Nucleic acid test device and use thereof

Abstract

Provided are a test device capable of more easily and quickly detecting a target nucleic acid, and a use thereof. A nucleic acid test device (2) is provided with: a first chamber (20) in which a chromatography carrier (50) for performing chromatography analysis on nucleic acid is accommodated; and a second chamber (30) capable of accommodating a liquid containing a component for a nucleic acid amplification reaction of a target nucleic acid derived from a sample, the first chamber (20) and the second chamber (30) being formed so that the liquid of the second chamber (30) can be conveyed to the first chamber (20) by an external operation, and the liquid of the second chamber (30) can be supplied to a development base of the chromatography carrier (50) of the first chamber (20).

Description

Technical Field

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority based on Japanese patent application No. 2023-14388 filed on February 2, 2023, the contents of which are incorporated herein by reference as a part of this specification. This specification relates to a nucleic acid testing device, a testing kit, etc. for detecting a target nucleic acid such as a target gene. Background Art

[0002] In order to detect a specific gene related to an infection, disease, etc. in a sample as a target nucleic acid, a nucleic acid amplification product amplified in association with the target nucleic acid is prepared, the nucleic acid amplification product is labeled, and the labeled nucleic acid amplification product is captured and detected by hybridization. As an apparatus for realizing such detection, for example, there is a device that detects the labeled nucleic acid amplification product by moving a probe that captures the labeled nucleic acid amplification product on a strip that is pre-fixed at a given position (e.g., Patent Document 1).

[0003] The device described in Patent Document 1 includes: a tube that contains an amplification reaction solution containing a labeled nucleic acid amplification product; and a piston rod that pushes a strip held in the tube so as to be immersed in the amplification reaction solution in the tube. Prior Art Literature Patent Literature

[0004] Patent Document 1: Japanese Patent Application Publication No. 2022-83347 Summary of the invention Technical problem to be solved by the invention

[0005] In the device described in Patent Document 1, the band is housed in a member different from the tube, and during inspection, the piston rod holding the band needs to be pushed into the tube. In addition, the piston rod needs to be mounted on the tube.

[0006] Depending on the inspection implementation environment such as when the number of samples is large and the inspection operator's operational level, there may be a case where it is desirable to avoid the operation of attaching or pressing the piston rod to each tube.

[0007] The present invention provides an inspection device capable of detecting a target nucleic acid more simply and rapidly and its use.

[0008] The present inventors intend to realize a device capable of implementing operations such as preparation of amplification products of a nucleic acid amplification reaction based on a target nucleic acid and development of a developing solution based on a chromatographic analysis on a strip in a closed device. The present inventors have conducted in-depth research and have obtained the following insights: a plurality of chambers are isolated in a manner that allows liquids to be connected by external operations, and a nucleic acid amplification reaction solution and a strip are respectively provided in the plurality of chambers, thereby enabling the process of nucleic acid chromatographic analysis to be easily realized. Based on such insights, the disclosure of this specification provides the following scheme.

[0009] [1] A device, which is a nucleic acid testing device, comprising: A first chamber that houses a chromatography carrier for performing chromatography analysis on nucleic acids; and a second chamber capable of containing a liquid containing components for a nucleic acid amplification reaction of a target nucleic acid derived from a sample, The first chamber and the second chamber are formed so that the liquid in the second chamber can be transferred to the first chamber by an external operation, and the liquid in the second chamber can be supplied to the development base of the chromatography carrier of the first chamber. [2] The device according to [1], wherein at least a portion of the second chamber is plastically deformable or elastically deformable and is formed so as to be able to transport the liquid in the second chamber to the first chamber through a deformation action on the second chamber. [3] The device according to [2], wherein a gate is provided between the first chamber and the second chamber, and the gate can allow liquid to communicate by deforming the second chamber. [4] A device, which is a nucleic acid testing device, comprising: A first chamber that houses a chromatography carrier for performing chromatography analysis on nucleic acids; a second chamber capable of containing a liquid containing components for a nucleic acid amplification reaction of a target nucleic acid derived from a sample; and a third chamber capable of receiving the liquid delivered to the second chamber, At least a portion of the third chamber is capable of plastic deformation or elastic deformation, and the third chamber and the second chamber are formed so that the liquid in the third chamber can be transported to the second chamber by a deformation action on the third chamber, and are formed so that a mixed liquid of at least a portion of the liquid in the second chamber and at least a portion of the liquid in the third chamber can be supplied to the deployment base. [5] The device according to [4] comprises the first chamber, the second chamber, and the third chamber connected in series in sequence. [6] The device according to [5], wherein a gate is provided between the first chamber and the second chamber and between the second chamber and the third chamber, respectively, and the gate can allow liquid to communicate by deforming the third chamber. [7] The device according to any one of [1] to [6], wherein the nucleic acid amplification reaction is an isothermal nucleic acid amplification reaction. [8] A container for use in the nucleic acid testing device according to any one of [1] to [3], comprising: a first chamber capable of housing the chromatographic carrier for chromatographic analysis of nucleic acids; A second chamber capable of containing the liquid containing components for a nucleic acid amplification reaction of a target nucleic acid derived from a sample, and at least a portion of which is plastically deformable or elastically deformable; and The gate is between the first chamber and the second chamber and can establish fluid communication by deforming the second chamber. [9] A nucleic acid testing kit comprising: [8] the container; The chromatographic carrier is in a state of being accommodated in the first chamber or not accommodated in the first chamber; and The liquid is in a state of being contained in the second chamber or not contained in the second chamber, and contains a component used for a nucleic acid amplification reaction of a target nucleic acid.

[10] A container for use in the nucleic acid testing device according to any one of [4] to [6], comprising: The first chamber contains the chromatography carrier for performing chromatography analysis on nucleic acid; the second chamber capable of containing the liquid containing components for a nucleic acid amplification reaction of a target nucleic acid derived from a sample; The third chamber is capable of receiving the liquid delivered to the second chamber, and at least a portion of the third chamber is capable of plastic deformation or elastic deformation; and The gates are respectively located between the first chamber and the second chamber and between the second chamber and the third chamber, and can allow liquid to communicate by deforming the third chamber.

[11] A nucleic acid testing kit comprising:

[10] The container; The chromatographic carrier is in a state of being accommodated in the first chamber or not accommodated in the first chamber; and The liquid is in a state of being contained in the second chamber or not contained in the second chamber, and contains a component used for a nucleic acid amplification reaction of a target nucleic acid derived from a sample.

[12] A method for testing nucleic acid, Using the nucleic acid testing device described in any one of [1] to [6], A step of performing a nucleic acid amplification reaction; and A step of supplying a liquid containing an amplification reaction product generated in the second chamber to a developing base of the chromatography carrier in the first chamber to perform chromatography analysis.

[13] According to the method described in

[12] , the nucleic acid amplification reaction is an isothermal nucleic acid amplification reaction. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 This is a diagram showing a plan view of an example of the device according to the embodiment in combination with a plan view of a cover and a tray. Figure 2 This is a diagram showing an exploded view of the device as a cross-sectional view. Figure 3 It is a diagram showing the gate 26 in an enlarged manner. Figure 4 This is a diagram showing an example of an inspection process using the device. Figure 5 This is a diagram showing an example of a detection signal of a target nucleic acid on a chromatographic carrier after inspection. Figure 6 This is a diagram showing another embodiment in which the cover 14 of the device 2 is formed as a flexible film. Figure 7 This is a diagram showing another embodiment in which the tray 4 and the cover 14 are formed of flexible films in the device 2 . Figure 8 This is a diagram showing another embodiment in which the arrangement of the second chamber 30 and the third chamber 40 is changed in the device 2 . Fig. 9 This is a diagram showing another embodiment in which the second chamber is made plastically deformable and the third chamber is omitted in the device 2 . Fig.10 This is a diagram showing another embodiment in which ribs for supporting the chromatographic carrier 50 are provided in the first chamber 20 of the device 2 . Fig.11 This is a diagram showing another embodiment in which a mixed liquid storage portion for limiting the amount of liquid delivered is provided in the first chamber 20 of the apparatus 2 . Fig.12 This is a diagram showing another embodiment in which a mixed liquid holding portion for limiting the liquid feeding amount is provided in the first chamber 20 of the apparatus 2 . DETAILED DESCRIPTION

[0011] The disclosure of the present invention relates to a nucleic acid inspection device (hereinafter referred to as the device) and its uses, etc. According to the device disclosed in this specification, a chromatographic carrier is accommodated in the first chamber, and a component for a nucleic acid amplification reaction is accommodated in the second chamber. The first chamber and the second chamber are formed to be able to transport a part of the liquid of the second chamber to the first chamber through an operation from the outside, and are formed to be able to supply the liquid of the second chamber, for example, a liquid containing a nucleic acid amplification product, to the development base of the chromatographic carrier of the first chamber. That is, according to the device, only by operating the device to connect the above-mentioned liquids, the liquid of the second chamber can be supplied to the chromatographic carrier of the first chamber, and chromatographic analysis can be performed on the target nucleic acid that may be contained in the liquid.

[0012] Therefore, it is possible to avoid complicated operations such as installation and pressing of the member for housing the chromatographic carrier after the nucleic acid amplification reaction, and the chromatographic analysis on the chromatographic carrier can be performed simply and quickly. In addition, since the nucleic acid amplification reaction and the chromatographic analysis can be completed in the device, it is possible to avoid contamination from the outside during these processes, thereby improving the reproducibility and accuracy of the inspection.

[0013] It should be noted that in this specification, nucleic acid can be any nucleic acid to be examined, such as DNA, RNA, etc. The source of such nucleic acid is not particularly limited, and typically includes pathogenic microorganisms or viruses, disease-related genes, SNPs, mutations, etc. of humans, etc.

[0014] In addition, in this specification, the inspection of nucleic acid refers to the detection, identification or quantification of the presence or absence of specific nucleic acid. Typically, it is detection or identification. In this specification, a sample refers to a sample that may contain nucleic acid collected from various known organisms or non-organisms. In addition, a sample can be any part or component of an organism or non-organism.

[0015] Hereinafter, representative and non-limiting specific examples of the disclosure of this specification are described in detail with appropriate reference to the accompanying drawings. This detailed description is intended only to show the details of preferred examples for implementing the present invention to those skilled in the art, and is not intended to limit the scope of the disclosure of this specification. In addition, in order to provide a further improved nucleic acid inspection device and its use, the additional features and inventions disclosed below can be used separately or in conjunction with other features or inventions.

[0016] In addition, the combination of features and processes disclosed in the following detailed description is not necessary for implementing the present invention in the broadest sense, but is only recorded for the purpose of specifically illustrating representative specific examples of the disclosure of this specification. Furthermore, the various features of the representative specific examples described above and below, as well as the various features described in the independent and dependent claims, do not necessarily have to be combined as in the specific examples described herein or in the order in which they are listed when providing additional and useful embodiments of the disclosure of this specification.

[0017] Except for the characteristic configurations described in the embodiments and / or claims, all the characteristics described in this specification and / or claims are intended to be disclosed individually and independently of each other as limitations on the original disclosure of the application and the specific matters to be protected. Furthermore, for the description involving all numerical ranges and groups or groups, it is intended to disclose the intermediate configurations thereof as limitations on the original disclosure of the application and the specific matters to be protected.

[0018] Hereinafter, the nucleic acid testing device disclosed in this specification, a container used therefor, a testing method, etc. will be described. Figure 1 A top view showing an example of a device according to an embodiment, Figure 2 Show the exploded view of the device using a cross-section view, Figure 3 The enlarged view shows gate 26, Figure 4 An example of an inspection process using a device is shown. Figure 5 An example of a detection signal of a target nucleic acid on a chromatographic carrier after inspection is shown.

[0019] (Nucleic acid testing device) Figure 1 The device 2 shown includes: a first chamber 20 that contains a chromatographic carrier for nucleic acid chromatography analysis and performs chromatographic analysis; a second chamber 30 that contains a liquid that performs a nucleic acid amplification reaction, the liquid containing components for nucleic acid amplification reaction of nucleic acid derived from a sample; and a third chamber 40 that contains a liquid that can transport the nucleic acid amplification reaction solution generated in the second chamber 30 to the first chamber 20. This embodiment includes the third chamber 40 that can be plastically deformed.

[0020] The device 2 is configured in series in sequence and includes a first chamber 20, a second chamber 30, and a third chamber 40, and through an operation from the outside, the liquid contained in the third chamber 40 is transported to the second chamber 30, and further, as a result, the liquid mixed in the second chamber 30 is also transported to the first chamber 20, as a result, it is formed to be able to perform chromatographic analysis in the first chamber 20.

[0021] The device 2 includes a gate 26 for isolating the first chamber 20 and the second chamber 30 and for supplying liquid, and a gate 36 for isolating the second chamber 30 and the third chamber 40 and for supplying liquid. The gate 26 extends between the first chamber 20 and the second chamber 30, and the gate 36 extends between the second chamber 30 and the third chamber 40.

[0022] The device 2 only needs to include the chambers 20, 30, 40 and the gates 26, 36 as described above, and its structure and molding method are not limited. The device 2 can be formed by injection molding or the like from a plastic material in its entirety, or it can be formed by vacuum molding or the like from a plurality of plastic parts. In this embodiment, for example, Figure 1and Figure 2 As shown, the device 2 includes a tray 4 and a cover 14, respectively, which are joined to form, wherein the tray 4 and the cover 14 are made of plastic material and have a given rigidity capable of maintaining the shape when molded.

[0023] The tray 4 includes, for example, convex wall portions 8, 10, 12 protruding downward from an elongated and flat plate 6. The convex wall portions 8, 10, 12 are configured to sequentially form a first chamber 20, a second chamber 30, and a third chamber 40 as hollow cavities in series with the lid 14.

[0024] The cover 14 covers the tray 4 and is bonded to at least the outer edges of the convex wall portions 8, 10, 12 of the tray 4 and the outer edges of the shutters 26, 36. The bonding method is not particularly limited, and adhesives, bonding agents, welding, etc. can be used appropriately. Adhesives and bonding agents can be used in sheet form as appropriate.

[0025] The gates 26 and 36 do not normally communicate with liquid, but are formed to such an extent that liquid can pass through when liquid with a certain momentum (hydraulic pressure) and / or amount and / or wettability or more is allowed to reach the gates.

[0026] Hereinafter, the details of the chambers 20 , 30 , 40 will be described, and then the details of the shutters 26 , 36 between the chambers 20 , 30 , 40 will be described.

[0027] (First Chamber) The first chamber 20 is a cavity for performing nucleic acid chromatography. The first chamber 20 is formed to a size capable of accommodating the chromatographic carrier 50.

[0028] The first chamber 20 has, for example, an internal volume and shape capable of holding the chromatogram carrier 50 in the first chamber 20 in a manner that does not hinder the chromatographic analysis during the chromatographic analysis. The first chamber 20 only needs to hold the chromatogram carrier 50 to a degree that allows the chromatographic analysis to be performed without moving, and typically can be set to a width of 2 mm to 10 mm, a thickness of 1.5 mm to 3 mm in the vertical direction, and a length of 30 mm to 80 mm.

[0029] In the first chamber 20 , an end portion (development base portion) 52 of the chromatographic carrier 50 which is a starting portion for development during chromatographic analysis is arranged at an end portion 20 a of the first chamber 20 that is close to the second chamber 30 .

[0030] The first chamber 20 may contain the chromatographic carrier 50 in advance or may contain the chromatographic carrier 50 when in use, but it is sometimes appropriate to contain the chromatographic carrier 50. When containing the chromatographic carrier 50 when in use, a sealable introduction port for containing the chromatographic carrier 50 may be appropriately provided in the first chamber 20. The introduction port may be provided with a sealing member for sealing the introduction port after the chromatographic carrier 50 is contained.

[0031] The chromatographic carrier 50 generally has a flat plate or rod-like shape that is elongated in the development direction. In addition, the chromatographic carrier 50 is formed of various porous bodies or fibrous bodies that allow liquid to move due to capillary phenomena. The chromatographic carrier 50 is generally formed of materials such as plastics and cellulose. Such a chromatographic carrier 50 may be formed only of such a material, or may further include a holder that lines the chromatographic carrier 50.

[0032] The chromatographic carrier 50 at least has a probe for capturing nucleic acid as an element for performing nucleic acid chromatography analysis. The probe, as an element for detecting nucleic acid, can adopt various methods known to those skilled in the art. Typically, the probe includes DNA having a base sequence that can hybridize with a portion of the amplification product of the target nucleic acid.

[0033] The probe is provided according to the type of nucleic acid to be detected or identified. When the nucleic acid to be detected is one, one probe is provided, and when the nucleic acid to be detected is two or more, two or more probes are provided. The one or more probes are respectively held in advance on the chromatographic carrier 50 at different positions in the development direction of the chromatographic carrier 50. For example, Figure 5 As shown, the probe holding region 54 is typically formed in a linear shape perpendicular to the development direction at a given position in the development direction of the chromatographic carrier 50. The method of fixing the probe to the chromatographic carrier 50 is well known to those skilled in the art, and the probe is fixed to the chromatographic carrier 50 using the well-known method.

[0034] The chromatographic carrier 50 can also hold a signal element for facilitating the detection of the target nucleic acid captured by the probe. Such signal elements are also well known to those skilled in the art, such as colored particles, particles that are easily bound to nucleic acids. Typically, a signal element that is colored and has a binding element (for example, streptavidin) can be cited, which interacts with nucleic acids or a label (for example, biotin) bound to nucleic acids.

[0035] Such a signal element can be held, for example, near the development base 52 of the chromatographic carrier 50. The target nucleic acid that has passed through the signal element holding region by chromatographic analysis binds to the signal element and is captured by the probe when it further reaches the probe holding region. As a result, the signal is selectively amplified in the probe holding region, and the nucleic acid of the inspection object is detected.

[0036] The signal element holding region is not particularly limited and can be formed on the chromatographic carrier 50 by a known method. Figure 5As shown, in the chromatographic carrier 50 , a pad holding a signal element and through which liquid can pass due to a capillary phenomenon is integrated with the chromatographic carrier 50 at a location away from the developing base 52 by a predetermined distance in the developing direction, thereby providing a signal element holding region 56 .

[0037] Furthermore, the chromatographic carrier 50 may be provided with a component for facilitating the chromatographic analysis of the target nucleic acid and the capture of the probe. Such a component may be a surfactant, urea, or the like having a property of modifying nucleic acid. The chromatographic carrier 50 may be provided with a region for holding such a component on the chromatographic carrier 50. Such a component holding region may be provided, for example, by integrating a pad holding a component with the chromatographic carrier 50 in the vicinity of the signal element holding region 56, similarly to the signal element holding region 56.

[0038] (Second chamber) The second chamber 30 is a cavity for implementing a nucleic acid amplification reaction. The second chamber 30 is formed to a size that can accommodate a liquid containing a component for a nucleic acid amplification reaction of a nucleic acid derived from a sample. The liquid contained in the second chamber 30 can contain, as a component for a nucleic acid amplification reaction, enzymes, primers, nucleotides, inorganic salts, buffer (water), signal elements, etc. Such components can be obtained by a person skilled in the art through commercial channels. Further, when used, the liquid can contain nucleic acids derived from the sample.

[0039] The second chamber 30 may contain components other than nucleic acid derived from the sample in advance, and when the device 2 is used, only nucleic acid derived from the sample is introduced into the second chamber 30. In addition, when the device 2 is used, components for nucleic acid amplification reaction including nucleic acid derived from the sample may be introduced into the second chamber 30. The second chamber 30 may include: an introduction port 32 for introducing various components into the second chamber 30 when the device 2 is used; and a sealing member 34 for sealing at least the introduction port 32 thereafter.

[0040] The second chamber 30 can have an internal volume and shape capable of performing a nucleic acid amplification reaction. Figure 1 and Figure 2 As shown, the convex wall portion 10 is formed in the shape of an outer skin protruding in a cylindrical shape with a circular cross-section. As a result, a second chamber 30 having a cylindrical cavity can be formed between the convex wall portion 10 and the cover 14. It should be noted that at least a portion of the second chamber 30 is formed to be able to be plastically deformed. As a result, the liquid in the second chamber 30 is easily transported to the first chamber 20. As a way of forming the second chamber 30 to be able to be plastically deformed, the following way can be cited: if an external force is applied to the convex wall portion 10 constituting the second chamber 30, it will deform, and the deformed shape will be maintained approximately permanently, and the volume of the second chamber 30 will be reduced. Such a convex wall portion 10 is, for example, formed of a plastic material and / or thickness and / or shape that can be easily plastically deformed.

[0041] The volume of the second chamber 30 can be set to, for example, 10 μl or more and 50 μl or less, for example, 50 μl or more and 250 μl or less, for example, 250 μl or more and 500 μl or the like.

[0042] The liquid volume of the liquid containing the components for the nucleic acid amplification reaction and the nucleic acid derived from the sample in the second chamber 30 can be set to, for example, 5 μl or more, for example, 10 μl or more, for example, 15 μl or more, for example, 20 μl or more, etc. In addition, the liquid volume is, for example, less than 50 μl, for example, less than 40 μl, for example, less than 30 μl, and for example, less than 20 μl. The range of the liquid volume can be set by appropriately combining these lower and upper limits, for example, it can be set to 5 μl or more and 10 μl or less, 10 μl or more and 20 μl or less, etc. It should be noted that the liquid volume of the liquid is also the liquid volume of the liquid containing the nucleic acid amplification product after the nucleic acid amplification reaction.

[0043] Furthermore, the second chamber 30 is formed so that, when the liquid is transported from the third chamber 40, the total amount of the liquid from the third chamber 40 and the nucleic acid amplification product-containing liquid after the nucleic acid amplification reaction liquid in the second chamber 30 can be transported to the first chamber 20, for example, 20 μl or more, for example, 30 μl or more, and for example, 40 μl or more. In addition, the liquid delivery amount is, for example, 50 μl or less, for example, 40 μl or less, and for example, 30 μl or less. The range of the liquid delivery amount can be set by appropriately combining these lower limits and upper limits, for example, it can be set to 15 μl or more and 30 μl or less, 20 μl or more and 40 μl or less, and for example, 25 μl or more and 50 μl or less.

[0044] The nucleic acid amplification reaction in the second chamber 30 can utilize various known nucleic acid amplification reactions. Nucleic acid amplification reactions include non-isothermal amplification reactions that repeatedly implement a temperature cycle including high temperature and low temperature, and isothermal amplification reactions that are implemented isothermally, and all of these known nucleic acid amplification reactions can be implemented. For example, by using isothermal amplification reactions, temperature control during inspection can be simplified, which has the advantages of being able to improve inspection accuracy and reduce device costs.

[0045] The second chamber 30 may also contain a developing medium component suitable for performing nucleic acid chromatography using the chromatographic carrier 50. The developing medium component may include, for example, an organic solvent compatible with water, a buffer, etc. It should be noted that such a developing medium component may be contained to such an extent that the nucleic acid amplification reaction in the second chamber 30 is not hindered.

[0046] (Third Chamber) The third chamber 40 is a cavity for containing a liquid, and the liquid containing the nucleic acid amplification product generated in the second chamber 30 is transported to the first chamber 20. By providing the third chamber 40, an effective amount of liquid containing the nucleic acid amplification product that can appropriately perform nucleic acid chromatography analysis in the chromatographic carrier 50 in the first chamber 20 can be transported to the first chamber 20.

[0047] The third chamber 40 is not particularly limited as long as it contains a liquid that does not interfere with nucleic acid chromatography or a liquid that is suitable for nucleic acid chromatography, and may be, for example, water and / or an organic solvent miscible with water.

[0048] The third chamber 40 is also a cavity for accommodating a liquid for diluting the liquid containing the nucleic acid amplification product generated in the second chamber 30. Such a diluting liquid may be water and / or an organic solvent miscible with water.

[0049] The third chamber 40 is also a cavity for accommodating a liquid containing a developing medium component. That is, the third chamber 40 may also contain a developing medium component suitable for performing nucleic acid chromatography using the chromatographic carrier 50. By containing the developing medium component in the third chamber 40 separately from the second chamber 30, for example, the type of developing medium component such as a surfactant or urea can be prepared in the third chamber 40 regardless of the execution of the nucleic acid amplification reaction. In addition, a liquid containing a sufficient amount of the developing medium component can be prepared in the third chamber 40 to perform nucleic acid chromatography.

[0050] As the developing medium component, as described above, for example, it can include a water-compatible organic solvent, a buffer solution, etc. Furthermore, it can also include the above-mentioned signal elements, etc. Such components can be easily obtained by those skilled in the art through commercial channels.

[0051] The third chamber 40 may contain a liquid containing a developing medium component in advance, or such a liquid may be introduced into the third chamber 40 when the device 2 is used. When the liquid is introduced into the third chamber when the device 2 is used, the third chamber 40 may include: an introduction port 42 for introducing the liquid into the third chamber 40 when the device 2 is used; and a sealing member 44 for sealing at least the introduction port 42 thereafter.

[0052] For nucleic acid chromatography analysis using the chromatography carrier 50, the third chamber 40 is formed to have a volume capable of conveying an appropriate amount of liquid, based on the conveyance of the liquid to the second chamber 30 or the conveyance of the liquid from the second chamber 30 to the first chamber 20. In addition, the third chamber 40 can have a volume, for example, 1.5 times or more, for example, 1.8 times or more, for example, 2 times or more, for example, 2.5 times or more, for example, 3 times or more, as compared to the second chamber 30. For example, it can be set to 300 μl or more and 600 μl or less, for example, 350 μl or more and 550 μl or less, for example, 400 μl or more and 500 μl or less. The amount of liquid containing the liquid conveying or developing medium contained in the third chamber 40 is, for example, 60% or more and 90% or less, for example, 65% or more and 80% or less, for example, 70% or more and 80% or less of the volume of the third chamber 40.

[0053] In addition, if Figure 1 and Figure 2 As shown, the convex wall portion 12 is formed so as to protrude in a hemispherical shape from the plate 6. As a result, a third chamber 40 having a hemispherical cavity can be formed between the convex wall portion 12 and the cover 14.

[0054] At least a portion of the third chamber 40 is formed to be plastically deformable. By forming the third chamber 40 to be plastically deformable, the volume of the third chamber 40 is reduced during deformation, and the liquid contained in the third chamber 40 itself makes the gate 36 liquid connected, so that, for example, 50% or more, for example, 60% or more, for example, 70% or more, for example, 80% or more, for example, 85% or more, for example, 90% or more, and for example, 95% or more of the liquid in the third chamber 40 can reach the second chamber 30 and further reach the first chamber 20.

[0055] As a method for forming the third chamber 40 to be plastically deformable, there is a method in which, when an external force is applied to the convex wall portion 12 constituting the third chamber 40, the convex wall portion 12 is deformed, the deformed shape is substantially permanently maintained, and the volume of the third chamber 40 is reduced. Such a convex wall portion 12 is formed, for example, with a plastic material and / or thickness and / or shape that can be easily plastically deformed.

[0056] The shape of the convex wall portion 12 that is formed to be plastically deformable in the third chamber 40 is not particularly limited, and may be, for example, cylindrical or hemispherical. Figure 1 and Figure 2 As shown, an external force is applied to the hemispherical convex wall portion 12 to compress and deform it. The hemispherical convex wall portion 12 can be easily compressed and deformed by, for example, the operator's fingers. In addition, the volume of the third chamber 40 is more effectively reduced by the compression deformation, and the liquid in the third chamber 40 is transported to the second chamber 30 through the gate 36. Furthermore, part of the liquid in the second chamber 30 reaches the first chamber 20.

[0057] (Gate) The gate 26 is provided between the first chamber 20 and the second chamber 30. When the third liquid is transported from the third chamber 40 to the second chamber 30, the gate 26 can transport the second liquid containing the nucleic acid amplification product in the second chamber 30 to the first chamber 20. On the other hand, the gate 26 is a flow path that communicates with the liquid and can transport the liquid, but is formed so that even if only the liquid in the second chamber 30 reaches the gate 26, it cannot reach the first chamber 20 through this portion.

[0058] The gate 26 in the device 2 is defined by the inner surface of the plate 6 corresponding to the gate 26 and the inner surface of the cover 14 corresponding to the gate 26. The gate 26 can be provided in various ways.

[0059] Such a gate 26 is formed on the inner surface of the plate 6 and / or the inner surface of the cover 14 defining the gate 26 as a flow path according to their size, shape, and surface properties (for example, wettability or liquid repellency).

[0060] For example, a very small slit or gap may be provided between the plate 6 defining the shutter 26 and the cover 14. For example, an opening cross section of 500 to 1000 μm may be provided. 2 Thus, the liquid in the second chamber 30 is usually unable to pass due to its surface tension, but can pass through the gate 26 only when further hydraulic pressure is applied.

[0061] In order to provide such a flow path, for example, the tray 4 and the cover 14 are bonded together using a bonding layer such as an adhesive layer or a bonding agent layer, but these layers are not provided in the area where the gate 26 is formed. In addition, for example, when such a bonding layer is not provided, a groove portion is formed in the plate 6 and / or the cover 14 by molding, cutting and / or etching in the area where the gate 26 is formed.

[0062] In addition, for example, a bonding sheet capable of forming the gate 26 can also be used. For example, the bonding sheet generally has a bonding layer of a given thickness such as an adhesive or a bonding agent. The bonding sheet has a non-bonding portion according to the shape of the formation area of ​​the first chamber 20, the second chamber 30 and the third chamber 40. The non-bonding portion is formed as an opening without a bonding layer in the bonding sheet. Further, the bonding sheet has a bonding layer with the same thickness as other bonding areas in the formation area of ​​the gate 26. In such a bonding sheet, it is also possible to treat the bonding or adhesiveness of the surface of the bonding part of the gate 26 in a manner that is suppressed or disappears. Thus, when the tray 4 is bonded to the cover 14 using the bonding sheet, the bonding and close contact between the tray 4 and the cover 14 are avoided in the formation area of ​​the gate 26. As a result, a narrow gap through which liquid can flow is easily formed in the formation area of ​​the gate 26. As a treatment of the surface of the bonding layer in the formation area of ​​the gate 26, for example, coating with a resin material, pasting with a tape, etc. can be cited.

[0063] Another example is that the gate 26 is formed into a flow path with a complex pattern having multiple bends, rather than a straight flow path connecting the first chamber 20 and the second chamber 30. As a result, the liquid in the second chamber 30 is usually unable to pass due to its complex curved flow path shape, but can pass through when further hydraulic pressure is added. Such a flow path with a complex pattern can be formed by providing a bonding layer along the outer edge of such a flow path pattern, for example, when a bonding layer is provided between the tray 4 and the cover 14. Another example is that in the absence of a bonding layer, it can also be formed by forming grooves and / or ribs with a complex pattern by molding, cutting and / or etching the tray 4 and / or the cover 14.

[0064] For example, even if the gate 26 is a flow path in a straight line or the like, at least a portion of the inner surface of the gate 26 may be subjected to liquid repellency treatment. Thus, normally, the liquid in the second chamber 30 is prevented from passing through due to liquid repellency, but when a high hydraulic pressure is applied, the liquid can pass through. Such liquid repellency treatment can be appropriately selected according to the type of liquid.

[0065] For example, even if the gate 26 is a linear flow path, a barrier that locally forms a liquid communication therein can be cited. Thus, normally, the liquid in the second chamber 30 is blocked from passing through, but can be allowed to pass through when a high hydraulic pressure is applied. With respect to the top view of the gate 26, one or more local barriers can be provided locally or dispersedly throughout.

[0066] When the barrier is locally provided in the gate 26, for example, one or more barriers can be provided in the center of the gate 26. When a plurality of barriers are provided in the center of the gate 26, for example, the barriers are formed in various patterns such as dots and streams. The shape of each barrier is not particularly limited and may be amorphous.

[0067] When barriers are provided dispersedly throughout the gate 26, for example, a plurality of barriers are formed in various patterns such as dots or streams between the groove 24 constituting the gate 26 and the cover 14. The shape of each barrier is not particularly limited and may be amorphous.

[0068] For example, when a bonding layer is provided between the tray 4 and the cover 14, such a local barrier can be formed by the bonding layer patterned into dots when the tray and / or the cover 14 are formed. In addition, when there is no bonding layer, it can also be formed by forming the flow path and the barrier (rib) by molding, cutting and / or etching the tray 4 and / or the cover 14. Furthermore, regardless of the presence or absence of a bonding layer, when or after the tray 4 and the cover 14 are bonded, the plate 6 and the cover 14 corresponding to the gate 26 can also be locally welded to form a barrier.

[0069] Furthermore, for example, in these various forms and their combinations, in order to facilitate communication of liquids by external operation, the opening cross-sectional area of ​​the shutter 26 may be gradually reduced toward the first chamber 20 .

[0070] The gate 26 is formed to transport a relatively small amount, for example, a mixed liquid of 15 μl or more and 60 μl or less of the liquid containing the nucleic acid amplification product and the liquid from the third chamber 40 from the second chamber 30 to the first chamber 20. Therefore, it is sometimes preferable to form the gate 26 with smaller (lower) liquid connectivity and liquid transport performance than the gate 36 described later.

[0071] exist Figure 3 In the embodiment, as an example of the gate 26, a flow path that linearly connects the first chamber 20 and the second chamber 30 is provided, and the flow path is first liquid-connected due to the liquid feeding pressure from the third chamber 40. The gate 26 is formed as a region without a bonding layer that bonds the tray 4 and the cover 14. That is, the region corresponding to the gate 26 is not provided with a bonding layer, and a bonding layer is provided on the outside along the outer edge of the region, thereby forming the gate 26.

[0072] The gate 36 is provided between the second chamber 30 and the third chamber 40. The gate 36 deforms the third chamber 40 by an external force, that is, a deformation action on the third chamber 40, thereby being able to transport the liquid in the third chamber 40 to the second chamber. The gate 36 is a flow path that communicates with the liquid and can transport the liquid, but is formed so that even if only the liquid in the third chamber 40 reaches the gate 36, it cannot reach the second chamber 30 through this portion.

[0073] The gate 36 in the device 2 is defined by the inner surface of the plate 6 corresponding to the gate 36 and the inner surface of the cover 14 corresponding to the gate 26. The gate 36 is formed according to the size, shape, and surface properties (e.g., wettability or liquid repellency) of the inner surface of the plate 6 and / or the inner surface of the cover 14 defining the gate 36 as a flow path.

[0074] The gate 36 can adopt various forms as described for the gate 26. That is, based on the description of the gate 26, the gate 36 can be set as any one of a slit or gap flow path that can deliver liquid, a flow path with a pattern of curved portions, a flow path with at least a portion of the inner surface treated to repel liquid, a flow path with a barrier partially inside, a flow path with an opening cross-sectional area gradually decreasing toward the second chamber 30, etc., or a suitable combination of these.

[0075] The gate 36 allows a relatively large amount of liquid, for example, about 100 μl to 600 μl, to pass directly due to the deformation of the third chamber 40 , and therefore it is sometimes preferable to form the gate 36 to have higher (larger) liquid connectivity and liquid feeding performance than the gate 26 .

[0076] On the other hand, Figure 3 As shown, the gate 36 can also make the liquid connectivity and liquid delivery performance smaller than the liquid connectivity and liquid delivery performance of the gate 26. Generally, in order to facilitate the liquid delivery to the second chamber 30 by the pressing operation of the operator, a relatively large amount of liquid is filled in the third chamber 40. Therefore, there is a risk that the liquid in the third chamber 40 accidentally reaches the second chamber 30. In addition, depending on the pressing force and pressing time of the operator on the third chamber 40, there is also a case where excess liquid is delivered to the second chamber 30. It is conceivable that due to the excess delivery, the liquid reaches the first chamber 20 in a state where it is not fully mixed with the liquid in the second chamber 30. In order to avoid such a risk, it is sometimes preferable to make the liquid connectivity and liquid delivery performance in the gate 36 smaller than the liquid connectivity and liquid delivery performance in the gate 26. For example, when the heights in the cross section of the gates 26 and 36 are the same, the width of the gate 36 can be set to, for example, 80% or less, 70% or less, 60% or less, 50% or less, 40% or less of the width of the gate 26. In addition, the lower limit can be set to, for example, 30% or more, 40% or more, etc.

[0077] exist Figure 3 In the embodiment, as an example of the gate 36, a flow path is provided for linearly connecting the second chamber 30 and the third chamber 40, and the flow path is first liquid-connected by the liquid feeding pressure from the third chamber 40. The gate 36 is formed as a region without a bonding layer for bonding the tray 4 and the cover 14, similarly to the gate 26.

[0078] Next, refer to Figure 4 and Figure 5 , the use of the device 2 to check whether the nucleic acid contained in the sample is the nucleic acid to be checked is described. It should be noted that in the following test, Figures 1 to 3 The first chamber 20 of the device 2 shown is pre-accommodated with an appropriate chromatographic carrier 50, the second chamber 30 with a volume of 150 μl is pre-accommodated with 7 μl of components for nucleic acid amplification reactions other than nucleic acids derived from samples, and the third chamber 40 with a volume of 500 μl is pre-accommodated with 350 μl of water for liquid delivery.

[0079] In addition, in the following description, the nucleic acid is DNA, and in the nucleic acid amplification reaction, a primer is prepared by an isothermal amplification reaction to generate a partially single-stranded DNA double strand as an amplification product, and the partially single-stranded DNA double strand is a DNA double strand, and the end of one DNA strand has a single-stranded portion extending further to the 5' side than the other DNA strand, and biotin is imparted to the 5' end of the other DNA strand.

[0080] First, a nucleic acid fraction is fractionated from a sample that may contain a target nucleic acid, and the fraction is used as a nucleic acid solution derived from the sample (step S10). This step may be omitted as necessary.

[0081] Next, the sealing member 34 of the second chamber 30 is peeled off, the introduction port 32 is opened, and 3 μl of the nucleic acid solution derived from the sample is introduced into the second chamber 30, so that the liquid volume of the nucleic acid amplification reaction solution in the second chamber 30 is 10 μl. Next, the lower part of the device 2 including the second chamber 30 is placed in a water bath preset at 65° C. for 40 minutes (step S20).

[0082] After taking out the device 2 from the water bath, while keeping the longitudinal direction of the device 2 in the horizontal direction and with the convex wall portion 12 facing upward, the convex wall portion 12 is pressed from above with a finger to roughly flatten the convex wall portion 12 to deform it. As a result, a portion of the liquid in the third chamber 40 is transported to the second chamber 30 through the gate 36. Further, a portion of the mixed solution containing the amplification reaction product liquid and the liquid in the second chamber is transported to the first chamber 20 through the gate 26. Typically, 25μl to 50μl of the mixed solution generated in the second chamber 30 is transported to the first chamber 20 (step S30). It should be noted that the deformation action of the convex wall portion 12 is not limited to the above-mentioned method, and the device 2 can be kept in a roughly vertical direction or kept in a roughly horizontal direction with the convex wall portion 12 facing downward.

[0083] Thus, the mixed solution containing the nucleic acid amplification product is transported to the first chamber 20. The mixed solution contacts the development base 52 of the chromatographic carrier 50, and the chromatographic analysis of the nucleic acid amplification product is started (step S40). It should be noted that since the deformation action of the third chamber 40 is performed by making the device 2 substantially horizontal, the chromatographic analysis in the first chamber 20 is also directly performed in the lateral direction. It should be noted that the device 2 can also be appropriately arranged along the vertical direction so that the development direction of the chromatographic carrier 50 is substantially vertically upward.

[0084] The mixed solution sent to the first chamber 20 rises from the development base 52 on the chromatographic carrier 50 by capillary phenomenon, reaches the signal element holding area 56, binds to the signal element which is a colored bead having streptavidin, and further reaches the probe holding area 54. When the nucleic acid amplification product is associated with the target nucleic acid, the held probe hybridizes with the DNA single-stranded portion and is captured by the probe holding area 54. The mixed solution from which the nucleic acid amplification product has been captured by the probe and removed further rises on the chromatographic carrier 50, reaches a given development end line, and the chromatographic analysis ends.

[0085] exist Figure 5 5 shows the chromatographic carrier 50 after the chromatographic analysis is completed. After the chromatographic analysis is completed, the presence or absence of coloration caused by the colored beads is visually observed in the probe holding area 54 (step S50). When coloration based on the colored beads is observed in the probe holding area 54, it can be said that the nucleic acid derived from the sample is the target nucleic acid or contains the target nucleic acid.

[0086] According to the device 2, by having the third chamber 40, the gates 36, and the gates 26, it is possible to easily perform nucleic acid chromatography. That is, according to the device 2, by the operator squashing the third chamber 40, the liquid containing the nucleic acid amplification product can be supplied to the chromatography carrier 50 via the gates 36, and the chromatography can be started. That is, the nucleic acid chromatography can be performed with such a simple and small amount of operation to reduce the possibility of contamination. In addition, according to the device 2, the chromatography carrier 50 is pre-accommodated in the first chamber 20, the components used for the nucleic acid amplification reaction other than the nucleic acid derived from the sample are pre-accommodated in the second chamber 30, and the water used for liquid delivery is pre-accommodated in the third chamber 40. Therefore, the operator can perform the nucleic acid amplification reaction only by further performing the operation of introducing the nucleic acid derived from the sample into the second chamber 30.

[0087] According to the device 2, since the first chamber 20, the second chamber 30, and the third chamber 40 are sequentially arranged in series, it is possible to appropriately implement the delivery of water from the third chamber 40, the mixing of water in the second chamber 30 with the nucleic acid amplification reaction solution, and the delivery of an appropriate amount of the mixed solution to the first chamber 20. It should be noted that when the second chamber 30 is formed to be plastically deformable, the mixed solution is more reliably delivered to the first chamber 20 by deforming the convex wall portion 10 of the second chamber 30.

[0088] In addition, since an isothermal amplification reaction is used as the nucleic acid amplification reaction, the nucleic acid amplification reaction can be easily performed. Furthermore, since colored beads are used as signal elements, the nucleic acid of the inspection object can be easily detected by visual observation.

[0089] In the device 2 of this embodiment, the cover 14 is described as a rigid body that maintains a predetermined shape capable of covering the tray 4, but the present invention is not limited thereto. Figure 6 As shown, the device 2' may be provided with a cover 14' having a flexible film. With such a cover 14', the sealing member 34 for introducing nucleic acid derived from a sample into the second chamber 30 can be omitted, and the structure of the device 2 can be simplified.

[0090] Further, if Figure 7 As shown, for example, both the tray 4" and the cover 14" may be formed as a whole from a flexible film. In the device 2", the second chamber 30" and the third chamber 40" are both flexible and elastically deformable. Here, elastically deformable refers to, for example, flexibility associated with softness and easy deformation, and properties of deformation by elasticity. Therefore, it can be said that when the second chamber 30" and the third chamber 40" formed by a membrane body or the like are capable of delivering liquid by deformation such as bending, these chambers are also elastically deformable.

[0091] It should be noted that it is sometimes preferred that the first chamber 20" is supported due to the rigidity of the chromatography carrier 50, etc. In addition, the first chamber 20" can also be formed by a rigid body. In the device 2", since the third chamber 40" can be elastically deformed, the liquid can be transported to the second chamber 30" by the deformation action of elastically deforming the third chamber 40", and the liquid can also be transported to the first chamber 20' according to the situation. In addition, following the deformation action of the third chamber 40", or at the same time as the deformation action of the third chamber 40", the liquid can be transported to the first chamber 20" by the deformation action of elastically deforming the second chamber 30". In the device 2", the gates 26", 36" can be set as sealing parts that are sealed before the liquid is sent to the third chamber 40" but are released by the liquid sending pressure during elastic deformation. Such sealing parts are well known to those skilled in the art. In addition, the second chamber 30" is appropriately provided with an introduction port 32" for introducing nucleic acid derived from the sample and a sealing member 34".

[0092] In the device 2, the first chamber 20, the second chamber 30 and the third chamber 40 are sequentially connected in series, but the present invention is not limited thereto. Figure 8 As shown in the tray 4'", the first chamber 20'", the third chamber 40'" and the second chamber 30'" can be arranged in series in the order of. In this case, by setting the second chamber 30'" for nucleic acid amplification reaction to be capable of plastic deformation, the nucleic acid amplification reaction solution can be transported to the third chamber 40'" for dilution, and the diluted mixed solution can be transported to the first chamber 20'". In this case, the volume of the second chamber 30'" can be, for example, greater than 5μl and less than 30μl, and the total amount of the nucleic acid amplification reaction solution can be, for example, greater than 5μl and less than 25μl, the volume of the third chamber 40'" can be, for example, greater than 100μl and less than 300μl, and the amount of liquid such as water can be, for example, greater than 50μl and less than 250μl.

[0093] The device 2 includes a first chamber 20, a second chamber 30, and a third chamber 40, but is not limited thereto. Fig. 9 As shown, it is also possible to not have the gate 36 and the third chamber 40, and the convex wall portion 10"" forming the second chamber 30"" can be plastically deformed, thereby allowing the gate 26"" to connect the liquid and transport a given amount of liquid containing the amplification reaction product to the first chamber 20"". In this case, the volume of the second chamber 30"" can be set to, for example, more than 30μl and less than 50μl, and the total amount of the nucleic acid amplification reaction liquid can be set to more than 25μl and less than 40μl, so that an appropriate amount of nucleic acid amplification reaction liquid can be transported to the first chamber 20.

[0094] In the device 2, the chromatographic carrier 50 is accommodated in the first chamber 20 without any special holding mechanism, but the present invention is not limited thereto. For example, ribs may be provided to allow the chromatographic carrier 50 to properly contact the mixed solution transported from the second chamber 30 and to properly spread. Fig.10 As shown, a rib 60 for holding the chromatographic carrier 50 so as not to contact the inner surface of the first chamber 20 can be provided inside the first chamber 20 and on the tray 4 side. Fig.10 In the embodiment, the rib 60 may be provided on the cover 14 side instead of the tray 4 side, or may be provided on both the tray 4 and the cover 14 .

[0095] In the device 2, the first chamber 20 is not particularly provided with a mechanism for controlling the amount of the mixed liquid delivered from the second chamber 30, but the present invention is not limited thereto. Fig.11 As shown in the tray 4, in order to limit the excess amount of mixed solution sent to the first chamber 20, a mixed solution storage portion 70 communicating with the cavity of the first chamber 20 can be provided. The mixed solution storage portion 70 can be provided near the position where the development base 52 of the chromatographic carrier 50 is arranged.

[0096] In addition, if Fig.12 As shown, a mixed liquid holding portion 80 having a given cavity in a manner communicating with the first chamber 20 may be provided between the gate 26 and the first chamber 20. The mixed liquid holding portion 80 may be formed by providing an additional convex wall portion continuous with the convex wall portion 8 on the tray 4. For example, the mixed liquid holding portion 80 may have a volume assuming an amount of mixed liquid to be excessively transported to the first chamber 20. An extension portion 58 extending further toward the gate 26 than the development base 52 of the chromatographic carrier 50 is inserted into the interior of the mixed liquid holding portion 80. The extension portion 58 is formed, for example, to a size that fills the cross section of the mixed liquid holding portion 80, and can receive and hold the excess mixed liquid that has passed through the gate 26. A portion of the mixed liquid held in the extension portion 58 is supplied to the development base 52 of the chromatographic carrier 50 by capillary action.

[0097] It should be noted that the extension portion 58 of the chromatogram carrier 50 does not necessarily need to be a part of the chromatogram carrier 50, and may be provided as a separate water-absorbing member in such a manner as to limit the amount of liquid supplied to the development base 52 of the chromatogram carrier 50 in the first chamber 20. In addition, the mixed liquid holding portion 80 may not include the extension portion 58 of the chromatogram carrier 50 or a separate water-absorbing member as long as the amount of liquid supplied can be limited.

[0098] It should be noted that in the above description, the device 2 is mainly described, and the device 2 contains a chromatographic carrier 50 in the first chamber 20, a liquid containing components for nucleic acid amplification reactions other than nucleic acids derived from a sample in advance in the second chamber 30, and a liquid is pre-contained in the third chamber 40, and the liquid is used to transport the liquid containing the amplification product reaction to the first chamber 20. However, as an embodiment of the present disclosure, it is possible to have a container for nucleic acid testing or a nucleic acid testing kit (for example, a container having chambers and gates (for example, a tray and a cover), which contains one or more of such contained objects and has a first chamber 20, a second chamber 30, and a third chamber 40 and gates 26, 36 (for example, a container having chambers and gates (for example, a tray and a cover), and includes elements in a state of being contained in each chamber, or elements in a state of not being contained in each chamber and to be contained in each chamber (in addition, it has a chromatographic carrier, a liquid element, etc.). In such a container or container kit, various methods regarding the device 2, the first chamber 20, the second chamber 30, the third chamber 40, and the gates 26, 36 that have been described can be applied.

[0099] In addition, in the above description, the device 2 is mainly described, but as an embodiment of the present disclosure, a method for testing nucleic acid using the device 2 is also provided. For those skilled in the art, nucleic acid extraction from a sample, nucleic acid amplification reaction and nucleic acid chromatography analysis are all well known, and by using the above-mentioned device 2, nucleic acid amplification reaction and nucleic acid chromatography analysis can be easily performed. Description of Reference Numerals

[0100] 2: device; 4: tray; 6: plate; 8, 10, 12: convex wall portion; 14: cover; 20: first chamber; 30: second chamber; 40: third chamber; 50: chromatographic carrier; 52: development base; 54: probe holding area; 56: signal element holding area; 58: extension portion; 60: rib; 70: mixed liquid storage portion; 80: mixed liquid holding portion.

Claims

1. A device, which is a nucleic acid testing device, comprising: A first chamber that houses a chromatography carrier for performing chromatography analysis on nucleic acids; and a second chamber capable of containing a liquid containing components for a nucleic acid amplification reaction of a target nucleic acid derived from a sample, The first chamber and the second chamber are formed so that the liquid in the second chamber can be transferred to the first chamber by an external operation, and the liquid in the second chamber can be supplied to the development base of the chromatography carrier in the first chamber.

2. The device according to claim 1, wherein: At least a portion of the second chamber is plastically deformable or elastically deformable, and is formed so that the liquid in the second chamber can be transferred to the first chamber by a deformation action on the second chamber.

3. The device according to claim 2, wherein: A shutter is provided between the first chamber and the second chamber, and the shutter can allow liquid to communicate by pressing the second chamber.

4. A device, which is a nucleic acid testing device, comprising: A first chamber that houses a chromatography carrier for performing chromatography analysis on nucleic acids; a second chamber capable of containing a liquid containing components for a nucleic acid amplification reaction of a target nucleic acid derived from a sample; and a third chamber capable of receiving the liquid delivered to the second chamber, At least a portion of the third chamber is capable of plastic deformation or elastic deformation, and the third chamber and the second chamber are formed so that the liquid in the third chamber can be transported to the second chamber by a deformation action on the third chamber, and are formed so that a mixed liquid of at least a portion of the liquid in the second chamber and at least a portion of the liquid in the third chamber can be supplied to the deployment base.

5. The device according to claim 4, wherein: The first chamber, the second chamber, and the third chamber are sequentially provided in series.

6. The device according to claim 5, wherein: A shutter is provided between the first chamber and the second chamber and between the second chamber and the third chamber, respectively, and the shutter can allow liquid to communicate by pressing the third chamber.

7. The device according to any one of claims 1 to 6, wherein: The nucleic acid amplification reaction is an isothermal nucleic acid amplification reaction.

8. A container, which is a container for the nucleic acid testing device according to any one of claims 1 to 3, comprising: The first chamber is capable of accommodating the chromatographic carrier for chromatographic analysis of nucleic acids; The second chamber is capable of containing the liquid containing components for the nucleic acid amplification reaction of the target nucleic acid derived from the sample, and at least a portion of the second chamber is capable of plastic deformation; and The gate is between the first chamber and the second chamber and can allow liquid to communicate by pressing the second chamber.

9. A nucleic acid testing kit comprising: The container according to claim 8; The chromatographic carrier is in a state of being accommodated in the first chamber or not accommodated in the first chamber; and The liquid is in a state of being contained in the second chamber or not contained in the second chamber, and contains a component used for a nucleic acid amplification reaction of a nucleic acid derived from a sample.

10. A container for use in the nucleic acid testing device according to any one of claims 4 to 6, comprising: The first chamber contains the chromatography carrier for performing chromatography analysis on nucleic acid; the second chamber capable of containing the liquid containing components for a nucleic acid amplification reaction of a target nucleic acid derived from a sample; The third chamber is capable of containing the liquid transported to the second chamber, and at least a portion of the third chamber is capable of plastic deformation or elastic deformation; and The gates are respectively provided between the first chamber and the second chamber and between the second chamber and the third chamber, and can allow liquid to communicate by deforming the third chamber.

11. A nucleic acid testing kit comprising: The container according to claim 10; The chromatographic carrier is in a state of being accommodated in the first chamber or not accommodated in the first chamber; and The liquid is in a state of being contained in the second chamber or not contained in the second chamber, and contains a component used for a nucleic acid amplification reaction of a nucleic acid derived from a sample.

12. A method for testing nucleic acid, comprising: A step of performing a nucleic acid amplification reaction using the nucleic acid testing device according to any one of claims 1 to 6; and A step of supplying a liquid containing an amplification reaction product generated in the second chamber to a developing base of the chromatography carrier in the first chamber to perform chromatography analysis.

13. The method according to claim 12, wherein: The nucleic acid amplification reaction is an isothermal nucleic acid amplification reaction.

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