Inspection cartridge

Abstract

This inspection cartridge is provided with a reagent container which seals a reagent that is supplied to a carrier that is supplied with a sample and a reagent, and which is crushed to externally discharge the reagent, a case which has a pressing operation part operated to apply a pressing force on the reagent container, and a first displacement section and a second displacement section which can be displaced inside of the case; the first displacement section has a first pressing surface for pressing the second displacement section against the reagent container by pressing the second displacement section, and the second displacement section is arranged between the first displacement section and the reagent container, and crushes the reagent container when pressed from the first pressing surface. The projected surface area that is viewed from the pressing direction when pressing the reagent container comprises a second pressing surface which is wider than the first pressing surface.

Description

Technical Field

[0001] The technology of the present disclosure relates to a test cartridge.

Background Art

[0002] International Publication No. 2017 / 104143 describes an immunochromatography kit for performing a test to determine whether a sample is positive or negative, that is, whether the sample contains a target substance, using the immunochromatography method. This immunochromatography kit is called a test cartridge, etc. The immunochromatography kit described in International Publication No. 2017 / 104143 includes an immunochromatography carrier (hereinafter referred to as a carrier) to which reagents such as a sample and an amplification solution are supplied, and a case that houses the carrier. Further, inside the case, pods in which the reagents are enclosed are housed. The pod has a container with one side open, and the container is sealed by covering the opening of the container with a sheet member. The pod is arranged in a posture where the sheet member and the carrier face each other, and a protrusion is provided between the sheet member and the carrier.

Summary of the Invention

Problems to be Solved by the Invention

[0003] In a test cartridge such as the immunochromatography kit shown in International Publication No. 2017 / 104143, a pressing button is provided on the case, and when the pressing button is operated, a pressing force is applied to press the container against the carrier side. When the container is pressed against the carrier side, the sheet member is pressed against the protrusion, and by this pressing, a part of the sheet member is broken. The reagent is discharged to the outside of the pod by the breakage of the sheet member.

[0004] It is being considered to create reagent containers, such as pods, using flexible packaging, such as pillow packaging. Such reagent containers discharge reagents to the outside when crushed. Compared to the pods with a sheet member rupture configuration described in International Publication No. 2017 / 104143, such reagent containers may have a simpler structure.

[0005] When squeezing out reagents from a reagent container by crushing it, it is preferable to press the reagent container over a wide area with a pressing member having a relatively wide pressing surface in order to suppress any remaining liquid.

[0006] One possibility for such a pressing member is to use a pressing operation part, such as a push button, provided on the case. However, in order for the pressing operation part provided on the case to function, it is necessary to ensure a range of motion in which the pressing operation part can be displaced. In order to ensure a range of motion for the pressing operation part within the case, it is not desirable to provide a pressing member that is too large in size on the pressing operation part.

[0007] Given these circumstances, there was a demand for measures to suppress liquid residue inside the packaging while ensuring the range of motion of the pressing mechanism on the case.

[0008] The technology disclosed herein provides a testing cartridge that, taking the above facts into consideration, can suppress residual liquid inside the reagent container while ensuring the range of motion of the pressing operation part provided in the case. [Means for solving the problem]

[0009] The test cartridge of this disclosure is a test cartridge used in an immunochromatographic test, comprising: a carrier to which a sample and a reagent are supplied; a reagent container in which the reagent supplied to the carrier is sealed and which discharges the reagent to the outside when crushed; a case to house the carrier and the reagent container, the case having a pressing operation part that is operated to apply a pressing force to the reagent container; and a first displacement part and a second displacement part that are displaceable within the case, wherein the first displacement part has a first pressing surface for pressing the second displacement part against the reagent container when the pressing operation part is operated, and the second displacement part is positioned between the first displacement part and the reagent container and is a second pressing surface that crushes the reagent container when pressed by the first pressing surface, and has a second pressing surface whose projected area, as viewed from the pressing direction that presses the reagent container, is larger than that of the first pressing surface.

[0010] In the test cartridge of this disclosure, it is preferable that the projected area of ​​the second pressing surface is larger than the projected area of ​​the reagent container.

[0011] In the inspection cartridge of this disclosure, it is preferable that the thickness of the second displacement portion is thinner than the thickness of the first displacement portion in the pressing direction.

[0012] In the test cartridge of this disclosure, it is preferable that the reagent container has a sealing portion that opens before other parts when the internal pressure increases due to pressure from the second pressing surface.

[0013] In the test cartridge of the present disclosure, in a reagent container, the side with the sealing portion is designated as the first end, the side opposite the sealing portion as the second end, and the direction connecting the first end and the second end is designated as the reference direction, it is preferable that the width of the second pressing surface is wider than the width of the first pressing surface in the reference direction.

[0014] In the inspection cartridge of this disclosure, it is preferable that the second displacement portion is provided such that, when pressed from the first displacement portion, the second pressing surface crushes the second end side before the first end side.

[0015] In the inspection cartridge of this disclosure, it is preferable that, in the reference direction, the center of the first displacement portion is located closer to the second end than the center of the second displacement portion.

[0016] In the inspection cartridge of this disclosure, the second displacement portion has a fixed end on the first end side and a free end on the second end side, and it is preferable that when pressure is applied from the first displacement portion, the second end side comes into contact with the reagent container before the first end side, thereby crushing the second end side before the first end side.

[0017] In the inspection cartridge of this disclosure, the second displacement portion is preferably formed of a deformable material.

[0018] In the inspection cartridge of this disclosure, the sealing portion is preferably sealed by welding.

[0019] In the test cartridge of this disclosure, when the reagent container has multiple sealing parts, it is preferable that one of the multiple sealing parts is a weak sealing part with a weaker sealing force than the other sealing parts.

[0020] In the inspection cartridge of this disclosure, it is preferable that the pressing operation portion and the first displacement portion are formed integrally.

[0021] In the inspection cartridge of this disclosure, it is preferable that the second displacement portion has a restricting portion formed therein that restricts the position of the first displacement portion.

[0022] The test cartridge of this disclosure preferably has a reagent container formed in pillow packaging. [Effects of the Invention]

[0023] The test cartridges described herein result in less wasted reagent compared to conventional methods. [Brief explanation of the drawing]

[0024] [Figure 1] This is a perspective view of the inspection cartridge related to this disclosure. [Figure 2] It is an exploded perspective view of the test cartridge according to the present disclosure. [Figure 3] FIG. 3A is a partially broken side view showing a state where the first pressing operation part of the test cartridge according to the present disclosure is pushed in, and FIG. 3B is a partially broken side view showing a state where the first pressing operation part and the second pressing operation part are pushed in. [Figure 4] It is a side view showing the positional relationship among the test strip, the multifunctional member, the first reagent holding part, and the second reagent holding part in the test cartridge according to the present disclosure. [Figure 5] It is an explanatory diagram of the immunochromatography method. [Figure 6] FIG. 6A is a cross-sectional view showing the first displacement part, the second displacement part, and the second reagent holding part of the test cartridge according to the present disclosure, and FIG. 6B is a cross-sectional view showing a state where the first displacement part and the second displacement part are displaced and the second reagent is discharged from the second reagent holding part. [Figure 7] FIG. 7A is a perspective view showing a sheet member for manufacturing the second reagent holding part applied to the test cartridge according to the present disclosure, FIG. 7B is a perspective view showing a state where the sheet member is rolled into a cylindrical shape, FIG. 7C is a perspective view showing a state where an end portion along the cylindrical axis direction is welded, FIG. 7D is a perspective view showing a state where one end portion in the cylindrical axis direction is welded, and FIG. 7E is a perspective view showing a state where the other end portion in the cylindrical axis direction is welded. [Figure 8] It is a plan view showing the multifunctional member of the test cartridge according to the present disclosure. [Figure 9] It is a cross-sectional view showing a state where the sealing part in the second reagent holding part of the test cartridge according to the present disclosure is fixed to the second accommodating part. [Figure 10] FIG. 10A is a plan view showing an example in which a connection part of a tubular body is formed in the second reagent holding part of the test cartridge according to the present disclosure, and FIG. 10B is a cross-sectional view. [Figure 11] FIG. 11A is a plan view showing a state where a part of the second reagent holding part of the test cartridge according to the present disclosure is formed as a connection part and the connection part is inserted into the supply port of the second accommodating part, and FIG. 11B is a cross-sectional view. [Figure 12]Figure 12A is a cross-sectional view showing a modified example in which the position of the first displacement portion of the inspection cartridge according to this disclosure has been changed, and Figure 12B is a cross-sectional view showing the state in which the second reagent holding portion is being pressed. [Figure 13] Figure 13A is a cross-sectional view showing a modified example in which one end of the second displacement portion of the inspection cartridge according to this disclosure is fixed, and Figure 13B is a cross-sectional view showing the state in which the second reagent holding portion is being pressed. [Figure 14] Figure 14A is a cross-sectional view showing a modified example in which a restricting portion is provided in the second displacement portion of the inspection cartridge according to this disclosure; Figure 14B is a cross-sectional view showing the state in which the second reagent holding portion is being pressed; and Figure 14C is a cross-sectional view along the CC line in Figure 14A. [Figure 15] Figure 15A is a cross-sectional view showing a modified example in which the first displacement portion of the inspection cartridge according to this disclosure is formed by a plurality of protrusions, and Figure 15B is a cross-sectional view showing the state in which the second reagent holding portion is being pressed. [Figure 16] Figure 16A is a perspective view showing a modified example in which the second reagent holding portion of the test cartridge according to this disclosure is formed as a blister pack, Figure 16B is a cross-sectional view of line BB in Figure 16A, and Figure 16C is a cross-sectional view showing a modified example in which a cut is formed in the substrate. [Modes for carrying out the invention]

[0025] 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.

[0026] 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.

[0027] 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.

[0028] <Overview of the Inspection Cartridge> Figure 1 is an external view of cartridge 100, which is an inspection cartridge according to one embodiment, and Figure 2 is an exploded perspective view of cartridge 100. Figure 3 shows the state in which the first pressing operation part 11 and the second pressing operation part 12 provided on cartridge 100 are operated. Figure 4 shows the main housing components inside cartridge 100.

[0029] Cartridge 100 is a single-use type, with one cartridge used for each sample to be tested. As shown in Figure 2, 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.

[0030] 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).

[0031] Any sample that may contain the test substance is acceptable, and the sample is not particularly limited. Examples of samples include biological samples, particularly animal (especially human) blood, serum, plasma, cerebrospinal fluid, tears, sweat, urine, pus, nasal secretions, nasal swabs, pharyngeal swabs, nasal aspirates, or other bodily fluids such as sputum, or excretions, organs, tissues, mucous membranes and skin or swabs containing them, or liquid samples containing plants and animals themselves or their dried forms. Examples of test substances include antigens, antibodies, proteins and low-molecular-weight compounds.

[0032] Cartridge 100 has a configuration that allows the user to visually confirm whether the sample is positive or negative. Such a cartridge 100 is also called an immunochromatographic testing device or an immunochromatographic testing kit.

[0033] As shown in Figures 1 and 2, the cartridge 100 includes, for example, a case 9 composed of a case body 20 and a cover member 10. The case 9 is made of, for example, a resin material. The case body 20 has an opening at the top and houses the test strip 1, as well as a first reagent holder 40 and a second reagent holder 45 inside. The cover member 10 is attached to the opening of the case body 20, thereby covering the opening of the case body 20. The case 9 has an overall elongated shape to match the elongated shape of the test strip 1.

[0034] In this example, the upper part of the case 9, which is formed by the cover member 10, is provided with a dropper port 16, an observation window 18, a first pressing operation part 11, and a second pressing operation part 12. These parts are integrally molded with the cover member 10 as an example. The dropper port 16 is an opening for dropping a sample into the inside of the case 9. A boss is erected on the edge of the dropper port 16, facing upwards.

[0035] (Observation window) The observation window 18 is an opening for observing the test area L1 from the outside. In this example, the size of the observation window 18 is such that, in addition to the test area L1, the control area L2 and the color development area L3, which will be described later, can also be observed. In the carrier 2, the area that can be observed from the observation window 18, including the test area L1, the control area L2, the color development area L3, and their surrounding areas, is called the observation area LA. The user can check the observation area LA through the observation window 18. The user can confirm whether the sample is positive or negative by observing the color development state of the test area L1 within the observation area LA.

[0036] (First pressing operation section, second pressing operation section) As shown in Figures 2, 3A, and 3B, 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.

[0037] As shown in Figure 3A, when an external force is applied to the first pressing operation part 11, such as by a user's pressing operation, the first pressing operation part 11 deforms. As shown in Figure 2, for example, the first pressing operation part 11 has a square pyramidal shape, and when a pressing force is applied from above to the area including the vertex of the square pyramidal shape, as shown in Figure 3A, the vertex of the square pyramidal shape deforms so that it sinks into the inside of the case 9. When the first pressing operation part 11 deforms in this way, a pressing force is applied to the first reagent holding part 40 inside the case 9. The first reagent holding part 40 undergoes deformation due to the pressing force applied through the first pressing operation part 11. Due to this deformation, the first reagent 41 held by the first reagent holding part 40 is supplied to the test strip 1.

[0038] 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.

[0039] Similarly, as shown in Figure 3B, when an external force is applied to the second pressing operation section 12, the second pressing operation section 12 deforms. As shown in Figure 2, the second pressing operation section 12 in this example, like the first pressing operation section 11, has a square pyramidal shape. When an external force is applied to the area including the vertex of the square pyramid from above, the vertex of the square pyramid deforms so that it sinks into the interior of the case 9, as shown in Figure 3B. When the second pressing operation section 12 deforms in this way, an external force is applied to the second reagent holding section 45 inside the case 9. The second reagent holding section 45 undergoes deformation due to the external force applied through the second pressing operation section 12. This deformation causes the second reagent 46 held by the second reagent holding section 45 to be supplied to the test strip 1.

[0040] Thus, the second pressing operation section 12 is a pressing operation section that is operated in order to supply the second reagent 46 in the second reagent holding section 45 to the carrier 2 by applying a pressing force to the second reagent holding section 45. The second pressing operation section 12 in this example is provided with a first displacement section 12b (see Figure 6) that is displaced inside the case 9 when the second pressing operation section 12 is operated. This first displacement section 12b is formed integrally with the second pressing operation section 12 and has a first pressing surface 12c (see Figure 6) for pressing the second displacement section 70 against the second reagent holding section 45 when the second pressing operation section 12 is operated. The second displacement section 70 is a plate material that is displaceable inside the case 9, which includes the cover member 10 on which the second pressing operation section 12 is formed, and inside the second housing section 32, which will be described later.

[0041] Furthermore, it is preferable that the second pressing operation section 12, like the first pressing operation section 11, maintains its deformed state after being deformed by pressing, and that the displaced state of the first displacement section 12b is maintained. This is because, when the second pressing operation section 12 is pressed by a user, it is easier to continue supplying the second reagent 46 if the deformation of the second pressing operation section 12 is maintained even after the user releases their hand.

[0042] (First reagent holding section) As shown in Figures 2, 3A, and 3B, the case body 20 houses the test strip 1, including the carrier 2, along its longitudinal direction. As shown in Figures 3A, 3B, and 4, the case body 20 has a first reagent holding section 40 located at one end in the longitudinal direction (the upstream side as shown in Figure 4). 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.

[0043] As shown in Figures 3A, 3B and 4, 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.

[0044] The pressing force applied from the first pressing operation section 11 is transmitted to the sheet member 43 of the first reagent holding section 40 via the end of the test strip 1, causing the sheet member 43 to break. As a result of the sheet member 43 breaking, the first reagent 41 is supplied to the test strip 1. In this example, the first pressing operation section 11 is provided with a protruding portion 11b that contacts the sheet member 43. The protruding portion 11b has an elongated shape, for example, with its longitudinal direction extending in the width direction of the test strip 1, and its tip is pointed toward the sheet member 43, in order to facilitate the breaking of the sheet member 43.

[0045] (Multifunctional component) Furthermore, as shown in Figures 2, 3A, and 3B, 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 4) and above the test strip 1. The multifunctional member 30 is a member in which the second housing section 32 and the flow path forming section 35 are integrally formed.

[0046] (Multifunctional component - second housing section) The second housing section 32 has a box-like shape with an open top. The second housing section 32 is located inside the case 9, which includes the cover member 10. The second housing section 32 is a housing section that houses the second reagent holding section 45, and is provided with a supply port 32A for supplying the second reagent 46 discharged from the second reagent holding section 45 to the carrier 2.

[0047] Within the second storage section 32, a second displacement section 70 is positioned between the first displacement section 12b of the second pressing operation section 12 and the second reagent holding section 45. The second reagent holding section 45 is made of a flexible material, as will be described later, and when the second pressing operation section 12 is pressed, the second reagent holding section 45 is crushed via the second displacement section 70. When the second reagent holding section 45 is crushed, it opens up and the second reagent 46 is discharged. The second reagent 46 is supplied to the carrier 2 from the supply port 32A.

[0048] (Multifunctional component - channel forming section) 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 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.

[0049] As will be described later (see Figure 6 and subsequent figures), the cartridge 100 in this example is characterized by the structure of the second reagent holder 45 and its surrounding area. The characteristics of the second reagent holder 45 and other parts will be explained after the basic configuration and basic usage method of the cartridge 100 have been described.

[0050] As shown in Figure 4, 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 supply port 32A, which is the opening at the bottom of the second housing 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.

[0051] An absorbent pad 6, described later, is positioned at the downstream end of the inspection strip 1. As shown in Figure 2, 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.

[0052] <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.

[0053] (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.

[0054] The diagram shows the test area L1, control area L2, and color-developing area L3 as lines, but these are not always present. As will be explained in detail later, before developing sample 50 (see Figure 5), the first reagent 41 (see Figure 4), and the second reagent 46 (see Figure 4), the colors of the test area L1 and control area L2 are 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 developed sample 50 is positive, as the color intensity increases. The color 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.

[0055] 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.

[0056] 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.

[0057] For example, a porous material such as a nitrocellulose membrane can be used as the carrier 2. The back adhesive sheet 7 to which the carrier 2 is fixed is a sheet-like substrate on which the surface to which the carrier 2 is attached is an adhesive surface.

[0058] (Carrier-labeling pad) As shown in Figure 5, 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 2) 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.

[0059] 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.

[0060] (Carrier-inspection area) As shown in Figure 5, 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.

[0061] (Carrier-control area) The control region L2 contains a third binding substance 58 that specifically binds to the first binding substance 52, and captures the labeled substance 53 via the first binding substance 52. When the sample 50 is applied to the label-holding pad 3, the labeled substance 53 modified with the first binding substance 52 that is not bound to the test substance 51 also spreads within the carrier 2 toward the test region L1 along with the sample 50. The labeled substance 53 that is not bound to the test substance 51 passes through the test region L1 without being captured. The labeled substance 53 that has passed through the test region L1 is captured in the control region L2 via the first binding substance 52, as the first binding substance 52 binds to the third binding substance 58. When the labeled substance 53 is captured in the control region L2, the color intensity of the control region L2 rises to a preset standard or higher. The control region L2 is a region for confirming the completion of the spread of the sample 50 by the label signal from the labeled substance 53 captured via the first binding substance 52. Therefore, the control region L2 is sometimes called the verification region.

[0062] (Carrier-Color Development Area) The color-developing region L3 contains a substance that reacts with the first reagent 41 to change its color state. The color-developing region L3 indicates that the first reagent 41 has reached that region by reacting with the first reagent 41 to develop color or by changing color. For example, when using a mixed aqueous solution of iron nitrate aqueous solution and citric acid (manufactured by Wako Pure Chemical Industries, Ltd., 038-06925) as the first reagent 41, it is preferable that the color-developing region L3 be composed of a color-developing reagent immobilization line in which bromocresol green (manufactured by Wako Pure Chemical Industries, Ltd.) is immobilized in a line. This is the embodiment of the color-developing region L3 in this example, and as described above, the color-developing region L3 in this example is dark green before reacting with the first reagent 41, and changes to orange when the first reagent 41 reaches the color-developing region L3. Furthermore, the color-developing region L3 is sometimes called the amplification indicator region because the change in color development indicates the timing for the first reagent 41 to be deployed and the supply of the second reagent 46.

[0063] (binding substance) The first binding substance 52 that 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, an antigen against the antibody if the test substance is an antibody, or an aptamer for proteins and low molecular weight compounds if the test substance is a protein and low molecular weight compound, etc., and is a substance that specifically binds to the test substance.

[0064] The second binding substance 56, which is fixed in the test area L1 and specifically binds to the test substance 51, is a substance that specifically binds to the test substance, such as an antibody against the antigen if the test substance is an antigen, an antigen against the antibody if the test substance is an antibody, or an aptamer against the protein and low molecular weight compounds if the test substance is a protein and low molecular weight compounds. The first binding substance 52 and the second binding substance 56 may be the same or they may be different.

[0065] The third binding substance 58 that specifically binds to the first binding substance 52 may be the test substance 51 itself, or it may be a compound that has a site recognized by the first binding substance 52. For example, a compound obtained by binding a derivative of the test substance 51 to a protein may be used.

[0066] For example, if the test substance 51 is influenza A virus or its biomarker, anti-influenza A monoclonal antibody (Anti-Influenza A SPTN-5 7307, manufactured by Medix Biochemica) can be used as the first conjugate 52 and the second conjugate 56, and anti-mouse IgG antibody (anti-mouse IgG(H+L), rabbit F(ab')2, catalog number 566-70621, manufactured by Wako Pure Chemical Industries, Ltd.) can be used as the third conjugate 58.

[0067] (Fluid transfer pads) The liquid delivery pad 4 is positioned in contact with one end of the carrier 2 and delivers the first reagent 41 to the carrier 2 from upstream of the point contact area (composed of the label holding pad 3). 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.

[0068] (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.

[0069] <Amplifying solution> In this embodiment, the first reagent 41 and the second reagent 46 are amplification solutions that, by reacting together, amplify the color development in the test region L1 and the control region L2. When a metallic labeling substance such as gold colloid is used as the labeling substance 53, as in this example, silver amplification is used as a method to amplify the labeling signal of the labeling substance 53. The first reagent 41 and the second reagent 46 are amplification solutions used for silver amplification as an example, and the reaction of the first reagent 41 and the second reagent 46 with the labeling substance 53 as a catalyst is the amplification reaction. The amplification reaction generates silver particles with a particle size relatively larger than that of the labeling substance 53.

[0070] 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 (see Figure 5) 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 on the labeled substance 53 generates silver particles 60 (see Figure 5) that are larger in particle size than the labeled substance 53. As a result, the labeling signal emitted by the labeled substance 53 is amplified, and consequently, the color development of the labeled substance 53 is amplified in the test area L1 and the control area L2.

[0071] (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. Preferred inorganic reducing agents include metal ions such as Fe2+, V2+, or Ti3+, which are reducing metal salts or reducing metal complexes whose valence can change. When using an inorganic reducing agent, it is necessary to remove or detoxify the oxidized ions by forming a complex or reducing them. For example, in a system using Fe2+ as a reducing agent, a complex of the oxide Fe3+ can be formed using citric acid or EDTA (ethylenediaminetetraacetic acid) to detoxify it. In this system, it is preferable to use such an inorganic reducing agent, and more preferably a metal salt of Fe2+.

[0072] Furthermore, developing agents used in wet silver halide photographic materials (e.g., methyl gallate, hydroquinone, substituted hydroquinone, 3-pyrazolidones, p-aminophenols, p-phenylenediamines, hindered phenols, amidoximes, azines, catechols, pyrogallols, ascorbic acid (or its derivatives), and leuco dyes), as well as other materials obvious to those skilled in the art, such as those described in U.S. Patent No. 6,020,117, can also be used.

[0073] As a reducing agent, ascorbic acid reducing agents are also preferred. Useful ascorbic acid reducing agents include ascorbic acid and its analogues, isomers and derivatives, and for example, D- or L-ascorbic acid and its sugar derivatives (e.g., γ-lactoascorbic acid, glucoascorbic acid, fucoscorbic acid, glucoheptascorbic acid, maltoascorbic acid), sodium salts of ascorbic acid, potassium salts of ascorbic acid, isoascorbic acid (or L-erythroascorbic acid), salts thereof (e.g., alkali metal salts, ammonium salts or salts known in the art), enediol-type ascorbic acid, enaminol-type ascorbic acid, thioenol-type ascorbic acid, etc., with D, L, or D,L-ascorbic acid (and its alkali metal salts) or isoascorbic acid (or its alkali metal salts) being particularly preferred, and sodium salts being preferred salts. Mixtures of these reducing agents can be used as needed.

[0074] (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, and examples include 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, and an example is silver hydroxythioether.

[0075] <Immunochromatography> Referring to Figure 5, 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.

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

[0077] 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.

[0078] Subsequently, the system waits until the first reagent 41 is deployed downstream (steps S3-S4). The "Wait" shown in Figure 5 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).

[0079] 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 labeled substance 53 is captured in the test area L1 via the test substance 51 and the first binding substance 52. On the other hand, the labeled 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.

[0080] 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.

[0081] 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).

[0082] The structure of the second reagent holding section 45 of the cartridge 100 and its surrounding area will be described with reference to Figure 6 and subsequent figures.

[0083] (Second reagent holding section) As shown in Figure 6A, the second reagent holding section 45 is an example of a reagent container supplied to the carrier 2. In this example, the second reagent holding section 45 is an enclosure in which the second reagent 46 supplied to the carrier 2 is sealed. Figure 6A shows a state in which no pressing force is applied to the second reagent holding section 45, and Figure 6B shows a state in which pressing force is applied to the second reagent holding section 45. As shown in Figure 6B, the second reagent holding section 45 has a sealing section 45A that opens before other parts when the internal pressure rises due to the application of pressing force. When the sealing section 45A opens, the second reagent 46 discharged from the second reagent holding section 45 flows out to the supply port 32A.

[0084] (Form and manufacturing method of the second reagent holder) Figures 7A to 7E show an example of the shape and manufacturing method of the second reagent holder 45. In this example, the second reagent holder 45 is formed from a single sheet member 45S rolled into a cylindrical shape. To manufacture the second reagent holder 45, first prepare the sheet member 45S shown in Figure 7A and roll it into a cylindrical shape as shown in Figure 7B.

[0085] As the sheet member 45S, a film formed from the second reagent 46 and any chemically inert material can be used. Specifically, a film formed from a general-purpose resin such as polypropylene, polyethylene, polyethylene terephthalate, or ABS (Acrylonitrile, Butadiene, Styrene) resin can be used. Furthermore, it is even more preferable to use a composite film in which an aluminum layer is added to the resin layer formed from these resins to prevent the permeation of moisture and gases.

[0086] Next, the ends 45C1 and 45C2 of the rolled sheet member 45S that are aligned along the cylindrical axis are welded together as shown in Figure 7C to form a sealing portion 45C.

[0087] Next, as shown in Figure 7D, one end in the axial direction of the cylinder is welded along a direction intersecting the axial direction of the cylinder to form a sealing portion 45A. Then, the second reagent 46 is filled into the interior of the sheet member 45S from the end opposite to the sealing portion 45A.

[0088] Next, as shown in Figure 7E, the opposite end of the sealing portion 45A is welded to form the sealing portion 45B. This forms the second reagent holding portion 45, which is an enclosed body in which the second reagent 46 is sealed.

[0089] The second reagent holder 45 in this example is manufactured by processing a single sheet member 45S into a cylindrical shape. This form of the second reagent holder 45 is generally called a pillow packaging. Therefore, it may be manufactured using a pillow packaging machine or the like.

[0090] In this way, by forming the second reagent holding portion 45 from a single sheet member 45S, the number of sealing portions can be reduced compared to the case where two or more sheets are combined to form the second reagent holding portion 45. This reduces the number of steps required for processing.

[0091] The second reagent holding section 45 has sealing sections 45A and 45B formed at each of its longitudinal ends. Of these, sealing section 45A is the sealing section located at the supply port 32A when the second reagent holding section 45 is positioned inside the second storage section 32. Sealing section 45B is the section located on the opposite side of the supply port 32A when the second reagent holding section 45 is positioned inside the second storage section 32.

[0092] Here, the "sealing portion located at the supply port" in this disclosure refers to the sealing portion 45A located in the second reagent holding portion 45, which is positioned closer to the supply port 32A than other portions. Another example of the "sealing portion located at the supply port" will be described later.

[0093] The sealing portions 45A and 45B are sealing portions that seal the second reagent holding portion 45 so that the second reagent 46 does not leak out of the second reagent holding portion 45 when no pressing force is acting on the second reagent holding portion 45, in other words, when no external force other than atmospheric pressure is acting on it. In this example, sealing portion 45A is a sealing portion that opens before the other portions when the internal pressure of the second reagent holding portion 45 increases due to a pressing force acting on the second reagent holding portion 45.

[0094] The sealing portions 45A and 45B are formed by heat welding the sheet member 45S. In other words, the sealing portions 45A and 45B are heat-welded portions. As shown in Figure 8, the welding width D1 of sealing portion 45A is smaller than the welding width D2 of sealing portion 45B. Therefore, the welding area of ​​sealing portion 45A is smaller than the welding area of ​​sealing portion 45B. On the other hand, the temperature, time, and pressure for welding sealing portions 45A and 45B are the same. As a result, sealing portion 45A is a weakly sealed portion with weaker sealing force compared to sealing portion 45B. Therefore, in this example, sealing portion 45A opens before other parts when the internal pressure of the second reagent holding portion 45 increases.

[0095] As shown in Figure 6, the second reagent holder 45 is housed inside the second housing 32, and the second displacement 70 is positioned between the second reagent holder 45 and the first displacement 12b. The second reagent holder 45 is housed in contact with the second displacement 70. Furthermore, as shown in Figure 8, which is a plan view of the second housing 32 from the pressing direction (Z direction) that presses the second reagent holder 45, the second reagent holder 45 is positioned inside the second housing 32 with its longitudinal direction aligned with the Y direction (longitudinal direction of the test strip 1, see Figure 2, etc.).

[0096] In the second containment section 32, the supply port 32A is located on the upstream side, closer to the inspection area L1. This allows the second reagent 46 discharged from the supply port 32A to be supplied more quickly to the inspection area L1 of the carrier 2, compared to, for example, the case where the supply port 32A is located on the downstream side of the second containment section 32.

[0097] Furthermore, the supply port 32A is narrower than the second storage section 32 and is located in the center of the second storage section 32. "Width" refers to the width along the shorter side (X direction) of the case body 20, and "center" refers to the center of the case body 20 in the shorter side (X direction). This center is located above the carrier 2. As a result, the second reagent 46 discharged from the supply port 32A is quickly delivered to the carrier 2.

[0098] As shown in Figure 6, the bottom surface 32B of the second housing section 32 abuts against the second reagent holding section 45, and the second reagent holding section 45 abuts against the second displacement section 70. The second displacement section 70 is an intermediate member positioned between the first displacement section 12b, which is integrally formed with the second pressing operation section 12, and the second reagent holding section 45. In the pressing direction (Z direction) when pressing the second reagent holding section 45, the thickness H2 of the second displacement section 70 is formed to be thinner than the thickness H1 of the first displacement section 12b.

[0099] Furthermore, the second displacement section 70 is equipped with a second pressing surface 70C. The second pressing surface 70C is a pressing surface that crushes the second reagent holding section 45 when the second displacement section 70 is pressed by the first pressing surface 12c of the first displacement section 12b. In addition, the second pressing surface 70C of the second displacement section 70, which faces and contacts the second reagent holding section 45, is a smooth, flat surface with few irregularities. This second pressing surface 70C also functions as a pressing surface that applies a pressing force to the second reagent holding section 45 when the second pressing operation section 12 is operated. The bottom surface 32B of the second housing section 32 also contacts the second reagent holding section 45 on the opposite side from the second pressing surface 70C. This bottom surface 32B is also a flat surface, similar to the second pressing surface 70C.

[0100] Furthermore, in Figure 8, the outlines of the first pressing surface 12c and the second pressing surface 70C are shown as dashed lines. In this example, the projected area of ​​the second pressing surface 70C, as viewed from the pressing direction that presses the second reagent holding part 45, is larger than that of the first pressing surface 12c. Also, the projected area of ​​the second pressing surface 70C, as viewed from the pressing direction that presses the second reagent holding part 45, is larger than the projected area of ​​the second reagent holding part 45.

[0101] <Mechanism of action, effect> (Effects of the second reagent holding section and the second storage section) As shown in Figure 6A, the cartridge 100 of this disclosure includes a second reagent holding portion 45 as an encapsulation body in which the second reagent 46 is sealed. The second reagent holding portion 45 has a sealing portion 45A that opens before other portions when the internal pressure increases due to the application of pressing force.

[0102] With this configuration, as shown in Figure 6B, the second reagent 46 is discharged to the outside of the second reagent holding portion 45 from the sealing portion 45A which opens first. Compared to the conventional configuration in which the reagent is broken by a projection, it is easier to control the direction in which the second reagent 46 is discharged. If the direction in which the second reagent 46 is discharged can be controlled, it is possible to suppress the generation of wasted second reagent 46 that is not supplied to the carrier 2 (see Figures 2, 3A, and 3B).

[0103] Furthermore, in the cartridge 100 of this disclosure, the second pressing surface 70C of the second displacement portion 70 is a smooth, flat surface with few irregularities, and is a pressing portion that applies a pressing force to the second reagent holding portion 45 when the second pressing operation portion 12 is operated.

[0104] Because the pressing force is applied to the second reagent holding portion 45 on such a flat surface, the pressing force is less likely to concentrate locally compared to the conventional configuration in which fracture is caused by a projection, and fracture of parts other than the sealing portion 45A can be suppressed.

[0105] Furthermore, in the cartridge 100 of this disclosure, a second housing section 32 is provided within the case 9 formed by the cover member 10 and the case body 20, which houses the second reagent holding section 45, which is an enclosed body. The second housing section 32 also has a supply port 32A for supplying the second reagent 46 discharged from the second reagent holding section 45 to the carrier 2. Moreover, in the second reagent holding section 45, the sealing section 45A is located at the supply port 32A.

[0106] As a result, the second reagent 46 discharged from the sealing section 45A can easily flow into the supply port 32A where the sealing section 45A is located. Therefore, the amount of reagent wasted flowing to places other than the supply port 32A is reduced.

[0107] In contrast, if, for example, the sealing portion 45A is located at a distance from the supply port 32A, the second reagent 46 discharged from the sealing portion 45A will flow towards the supply port 32A within the second storage portion 32. In this case, there is a possibility of residual liquid remaining in the portion between the sealing portion 45A and the supply port 32A. Furthermore, in order to suppress residual liquid, it may be necessary to provide a slope on the bottom surface 32B of the second storage portion 32 to allow the second reagent 46 to flow towards the supply port 32A, which would complicate the configuration of the second storage portion 32.

[0108] Furthermore, in the cartridge 100 of this disclosure, the second reagent holding section 45 is provided with a plurality of sealing sections, namely sealing sections 45A and 45B. One of the plurality of sealing sections 45A and 45B, sealing section 45A, is a weakly sealing section with weaker sealing force than the other sealing sections 45B. As a result, the second reagent 46 is discharged from the weakly sealing section 45A and flows easily into the supply port 32A. This reduces the amount of second reagent 46 that flows to places other than the supply port 32A.

[0109] In this embodiment, of the sealing portions 45A and 45B, the sealing portion 45A located at the supply port 32A is a weak sealing portion, but the embodiments of this disclosure are not limited to this. For example, the welding areas of the sealing portions 45A and 45B may be made equal, and the sealing force of the two sealing portions 45A and 45B may be made equal.

[0110] In this case, the sealing portions 45A and 45B may open simultaneously, or one of them may open first, but if at least one of these sealing portions 45A and 45B opens before the other parts of the second reagent holding portion 45, it is easier to restrict the direction in which the second reagent 46 is discharged. Alternatively, for example, the second reagent holding portion 45 may be positioned such that the cylindrical axis direction connecting the sealing portions 45A and 45B intersects the longitudinal direction of the carrier 2, and the distance between each of the sealing portions 45A and 45B and the supply port 32A may be equal. That is, the second reagent holding portion 45 may be positioned in a position lateral to the longitudinal direction of the carrier 2. In this case, since the two sealing portions 45A and 45B are positioned on both sides of the longitudinal direction of the carrier 2, the distance between them and the supply port 32A located directly above the carrier 2 becomes equal. In this case, even if both sealing portions 45A and 45B open, the second reagent 46 discharged from both can flow out into the supply port 32A.

[0111] Furthermore, in the cartridge 100 of this disclosure, the sealing portions 45A and 45B are welded together. This makes manufacturing easier and reduces the risk of leakage compared to sealing with tape, for example. In addition, these sealing portions 45A and 45B are heat-sealed. Heat sealing is a more common method for sealing inclusions such as the second reagent holding portion 45, making it easier to manufacture. Moreover, since there is no need to seal using adhesives other than the material forming the second reagent holding portion 45, adverse effects caused by chemical reactions between such adhesives and the second reagent 46 can be reduced.

[0112] Furthermore, in the cartridge 100 of this disclosure, the sealing portion 45A is a weakly sealing portion because its welded area is smaller than that of the sealing portion 45B. The method of adjusting the sealing force by the welded area is simple because it does not require adjusting the welding temperature, welding pressure, and welding time between multiple sealing portions. For this reason, it is easier to adjust the sealing force compared to adjusting the welding temperature, welding pressure, or welding time.

[0113] In addition, the cartridge 100 of this disclosure may employ methods other than adjusting the welding area to form a weakly sealed portion. For example, a weakly sealed portion may be formed by controlling the thermal energy applied to the second reagent holding portion 45. Methods for controlling thermal energy include adjusting the welding temperature, welding pressure, or welding time.

[0114] For example, if the welding temperature is lower than the welding temperature of other sealing parts, the amount of melted sheet member 45S, which is the material forming the second reagent holding part 45, is reduced, and a weak seal can be formed. Also, if the welding pressure is lower than the welding pressure of other sealing parts, the degree of adhesion between the molten parts is reduced, and a weak seal can be formed. Furthermore, even if the welding time is shortened, the amount of melted material forming the second reagent holding part 45 is reduced, and a weak seal can be formed.

[0115] By adjusting the welding temperature, welding pressure, or welding time, rather than the welding area, a weakly sealed area can be formed, making multiple welding areas equal in size. In other words, it is not necessary to make the area of ​​the sealing areas other than the weakly sealed areas larger than the area of ​​the weakly sealed areas. This allows for miniaturization of the second reagent holding section 45 and the second storage section 32.

[0116] Thus, by employing a method of sealing the sealing parts 45A and 45B by heat welding, the number of adjustment parameters, such as welding temperature, welding pressure (pressure of the heating element), welding time, and welding area, is relatively large, making it easy to adjust the sealing force.

[0117] In this embodiment, heat welding is used as the welding method for the sealing portions 45A and 45B, but the embodiments of this disclosure are not limited to this. For example, high-frequency welding, ultrasonic welding, etc., may be used as the welding method for the sealing portions 45A and 45B. Alternatively, welding can be performed using the second reagent 46 and a chemically inert solvent.

[0118] In this embodiment, as shown in Figure 6A, the sealing portions 45A and 45B are not fixed in position within the second housing portion 32, but the embodiments of this disclosure are not limited to this. For example, as shown in Figure 9, the position of the sealing portion 45A located in the supply port 32A may be fixed. One way to fix the position of the sealing portion 45A is to fix the sealing portion 45A to the bottom surface 32B of the second housing portion 32 with double-sided tape or the like.

[0119] In this way, if the position of the sealing portion 45A is fixed, when the second reagent holding portion 45 is pressed, it is prevented that the sealing portion 45A will not be displaced due to the sealing portion 45A lifting up, and the sealing portion 45A will not be separated from the supply port 32A.

[0120] In the example shown in Figure 9, only the sealing portion 45A is fixed to the bottom surface 32B of the second housing portion 32. However, the sealing portion 45B may also be fixed to the bottom surface 32B, or the portion other than the sealing portions 45A and 45B may be fixed to the bottom surface 32B.

[0121] Furthermore, in the second reagent holding section 45 shown in Figures 6A and 9, the sealing section 45A is positioned close to the supply port 32A, but the embodiments of this disclosure are not limited to this. For example, the sealing section 45A may be connected to the supply port 32A via a "connection section".

[0122] As an example of a second reagent holder with a connecting portion, Figure 10A shows a second reagent holder 72. Figure 10A is a plan view of the second reagent holder 72 as seen from the Z direction, which is the pressing direction, and Figure 10B is a cross-sectional view as seen from the X direction. The second reagent holder 72 shown in Figure 10A also has two sealing portions 72A and 72B, with sealing portion 72A being a weaker sealing portion with less sealing force than sealing portion 72B. A tubular body 74, which is a separate component from the second reagent holder 72, is connected to this sealing portion 72A as a connecting portion.

[0123] In this way, by positioning the sealing portion 72A at the supply port 32C via the tubular body 74 as a connecting portion within the second storage portion 32, the second reagent 46 discharged from the sealing portion 72A can easily flow into the supply port 32C. This reduces the amount of second reagent 46 that flows outside the supply port 32C. Furthermore, connecting the sealing portion 72A to the supply port 32C via the tubular body 74 increases the flexibility of the positioning of the sealing portion 72A.

[0124] Furthermore, by using a tubular body separate from the second reagent holding section 72 as the connection part, the shape and material of the connection part can be freely selected. This makes it possible to provide an appropriate connection part considering the shape of the second storage section 32, the shape of the supply port 32C, the shape and material of the second reagent holding section 72, etc.

[0125] For example, the tubular body 74 is made of a material harder than the sheet member 45S that forms the second reagent holding portion 72, and is inserted into the supply port 32A. This stabilizes the flow of the second reagent 46. The tubular body 74 and the supply port 32C are formed so that the outer surface of the tubular body 74 and the inner surface of the supply port 32C are in contact. This makes it difficult for the tubular body 74 to shift position when inserted into the supply port 32C. As with the sheet member 45S, any material that is chemically inert to the second reagent 46 can be used for the tubular body 74. Specifically, a film made of a general-purpose resin such as polypropylene, polyethylene, polyethylene terephthalate, or ABS (Acrylonitrile, Butadiene, Styrene) resin can be used. Furthermore, it is even more preferable to use a composite film in which an aluminum layer is added to the resin layer formed of these resins to prevent the permeation of moisture and gas.

[0126] Furthermore, as another example of a second reagent holder with a connecting portion, Figures 11A and 11B show a second reagent holder 76. Figure 11A is a plan view of the second reagent holder 76 as seen from the Z direction, and Figure 11B is a cross-sectional view as seen from the X direction. The second reagent holder 76 also has two sealing portions 76A and 76B, with sealing portion 76A being a weaker sealing portion with less sealing force than sealing portion 76B. A connecting portion 76C is connected to this sealing portion 76A. The connecting portion 76C is part of the second reagent holder 76, has the same width as the second reagent holder 76, and is a portion that extends in the longitudinal direction of the second reagent holder 76.

[0127] With the second reagent holding section 76 housed in the second storage section 32, the connecting section 76C extends from the sealing section 76B toward the supply port 32D and is further inserted into the supply port 32D. The supply port 32D is the same width as the second storage section 32 in the short direction (X direction) of the case body 20 so that the connecting section 76C can be inserted, and is a wider opening compared to the supply port 32A shown in Figure 9.

[0128] By making the connection part 76C part of the second reagent holder, the number of parts is reduced and the second reagent holder can be manufactured at a lower cost compared to when the connection part is a separate component from the second reagent holder. Furthermore, because the connection part 76C is formed to be the same width as the second reagent holder 76 and is inserted into the wider supply port 32D, the second reagent 46 is more easily discharged from the supply port 32D.

[0129] In addition to the connection part 76C, the sealing part 76A may also be inserted into the supply port 32D. Thus, the "sealing part located in the supply port" in this disclosure includes the sealing part 76A inserted into the supply port 32D.

[0130] Furthermore, in this example, a second reagent holding section 45 without a connecting section, as shown in Figure 6A, may be placed in the second storage section 32, which has a wide supply port 32D. In this case as well, the wide supply port 32D allows for easier discharge of the second reagent 46 from the supply port 32D. At this time, the sealing section 45A of the second reagent holding section 45 may be fixed to the bottom surface 32B, or it may be positioned facing the supply port 32D. Thus, the "sealing section positioned at the supply port" in this disclosure includes the sealing section 45A facing the supply port 32D.

[0131] (Effects of the first and second displacement sections) As shown in Figure 6B, in the cartridge 100 of this disclosure, the second reagent holding portion 45 is crushed when pressure is applied, thereby discharging the second reagent 46 to the outside. The cartridge 100 also includes a first displacement portion 12b and a second displacement portion 70 that are displaceable within the case 9.

[0132] The first displacement section 12b has a first pressing surface 12c for pressing the second displacement section 70 against the second reagent holding section 45 by pressing the second displacement section 70 when the second pressing operation section 12, which is a pressing operation section, is operated.

[0133] The second displacement portion 70 is positioned between the first displacement portion 12b and the second reagent holding portion 45, and has a second pressing surface 70C that crushes the second reagent holding portion 45 when pressed by the first pressing surface 12c. As shown in Figure 8, the projected area of ​​this second pressing surface 70C, when viewed from the pressing direction (Z direction) that presses the second reagent holding portion 45, is larger than that of the first pressing surface 12c.

[0134] Here, the size of the first displacement portion 12b, which is closer to the second pressing operation portion 12 (and in this embodiment, integrated with the second pressing operation portion 12), can be relatively small, making it easier to secure the range of motion of the second pressing operation portion 12. On the other hand, the area of ​​the second pressing surface 70C of the second displacement portion 70, which is closer to the second reagent holding portion 45, can be made relatively large.

[0135] In other words, since the size of the first displacement part 12b can be relatively small, it is easy to secure the range of motion of the second pressing operation part 12. Also, since the second pressing surface 70C of the second displacement part 70 can be made relatively wide, it is possible to crush a relatively wide area of ​​the second reagent holding part 45. As a result, it is possible to suppress the residue of the second reagent 46 remaining inside the second reagent holding part 45.

[0136] Furthermore, in the cartridge 100 of this disclosure, in the second reagent holding portion 45, the side with the sealing portion 45A is designated as the first end 45AE, and the end opposite to the sealing portion 45A is designated as the second end 45BE. When the direction connecting the first end 45AE and the second end 45BE is designated as the reference direction (direction along the Y direction), in this reference direction, the width of the second pressing surface 70C is wider than the width of the first pressing surface 12c of the first displacement portion 12b.

[0137] In order to squeeze out the second reagent 46 from the second end 45BE side toward the first end 45AE side where the sealing portion 45A is located, it is preferable that the second reagent holding portion 45 be pressed over a wide area in the reference direction. By making the width of the second pressing surface 70C wider than the width of the first pressing surface 12c in the reference direction, residual liquid of the second reagent 46 is further suppressed. In addition, since the enlargement of the first pressing surface 12c is suppressed, it is easier to secure the range of motion of the second pressing operation portion 12.

[0138] In addition, in the above reference direction, the width of the second pressing surface 70C may be narrower than the width of the first pressing surface 12c of the first displacement part 12b. Even in this case, for example, in the direction intersecting the reference direction (X direction), the width of the second pressing surface 70C may be made wider than the width of the first pressing surface 12c of the first displacement part 12b, so that the projected area of ​​the second pressing surface 70C of the second displacement part 70 is wider than the projected area of ​​the first pressing surface 12c of the first displacement part 12b. If the projected area of ​​the second pressing surface 70C of the second displacement part 70 is formed to be wider than the projected area of ​​the first pressing surface 12c of the first displacement part 12b, then, compared to the case where the projected area is narrower, the effect of suppressing the residue of the second reagent 46 remaining inside the second reagent holding part 45 can be obtained.

[0139] Furthermore, in the cartridge 100 of this disclosure, as shown in Figure 8, the projected area of ​​the second pressing surface 70C is larger than the projected area of ​​the second reagent holding portion 45. Therefore, the second displacement portion 70 can press over the entire area of ​​the second reagent holding portion 45. This further suppresses the residue of the second reagent 46 inside the second reagent holding portion 45.

[0140] Furthermore, in the cartridge 100 of this disclosure, as shown in Figures 6A, 6B, 10A, 10B, 11A, and 11B, in the pressing direction that presses the second reagent holding portion 45, the thickness H2 of the second displacement portion 70 is thinner than the thickness H1 of the first displacement portion 12b. By making the thickness of the second displacement portion 70 thinner in this way, it is easier to secure the range of motion of the second pressing operation portion 12.

[0141] Furthermore, in the cartridge 100 of this disclosure, as shown in Figures 6A, 6B, 10A, 10B, 11A, and 11B, the second pressing operation part 12 and the first displacement part 12b are integrally formed. This reduces the number of parts in the cartridge 100 compared to a configuration in which the second pressing operation part 12 and the first displacement part 12b are made of separate components.

[0142] In the cartridge 100 of this disclosure, as shown in Figures 6A, 6B, 10A, 10B, 11A, and 11B, when the second displacement portion 70 is pressed by the first displacement portion 12b, the second pressing surface 70C evenly presses the second reagent holding portion 45, that is, it presses so that the amount of sinking on the first end portion 45AE side and the second end portion 45BE side are equal. However, the embodiments of this disclosure are not limited to this.

[0143] For example, the second displacement portion of the present disclosure may crush the second end portion 45BE before the first end portion 45AE of the second reagent holding portion 45. An example of such an embodiment is the one shown in Figures 12A and 12B.

[0144] In this embodiment, as shown in Figure 12A, in the reference direction described above, the center of the first displacement portion 12b, indicated by axis CL1, is located closer to the second end portion 45BE than the center of the second displacement portion 70, indicated by axis CL2.

[0145] As a result, as shown in Figure 12B, the second pressing surface 70C crushes the second end 45BE side of the second reagent holding portion 45 before the first end 45AE side. This makes it easier to squeeze the second reagent 46 from the second end 45BE side of the second reagent holding portion 45 towards the sealing portion 45A side. Therefore, residual liquid of the second reagent 46 is suppressed.

[0146] In this way, with a simple configuration that adjusts the relative positional relationship between the first displacement part 12b and the second displacement part 70, the second end 45BE side can be crushed first, and the remaining liquid of the second reagent 46 is suppressed.

[0147] Another example of an embodiment in which the second displacement portion crushes the second end 45BE side of the second reagent holding portion 45 before the first end 45AE side is the embodiment shown in Figures 13A and 13B.

[0148] As shown in Figure 13A, the second displacement portion 82 used in this embodiment has a fixed end 82A on the first end 45AE side and a free end 82B on the second end 45BE side. Therefore, as shown in Figure 13B, when the second displacement portion 82 is pressed by the first displacement portion 12b, the second end 45BE side of the second displacement portion 82 contacts the second reagent holding portion 45 before the first end 45AE side. The second end 45BE side is then crushed before the first end 45AE side.

[0149] The "fixed end" is, for example, an end that is fixed to the inner circumferential surface of the second housing 32 using adhesive or the like, and is an end that will not come off the second housing 32 due to the pressing force acting from the first displacement part 12b. The "free end" is an end that is not fixed anywhere and is a part that can easily move due to the pressing force acting from the first displacement part 12b.

[0150] Thus, since the end 82A on the first end 45AE side of the second displacement part 82 is a fixed end and the end 82B on the second end 45BE side is a free end, the second displacement part 82 can rotate around the end 82A on the first end 45AE side as a pivot point.

[0151] Furthermore, when the second displacement portion 82 is pressed by the first displacement portion 12b, the second end portion 45BE of the second displacement portion 82 contacts the second reagent holding portion 45 before the fixed first end portion 45AE. As a result, the second pressing surface 82C can be crushed from the second end portion 45BE side of the second reagent holding portion 45 first, thereby suppressing residual liquid of the second reagent 46.

[0152] The second displacement portion 82 may be formed from a material that does not undergo or is unlikely to undergo deformation other than rotation of the fixed end when pressed by the first displacement portion 12b, but it is preferable to form it from a deformable material as shown in Figure 13B. This increases the area that crushes the second reagent holding portion 45 compared to when the second displacement portion 82 does not deform. As a result, residual liquid of the second reagent 46 is suppressed.

[0153] In contrast, if the second displacement portion 82 does not deform, after the free end on the second end portion 45BE side has moved to its limit of movement, it becomes difficult to transmit the pressing force to the second reagent holding portion 45. Elastic deformation is preferred for the deformation of the second displacement portion 82. If the second displacement portion 82 undergoes plastic deformation, there is a risk that it may crack. In this case, the broken fragments of the second displacement portion 82 may obstruct the flow of the second reagent 46. Therefore, it is preferable for the second displacement portion 82 to undergo elastic deformation.

[0154] Furthermore, in the cartridge 100 of this disclosure, instead of the second displacement portion 70, a restricting portion 84A that restricts the position of the first displacement portion 12b may be provided, as shown in Figures 14A, 14B, and 14C, as the second displacement portion 84. As shown in Figures 14A and 14B, the restricting portion 84A is a protruding portion that extends from the plate-shaped second displacement portion 84 toward the first displacement portion 12b.

[0155] As shown in Figure 14C, this restricting portion 84A is arranged, for example, so as to surround the first displacement portion 12b and is fixed to the first displacement portion 12b.

[0156] In this way, since the first displacement part 12b is positioned relative to the second displacement part 84, the position in which the first displacement part 12b presses against the second displacement part 84 is stabilized. As a result, even if the pressing method, such as the pressing position and pressing force against the second pressing operation part 12, differs from person to person, the position and posture in which the second displacement part 84 presses against the second reagent holding part 45 are stabilized compared to the case without the regulating part 84A. Consequently, even if the pressing method differs, the effect of suppressing liquid residue can be stably achieved.

[0157] In each of the above embodiments, the first displacement portion 12b is trapezoidal in side view, as shown in Figure 6A, and while maintaining this shape, it presses against the second displacement portion 70, as shown in Figure 6B. However, the embodiments of this disclosure are not limited to this.

[0158] For example, the first displacement portion may have a plurality of protrusions 12d1, 12d2, 12d3, and 12d4, as shown in Figures 15A and 15B, for example, the first displacement portion 12d. As shown in Figure 15A, a gap is formed between each of the protrusions. The first displacement portion 12d formed in this manner deforms so that the gaps between the protrusions open up when the second displacement portion 70 is pressed against it, as shown in Figure 15B.

[0159] In the first displacement portion 12d that deforms in this manner, the first pressing surface is, for example, the pressing surfaces 12e2 and 12e3 that are in contact with the second displacement portion 70 in the initial state before deformation. In this case, the projected area of ​​the first pressing surface is the sum of the areas of the pressing surfaces 12e2 and 12e3.

[0160] (A modified example of a reagent container) The second reagent holding section 45 (see Figure 9), the second reagent holding section 72 (see Figure 10A), and the second reagent holding section 76 (see Figure 11A) shown in the above embodiment are not only sealed bodies having a sealing section that opens before other parts when the internal pressure rises due to the application of pressing force, but are also examples of reagent containers in which reagents are sealed and which discharge the reagent to the outside when crushed. Examples of reagent containers include the following reagent containers.

[0161] The reagent container 79 may be formed in the form of a blister pack, as shown in Figures 16A and 16B. This reagent container 79 comprises a sheet-like base material 79A and an sealing member 79B. Figure 16A is a perspective view of the reagent container 79, and Figure 16B is a cross-sectional view.

[0162] The encapsulating member 79B comprises a bulge 79B1 that functions as an encapsulating space in which the reagent is encapsulated, and a flat portion 79B2 formed around the bulge 79B1 and joined to the base material 79A. The base material 79A functions as a sealing portion.

[0163] When the reagent container 79 is subjected to pressure, the bulge portion 79B1 is crushed. When the bulge portion 79B1 is crushed, the internal pressure of the bulge portion 79B1 increases. As a result, the base material 79A peels off from the bulge portion 79B1 and the reagent container 79 opens. The second reagent 46 is discharged from the sealing portion 78A through this opening. Such a reagent container 79 may be applied to the above embodiment.

[0164] Furthermore, as shown in Figure 16C, the base material 79A may have a notch 79A1 that is more easily broken than other parts. Providing such a notch 79A1 also has the effect of restricting the direction in which the second reagent 46 is discharged.

[0165] Furthermore, the reagent container may be a container formed into a cylindrical shape by blow molding or the like, similar to a toothpaste tube.

[0166] As described above, the user can visually confirm the color development state of the test area L1 through the observation window 18 of the cartridge 100. Furthermore, the color development state of the test area L1 can also be confirmed using an immunochromatographic testing device (hereinafter simply referred to as the testing device), which is not shown in the figures. The testing device detects the color development state of the test area L1 of the loaded cartridge 100, determines whether the sample is positive or negative based on the detected color development state, and presents the result. Some such testing devices are equipped with an internal mechanism that presses a pressing operation part, such as the second pressing operation part 12, when the cartridge 100 is loaded. The internal mechanism consists of an actuator such as a solenoid and a motor, which have movable parts. Thus, the pressing operation part may be operated by an actuator in addition to or instead of a person. The technology of this disclosure is also effective when the pressing operation part is operated by an actuator.

[0167] This disclosure is not limited to the embodiments described above, and may be implemented with appropriate modifications, such as omitting or replacing components, without departing from the spirit of this disclosure.

[0168] The disclosure of Japanese Patent Application No. 2021-054327, filed on 26 March 2021, is incorporated herein by reference in its entirety. All documents, patent applications, and technical standards described herein are incorporated by reference to the same extent as if each individual document, patent application, and technical standard were specifically and individually noted to be incorporated by reference.

Claims

1. A test cartridge used in immunochromatographic testing, A carrier to which the sample and reagent are supplied, A reagent container in which the reagent supplied to the carrier is sealed, the reagent container being crushed to discharge the reagent to the outside, A case for housing the carrier and the reagent container, the case having a pressing operation part that is operated to apply a pressing force to the reagent container, A first displacement part and a second displacement part that are displaceable within the case, It is equipped with, The first displacement portion has a first pressing surface for pressing the second displacement portion against the reagent container when the pressing operation portion is operated, The second displacement portion is positioned between the first displacement portion and the reagent container, and is a second pressing surface that crushes the reagent container when pressed from the first pressing surface, and has a projected area of ​​the second pressing surface that is larger than that of the first pressing surface when viewed from the pressing direction that presses the reagent container. Inspection cartridge.

2. The inspection cartridge according to claim 1, wherein the projected area of ​​the second pressing surface is larger than the projected area of ​​the reagent container.

3. In the pressing direction, the thickness of the second displacement portion is thinner than the thickness of the first displacement portion. The inspection cartridge according to claim 1 or 2.

4. The reagent container has a sealing portion that opens before other parts when the internal pressure increases due to pressure from the second pressing surface. The inspection cartridge according to any one of claims 1 to 3.

5. In the reagent container, when the side with the sealing portion is designated as the first end, the side opposite the sealing portion as the second end, and the direction connecting the first end and the second end is designated as the reference direction, In the aforementioned reference direction, the width of the second pressing surface is wider than the width of the first pressing surface. The inspection cartridge according to claim 4.

6. The second displacement portion is provided such that, when pressed by the first displacement portion, the second pressing surface crushes the second end side before the first end side. The inspection cartridge according to claim 5.

7. In the aforementioned reference direction, the center of the first displacement portion is located closer to the second end than the center of the second displacement portion. The inspection cartridge according to claim 6.

8. The second displacement portion has a fixed end on the first end side and a free end on the second end side. Furthermore, when pressure is applied from the first displacement portion, the second end comes into contact with the reagent container before the first end, thereby crushing the second end before the first end. The inspection cartridge according to claim 6 or 7.

9. The second displacement portion is formed of a deformable material. The inspection cartridge according to claim 8.

10. The inspection cartridge according to any one of claims 4 to 9, wherein the sealing portion is sealed by welding.

11. When the reagent container has a plurality of sealing portions, One of the multiple sealing portions is a weak sealing portion with a weaker sealing force than the other sealing portions. The inspection cartridge according to any one of claims 4 to 10.

12. The inspection cartridge according to any one of claims 1 to 11, wherein the pressing operation part and the first displacement part are formed integrally.

13. The second displacement portion is formed with a restricting portion that restricts the position of the first displacement portion. The inspection cartridge according to claim 9.

14. The reagent container is formed in pillow packaging. The inspection cartridge according to any one of claims 1 to 13.

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