diffuse light transmittance is 0.1% to 50% for red light with a central wavelength of approximately 650 nm. A translucent material having such light transmission characteristics is, for example, a resin material containing a large amount of red component.

[0134] Thus, when using a translucent material with high diffuse light transmittance for red wavelengths, using red light as illumination light allows for obtaining the necessary amount of light to detect the coloration state of the observation area LA. Of course, since white light also contains a red wavelength component, it is also possible to combine such a translucent material with white light illumination. Since the observation area LA will be irradiated with red light, it is easier to confirm the coloration of the inspection area, for example, if the inspection area develops a color other than red. In the case of a translucent material having the light transmission characteristics shown in Figure 12B, it is preferable that the lower limit of the diffuse light transmittance is 0.1% or higher, as this ensures the amount of light necessary to detect the coloration state of the observation area LA, and that the upper limit of the diffuse light transmittance is less than 50%, thereby suppressing unwanted light caused by light leakage.

[0135] Furthermore, if the diffuse light transmittance of the light-transmitting material is 0.1% or more and 50% or less for light of a specific wavelength, it is preferable that the parallel light transmittance for light of that specific wavelength be lower than the diffuse light transmittance and 0.5% or less. Assuming that the diffuse light transmittance for light of a specific wavelength is within the above range, by setting the parallel light transmittance to be lower than the diffuse light transmittance and 0.5% or less, it is possible to almost eliminate the straight-line component while ensuring the diffuseness of the light-transmitting material, thereby further reducing unwanted light caused by leakage.

[0136] As mentioned above, the specific wavelength shown in Figure 12B is just one example; other wavelengths besides red may be used, such as green light with a central wavelength of approximately 550 nm. The specific wavelength is selected according to the color emitted by the inspection area L1, etc., included in the observation area LA.

[0137] <Example 1> Furthermore, in the above example, the contact position of the emission end 115BE of the lighting unit 115 was set to a flat portion 10A, but as shown in Figure 13, it may also be set to an inclined portion 10B.

[0138] By making the contact position of the emission end 115BE an inclined portion 10B, the contact position between the observation window 18 and the emission end 115BE becomes closer. The shorter this distance, the more the loss of light transmitted through the inside of the cover member 10 can be suppressed. As a result, it is easier to increase the amount of light illuminating the observation area LA compared to when the distance is longer.

[0139] Although the inclined portion 10B is described as a flat surface, it may also be a curved surface. Even if the inclined portion 10B is a curved surface, an elastically deformable light-shielding member 115D is provided at the exit end 115BE, so the light-shielding member 115D deforms along the curved surface of the inclined portion 10B, thereby suppressing light leakage from the exit end 115BE.

[0140] As mentioned above, both the flat portion 10A and the inclined portion 10B are outer surfaces facing the detection unit 114. Thus, it is preferable that the contact position of the ejection end 115BE be on the "outer surface facing the detection unit 114," including the flat portion 10A and the inclined portion 10B. By making the contact position of the ejection end 115BE on the outer surface facing the detection unit 114, it is easier to bring the contact position of the observation window 18 closer to the contact position of the ejection end 115BE compared to the case where the ejection end 115BE is in contact with an outer surface that "does not face" the detection unit 114. An outer surface that does not face is, for example, the side of the case 9.

[0141] The explanation will be based on the example where the contact position of the ejection end 115BE is in contact with the outer surface facing the detection unit 114. TaHowever, the embodiments of this disclosure are not limited thereto. That is, the contact position of the exit end 115BE may be an outer surface that does not face the detection unit 114, such as the side of the case 9, as long as it is a position that can guide light to the inner edge 18A of the observation window 18 by passing it through the outer shell of the case 9. In this case, it is preferable that the case body 20 be made of a light-transmitting material.

[0142] <Modification 2> The case 9 of the cartridge 100 according to this disclosure may include a light guide member 70 as shown in Figure 14A. The light guide member 70 is a member made of a light-transmitting material that has a higher light transmittance than the light-transmitting material that forms the cover member 10, which is the outer shell of the case 9. The light guide member 70 guides the light incident from the exit end 115BE of the illumination unit 115 to the inner edge of the observation window 18, as shown by arrow E2.

[0143] The transmitted light that passes through the light guide member 70 is emitted from the inner edge of the observation window 18, illuminating the observation area LA. Since the light guide member 70 has a higher light transmittance than the translucent material forming the outer shell of the cover member 10, there is less light attenuation. Therefore, the amount of light illuminating the observation area LA can be increased compared to when the light guide member 70 is not present.

[0144] Furthermore, the light guide member 70 is positioned on the outer surface of the outer shell of the cover member 10. Specifically, it is positioned from the flat portion 10A to the inclined portion 10B of the cover member 10. In the light guide member 70, the portion positioned on the flat portion 10A of the cover member 10 is in contact with the output end 115BE of the illumination unit 115 (more specifically, the light shielding member 115D provided on the output end 115BE).

[0145] Furthermore, the area of ​​the light guide member 70 other than the contact portion in which the exit end 115BE makes contact is shielded from light by the light shielding member 72. This light shielding member 72 is, for example, a light-shielding paint applied to the surface of the light guide member 70. Alternatively, a light-shielding tape or the like may be used as the light shielding member 72. These light shielding members 72 have a light transmittance that is lower than that of the light-transmitting material forming the outer shell of the cover member 10.

[0146] As described above, the light guide member 70 is positioned on the outer surface of the outer shell of the cover member 10, and the illumination unit 115 is positioned in contact with it. Therefore, light is directly incident on the light guide member 70 from the illumination unit 115. This allows light to be transmitted into the interior of the light guide member 70 without being affected by the attenuation of light caused by the translucent material forming the outer shell. As a result, the amount of light illuminating the observation area LA can be increased.

[0147] Furthermore, the portion of the light guide member 70 other than the contact portion that the light shielding member 115D of the illumination unit 115 contacts is shielded by the light shielding member 72. This prevents light incident on the light guide member 70 from the output end 115BE of the illumination unit 115 from emitting from portions other than the contact portion, thereby improving the efficiency of light utilization.

[0148] As shown in Figure 14B, the light guide member 70 may be embedded in the translucent material forming the outer shell of the cover member 10. When the light guide member 70 is arranged in this manner, the light emitted from the output end 115BE of the illumination unit 115 passes through the translucent material forming the outer shell of the cover member 10 and enters the light guide member 70.

[0149] In this case, although the light is attenuated before it enters the light guide member 70, after it enters the light guide member 70, it can be transmitted into the interior of the light guide member 70 without being affected by the attenuation of light by the light-transmitting material forming the outer shell. This increases the efficiency of light utilization compared to when there is no light guide member 70.

[0150] Furthermore, in the inspection apparatus 110 of this disclosure, a light-shielding member 115D is used as a suppression unit to suppress light leakage that leaks out around the output end 115BE of the illumination unit 115 without entering the outer shell of the cover member 10, but the embodiments of this disclosure are not limited to this.

[0151] Such a suppression part may be, for example, the screen 80 shown in Figure 15A. By providing the screen 80 around the emission end 115BE of the lighting unit 115, leakage light leaking out around the emission end 115BE can be suppressed. Alternatively, for example, as shown in Figure 15B, a portion for fitting the emission end 115BE may be formed on the surface of the cover member 10, and this recess 82 may function as a suppression part to suppress leakage light.

[0152] Furthermore, as shown in Figure 15C, it is not necessary to provide such a suppression section. That is, if the planar portion 10A of the cover member 10 is a flat surface, and the surface facing the planar portion 10A at the emission end 115BE is also a flat surface without irregularities, light leakage can be suppressed.

[0153] Furthermore, in the above example, a lifting device 125 was provided as a moving mechanism to move the illumination unit 115 between a contact position and a retracted position, but it is not necessary to provide the lifting device 125. For example, in the inspection device 110, when the cartridge 100 is loaded, it is sufficient to simply spring-bias the illumination unit 115 so that a part of the illumination unit 115 is located within the entry path while ensuring an entry path for the cartridge 100 to enter. In this case, when the cartridge 100 is loaded, the cartridge 100 advancing along the entry path comes into contact with the illumination unit 115, and while maintaining the contact state of the illumination unit 115, it moves in the direction of retraction from the entry path against the spring bias. Since the illumination unit 115 is spring-biased toward the entry path, the contact state between the illumination unit 115 and the cartridge 100 continues while the cartridge 100 is loaded.

[0154] 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, the color state discrimination unit 123, and the display control unit 124, 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.

[0155] 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.

[0156] 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.

[0157] Furthermore, the hardware structure of these various processors can more specifically utilize an electrical circuit (circuitry) that combines circuit elements such as semiconductor elements. Moreover, this disclosure is not limited to the embodiments described above, and can be implemented with appropriate modifications, such as omitting or replacing components, within the scope of the purpose of this disclosure.

Claims

1. An inspection device used for immunochromatographic testing, A loading section into which a cartridge is loaded, comprising: a carrier having a test area whose coloration changes depending on whether the sample is positive or negative; a case that houses the carrier in an internal space defined by an outer shell made of a translucent material, the case having an opening formed in a part of the outer shell for observing an observation area including the test area; An illumination unit having an emitting end that emits light to illuminate the observation area, wherein the illumination unit is positioned on the outer surface of the outer shell of the loaded cartridge at a position separated from the opening, and can be positioned with at least a portion of the emitting end in contact with the outer shell at a position in which light incident into the outer shell from the emitting end can be guided to the inner edge of the opening by passing through the inside of the outer shell, A detection unit positioned opposite the opening of the loaded cartridge and for detecting the color development state of the inspection area, the detection unit optically detects the color development state by receiving reflected light emitted from the inner edge of the opening and reflected off the surface of the observation area, An inspection device equipped with the following features.

2. The inspection apparatus according to claim 1, wherein the emission end is provided with a suppression unit that suppresses light leakage that leaks out around the emission end without entering the outer shell.

3. The aforementioned emission end has an emission window for emitting light and a window frame surrounding the emission window. The inspection apparatus according to claim 2, wherein the suppression portion is a light-shielding elastic member provided on the window frame and which elastically deforms when pressed against the outer surface of the outer shell.

4. The inspection apparatus according to any one of claims 1 to 3, wherein the contact position of the ejection end is the outer surface of the outer shell facing the detection unit.

5. The inspection apparatus according to claim 4, wherein there are at least two illumination units, and the two illumination units are arranged one on each side of the opening in the outer shell.

6. The inspection apparatus according to any one of claims 1 to 5, wherein the light source of the illumination unit is a semiconductor light source.

7. A cartridge used for immunochromatographic testing, A carrier having a test area whose color development changes depending on whether the sample is positive or negative, A case for housing the carrier in an internal space defined by an outer shell made of a light-transmitting material, wherein an opening for observing an observation area including the inspection area is formed in a part of the outer shell, and light incident from a position on the outer surface of the outer shell spaced apart from the opening can be guided to the inner edge of the opening by passing through the inside of the outer shell, Equipped with, The aforementioned light-transmitting material is a light-transmitting material that has diffusive properties that diffuse light, Furthermore, the diffuse light transmittance of the light-transmitting material is, when the transmission distance is 2 mm, 0.1% to 50% or, at least for light of a specific wavelength, or 1% to 40% or, when the transmission distance is 2 mm, for light with a wavelength of 420 nm to 680 nm. cartridge.

8. The cartridge according to claim 7, wherein the case is a light guide member made of a light-transmitting material that has a higher light transmittance than the light-transmitting material forming the outer shell, and the light guide member guides the incident light to the inner edge of the opening.

9. The light guide member is arranged on the outer surface of the outer shell, and can be positioned such that at least a portion of the light-emitting end of the illumination unit is in contact with a part of the light guide member. Furthermore, the cartridge according to claim 8, wherein the light guide member is shielded from light in areas other than the contact portion in which the emission end contacts.

Images