Flow path device and inspection device

Abstract

Provided are a flow path device and an inspection device, wherein: a flow path of the flow path device includes a first liquid chamber that accommodates a sample liquid, a second liquid chamber in which there is accommodated a cleaning liquid for removing impurities contained in the sample liquid, and a third liquid chamber in which there is accommodated an eluate for eluting a detection object; in the flow path, the sample liquid, the cleaning liquid, and the eluate can be accommodated in a state of being separated by a hydrophobic liquid; the flow path is a continuous flow path extending from a start end to a terminal end, the flow path being formed in a state of surrounding a rotation center when the flow path is centrifuged by a centrifuge; and there is furthermore comprised a reagent storage part that individually stores the cleaning liquid, the eluate, and the hydrophobic liquid in a state before being introduced into the flow path.

Description

Flow path device and inspection device

[0001] The present disclosure relates to a flow path device and an inspection apparatus.

[0002] In the testing of specimens collected from living organisms, in order to detect the target substance with high sensitivity, a purification procedure to remove the influence of contaminants contained in the specimen is required. A known purification method uses magnetic particles whose surfaces are modified with a binding substance that binds to the target substance, and traps the target substance on the magnetic particles via the binding substance to remove the contaminants.

[0003] Japanese Patent Application Laid-Open No. 2013-130548 proposes a chip device that enables purification operations using magnetic particles.

[0004] The chip device disclosed in JP 2013-130548 A includes an internal space formed by grooves formed in a substrate, a chip containing gel phases and aqueous liquid phases alternately arranged in the longitudinal direction, and a magnetic field application means for applying a magnetic field to the chip and moving the magnetic particles. In this chip device, magnetic particles can be moved inside the alternatingly arranged gel phase and aqueous liquid phase by moving the magnetic field along the longitudinal direction of the chip groove. If the aqueous liquid phase includes, for example, a washing solution and an elution solution interposed between the gel phase, the magnetic particles can be passed through the washing solution and then moved to the elution solution via the gel phase, thereby purifying and extracting the target substance.

[0005] JP 2015-518708 A discloses a device including a plurality of reagent storage units and a reagent storage compartment having blister areas that are communicable with each reagent storage unit via a rupturable seal layer. In the device of JP 2015-518708 A, each reagent is stored individually in its own blister area, and the device is configured so that, during testing, the seal layer between each blister area and the reagent storage unit is ruptured to supply the reagent to the reagent storage unit.

[0006] In the chip described in JP 2013-130548 A, different types of aqueous liquid phases are separated and held by a gel phase, but there are concerns about the storage stability of the reagents in the aqueous liquid phase.

[0007] In the device described in JP 2015-518708 A, each reagent is stored individually in a blister area, resulting in high storage stability of the reagents. However, the flow path structure, including the reagent storage section and the water channels connecting the reagent storage section and the reagent storage section, is complex, making it difficult to reduce the cost of the device.

[0008] The present disclosure has been made in consideration of the above circumstances, and provides a flow path device and testing apparatus that performs purification using magnetic particles that bind to the target substance, is capable of storing reagents with high stability, and has a simplified flow path structure.

[0009] The flow path device of the present disclosure is a flow path device that has a flow path capable of containing a specimen liquid containing a detection target that binds to magnetic particles, and that purifies the detection target by moving the detection target within the flow path using the magnetic particles, wherein the flow path has a first liquid chamber that contains the specimen liquid, a second liquid chamber that contains a washing liquid that removes impurities contained in the specimen liquid, and a third liquid chamber that contains an elution liquid that elutes the detection target, wherein the specimen liquid, washing liquid, and elution liquid can be contained within the flow path while being separated by a hydrophobic liquid, the flow path is a continuous flow path from its starting end to its end end, and is formed in a manner that surrounds the center of rotation when centrifuged in a centrifuge, and further comprises a reagent storage unit that separately stores the washing liquid, elution liquid, and hydrophobic liquid before they are introduced into the flow path.

[0010] The flow path preferably has a communication path connecting the first liquid chamber and the second liquid chamber, and the second liquid chamber and the third liquid chamber, and is arranged such that the outermost periphery of the communication path is closer to the center of rotation than the outermost peripheries of the first liquid chamber, the second liquid chamber, and the third liquid chamber.

[0011] It is preferable that the first liquid chamber is provided at the start end of the flow path, the second liquid chamber is provided between the start end and the end end of the flow path, and the third liquid chamber is provided at the end end of the flow path.

[0012] The reagent storage unit may be a member independent of the main body having the flow paths and slidably disposed relative to the main body, and the reagent storage unit may include wells for individually storing the cleaning liquid, elution liquid, and hydrophobic liquid. In this case, the main body preferably has liquid inlets for introducing the liquids into the flow paths, and the wells preferably have openings that communicate with the flow paths when the reagent storage unit is slid relative to the main body and aligned with the liquid inlets.

[0013] The reagent storage unit may be installed so as to be rotatable about a rotation center relative to the main body.

[0014] The reagent storage unit has a main body with a flow path, and the main body has liquid inlets for introducing each liquid into parts of the flow path that communicate with each area that contains the cleaning liquid, elution liquid, and hydrophobic liquid, and the reagent storage unit may have storage units that store each liquid individually, and each storage unit is arranged corresponding to the liquid inlet for introducing each liquid, and the storage units and the liquid inlets may be separated by a breakable sealing member, and the storage units may be able to communicate with the liquid inlets by breaking the sealing member due to an external force.

[0015] The reagent storage section may store a magnetic particle solution containing magnetic particles separately from the washing liquid, the elution liquid, and the hydrophobic liquid.

[0016] The flow path may have a communication path between the first liquid chamber and the second liquid chamber, and between the second liquid chamber and the third liquid chamber, and the communication path may be composed of one or more arc-shaped flow paths having the same radius, and the arc-shaped flow paths may be arranged in a manner that is convex toward the center of rotation.

[0017] The first liquid chamber may contain a magnetic particle solution containing magnetic particles.

[0018] It is preferable that at least one of the first liquid chamber, the second liquid chamber and the third liquid chamber is subjected to a hydrophilic treatment.

[0019] The device may include a reagent storage section connected to the third liquid chamber via a valve, located farther from the center of rotation than the third liquid chamber, and containing a reagent for the substance to be detected, and a processing chamber located farther from the center of rotation than the reagent storage section, in which a mixture of the reagent and the substance to be detected is processed.

[0020] The apparatus may also include a detection chamber that contains the mixed liquid processed in the processing chamber and in which the substance to be detected is optically detected from the outside.

[0021] The hydrophobic liquid preferably has a lower specific gravity than the washing liquid and the elution liquid.

[0022] Preferably, the hydrophobic liquid is silicone oil.

[0023] The flow path is preferably formed by a main body member having a recess on one surface and a thin film bonded to the main body member in a manner that covers the recess on one surface.

[0024] The inspection device disclosed herein comprises a loading section for detachably loading a flow path device, a device rotation mechanism for rotating the flow path device loaded in the loading section, and a magnet rotation mechanism for rotating a magnet along a circle having the same radius as the radius of the arc-shaped flow path, and by combining the rotation of the flow path device and the rotation of the magnet, magnetic particles are moved along the flow path.

[0025] According to the present disclosure, it is possible to provide a flow path device and an inspection apparatus that have the function of purifying using magnetic particles that bind to the target substance, are capable of storing reagents with high stability, and have a simplified flow path structure.

[0026] 1 is a perspective view of a flow path device of an embodiment; FIG. 2 is a plan view showing the flow paths of a flow path device of an embodiment; FIG. 3 is a perspective view showing cross sections of a main body member, a thin film, and a reagent storage unit; FIG. 4 is a perspective view of the main body member as seen from the back side; FIG. 5 is a perspective view of the main body member as seen from the front side; FIG. 6 is a perspective view of the reagent storage unit as seen from the front side; FIG. 7 is a plan view of the front side of the reagent storage unit installed on the main body member; and FIG. 8 is a plan view showing the relationship between wells of the reagent storage unit and the flow paths of the main body member; and FIG. 9 is a diagram showing a schematic configuration of a testing device; and FIG. 10 is an explanatory diagram of the rotation orbit of a magnet by a magnet rotation mechanism of the testing device and the flow paths of the device; and FIG. 11 is a diagram showing a pretreatment process; and FIG. 12 is a diagram showing a purification process; and FIG. 13 is a diagram showing a purification process; and FIG. 14 is a diagram showing a detection process. and FIG. 15 is a perspective view of a flow path device of a modified example; and

[0027] Hereinafter, embodiments of the present disclosure will be described in detail with reference to the drawings. Note that the scale of each component in the drawings has been appropriately changed from the actual scale. In each drawing, the same components are denoted by the same reference numerals.

[0028] "Flow Channel Device" FIG. 1 is a perspective view that schematically shows a flow channel device 10 (hereinafter simply referred to as device 10) according to one embodiment.

[0029] The device 10 shown in Fig. 1 includes a flow channel 20 capable of accommodating a sample liquid containing a target substance that binds to magnetic particles (see Fig. 2). In the device 10, the target substance is purified by moving it within the flow channel 20 using the magnetic particles. In this example, in addition to the purification flow channel 20, detection flow channels 44 and 46 are provided at the end of the purification flow channel for sending an extract containing the target substance to a processing chamber.

[0030] The particle size of the magnetic particles is, for example, 0.1 μm to 500 μm. The surfaces of the magnetic particles are provided with modifiers such as silica or functional groups that specifically bind to the target substance.

[0031] First, a brief description of the purification method for the analyte is provided. Magnetic particles bearing modifiers that specifically bind to the analyte are prepared, and a magnetic particle solution containing these magnetic particles is mixed with a sample solution. If the analyte is contained in the sample solution, the analyte binds to the modifiers on the magnetic particles. The magnetic particles that have captured the analyte are trapped with a magnet and transferred from the mixture of the sample solution and magnetic particle solution into a washing solution for washing. This allows impurities adhering to the magnetic particles to be removed by the washing solution. The magnetic particles that have captured the analyte are then transferred into an elution solution. The elution solution has the function of breaking down the bond between the analyte and the modifier, and the analyte is released from the magnetic particles in the elution solution. After the analyte is released from the magnetic particles, a purified extract of the analyte is obtained by transferring only the magnetic particles from the elution solution.

[0032] In the flow channel 20 of the device 10, a purification process for the object to be detected is carried out, and an extract of the object to be detected can be obtained.

[0033] As shown in Fig. 1, the device 10 includes a main body 14 having a main body member 12 and a thin film 13, a reagent storage unit 15, and a valve 16. For ease of explanation, the reagent storage unit 15 side visible in Fig. 1 will be referred to as the front surface of the device 10, and the thin film 13 side will be referred to as the back surface of the device 10. Accordingly, the surface of the main body member 12 on which the reagent storage unit 15 is located will be referred to as the front surface 12a of the main body member 12, and the surface on the thin film 13 side will be referred to as the back surface 12b. Similarly, the surface of the reagent storage unit 15 visible in Fig. 1 will be referred to as the front surface 15a, and the surface on the main body member 12 side will be referred to as the back surface 15b.

[0034] 1 , the device 10 has an outer shape including, for example, a circular portion provided with a reagent storage section 15 and a rectangular portion extending radially from a part of the outer periphery of the circular portion. A valve 16 is provided in part of the rectangular portion. The valve 16 is attached to the main body member 12 by a valve holder 17 in a biased state.

[0035] 2 is a plan view of the flow channel 20 of the device 10 as seen from the front surface side of the device 10. The flow channel 20 is indicated by a dashed line in FIG. 2. In reality, the flow channel 20 cannot be seen from the front surface 20a side of the device 10. The flow channel 20 is provided in the main body 14.

[0036] 2, the flow path 20 of the device 10 includes four liquid chambers 21 to 24 arranged at approximately 90° intervals around a center point C of the circular portion, and communication paths 25 to 27 connecting the four liquid chambers 21 to 24 so as to surround the center point C of the circular portion. In this example, the center point C of the circular portion is the center of rotation when centrifuged in a centrifuge, which will be described later, to apply centrifugal force to the flow path 20.

[0037] At the beginning of the flow path 20, a first liquid chamber 21 is provided as a sample liquid storage chamber that stores a sample liquid. The first liquid chamber 21 stores a magnetic particle solution S1 together with the sample liquid. A second liquid chamber 22 is provided at a position 90° counterclockwise from the first liquid chamber 21 as a washing liquid storage chamber that stores a washing liquid S2 that removes impurities from the sample liquid. A third liquid chamber 23 is provided at a position 180° rotated from the second liquid chamber 22 as an elution liquid storage chamber that stores an elution liquid S3 that elutes the target substance. In this example, a fourth liquid chamber 24 is provided as a hydrophobic liquid storage chamber that stores a hydrophobic liquid S4, located 90° counterclockwise from the second liquid chamber 22, between the second liquid chamber 22 and the third liquid chamber 23. As will be described in detail later, the magnetic particle solution S1, the washing liquid S2, and the elution liquid S3 can be stored in the flow path 20 while being separated by the hydrophobic liquid S4.

[0038] The magnetic particle solution S1, the cleaning solution S2, and the eluate S3 are mixtures containing water as a main component, and water or mixtures containing water as a main component will be referred to hereinafter as aqueous liquids. The hydrophobic liquid S4 is a liquid that does not mix with aqueous liquids and remains separated from them even in the same container. At least one of the first liquid chamber 21, the second liquid chamber 22, and the third liquid chamber 23, which contain the aqueous liquids magnetic particle solution S1, the cleaning solution S2, and the eluate S3, is preferably subjected to a hydrophilic treatment. It is more preferable that all of the first liquid chamber 21, the second liquid chamber 22, and the third liquid chamber 23 are subjected to the hydrophilic treatment. If the first liquid chamber 21, the second liquid chamber 22, and the third liquid chamber 23, which contain the aqueous liquids, are subjected to the hydrophilic treatment, the aqueous liquid can be more easily contained in the respective positions and the migration of the aqueous liquid to other regions can be restricted.

[0039] The hydrophobic liquid S4 preferably has a specific gravity smaller than that of the magnetic particle solution S1, the cleaning liquid S2, and the eluate S3. Silicon oil is suitable as the hydrophobic liquid S4.

[0040] The first liquid chamber 21 is connected to the second liquid chamber 22 by a first communication path 25. The second liquid chamber 22 is connected to the fourth liquid chamber 24 by a second communication path 26. The fourth liquid chamber 24 is connected to the third liquid chamber 23 via a third communication path 27. The first liquid chamber 21, the first communication path 25, the second liquid chamber 22, the second communication path 26, the fourth liquid chamber 24, the third communication path 27, and the third liquid chamber 23 are arranged in a manner surrounding a center point C. In this way, in the flow path 20 surrounding the center point C, the first liquid chamber 21 is provided at the starting end, and the third liquid chamber 23 is provided at the end of the flow path 20 surrounding the center point C.

[0041] The communication paths 25 to 27 are arranged such that their outermost peripheries are closer to the center point C than the outermost peripheries of the liquid chambers 21 to 24. The first communication path 25, the second communication path 26, and the third communication path 27 are arc-shaped flow paths with the same radius in a plan view. The arc-shaped flow paths convex toward the center point C in a plan view are arranged. Here, the "same radius" means that the radii are substantially the same, and may be different from being completely the same within a range in which magnetic particles inside can move due to rotation of a magnet, which will be described later.

[0042] The main body 14 is provided with liquid inlets 31-37 for introducing each of the liquids S1-S4 into portions that communicate with the regions that accommodate the liquids S1-S4 of the flow path 20. Specifically, a liquid inlet 31 for introducing the sample liquid into the first liquid chamber 21 is provided in the portion that communicates with the first liquid chamber 21, a liquid inlet 32 ​​for introducing the cleaning liquid S2 into the second liquid chamber 22 is provided near the second liquid chamber 22, and a liquid inlet 33 for introducing the elution liquid S3 into the third liquid chamber 23 is provided near the third liquid chamber 23. A liquid inlet 34 for introducing the hydrophobic liquid S4 into the fourth liquid chamber 24 is provided near the fourth liquid chamber 24, and liquid inlets 35-37 for introducing the hydrophobic liquid S4 are provided near the centers of the first communication path 25, the second communication path 26, and the third communication path 27, respectively.

[0043] In this example, the rectangular section is further provided with a testing processing section, which includes a reagent storage section 40 connected to the third liquid chamber 23 via the valve 16, and a processing chamber 42. The third liquid chamber 23 and the valve 16 are connected by a detection flow path 44 that extends from the outer periphery of the third liquid chamber 23 toward the valve 16, and a detection flow path 46 that extends from the processing chamber 42 toward the valve 16.

[0044] The reagent storage section 40 stores a reagent S6 for the detection target substance. In the processing chamber 42, a process such as a reaction between the reagent S6 and the detection target substance is carried out. The processing chamber 42 may also serve as a detection chamber for optically detecting the detection target substance from the outside.

[0045] In this example, the valve 16 is a rotary valve that houses the reagent storage unit 40. Rotating the valve 16 switches between a first state in which the reagent storage unit 40 is connected to the third liquid chamber 23, a second state in which the reagent storage unit 40 is connected to the treatment chamber 42, and a third state in which the reagent storage unit 40 is closed and not connected to either the third liquid chamber 23 or the treatment chamber 42. In the first state, a hole 40a on the bottom surface of the reagent storage unit 40 is aligned with a hole 44a at the end of a flow path 44 that communicates with the third liquid chamber 23. In the second state, a hole 40a in the reagent storage unit 40 is aligned with a hole 46a at the end of a flow path 46 that communicates with the treatment chamber 42. In the third state, a hole 40a in the reagent storage unit 40 is not aligned with either the hole 44a in the flow path 44 or the hole 46a in the flow path 46. The valve 16 can be rotated by inserting the claws of a rotation mechanism into four holes 16a (see FIG. 1) provided in the lid, and by driving the rotation mechanism with a motor.

[0046] 3 is a perspective view showing a cross section of the main body member 12, the thin film 13, and the reagent storage section 15. In FIG. 3, the main body member 12 and the thin film 13 that constitute the main body 14 are shown in a separated state.

[0047] As shown in FIG. 3 , the reagent storage unit 15 is installed on the surface 12a of the main body member 12 via a gasket 56. The gasket 56 is annular and is positioned to correspond to the portion where the liquid inlets 31-37 are formed. A cylindrical portion 19, which protrudes toward the surface 12a from the center of the circular portion of the main body member 12, is inserted into a through-hole 60 located at the center of the disk-shaped reagent storage unit 15. The reagent storage unit 15 is then attached to the main body member 12 by being screwed in place with a fastener 19a (see FIG. 1 ) that threads onto the cylindrical portion 19. A female thread (not shown) is formed in the cylindrical portion 19, and the fastener 19a has a head with a larger diameter than the cylindrical portion 19 and a male thread. The reagent storage unit 15 is installed to be rotatable relative to the reagent storage unit 15 around a center point C. Alternatively, a groove may be formed on the outer periphery of the cylindrical portion 19, and the reagent storage unit 15 may be attached to the main body member 12 by a retaining ring. Alternatively, the cylindrical portion 19 may be provided with a structure such as a snap fit, so that the reagent storage portion 15 can be attached to the main body member 12 .

[0048] The main body member 12 has a recess 50 on its back surface 12b side that forms the flow path 20 (see FIG. 2 ). A thin film 13 is bonded to the back surface 12b of the main body member 12 in a manner that covers the recess 50. The back surface 12b of the main body member 12 corresponds to "one surface of the main body member" in the technology of the present disclosure. The flow path 20 is formed by the recess 50 and the thin film 13 that covers the recess 50.

[0049] The material of the main body member 12 can be any known resin molded plastic material without any particular restrictions, but polycarbonate, polypropylene, cycloolefin or silicone resin is preferred from the viewpoint of heat resistance and transparency.

[0050] As with the main body member 12, the thin film 13 can be made of any known plastic material without any restrictions, but it is preferable that the thin film 13 be made of the same material as the main body member 12 in terms of adhesion to the main body member 12. The main body member 12 is rigid, and the thin film 13 is flexible.

[0051] Fig. 4 is a perspective view of the main body member 12 viewed from the rear surface 12b side, Fig. 5 is a perspective view of the main body member 12 viewed from the front surface 12a side, Fig. 6 is a perspective view of the reagent storage unit 15 viewed from the front surface 15a side, Fig. 7 is a perspective view of the reagent storage unit 15 viewed from the rear surface 15b side, and Fig. 8 is a plan view of the front surface 15a side of the reagent storage unit 15 installed on the main body member 12.

[0052] As shown in Fig. 4, a recess 50 that constitutes the flow path 20 is formed on the back surface 12b of the main body member 12. The shape of the recess 50 formed in the main body member 12 in a plan view is the same as the shape of the flow path 20 in a plan view, and in Fig. 4 and subsequent figures, the regions that constitute the liquid chambers 21 to 24 and the communication paths 25 to 27 of the recess 50 are indicated using the symbols of the liquid chambers 21 to 24 and the communication paths 25 to 27, respectively.

[0053] 4 and 5, liquid inlets 31-37 communicating with flow path 20 are through-holes provided in main body member 12 so as to penetrate from front to back. Liquid inlet 31, through which sample liquid is introduced, is provided in a position closest to center point C within first liquid chamber 21. Liquid inlets 32-34, through which liquids are introduced into second liquid chamber 22, third liquid chamber 23, and fourth liquid chamber 24, are provided closer to center point C than the liquid chambers 22-24, respectively. Liquid inlets 31-34 are provided in positions that allow introduced liquids to be properly placed in liquid chambers 21-24 by centrifugal force.

[0054] As shown in Figure 5, in this example, the inlets 31 to 37 are arranged on a circle centered at the center point C. On the surface 12a of the main body member 12, a ring-shaped portion 52 where the inlets 31 to 37 are arranged is provided with a step so that the surface is lower than the other portions. The gasket 56 described above is installed on this ring-shaped portion 52. The ring-shaped portion 52 is provided with small protrusions 53 to prevent the gasket 56 from slipping. The gasket 56 may be made of an elastomer material or the like and may be formed integrally with the main body member 12 by two-color molding.

[0055] A cylindrical valve housing portion 54 for housing the valve 16 is provided in the rectangular portion on the front surface 12a side of the main body member 12. Holes 44a, 46a provided at the ends of the detection flow paths 44, 46 open to the bottom surface of the valve housing portion 54.

[0056] Four through holes 48 are provided in the circular portion of the main body member 12, closer to the outer periphery than the recess 50 that forms the flow path 20. The through holes 48 are used when chucking the device 10 into a chuck mechanism of a centrifuge (a device rotation mechanism 110 described below). Four through holes 49 are also provided in the rectangular portion of the main body member 12. The through holes 49 are holes for inserting fixing pins to fix the valve holder 17 to the main body member 12.

[0057] The reagent storage unit 15 is a member independent of the main body 14 and is slidably mounted relative to the main body 14. As shown in FIGS. 6 to 8 , the reagent storage unit 15 has a disk-shaped outer shape and a through-hole 60 at its center, into which the cylindrical portion 19 of the main body member 12 is fitted. The reagent storage unit 15 also has multiple wells 61-67 arranged to surround the through-hole 60. Each of the wells 61-67 is capable of containing a liquid. The reagent storage unit 15 has openings for the wells 61-67 on its front surface 15a, while each has hole-like openings 61a-67a on its back surface 15b, which corresponds to the bottom surface of the wells 61-67. The well 61 has an opening on its front surface that is larger than the other wells 62-67, and its edge forms a boss-like projection that protrudes from the front surface 15a. A removable lid 18 (see FIG. 1 ) is attached to the end of a boss-like projection 70 connected to the edge of the well 61. An opening 72 at the end of the protrusion 70 is a sample liquid inlet into which the sample liquid is introduced.

[0058] The reagent storage unit 15 is attached to the surface 12a of the main body member 12. FIG. 9 is a plan view showing the positional relationship between the wells of the reagent storage unit 15 and the flow path 20 of the main body member 12. As shown in FIG. 9, in the initial state, the reagent storage unit 15 is attached to the main body member 12 so that the openings 61a to 67a of each well 61 to 67 do not coincide with the liquid inlets 31 to 37 of the main body member 12. By sliding and rotating the reagent storage unit 15 relative to the main body member 12, the openings 61a to 67a of each well 61 to 67 can be aligned with the liquid inlets 31 to 37 of the main body member 12, respectively. When the openings 61a to 67a of each well 61 to 67 coincide with the liquid inlets 31 to 37 provided on the surface 12a of the main body member 12, each well 61 to 67 is in communication with the flow path 20, and liquid in each well 61 to 67 can be sent to the flow path 20.

[0059] 8, with the reagent storage unit 15 attached to the main body member 12, the magnetic particle solution S1 is stored in well 61, the cleaning solution S2 is stored in well 63, and the elution solution S3 is stored in well 67, while the hydrophobic liquid S4 is stored in wells 62, 64, 65, and 66. In this way, the reagent storage unit 15 stores the magnetic particle solution S1, the cleaning solution S2, the elution solution S3, and the hydrophobic liquid S4 independently in the wells 61 to 67.

[0060] When the reagent storage unit 15 is rotated relative to the main body member 12, the openings 61a to 67a of each well 61 to 67 do not simultaneously coincide with the liquid inlets 31 to 37 of the main body member 12. In this example, the openings 61a, 63a, and 67a of the wells 61, 63, and 67 that contain the magnetic particle solution S1, cleaning solution S2, and elution solution S3, which are aqueous liquids, simultaneously coincide with the liquid inlets 31, 32, and 33 that communicate with the first liquid chamber 21, the second liquid chamber 22, and the third liquid chamber 23, respectively. Furthermore, the openings 62a, 64a, 65a, and 66a of the wells 62, 64, 65, and 66 that contain the hydrophobic liquid S4 simultaneously coincide with the liquid inlets 35 to 37 that communicate with the fourth liquid chamber 24, the first communication path 25, the second communication path 26, and the third communication path 27, respectively. This allows the magnetic particle solution S1, cleaning liquid S2, and elution liquid S3, which are water-based liquids, to be introduced into the flow path 20 simultaneously, and also allows the hydrophobic liquid S4 to be introduced into multiple locations in the flow path 20 simultaneously.

[0061] As already mentioned, the opening of the well 61 is sealed by the lid 18. The openings of the other wells 62 to 67 are sealed by sealing films (not shown).

[0062] "Testing Apparatus" Here, a testing apparatus applicable to a method for testing an object to be detected, including a purification process for the object to be detected, using device 10 will be described. Device 10 is loaded into testing apparatus 100, the schematic configuration of which is shown in Fig. 10, and testing of the object to be detected is carried out. One example of testing apparatus 100 is a nucleic acid testing apparatus, and the object to be detected is a specific nucleic acid.

[0063] The inspection device 100 shown in Fig. 10 includes a device rotation mechanism 110, a magnet rotation mechanism 120, a heating unit 130, and a light detection unit 140. Fig. 11 is a plan view showing the positional relationship between the device 10 and the rotation axis A of the device rotation mechanism 110 and the rotation orbit of the magnet 124 caused by the magnet rotation mechanism 120.

[0064] The device rotation mechanism 110 includes a rotation drive unit 112 such as a motor, a mounting unit 113 to which the device 10 is mounted, and a rotary coupler 114 connected to the shaft of the rotation drive unit 112 and rotatably supporting the mounting unit 113. The mounting unit 113 is equipped with a chuck mechanism that chucks the device 10. The mounting unit 113 is an example of a "loading unit" in the technology disclosed herein. The device 10 is detachable from the mounting unit 113. The chuck mechanism is, for example, a claw that fits into a through-hole 48 formed in the device 10. By driving the rotation drive unit 112, the mounting unit 113 is rotated about a rotation axis A, thereby rotating the device 10. As shown in FIG. 11 , axis A, which is the rotation center of the device rotation mechanism 110, passes through a center point C of the circular portion of the device 10. In other words, the device 10 rotates around center point C. The device rotation mechanism 110 is an example of a "centrifuge" in the technology disclosed herein.

[0065] The magnet rotation mechanism 120 includes a rotation drive unit 122 such as a motor, a magnet 124, and a support unit 126 that rotates the magnet 124 around a rotation axis B. The magnet 124 may be a permanent magnet or an electromagnet, but a permanent magnet is preferred due to its simple configuration. FIG. 11 is a plan view showing the positional relationship between the device 10 and the rotational orbit of the magnet 124 caused by the magnet rotation mechanism 120. The magnet 124 rotates around axis B and moves along the communication path of the flow path 20. The magnet rotation mechanism 120 rotates the magnet 124 along a circle with the same radius as the radius of the arc of the communication paths 25-27 of the device 10, which are arc-shaped flow paths. The rotational radius of the magnet 124 being the same as the radius of the arc of the communication paths 25-27 means that, as shown in FIG. 11, the rotational orbit of the magnet 124 approximately coincides with the arc-shaped flow path, and that the range of movement of the magnet within the arc-shaped flow path as the magnet 124 rotates coincides.

[0066] By combining the rotation of the magnet 124 by the magnet rotation mechanism 120 and the rotation of the device 10 by the device rotation mechanism 110, the magnet 124 can be moved from the first liquid chamber 21 located at the beginning of the flow path 20 to the third liquid chamber 23 located at the end.

[0067] The heating unit 130 is provided so as to be movable between a position in contact with the bottom surface of the processing chamber 42 of the device 10 attached to the testing apparatus 100 and a position spaced apart from it. The heating unit 130 is disposed at a position spaced apart from the device 10 while the device 10 is being rotated by the device rotation mechanism 110, and is disposed at a position in contact with the bottom surface of the processing chamber 42 when the device 10 is stationary. The heating unit 130 heats the liquid contained in the processing chamber 42. Here, the processing chamber 42 contains a mixture of an eluate containing a purified detection target and a reagent S6.

[0068] The heating unit 130 is equipped with a Peltier element or the like and is capable of controlling the temperature, and performs a temperature cycle for nucleic acid amplification.

[0069] The light detection unit 140 optically detects whether or not a detection target substance is contained. The light detection unit 140 is disposed opposite the heating unit 130 across the device 10. Light detection by the light detection unit 140 is also performed when the rotation of the device 10 by the rotation mechanism 110 is stopped. The light detection unit 140 irradiates the treatment chamber 42 with excitation light L1 of a specific wavelength and detects fluorescence L2 emitted from the fluorescent probe excited by the excitation light L1. The excitation light L1 is selected according to the excitation wavelength of the fluorescent probe.

[0070] The light detection unit 140 includes a light source such as an LED or laser as a mechanism for irradiating excitation light, a wavelength selection filter that transmits only the wavelength of light emitted from the light source that corresponds to the excitation wavelength of the probe, and a condenser lens. The light detection unit 140 also includes a photodetector such as a photodiode or a photomultiplier tube as a mechanism for detecting fluorescence. The light detection unit 140 may also use an image sensor such as a CMOS (Complementary Metal Oxide Semiconductor) or a CCD (Charge Coupled Device) as the photodetector to acquire a two-dimensional image of the fluorescence emitted from the fluorescent probe.

[0071] The testing device 100 also includes a reagent storage section rotation mechanism (not shown) that causes the reagent storage section 15 to slide and rotate around a center point C relative to the main body member 12, and a valve rotation mechanism that rotates the valve 16 to switch between the first state, the second state, and the third state.

[0072] Furthermore, the inspection device 100 includes a control unit (not shown) that controls the operation of the entire device. The control unit is realized by a computer including a processor configured by a central processing unit (CPU), non-volatile memory (NVM), random access memory (RAM), etc.

[0073] "Testing Method" The user removes the lid 18 of the device 10 from the protrusion 70 connected to the edge of the well 61, pours a sample liquid into the opening 72, and then attaches the lid 18. For example, the sample liquid may be obtained by dissolving a sample collected from the nasal cavity, pharynx, or oral cavity of a subject or an affected area using a swab or the like into a solution, or a body fluid such as a nasal cavity, pharynx, or oral cavity wash, saliva, urine, or blood.

[0074] The well 61 having the opening 72 at its end contains the magnetic particle solution S1, and the sample liquid is mixed with the magnetic particle solution S1 in the well 61. The substance to be detected in the sample liquid binds to the modifiers that modify the magnetic particles M, and is thereby captured by the magnetic particles M.

[0075] The user mounts the device 10 on the mounting portion 113 of the testing device 100. The following processing is performed within the testing device 100. First, the pre-processing step of arranging the liquids S1 to S4 contained in the wells 61 to 67 at predetermined positions within the flow path 20 prior to the purification processing will be described with reference to FIGS.

[0076] In the initial state shown in step ST1, each of the wells 61 to 67 of the reagent storage unit 15 of the device 10 is in a closed state and not in communication with the flow path 20 of the main body member 12. In step ST2, the reagent storage unit 15 is rotated, and as shown in step ST3, the openings 61 a, 63 a, and 67 a of the wells 61, 63, and 67, which respectively contain the mixed liquid of the magnetic particle solution S1 and the specimen liquid, the cleaning liquid S2, and the elution liquid S3, are aligned with the liquid inlets 31, 32, and 33, which respectively communicate with the first liquid chamber 21, the second liquid chamber 22, and the third liquid chamber 23. That is, in step ST3, the wells 61, 63, and 67, which contain the aqueous liquid, are in communication with the flow path 20.

[0077] Thereafter, in step ST4, the device 10 is rotated and centrifuged by the device rotation mechanism 110. As a result, the mixed liquid of the magnetic particle solution S1 and the specimen liquid in the well 61 is sent to the first liquid chamber 21, the washing liquid S2 in the well 63 is sent to the second liquid chamber 22, and the elution liquid S3 in the well 67 is sent to the third liquid chamber 23. As a result, as shown in step ST5, the water-based liquids S1 to S3 are each placed in their respective predetermined positions. Specifically, the mixed liquid of the magnetic particle solution S1 and the specimen liquid is contained in the first liquid chamber 21, the washing liquid S2 is contained in the second liquid chamber 22, and the elution liquid S3 is contained in the third liquid chamber 23.

[0078] Next, in step ST6 (see FIG. 13), the reagent storage unit 15 is rotated, and as shown in step ST7, the openings 62a, 64a, 65a, and 66a of the wells 62, 64 to 66 containing the hydrophobic liquid S4 are aligned with the liquid inlets 35, 36, 34, and 37 which respectively communicate with the first communication path 25, the second communication path 26, the fourth liquid chamber 24, and the third communication path 27. That is, in step ST6, the wells 62, 64 to 66 containing the hydrophobic liquid S4 are in communication with the flow path 20.

[0079] Thereafter, in step ST8, the device 10 is rotated and centrifuged by the device rotation mechanism 110. As a result, the hydrophobic liquid S4 in the well 62 is sent to the first communication path 25, the hydrophobic liquid S4 in the well 64 is sent to the second communication path 26, the hydrophobic liquid S4 in the well 65 is sent to the fourth liquid chamber 24, and the hydrophobic liquid S4 in the well 66 is sent to the third communication path 27. As a result, as shown in step ST9, the hydrophobic liquid S4 is disposed in each of the predetermined positions. Specifically, the hydrophobic liquid S4 is contained in each of the first communication path 25, the second communication path 26, the fourth liquid chamber 24, and the third communication path 27.

[0080] Through the above process, the mixture of the magnetic particle solution S1 and the sample liquid contained in the first liquid chamber 21, the cleaning liquid S2 contained in the second liquid chamber 22, and the elution liquid S3 contained in the third liquid chamber 23 are contained in the flow path 20 in a state separated by the hydrophobic liquid S4.

[0081] Thereafter, in step ST10, the reagent storage unit 15 is rotated relative to the main body member 12 to bring the reagent storage unit 15 into a state in which none of the wells 61 to 67 communicate with the flow channel 20, similar to the initial state.

[0082] Next, the purification process and the detection process will be described with reference to FIGS. 14 to 16. A magnet 124 is rotated while in contact with the thin film 13 on the back surface of the device 10. The two-dot chain line in FIG. 14 indicates the rotational orbit of the magnet 124. First, as shown in step ST11, the magnet 124 moves from one end of the first liquid chamber 21 to the other along the solid arrow. As a result, as shown in step ST12, magnetic particles M in the mixture of the magnetic particle solution S1 and the sample liquid contained in the first liquid chamber 21 are attracted to the magnet 124 and move together with the magnet 124. If a detection target is present in the sample liquid, the detection target will be bound to the magnetic particles M, and will move together with the magnetic particles M as the magnet 124 moves.

[0083] 15 , the device 10 is rotated by 90°. Then, by rotating the magnet 124, it is moved along the first communication path 25 to the second liquid chamber 22. As the magnet 124 moves, the magnetic particles M are transported from the first liquid chamber through the first communication path 25 into the cleaning solution S2 in the second liquid chamber 22. In the cleaning solution S2, the sample liquid, the magnetic particle solution, and impurities adhering to the magnetic particles M are removed.

[0084] Thereafter, the device 10 is rotated 90° to move the magnet 124 from the second liquid chamber 22 to the fourth liquid chamber 24 along the second communication path 26, and the device 10 is further rotated 90° to move the magnet 124 from the fourth liquid chamber 24 to the third liquid chamber 23 along the third communication path 27. In this way, by combining the rotation of the device 10 and the rotation of the magnet 124, the magnet 124 moves within the flow path 20 from the first liquid chamber 21 located at the start end to the third liquid chamber 23 located at the end end, as shown in step ST14, thereby transporting the magnetic particles M to the third liquid chamber 23. As a result, the magnetic particles M are transported from the magnetic particle solution S1 through the hydrophobic liquid S4, the washing liquid S2, and the hydrophobic liquid S4, and into the elution liquid S3.

[0085] When the magnetic particles M are moved into the elution solution S3, the nucleic acids bound to the magnetic particles M are released and eluted into the elution solution S3.

[0086] Through the above steps, the nucleic acid is purified, and an eluate S3 (hereinafter referred to as an extract S31) containing purified nucleic acid is obtained in the third liquid chamber 23.

[0087] Here, the magnetic particles M from which the nucleic acids have been released are moved from the third liquid chamber 23 to the fourth liquid chamber 24. By rotating the magnet 124 in the opposite direction, the magnet 124 can be moved from the third liquid chamber 23 to the fourth liquid chamber 24 via the third communication path 27, and the magnetic particles M can be moved to the fourth liquid chamber 24. At this time, the magnetic particles M may also be moved further to the second liquid chamber 22 or the first liquid chamber 21.

[0088] Thereafter, the following process is performed as the detection step. As shown in step ST15 of Fig. 16 , the valve 16 of the device 10 is rotated to switch to a first state in which the third liquid chamber 23 and the reagent containing section 40 are in communication with each other. The device 10 is then rotated and centrifuged by the device rotation mechanism 110. The centrifugal force of this rotation sends the extracting liquid S31 in the third liquid chamber 23 to the reagent containing section 40. In the reagent containing section 40, the extracting liquid S31 and the freeze-dried reagent S6 (hereinafter referred to as the freeze-dried reagent S6) are mixed.

[0089] Next, the valve 16 is rotated to switch to the second state in which the reagent storage unit 40 and the processing chamber 42 are in communication with each other. Thereafter, the device 10 is rotated and centrifuged by the device rotation mechanism 110. The centrifugal force of the rotation sends the mixture of the extracting liquid S31 and the lyophilized reagent S6 in the reagent storage unit 40 to the processing chamber 42. After the mixture has been sent to the reagent storage unit 40, the valve 16 is rotated to switch to the first state or the third state so as to seal the processing chamber 42.

[0090] In this state, the device 10 is rotated so that the processing chamber 42 of the device 10 coincides with the processing position where the heating unit 130 and the light detection unit 140 are arranged.

[0091] In this example, the freeze-dried reagent S6 contains a nucleic acid amplification reagent and a fluorescent probe, and the nucleic acid amplification process and the fluorescence detection process are carried out in the process chamber 42.

[0092] Nucleic acid amplification is a process for amplifying a specific nucleic acid, which is a target substance to be detected. The heating unit 130 is moved to a position where it contacts the bottom of the processing chamber 42, and the heating unit 130 performs a temperature cycle on the liquid in the processing chamber 42, thereby amplifying the nucleic acid. While the nucleic acid amplification method is not limited, examples include polymerase chain reaction (PCR) and reverse transcription PCR (RT-PCR). When PCR is used, the following steps are repeated: a thermal denaturation step in which double-stranded DNA (deoxyribonucleic acid) is dissociated into single-stranded DNA at high temperature; an annealing step in which the temperature is then lowered to allow primers to bind to the single-stranded DNA; and an extension step in which new double-stranded DNA is synthesized using polymerase with the single-stranded DNA as a template. An example of the temperature cycle for the thermal denaturation step, annealing step, and extension step is one cycle of 94°C for 1 minute, 50-60°C for 1 minute, and 72°C for 1-5 minutes, repeated 20-50 times. Alternatively, the thermal denaturation step and annealing step may be performed at a single temperature. An example of such a temperature cycle is one cycle of 94°C for 1 minute and 60°C for 1 minute, repeated 20-50 times. There are no particular limitations on the temperature and time of the temperature cycle in the amplification step, and these may be selected as desired depending on the performance of the polymerase and primers.

[0093] The fluorescence detection process is performed by the light detection unit 140. The light detection unit 140 irradiates the process chamber 42 with excitation light L1 of a specific wavelength and detects fluorescence L2 emitted from the fluorescent probe upon excitation by the excitation light L1. For example, if the nucleic acid amplification process is a PCR method, fluorescence detection is performed for each temperature cycle described above to monitor the amplification status in real time.

[0094] If a specific nucleic acid is present in the sample solution, the nucleic acid is amplified in the amplification step, and fluorescence L2 is detected when excitation light L1 is irradiated onto the fluorescent probe labeled with this specific nucleic acid. On the other hand, if the specific nucleic acid sequence is not present in the sample solution, fluorescence L2 is not detected even when excitation light L1 is irradiated. This makes it possible to determine whether or not the specific nucleic acid is present.

[0095] As described above, the device 10 of this embodiment stores the cleaning solution S2, elution solution S3, and hydrophobic liquid S4 individually, allowing for highly stable storage of reagents such as the cleaning solution S2 and elution solution S3. The flow path 20 has a simple flow path structure including the first to third liquid chambers 21 to 23, and is formed in a manner surrounding the center of rotation (here, center point C). Because the flow path structure is simple, manufacturing costs can be reduced.

[0096] In the device 10 of this embodiment, the flow path 20 includes the first liquid chamber 21 to the fourth liquid chamber 24 and the first to third communication paths 25 to 27. However, as long as the first liquid chamber 21 to the third liquid chamber 23 are included, the fourth liquid chamber 24 may not be included. In this case, the first liquid chamber 21, the second liquid chamber 22, and the third liquid chamber 23 may be arranged at 120° intervals.

[0097] Within the flow path 20, the specimen liquid (in the above example, a mixture of the specimen liquid and the magnetic particle solution S1), the cleaning liquid S2, and the elution liquid S3 can be contained in a state separated by the hydrophobic liquid S4. Then, as a pretreatment for the purification process, the aqueous liquids S1 to S3 and the hydrophobic liquid S4 are alternately arranged. As a result, when the magnetic particles M pass through the interface between the aqueous liquids S1 to S3 and the hydrophobic liquid S4, or when they move through the hydrophobic liquid S4, water containing impurities present around the detection target substance is peeled off by contact resistance with the hydrophobic liquid S4, thereby enhancing the cleaning effect.

[0098] In the device 10 of this embodiment, the communication paths 25-27 are arc-shaped flow paths with the same radius, and the arc-shaped flow paths are arranged in a manner that convexes toward the center point C, which is the center of rotation. Because the communication paths 25-27 are arc-shaped and convex toward the inner diameter side, the outermost peripheries of the communication paths 25-27 can be positioned more inward with respect to the center of rotation than the liquid chambers 21-24. Because the liquid chambers 21-24 are positioned more outer than the communication paths 25-27, when centrifuged, each liquid delivered to the liquid chambers is filled sequentially from the outermost periphery of the liquid chamber, preventing unintentional delivery of liquid to the communication paths, and enabling stable liquid placement.

[0099] In the device 10 of this embodiment, the magnetic particle solution S1 is stored in a well 61 of the reagent storage unit 15. However, the magnetic particle solution S1 does not have to be stored in the reagent storage unit 15. The user may mix the specimen liquid and the magnetic particle solution S1 in advance outside the device 10 and then add the mixture to the well 61. Alternatively, the user may sequentially add the specimen liquid and the magnetic particle solution S1 to the well 61. Furthermore, the magnetic particle solution S1 may be contained in the first liquid chamber 21 in the flow path 20 of the main body 14, into which the specimen liquid is added.

[0100] In the device 10 of this embodiment, the reagent storage unit 15 is rotatably installed relative to the main body member 12 of the main body 14, and by rotating it, the wells 61 to 67 of the reagent storage unit 15 can be connected to the flow path 20. The reagent storage unit 15 is not limited to being rotatable as in this embodiment, but may be moved linearly to connect the wells containing various liquids to the flow path.

[0101] The device 10 of this embodiment includes a reagent storage section 40 and a processing chamber 42 that also serves as a detection chamber, allowing a series of testing processes from purification to detection to be performed within a single device. In this example, the processing chamber 42 also serves as the detection chamber, but a separate detection chamber may also be provided. When a processing chamber and a detection chamber are separately provided, the detection chamber is preferably located radially farther from the center point C than the processing chamber. On the other hand, the flow path device of the present disclosure may not include a reagent storage section 40 or a processing chamber 42, and may only perform purification and extraction of the target substance. In other words, the device 10 may have only a circular portion and no rectangular portion. In this case, the eluate containing the purified target substance can be removed from the device and mixed with a reagent and subjected to detection processing in a separate testing device.

[0102] As in the device 10 of this embodiment, if a reagent storage section 40 for storing reagent S6 is provided separately from the flow path 20 for the purification process, and the device is configured to be able to hold reagent S6 when the reagent storage section 40 is closed by the valve 16, a highly stable freeze-dried reagent can be used.

[0103] In the device 10 of the above embodiment, the reagent storage unit 15 is slidably attached to the main body 14, and the liquids S1 to S4 in the wells 61 to 67 are introduced into the flow path 20 by aligning the openings 61a to 67a provided in the wells 61 to 67 with the liquid inlets 31 to 37 provided in the main body 14. The reagent storage unit is not limited to this configuration. Below, a modified device 210 having a different configuration of the reagent storage unit will be described with reference to FIG. 17. The same components as those of the device 10 are designated by the same reference numerals.

[0104] Modified Device 210 A modified device 210 includes a plurality of blister packs 221 to 226 as a reagent storage section 215. The configuration of the main body member 212 is substantially the same as that of device 10, but because the reagent storage section is not configured to slide relative to the main body member 212, annular portion 52 on which gasket 56 is disposed is not provided.

[0105] Like device 10, device 210 has liquid inlets 31 to 37 that communicate with flow path 20 (see FIGS. 4 and 5). Device 210 includes a cylindrical portion 214 that surrounds liquid inlet 31 and protrudes from the surface. The opening of cylindrical portion 214 is sealed by a detachable lid (not shown) that is attached to the tip of cylindrical portion 214.

[0106] Blister packs 221-226 are positioned and adhered to cover liquid inlets 32-37. As an example, cleaning liquid S2 is stored in blister pack 222, elution liquid S3 is stored in blister pack 226, and hydrophobic liquid S4 is stored in blister packs 221, 223, 224, and 225. Each of liquids S2-S4 is sealed and stored in blister packs 221-226. Breaking protrusions are formed around liquid inlets 32-37, and the surfaces of blister packs 221-226 facing main body member 212 are formed with a sealing member made of a thin film that can be easily broken by the breaking protrusions. When blister packs 221-226 are pressed from the front side, the thin film is broken by the breaking protrusions, and the liquid inside flows out from the broken portion of the thin film. By breaking the thin film, the spaces within the blister packs 221 to 226 are connected to the flow path 20, and the liquids S1 to S4 contained in the blister packs 221 to 226 can be supplied into the flow path 20. The blister packs are an example of a "storage section" in the technology of the present disclosure.

[0107] The testing apparatus for the modified device 210 may be the testing apparatus 100 described above, provided with a pressing mechanism that selectively applies a pressing force as an external force to the blister packs 221 to 226, instead of the reagent storage section rotation mechanism that rotates the rotary reagent storage section 15.

[0108] The following additional notes are further disclosed regarding the above embodiment.

[0109] <Supplementary Note 1> A flow path device comprising a flow path capable of containing a specimen liquid containing a detection target that binds to magnetic particles, wherein the detection target is purified by moving the detection target within the flow path using the magnetic particles, wherein the flow path has a first liquid chamber that contains the specimen liquid, a second liquid chamber that contains a washing liquid that removes impurities contained in the specimen liquid, and a third liquid chamber that contains an elution liquid that elutes the detection target, wherein the specimen liquid, the washing liquid, and the elution liquid can be contained within the flow path while being separated by a hydrophobic liquid, wherein the flow path is a continuous flow path from a start end to a finish end, and is formed in a manner that surrounds the center of rotation when centrifuged in a centrifuge, and further comprising a reagent storage unit that separately stores the washing liquid, the elution liquid, and the hydrophobic liquid before they are introduced into the flow path. <Supplementary Note 2> The flow path device according to Supplementary Note 1, wherein the flow path includes communication paths connecting the first liquid chamber and the second liquid chamber, and the second liquid chamber and the third liquid chamber, and wherein the outermost periphery of the communication paths is closer to the center of rotation than the outermost peripheries of the first liquid chamber, the second liquid chamber, and the third liquid chamber. <Supplementary Note 3> The flow path device according to Supplementary Note 1 or Supplementary Note 2, wherein the flow path includes communication paths connecting the first liquid chamber and the second liquid chamber, and the second liquid chamber and the third liquid chamber, and wherein the outermost periphery of the communication paths is closer to the center of rotation than the outermost peripheries of the first liquid chamber, the second liquid chamber, and the third liquid chamber. <Supplementary Note 4> The flow path device according to any one of Supplementary Note 1 to Supplementary Note 3, wherein the reagent storage unit is made of a member independent of the main body including the flow path and is installed slidably relative to the main body, and the reagent storage unit includes wells that individually store each of the cleaning solution, the elution solution, and the hydrophobic liquid, and the main body has liquid inlets for introducing each liquid into the flow path, and the wells have openings that communicate with the flow path when the reagent storage unit is slid relative to the main body to align with the liquid inlets. <Supplementary Note 5> The flow path device according to Supplementary Note 4, wherein the reagent storage unit is installed rotatably around the rotation center relative to the main body.<Supplementary Note 6> The flow path device according to any one of Supplementary Note 1 to Supplementary Note 5, comprising a main body provided with flow paths, wherein the main body has liquid inlets for introducing each of the cleaning liquid, elution liquid, and hydrophobic liquid into portions of the flow path that communicate with each region of the flow path that accommodates each of the liquids, and the reagent storage unit has storage units for individually storing each of the liquids, each storage unit being arranged corresponding to the liquid inlet for introducing the corresponding liquid, the storage units and the liquid inlets being isolated by a breakable sealing member, and the storage units can communicate with the liquid inlets when the sealing member is broken by an external force. <Supplementary Note 7> The flow path device according to any one of Supplementary Note 1 to Supplementary Note 6, wherein the reagent storage unit stores a magnetic particle solution containing magnetic particles independently of the cleaning liquid, elution liquid, and hydrophobic liquid. <Supplementary Note 8> The flow path device according to Supplementary Note 2 and Supplementary Note 3 to Supplementary Note 7 which cite Supplementary Note 2, wherein the communication path is composed of one or more arc-shaped flow paths having the same radius, and the arc-shaped flow paths are arranged in a manner that they are convex toward the center of rotation. <Supplementary Note 9> The flow path device according to any one of Supplementary Notes 1 to 8, wherein the first liquid chamber contains a magnetic particle solution containing magnetic particles. <Supplementary Note 10> The flow path device according to any one of Supplementary Notes 1 to 10, wherein at least one of the first liquid chamber, the second liquid chamber, and the third liquid chamber is subjected to a hydrophilic treatment. <Supplementary Note 11> The flow path device according to any one of Supplementary Notes 1 to 10, comprising: a reagent containing section connected to the third liquid chamber via a valve, the reagent containing section being arranged farther from the center of rotation than the third liquid chamber, and containing a reagent for the detection target; and a treatment chamber being arranged farther from the center of rotation than the reagent containing section, for treating a mixture of the reagent and the detection target. <Supplementary Note 12> The flow path device according to Supplementary Note 11, comprising a detection chamber for containing the mixture treated in the treatment chamber, and for optically detecting the detection target from the outside. <Supplementary Note 13> The flow path device according to any one of Supplementary Note 1 to Supplementary Note 12, wherein the hydrophobic liquid has a specific gravity lower than that of the cleaning liquid and the elution liquid. <Supplementary Note 14> The flow path device according to Supplementary Note 13, wherein the hydrophobic liquid is silicone oil.<Supplementary Note 15> The flow channel device according to any one of Supplementary Note 1 to Supplementary Note 14, wherein the flow channel is formed by a main body member having a recess on one surface and a thin film bonded to one surface of the recess. <Supplementary Note 16> An inspection apparatus comprising: a loading section for detachably loading the flow channel device according to Supplementary Note 8 and Supplementary Note 9 to Supplementary Note 15 which cite Supplementary Note 8; a device rotation mechanism for rotating the flow channel device loaded in the loading section; and a magnet rotation mechanism for rotating a magnet along a circle having the same radius as the radius of the arc-shaped flow channel, wherein the magnetic particles are moved along the flow channel by combining the rotation of the flow channel device and the rotation of the magnet.

[0110] The disclosure of Japanese Patent Application No. 2023-145445, filed on September 7, 2023, is incorporated herein by reference in its entirety. All documents, patent applications, and technical standards mentioned herein are incorporated herein by reference to the same extent as if each individual document, patent application, and technical standard was specifically and individually indicated to be incorporated by reference.

Claims

1. A flow path device having a flow path capable of containing a specimen liquid containing a detection target that binds to magnetic particles, and in which the detection target is purified by moving the detection target within the flow path using the magnetic particles, wherein the flow path has a first liquid chamber that contains the specimen liquid, a second liquid chamber that contains a washing liquid that removes impurities contained in the specimen liquid, and a third liquid chamber that contains an elution liquid that elutes the detection target, wherein the specimen liquid, the washing liquid, and the elution liquid can be contained within the flow path in a state separated by a hydrophobic liquid, wherein the flow path is a continuous flow path from a starting end to an end end and is formed in a manner that surrounds the center of rotation when centrifuged in a centrifuge, and further comprising a reagent storage section that separately stores the washing liquid, the elution liquid, and the hydrophobic liquid before they are introduced into the flow path.

2. A flow path device as described in claim 1, wherein the flow path has connecting paths respectively connecting the first liquid chamber and the second liquid chamber, and the second liquid chamber and the third liquid chamber, and the outermost periphery of the connecting paths is arranged closer to the center of rotation than the outermost peripheries of the first liquid chamber, the second liquid chamber, and the third liquid chamber.

3. A flow path device as described in claim 1 or 2, wherein the first liquid chamber is provided at the starting end of the flow path, the second liquid chamber is provided between the starting end and the ending end of the flow path, and the third liquid chamber is provided at the ending end of the flow path.

4. A flow path device as described in claim 1 or 2, wherein the reagent storage unit is made of a member independent of a main body having the flow path and is installed so as to be slidable relative to the main body, and the reagent storage unit has wells for individually storing each of the cleaning solution, the elution solution and the hydrophobic liquid, the main body has liquid inlets for introducing each of the liquids into the flow path, and the well has an opening that communicates with the flow path by sliding the reagent storage unit relative to the main body to align it with the liquid inlets.

5. The flow path device according to claim 4, wherein the reagent storage section is rotatably installed on the main body with the center of rotation as an axis.

6. A flow path device as described in claim 1 or 2, comprising a main body having the flow path, the main body having liquid inlets for injecting each of the cleaning solution, the elution solution and the hydrophobic liquid into portions of the flow path that communicate with each of the regions that accommodate the cleaning solution, the elution solution and the hydrophobic liquid, the reagent storage unit having storage sections that store each of the liquids individually, each of the storage sections being arranged corresponding to the liquid inlets for injecting the liquid, the storage sections and the liquid inlets being isolated by a breakable sealing member, and the storage sections can be connected to the liquid inlets by breaking the sealing member due to an external force.

7. The flow path device according to claim 1 or 2, wherein the reagent storage section stores a magnetic particle solution containing the magnetic particles separately from the cleaning liquid, the elution liquid, and the hydrophobic liquid.

8. A flow path device as described in claim 2, wherein the communication path is composed of one or more arc-shaped flow paths having the same radius, and the arc-shaped flow paths are arranged in a convex manner toward the center of rotation.

9. A flow path device according to claim 1 or 2, wherein the first liquid chamber contains a magnetic particle solution containing the magnetic particles.

10. The flow path device according to claim 1 or 2, wherein at least one of the first liquid chamber, the second liquid chamber and the third liquid chamber is subjected to a hydrophilic treatment.

11. A flow path device as described in claim 1 or 2, comprising: a reagent storage section connected to the third liquid chamber via a valve, the reagent storage section being positioned farther from the center of rotation than the third liquid chamber and containing a reagent for the substance to be detected; and a processing chamber being positioned farther from the center of rotation than the reagent storage section, in which a processing is performed on a mixture of the reagent and the substance to be detected.

12. The flow path device according to claim 11, further comprising a detection chamber for containing the mixed liquid processed in the processing chamber and for optically detecting the detection target substance from the outside.

13. The flow path device according to claim 1 or 2, wherein the hydrophobic liquid has a specific gravity smaller than that of the cleaning liquid and the elution liquid.

14. The flow path device of claim 13, wherein the hydrophobic liquid is silicone oil.

15. A flow path device according to claim 1 or 2, wherein the flow path is formed by a main body member having a recess on one surface and a thin film bonded to the one surface in a manner covering the recess.

16. An inspection apparatus comprising: a loading section for detachably loading the flow path device described in claim 8; a device rotation mechanism for rotating the flow path device loaded in the loading section; and a magnet rotation mechanism for rotating a magnet along a circle having the same radius as the radius of the arc-shaped flow path, wherein the magnetic particles are moved along the flow path by combining the rotation of the flow path device and the rotation of the magnet.

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