Inspection tool

Abstract

To realize an inspection tool capable of greatly increasing sample volume used for an immuno-chromatography method.SOLUTION: An inspection tool (1) for inspecting a subject contained in a sample by an immuno-chromatography method includes: a test strip (20) having a sample pad (21) for temporarily holding a sample and a membrane (22) for developing a sample held by the sample pad (21) and detecting a subject; and a test strip housing body (10) for housing the test strip (20). The test strip housing body (10) includes: a sample holding container (13) for temporarily holding samples; and an orifice hole (14) that is provided at a bottom section (13L) of the sample holding container (13) and continuously supplies samples held by the sample holding container (13) to the sample pad (21).SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present disclosure relates to a testing device, and more particularly to a testing device for testing an analyte contained in a sample by immunochromatography. [Background technology]

[0002] Immunochromatography is a method for quickly and easily testing minute amounts of a substance in a sample (specimen). In immunochromatography, the immune complex formed by reacting the substance with a labeled antibody or labeled antigen is slowly moved over the membrane of a test strip by capillary action, and the immune complex is trapped (captured) by the antibody or antigen fixed on the membrane, and the substance is tested by utilizing the coloring (based on the coloring pattern or color development pattern) of the accumulated labeled antibody or labeled antigen.

[0003] For the sample to be tested by the immunochromatography method, it is necessary to appropriately select a body fluid (urine, blood, mucus, etc.) that contains a large amount of antigen or antibody to be detected. For example, to detect infection by influenza virus, mucus containing a large amount of viral antigen can be collected from the nasopharynx or nasal cavity to be used as a sample. When collecting mucus from the nasopharynx or nasal cavity, it is necessary to physically collect it with a cotton swab, which is a burden for the patient and also poses a risk of exposure for the collector. When blood is used, blood containing a large amount of antibodies against the AIDS virus can be used as a sample to detect infection by the AIDS virus. When blood is used for the test, it is usually several μL to several hundred μL. However, since blood must be collected by puncturing the skin, it places a large psychological and physical burden on the patient undergoing the blood test.

[0004] On the other hand, when testing for a test substance contained in a large amount in urine, such as human luteinizing hormone (hLH) or human chorionic gonadotropin (hCG), urine is used as a sample. When testing using urine as a sample by immunochromatography, a large amount of sample can be easily obtained, so a method of directly collecting urine with a testing instrument and detecting it has been considered (see, for example, Patent Document 1). [Prior art documents] [Patent documents]

[0005] [Patent Document 1] JP 2011-17689 A Summary of the Invention [Problem to be solved by the invention]

[0006] However, when detecting analytes such as human luteinizing hormone (hLH) and human chorionic gonadotropin (hCG) contained in urine, the analytes are contained in large amounts in urine, so that sufficient detection is possible even if urine is used as a sample. However, when detecting analytes that are usually detected by blood tests, the analytes are hardly contained in urine. For example, whether or not a person is infected with human immunodeficiency virus (HIV) can be determined by examining HIV antibodies in the body, but the concentration of HIV antibodies in urine is about 1 / 5 lower than that in blood. Therefore, when detecting HIV antibodies using urine instead of blood as a sample, the detection sensitivity is insufficient and sufficient detection cannot be achieved with a sample volume of several μL to several hundred μL used in the conventional immunochromatography method.

[0007] On the other hand, it is possible to increase the amount of sample in order to improve the detection sensitivity, but in a test device using a normal immunochromatography method, if the sample amount is increased any further, the sample will overflow beyond the allowable range of capillary action in the membrane. In this case, the test substance in the overflowing sample will not be detected correctly, so even if the sample amount is increased, the detection sensitivity will not improve and appropriate detection will not be possible. In other words, a large amount of sample cannot be processed with a test device using a normal immunochromatography method.

[0008] The present disclosure has been made in consideration of the above points, and an object of the present disclosure is to realize a testing device that can significantly increase the amount of sample to be subjected to testing in immunochromatography. [Means for solving the problem]

[0009] In order to solve the above problems, the present disclosure provides a method for temporarily holding a sample containing a test substance and continuously supplying the sample to a sample pad.

[0010] Specifically, one aspect of the testing instrument disclosed herein is directed to a testing instrument for testing a analyte contained in a sample by immunochromatography, and comprises a sample pad for temporarily holding the sample, a test strip having a membrane for developing the sample held in the sample pad and detecting the analyte, and a test strip storage body for storing the test strip, the test strip storage body having a sample holding container for temporarily holding the sample, and an orifice hole provided at the bottom of the sample holding container for continuously supplying the sample held in the sample holding container to the sample pad.

[0011] According to one aspect of the test instrument, the test strip housing body has a sample holding container and an orifice hole at its bottom, so that even if the amount of sample is significantly increased, a large amount of sample is prevented from being supplied to the sample pad at one time. As a result, the sample is prevented from overflowing beyond the allowable range of capillary action in the membrane. This makes it possible to detect most of the analytes present in the sample, and the detection sensitivity can be improved by the amount of increased sample. Therefore, a test instrument that can significantly increase the amount of sample to be used in the immunochromatography test can be realized.

[0012] In one aspect of the testing device, the bottom of the sample-holding container may be formed in a convex curved surface or a capillary shape toward the sample pad, thereby specifying the shape of the bottom of the sample-holding container.

[0013] In one aspect of the testing instrument, at least a part of the inner shape of the sample-holding container may be tapered toward the bottom, which makes it easier for the sample to flow toward the bottom of the sample-holding container, i.e., makes it easier for the sample to be continuously supplied to the sample pad.

[0014] In one aspect of the testing device, the outer shape of the sample-holding container may be cylindrical or rectangular, thereby improving the strength of the sample-holding container.

[0015] In one aspect of the testing device, the maximum outer dimension of the sample-holding container may be smaller than the width of the test strip housing body. This allows the relationship between the size of the sample-holding container and the size of the test strip housing body to be specified. In this way, the size of the sample-holding container fits within the width of the test strip housing body, reducing the impact on packaging and storage of the testing device.

[0016] In one aspect of the testing instrument, the ratio of the volume of the bottom of the sample-holding container to the capacity of the sample-holding container may be 1:10 to 1:3000. This specifies the volume ratio of the bottom to the sample-holding container (as a whole). If the volume ratio is within the above range, the supply speed of the sample supplied to the sample pad is adjusted.

[0017] In one embodiment of the test tool, the diameter of the orifice hole may be 0.1 mm or more and 2.0 mm or less. This prevents a large amount of sample from being supplied to the sample pad at one time. As a result, the sample is prevented from overflowing beyond the allowable range of capillary action in the membrane.

[0018] In one embodiment of the test instrument, the volume of the sample-holding container may be 1 mL or more. In this way, even if the concentration of the analyte contained is low and the amount of sample used in a typical immunochromatography test is insufficient for sufficient detection, the detection sensitivity can be improved by significantly increasing the amount of sample. Effect of the Invention

[0019] As described above, according to the present disclosure, a test instrument capable of greatly increasing the amount of sample to be used in the immunochromatography test can be realized. With the test instrument of the present disclosure, even when the content of the detected substance in the specimen is small, it can be detected by increasing the amount of sample. Furthermore, when using the test instrument of the present disclosure, urine, which is easier to collect than blood or saliva samples, can be used for detection, resulting in a detection method that is simple and reduces the psychological and physical burden on the subject, as well as preventing secondary infection. [Brief description of the drawings]

[0020] [Figure 1] FIG. 1 is a plan view showing a testing device according to a first embodiment. [Diagram 2] FIG. 1 is a side view showing a testing instrument according to a first embodiment. [Diagram 3]FIG. 2 is an exploded perspective view showing the test instrument according to the first embodiment in an exploded state. [Figure 4] 4 is an enlarged cross-sectional view showing the test device according to the first embodiment taken along the line IV-IV in FIG. [Diagram 5] FIG. 2 is a longitudinal cross-sectional view showing an example of a test strip. [Figure 6] FIG. 5 is an enlarged cross-sectional view showing a test device according to a second embodiment, and corresponds to FIG. [Figure 7] FIG. 11 is a plan view showing a testing device according to a third embodiment, and corresponds to FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] Hereinafter, an examination device according to one embodiment will be described in detail with reference to the drawings. The following description of the preferred embodiment is merely exemplary in nature and is not intended to limit the present invention, its application, or its uses.

[0022] (Embodiment 1) <Testing equipment> 1 to 4 show a test device 1 according to this embodiment. This test device 1 is a test device (test kit) that tests for a analyte (target antigen or target antibody) in a sample by immunochromatography.

[0023] The test device 1 includes a test strip housing body 10 and a test strip 20 (see FIG. 5).

[0024] (Test strip housing body) Test strip housing body (hereinafter also simply referred to as “housing body”) 10 houses test strip 20.

[0025] 1 to 3, the storage body 10 is formed in a flat rectangular parallelepiped shape. The storage body 10 is composed of a front body 11 and a back body 12. As shown in Fig. 4, a storage space S1 capable of storing a test strip 20 is formed in the storage body 10 in which the front body 11 and the back body 12 are assembled.

[0026] The material constituting the housing body 10 (the front body 11 and the back body 12) can be appropriately selected depending on the transparency, opacity, moldability, strength, etc. and the purpose, and may be, for example, a resin material, etc. Also, the materials constituting the front body 11 and the back body 12 may be the same or different.

[0027] Here, in the testing instrument 1, as shown in FIGS. 1 to 4, the storage body 10 (front body 11) has a sample holding container (hereinafter also simply referred to as a “holding container”) 13 and an orifice hole 14.

[0028] As described above, when testing a specimen that is usually present only in trace amounts in a biological sample using the immunochromatography method, it is necessary to significantly increase the amount of sample in order to improve the detection sensitivity. In a typical (conventional) test device using the immunochromatography method, a small amount of sample, such as several μL to several hundred μL, is used for detection. Therefore, if the amount of sample is significantly increased, the speed at which the sample spreads on the membrane 22 described later increases, and the sample overflows beyond the allowable range of the capillary phenomenon in the membrane 22. In this case, the specimen in the overflowing sample is not trapped by the antibody that specifically binds to the specimen described later, and is not detected correctly, so that the detection sensitivity does not improve even if the amount of sample is increased. It is also possible to increase the concentration of the specimen in the sample, but in this case, complicated operations (pretreatment) such as concentration and the associated processes are required. In order to solve the above-mentioned inconveniences at once, the inventors reversed the conventional idea of ​​performing detection with small sample amounts in testing devices using immunochromatography, and came up with a testing device that can significantly increase the amount of sample used for testing, and completed testing device 1 equipped with a holding container 13 and an orifice hole 14.

[0029] (Sample holding vessel) The holding container 13 temporarily holds a sample to be tested. In this specification, temporarily holding a sample means that the sample supplied to the holding container 13 is gradually supplied to the sample pad 21 described below, and remains in the holding container 13 until the entire amount is supplied to the sample pad 21 (sample development time).

[0030] As shown in Figs. 1 to 4, the holding container 13 is provided at one end (left end in Figs. 1 to 4) in the longitudinal direction of the front body 11 so as to protrude outward (upward in Figs. 2 to 4) from the surface of the front body 11. Specifically, as shown in Fig. 4, the holding container 13 overlaps the sample pad 21 in a plan view in a completed state of the testing device 1 (a state in which the front body 11 and the back body 12 are assembled). The bottom surface of the holding container 13 is formed as a curved surface that is convex toward the lower side (back body 12 side) of the surface of the front body 11. The apex of this curved surface is in contact with the sample pad 21. That is, the bottom 13L of the holding container 13 can be said to be a curved portion formed as a curved surface that is convex toward the sample pad 21. The curved portion is provided inside the storage body 10 (inside the storage space S1).

[0031] Here, the volume V of the bottom 13L of the holding container 13 13L and the volume V of the holding vessel 13 13 (the volume ratio of the bottom 13L to the holding container 13, V 13L :V 13 The volume V of the bottom 13L of the holding vessel 13 is preferably 1:10 to 1:3000, and more preferably 1:50 to 1:2000. 13L " refers to the volume of the curved portion located within the storage space S1 in a cross-sectional view as shown in Fig. 4. In addition, when the thickness of the storage body 10 (front body 11) is sufficiently thin, for example, about 1 mm or less, the volume of the curved portion located within the storage body 10 including the top surface (the height position) of the front body 11 as shown by the dotted line in Fig. 4 is the volume V of the bottom 13L of the holding container 13. 13L The capacity of the holding vessel 13 is V 13" refers to the total volume of the holding vessel 13 located in the space S2, and the volume V of the bottom 13L 13L The volume ratio (V 13L :V 13 ) is within the above range, the supply rate of the sample supplied to the sample pad 21 is adjusted to a desired range.

[0032] Capacity V of holding vessel 13 13 The volume V of the holding container 13 is not particularly limited and may be appropriately determined depending on the amount of sample, but is, for example, about 1 mL to 3 mL. 13 If the amount of sample is set to 1 mL or more, the sample can be temporarily held in holding container 13 even if the amount of sample is significantly increased in order to improve detection sensitivity, and it is also possible to replenish the sample with additional sample.

[0033] The holding container 13 (and its bottom 13L) may be formed integrally with the front side main body 11, or may be formed separately (separably) from the front side main body 11. The shape of the holding container 13 is not particularly limited as long as it has a required capacity according to the amount of sample, and examples of the shape include a cylindrical shape, a square tube shape (rectangular parallelepiped shape, etc.), a cone shape, and a shape that is a combination of these shapes. The material constituting the holding container 13 may be the same as or different from the material constituting the storage body 10.

[0034] In the test instrument 1, as shown in Figs. 2 to 4, the external shape (outer shape) of the holding container 13 is formed in a cylindrical shape from the upper part to the middle part, and is formed in an inverted cone shape from the middle part to the lower part (bottom part 13L) continuously from the cylindrical part. The internal shape (inner shape) of the holding container 13 has a similar shape (a shape combining a cylindrical shape and an inverted cone shape) along the external shape. That is, at least a part of the inner shape of the holding container 13, specifically, from the middle part to the lower part (bottom part 13L), is formed in a tapered shape. This makes it easier for the sample to flow toward the bottom part 13L, and makes it easier for the sample to be continuously supplied to the sample pad 21.

[0035] As shown in FIG. 1, the maximum outer dimension of holding container 13 (the outer diameter of the top or open end of holding container 13) is smaller than the width (the dimension in the short side direction (the vertical direction in FIG. 1)) of storage body 10. In other words, holding container 13 fits within the width dimension of storage body 10 and does not protrude, so it is less likely to come into contact with, for example, holding containers 13 adjacent in the width direction or with the hand operating it. This reduces the impact of the size of holding container 13 on packaging, storage, and testing of testing instrument 1, and suppresses inconveniences such as breakage of holding container 13.

[0036] (Orifice hole) The orifice hole 14 continuously supplies the sample temporarily held in the holding container 13 to the sample pad 21 .

[0037] 1 and 4, the orifice hole 14 is formed in the bottom surface (specifically, the apex of the curved surface) of the holding container 13 (its bottom portion 13L). The orifice hole 14 is a through hole that penetrates the bottom surface of the holding container 13 in the thickness direction. That is, the orifice hole 14 communicates between the storage space S1 in the storage body 10 and the space S2 in the holding container 13. The number of orifice holes 14 may be one or more.

[0038] Furthermore, in the completed state of the testing instrument 1, the orifice hole 14 overlaps with the sample pad 21 in a plan view. The open end of the orifice hole 14 on the accommodation space S1 side is in contact with the sample pad 21. As a result, the sample temporarily held in the holding container 13 is continuously supplied (permeates) into the sample pad 21 through the orifice hole 14.

[0039] The spreading speed of the sample on the membrane 22 (flow speed within the membrane, called capillary flow rate) is not particularly limited as long as it is equal to or lower than the allowable spreading speed of the membrane 22, and may be, for example, about 10 to 60 seconds / cm.

[0040] The sample development time (test time) refers to the time from when the sample is supplied to the holding container 13 until the control line 25 described below develops a color. The sample development time may be appropriately determined depending on the type and amount of the sample as well as the types of the sample pad 21 and membrane 22, and is, for example, about 10 to 30 minutes.

[0041] The diameter of the orifice hole 14 can be appropriately changed according to the developing speed of the sample, and is not particularly limited, but is, for example, 0.1 mm to 2.0 mm, preferably 0.1 mm to 0.5 mm. In this way, by setting the diameter of the orifice hole 14 within the above range, the sample temporarily held in the holding container 13 is not supplied to the sample pad 21 all at once, but is supplied gradually (the amount of sample supply is adjusted). As a result, the developing speed of the sample on the membrane 22 is adjusted to be equal to or lower than the allowable developing speed of the membrane 22.

[0042] (others) As shown in Fig. 1 and Fig. 3, a determination window 15 for making the determination result after the test clear at a glance is provided on the holding container 13 side of the longitudinal center of the front body 11. In a completed state of the test device 1, the determination window 15 overlaps a test line 24 and a control line 25 described below in a plan view. The number and shape of the determination windows 15 are not particularly limited and can be appropriately selected depending on the display mode of the determination result. The resin film or the like that covers the determination window 15 is preferably transparent or semi-transparent to facilitate visibility.

[0043] Furthermore, the other end in the longitudinal direction of the front body 11 (the end opposite to the holding container 13 side, the right end in Figs. 1 and 3) is provided with a plurality of air holes 16. When the test device 1 is in a completed state, the air holes 16 overlap with the absorbent pad 26, which will be described later, in a plan view. The number and shape of the air holes 16 are not particularly limited and can be appropriately selected depending on the type of absorbent pad 26, the amount of sample, etc.

[0044] (Test Strips) The test strip 20 is a test sheet for detecting the presence or absence of a specimen in an immunochromatography method. As shown in Figs. 3 to 5, the test strip 20 has a sample pad 21 and a membrane 22. Specifically, the sample pad 21 is disposed at one end (the left end in Figs. 3 to 5) in the longitudinal direction of the membrane 22 formed in a strip shape (sheet shape, rectangular shape). Note that the direction X indicated by the arrow in Figs. 3 and 5 indicates the developing direction of the sample.

[0045] The sample pad 21 is an absorbent member that temporarily holds the sample supplied through the orifice hole 14. The sample pad 21 also absorbs the sample and transports it to the membrane 22. Examples of materials that form the sample pad 21 include nonwoven fabrics. The shape, size, etc. of the sample pad 21 may be appropriately determined depending on the type, amount, etc. of the sample.

[0046] 3 to 5, a conjugate pad 23 is formed, if necessary, below the sample pad 21. The conjugate pad 23 is interposed between the sample pad 21 and the membrane 22. In other words, the conjugate pad 23 and the sample pad 21 are layered in this order on the membrane 22.

[0047] The conjugate is used to label the specimen in the sample held in the sample pad 21. That is, a labeled antibody or a labeled antigen capable of binding to the specimen is provided (immobilized (solid-phased)) in the conjugate pad 23. The material constituting the conjugate pad 23 is appropriately selected according to the type of specimen, and for example, various nonwoven fabrics, glass fibers, etc. are used.

[0048] The antibody in the labeled antibody is not particularly limited as long as it can bind to plasma proteins or other target antigens, and in the case of prealbumin, examples include goat-derived anti-prealbumin antibody, rabbit-derived anti-prealbumin antibody, etc. The antigen in the labeled antigen is not particularly limited as long as it can bind to HIV antibody or other target antibody.

[0049] A labeling substance is bound to the labeled antibody or the labeled antigen. The labeling substance is not particularly limited, and can be selected from those generally used in immunochromatography. Examples of the labeling substance include metal colloids such as gold colloid, platinum colloid, and palladium colloid, and latex particles.

[0050] For example, when using a sample containing a labeled antibody or a labeled antigen bound to the specimen, which has been reacted with the specimen in advance (a sample in which the specimen has been labeled in advance), or when a conjugate bound to a labeling substance (a labeled antibody or a labeled antigen capable of binding to the specimen) or the like is applied in advance to the inner surface of the holding container 13, the conjugate pad 23 does not need to be provided on the test strip 20. In this case, the conjugate pad 23 is not layered on the membrane 22, and only the sample pad 21 is layered.

[0051] The membrane 22 is a spreading layer that spreads the sample (the sample in which the specimen has been labeled in advance by the conjugate pad 23 or the specimen) temporarily held in the sample pad 21. That is, the membrane 22 allows the specimen contained in the sample to move by capillary action. Therefore, the membrane 22 has pores with a pore diameter of about 5 μm to 100 μm so that the specimen does not become clogged. Examples of materials that constitute the membrane 22 include various nonwoven fabrics made of cotton, hemp, silk, cellulose, rock wool, animal hair, nitrocellulose, cellulose acetate, glass fiber, carbon fiber, boron fiber, polyamide, aramid, polyvinyl alcohol, polyvinyl acetate, rayon, polyester, polyacrylic acid, polyacrylic acid ester, polypropylene, polyethylene, polyvinyl chloride, polyvinylidene chloride, etc.

[0052] The membrane 22 detects the analyte in the sample. In order to display the detection result as a colored pattern, a test line 24 and a control line 25 are provided on the membrane 22 in accordance with the position of the determination window 15 of the storage body 10. Based on the colored patterns of the test line 24 and the control line 25, a positive or negative test is performed.

[0053] The test line 24 is formed by immobilizing an antibody that specifically binds to the analyte (hereinafter referred to as "analyte-specific antibody") across the short side direction (width direction, direction perpendicular to the paper surface in FIG. 5) of the membrane 22. As a result, the labeled antibody or labeled antigen that binds to the analyte is trapped (bound) by the analyte-specific antibody and accumulates, causing the test line 24 to develop a color. On the other hand, when the analyte is not bound to the analyte-specific antibody, the test line 24 is not colored and is difficult to visually observe. The test line 24 is located closer to the sample pad 21 than the control line 25.

[0054] The control line 25 is formed by immobilizing an antibody that specifically binds to a labeled antibody or labeled antigen that is not bound to the specimen (hereinafter referred to as a "labeled antibody (labeled antigen) specific antibody") across the width direction of the membrane 22. As a result, the labeled antibody or labeled antigen that is not bound to the specimen is trapped and accumulated by the labeled antibody (labeled antigen) specific antibody, causing the control line 25 to develop a color. On the other hand, when the labeled antibody or labeled antigen is not bound to the labeled antibody (labeled antigen) specific antibody, the control line 25 is not colored and is difficult to visually observe.

[0055] The antibody specific to the labeled antibody may be, for example, an antigen or secondary antibody other than the plasma protein capable of binding to the antibody in the labeled antibody. For example, when prealbumin (target antigen) is used as the plasma protein and a gold colloid-labeled goat-derived anti-prealbumin antibody is used as the labeled antibody, an antibody that specifically binds to the labeled antibody not bound to the plasma protein may be a rabbit-derived anti-goat IgG antibody or the like. When an HIV antibody is used as the labeled antibody, an anti-HIV antibody, a rabbit-derived anti-mouse IgG antibody, an anti-alkaline phosphatase antibody, or the like may be used as the antibody that specifically binds to the labeled antibody not bound to the HIV antigen (target protein).

[0056] The membrane 22 may be composed of a single chromatographic medium, or may have several types of chromatographic media in the development direction (direction X). Examples of the latter include a membrane in which several types of chromatographic media are directly connected to each other, a membrane in which a short chromatographic medium is partially attached to a long chromatographic medium, and a membrane in which several types of chromatographic media are connected to each other by another chromatographic medium.

[0057] In addition, an absorbent pad 26 is laminated on the membrane 22 at the end opposite to the sample pad 21 side (the other end in the longitudinal direction of the membrane 22, the right end in FIG. 5).

[0058] The absorbent pad 26 is for absorbing excess sample that has permeated the membrane 22. The absorbent pad 26 also controls the speed at which the sample develops on the membrane 22. The thickness of the absorbent pad 26 is not particularly limited, but is, for example, 2 cm or more from the viewpoint of sufficiently absorbing excess sample that has permeated the membrane 22 and controlling the speed at which the sample develops on the membrane 22. Examples of materials that constitute the absorbent pad 26 include cellulose filter paper. A desiccant may be added to the absorbent pad 26. The absorbent pad 26 is a member that is provided as necessary, and does not necessarily have to be provided on the test strip 20.

[0059] 3 to 5, in order to support the sample pad 21, the membrane 22, the conjugate pad 23 provided as necessary, the absorbent pad 26, etc., a base sheet 27 may be provided under each of these members 21, 22, 23, 26. Examples of materials constituting the base sheet 27 include nitrocellulose, glass filter, etc.

[0060] Each of the members 21, 22, 23, and 26 constituting the test strip 20 can be appropriately selected according to the type, amount, viscosity, etc. of the sample. Also, the type of antibody or antigen to be immobilized, the type of labeling substance, the material for providing the labeling substance, the arrangement of the antibody or antigen, etc. can be arbitrarily selected according to the type of the test specimen. Also, the test strip 20 can be a commercially available product.

[0061] <Test object> The specimens include, for example, plasma proteins (antigens), HIV antibodies, and other specimens that are hardly contained in urine and are usually detected by blood tests. Plasma proteins refer to proteins that account for about 7% of plasma. Examples of plasma proteins include albumin, prealbumin, globulin, fibrinogen, antithrombin, transferrin, ceruloplasmin, and C-reactive protein (CRP). Currently, HIV virus types are broadly classified into HIV-1 (HIV type 1) and HIV-2 (HIV type 2) based on serological and genetic properties. HIV antibodies include HIV-1 antibodies and HIV-2 antibodies. In addition, human luteinizing hormone (hLH) and human chorionic gonadotropin (hCG), which are contained in large amounts in urine, and substances contained in biological samples other than blood and urine can also be used as specimens. For testing for novel coronavirus infection (COVID-19), the novel coronavirus (SARS-CoV-2) contained in biological samples other than blood can also be used as a specimen.

[0062] <Sample> The sample is not particularly limited as long as it is in a liquid state (liquid specimen), and examples thereof include urine itself, a liquid biological sample such as urine or blood diluted with a liquid generally used for developing the test strip 20 (hereinafter referred to as a "developing liquid"), a sample that becomes liquid through pretreatment such as a stool suspension, a nasal swab, a nasopharyngeal swab, a nasal aspirate, saliva, stool, etc. that have been pretreated with a developing liquid, etc. Examples of the developing liquid include physiological saline, phosphate buffered saline (PBS), Tris buffered saline (TBS), etc.

[0063] Furthermore, the sample may contain an immune complex in which the analyte in the sample is bound to a labeled antibody or a labeled antigen in advance, instead of binding the analyte in the sample to a labeled antibody or a labeled antigen in the conjugate pad 23. In this case, the analyte in the sample may be reacted with the labeled antibody or the labeled antigen in advance when the sample is prepared.

[0064] The viscosity of the sample (liquid sample) containing the test substance can be appropriately changed depending on the type of biological sample, the diameter of the orifice hole 14, etc., and is not particularly limited because it also changes depending on the surface tension of the sample relative to the material of the immunochromatography cartridge, temperature, pressure, etc. For example, the viscosity of the sample can be appropriately adjusted so that the sample can pass through the orifice hole 14 with a diameter of 0.1 mm or more and 2.0 mm or less without applying pressure.

[0065] <Method of testing the substance in the sample by immunochromatography using a test device> Next, a method for testing an analyte in a sample by immunochromatography using the testing device 1 will be described below.

[0066] First, a sample is prepared. At this time, the amount of sample may be appropriately determined depending on the type of sample and the amount (concentration) of the analyte in the sample, but from the viewpoint of improving detection sensitivity, the amount is prepared to, for example, 1 mL or more. From the viewpoint of supplying the sample into the holding container 13 all at once, the upper limit of the sample amount is preferably equal to or less than the capacity of the holding container 13. Note that the sample amount may be an amount exceeding the capacity of the holding container 13 when the amount of the analyte present in the sample is minute and a sample amount greater than the capacity of the holding container 13 is required.

[0067] Next, the sample prepared as described above is supplied to the holding container 13 all at once or in appropriate amounts in several batches. This causes the sample to be temporarily held in the holding container 13. Then, the sample temporarily held in the holding container 13 is continuously supplied to the sample pad 21 through the orifice hole 14 by capillary action.

[0068] The sample continuously supplied to the sample pad 21 passes through the conjugate pad 23 and is developed in the longitudinal direction (direction X) of the membrane 22. When the sample passes through the conjugate pad 23, the analyte in the sample binds to the labeled antibody or labeled antigen immobilized on the conjugate pad 23.

[0069] The sample (including the labeled antibody or labeled antigen bound to the analyte) developed on the membrane 22 moves on the membrane 22 by capillary action. Then, when the sample reaches the test line 24 on the membrane 22, the labeled antibody or labeled antigen bound to the analyte binds to the analyte-specific antibody fixed to the test line 24. As a result, an immune complex of the analyte, the labeled antibody or labeled antigen, and the analyte-specific antibody is formed (accumulated) on the test line 24. As a result, the test line 24 develops a color.

[0070] Furthermore, when the sample moves in the direction X and reaches the control line 25 on the membrane 22, the labeled antibody or labeled antigen that is not bound to the specimen binds to the antibody specific to the labeled antibody (labeled antigen) immobilized on the control line 25. This forms an immune complex between the labeled antibody or labeled antigen that is not bound to the specimen and the antibody specific to the labeled antibody (labeled antigen). As a result, the control line 25 develops a color.

[0071] If necessary, after the sample is developed on the membrane 22, the developing solution may be supplied to the holding container 13.

[0072] Finally, the colored patterns of the test line 24 and the control line 25 after the sample is developed are confirmed, for example, visually. When a substance to be examined in a sample is to be quantitatively analyzed, the color intensity of these colored patterns may be detected, for example, by an immunochromatographic reader. A commercially available immunochromatographic reader may be used.

[0073] By the above operations, the test device 1 can be used to test the analyte in the sample by immunochromatography.

[0074] <Effects> As described above, the test device 1 according to this embodiment can provide the following effects.

[0075] (1) In the test tool 1, the holding container 13 is provided so as to protrude from one end of the storage body 10 (front body 11), and an orifice hole 14 is formed in the bottom 13L of the holding container 13. As a result, even if the amount of sample is significantly increased from the amount of sample used in a normal immunochromatography method, the sample is temporarily held in the holding container 13 while it is continuously supplied to the sample pad 21, and the amount of sample continuously supplied to the sample pad 21 is adjusted by the orifice hole. That is, since the sample moves slowly on the membrane, the inconvenience of the sample overflowing beyond the allowable range of the capillary phenomenon in the membrane is suppressed. As a result, most of the analyte present in the sample (the labeled antibody or labeled antigen bound to the analyte) is trapped by the analyte-specific antibody, and the detection sensitivity is improved by the amount of the increased sample amount. Therefore, the test device 1 can significantly increase the amount of sample used for testing in immunochromatography, and can detect with high sensitivity specimens that cannot be adequately detected using the amount of sample used for testing in conventional immunochromatography due to insufficient detection sensitivity.

[0076] (2) In the testing device 1, the diameter of the orifice hole 14 is set to 0.1 mm or more and 2.0 mm or less so that the development speed of the sample on the membrane 22 falls within a predetermined range. As a result, even if the amount of sample is significantly increased, the inconvenience of the sample overflowing beyond the allowable range of capillary action in the membrane is suppressed.

[0077] (3) In the test device 1, the bottom 13L of the holding container 13 is formed into a convex curved surface toward the sample pad 21, and the volume V 13L and the volume V of the holding vessel 13 13 Ratio to (V 13L :V 13 ) is set to 1:10 to 1:3000, the supply rate of the sample supplied to the sample pad 21 is adjusted to a desired range.

[0078] (Embodiment 2) Next, a second embodiment of the present disclosure will be described. Fig. 6 shows a test tool 2 according to this embodiment. The overall configuration of the test tool 2 is the same as that of the above-mentioned first embodiment, so a detailed description will be omitted here. Also, the same components as those of the above-mentioned first embodiment will be denoted by the same reference numerals and the description thereof will be omitted.

[0079] 6, the test instrument 2 includes a holding container 130 instead of the holding container 13 included in the test instrument 1 according to the above-described first embodiment. Other than that, the test instrument 2 has the same configuration as the test instrument 1. In other words, all of the matters described for the test instrument 1, except for the matters detailed below, also apply to the test instrument 2.

[0080] (Sample holding vessel) Holding container 130, like holding container 13, temporarily holds a sample to be tested, but differs from holding container 13 in its outer shape, bottom shape, etc., as shown in FIG.

[0081] The inner shape of the holding container 130 is tapered from the middle to the lower part (bottom 130L) like the holding container 13. On the other hand, the entire outer shape of the holding container 130 is cylindrical. As a result, in the test instrument 2, the thickness of the part from the middle to the bottom 130L of the holding container 130, i.e., the connection part between the holding container 130 and the housing body 10 (front side body 11) is larger than the thickness of the connection part between the holding container 13 and the housing body 10 (front side body 11) of the test instrument 1. As a result, inconveniences such as breakage of the holding container 130 during packaging or inspection of the test instrument 2 are suppressed. Note that the maximum outer dimension of the holding container 130 (outer diameter in the holding container 130) is smaller than the width of the housing body 10 like the holding container 13.

[0082] The bottom 130L of the holding container 130 is formed in a capillary shape. In other words, the path (flow path) connecting the sample in the holding container 130 and the sample pad 21 is composed of a capillary (thin tube). The capillary is provided inside the storage body 10 (inside the storage space S1). With this configuration, the supply speed of the sample supplied to the sample pad 21 can be further adjusted within a desired range.

[0083] In the test tool 2, the volume V of the bottom 130L of the holding container 130 is 130L and the capacity V of the holding vessel 130 130 (the volume ratio of the bottom 130L to the holding container 130, V 130L :V 130 The volume V of the bottom 130L of the holding vessel 130 is preferably 1:10 to 1:3000, and more preferably 1:50 to 1:2000. 130L " refers to the volume of the capillary located within the storage body 10 in cross-sectional view, as shown by the dotted line in FIG. 6. "Volume V of the holding container 130 130 " is the capacity V of the holding vessel 13 13 " refers to the total volume of the holding container 130 located within the space S2.

[0084] 6, the orifice hole 14 is formed in the bottom 130L of the holding container 130, i.e., in the capillary. That is, the diameter of the orifice hole 14 can be said to be the inner diameter of the capillary or the opening diameter on the sample pad 21 side. The diameter of the orifice hole 14 can be appropriately changed according to the development speed of the sample, similar to the testing instrument 1, and is not particularly limited, for example, from 0.1 mm to 2.0 mm, and preferably from 0.1 mm to 0.5 mm.

[0085] The viscosity of the sample (liquid sample) containing the test substance can be appropriately changed depending on the type of biological sample, the diameter of the orifice hole 14, etc., and is not particularly limited because it also changes depending on the surface tension of the sample relative to the material of the immunochromatography cartridge, temperature, pressure, etc. For example, the viscosity of the sample can be appropriately adjusted so that the sample can pass through the orifice hole 14 with a diameter of 0.1 mm or more and 2.0 mm or less without applying pressure.

[0086] According to the test device 2 according to this embodiment configured as above, in addition to the above-mentioned advantages (1) and (2), the following advantages can be obtained.

[0087] (4) In the test device 2, the bottom 130L of the holding container 130 is formed in a capillary shape, and the volume V 130L and the capacity V of the holding vessel 130 130 Ratio to (V 130L :V 130 ) is set to 1:10 to 1:3000, the supply rate of the sample supplied to the sample pad 21 can be further adjusted to a desired range.

[0088] (5) In the test tool 2, the inner shape of the holding container 130 is tapered from the middle part to the lower part (bottom part 130L), while the outer shape is cylindrical as a whole, so that the connection part between the holding container 130 and the housing body 10 is thick. As a result, problems such as breakage of the holding container 130 are suppressed, and the strength and safety of the test tool 2 itself can be improved.

[0089] (Embodiment 3) Next, a third embodiment of the present disclosure will be described. Fig. 7 shows a test tool 3 according to this embodiment. The overall configuration of the test tool 3 is the same as that of the above-mentioned first embodiment, so a detailed description will be omitted here. Also, the same components as those of the above-mentioned first embodiment will be given the same reference numerals and the description thereof will be omitted.

[0090] 7, the test device 3 is configured in the same manner as the test device 1 according to the above-mentioned embodiment 1, and is arranged in parallel along its longitudinal direction. That is, the test device 3 is equipped with a first test strip 20a and a second test strip 20b. The test device 3 can be suitably used, for example, in an HIV antibody test or the like, when there are two types of test specimens, HIV-1 antibody (first test specimen) and HIV-2 antibody (second test specimen), or when two types of samples are tested simultaneously.

[0091] The storage body 10 is composed of one front body 11 and one back body 12. Both test strips 20a and 20b are stored in the storage space S1 in which the front body 11 and the back body 12 are assembled.

[0092] In addition, in the housing body 10 (front body 11), holding containers 13a and 13b, orifice holes 14a and 14b, determination windows 15a and 15b, and a plurality of air holes 16a and 16b are arranged.

[0093] Test strips 20a and 20b are arranged in parallel along the longitudinal direction and spaced apart from each other.

[0094] The types of sample pads 21a, 21b, membranes 22a, 22b, conjugate pads 23a, 23b, absorbent pads 26a, 26b, etc. in the test strips 20a, 20b may be the same or different. The types of antibodies or antigens immobilized on the test lines 24a, 24b and control lines 25a, 25b in the conjugate pad 23a and the membranes 22a, 22b, the types of labeling substances, materials for providing labeling substances, and the arrangement of antibodies or antigens can be selected arbitrarily according to the type of specimen.

[0095] According to the test device 3 according to this embodiment configured as above, in addition to the above-mentioned advantages (1) to (3), the following advantages can be obtained.

[0096] (6) In the test instrument 3, two holding containers 13a, 13b and two orifice holes 14a, 14b are arranged in the front body 11. Two test strips 20a, 20b are accommodated in the accommodation body 10 according to the positions of the holding containers 13a, 13b and the orifice holes 14a, 14b. As a result, the test time required to test two types of specimens using the same (one type) sample or to test one type of specimen using two types of samples is approximately the same as the test time required to test one type of specimen using one type of sample in the test instrument 1 according to the above-mentioned first embodiment. Therefore, the test time can be shortened.

[0097] (Modification of the third embodiment) In the test tool 3, two test tools configured similarly to the test tool 1 according to the above-mentioned embodiment 1 may be arranged in series in the longitudinal direction. In this case, the number of the holding container 13, the orifice hole 14, the judgment window 15, the test strip 20, etc. may be one. For example, the judgment window 15 and the test strip 20 extend in the longitudinal direction. Then, on the membrane 22, a first test line 24a for detecting the first test substance, a second test line 24b for detecting the second test substance, and at least one control line 25 may be provided in this order in the direction X according to the position of the judgment window 15. In this modified example, the amount of sample required is about half that when the test tool 3 is used for testing.

[0098] (Other embodiments) In the test instruments 1 to 3, the holding containers 13 and 130 are provided so as to protrude from the front body 11, but this is not limiting and they may be provided so as to be recessed into the storage body 10.

[0099] In the test instruments 1 to 3, the holding containers 13, 130 are provided integrally with the storage body 10 (front side body 11), but the present invention is not limited thereto and may be provided separately (separately) from the storage body 10. For example, the orifice hole 14 is provided in the front side body 11 according to the position of the sample pad 21. Then, a through hole for supplying a sample may be formed in the bottom surface of the holding container, and the through hole and the orifice hole 14 may be connected by a tube or the like.

[0100] In the test instruments 1 to 3, in the completed state, the open end of the orifice hole 14 on the storage space S1 side is in contact with the sample pad 21, but is not limited to this. As long as the sample can be continuously supplied (permeated) into the sample pad 21, the open end of the orifice hole 14 does not need to be in contact with the sample pad 21.

[0101] In the test instruments 1 and 3, the outer shape of the holding container 13 is formed into a shape that combines a cylindrical shape and an inverted cone shape, but is not limited to this, and the entire container may be formed into a cylindrical shape or a square tube shape, etc.

[0102] In the test instrument 2, the outer shape of the holding container 130 is formed into a cylindrical shape, but is not limited to this, and may be formed into a shape that combines a cylindrical shape with an inverted cone shape, or the like.

[0103] In the testing device 3, the bottom 13L of the holding container 13 is formed into a curved surface, but is not limited to this and may be formed into a capillary shape. [Industrial Applicability]

[0104] The test device of the present disclosure can be applied to a test device that tests for an analyte contained in a sample by immunochromatography. [Explanation of symbols]

[0105] 1~3 Inspection equipment 10 Test strip housing body 11 Front body 12 Back side body 13, 13a, 13b, 130 Sample holding vessel 13L,130L bottom 14, 14a, 14b Orifice hole 15, 15a, 15b Judgment window 16, 16a, 16b Air holes 20, 20a, 20b Test strips 21, 21a, 21b Sample Pad 22, 22a, 22b Membrane 23, 23a, 23b Conjugate Pad 24, 24a, 24b Test Line 25, 25a, 25b Control Line 26, 26a, 26b Absorbent pads 27 Base sheet

Claims

1. A test device for testing a specimen contained in a sample by an immunochromatography method, a test strip having a sample pad for temporarily holding the sample and a membrane for developing the sample held on the sample pad and detecting the analyte; a test strip housing body that houses the test strip; The test strip housing body includes: a sample holding container for temporarily holding the sample; and an orifice hole provided at the bottom of the sample holding container for continuously supplying the sample held in the sample holding container to the sample pad.

2. 2. The testing device according to claim 1, wherein the bottom of the sample holder is formed into a convex curved surface facing the sample pad.

3. 2. The testing device of claim 1, wherein the bottom of the sample holder is formed in a capillary shape.

4. 2. The testing device according to claim 1, wherein at least a portion of the inner shape of the sample-holding container is tapered toward the bottom.

5. 2. The testing device according to claim 1, wherein the sample holding container has an outer shape of a cylinder or a rectangular tube.

6. 10. The testing device of claim 1, wherein a maximum outer dimension of the sample holder is less than a width of the test strip receiving body.

7. 2. The testing device according to claim 1, wherein a ratio between a volume of the bottom of the sample-holding container and a volume of the sample-holding container is between 1:10 and 1:3000.

8. 2. The inspection tool according to claim 1, wherein the orifice hole has a diameter of 0.1 mm or more and 2.0 mm or less.

9. The testing device of claim 1 , wherein the sample holding vessel has a volume of 1 mL or more.

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