Inspection Equipment

Abstract

To provide an inspection apparatus.SOLUTION: An inspection apparatus employs an amplification reaction solution for amplifying a causative substance in a specimen, a coloring solution containing a substance that develops color in response to the specimen after amplification, and an inspection body for detecting presence or absence of the causative substance by contacting a mixture solution of the specimen and the coloring solution. The inspection apparatus includes: a specimen storage tube; a tank cap detachably attached to an opening of the specimen storage tube; a tube body detachably attached to the other end of the tank cap; and a piston rod press-fitted into the tube body from the other end of the tube body. A sealing film for closing both openings of the tank cap is provided, and a coloring solution is sealed in the tank cap. A holder member having an inspection body is arranged on the tip of the piston rod, the sealing film can be broken through the holder member by press-fitting the piston rod into the tube body, and the inspection body can be freely immersed in the mixture solution.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a testing device for testing target substances such as bacteria and viruses. [Background technology]

[0002] Currently, testing devices are being developed that can easily determine in medical settings whether or not a person is infected with a specific infectious disease. There are various infectious diseases known in the world, such as tuberculosis, HIV (Human Immunodeficiency Virus), malaria, dengue fever, and Zika fever, and the causative bacteria or viruses of these infectious diseases each have a unique genetic structure. Therefore, by using tagged primers that specifically bind to these unique genetic structure parts and reacting them, it is possible to test for the type of infectious disease a person is infected with.

[0003] For example, in the DNA chromatography method, DNA capable of trapping tag DNA that binds to the specific gene structure portion described above is printed on a test strip, and the strip is immersed in a test solution. The reagent is then drawn to the strip by capillary action, and when a reaction occurs with the reagent, the strip turns a specific color, allowing the presence or absence of infection to be visually determined. By adopting this testing method, the presence or absence of causative bacteria or viruses can be determined inexpensively and quickly by anyone on-site, even if they are not a specialized testing institution. In addition, the above-mentioned testing method has the advantage of enabling highly accurate and inexpensive food hygiene testing, as it can determine the presence or absence of food poisoning bacteria.

[0004] Recently, the spread of coronavirus infections has become a problem, and nucleic acid amplification tests such as the Polymerase Chain Reaction (PCR) method and the Loop-Mediated Isothermal Amplification (LAMP) method, which are used to test for the presence or absence of coronavirus infection, have been attracting attention. A LAMP test using general DNA chromatography is carried out according to the procedure shown in Fig. 14. First, DNA extracted from a specimen collected from a subject and a LAMP nucleic acid amplification reaction solution 101 are placed inside a tube 100 that contains the specimen, and a required amount of developing solution 102 is poured into the tube 100 using a dropper 103. Next, a cap 106 is screwed onto a threaded portion 105 around an inlet 104 of the tube 100 to seal the tube 100.

[0005] The sealed tube 100 is then placed in a thermostatic chamber 107 for isothermal amplification to amplify the DNA of the bacteria or virus to be tested. After a predetermined reaction time, the tube 100 is removed from the thermostatic chamber 107, the cap 106 is opened to open the inlet 104 of the tube 100, and a predetermined amount of coloring liquid 109 is added through the inlet 104 using a dropper 108. The coloring liquid is a liquid in which particles that react with the nucleic acid amplification products to be tested, such as coronaviruses, are dispersed in water.

[0006] After adding coloring liquid 109 to nucleic acid amplification reaction liquid 101 after isothermal amplification to prepare mixture 110, a test strip 111 is inserted from inlet 104 of tube 100 and immersed in mixture 110. Since mixture 110 is drawn up into strip 111 by capillary action, when DNA printed on strip 111 reacts with tag DNA in mixture 110, a coloring reaction appears at a predetermined position on strip 111. Depending on the presence or absence of this coloring reaction, it is possible to determine whether or not the nucleic acid amplification reaction liquid 101 after isothermal amplification contains coronavirus.

[0007] Currently, nucleic acid amplification tests such as PCR and LAMP are considered to be the most important testing methods for determining whether or not someone is infected with the coronavirus, and are widely used in Japan and around the world. 14, however, in the LAMP method test using DNA chromatography, it is necessary to seal the tube 100, keep the temperature constant in the thermostatic chamber 107, and then remove the cap 106 again to inject the coloring liquid 109. Therefore, when the cap 106 is removed as shown in FIG. 14(c), droplets or mist containing the amplified nucleic acid contained in the specimen 101 may scatter outside the tube 100, possibly causing contamination of other specimen tubes.

[0008] In this way, if contamination occurs with amplified nucleic acids contained in droplets or mist that have scattered into other sample tubes, there is a serious problem of samples that should actually be determined to be negative being determined to be positive, resulting in a false positive.

[0009] For this reason, it would be desirable to be able to complete the nucleic acid amplification test while keeping the tube sealed once the sample has been placed in the tube; however, currently there is no testing equipment available that allows the nucleic acid amplification test to be completed while keeping the tube sealed.

[0010] Furthermore, as described in Patent Document 1 below, a testing device is known that has a cylindrical body and plunger connected to a tube for holding a specimen, and is configured to sequentially mix a first liquid (bacterial culture liquid) and a second liquid (sterilizing liquid) provided inside the body with the specimen in the tube. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] JP 2011-247757 A Summary of the Invention [Problem to be solved by the invention]

[0012] There is a demand for a testing device that can carry out a nucleic acid amplification test to the end while keeping the tube sealed once a sample has been placed in the tube. However, the testing device described in Patent Document 1 is capable of mixing the first and second liquids while keeping the tube sealed, but does not specifically disclose any other means of carrying out tests, etc. For this reason, when performing a nucleic acid amplification test, it is desirable to provide a testing device that can perform the test to the end while keeping the tube in a sealed state.

[0013] The present invention has been made in light of the above circumstances, and has an object to provide a testing device that can perform a nucleic acid amplification test to the end while keeping the tube in a sealed state. [Means for solving the problem]

[0014] (1) The testing device according to this embodiment is a testing device used for causative substance testing using an amplification reaction liquid for amplifying a causative substance contained in a specimen to be tested, a coloring liquid containing a substance that reacts with the specimen after the causative substance has been amplified and develops a color, and a test body for detecting the presence or absence of the causative substance by contacting a mixture of the specimen after the amplified causative substance and the coloring liquid, and is equipped with a specimen containing tube having a closed front end and an open rear end, a tank cap having one end removably attached to the opening of the specimen containing tube, a tube body having one end removably attached to the other end of the tank cap, and a piston rod press-fitted into the tube body from the other end of the tube body, and the tank cap is provided with an opening on the specimen containing tube side and an opening on the tube body side, respectively. Closed A sealing film is provided, and the coloring liquid is provided inside the tank cap. Enclosed The present invention is characterized in that a holder member equipped with the inspection body is provided on the tip side of the piston rod, the holder member can pierce and break the sealing film by pressing the piston rod into the tube body, and the inspection body can be freely immersed in the mixed liquid.

[0015] (2) In the inspection device according to this embodiment, it is preferable that the tank cap has an opening provided with a sealing film made of a resin film and heat-sealed. The opening of the tank cap can be sealed by the heat-sealed sealing film. If the sealing structure is a heat-sealed sealing film, the sealing structure of the tank cap can be realized simply and easily.

[0016] (3) In the testing device according to this embodiment, it is preferable that the amplification reaction solution is a developing solution for amplifying a gene of the causative substance contained in the specimen.

[0017] (4) In the testing device according to this embodiment, it is preferable that the tube body is made of a transparent tube, and the holder member is capable of accommodating a strip-shaped test object. If the tube body and holder member are transparent, when the test specimen contained in the holder member develops color, the user can easily confirm the color change of the test specimen from outside the tube body.

[0018] (5) In the testing device according to this aspect, it is preferable that a threaded joint is formed at the joint between the sample containing tube and the tank cap, and a threaded joint is formed at the joint between the tank cap and the tube body. If the specimen containing tube, tank cap, and tube body are joined by threaded joints, it is possible to provide a testing device that is easy to assemble. Effect of the Invention

[0019] According to the present invention, a specimen containing tube containing a specimen is sealed with a tank cap, and after constant temperature treatment in a thermostatic bath, a tube body equipped with a piston rod, a holder member and a test object is attached, and the piston rod is pressed to break the sealing film of the tank cap with the holder member, thereby mixing the colored liquid in the tank cap with the specimen to form a mixed liquid, and the test object can be immersed in the mixed liquid. By immersing the test object in the mixed liquid containing the specimen, if the specimen contains a causative agent to be tested such as bacteria or viruses, a colored portion will appear on the test object, making it possible to test for the presence or absence of the causative agent.

[0020] In the testing device according to the present invention, after the specimen containing tube containing the specimen is sealed with a tank cap, the constant temperature treatment, mixing of the coloring liquid, and immersion of the test object can be performed without breaking the sealed state. Therefore, there is no risk of causative substances leaking from the specimen during the test, and the tester does not have to touch the specimen, so the test can be performed in a safe environment. In addition, since no contamination occurs during the test, there is an effect of preventing erroneous tests caused by contamination even when multiple specimen containing tubes are placed next to each other and tested together.

[0021] When a piston is pressed into the tube body and the sealing film is broken with the holder member, the internal pressure within the tube body can be made higher than the internal pressure on the tank cap side and the internal pressure on the specimen containing tube side, so that the coloring liquid contained in the tank cap can be reliably introduced into the specimen containing tube side. As a result, the coloring liquid can be reliably mixed with the specimen after the thermostatic treatment, and the test body can be reliably immersed in the mixed liquid obtained by mixing the coloring liquid with the specimen, thereby providing a testing device capable of highly accurately testing for causative substances contained in the specimen. Furthermore, with the testing device of the present invention, the specimen can be reliably mixed with the coloring liquid by simply pressing the piston and breaking the sealing film with the holder member, and the test object can be immersed in the mixed liquid. This makes it possible to provide a testing device that can safely perform real-time testing with simple operations in medical settings, etc. [Brief description of the drawings]

[0022] [Figure 1] 1 is an exploded side view of an inspection device according to a first embodiment of the present invention. [Diagram 2] FIG. 2 is a side view showing the inspection device in a pre-inspection state. [Diagram 3] FIG. 4 is a side view showing the state of the inspection device after inspection. [Figure 4] The figures show details of the tube and holder provided in the testing device, with (a) being a partial cross-sectional view showing the holder joined to the tube, and (b) being an enlarged cross-sectional view of the holder. [Diagram 5] The diagrams show the steps of a PCR test using this testing device, with (a) being an explanatory diagram showing the state in which the amplification reaction solution is poured into the tube, (b) being an explanatory diagram showing the state in which the tube sealed with a tank cap is placed in a constant temperature bath, and (c) being an explanatory diagram showing the state in which the tube body, holder member, and piston member are attached to the tank cap and the piston member is pressed in. [Figure 6] 13 is an explanatory diagram showing a state in which one sealing film of the tank cap is pierced by a holder member in the inspection device. FIG. [Figure 7] 13 is an explanatory diagram showing a state in which the holder member has pierced the other sealing film of the tank cap in the inspection device. FIG. [Figure 8] 5 shows an inspection device according to a second embodiment of the present invention, in which (a) is a cross-sectional view showing the piston rod in the pushed-in state, (b) is an oblique view showing the piston rod and holder member, (c) is an enlarged oblique view showing the tip of the holder member, and (d) is an oblique view of the end cap. [Figure 9] FIG. 4 is a perspective view showing a connection portion between a piston rod and a pressure plate in the inspection device. [Figure 10] FIG. 2 is a perspective view showing a connection portion between a piston rod and an end cap in the inspection device. [Figure 11] 1 shows the inspection device, where (a) is a cross-sectional view showing the piston rod pulled out, and (b) is a perspective view of the tank cap. [Figure 12]12 is a cross-sectional view showing a connection portion between a piston rod and an end cap in a state in which the piston rod shown in FIG. 11 is pulled out. FIG. [Figure 13] 12 is a cross-sectional view showing a connection portion between a specimen containing tube, a tank cap, and a tube in a state in which the piston rod shown in FIG. 11 is pulled out. FIG. [Figure 14] The figures show an example of a typical LAMP method test in the order of steps, where (a) is an explanatory diagram showing the state in which an amplification reaction solution is poured into a tube, (b) is an explanatory diagram showing the state in which the tube sealed with a cap is placed in a constant temperature bath, (c) is an explanatory diagram showing the state in which a colored solution is poured into the tube after the cap has been removed and it has been opened to keep at a constant temperature to make a mixed solution, and (d) is an explanatory diagram showing the state in which a test substance is poured into the mixed solution through an opening opened by removing the cap. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] "First embodiment" Hereinafter, the present invention will be described in detail based on a first embodiment. 1 and 2, the testing device K1 of the first embodiment has a specimen containing tube 1, a tank cap 2, a tube body 3, and a piston rod 4. Furthermore, sealing films 5 and 6 for closing the opening are provided on both sides of the tank cap 2, an end cap 7 is attached to the end of the tube body 3, and a cylindrical holder member 8 protrudes from the tip side of the piston rod 4. Furthermore, a test object (test paper) E is inserted inside the holder member 8. The shape of the holder member 8 is not important as long as it can freely accommodate the test object E.

[0024] The specimen containing tube 1 is made of a resin tube body having a tapered tip and an opening at the rear end as an insertion port 1a, and a threaded portion 1b is formed on the outer periphery of the rear end. As shown enlarged in FIG. 4, the tank cap 2 has a short resin cylindrical pipe body 2A, a flange-shaped outer tube portion 2B is formed on one end side (the lower end side in FIG. 4), and a threaded portion 2c is formed on the inner periphery side of the outer tube portion 2B. The opening 2b of the outer tube portion 2B is opened so as to be almost flush with the opening 2d on one end side of the pipe body 2A. The outer diameter of the part of the pipe body 2A located inside the outer tube portion 2B is formed to be almost the same as or slightly smaller than the inner diameter of the opening on the inlet side of the sample containing tube 1. The innermost side of the outer tube portion 2B is integrated with the pipe body 2A by the end wall 2D. A seal ring 10 such as a sealing O-ring is housed in the part surrounded by the pipe body 2A, the outer tube portion 2B, and the end wall 2D. The other end side of the pipe body 2A is formed into a pipe shape that is slightly thicker than one end side of the pipe body 2A, and an external thread portion 2E is formed on the other end side of the pipe body 2A, and a seal ring 2F such as an O-ring is extrapolated onto the outer periphery of the base end side of the external thread portion 2E.

[0025] The threaded portion 2c provided on the inside of the outer cylindrical portion 2B is formed to a size that allows it to be screwed onto the threaded portion 1b of the specimen containing tube 1. Therefore, the tank cap 2 can be attached liquid-tight to the opening of the specimen containing tube 1 by screwing the threaded portion 2c onto the threaded portion 1b of the specimen containing tube 1 and pressing the seal ring 10 against the peripheral portion of the insertion port of the specimen containing tube 1. Therefore, the tank cap 2 is detachably connected to the specimen containing tube 1 via the threaded joint S1 shown in FIG. 2, which is composed of the threaded portion 2c and the threaded portion 1b.

[0026] A predetermined amount of coloring liquid C such as latex liquid is contained inside the pipe body 2A, and an opening on one side of the pipe body 2A (the opening on the lower end side in Figure 4(b)) is closed by a sealing film 5, and an opening on the other side of the pipe body 2A (the opening on the upper end side in Figure 4(b)) is closed by a sealing film 6. For this reason, a coloring liquid C is enclosed inside the pipe body 2A. The coloring liquid C is a liquid that can also be called a latex liquid, and an example of the coloring liquid is a suspension in which fine particles that react with the causative substance to be tested and develop color are dispersed in an aqueous solvent. The sealing films 5 and 6 are made of a resin film that can be heat-sealed to the pipe body 2A, such as a PET (polyethylene terephthalate) film, or may be made of a metal film, such as an aluminum foil, that has excellent airtightness.

[0027] The tube body 3 is cylindrical and slightly longer than the specimen storage tube 1, with an internal thread portion 3a formed on one end and an external thread portion 3b formed on the other end. The tube body 3 is made of a transparent resin. The internal thread portion 3a is formed to a size that allows it to be screwed into the external thread portion 2E of the tank cap 2, and an end cap 7 is screwed onto the external thread portion 3b. The end cap 7 has a short cylindrical shape, with an internal thread portion 7a formed on one end thereof and a cylindrical portion 7b, through which a piston rod 4 described below is inserted, formed on the other end thereof. The tube body 3 is screwed into the external thread portion 2E of the tank cap 2 via the internal thread portion 3a, and therefore the tube body 3 is detachably connected to the tank cap 2 via a threaded connection portion S2 consisting of the internal thread portion 3a and the external thread portion 2E.

[0028] The piston rod 4 has an outer diameter that allows the cylindrical portion 10b of the end cap 7 to be inserted therein, and a cylindrical holder member 8 is formed and extends from the tip end of the piston rod 4. A pressure plate 9 is formed at the rear end of the piston rod 4. A seal ring 11 such as an O-ring is attached to the tip of the piston rod 4 so as to surround the circumferential surface of the tip. A circumferential groove (not shown) is formed on the outer periphery of the tip of the piston rod 4, and the seal ring 11 is attached so as to fill this circumferential groove and protrude a predetermined thickness outside the piston rod 4. This seal ring 11 is formed to a thickness that allows it to be elastically pressed against the inner circumferential surface of the tube body 3 when the piston rod 4 is inserted (press-fitted) into the inside of the tube body 3. The length of the piston rod 4 is slightly shorter than the length of the tube main body 3, and the holder member 8 is slightly shorter than the piston rod 4. The holder member 8 is made of, for example, a transparent resin, and is formed into a cylindrical shape having an inner diameter and length capable of accommodating a test object E described below. The use of transparent resin and the cylindrical shape are just one example, and the holder member may have another shape as shown in the example described below, and may be configured separately from the piston rod 4.

[0029] The test piece (test paper) E is a substrate such as paper on which a substance that reacts with a target causative substance and changes color when testing is performed using the testing device K1 of this embodiment is printed. The test piece E is formed into a long, thin strip that can be stored in the holder member 8. If the testing equipment K1 of this embodiment is used for nucleic acid amplification testing for coronaviruses, the test object E can be an STH-PAS, which is well-known as a visual assessment test strip (PAS: Printed Array-Strip) applied to the STH method (Single-stranded Tag Hybridization).

[0030] This test element E, for example, takes advantage of the fact that there is a genetic structural portion specific to coronaviruses, and prints and arranges DNA on a paper substrate that can trap and color tagged primers (primers that specifically bind to genes and tag DNA that serves as a marker) that bind to this genetic structural portion. When a reagent is immersed in this test element E, the reagent can be pulled up along the paper substrate by capillary action, and if a reaction occurs in response to the presence of the above-mentioned tag DNA, it will turn blue or other color, allowing a visual determination.

[0031] The testing device K1 of this embodiment is not limited to the above-mentioned nucleic acid amplification test, and in the medical field, it can be widely applied to testing (detecting) causative agents such as tuberculosis bacteria, malaria, dengue fever, diarrhea-causing bacteria, HPV (Human Papilloma Virus), HIV (Human Immunodeficiency Virus), hepatitis virus, avian influenza virus, sexually transmitted diseases, sepsis, oral infections, and various pathogenic bacteria. In the food testing field, it can be widely applied to testing food poisoning bacteria, aquaculture disease bacteria, etc. In addition, it may be applied to the testing of livestock meat and agricultural products, food management applications, GMOs (genetically modified foods) for product hygiene management and quality control in factories, food allergens, halal testing, etc. By using an amplification reaction solution, a staining solution (developing solution) C, and a test object E, which will be described later, according to each application, the testing device K1 of this embodiment can be applied to any of the above-mentioned testing applications.

[0032] FIG. 2 shows the inspection device K1 of this embodiment in a pre-inspection state, and FIG. 3 shows the inspection device K1 in a post-inspection state. In the pre-inspection state shown in Figure 2, the piston rod 4 is inserted into the tube body 3 with the holder member 8 first, but most of the rear end of the piston rod 4 protrudes outside the tube body 3. In the post-inspection state shown in FIG. 3, the piston rod 4 is inserted deeply into the tube body 3 and the holder member 8 is inserted deeply into the inside of the specimen containing tube 1. The post-inspection state shown in Figure 3 shows the state in which the piston rod 4 is pushed in until the pressure plate 9 abuts against the end cap 7, and in this state the tip of the holder member 8 is inserted close to the tip of the specimen containing tube 1.

[0033] The inspection method according to the LAMP method using the inspection device K1 according to this embodiment will be described below with reference to FIG. A sample A of nucleic acid extracted from a subject's nasopharyngeal swab or saliva is collected, and as shown in FIG. 5(a), the tank cap 2 is removed to open the inlet 1a, and the sample A is poured into the specimen holding tube 1 which is placed upright. Next, a specified amount of amplification reaction solution B is poured in using a dropper 12. After the amplification reaction solution B is poured in, the threaded portion 2c of the tank cap 2 is screwed into the threaded portion 1b of the specimen holding tube 1 to seal the specimen holding tube 1. As shown in Fig. 4, a seal ring 10 is provided on the inner side of the threaded portion 2c, so that by screwing the threaded portion 2c of the tank cap 2 into the threaded portion 1b of the specimen holding tube 1, the seal ring 10 can be pressed against the periphery of the insertion port of the specimen holding tube 1. The opening of the tank cap 2 is closed with sealing films 5 and 6, so that by screwing the tank cap 2 into the specimen holding tube 1, the specimen holding tube 1 can be sealed.

[0034] If the opening of the tank cap 2 is closed by the heat-sealed sealing films 5, 6, the tank cap 2 can be completely sealed, and there will be no leakage of the coloring liquid (developing liquid) C. Furthermore, if the specimen holding tube 1 is sealed by screwing the tank cap 2 having a sealing structure with the heat-sealed sealing films 5, 6, the specimen holding tube 1 can be simply and easily sealed.

[0035] As shown in FIG. 5(b), the sealed sample-containing tube 1 is placed in a thermostatic chamber (isothermal amplifier) ​​13 and kept at a desired temperature for a predetermined period of time, and the nucleic acid of causative substances such as viruses or bacteria that may be contained in the sample 1 is amplified by the LAMP method.

[0036] After a predetermined time of constant temperature treatment, the specimen containing tube 1 is held vertically as shown in FIG. 5(c), and the tube body 3 equipped with the holder member 8 and the piston rod 4 is screwed to the tank cap 2. The tank cap 2 has an outer threaded portion 2E at its upper end, and the tube body 3 can be screwed to the tank cap 2 by screwing the inner threaded portion 3a of the tube body 3 to the outer threaded portion 2E. When screwing the tube body 3, only the tip side of the piston rod 4 is inserted into the tube body 3, and the rear end side of the piston rod 4 is protruding outside the tube body 3. In addition, the specimen E required for the test is inserted inside the holder member 8, and the holder member 8 is positioned so that the entire holder member 8 is accommodated inside the tube body 3. This state is the pre-inspection state shown in FIG.

[0037] Next, while holding the specimen containing tube 1 vertically, the piston rod 4 is pushed down to lower the holder member 8 inside the tube body 3. As the piston rod 4 descends, the seal ring 11 moves while being pressed against the inner peripheral surface of the tube body 3, so that the movement of the piston rod 4 compresses the air in the tube body 3, and the internal pressure of the tube body 3 can be increased.

[0038] As the holder member 8 descends, the tip of the holder member 8 first penetrates and breaks the sealing film 6 as shown in Fig. 6. In the state in which the sealing film 6 has been penetrated and broken, the internal space of the tube body 3 and the internal space of the tank cap 2 are both in a positive pressure state, so the coloring liquid C contained inside the tank cap 2 does not flow back into the tube body 3 or splash out, and does not move.

[0039] 7, as the holder member 8 descends, the tip of the holder member 8 penetrates and breaks the sealing film 5. In this state, the internal pressures of the tube body 3 and the tank cap 2 are higher than the internal pressure of the specimen containing tube 1, and so these pressures are released to the specimen containing tube 1 side. As a result, the coloring liquid (developing liquid) C contained in the tank cap 2 spurts out or flows toward the inside of the specimen containing tube 1. As a result, the coloring liquid (developing liquid) C is reliably mixed with the specimen A and the amplification reaction liquid B' after the thermostatic treatment, and the mixed liquid D shown in FIG. 5 can be obtained.

[0040] Fig. 3 shows a state in which the piston rod 4 has been further advanced from the state shown in Fig. 7 to insert the holder member 8 deep inside the specimen containing tube 1. Fig. 3 shows the state after testing, in which the test specimen E contained in the holder member 8 can be securely immersed in the mixed liquid D. If the specimen A contains a specified amount of coronavirus, the tag DNA imparted by the coloring liquid C can be trapped, and multiple particles containing DNA that exhibit color are arranged on the test specimen D by a method such as printing, so that if the printed state is a line-shaped print, for example, a colored line such as blue will appear. By checking for the presence or absence of this line, the user can easily visually determine whether or not sample A contains coronavirus nucleic acid.

[0041] If the testing device K1 having the above configuration is used, once the specimen A is contained in the specimen holding tube 1, the specimen holding tube 1 can be tested while being kept sealed by the tank cap 2 or the tank cap 2, the tube body 3, and the piston rod 4 until the end of the test. Therefore, even if a large number of specimen holding tubes 1 containing specimens from different patients are arranged and a LAPM test is performed, there will be no contamination of amplified nucleic acids between the many specimens. Therefore, contamination of nucleic acids extracted from coronaviruses or amplified nucleic acids will not cause false positive judgments in the LAMP test.

[0042] By using the testing device K1 having the above configuration, it is possible to easily, safely, and accurately perform LAMP testing at a medical facility without having to request sample testing from a specialized testing organization. Therefore, according to this embodiment, it is possible to provide a testing device K1 that can contribute to the implementation of PCR testing at medical facilities, etc.

[0043] As described above, the testing device K1 having the above configuration can be widely applied to testing for causative agents such as tuberculosis bacteria, malaria, dengue fever, diarrhea-causing bacteria, HPV, HIV, hepatitis virus, avian influenza virus, sexually transmitted diseases, sepsis, oral infections, and various pathogens, by appropriately changing the combination of the amplification reaction solution B, the coloring solution C, and the test object E. Furthermore, the testing device K1 having the above configuration can be applied to testing for food poisoning bacteria, aquaculture disease bacteria, etc. in the food testing field, testing livestock meat and agricultural products, food management applications, and testing GMOs (genetically modified foods), allergens, and halal for product hygiene management and quality control in factories, etc. Therefore, by using the testing device K1 having the above-described configuration, various tests for these applications can be performed easily, safely, and accurately at various sites such as medical institutions, without having to request sample testing from a specialized testing institution.

[0044] In the inspection device K1, the tube body 3 is made of a transparent resin, and the holder member 8 is also made of a transparent resin, so that the colored state of the inspection object E can be easily and accurately confirmed from the outside of the tube body 3. Furthermore, since the tube body 3 is made of transparent resin, it is easy to confirm the position of the holder member 8 moving inside it, and when the piston rod 4 is inserted deep inside the tube body 3, it is easy to visually confirm whether the test specimen E contained in the holder member 8 is securely immersed in the mixed liquid. When the piston rod 4 is pushed into the tube body 3 until the pressure plate 9 formed on the outer end of the piston rod 4 hits the end cap 7, it can be recognized that the entire test piece E contained in the holder member 8 has been reliably immersed in the mixed liquid D. Therefore, it can be grasped that the entire test piece E has been reliably immersed in the specimen A by the abutment of the pressure plate 9 and the end cap 7.

[0045] Incidentally, in the inspection device K1 of the embodiment described above, both the tube body 3 and the holder member 8 are made of transparent materials so that the user can visually recognize the colored portion displayed on the inspection object E. However, since it is sufficient for the tube main body 3 and the holder member 8 to be able to view only the colored portion of the inspection object E from the outside, they may be made of two-color molded resin in which only a portion of the tube main body 3 and a portion of the holder member 8 corresponding to the outside of the colored portion of the inspection object E are transparent, and the other portions are opaque. Alternatively, only a portion of the tube main body 3 and a portion of the holder member 8 corresponding to the outside of the colored portion of the inspection object E may be provided with a transparent window, and the other portions may be made of opaque resin.

[0046] "Second embodiment" Figures 8 to 13 show an inspection device K2 according to a second embodiment of the present invention. The inspection device K2 of the second embodiment, the overall structure of which is shown in Figure 8(a), also has a sample containing tube 1, a tank cap 2, a tube main body 3, and a piston rod 4, similar to the inspection device K1 of the first embodiment. Sealing films 5 and 6 for closing the opening are provided on both sides of the tank cap 2, an end cap 7 is attached to the end of the tube body 3, and a holder member 8 protrudes from the tip side of the piston rod 4. The configuration in which a test body (test paper) E is inserted inside the holder member 8 is also the same as in the first embodiment. As shown in Figures 8(b), (c), and (d), the inspection equipment K2 of the second embodiment has some differences in the shapes of the piston rod 4, end cap 7, and holder member 8, but the other configurations are the same as those of the inspection equipment K1 of the first embodiment, so the following description will focus on the different parts of the configuration.

[0047] In the inspection device K2 of the second embodiment, the piston rod 4 has a cylindrical portion 4B on the tip side of a rectangular plate-shaped main body portion 4A, and a holder member 8 having a U-shaped cross section is integrated with the tip of the cylindrical portion 4B. A sharp portion 8a is formed at the tip of the holder member 8 by cutting the tip obliquely. This sharp portion 8a is formed so that it can easily penetrate the sealing films 5, 6 when the piston rod 4 is advanced to break the sealing films 5, 6 of the tank cap 2 with the sharp portion 8a. The holder member 8 of the second embodiment is formed from a non-transparent resin. In the piston rod 4, reinforcing ribs 4C are formed in the center of both sides of the main body 4A so as to extend from the base end side to near the tip end of the piston rod 4. The tip side of this reinforcing rib 4C is an arm portion 4D that is separated from the main body 4A, and a hook-shaped locking claw 4E is formed at the tip of the arm portion 4D. 8(a), a recess 3E capable of accommodating the locking claw 4E is formed on the inner surface of the tube body 3 where the locking claw 4E is located when the entire piston rod 4 is inserted into the tube body 3. By inserting the locking claw 4E into this recess 3E, the piston rod 4 is inserted completely into the tube body 3, and the piston rod 4 is lightly locked. When the piston rod 4 is pulled out of the tube body 3 as shown in Figures 11 and 12, the locking claw 4E is locked to the inner peripheral part of the end cap 7, and serves as a locking member to prevent it from coming off.

[0048] The piston rod 4 is inserted through the end cap 7 which is screwed to the tube body 3, and a key groove 7d is formed on part of the inner circumference of the cylindrical portion 7b of the end cap 7. In addition, a lock protrusion 4F is formed on the base end side of the reinforcing rib 4C of the piston rod 4, in a portion close to the pressing plate 9. The distance d (see Fig. 8(b), Fig. 9, etc.) between the locking protrusion 4F and the pressure plate 9 is formed to be slightly larger than the thickness of the cylindrical portion 7b of the end cap 7. For this reason, when the piston rod 4 is rotated slightly circumferentially in a state where the pressure plate 9 is in contact with the end cap 7 as shown in Fig. 8(a) and Fig. 10, and the locking protrusion 4F is placed in a position disengaged from the key groove 7d, the locking protrusion 4F comes into contact with the cylindrical portion 7b of the end cap 7, preventing the piston rod 4 from coming out.

[0049] The inspection device K2 of the second embodiment is used in the same manner as the inspection device K1 of the first embodiment. That is, the inspection object E is accommodated in the holder member 8, and the piston rod 4 is pushed down from the state shown in Fig. 11 to break through the sealing films 5 and 6 with the holder member 8, and the inspection object E is inserted into the specimen containing tube 1. By immersing the inspection object E in the specimen A, it can be used for various inspections in the same manner as the first embodiment described above.

[0050] In order to make the display of the test object E easier to see after immersing the test object E in the specimen A, it is desirable to pull up the piston rod 4 as shown in Fig. 11 to position the test object E easily visible through the tube body 3. In this case, as shown in Figs. 11 and 12, the locking claw 4E hooks onto the inner circumference of the end cap 7, preventing the piston rod 4 from coming out. When the piston rod 4 is pulled out, the test object E including the specimen A is pulled out toward the tube body 3. However, if the test object E is exposed to the outside of the tube body 3, there is a risk that the specimen A will come out, so it is preferable for the piston rod 4 to have a function of preventing it from coming out as described above.

[0051] When the piston rod 4 is pushed into the tube body 3, the sealing films 6, 5 are successively broken by the holder member 8 while increasing the internal pressure, and the test specimen E is immersed in the specimen A, since the internal pressure is increasing on the side ahead of the piston rod 4, it is conceivable that when the finger is removed from the pressure plate 9, the internal pressure will push back the piston rod 4, causing the test specimen E to separate from the specimen A. When immersing the test specimen E in the specimen A, it is necessary to reliably immerse the test specimen E in the specimen A for a certain period of time.

[0052] To address this issue, the piston rod 4 is rotated slightly in a circumferential direction while the pressure plate 9 is in contact with the end cap 7, as shown in Figures 8(a) and 10. This rotation operation shifts the locking protrusion 4F to a position where it is removed from the key groove 7d, and the cylindrical portion 7b of the end cap 7 holds down the locking protrusion 4F, preventing the piston rod 4 from being pushed back. After immersion for a certain period of time, the piston rod 4 is rotated again in the opposite direction to align the key groove 7d with the lock protrusion 4F, whereby the piston rod 4 can be pulled back. When the piston rod 4 is returned and the test object E is returned to the tube main body 3 side, the test object E can be easily visually confirmed, so that the test result can be easily understood. Regarding other operational effects, the inspection device K2 of the second embodiment can obtain operational effects similar to those of the inspection device K1 of the first embodiment.

[0053] Incidentally, in the testing devices K1 and K2 of the first and second embodiments described above, sealing films 5 and 6 are provided on both sides of the tank cap 2, but the sealing film 5 may be provided only on the opening of the tank cap 2 facing the sample containing tube, and the sealing film 6 may be omitted. By providing a sealing film 5 that separates the tank cap 2 and the sample containing tube 1, the testing devices K1 and K2 according to the present invention can achieve their objects. Also, the tank cap 2 may be filled with coloring liquid in advance, or only the sealing film 5 may be provided, and the coloring liquid may be poured into the tank cap 2 before the inspection, and then the piston rod 4 may be inserted into the tube body 3 and used for the inspection. [Explanation of symbols]

[0054] A...sample, A'...sample after amplified, B...amplification reaction solution, C...staining solution (developing solution), D...mixed solution, E...test body, K1, K2...testing equipment, 1...sample containing tube, 1a...inlet, 2...tank cap, 2A...pipe main body, 2B...outer cylinder portion, 2c...threaded portion, 2E...external threaded portion, 3...tube main body, 3a...internal threaded portion, 3b...external threaded portion, 4...piston rod, 5...sealing film, 6...sealing film, 7...end cap, 8...holder member, 10...sealing ring, 11...sealing ring, S1, S2...screw connection portion.

Claims

1. The testing device is used for causative substance testing using an amplification reaction solution for amplifying a causative substance to be tested contained in a specimen, a coloring solution containing a substance that reacts with the specimen after the causative substance has been amplified and develops a color, and a test body that contacts a mixture of the specimen after the amplified causative substance and the coloring solution to detect the presence or absence of the causative substance, The apparatus comprises a specimen containing tube having a closed front end and an open rear end, a tank cap having one end removably attached to the opening of the specimen containing tube, a tube body having one end removably attached to the other end of the tank cap, and a piston rod press-fitted into the tube body from the other end of the tube body, The tank cap is provided with sealing films for closing the specimen containing tube side opening and the tube body side opening, and the coloring liquid is sealed inside the tank cap. a holder member having the inspection body provided on the tip side of the piston rod; An inspection device characterized in that the sealing film can be pierced and broken by the holder member when the piston rod is pressed into the tube body, and the inspection body can be freely immersed in the mixed liquid.

2. 2. The inspection device according to claim 1, further comprising a sealing film made of a resin film and heat-sealed to the opening of the tank cap.

3. 3. The testing device according to claim 1, wherein the amplification reaction solution is a developing solution for amplifying a gene of the causative substance contained in the specimen.

4. 4. The inspection device according to claim 1, wherein the tube body is made of a transparent tube, and the holder member is capable of accommodating a strip-shaped inspection object.

5. The testing device according to any one of claims 1 to 4, characterized in that a threaded connection is formed at the connection between the sample containing tube and the tank cap, and a threaded connection is formed at the connection between the tank cap and the tube body.

Images