Fluid control device and inspection device

Abstract

In a microchip, we aim to realize a fluid control device that can dilute one fluid with another. [Solution] The fluid control device 11 is a fluid control device on a microchip that discharges both a first fluid 17 and a second fluid 18B that have been introduced, and comprises a main flow channel 20 having a flow channel groove 21 formed on at least one surface of a substrate 10 and a covering material that covers the flow channel groove 21, an outlet 40 that is in fluid communication downstream of the main flow channel 20 and guides both the first fluid 17 and the second fluid 18B, a first reservoir 33 and a second reservoir 38 that are in fluid communication with the main flow channel 20 and store the first fluid 17 and the second fluid 18B respectively, a first fluid control mechanism that controls the discharge of the first fluid 17 from the first reservoir 33, and a second fluid control mechanism that controls the discharge of the second fluid 18B from the second reservoir 38.

Description

Technical Field

[0001] The present invention relates to a fluid control device and an inspection device.

Background Art

[0002] There is known a flow path device that provides a flow path on a substrate and performs biochemical measurement or chemical synthesis by flowing a fluid through the flow path. In particular, microanalysis devices and microreaction devices manufactured using microfabrication technology are preferably used from the viewpoints of miniaturization, portability, small sample volume, small reagent volume, small waste liquid volume, rapidity, etc.

[0003] Also, a microchannel chip used as part of an inspection device has been proposed. For example, International Publication No. 2012 / 060186 (Patent Document 1) discloses a microchannel chip including a resin substrate having a channel groove on one surface and a resin film joined to the resin substrate so as to cover the channel groove. This microchannel chip is manufactured by joining a substrate having a groove for a flow path and a covering material covering the groove, and is used as part of an inspection device capable of performing gene analysis using polymerase chain reaction (PCR) or electrophoresis. In the above-described inspection device, first, in the reaction chamber of the microchip, target DNA in a sample is amplified (gene amplification) by gene analysis (PCR method) using PCR. Then, in a detection region communicating with the reaction chamber through a microchannel, the target substance contained in the generated liquid is optically detected.

[0004] On the other hand, in recent years, as a rapid diagnostic method for viruses and bacteria such as the novel coronavirus, inspection kits using nucleic acid amplification methods have been commercially available. The nucleic acid amplification method is performed in the following procedure. (1) Prepare a nucleic acid amplification reagent that acts to amplify a part of the virus gene, and add a sample (such as saliva or nasopharyngeal swab) to the nucleic acid amplification reagent. (2) Perform an amplification reaction of the virus gene (nucleic acid) in the sample by the nucleic acid amplification reagent to obtain an amplification reaction solution. (3) Detect the virus gene (gene amplification product) amplified by several tens of thousands of times by the reaction with the nucleic acid amplification reagent from the amplification reaction solution. The PCR method described above is also one type of nucleic acid amplification method. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] International Publication No. 2012 / 060186 [Overview of the project] [Problems that the invention aims to solve]

[0006] The testing device described in Patent Document 1 involves a micro-pump connected to a microchip that delivers the reacted sample to the detection unit. This requires an external pump, which tends to make the device complex. In the nucleic acid amplification test kit described above, a high sample concentration is desirable during the amplification reaction stage described in (2) above. However, if the viscosity, concentration, etc., of the amplification reaction solution described in (3) above are too high, the gene amplification product may be difficult to detect in the detection unit. However, adding a further step to dilute the amplification reaction solution to a state (viscosity, concentration, etc.) suitable for detection may make the test complicated, even while maintaining the form of a test kit.

[0007] Therefore, there is a need for a fluid control device that can autonomously dilute one fluid with another in a microfluidic chip, and for an inspection device that applies this device. [Means for solving the problem]

[0008] The fluid control device according to the present invention is a fluid control device on a microchip that discharges both a first fluid and a second fluid that have been introduced, and is characterized by comprising: a main channel having a flow channel groove formed on at least one surface of a substrate and a covering material covering the flow channel groove; an outlet that is in fluid communication downstream of the main channel and guides both the first fluid and the second fluid; a first reservoir and a second reservoir that are in fluid communication with the main channel and store the first fluid and the second fluid, respectively; a first fluid control mechanism that controls the discharge of the first fluid from the first reservoir; and a second fluid control mechanism that controls the discharge of the second fluid from the second reservoir.

[0009] This configuration includes a first reservoir and a second reservoir, each storing a first fluid and a second fluid, respectively, a first fluid control mechanism for controlling the outflow of the first fluid from the first reservoir, and a second fluid control mechanism for controlling the outflow of the second fluid from the second reservoir. This allows for the simultaneous outflow of two fluids in small volumes, and one fluid can be used to dilute the other.

[0010] Furthermore, the inspection device according to the present invention is an inspection device comprising a fluid control unit that discharges both an introduced sample and a diluent solvent, and a detection unit capable of detecting the sample discharged from the fluid control unit, on a microchip, wherein the fluid control unit comprises a main flow path having a flow path groove formed on at least one surface of a substrate and a covering material covering the flow path groove, an outlet that is in fluid communication downstream of the main flow path and guides both the sample and the diluent solvent, a first reservoir and a second reservoir that are in fluid communication with the main flow path and store the diluent solvent and the sample, respectively, a first fluid control mechanism that controls the discharge of the diluent solvent from the first reservoir, and a second fluid control mechanism that controls the discharge of the sample from the second reservoir, and the detection unit is in fluid communication with the outlet.

[0011] This configuration includes a first reservoir and a second reservoir, each storing the diluent and sample in the microchip, a first fluid control mechanism for controlling the outflow of the diluent from the first reservoir, and a second fluid control mechanism for controlling the outflow of the sample from the second reservoir. This allows both the diluent and sample to be discharged, and the sample to be diluted with the diluent. Furthermore, a grace period can be provided before the sample and diluent mix in the second reservoir, and it is also possible to react the sample with the reaction reagent in the second reservoir and then dilute it with the diluent in the first reservoir. Therefore, it is possible to increase the sample concentration during the nucleic acid amplification reaction between the sample and the reaction reagent, and then dilute the sample solution to the optimal properties (viscosity, concentration, etc.) for detection before detecting the sample (gene amplification product) after the reaction.

[0012] Preferred embodiments of the present invention will be described below. However, the scope of the present invention is not limited by the examples of preferred embodiments described below.

[0013] In the fluid control device according to the present invention, the first reservoir and the second reservoir have a predetermined volume ratio, one is located upstream and the other downstream in the main flow path, the outlet, the first reservoir, and the second reservoir each have through holes formed in the substrate, a covering material covering the lower opening of the through holes is provided at the bottom, and it is preferable that the first fluid and the second fluid flow out together in the predetermined volume ratio.

[0014] With this configuration, both the first fluid and the second fluid are easily discharged in a volume ratio corresponding to the volume ratio of the first reservoir and the second reservoir.

[0015] In the fluid control device according to the present invention, the first reservoir and the second reservoir are configured such that one of them protrudes above the substrate, and it is preferable that one of them is taller than the other.

[0016] In this configuration, of the first fluid in the first reservoir and the second fluid in the second reservoir, the one with the higher liquid level will preferentially flow out to the outlet based on the difference in potential energy (difference in potential head). When the liquid levels of both become equal, the other fluid in the other reservoir will flow out simultaneously with the first fluid, thus facilitating the sequential flow of the first and second fluids.

[0017] In the fluid control device according to the present invention, it is preferable that the height of the second reservoir is greater than the height of the first reservoir, and that the communication portion between the second reservoir and the main flow path is located on the outlet side of the communication portion between the first reservoir and the main flow path.

[0018] With this configuration, based on the difference in potential energy (difference in potential head) between the first fluid in the first reservoir and the second fluid in the second reservoir, the second fluid in the second reservoir flows out to the outlet until the liquid levels of the first and second fluids are equal. Once the liquid levels are equal, the first fluid in the first reservoir also flows out simultaneously. This makes it easy to enable sequential flow, where the second fluid flows out first, followed by the first fluid. For example, if a diluent is introduced as the first fluid in the first reservoir and a sample is introduced as the second fluid in the second reservoir, the sample with a higher concentration will flow out towards the outlet first, followed by the diluent, making it easy to create a configuration where the high-concentration sample is flushed out by the diluent.

[0019] The fluid control device according to the present invention has a predetermined volume ratio between the first reservoir and the second reservoir, and the main flow path has a branching point, a first branch path that communicates fluid to the first reservoir between the branching point and the outlet, and a second branch path that communicates fluid to the second reservoir between the branching point and the outlet, and it is preferable that the length of the flow path from the branching point to the communication portion between the first reservoir and the first branch path and the length of the flow path from the branching point to the communication portion between the second reservoir and the second branch path are different, and that both the first fluid and the second fluid flow out in the predetermined volume ratio.

[0020] With this configuration, by branching the main flow path and varying the length of the flow path from the branching point to each connecting section, the first fluid and the second fluid can be discharged with a time difference.

[0021] The fluid control device according to the present invention comprises a first communication passage that fluidly connects the main flow path and the first reservoir, and a second communication passage that fluidly connects the main flow path and the second reservoir, wherein the main flow path is in fluid communication with the first communication passage and the second communication passage at least one of the side surface and bottom surface of the flow groove of the main flow path, the first fluid control mechanism comprises the first property that the surface of the flow groove of the main flow path is either hydrophobic or hydrophilic, the second property that the surface of the coating material on the flow groove side is the other of hydrophobic or hydrophilic, the first communication passage has the second property, and the first guide portion guides the first fluid introduced into the first reservoir to the first connection portion between the main flow path and the first communication passage, and when the first fluid is introduced into the first reservoir, it is guided to the first guide portion Preferably, the outflow of the first fluid from the first reservoir is controlled by the first fluid forming a first droplet at the first connection portion, and the second fluid control mechanism is characterized in that the main flow path has a first property in which the surface of the flow path groove is either hydrophobic or hydrophilic, and the surface of the coating material on the flow path groove side has a second property in which it is the other of hydrophobic or hydrophilic, and the second communication passage has the second property, and has a second guide portion that guides the second fluid introduced into the second reservoir to the second connection portion between the main flow path and the second communication passage, and when the second fluid is introduced into the second reservoir, the outflow of the second fluid from the second reservoir is controlled by the second fluid guided by the second guide portion forming a second droplet at the second connection portion.

[0022] With this configuration, since the first and second fluid control mechanisms utilize surface tension as described above, a fluid control mechanism can be realized in which the first and second fluids mix autonomously.

[0023] The inspection device according to the present invention includes a communication passage that fluidly connects the main flow path and the first reservoir. The main flow path fluidly communicates with the communication passage at at least one of the side surface and the bottom surface of the flow path groove. The first fluid control mechanism is such that the main flow path has a first property of being either hydrophobic or hydrophilic on the surface of the flow path groove, and the surface of the coating material on the flow path groove side has a second property of being the other of hydrophobic and hydrophilic. The communication passage has the second property, and has a guiding portion that guides either the specimen or the dilution solvent introduced into the first reservoir to the connection portion between the main flow path and the communication passage. When either the specimen or the dilution solvent is introduced into the first reservoir, either the specimen or the dilution solvent guided by the guiding portion forms droplets at the connection portion, thereby controlling the outflow of either the specimen or the dilution solvent from the first reservoir, which is preferable.

[0024] According to this configuration, since the first fluid control mechanism and the second fluid control mechanism are configured to utilize the surface tension as described above, a fluid control mechanism in which the specimen and the dilution solvent are autonomously mixed can be realized.

[0025] The inspection device according to the present invention is such that the flow path groove of the main flow path has a restricted section where the required time for the fluid to pass is regulated, and includes a fluid inlet that fluidly communicates with the flow path groove of the main flow path and introduces the fluid. When the fluid, the dilution solvent, and the specimen are respectively introduced into the fluid inlet, the first reservoir, and the second reservoir, it is preferable that the fluid contacts the droplets at the connection portion and the specimen and the dilution solvent both flow out after a predetermined time.

[0026] According to this configuration, since the flow path groove of the main flow path has a restricted section where the required time for the fluid to pass is regulated, the specimen and the dilution solvent can both flow out after a predetermined time. Therefore, it is easy to cause the specimen that has reacted for a predetermined time to flow out together with the dilution solvent.

[0027] In the inspection apparatus according to the present invention, it is preferable that the regulated section includes a section in which the flow channel groove has a width of 0.8 to 2.0 mm and a depth of 70 to 100 μm.

[0028] This configuration allows for a reduction in the variation in the time required for fluid passage by having the aforementioned section within the regulated area.

[0029] Further features and advantages of the present invention will become clearer through the following description of exemplary and non-limiting embodiments, with reference to the drawings. [Brief explanation of the drawing]

[0030] [Figure 1] Plan view showing an inspection apparatus according to the first embodiment of the present invention. [Figure 2] Cross-sectional view of the inspection device at line AA in Figure 1. [Figure 3] Enlarged view of the main part of the inspection device at line BB in Figure 1. [Figure 4] Enlarged view of the main part of Figure 1 [Figure 5] Cross-sectional view of line CC in Figure 4 [Figure 6] A plan view illustrating the usage status of the inspection device shown in Figure 1. [Figure 7] Figure 6: Cross-sectional view of line DD [Figure 8] A plan view illustrating the usage status of the inspection device shown in Figure 1. [Figure 9] A plan view illustrating the usage status of the inspection device shown in Figure 1. [Figure 10] Figure 9: Cross-sectional view of the FF line [Figure 11] A plan view illustrating the usage status of the inspection device shown in Figure 1. [Figure 12] A plan view illustrating the usage status of the inspection device shown in Figure 1. [Figure 13] A cross-sectional view showing the changes in the liquid levels of the dilution solvent reservoir (first reservoir) and the sample solution reservoir (second reservoir) when using the testing device shown in Figure 1. [Figure 14] Plan view showing an inspection apparatus according to a second embodiment of the present invention. [Figure 15]Enlarged view of the main part of the cross-section of line II in Figure 14. [Figure 16] A cross-sectional view showing the changes in the liquid levels of the dilution solvent reservoir (first reservoir) and the sample solution reservoir (second reservoir) when using the testing device shown in Figure 14. [Figure 17] Plan view showing an inspection apparatus according to a third embodiment of the present invention. [Figure 18] Figure 17 is a plan view illustrating the usage status of the inspection device. [Figure 19] Figure 17 is a plan view illustrating the usage status of the inspection device. [Figure 20] Figure 17 is a plan view illustrating the usage status of the inspection device. [Figure 21] Figure 17 is a cross-sectional view showing the change in liquid level in the (first reservoir) and the sample solution reservoir (second reservoir) when using the testing device. [Figure 22] This figure shows an example of other connection parts in the fluid control unit (fluid control device) of the present invention. [Figure 23] Enlarged view of the main part of the MM line cross-section in Figure 22. [Figure 24] This figure shows an example of other connection parts in the fluid control unit (fluid control device) of the present invention. [Figure 25] Enlarged view of the main part of the cross-section along the NN line in Figure 24. [Modes for carrying out the invention]

[0031] 1. Inspection apparatus according to the first embodiment The inspection apparatus 1 as a first embodiment of the inspection apparatus according to the present invention, and the fluid control unit 11 in the inspection apparatus 1 as a first embodiment of the fluid control device according to the present invention, will be described with reference to Figures 1 to 13. The fluid control unit 11 according to this embodiment is provided on a microchip substrate 10 (hereinafter referred to as substrate 10) with respect to three inlets (fluid inlet 23, dilution solvent reservoir 33, and sample solution reservoir 38) into which a fluid 16, a diluent solvent 17 (an example of the first fluid), and a sample solution 18A (an example of the second fluid), an outlet 40 through which both the diluent solvent 17 and the sample solution 18B flow out, and various flow paths that communicate with these fluids (Figure 1). A first coating material 22 laminated on one side of the substrate 10 forms the bottom surface of the three inlets. The inspection apparatus 1 according to this embodiment is used with the side where the three inlets open (front side in Figure 1) facing upwards and the side where the first coating material 22 is laminated (back side in Figure 1) facing downwards. In the following description, when referring to the direction of the inspection device 1, it refers to the vertical direction based on the orientation in which the inspection device 1 is placed so that the first covering material 22 is in contact with the ground (the orientation shown in Figures 2, 3, and 5). When referring to the horizontal direction of the inspection device 1, it refers to the direction perpendicular to the vertical direction (i.e., the left-right direction in Figures 2, 3, and 5, or the direction perpendicular to the plane of the paper). The depth direction and height direction are the same as the vertical direction. In the following description, the substrate 10 is defined as having a front surface on the side where the three inlet openings are located, and a back surface on the side where the first covering material 22 is laminated.

[0032] [Overview of the inspection equipment] The testing device 1 according to this embodiment is used as a testing kit for infectious diseases caused by viruses, bacteria, etc., and as shown in Figure 1, it comprises a fluid control unit 11 (an example of a fluid control device) and a detection unit 50 capable of detecting diluted sample solution flowing out from the fluid control unit 11 on a microchip. As shown in Figure 6, the testing device 1 is used by introducing the dilution solvent 17 into the dilution solvent reservoir 33 (an example of a first reservoir), introducing the sample solution 18A, which is a reaction solution obtained by mixing the reaction reagent and the sample, into the sample solution reservoir 38 (an example of a second reservoir), and introducing the fluid 16 into the fluid inlet 23. When the dilution solvent 17, the sample solution 18A which is the reaction solution, and the fluid 16 are introduced into the dilution solvent reservoir 33, the sample solution reservoir 38, and the fluid inlet 23, respectively, after a predetermined time of several minutes or more has elapsed, as shown in Figure 11, the sample solution 18B containing the gene amplification product after the reaction with the dilution solvent 17 flows out together as a mixture 19 from the outlet 40. Thus, a mixed solution 19, which is the sample solution 18B after the reaction diluted with diluent solvent 17, flows out of the outlet 40. Then, as shown in Figure 12, the gene amplification product (target substance) in the mixed solution 19 is detected by the detection unit 50. In this specification, the terms "sample" and "sample solution" shall be used regardless of whether the reaction has occurred or the stage of the reaction.

[0033] [Configuration of the fluid control unit] The fluid control unit 11 (an example of a fluid control device) has the function of discharging both the diluent 17 and the sample solution 18A (which is the reaction solution) when they are introduced into the microchip. In other words, the fluid control unit 11 has the function of diluting the sample solution 18B with the diluent 17 on the microchip.

[0034] As shown in Figure 11, the fluid control unit 11 includes a main flow path 20, an outlet 40 downstream of the main flow path 20 that is in fluid communication with the main flow path 20 and guides both the diluent solvent 17 and the sample solution 18B, and a diluent solvent reservoir 33 and a sample solution reservoir 38 that are in fluid communication with the main flow path 20 and store the diluent solvent 17 and the sample solution 18 (18A, 18B), respectively. In this embodiment, the main flow path 20 and the diluent solvent reservoir 33 are in fluid communication via a first communication passage 30, and the main flow path 20 and the sample solution reservoir 38 are in fluid communication via a second communication passage 35. For the sake of distinction, the sample solution 18 immediately after storage, before the reaction has progressed, is referred to as sample solution 18A, and the sample solution 18 after the reaction is referred to as sample solution 18B.

[0035] The fluid control unit 11 includes a first fluid control mechanism that controls the outflow of diluent 17 from the diluent reservoir 33, and a second fluid control mechanism that controls the outflow of sample solution 18 (18A, 18B) from the sample solution reservoir 38.

[0036] Next, the configuration of each part of the fluid control unit 11 will be described in detail.

[0037] As shown in the cross-sectional view in Figure 2, the main channel 20 has a channel groove 21 formed on at least one surface of the substrate 10 and a first covering material 22 that covers the channel groove 21.

[0038] In this embodiment, as shown in detail in Figures 4 and 5, the main flow path 20 is in fluid communication with the first communication passage 30 at a first connection portion X1 in a part of the bottom surface of the flow groove 21 (21B) of the main flow path 20. The main flow path 20 is also in fluid communication with the second communication passage 35 at a second connection portion X2 in a part of the bottom surface of the flow groove 21 (21B) of the main flow path 20.

[0039] In this embodiment, as shown in Figure 1, the flow channel grooves 21 (21A, 21B) of the main flow channel 20 extend in a meandering manner on the substrate 10 in the longitudinal direction (flow direction of the fluid 16). Specifically, the flow channel grooves 21 (21A, 21B) of the main flow channel 20 have five parallel straight sections and four arc-shaped curved sections connecting the five straight sections. With this configuration, the fluid 16 introduced into the fluid inlet 23 is configured to reach the first connection section X1 in a required time of several minutes to several tens of minutes (for example, 5 to 60 minutes) while making four U-turns on the substrate 10. The flow channel grooves 21 of the main flow channel 20 in this embodiment are composed of flow channel grooves 21A and 21B with different depths, as shown in Figures 1 and 3. Specifically, flow channel groove 21A connects to the deeper flow channel groove 21B at point P. The flow channel grooves 21 (21A, 21B) have a restricted section 14 in which the required time for the fluid 16 to pass through is restricted. Details of the regulated section 14 will be described later, but the flow channel grooves 21 (21A, 21B) of the main flow channel 20 are set to have a width of 0.8 to 2.0 mm and a depth of 0.02 to 1 mm, for example.

[0040] (First fluid control mechanism and second fluid control mechanism) The first and second fluid control mechanisms according to this embodiment are both passive valves using surface tension and have the same configuration. In this embodiment, as shown in Figure 6, the first fluid control mechanism releases the diluent 17, which has been introduced into the diluent solvent reservoir 33 and remains in the diluent solvent reservoir 33 and the first communication passage 30, through the action of the fluid 16 introduced into the main flow path 20, and causes it to flow out toward the second connection portion X2 (Figures 8 and 9). The second fluid control mechanism, as shown in Figure 8, releases the sample solution 18 (18B), which has been introduced into the sample solution reservoir 38 and remains in the sample solution reservoir 38 and the second communication passage 35, through the action of the diluent solvent 17, and causes it to flow out toward the outlet 40 (Figures 9 and 11). At this time, the sample solution 18B becomes a mixture 19 with the diluent solvent 17. In other words, the first fluid control mechanism functions as a passive valve that opens the first communication passage 30 in response to the action of the fluid 16, and the second fluid control mechanism functions as a passive valve that opens the second communication passage 35 in response to the action of the diluent solvent 17.

[0041] As shown in Figure 5, the first communication passage 30 according to this embodiment has a first flow channel groove 31 formed to open to the surface of the substrate 10 opposite to the flow channel groove 21 (21B) of the main flow channel 20 (the upper surface in Figure 4), and a second covering material 32 that covers the first flow channel groove 31. The second communication passage 35, similar to the first communication passage 30, has a second flow channel groove 36 formed to open to the surface of the substrate 10 opposite to the flow channel groove 21 of the main flow channel 20 (the upper surface in Figure 4), and a second covering material 32 that covers the second flow channel groove 36. The second covering material 32 partially covers the surface of the substrate 10 (the upper surface in Figure 5) so as to cover both the first flow channel groove 31 and the second flow channel groove 36. The second coating material 32 only needs to cover the first flow channel groove 31 and the second flow channel groove 36, and its shape and size are not limited. However, in this embodiment, as shown in Figure 4, the second coating material 32 covers the first flow channel groove 31 and the second flow channel groove 36, as well as partially covering the dilution solvent reservoir 33 and the sample solution reservoir 38. The parts of the dilution solvent reservoir 33 and the sample solution reservoir 38 that are not covered by the second coating material 32 are left as openings. In this embodiment, the first communication passage 30 and the first fluid control mechanism and the second communication passage 35 and the second fluid control mechanism have the same configuration. Therefore, the first communication passage 30 and the first fluid control mechanism will be described in detail below, and a detailed description of the second communication passage 35 and the second fluid control mechanism will be omitted. Note that in Figures 6, 8, 9, 11, and 12, the second coating material 32 is present on the surface of the substrate 10, similar to Figure 1, but it is omitted from the illustration for explanatory purposes.

[0042] In this embodiment, the first flow channel groove 31 in the first communication passage 30 is a straight groove that is shallower and shorter than the flow channel groove 21B of the main flow passage 20. Specifically, as shown in Figure 4, the length of the first flow channel groove 31 is set such that the length of the main flow passage 20 from the outlet of the fluid inlet 23 to the first connection portion X1 (let's call it the flow channel length M1, not shown) is greater than the length of the first communication passage 30 from the outlet of the dilution solvent reservoir 33 to the first connection portion X1 (let's call it the flow channel length M2). In this embodiment, the flow channel length M1 is set to be sufficiently long, for example, 10 times or more the length of the flow channel length M2.

[0043] The width and depth of the first flow channel groove 31 in the first communication passage 30 are not particularly limited, but in this embodiment, for example, the width is set to be in the range of 0.8 to 2.0 mm and the depth to be in the range of 0.1 to 0.4 mm.

[0044] As shown in Figures 4 and 5, the main channel 20 and the first connecting passage 30 are in fluid communication with each other at the first connection portion X1, by the intersection of parts of their respective flow grooves 21(21B) and 31. Similarly, the main channel 20 and the second connecting passage 35 are in fluid communication with each other at the second connection portion X2, by the intersection of parts of their respective flow grooves 21(21B) and 36. In this embodiment, as shown in the plan view of Figure 4, the first connecting passage 30 and the second connecting passage 35 are connected in such a way that they protrude into the main channel 20. In this embodiment, the first connection portion X1 is located downstream of the fifth straight section of the main channel 20, and the second connection portion X2 is located downstream of the first connection portion X1. In this embodiment, it is preferable that the length of the flow groove 21B between the first connection portion X1 and the second connection portion X2 be shorter, for example, shorter than the length of the first connecting passage 30 and the second connecting passage 35.

[0045] In this embodiment, the thickness of the substrate 10 is approximately 0.75 mm. The depth D2 of the flow channel groove 21B of the main flow channel 20 is approximately 0.6 mm, and the depth D3 of the first flow channel groove 31 of the first connecting passage 30 is approximately 0.15 mm. Therefore, the groove bottom portions (21Bb and 31b) of the flow channel grooves of the main flow channel 20 and the first connecting passage 30 are substantially on the same plane, and the flow channel groove 21B of the main flow channel 20 and the second flow channel groove 36 overlap at their groove bottom portions, and are in fluid communication with each other. With this configuration, a through hole is formed in the substrate 10 at the first connection portion X1, and the first covering material 22 and the second covering material 32 are located on both sides of the through hole, respectively.

[0046] As described above, the second covering material 32 is positioned on the surface of the substrate 10 opposite to the first covering material 22, at least in a location that covers the first flow channel groove 31 of the first communication passage 30 and the second flow channel groove 36 of the second communication passage 35. In this embodiment, the second covering material 32 is positioned to overlap the first connection portion X1 and the second connection portion X2, respectively, in a plan view of the substrate 10. In this embodiment, the second covering material 32 is not positioned on the upper surfaces of the dilution solvent reservoir 33 and the sample solution reservoir 38, but it may extend from the first flow channel groove 31 toward the dilution solvent reservoir 33 and the sample solution reservoir 38. Also, in this embodiment, the first flow channel groove 31 and the second flow channel groove 36 are covered with the same second covering material 32, but the first flow channel groove 31 and the second flow channel groove 36 may be covered with separate covering materials.

[0047] In this embodiment, a substrate 10 made of a hydrophobic resin is used, and the surface (side surface 21Ba and top surface 21Bb) of the channel groove 21B of the main channel 20 is hydrophobic (first property). Note that the bottom surface of the channel groove 21B of the main channel 20 is positioned on the upper side to form the top surface when the inspection device 1 is in use, as shown in Figure 5, and is therefore referred to as the top surface 21Bb in the following description. The resin components constituting the substrate 10 are not particularly limited, but in this embodiment, one or more hydrophobic resins from the group consisting of polycarbonate, cycloolefin copolymer, cycloolefin polymer, polymethylpentene, polystyrene, polymethyl (meth)acrylate, and polyethylene terephthalate are selected. The resin constituting the substrate 10 is preferably one that possesses either heat resistance or transparency, or both.

[0048] The surface of the first covering material 22 that covers the channel grooves 21 of the main channel 20 is hydrophilic (second property). The first covering material 22 only needs to have a hydrophilic surface on the channel groove 21 (21A, 21B) side of the main channel 20, but in this embodiment, a hydrophilic resin film such as hydrophilic acrylic resin is used. The resin constituting the first covering material 22 is preferably one that possesses either heat resistance or transparency, or both. Alternatively, a hydrophilic portion may be provided by applying a hydrophilic coating to a covering material made of hydrophobic resin, or the surface may be made hydrophilic by performing a hydrophilization treatment such as plasma treatment on a covering material made of hydrophobic resin. In this embodiment, the first covering material 22 covers the entire back surface (bottom surface in Figure 5) of the substrate 10, including the channel grooves 21 (21A, 21B) of the main channel 20.

[0049] Since the first channel groove 31 is formed on the same substrate 10 as the channel groove 21 of the main channel 20, the surface (side surface 31a and bottom surface 31b) of the first channel groove 31 is hydrophobic (first property). In this embodiment, the second coating material 32 uses the same hydrophilic resin film as the first coating material 22, and the surface 32A of the second coating material 32 is hydrophilic (second property).

[0050] The sample solution 18 (18A, 18B) used in the testing apparatus 1 of this embodiment is an aqueous solution containing a reaction reagent and the sample. Furthermore, the diluent 17 and the fluid 16 introduced into the fluid inlet 23 are aqueous solutions such as water or a buffer solution. Since the sample solution 18, diluent 17, and fluid 16 are all hydrophilic liquids, in the main channel 20, the fluid 16 is repelled from the surface of the channel grooves 21 (21A, 21B) of the main channel 20 and exhibits wetting properties on the surface of the first coating material 22. Similarly, the diluent solvent 17 is repelled from the surface of the channel groove 21 in the main channel 20 and the surface of the first channel groove 31 in the first connecting passage 30, and exhibits wetting properties on the surfaces of the first coating material 22 and the second coating material 32. The sample solution 18 is repelled from the surface of the channel groove 21 (21A, 21B) in the main channel 20 and the surface of the second channel groove 36 in the second connecting passage 35, and exhibits wetting properties on the surfaces of the first coating material 22 and the second coating material 32.

[0051] Therefore, when fluid 16 is introduced into the main channel 20 from the fluid inlet 23, the fluid 16 flows through the main channel 20 along the surface of the hydrophilic first coating material 22. Similarly, when dilution solvent 17 is introduced into the dilution solvent reservoir 33, the dilution solvent 17 flows through the first communication passage 30 along the surface 32A of the hydrophilic second coating material 32, forming a droplet 17a at the first connection portion X1. When sample solution 18A is introduced into the sample solution reservoir 38, the sample solution 18A flows through the second communication passage 35 along the surface 32A of the hydrophilic second coating material 32, forming a droplet at the second connection portion X2.

[0052] In this embodiment, the first property is hydrophobic and the second property is hydrophilic. The first property is that the working fluid does not spread (i.e., repels), and the second property is that the working fluid spreads, and the degree and physical properties of these properties are not particularly limited. In this embodiment, the surface of the substrate 10, which is hydrophobic (first property), has a contact angle with water of, for example, 60° to 100°. The lower limit of the contact angle of the substrate 10 with respect to water is preferably 70° or more, and more preferably 80° or more. The upper limit of the contact angle of the substrate 10 with respect to water is preferably 95° or less, and more preferably 90° or less. Furthermore, the contact angles of the surfaces of the first coating material 22 and the second coating material 32, which are hydrophilic (second property), with respect to water are, for example, 0° to 40°. The upper limit of the contact angle of the first coating material 22 and the second coating material 32 is preferably 20° or less, and more preferably 10° or less. The contact angles with respect to water in this embodiment are values ​​measured at 25°C using a commercially available contact angle meter.

[0053] The fluid inlet 23 is composed of a through-hole formed in the substrate 10 and a first covering material 22. That is, the fluid inlet 23 is configured to store fluid 16, with the through-hole formed in the substrate 10 as the inner wall portion and the first covering material 22 extending from the main flow path 20 as the bottom portion. The shape and size of the fluid inlet 23 are not limited as long as the fluid 16 can be introduced into the main flow path 20, but in this embodiment it is cylindrical with a diameter of 2 to 5 mm (for example, a diameter of 4 mm). The upper part of the through-hole of the fluid inlet 23 is open.

[0054] In this embodiment, the outlet 40 represents the region downstream from the second connection portion X2 and includes the downstream portion, which includes the end of the main flow path 20, and a notch 40A that is in fluid communication with the end of the main flow path 20. The notch 40A opens on one side of the substrate 10 and penetrates in the thickness direction of the substrate 10, and is the location where the detection unit 50 is attached. The side wall of the notch 40A is hydrophobic, similar to the substrate 10. The open lower surface of the notch 40A is covered with a hydrophilic first coating material 22 that extends from the main flow path 20.

[0055] The external shape and size of the substrate 10 can be set as appropriate, taking into consideration handling and other factors. For example, if it is a rectangle (square or rectangle), it is preferable that each side be between 10 mm and 200 mm, and more preferably between 10 mm and 100 mm. The external shape of the substrate 10 is not particularly limited and may be other polygons, circles, or ellipses. The thickness of the substrate 10 is also not particularly limited and can be, for example, 5 to 20 mm. The resin substrate 10 can be manufactured by resin molding technology, for example, by injection molding, transfer molding, or extrusion molding.

[0056] The dilution solvent reservoir 33, like the fluid inlet 23, is composed of a through-hole formed in the substrate 10 and a first coating material 22. That is, the dilution solvent reservoir 33 is configured to store the dilution solvent 17, with the through-hole formed in the substrate 10 serving as the inner wall portion and the first coating material 22 extending from the main flow path 20 serving as the bottom portion. The upper part of the through-hole of the dilution solvent reservoir 33 is open.

[0057] The sample solution reservoir 38, like the fluid inlet 23 and the dilution solvent reservoir 33, is composed of a through-hole formed in the substrate 10 and a first covering material 22. That is, the sample solution reservoir 38 is configured to store the sample solution 18 (18A, 18B) with the through-hole formed in the substrate 10 as its inner wall portion and the first covering material 22 extending from the main flow path 20 as its bottom portion. The upper part of the through-hole of the sample solution reservoir 38 is open.

[0058] In the fluid control unit 11 according to this embodiment, the fluid inlet 23, the dilution solvent reservoir 33, and the sample solution reservoir 38 have their bottom surfaces composed of a single first covering material 22 and are located on the same plane.

[0059] The dilution solvent reservoir 33 and the sample solution reservoir 38 are configured such that when they are completely filled with dilution solvent 17 and sample solution 18A, the sample solution 18B after the nucleic acid amplification reaction is at a predetermined dilution ratio. In this embodiment, the heights of the dilution solvent reservoir 33 and the sample solution reservoir 38 are the same as the thickness of the substrate 10, and the volume ratio is set by setting the cross-sectional area ratio of the dilution solvent reservoir 33 and the sample solution reservoir 38 to the desired dilution ratio. In this embodiment, the ratio of the cross-sectional area of ​​the sample solution reservoir 38 to the cross-sectional area of ​​the dilution solvent reservoir 33 (cross-sectional area of ​​dilution solvent reservoir 33: cross-sectional area of ​​sample solution reservoir 38) is set to a ratio such as 10:1 to 2:1, preferably 6:1 to 2:1 (for example, about 5:1), and the volume of the dilution solvent reservoir 33 is set to be larger than the volume of the sample solution reservoir 38.

[0060] In this embodiment, the dilution solvent reservoir 33 is cylindrical with a diameter of 3 to 6 mm (for example, 4 mm). The shape of the dilution solvent reservoir 33 is not limited as long as the dilution solvent 17 can be introduced into the first communication passage 30.

[0061] In this embodiment, the sample solution reservoir 38 is cylindrical with a diameter of 1 to 3 mm (for example, 1.5 mm). The shape of the sample solution reservoir 38 is not limited as long as it can introduce the sample solution 18 (18A, 18B) into the second communication passage 35. In this embodiment, the sample solution reservoir 38 is used as a reaction vessel for carrying out a nucleic acid amplification reaction that amplifies genes in the sample. Therefore, the sample solution reservoir 38 is kept warm at a constant temperature (for example, a predetermined temperature between 25 and 65°C) so that the reaction can be carried out at a constant temperature. The warming or heating of the sample solution reservoir 38 may be done by placing the entire testing apparatus 1 in a constant temperature bath or constant temperature chamber, or by placing a heating device such as a heater in contact with the lower surface of the dilution solvent reservoir 33.

[0062] With the above configuration, the diluent solvent 17 in the diluent solvent reservoir 33 and the sample solution 18B in the sample solution reservoir 38 can simultaneously flow out toward the outlet 40 in a volume ratio corresponding to the cross-sectional area ratio of the through-holes, while maintaining the same liquid level.

[0063] In this embodiment, the dilution solvent reservoir 33 and the sample solution reservoir 38 are positioned such that the dilution solvent reservoir is located upstream of the main flow path 20 and the sample solution reservoir 38 is located downstream of the main flow path 20.

[0064] The thickness of the first covering material 22 is not particularly limited, but can be, for example, 0.05 mm or more and 2 mm or less. A thickness of 0.05 mm or more makes it less likely for wrinkles to occur during bonding and makes it easier to adequately seal the flow channel groove 21 of the main flow channel 20. A thickness of 2 mm or less makes it easier to obtain good conformability to the unevenness of the substrate 10.

[0065] The first covering material 22 and the substrate 10 may be joined by providing an adhesive layer on the first covering material 22 side that serves as a bonding layer with the substrate 10, by bonding the substrate 10 and the covering material with an adhesive, or by pressing the substrate 10 and the first covering material 22 together by heat compression.

[0066] The first coating material 22 and the second coating material 32 described above may differ in material, thickness, etc., as long as their surfaces are hydrophilic. Also, the method of joining the substrate 10 and the second coating material 32 may differ from the method of joining the substrate 10 and the first coating material 22. In this embodiment, since the area of ​​the second coating material 32 is smaller than the area of ​​the first coating material 22, the first coating material 22 may be heat-pressed, and the second coating material 32 may be bonded using an adhesive layer or bonding layer.

[0067] (Restricted section) As shown in Figure 1, the fluid control unit 11 according to this embodiment has a restricted section 14 in the flow channel groove 21 (21A, 21B) of the main flow channel 20, where the time required for the fluid 16 to pass through is restricted. That is, the fluid 16 passes through the restricted section 14 of the flow channel groove 21 of the main flow channel 20 for a time required according to a predetermined time set in advance, so the outflow time from the introduction of the sample solution 18A until both the sample solution 18B and the diluent 17 are discharged can be restricted.

[0068] In the restricted section 14, the fluid 16 passes through the flow channel groove 21 of the restricted section 14 for a predetermined time, for example, 5 minutes, 10 minutes, 20 minutes, etc., within a range of 5 to 30 minutes. In this embodiment, the required time in the restricted section 14 is appropriately set according to the reaction time for the sample in the sample solution 18A to react with the reaction reagent, and it is desirable that the predetermined time and the required time for the fluid 16 to pass through be within a tolerance of ±10%, preferably within a tolerance of ±5%. With this configuration, the dilution solvent 17 can be discharged from the first connection part X1 after the predetermined time.

[0069] In the regulated section 14, it is sufficient that the time required for the fluid 16 to pass through is restricted. The regulated section may be set retrospectively by measuring the time required for the flow channel groove 21 of the main flow channel 20 that has already been created, or the time required for the fluid 16 to pass through may be set by adjusting the length, width, depth, etc. of the flow channel groove 21 of the main flow channel 20 to predetermined dimensions.

[0070] The regulated section 14 according to this embodiment includes a first section L1 (not shown). In this embodiment, the first section L1 starts from the starting point S and extends to a point P in the middle of the fifth straight section of the main flow channel 20. The first section L1 is a section in which the width W1 of the flow channel groove 21A of the main flow channel 20 is 0.8 to 2.0 mm and the depth D1 is 0.07 to 0.10 mm (70 to 100 μm). By keeping the width W1 and depth D1 of the flow channel groove 21A of the main flow channel 20 within this range, variations in the flow velocity of the fluid flowing through the channel can be suppressed.

[0071] The width W1 of the channel groove 21A of the main channel 20 is preferably 0.8 to 1.5 mm, and more preferably 0.9 to 1.2 mm. The depth D1 of the channel groove 21A of the main channel 20 is preferably 0.09 to 0.10 mm, and more preferably 0.095 to 0.100 mm.

[0072] In this embodiment, as shown in Figure 3, the main channel 20 has a second section L2 that is deeper than the channel groove 21A of the main channel 20 in the first section L1, which is continuous with the first section L1 (not shown). In this embodiment, the depth D2 of the channel groove 21B of the main channel 20 in the second section L2 is set to 2 to 10 times the depth W1 of the channel groove 21A of the first section (6 times in this embodiment). In the main channel 20, the width W2 of the channel groove 21B of the second section is the same as the width W1 of the channel groove 21A of the first section. By having the second section L2 in the main channel 20, the flow velocity can be reduced, and a long time can be measured without increasing the size of the device. Therefore, a long time (for example, 10 to 30 minutes) can be set as the predetermined time.

[0073] Point P, which is the point where the flow changes from the flow channel groove 21A of the main flow channel 20 in the first section L1 to the flow channel groove 21B of the second section L2, has an inclined surface 21C as shown in Figure 3. In this embodiment, the angle θ between the top surface 21E of the flow channel groove 21B of the main flow channel 20 and the inclined surface 21C in Figure 3 is set to 100°. At point P, the flow channel groove 21A of the main flow channel 20 relating to the first section L1 rapidly expands from a depth D1 to a depth D2 of the flow channel groove 21B relating to the second section L2. This is a so-called rapidly expanding pipe, and when the fluid 16 enters the flow channel groove 21B from the flow channel groove 21A, the flow of the fluid 16 cannot immediately follow the flow channel shape and entrains the surrounding fluid 16, forming a vortex in the rapidly expanding section. Since this vortex is a flow that remains in place, a pressure loss occurs, but in this embodiment, this pressure loss is used to reduce the fluid velocity. The angle θ between the top surface 21E and the inclined surface 21C of the flow channel groove 21B of the main flow channel 20 is not particularly limited, but is preferably 95° to 105°.

[0074] The ratio of the lengths of the first section L1 to the second section L2 (length of L1:length of L2) is not particularly limited, but is preferably 9:1 to 5:5. With such a ratio, it is easy to obtain the effect of suppressing time variability in the first section L1.

[0075] In this embodiment, the cross-sectional shape of the channel grooves 21 (21A, 21B) of the main channel 20 is a rectangle (especially a square), but the shape is not limited. The cross-sectional shape of the channel grooves 21 (21A, 21B) of the main channel 20 may be a trapezoid or a semicircle, and in particular, if the channel grooves 21 (21A, 21B) of the main channel 20 are trapezoidal in shape, with the side on the opening side (the side with the first covering material 22) being larger than the side at the bottom of the groove, the channel grooves 21 of the main channel 20 can be easily manufactured using a mold. In the case of such a shape, the widths W1, W2 and depths D1, D2 of the channel grooves 21 (21A, 21B) refer to the maximum width and maximum depth of the channel grooves 21 (21A, 21B).

[0076] In this embodiment, the main flow path 20 is configured to have a greater flow resistance than the first connecting passage 30. The flow resistance of a flow path is determined by various conditions, and generally, if the main flow path 20 is longer than the first connecting passage 30, has a larger coefficient of friction, is narrower, or has a higher flow velocity, the flow resistance of the main flow path 20 will be greater than that of the first connecting passage 30. In this embodiment, as described above, the flow path length M1 from the fluid inlet 23 to the first connection portion X1 is sufficiently greater than the flow path length M2 from the dilution solvent reservoir 33 to the first connection portion X1, and the flow resistance of the main flow path 20 is greater than that of the first connecting passage 30.

[0077] [Detection Unit Configuration] In the inspection device 1, the detection unit 50 is attached to a notch 40A of the outlet 40 provided on the substrate 10. With this configuration, the detection unit 50 in the inspection device 1 is in fluid communication with the outlet 40 of the fluid control unit 11, and a hydrophilic first coating material 22 provided on the lower surface of the outlet 40 guides the mixed solution 19 of the diluent solvent 17 and the sample solution 18B to the detection unit 50. The detection unit 50 is then able to detect the target substance (gene amplification product) contained in the mixed solution 19 that flows out from the outlet 40. The fluid control unit 11 allows the sample solution 18B, after the nucleic acid amplification reaction has proceeded for a predetermined time, to flow into the detection unit 50 together with the diluent solvent 17. The mixed solution 19 flowing into the detection unit 50 is the sample solution 18B diluted to properties (viscosity, concentration, etc.) suitable for detection, making it easy to detect the target substance (gene amplification product). As the detection unit 50, a detection unit from a commercially available immunochromatographic test kit can be used, and in this embodiment, a detection unit using chromatographic paper with a conjugate pad (for example, a nucleic acid chromatographic strip) is used. Using a detection unit 50 with chromatographic paper with a conjugate pad eliminates the need to add developing solution.

[0078] [Inspection method using inspection equipment] Next, we will explain the inspection method using the inspection device 1, in relation to the functions and operations of each part of the inspection device 1.

[0079] In advance, the sample solution 18A, diluent solvent 17, and fluid 16 are prepared. The sample solution 18A is a reaction solution obtained by mixing a sample, such as saliva or nasopharyngeal swab collected from a person or animal, with a reaction reagent such as a nucleic acid amplification reagent, before the nucleic acid amplification reaction proceeds. The diluent solvent 17 is a solvent used to dilute the sample solution 18B after the nucleic acid amplification reaction, and liquids such as water or buffer are used. The fluid 16 is a fluid control fluid that causes the sample solution 18A remaining in the first communication passage 30 and the diluent solvent reservoir 33 to flow out toward the second connection part X2, and also serves as a timing fluid that measures a predetermined time by the time it takes to pass through the regulated section 14 of the main flow path 20. For this reason, the fluid 16 is a liquid such as water or buffer with small viscosity variations, and it has been confirmed in advance that the time required for the fluid 16 introduced into the fluid inlet 23 to reach the first connection part X1 is within a tolerance of ±5% of the predetermined time. The sample solution 18, diluent 17, and fluid 16 are all hydrophilic.

[0080] First, as shown in Figure 6, fluid 16 is introduced into the fluid inlet 23, diluent 17 into the diluent 17 reservoir 33, and sample solution 18A into the sample solution reservoir 38. The introduction of fluid 16 into the fluid inlet 23 and sample solution 18A into the sample solution reservoir 38 is preferably simultaneous, but may be done slightly out of order, and the order of introduction is not particularly limited. The diluent 17 only needs to be introduced into the diluent 17 reservoir 33 before fluid 16 reaches the first connection part X1, and may be introduced before fluid 16 and sample solution 18A, at the same time as fluid 16 and sample solution 18A, or after fluid 16 and sample solution 18A have been introduced and before fluid 16 reaches the first connection part X1.

[0081] As shown in Figures 6 and 7, the diluting solvent 17 introduced into the diluting solvent reservoir 33 is partially guided out of the diluting solvent reservoir 33 by the surface 32A of the second coating material 32 in the first communication passage 30, filling the first communication passage 30 and being guided further to the first connection portion X1. The diluting solvent 17 then forms a droplet 17a at the first connection portion X1. In this embodiment, as shown in Figure 7, the droplet 17a wets and spreads on the surface 32A of the second coating material 32 above the first connection portion X1, and is held on the surface 32A of the second coating material 32 in a state where it hangs downward due to surface tension and gravity. At this time, the droplet 17a does not come into contact with the first coating material 22. Even if the droplet 17a comes into contact with the side surface 21Ba and top surface 21Bb of the channel groove 21 of the main channel 20, and the side surface 31a and bottom surface 31b of the first channel groove 31, the droplet 17a does not spread out because all of these surfaces are hydrophobic, and remains rounded due to surface tension. With this configuration, the droplet 17a is held in the first connection part X1, and the diluent solvent 17 does not flow out of the first connection part X1 before contact with the fluid 16.

[0082] Similarly, as shown in Figure 6, the sample solution 18A introduced into the sample solution reservoir 38 is guided by the surface 32A of the second coating material 32 in the second communication passage 35, which allows a portion of the sample solution 18A to flow out of the sample solution reservoir 38, filling the second communication passage 35, and further guiding it to the second connection portion X2. The sample solution 18A then forms droplets 18a at the second connection portion X2. The droplets 18a of the sample solution 18A are in a state similar to the droplets 17a of the diluent solvent 17 in Figure 7, and are held on the surface 32A of the second coating material 32. With this configuration, the droplets 18a of the sample solution 18 (18A, 18B) are held at the second connection portion X2, and the sample solution 18 (18A, 18B) does not flow out of the second connection portion X2 before contact with the diluent solvent 17.

[0083] On the other hand, when the fluid 16 is introduced into the fluid inlet 23, it departs from the starting point S, passes through the restricted section 14 of the main flow path 20 in a predetermined time (for example, a pre-set time such as 20 minutes), and reaches just before the first connection section X1 (Figure 8). In this embodiment, the main flow path 20 can restrict the predetermined time by the time required to pass through the main flow path 20, and during this predetermined time, the nucleic acid amplification reaction between the sample and reaction reagent in the sample solution 18A proceeds, resulting in the sample solution 18B containing the nucleic acid amplification product.

[0084] As described above, when the fluid 16 that has passed through the main channel 20 over a predetermined period of time reaches the first connection section X1, it comes into contact with the droplets 17a of the diluent solvent 17. Then, as shown in Figures 9 and 10, at least the diluent solvent 17 flows out from the first connection section X1. In this way, the fluid 16 that has passed through the main channel 20 acts to cause the diluent solvent 17 that had remained in the first communication passage 30 and the diluent solvent reservoir 33 to flow out. The fluid 16 that has passed through the main channel 20, which has a long channel length, loses pressure (propulsion force) due to friction with the walls of the channel before reaching the first connection section X1. Therefore, at the first connection section X1, the outflow of the diluent solvent 17 from the first communication passage 30 takes precedence over the outflow of the fluid 16 from the main channel 20. The fluid control unit 11, at the first connection section X1 where the two channels are connected, opens the other channel by allowing the fluid that has passed through one channel to break the balance of surface tension of the fluid in the other channel, so it can also be called a "surface tension valve" that utilizes surface tension.

[0085] According to the fluid control unit 11 of this embodiment, the dilution solvent 17 in the first communication passage 30 can be released by the action of the fluid 16 introduced into the same substrate 10, without having to perform an operation to open the first communication passage 30 from outside the microchip. Furthermore, in the fluid control unit 11 of this embodiment, the second coating material 32 overlaps at least partially with the first connection portion X1 in a plan view of the substrate 10, so the surface 32A of the second coating material 32 can guide the dilution solvent 17 to the first connection portion X1. That is, in the fluid control unit 11, the surface 32A of the second coating material 32 in the first communication passage 30 acts as a guide that guides the dilution solvent 17 to the first connection portion X1.

[0086] In this embodiment, the fluid control unit 11 is configured such that the flow path length M1 of the main flow path 20 from the fluid inlet 23 to the first connection portion X1 is greater than the flow path length M2 of the first communication passage 30 from the dilution solvent reservoir 33 to the first connection portion X1, and the main flow path 20 has greater tubing resistance than the first communication passage 30. Therefore, when the fluid 16 that has passed through the main flow path 20 comes into contact with the droplets 17a of dilution solvent 17 formed in the first connection portion X1, the dilution solvent 17 flows out of the first connection portion X1 and into the second connection portion X2.

[0087] Similarly, the diluent 17 flowing out from the first connection part X1 reaches just before the second connection part X2 (Figure 9) and comes into contact with the droplet 18a of the sample solution 18B. Then, the sample solution 18B flows out from the second connection part X2 together with the diluent 17. In other words, the diluent 17 flowing out from the first connection part X1 acts to cause the sample solution 18B that had been remaining in the second communication passage 35 and the sample solution reservoir 38 to flow out. This is the same action as the first connection part X1, acting as a "surface tension valve".

[0088] Here, the second connecting passage 35 and the flow channel groove 21B of the main flow channel 20 between the first connection section X1 and the second connection section X2 are both short, and the cross-sectional area of ​​the flow channel groove 21B is large, so the pressure loss due to friction is sufficiently small, and there is no significant difference in the pipeline resistance of the two. Therefore, there is virtually no advantage or disadvantage in terms of pipeline resistance for the outflow of the diluent solvent 17 and the outflow of the sample solution 18B from the second connection section X2. The outflow of the diluent solvent 17 and the sample solution 18B at the second connection section X2 is carried out so that the potential energy (potential head) of both is the same, by matching the liquid level height H1 of the diluent solvent 17 in the diluent solvent reservoir 33 and the liquid level height H2 of the sample solution 18B in the sample solution reservoir 38.

[0089] The outflow of diluent 17 from the diluent reservoir 33 and the outflow of sample solution 18B from the sample solution reservoir 38 will be explained using the cross-sectional views of each reservoir shown in Figure 13. In Figure 13, S1 shows the cross-section along the EE line in Figure 8, S2 shows the cross-section along the GG line in Figure 11, and S3 shows the cross-section along the HH line in Figure 12. As shown in Figure 8, the diluent 17 and sample solution 18B are introduced into the diluent reservoir 33 and the sample solution reservoir 38, respectively, to approximately full volume before outflow. Since the height of each reservoir is equal to the thickness of the substrate 10, the liquid level height H1 of the diluent reservoir 33 and the liquid level height H2 of the sample solution 18B in the sample solution reservoir 38 are the same (S1). Next, due to the action of the fluid 16, the diluent solvent 17 flows out from the first connection part X1, and as shown in Figure 11, when the diluent solvent 17 and sample solution 18B flow out from the second connection part X2, the diluent solvent 17 and sample solution 18B flow out together while maintaining the same liquid level heights H1 and H2 (S2). At this time, the flow rate ratio of the diluent solvent 17 and sample solution 18B is the ratio of the cross-sectional areas of the diluent solvent reservoir 33 and the sample solution reservoir 38. Finally, the diluent solvent 17 and sample solution 18B flow out while matching the liquid level heights H1 and H2 to the same height until a liquid level that can be discharged is reached (S3). In this embodiment, the diluent solvent 17 in the diluent solvent reservoir 33 and the sample solution 18B in the sample solution reservoir 38 flow out together toward the outlet 40 in a volume ratio corresponding to the cross-sectional area ratio of each reservoir, so the sample solution 18B is diluted by the diluent solvent 17 at a constant dilution ratio.

[0090] Since the lower opening of the notch 40A of the outlet 40 is covered with a first hydrophilic coating material 22 that extends from the main flow path 20, the mixture 19 of the hydrophilic diluent 17 and the sample solution 18B can be quickly introduced onto the chromatographic paper with the conjugate pad of the detection unit 50. Through the above process, the gene amplification product (target substance) can be detected in the detection unit 50.

[0091] The test result in the testing device 1 is confirmed by whether or not both detection line C and detection line T appear in the detection unit 50, as shown in an example in Figure 12. If both detection line C and detection line T appear in the detection unit 50, the result is positive; if only detection line C appears, the result is negative.

[0092] In the fluid control unit 11 of the inspection device 1, when the fluid 16 reaches the first connection part X1, the mixed solution 19 of the diluent solvent 17 and the sample solution 18B eventually flows out of the outlet 40 on its own. In this way, the fluid control unit 11 opens the first communication passage 30 in response to the action of the fluid 16, and opens the second communication passage 35 in response to the action of the diluent solvent 17, allowing the diluent solvent 17 and the sample solution 18B to flow out.

[0093] Furthermore, in this embodiment, the fluid control unit 11 allows the fluid 16 introduced into the fluid inlet 23 to pass through the restricted section 14 of the main flow path 20 for a predetermined time, after which both the diluent 17 and the sample solution 18B are discharged. Therefore, when the sample solution 18A, which is the reaction solution before the reaction, is introduced, the sample solution 18B, which has undergone nucleic acid amplification reaction for a predetermined time, can be diluted and introduced into the detection unit 50. The presence of the restricted section 14 suppresses variations in test results caused by variations in reaction time, and since the sample solution 18B is diluted to properties (viscosity, concentration, etc.) suitable for detection before the detection of the nucleic acid amplification product, the accuracy of the test can be improved while maintaining the form of a test kit that is simple and can be detected in a short time.

[0094] As described above, the fluid control unit 11 of the inspection device 1 of this embodiment allows both the diluent 17 and the sample solution 18B in small volumes to flow out on the microchip. In this case, the diluent 17 and the sample solution 18B can be flowed out together in a volume ratio corresponding to the ratio of the internal volumes of the diluent 33 and the sample solution reservoir 38. In particular, in this embodiment, the diluent 17 in the diluent 33 and the sample solution 18B in the sample solution reservoir 38 can flow out toward the outlet 40 simultaneously while maintaining liquid level heights H1 and H2, in a volume ratio corresponding to the cross-sectional area ratio of the through-holes.

[0095] Furthermore, since the first and second fluid control mechanisms of this embodiment are surface tension valves, a fluid control mechanism can be realized in which the diluent solvent 17 and the sample solution 18B are mixed autonomously without any external intervention.

[0096] Furthermore, in this embodiment, the fluid control unit 11 has a restricted section 14 in the flow channel groove 21 of the main flow channel 20. When the fluid 16 is introduced into the main flow channel 20 and comes into contact with a droplet 17a of the diluent solvent 17 at the first connection part X1, the diluent solvent 17 flows out from the first connection part X1. Subsequently, when the diluent solvent 17 comes into contact with a droplet of the sample solution 18B at the second connection part X2, the sample solution 18B can be discharged from the second connection part X2 together with the diluent solvent 17.

[0097] 2. Inspection apparatus according to the second embodiment A second embodiment of the present invention, inspection apparatus 2, will be described with reference to Figures 14 to 16. Inspection apparatus 2 according to the second embodiment differs from the first embodiment in the configuration of the fluid control unit. Specifically, it includes a fluid control unit 12 equipped with a sample liquid reservoir 60, which has a different shape from the sample liquid reservoir 38 of the first embodiment. Inspection apparatus 2 is used in the same manner as inspection apparatus 1. The following description will focus on the differences from the first embodiment. Points not specifically described are the same as in the first embodiment.

[0098] In the testing apparatus 2, the sample liquid reservoir 60 is formed by joining a cylindrical member 61 above the through hole 39 of the substrate 10, and the sample liquid reservoir 60 protrudes above the substrate 10. More specifically, the inner wall of the sample liquid reservoir 60 is formed by connecting the inner wall 61A of the cylindrical member 61 to the side wall 39A of the through hole 39 of the substrate 10. The height of the inner wall of the sample liquid reservoir 60 is 5 to 15 times (for example, 8 to 9 times) that of the sample liquid reservoir 38 of the first embodiment. Here, the height of the dilution solvent reservoir 33 is the shortest distance from the back surface to the front surface of the substrate 10 (i.e., the thickness of the substrate 10), and the height of the sample liquid reservoir 60 is the shortest distance from the back surface of the substrate 10 to the open upper surface of the sample liquid reservoir 60 (upper surface 61B of the cylindrical member 61) in the installed state of the testing apparatus 2 (Figure 15). Furthermore, the cross-sectional area of ​​the through-hole 39 in the substrate 10 and the cross-sectional area of ​​the inner diameter of the cylindrical member 61 are made smaller than the cross-sectional area of ​​the sample liquid reservoir 38 according to the first embodiment. The cross-sectional area of ​​the sample liquid reservoir 60 is not limited to this, but in this embodiment it is set to 1 / 16 to 1 / 4 (for example, 1 / 8) of the cross-sectional area of ​​the sample liquid reservoir 38. In this way, the sample liquid reservoir 60 of this embodiment has the same internal volume as the sample liquid reservoir 38 according to the first embodiment by changing the cross-sectional area and height.

[0099] While not limited to this, an example is to set the dilution solvent reservoir 33 to a height of 0.75 mm and an inner diameter of 4.0 mm, and the sample solution reservoir 60 to a height of 6.45 mm (height of the cylindrical member 5.7 mm) and an inner diameter of 1.5 mm. In this case, the internal volume of the dilution solvent reservoir 33 is 9.4 mm³. 3 The internal volume of the sample solution reservoir 60 is 11.4 mm³. 3 This is the result.

[0100] The dilution solvent reservoir 33 remains unchanged from the first embodiment, and the height of the sample solution reservoir 60 is relatively greater than the height of the dilution solvent reservoir 33. With this configuration, the communication portion (i.e., the second connection portion X2) where the taller sample solution reservoir 38 and the main flow path 20 communicate is located closer to the outlet 40 than the communication portion (i.e., the first connection portion X1) between the dilution solvent reservoir 33 and the main flow path 20.

[0101] The outflow of the diluent solvent 17 from the diluent solvent reservoir 33 and the outflow of the sample solution 18B from the sample solution reservoir 60 will be explained using the cross-sectional views of each reservoir shown in Figure 16. S1 shows the state of the fluid 16, diluent solvent 17, and sample solution 18B corresponding to the EE line cross-section (Figure 8) in the first embodiment. Similarly, S2 shows the state of the fluid 16, diluent solvent 17, and sample solution 18B corresponding to the GG line cross-section (Figure 11), and S3 shows the state of the fluid 16, diluent solvent 17, and sample solution 18B corresponding to the HH line cross-section (Figure 12).

[0102] According to the fluid control unit 12 of the inspection device 2, in the state shown in Figure 8 in the first embodiment, the cross-sections of the diluent solvent reservoir 33 and the sample solution reservoir 38 are in the state shown in S1 in Figure 16. When the diluent solvent 17 and the sample solution 18A are completely filled into the diluent solvent reservoir 33 and the sample solution reservoir 38, respectively, the liquid level height H3 of the sample solution 18B in the sample solution reservoir 60 is greater than the liquid level height H1 of the diluent solvent 17. In this embodiment, the liquid level height H3 is set to approximately 8 times the liquid level height H1.

[0103] Subsequently, due to the action of the fluid 16, the diluent 17 flows out from the first connection part X1, and when the diluent 17 reaches the second connection part X2, it comes into contact with the droplet 18a of the sample solution 18B and opens the second communication passage 35. In this embodiment, based on the difference in potential energy (difference in potential head) between the diluent 17 and the sample solution 18, the sample solution 18B with a higher liquid level H3 preferentially flows out from the second connection part X2 toward the outlet 40. The sample solution 18B continues to preferentially flow out from the second connection part X2 until it matches the liquid level H1 of the diluent 17. Then, as shown in S2 of Figure 16, when the liquid level H3 of the sample solution 18B matches the liquid level H1 of the diluent 17, the diluent 17 and the sample solution 18B flow out together to match each other's liquid levels. At this time, the flow rate ratio of the diluent 17 and the sample solution 18B is the same as in the first embodiment, which is the ratio of the cross-sectional areas of the diluent reservoir 33 and the sample solution reservoir 60. Since the cross-sectional area of ​​the diluent reservoir 33 is larger than that of the sample solution reservoir 60, in the stages from S2 to S3, a mixture with a higher ratio of diluent 17 than sample solution 18B flows out.

[0104] According to the inspection apparatus 2 of this embodiment, the sample solution 18B is preferentially flowed towards the outlet 40 first, and then the diluent solvent 17 is preferentially discharged afterward, so that the sample solution 18B and the diluent solvent 17 can be discharged sequentially. With this configuration, the main flow path 20 and the outlet 40 can be configured to wash away high-concentration or high-viscosity solutions such as the sample solution 18B with the diluent solvent. Even with this configuration, the diluent solvent 17 in the diluent solvent reservoir 33 and the sample solution 18B in the sample solution reservoir 60 both flow towards the outlet 40 in a volume ratio corresponding to the ratio of the internal volumes of each reservoir, so that the sample solution 18B is diluted by the diluent solvent 17 at a constant dilution ratio. Even if the diluent solvent 17 is discharged sequentially after the sample solution 18B in this way, the sample solution 18B can easily reach the detection unit 50, and nucleic acid amplification products (target substances) can be quickly detected in the detection unit 50.

[0105] 3. Inspection apparatus according to the third embodiment Next, the inspection apparatus 3, which is a third embodiment of the present invention, will be described using Figures 17 to 21. The fluid control unit 13 according to the third embodiment differs from the fluid control unit 11 according to the first embodiment in the shape of the main flow path 20 and the arrangement of the diluent solvent reservoir 33 and the sample solution reservoir 38 relative to the main flow path 20. The following description will focus on the differences from the first embodiment. Points that are not specifically described are the same as in the first embodiment. Although the arrangement of the diluent solvent reservoir 33 and the sample solution reservoir 38 according to this embodiment differs from that of the first embodiment, their shape and size are the same.

[0106] The main flow path 20 in the inspection device 3 has, downstream of the regulated section 14, a branch point Q, a first branch path 71 that fluidly communicates with the dilution solvent reservoir 33 between the branch point Q and the outlet 40, and a second branch path 72 that fluidly communicates with the sample solution reservoir 38 between the branch point Q and the outlet 40. The flow path length L3 from the branch point Q to the first connection portion X1 (i.e., the portion communicating between the dilution solvent reservoir 33 and the first branch path 71) and the flow path length L4 from the branch point Q to the second connection portion X2 (i.e., the portion communicating between the sample solution reservoir 38 and the second branch path 72) are different. In this embodiment, the flow path length L3 is longer than the flow path length L4. The first branch path 71 and the second branch path 72 each have direct fluid communication with the outlet 40. Therefore, in this embodiment, the outlet 40 is only the portion of the notch 40A in the substrate 10.

[0107] In the testing apparatus 3, first, as shown in Figure 18, the fluid 16, diluent 17, and sample solution 18A are introduced into the fluid inlet 23, diluent 17 reservoir 33, and sample solution reservoir 38, respectively. Before the outflow of the diluent 17 and sample solution 18B, the liquid levels H1 of the diluent 17 and H2 of the sample solution 18B are approximately the same, as shown in the cross-sectional view of Figure 21(S1).

[0108] The fluid 16 passes through the restricted section 14 and branches into a first branch 71 and a second branch 72 at branch point Q, reaching the second connection section X2 before the first connection section X1, as shown in Figure 19. As a result, the fluid 16 comes into contact with the droplets 18a of the sample solution 18B first at the second connection section X2, and the sample solution 18B flows out of the second connection section X2 first. The liquid levels of the diluent solvent 17 and the sample solution 18B in Figure 19 decrease only in the liquid level H2 of the sample solution reservoir 38, as shown in the cross-sectional view of Figure 21(S2).

[0109] Subsequently, when the fluid 16 reaches the first connection portion X1 and comes into contact with the droplet 17a of the first connection portion X1, the diluent solvent 17 flows out from the second connection portion X2 toward the outlet 40, as shown in Figure 20. Then, as shown in the cross-sectional view in Figure 21(S3), the liquid level of the diluent solvent 17 decreases with a time difference. The flow rate ratio of the diluent solvent 17 and the sample solution 18B that flow out with a time difference is the same as in the first embodiment, as the cross-sectional area ratio of the diluent solvent reservoir 33 and the sample solution reservoir 60. In this way, the diluent solvent 17 and the sample solution 18B flow out to the outlet 40 through the first branch 71 and the second branch 72, respectively, and the nucleic acid amplification product is detected in the detection unit 50.

[0110] In this configuration, the diluent solvent 17 in the diluent solvent reservoir 33 and the sample solution 18B in the sample solution reservoir 38 both flow out toward the outlet 40 in a volume ratio corresponding to the ratio of the internal volumes of each reservoir (in this embodiment, the ratio of the cross-sectional areas of the through-holes of each reservoir), so that the sample solution 18B is diluted at a constant dilution ratio. Furthermore, by branching the main flow path 20 and making the flow path lengths L3 and L4 from the branching point Q to each connecting section different, the diluent solvent 17 and the sample solution 18B can be discharged with a time difference. Even if the diluent solvent 17 flows out after the sample solution 18B with a time difference, the sample solution 18B can easily reach the detection unit 50, and the nucleic acid amplification product (target substance) can be quickly detected in the detection unit 50.

[0111] 4. Other Embodiments Other embodiments of the fluid control device and inspection device according to the present invention will be described below. The configurations disclosed in each of the following embodiments can be applied in combination with configurations disclosed in other embodiments, provided that no inconsistencies arise.

[0112] In the first and second embodiments described above, the diluent reservoir 33 and the sample solution reservoir 38 were described as being located upstream and downstream of the main flow path 20, respectively. However, the configuration is not limited to this, and the diluent reservoir 33 may be located downstream and the sample solution reservoir 38 upstream.

[0113] In the second embodiment described above, the dilution solvent reservoir 33 and the sample solution reservoir 38 were described as having a configuration in which the height of the sample solution reservoir 38 is greater than that of the dilution solvent reservoir 33. However, the configuration is not limited to this, and the height of the dilution solvent reservoir 33 may be greater than that of the sample solution reservoir 38.

[0114] In the third embodiment described above, a configuration in which the channel length L3 is longer than the channel length L4 was explained as an example. However, the configuration is not limited to this, and a configuration in which the channel length L4 is longer than the channel length L3 is also possible.

[0115] In the above embodiment, a fluid control mechanism using a surface tension valve was described as an example. However, the fluid control mechanism is not limited to such a configuration, and other fluid control devices using other fluid control mechanisms may be used, for example.

[0116] In the above embodiments, an example was described in which, in the fluid control mechanism relating to inspection devices 1 to 3, the main flow path 20 and the first connecting passage 30 overlap at the bottom of their respective flow path grooves, and the first connecting passage 30 protrudes into the main flow path 20 in the front view, thereby forming the first connection portion X1. However, the first connection portion X1 and the second connection portion X2 are not limited to such a configuration, as long as the main flow path 20 and the first connecting passage 30, and the main flow path 20 and the second connecting passage 35 are in fluid communication. For example, as shown in Figures 22 and 23, the first connection portion X1 and the second connection portion X2 may be formed by providing the first connecting passage 30 and the second connecting passage 35, respectively, so as to transverse the main flow path 20 in the plan view. In this case, in a microfluidic device having fine flow paths, it is not necessary to precisely control the machining dimensions of the connection portion between the flow path groove 21 of the main flow path 20 and the first flow path groove 31, and the connection portion between the flow path groove 21 of the main flow path 20 and the second flow path groove 36, making it easier to manufacture the fluid control mechanism. Alternatively, as shown in Figures 24 and 25, for example, a first connecting passage 30 and a second connecting passage 35 may be provided so as to abut against the side wall of the main flow path 20, and a connection portion may be formed by fluid communication between the main flow path 20 and the first connecting passage 30, and between the main flow path 20 and the second connecting passage 35 at the side wall portion of each flow channel groove. In this case, the depth D4 of the second flow channel groove is deeper than D3 in the above embodiment.

[0117] In the embodiments described above, the testing devices 1 to 3 were used as testing kits for infectious disease testing, such as testing for viruses and bacteria. However, the configuration is not limited to this, and they may be used for other tests not mentioned above.

[0118] In the above embodiment, an example was described in which the main flow path 20 and the flow path grooves 21 (21A, 21B) constituting it have a restricted section 14. However, the configuration is not limited to such an example, and it is not necessary to have a restricted section 14.

[0119] In the above embodiment, an example was described in which the regulated section 14 is provided in the order of a first section L1 and a second section L2 from the starting point S. However, the configuration is not limited to this, and the second section L2 may be provided before the first section L1, or the second section L2 may be sandwiched between the first section L1, or the first section L1 may be sandwiched between the second section L2, and so on. Also, although an example was described in which the first section L1 is longer than the second section L2, the configuration is not limited to this, and the second section may be longer than the first section L1. Furthermore, although an example was described in which the second section L2 has the same width as the first section L1, the configuration is not limited to this, and the width of the second section L2 may be greater than the width of the first section. For example, the width of the second section L2 may be 2 to 4 times that of the first section L1.

[0120] With regard to other configurations, the embodiments disclosed herein are illustrative in all respects, and it should be understood that the scope of the present invention is not limited thereto. Those skilled in the art will readily understand that modifications can be made as appropriate without departing from the spirit of the invention. Therefore, other embodiments modified without departing from the spirit of the invention are naturally included within the scope of the present invention. [Industrial applicability]

[0121] The present invention can be used, for example, as a dilution device for microchips and an inspection device using the same. [Explanation of Symbols]

[0122] 1-3: Inspection equipment 10: Circuit board 11-13: Fluid control unit (fluid control device) 16 :Fluid 17: Diluting solvent 17a:Droplet 18 (18A, 18B): Sample solution (sample) 18a:Droplet 19: Diluted sample solution 20: Main channel 21: Main channel channel groove 22: First covering material 23: Fluid inlet 30: First connecting corridor 31: Flow channel groove of the first connecting passage (first flow channel groove) 32: Second covering material 32A: Surface of the second coating material 33: Dilution solvent reservoir (first reservoir) 35: Second passageway 36: Second channel channel groove (second channel groove) 38, 60: Sample solution reservoir (second reservoir) 40: Outlet 50: Detection unit 71: The First Crossroads 72: The second fork in the road X1: First connection part X2:Second connection part Q: Branching point W: Width of the channel groove D: Depth of the channel groove

Claims

1. A fluid control device on a microchip that discharges both the introduced first fluid and the second fluid, A main channel having a channel groove formed on at least one surface of a substrate, and a covering material covering the channel groove, A fluid outlet is provided downstream of the main flow path, which communicates with the fluid and guides both the first fluid and the second fluid. A first reservoir and a second reservoir are connected to the main flow path, and the first fluid and the second fluid are stored in them, respectively. A first fluid control mechanism for controlling the outflow of the first fluid from the first reservoir, A second fluid control mechanism for controlling the outflow of the second fluid from the second reservoir, A fluid control device equipped with the following features.

2. The first reservoir and the second reservoir have a predetermined volume ratio, and in the main flow path, one is located on the upstream side and the other on the downstream side. The outlet, the first reservoir, and the second reservoir each have through holes formed in the substrate, and a covering material covering the lower opening of the through holes forms the bottom. The fluid control device according to claim 1, wherein the first fluid and the second fluid are discharged together in the predetermined volume ratio.

3. The fluid control device according to claim 2, wherein the first reservoir and the second reservoir are configured such that one of them protrudes above the substrate, and one of them is taller than the other.

4. The height of the second reservoir is greater than the height of the first reservoir. The fluid control device according to claim 3, wherein the communication portion between the second reservoir and the main flow path is located on the outlet side of the communication portion between the first reservoir and the main flow path.

5. The first reservoir and the second reservoir have a predetermined volume ratio, The main flow path includes a branching point, a first branching path that provides fluid communication to the first reservoir between the branching point and the outlet, and a second branching path that provides fluid communication to the second reservoir between the branching point and the outlet. The length of the flow path from the aforementioned branching point to the communication point between the first reservoir and the first branching path is different from the length of the flow path from the aforementioned branching point to the communication point between the second reservoir and the second branching path. The fluid control device according to claim 1, wherein the first fluid and the second fluid are discharged together in the predetermined volume ratio.

6. The system comprises a first communication passage that fluidly connects the main flow path and the first reservoir, and a second communication passage that fluidly connects the main flow path and the second reservoir. The main channel is in fluid communication with the first communication passage and the second communication passage at least one of the side surface and bottom surface of the channel groove of the main channel. The first fluid control mechanism is, The main flow channel is The surface of the channel groove has a first property, which is either hydrophobic or hydrophilic. The surface of the coating material on the channel groove side has a second property, which is the other of hydrophobic and hydrophilic. The first communication passage has the second property and includes a first guide portion that guides the first fluid introduced into the first reservoir to the first connection portion between the main flow path and the first communication passage. When the first fluid is introduced into the first reservoir, the first fluid guided by the first guide portion forms a first droplet at the first connection portion, thereby controlling the outflow of the first fluid from the first reservoir. The second fluid control mechanism is, The main flow channel is The surface of the channel groove has a first property, which is either hydrophobic or hydrophilic. The surface of the coating material on the channel groove side has a second property, which is the other of hydrophobic and hydrophilic. The second communication passage has the second property and includes a second guide portion that guides the second fluid introduced into the second reservoir to the second connection portion between the main passage and the second communication passage. A fluid control device according to any one of claims 2 to 5, wherein when the second fluid is introduced into the second reservoir, the second fluid guided by the second guide portion forms a second droplet at the second connection portion, thereby controlling the outflow of the second fluid from the second reservoir.

7. An inspection device comprising a fluid control unit that discharges both the introduced sample and the diluent, and a detection unit capable of detecting the sample discharged from the fluid control unit, on a microchip, The fluid control unit, A main channel having a channel groove formed on at least one surface of a substrate, and a covering material covering the channel groove, Downstream of the main channel, there is an outlet that communicates with the fluid and guides both the sample and the diluent, A first reservoir and a second reservoir are connected to the main flow channel, and each reservoir stores the dilution solvent and the sample, respectively. A first fluid control mechanism for controlling the outflow of the diluent from the first reservoir, A second fluid control mechanism for controlling the outflow of the sample from the second reservoir, Equipped with, An inspection device in which the detection unit is in fluid communication with the outlet.

8. The main flow channel and the first reservoir are provided with a connecting passage that provides fluid communication between them, and the main flow channel is in fluid communication with the connecting passage at least one of the side surface and bottom surface of the flow channel groove. The first fluid control mechanism is, The main flow channel is The surface of the channel groove has a first property, which is either hydrophobic or hydrophilic. The surface of the coating material on the channel groove side has a second property, which is the other of hydrophobic and hydrophilic. The aforementioned connecting passage, Having the second property described above, and having a guide portion that guides either the sample or the diluent introduced into the first reservoir to the connection portion between the main flow path and the communication passage, The inspection apparatus according to claim 7, wherein when one of the sample or the diluent is introduced into the first reservoir, the one of the sample or the diluent guided by the guide portion forms a droplet at the connection portion, thereby controlling the outflow of the one of the sample or the diluent from the first reservoir.

9. The channel groove of the main channel has a restricted section in which the time required for the fluid to pass through is restricted. The main flow channel is provided with a fluid inlet that communicates with the flow channel groove and introduces the fluid, The inspection apparatus according to claim 8, wherein when the fluid, the diluent, and the sample are introduced into the fluid inlet, the first reservoir, and the second reservoir, respectively, the fluid comes into contact with the droplets at the connection portion, and after a predetermined time, both the sample and the diluent are discharged.

10. The inspection apparatus according to claim 9, wherein the regulated section includes a section in which the flow channel groove has a width of 0.8 to 2.0 mm and a depth of 70 to 100 μm.

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