JP2016130652A - Inspection device, inspection method and inspection apparatus - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an inspection device that can deliver liquid without using a pump.SOLUTION: An inspection device comprises: a first channel 3 and a second channel 4 that are extended in one direction while arranged side by side; a plurality of capillary channels 5 that connect the first channel 3 and the second channel 4 while arranged side by side in the one direction; liquid injection parts 8a and 8b that inject liquid from one end of any of the first channel 3 and the second channel 4; and a liquid recovery part 18 that recovers a liquid flowing from the other end of any of the first channel 3 and the second channel 4.SELECTED DRAWING: Figure 1

Description

  The present invention relates to an inspection device, an inspection method, and an inspection apparatus.

  An antibody has a property of specifically binding to a substance such as a specific protein or pathogen that becomes an antigen (referred to as an antigen-antibody reaction). Immunoassay (immunoassay) uses such an antigen-antibody reaction and uses an antibody that specifically binds to the antigen to be measured, for example, a specific substance contained in a sample (specimen) such as blood or urine. It is a technique for detecting the antigen of. Immunoassays are used for various tests and diagnoses such as influenza, hepatitis, and pregnancy.

  As a typical immunoassay, there is an immunochromatography method. This method is a kind of chromatography, and is a technique in which a specimen containing an antigen is dropped onto a membrane on which a labeled antibody, a capture antibody, a metal colloid, and the like are fixed. In the case of this technique, a specific antigen is captured on the capture antibody, and the presence or absence of the specific antigen can be detected by observing the metal colloid attached to the labeled antibody. This method has a relatively short inspection time of several minutes to several tens of minutes, and the inspection method is relatively simple. This method is widely used, for example, for test kits used by individuals such as pregnancy test drugs, and for quick diagnosis of influenza in hospitals.

  As one of methods for quantitatively detecting not only the presence / absence of the antigen described above but also the amount and concentration of the antigen contained in the specimen, there is an enzyme immunoassay (ELISA) method. In this method, first, an antigen is immobilized on a well serving as a reaction field, a primary antibody that specifically adsorbs to the antigen is adsorbed, and then a secondary antibody labeled with an enzyme is adsorbed to the primary antibody. In this method, a reagent that develops color or emits light by reacting with an enzyme is added. In the case of this method, the amount and concentration of the antigen contained in the specimen can be quantitatively detected by measuring the intensity of color development / luminescence. This method is used for testing allergens contained in foods, testing for trace amounts of viruses, and the like.

  Immunoassay methods such as ELISA and EIA (Enzyme Immunoassay) separate the antigen bound to the antibody and the antigen not bound to the antibody by washing with water (B / F separation). It is known that higher quantitativeness can be obtained in concentration measurement and the like than the immunochromatography method shown in 1.

  In addition, the ELISA method can test with fewer samples than the immunochromatography method. On the other hand, the examination takes a very long time and is difficult to use for quick diagnosis. Therefore, a chemiluminescence immunoassay device using magnetic fine particles having an antigen or antibody as a solid phase on the surface has been proposed as an ELISA method capable of shortening the examination time (see Patent Document 1).

  In this immunoassay apparatus, a cartridge (test device) that contains reagents necessary for immunoassay and performs a predetermined reaction process is used. Further, as a means for feeding a reagent or the like to the reaction field of the cartridge, for example, a flow pump by mechanical control is used. In addition, as an example of a flow pump, the flow type pump (Sep-Pak concentrator Uni) for pressurized solid phase extraction made from Waters is mentioned.

Japanese Patent No. 3839349

  In the conventional chemiluminescence immunoassay device, a mechanically controlled flow pump equipped with a complicated mechanism has been used in order to control the amount and flow rate of the reagent fed to the reaction field of the cartridge with high accuracy. However, the mechanically controlled flow rate pump having a complicated mechanism has a problem that the chemiluminescence immunoassay apparatus is increased in size to increase the apparatus cost, and the maintenance is difficult due to the complicated apparatus configuration.

  The present invention has been proposed in view of such a conventional situation, and without using a pump having a complicated mechanism, the liquid flow rate and flow velocity can be easily controlled by a simple mechanism to feed the liquid. An inspection device capable of allowing a certain amount of liquid to flow into the reaction field with high reproducibility by performing liquid and enabling easier B / F separation, and an inspection method and an inspection apparatus using such an inspection device The purpose is to provide.

  In order to achieve the above object, an inspection device according to one aspect of the present invention includes a first flow path and a second flow path that are extended in one direction while being aligned with each other; One end side of any of a plurality of capillary channels that connect the first channel and the second channel in parallel, and the first channel and the second channel A liquid injecting unit for injecting a liquid from the liquid, and a liquid recovery unit for recovering the liquid flowing out from the other end of either the first channel or the second channel. .

  In the inspection device, the first channel and the second channel are channels in which a channel cross-sectional area is constant in the one direction while being connected to at least the plurality of capillary channels. You may have a straight part.

  Further, in the inspection device, the first channel and the second channel have a channel change in which a channel cross-sectional area changes in the one direction while being connected to at least the plurality of capillary channels. May have a part.

  In the inspection device, the flow path changing portion may have a tapered shape in which the flow path cross-sectional area continuously decreases or increases in the one direction.

  In the inspection device, the flow path changing portion may be directed from one end side in the one direction toward the minimum cross-sectional area portion with a cross-sectional area minimum portion having a minimum flow path cross-sectional area in the one direction interposed therebetween. In addition, the cross-sectional area of the flow path may be continuously reduced, and the constriction shape may be such that the cross-sectional area of the flow path continuously increases from the minimum cross-sectional area portion toward the other end side in the one direction.

  In addition, the inspection device may include a part of the flow path between the other end side of the first flow path and the second flow path and the liquid recovery unit in the other direction. You may provide the flow path trap part turned up in the direction which goes to an end side from an end side.

  In addition, the inspection device includes a flow channel enlargement unit that enlarges a part of the flow channel between one end side of the first flow channel and the second flow channel and the liquid injection unit. It may be.

  In the inspection device, the liquid injection unit may include either an injection source for injecting a liquid stored in the interior in advance or an injection port for injecting a liquid from the outside.

  In the inspection device, the liquid recovery unit may be provided with an absorbing material that absorbs the liquid.

  In addition, the inspection device includes a first base material in which a first concave portion constituting the first flow path and a second concave portion constituting the second flow path are formed on one surface; A plurality of capillary channels, and a second base material provided with one end side opening and the other end side opening of each capillary channel opened on one surface, respectively, The first surface between the first recess and the surface on which the one end side opening of each capillary channel is formed by abutting the one surface of the base material and the one surface of the second base material with each other. The second channel may be configured between the second channel and the surface on which the second recess and the other-end opening of each capillary channel are formed.

  The inspection device may include a tip portion including at least the plurality of capillary channels, and a main body portion provided with a tip mounting portion to which the tip portion is detachably attached.

  In the inspection device, a polymer that specifically binds to a specific substance may be fixed to the inner wall surface of the capillary channel.

  Further, an inspection method according to one aspect of the present invention is an inspection method using any one of the above-described inspection devices, wherein the capillary channel is used as a reaction field for immunoassay, and the first through the liquid injection unit. The inspection device is held so that the one direction is a direction along gravity when a liquid is injected into one end side of any one of the second flow path and the second flow path. And

  Further, in the inspection method, while the liquid is circulated from one end side to the other end side of either the first flow path or the second flow path by gravity, a part of the liquid is After flowing into the capillary channel due to a capillary phenomenon, the liquid flowing into the capillary channel is discharged to the outside of the capillary channel. An operation may be performed.

  Further, the testing method includes a step of feeding a liquid containing a specimen to be examined, a step of feeding a liquid containing a primary antibody that specifically binds to a specific antigen in the specimen, and a blocking agent. A step of feeding a liquid containing, a step of feeding a liquid containing a secondary antibody labeled with a luminescent substance or an enzyme, and a step of feeding a liquid containing a reagent that reacts with the enzyme to develop or emit light. Of these, any step may be included.

  Further, the inspection method may include a step of feeding a liquid for cleaning the inside of the flow channel after feeding any of the liquids.

  An inspection apparatus according to an aspect of the present invention is an inspection apparatus using any one of the inspection devices, and includes a device holding unit that holds the inspection device, and the device holding unit includes the liquid injection The inspection device is arranged so that the one direction is a direction along gravity when a liquid is injected from one part to one end side of the first flow path and the second flow path. It is characterized by holding.

  The inspection apparatus may include a device inspection unit that inspects the inspection device.

  The inspection apparatus may further include an injection driving unit that operates to inject liquid from the liquid injection unit.

  The inspection apparatus may include a device driving unit that moves and operates the inspection device.

  As described above, according to the present invention, without using a pump having a complicated mechanism, it is possible to easily control a flow rate and a flow rate of a liquid by a simple mechanism, and to deliver a certain amount of liquid. It is possible to provide an inspection device that can flow into the reaction field with high reproducibility and perform B / F separation more easily, and an inspection method and an inspection apparatus using such an inspection device.

It is a top view showing composition of an inspection device concerning a 1st embodiment of the present invention. It is the see-through | perspective perspective view which looked at the test | inspection device shown in FIG. 1 from the one surface side. It is the see-through | perspective perspective view which looked at the test | inspection device shown in FIG. 1 from the other surface side. It is a top view which shows the structural example of the chip | tip mounting part with which the test | inspection device shown in FIG. 1 is equipped, and a chip | tip part. It is a top view for demonstrating liquid feeding operation with respect to the capillary channel of the test | inspection device shown in FIG. It is a top view which shows the structure of the test | inspection device which concerns on the 2nd Embodiment of this invention. It is a top view for demonstrating the flow of the liquid in the flow-path change part of the test | inspection device shown in FIG. It is a top view which shows the structure of the test | inspection device which concerns on the 3rd Embodiment of this invention. It is a top view for demonstrating the flow of the liquid in the flow-path change part of the test | inspection device shown in FIG. It is a top view which shows an example of the test | inspection device which concerns on the 4th Embodiment of this invention. It is the see-through | perspective perspective view which looked at the test | inspection device shown in FIG. 10 from the one surface side. It is a top view which shows the other example of the test | inspection device which concerns on the 4th Embodiment of this invention. It is a top view for demonstrating the flow of the liquid in the flow-path trap part of the test | inspection device shown in FIG. It is a top view for demonstrating the flow of the liquid in the flow-path trap part of the test | inspection device shown in FIG. It is sectional drawing which shows the structure of the test | inspection device which concerns on the 5th Embodiment of this invention. It is sectional drawing which illustrates the cross-sectional shape of a several capillary channel. It is a top view which shows the modification of a 1st flow path and a 2nd flow path. It is a top view which shows the structure which has arrange | positioned the several capillary flow path group. It is a top view which shows the structural example which the some capillary flow path connected between the 1st flow path expansion part and the 2nd flow path expansion part. It is a schematic diagram which shows the case where a capillary channel is used as a reaction field of immunoassay. It is a top view for demonstrating each process of an immunoassay in order. It is a top view for demonstrating each process of an immunoassay in order. It is a top view for demonstrating each process of an immunoassay in order. It is a top view for demonstrating each process of an immunoassay in order. It is a top view for demonstrating each process of an immunoassay in order. It is a top view for demonstrating each process of an immunoassay in order. It is a top view for demonstrating each process of an immunoassay in order. It is a top view for demonstrating each process of an immunoassay in order. It is a top view for demonstrating each process of an immunoassay in order. It is a block diagram which shows the structural example of the test | inspection apparatus which concerns on one Embodiment of this invention. It is a block diagram which shows the structure which added the injection drive part to the test | inspection apparatus shown in FIG. It is a block diagram which shows the structure which added the device drive part to the test | inspection apparatus shown in FIG. It is sectional drawing which shows an example of the detection optical system which comprises a device test | inspection part.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.
In addition, in the drawings used in the following description, in order to make the features easy to understand, there are cases where the portions that become the features are enlarged for the sake of convenience, and the dimensional ratios of the respective components are not always the same as the actual ones. Absent. In addition, the materials, dimensions, and the like exemplified in the following description are merely examples, and the present invention is not necessarily limited thereto, and can be appropriately modified and implemented without departing from the scope of the invention. .

(Inspection device)
[First Embodiment]
First, as a first embodiment of the present invention, for example, an inspection device 1A shown in FIGS. 1, 2, and 3 will be described. FIG. 1 is a plan view showing the configuration of the inspection device 1A. FIG. 2 is a see-through perspective view of the inspection device 1A viewed from one side (hereinafter referred to as a front surface). FIG. 3 is a see-through perspective view of the inspection device 1A as viewed from the other side (hereinafter referred to as the rear side). In the following description, an XYZ orthogonal coordinate system is set, the X-axis direction is the length direction (vertical direction) of the inspection device 1A, the Y-axis direction is the width direction (horizontal direction) of the inspection device 1A, and the Z-axis direction is As the thickness direction (front-rear direction) of the inspection device 1A, the positional relationship between the respective parts will be described.

  As shown in FIGS. 1, 2, and 3, the inspection device 1 </ b> A includes a cartridge body 2. The cartridge main body 2 includes a main body portion (first base material) 2a and a panel portion (second base material) 2b that covers the front surface of the main body portion 2a.

  The main body 2a is a transparent resin material having chemical resistance such as polyethylene terephthalate (PET) resin, polystyrene (PS) resin, polymethyl methacrylate (PMMA) resin, acrylonitrile styrene resin (AS) resin, or the like. It is formed in a substantially rectangular flat plate shape with a predetermined thickness using a glass material or the like. The panel portion 2b is formed to have an outer shape substantially coincident with the main body portion 2a using a substrate made of the same resin material or glass material as the main body portion 2a. The cartridge body 2 is joined and integrated in a state where the panel portion 2b is abutted against the front surface of the body portion 2a.

  The cartridge body 2 includes a first flow path 3 and a second flow path 4 that are arranged in parallel to each other, and a plurality of capillary flow paths 5 that connect between the first flow path 3 and the second flow path 4. And.

  The first flow path 3 and the second flow path 4 constitute a flow space for allowing the liquid to flow into or out of the capillary flow path 5 inside the cartridge body 2. The first flow path 3 and the second flow path 4 are provided so as to extend in the length direction of the cartridge body 2 in one direction. The cross-sectional areas of the first flow path 3 and the second flow path 4 are constant in the extending direction (X-axis direction).

  The 1st flow path 3 comprises the said distribution space between the 1st recessed part 3a formed in the front surface of the main-body part 2a, and the panel part 2b. The 2nd flow path 4 comprises the said distribution space between the 2nd recessed part 4a formed in the front surface of the main-body part 2a, and the panel part 2b.

  The plurality of capillary channels 5 constitutes a minute space serving as a reaction field of an immunoassay described later within the cartridge body 2. The plurality of capillary channels 5 are provided so as to extend in the width direction of the cartridge body 2 in a state of being parallel to the length direction of the cartridge body 2. Further, the channel cross-sectional area of each capillary channel 5 is substantially constant in the extending direction (Y-axis direction). In addition, the plurality of capillary channels 5 are arranged close to each other to constitute one capillary channel group 5A.

  The one end side opening 5 a of each capillary channel 5 is provided to open to the inner wall surface of the first channel 3. The other end side opening 5 b of each capillary channel 5 is provided to open on the inner wall surface of the second channel 4. Thereby, the circulation space constituted by the first flow path 3 and the circulation space constituted by the second flow path 4 are communicated with each minute space constituted by each capillary flow path 5.

  As shown in FIG. 4A, the cartridge body 2 includes a chip mounting portion 6A provided on the front surface of the main body portion 2a, and a chip portion 7A that is detachably attached to the chip mounting portion 6A. Yes. FIG. 4A is a plan view showing a state where the chip portion 7A is mounted on the chip mounting portion 6A.

  The chip mounting portion 6A includes a fitting recess 6a that connects between the first recess 3a and the second recess 4a. The tip portion 7A is made of a resin-made or glass-made transparent base material on which a plurality of capillary channels 5 are formed. 7 A of chip | tip parts are hold | maintained between the main-body part 2a and the panel part 2b in the state fitted by 6A of chip | tip mounting parts (fitting recessed part 6a).

  Further, as shown in FIG. 3, the chip mounting portion 6A is provided with a window hole 6b penetrating the main body portion 2a. The panel portion 2b is provided with a window hole 6c that passes through a position facing the window hole 6b. In the inspection device 1A, a plurality of capillary channels 5 (capillary channel group 5A) are exposed from these window holes 6b and 6c.

  Further, as shown in FIG. 4B, the cartridge main body 2 includes a chip mounting portion 6B provided on the front surface of the main body portion 2a and a chip portion 7B that is detachably attached to the chip mounting portion 6B. It is good also as a structure provided. FIG. 4B is a plan view showing a state where the chip portion 7B is mounted on the chip mounting portion 6B.

  The chip mounting portion 6B includes a fitting recess 6d that divides between the first recess 3a and the second recess 4a. The tip portion 7B is made of a transparent substrate made of resin or glass in which a plurality of capillary channels 5 and a part of the first recess 3a and the second recess 4a are formed. The chip part 7B is held between the main body part 2a and the panel part 2b in a state of being fitted to the chip mounting part 6B (fitting recess 6d).

  As shown in FIGS. 1, 2, and 3, the cartridge body 2 includes a first liquid injection portion 8 a that injects liquid from the upper end side of the first flow path 3, and the upper end side of the second flow path 4. And a second liquid injecting portion 8b for injecting liquid from.

  The first liquid injection part 8a and the second liquid injection part 8b are composed of an injection source 9 for injecting liquid stored in the cartridge body 2 in advance, and an injection port 10 for injecting liquid from the outside of the cartridge body 2. One of these.

  In the present embodiment, the first liquid injection part 8 a is constituted by two injection sources 9, and the second liquid injection part 8 b is constituted by one injection source 9 and one injection port 10. These three injection sources 9 and one injection port 10 are provided side by side in the width direction of the cartridge body 2.

  The injection source 9 includes a liquid storage unit 11 that stores a liquid and a liquid feed unit 12 that pumps the liquid stored in the liquid storage unit 11. The liquid storage portion 11 constitutes a storage space extending in the length direction of the cartridge main body 2 between the concave portion 11a formed on the front surface of the main body portion 2a and the panel portion 2b.

  An outlet channel 13 is continuously provided on the lower end side of the liquid storage unit 11. The outlet channel 13 is provided extending in the length direction of the cartridge body 2. The outlet flow path 13 constitutes a space communicating with the storage space of the liquid storage portion 11 between the recess 13a formed on the front surface of the main body portion 2a and the panel portion 2b.

  The liquid feeding unit 12 has a configuration in which a diaphragm valve 12b is attached to a hole 12a penetrating the bottom surface of the recess 11a. The liquid feeding unit 12 is provided biased on the upper end side of the liquid storage unit 11. In the liquid feeding part 12, the liquid accommodated in the liquid accommodating part 11 can be pressure-fed to the outlet flow path 13 by pressing the diaphragm valve 12b from the rear surface side of the main body part 2a.

  The injection source 9 is not limited to the configuration described above, and for example, the liquid container 11 is packaged, and an external force is applied from the hole 12a of the liquid feeding unit 12 to open a part of the packaging seal, It is good also as a structure from which the liquid flows out out of the accommodating part 11 to the exit flow path 13. In addition, as a method of opening a part of the package seal, a method of pressing the package or removing a package lid by pulling a film serving as a package lid can be used.

  The injection port 10 has a liquid storage portion 14 in which a liquid is temporarily stored. The liquid storage portion 14 constitutes a storage space extending in the length direction of the cartridge main body 2 between the concave portion 14a formed on the front surface of the main body portion 2a and the panel portion 2b. Moreover, the upper end side of the recessed part 14a forms the opening part 14b in the upper end surface of the main-body part 2a. In the inlet 10, the liquid can be injected from the outside of the cartridge body 2 into the liquid storage portion 14 through the opening 14 b.

  An outlet channel 15 is continuously provided on the lower end side of the liquid storage unit 14. The outlet channel 15 is provided extending in the length direction of the cartridge body 2. The outlet channel 15 constitutes a space communicating with the storage space of the liquid storage portion 14 between the recess portion 15a formed on the front surface of the main body portion 2a and the panel portion 2b.

  The cartridge main body 2 includes a first flow passage expanding portion 16 in which a part of a flow passage between the upper end side of the first flow passage 3 and the first liquid injection portion 8a is enlarged, and a second flow passage 4. And a second flow path enlargement part 17 in which a part of the flow path between the upper end side of the first liquid injection part and the second liquid injection part 8b is enlarged.

  The first flow path expanding portion 16 and the second flow path expanding portion 17 constitute a buffer space inside the cartridge body 2. The buffer space prevents, for example, the backflow of the liquid flowing out from the first liquid injection part 8a and the second liquid injection part 8b, or the liquid flowing through the first flow path 3 and the second flow path 4 It has a function to prevent air from biting. The first flow path enlargement portion 16 constitutes the buffer space between the recess portion 16a formed on the front surface of the main body portion 2a and the panel portion 2b. The second flow path enlargement portion 17 constitutes the buffer space between the recess portion 17a formed on the front surface of the main body portion 2a and the panel portion 2b.

  The upper end side of the first flow passage expanding portion 16 is provided continuously to the first liquid injection portion 8a, that is, the lower end sides of the outlet flow passages 13, 13 of the two injection sources 9, 9. The lower end side of the first flow path expanding portion 16 is continuously provided on the upper end side of the first flow path 3. The first flow path expanding portion 16 is constant with the cross-sectional area in the width direction extending from the upper end portion toward the midway portion in the length direction, and the flow in the width direction from the midway portion toward the lower end portion. The road cross-sectional area has a shape that continuously decreases. Further, the first flow path expanding portion 16 is an inner inner surface that is flush with the inner wall surface of the first flow path 3 that is connected to the plurality of capillary flow paths 5 (hereinafter referred to as the inner side). It has a wall surface and an outer wall surface that is inclined with respect to the inner wall surface on the side opposite to the side connected to the plurality of capillary channels 5 of the first channel 3 (hereinafter referred to as the outer side). .

  Similarly, the upper end side of the second flow path expanding section 17 is continuous with the lower end side of the second liquid injection section 8b, that is, the outlet flow paths 13 and 15 of one injection source 9 and one injection port 10. Is provided. The lower end side of the second flow path expanding portion 17 is provided continuously to the upper end side of the second flow path 4. The second flow path enlargement portion 17 is constant while the cross-sectional area in the width direction is enlarged from the upper end portion toward the midway portion in the length direction, and the flow in the width direction is extended from the midway portion toward the lower end portion. The road cross-sectional area has a shape that continuously decreases. Further, the second flow path expanding portion 17 is an inner inner surface that is flush with the inner wall surface of the second flow path 4 that is connected to the plurality of capillary flow paths 5 (hereinafter referred to as the inner side). It has a wall surface and an outer wall surface that is inclined with respect to the inner wall surface on the side opposite to the side connected to the plurality of capillary channels 5 of the second channel 4 (hereinafter referred to as the outer side). .

  The cartridge body 2 includes a liquid recovery unit 18 that recovers the liquid that has flowed out from the lower ends of the first flow path 3 and the second flow path 4. The liquid recovery unit 18 is communicated with the flow space of the first flow path 3 and the flow space of the second flow path 4 between the recess 18a formed on the front surface of the main body 2a and the panel portion 2b. This constitutes a collection space.

  The liquid recovery unit 18 has a lower space that is expanded in the length direction and the width direction from the lower ends of the first flow path 3 and the second flow path 4 inside the cartridge body 2. In addition, the liquid recovery unit 18 is located above both lower ends of the first flow path 3 and the second flow path 4 on both sides in the width direction across the first flow path 3 and the second flow path 4. Each upper space is located.

  The liquid recovery part 18 has an air hole 19 and a protective wall 20 at a position constituting the upper space on one side. The air hole 19 is provided through the main body 2a. In the inspection device 1, the air in the liquid recovery unit 18 can be degassed outside through the air holes 19. The protective wall 20 is provided so as to protrude from the bottom surface of the recess 18a so as to partition a part between the upper space and the lower space in which the air holes 19 are provided. In the inspection device 1, the protective wall 20 prevents liquid from leaking out of the air holes 19. In addition, about the air hole 19 and the protective wall 20, it is good also as a structure provided in the panel part 2b side.

  Further, an absorbent material 21 that absorbs liquid may be provided inside the liquid recovery unit 18. As the absorbent material 21, for example, sponge, fiber, polymer, or the like can be used. In the inspection device 1 </ b> A, the absorbent 21 absorbs the liquid, so that the liquid flowing out from the lower ends of the first flow path 3 and the second flow path 4 can be stably held in the liquid recovery unit 18. it can. Therefore, even when the inspection device 1A is tilted, the liquid in the liquid recovery unit 18 is prevented from flowing back into the first flow path 3 and the second flow path 4 or leaking out from the air holes 19. be able to.

  In the testing device 1A having the above-described configuration, the capillary channel 5 can be used as a reaction field for immunoassay. Specifically, when the capillary channel 5 is used as a reaction field for immunoassay, the first channel 3 and the second flow from either the first liquid injection part 8a or the second liquid injection part 8b. Liquid is injected into any of the channels 4. At this time, the inspection device 1 </ b> A is held such that the length direction (one direction) of the cartridge body 2 is a direction along the gravity. Thereby, a liquid can be distribute | circulated from the upper end side of either the 1st flow path 3 and the 2nd flow path 4 to a lower end side using gravity.

  Here, holding the inspection device 1A in the direction along the gravity means a direction in which the liquid naturally flows from the upper end side to the lower end side of either the first flow path 3 or the second flow path 4 by gravity. In addition, this means holding the inspection device 1A. Therefore, in the present embodiment, not only the case where the inspection device 1A is held so that the length direction of the cartridge body 2 and the gravity direction coincide with each other, but the first flow path 3 and the second flow are utilized using gravity. If the liquid can flow from either upper end side to the lower end side of the path 4, the inspection device 1A can be held so as to be inclined with respect to the direction of gravity.

  Further, in the inspection device 1A of the present embodiment, a part of the liquid is flowing while the liquid is circulated from the upper end side to the lower end side of either the first flow path 3 or the second flow path 4 by gravity. After the liquid flows into the capillary channel 5 due to the capillary phenomenon, the liquid flowing into the capillary channel 5 flows out of the capillary channel 5 to be sent to the capillary channel 5. Liquid operation can be performed.

  Specifically, the liquid feeding operation for the capillary channel 5 of the inspection device 1A will be described with reference to FIGS. 5 (A) and 5 (B). 5A is a plan view showing a state in which the liquid L has flowed from the first flow path 3 into the capillary flow path 5. FIG. FIG. 5B is a plan view showing a state in which the liquid L has flowed from the capillary channel 5 to the first channel 3.

  In the inspection device 1A, as shown in FIG. 5A, when the liquid L flows from the upper end side of the first flow path 3, the first flow path 3 is filled with the liquid L and the first L It flows down from the upper end side of the flow path 3 toward the lower end side.

  Here, the first flow path 3 and the fourth flow path 4 are flow path linear portions in which the flow path cross-sectional area while being connected to the plurality of capillary flow paths 5 is constant in the length direction of the cartridge body 2. 3A and 4A are configured. For this reason, the liquid L in the first flow path 3 flows down at a substantially constant flow rate while being connected to the plurality of capillary flow paths 5 (flow path linear portion 3A).

  In addition, a part of the liquid L flowing down in the first flow path 3 enters the inside of the capillary flow path 5 from the one end side opening 5 a of each capillary flow path 5. The liquid L that has entered the capillary channel 5 permeates (moves) toward the other end side opening 5b by capillary action. Thereby, the liquid L flows in from the one end side opening part 5a of each capillary flow path 5. FIG.

  Thereafter, as shown in FIG. 5B, as the liquid L in the first flow path 3 passes through the connection with the plurality of capillary flow paths 5 (flow path linear portion 3A), the capillary tube The liquid L in the flow path 5 moves toward the one end side opening 5a. This is a process of drying the film of the liquid L remaining near the boundary between the inner wall surface of the first flow path 3 and the one end side opening 5a, as schematically shown in the encircled portion in FIG. 5B. This is because the liquid L in the capillary channel 5 in contact with the membrane is attracted to the one end side opening 5a by the tension of the membrane. Thereby, the liquid L flows out from the one end side opening part 5a of each capillary channel 5. FIG.

  In the inspection device 1A of the present embodiment, not only the case where the liquid L is sent from the first flow path 3 side to the capillary flow path 5 described above, but the capillary flow path from the second flow path 4 side. In the case where the liquid L is supplied to the liquid 5, the same liquid supply operation can be performed.

  Here, when performing the liquid feeding operation on the capillary flow path 5 using the above-described gravity, the capillary diameter of the capillary flow path 5 is set in the order of nm to μm in order to generate a capillary phenomenon in the capillary flow path 5. ing. On the other hand, the diameter of the first channel 3 and the second channel 4 connected to the plurality of capillary channels 5 needs to be sufficiently larger than the diameter of the capillary channel 5. If the diameters of the first flow path 3 and the second flow path 4 are too small, the capillary force (surface tension) acting on the liquid L is superior to the gravity acting on the liquid L.

For example, when the first flow path 3 and the second flow path 4 are circular pipes having a radius d [m], the surface tension acting on the liquid L is T [mN / m], and the liquid L and the circular pipe When the contact angle is θ [rad], the force that pushes the liquid upward is 2πd × T · cos θ [N]. On the other hand, the force that the liquid L tries to flow downward due to gravity is the gravitational acceleration g [m] when the density of the liquid is ρ [kg / m ³ ] and the height of the liquid column is H [m]. / S ² ] and represented by πd ² × H × ρ × g [N]. Therefore, when liquid is fed using gravity, πd ² × H × ρ × g> 2πd × T · cos θ must be satisfied. Accordingly, the radius d of the circular pipe needs to be larger than 2T · cos θ / ρ · g · H.

  In addition, the greater the volume of the liquid L, the greater the force that tends to flow downward due to gravity. On the other hand, the amount of the specimen (for example, blood) used in the examination needs to be suppressed to a small amount. Therefore, the volume of the liquid L is preferably in the range of 0.1 to 100 [ml].

Further, the falling speed v of the liquid L to be Nagareochiyo downward by gravity [m / s] is the clay of the liquid L when the ^{η [Pa · s], d} 2 / 8η × (ρ · g- 2T / d · H). Therefore, in order to shorten the inspection time (increase the falling speed v), it is preferable that the radius d of the circular pipe is large.

  In addition, when the liquid L to be fed contains fine particles, the radius d of the circular tube is set in the cm order so that the liquid is fed using gravity without the circular tube being blocked by the fine particles. Is more preferable.

  As described above, in the inspection device 1A of the present embodiment, the liquid L can be supplied to the capillary channel 5 by using the above-described liquid supply operation using gravity without using a pump. In addition, regarding the amount and flow rate of the liquid fed to the capillary channel 5, the channel breakage while being connected to the plurality of capillary channels 5 of the first channel 3 and the second channel 4 is also performed. It can be easily controlled by controlling the area (caliber).

[Second Embodiment]
Next, an inspection device 1B shown in FIG. 6 will be described as a second embodiment of the present invention. FIG. 6 is a plan view showing the configuration of the inspection device 1B. Moreover, in the following description, about the site | part equivalent to the said test | inspection device 1A, while omitting description, the same code | symbol shall be attached | subjected in drawing.

  As shown in FIG. 6, the inspection device 1 </ b> B has a channel cross-sectional area between the first channel 3 and the second channel 4 connected to the plurality of capillary channels 5 in the length direction of the cartridge body 2. Have flow path changing portions 3B and 4B that change at. The flow path changing portions 3B and 4B have a taper shape in which the cross-sectional area in the width direction at the upper end is enlarged and the cross-sectional area in the width direction is continuously reduced from the upper end to the lower end. doing. In the flow path changing portions 3B and 4B, the outer inner wall surface is inclined with respect to the inner inner wall surface. The rest of the configuration is basically the same as that of the inspection device 1A.

  In the testing device 1B having the above-described configuration, the capillary channel 5 can be used as a reaction field for immunoassay, as in the case of the testing device 1A. Specifically, when the capillary channel 5 is used as a reaction field for immunoassay, the first channel 3 and the second flow from either the first liquid injection part 8a or the second liquid injection part 8b. Liquid is injected into any of the channels 4. At this time, the inspection device 1B is held so that the length direction (one direction) of the cartridge body 2 is the direction along the gravity. Thereby, a liquid can be distribute | circulated from the upper end side of either the 1st flow path 3 and the 2nd flow path 4 to a lower end side using gravity.

  Further, in the inspection device 1B of the present embodiment, a part of the liquid is flowing while the liquid is circulated from the upper end side to the lower end side of either the first flow path 3 or the second flow path 4 by gravity. After the liquid flows into the capillary channel 5 due to the capillary phenomenon, the liquid flowing into the capillary channel 5 flows out of the capillary channel 5 to be sent to the capillary channel 5. Liquid operation can be performed.

  Thereby, in the test | inspection device 1B of this embodiment, it is possible to perform liquid feeding operation with respect to the capillary flow path 5 using gravity, without using a pump. Here, as shown in FIG. 7, the flow of the liquid L in the tapered flow path changing portion 3B will be described. FIG. 7 is a plan view showing the state of the liquid L in the flow path changing portion 3B.

  As shown in FIG. 7, the liquid L flowing down in the first flow path 3 is once stored in the tapered flow path changing portion 3 </ b> B. In this case, the liquid L in the flow path changing portion 3B stays for a shorter period of time while being connected to the plurality of capillary flow paths 5 than when flowing in the flow path linear portion 3A. Thereby, the time until the liquid L flows in from the one end side opening part 5a of each capillary channel 5 and the liquid L flows out from the one end side opening part 5a of each capillary channel 5 can be shortened. On the other hand, the flow path straight portions 3A and 4A have an advantage that the amount of the liquid L to be used is smaller than that of the tapered flow path changing portions 3B and 4B.

[Third Embodiment]
Next, an inspection device 1C shown in FIG. 8 will be described as a third embodiment of the present invention. FIG. 8 is a plan view showing the configuration of the inspection device 1C. Moreover, in the following description, about the site | part equivalent to the said test | inspection device 1A, while omitting description, the same code | symbol shall be attached | subjected in drawing.

  As shown in FIG. 8, the inspection device 1 </ b> C has a channel cross-sectional area between the first channel 3 and the second channel 4 connected to the plurality of capillary channels 5 in the length direction of the cartridge body 2. The flow path changing portions 3C and 4C that change in FIG. The flow path changing portions 3C and 4C have the cross-sectional area in the width direction from the upper end portion to the cross-sectional area minimum portions 31 and 41 with the cross-sectional area minimum portions 31 and 41 having the minimum flow-path cross-sectional area in between. Tapered portions 32 and 42 that are continuously reduced, and reverse tapered portions 33 and 43 that are continuously increased in cross-sectional area in the width direction from the smallest cross-sectional area portions 31 and 41 toward the lower end portion. It has a shape. The cross-sectional area minimum portions 31 and 41 are located substantially in the middle of the plurality of capillary channels 5 arranged in parallel in the length direction. The tapered portions 32 and 42 and the inverse tapered portions 33 and 43 have shapes that are symmetric with respect to the minimum cross-sectional area portions 31 and 41. As for the taper parts 32 and 42, the inner wall surface of the outer side inclines with respect to the inner wall surface of an inner side. As for the reverse taper parts 33 and 43, the inner wall surface of the outer side inclines with respect to the inner wall surface of the inner side. The rest of the configuration is basically the same as that of the inspection device 1A.

  In the testing device 1C having the above-described configuration, the capillary channel 5 can be used as a reaction field for immunoassay as in the case of the testing device 1A. Specifically, when the capillary channel 5 is used as a reaction field for immunoassay, the first channel 3 and the second flow from either the first liquid injection part 8a or the second liquid injection part 8b. Liquid is injected into any of the channels 4. At this time, the inspection device 1 </ b> C is held so that the length direction (one direction) of the cartridge body 2 is a direction along the gravity. Thereby, a liquid can be distribute | circulated from the upper end side of either the 1st flow path 3 and the 2nd flow path 4 to a lower end side using gravity.

  Further, in the inspection device 1C of the present embodiment, a part of the liquid is flowing while the liquid is circulated from the upper end side to the lower end side of either the first flow path 3 or the second flow path 4 by gravity. After the liquid flows into the capillary channel 5 due to the capillary phenomenon, the liquid flowing into the capillary channel 5 flows out of the capillary channel 5 to be sent to the capillary channel 5. Liquid operation can be performed.

  Thereby, in the test | inspection device 1C of this embodiment, it is possible to perform liquid feeding operation with respect to the capillary flow path 5 using gravity, without using a pump. Here, as shown in FIG. 9, the flow of the liquid L in the constricted flow path changing portion 3C will be described. FIG. 9 is a plan view showing the state of the liquid L in the flow path changing portion 3C.

  As shown in FIG. 9, the liquid L flowing down in the first flow path 3 is once stored in the taper portion 32 in the flow path changing portion 3 </ b> C, and then passes through the cross-sectional area minimum portion 31 and from the reverse taper portion 33. It will be leaked. In this case, the liquid L in the flow path changing portion 3C stays for a longer time while being connected to the plurality of capillary flow paths 5 than when flowing in the flow path linear portion 3A. Thereby, it is possible to earn time until the liquid L flows from the one end side opening 5 a of each capillary channel 5 and flows out from the one end side opening 5 a of each capillary channel 5. On the other hand, the liquid L that has passed through the minimum cross-sectional area portion 31 quickly flows down through the reverse tapered portion 33. Thereby, the time until the liquid L flowing down in the first flow path 3 is recovered by the liquid recovery unit 18 can be shortened.

[Fourth Embodiment]
Next, as a fourth embodiment of the present invention, an inspection device 1D1 shown in FIGS. 10 and 11 and an inspection device 1D2 shown in FIG. 12 will be described. FIG. 10 is a plan view showing the configuration of the inspection device 1D1. FIG. 11 is a perspective view showing the configuration of the inspection device 1D1. FIG. 12 is a plan view showing the configuration of the inspection device 1D2. Moreover, in the following description, about the site | part equivalent to the said test | inspection device 1A, while omitting description, the same code | symbol shall be attached | subjected in drawing.

  As illustrated in FIGS. 10 and 11, the inspection device 1 </ b> D <b> 1 includes a flow path trap unit 50 </ b> A between the other end side of the first flow path 3 and the liquid recovery unit 18. The flow path trap section 50 </ b> A has a part of the flow path between the lower end side of the first flow path 3 and the liquid recovery section 18 in the direction from the lower end side to the upper end side of the cartridge main body 2 and the cartridge main body 2. It has a shape folded back in order from the upper end side to the lower end side.

  Specifically, the channel trap part 50A includes a first bent channel 51, an upward channel 52, and a second channel from the lower end side of the first channel 3 toward the liquid recovery unit 18 side. A bending channel 53 and a downward channel 54 are provided in this order. Further, the flow path trap section 50 includes a first bent flow path 51, an upward flow path 52, and a second bent flow between the recess 50a formed on the front surface of the main body section 2a and the panel section 2b. A trap space including the path 53 and the downward flow path 54 is configured.

  The first bent flow path 51 is provided to bend from the lower end portion of the first flow path 3 obliquely upward to the outside of the cartridge body 2. The upward flow path 52 is provided to extend obliquely between the first bent flow path 51 and the second bent flow path 53. The second bent flow path 53 is bent from the upper end portion of the upward flow path 52 toward the lower side of the cartridge body 2. The downward flow path 54 is provided to extend in the length direction of the cartridge body 2 between the second bent flow path 53 and the liquid recovery unit 18. The downward flow path 54 communicates with the upper space on the opposite side of the liquid recovery unit 18 from the side where the air holes 19 are provided. Other than that, the configuration is basically the same as that of the inspection device 1A.

  On the other hand, the inspection device 1D2 illustrated in FIG. 12 includes a flow path trap unit 50A between the other end side of the first flow path 3 and the liquid recovery unit 18. A flow path trap unit 50B is provided. The flow path trap part 50B has a shape in which a part of the flow path between the lower end side of the first flow path 3 and the liquid recovery part 18 is folded back in the direction from the lower end side to the upper end side of the cartridge body 2. Have.

  Specifically, the flow path trap 50 </ b> B includes a first bent flow path 51 and an upward flow path 52 from the lower end side of the first flow path 3 toward the liquid recovery unit 18. Further, the flow path trap portion 50B constitutes a trap space including a first bent flow path 51 and an upward flow path 52 between the recess 50a formed on the front surface of the main body 2a and the panel portion 2b. doing.

  The first bent flow path 51 is provided to bend from the lower end portion of the first flow path 3 obliquely upward to the outside of the cartridge body 2. The upward flow path 52 is provided to extend obliquely between the first bent flow path 51 and the second bent flow path 53. The upward flow path 52 communicates with the upper space on the side opposite to the side where the air holes 19 of the liquid recovery unit 18 are provided. Other than that, the configuration is basically the same as that of the inspection device 1D1.

  In the inspection devices 1D1 and 1D2 having the above-described configuration, the capillary channel 5 can be used as a reaction field for immunoassay as in the case of the inspection device 1A. Specifically, when the capillary channel 5 is used as a reaction field for immunoassay, the first channel 3 and the second flow from either the first liquid injection part 8a or the second liquid injection part 8b. Liquid is injected into any of the channels 4. At this time, the inspection device 1 </ b> C is held so that the length direction (one direction) of the cartridge body 2 is a direction along the gravity. Thereby, a liquid can be distribute | circulated from the upper end side of either the 1st flow path 3 and the 2nd flow path 4 to a lower end side using gravity.

  Further, in the inspection devices 1D1 and 1D2 of the present embodiment, while the liquid is circulated from the upper end side to the lower end side of either the first flow path 3 or the second flow path 4 by gravity, A part of the capillary channel 5 flows into the capillary channel 5 due to a capillary phenomenon, and then the liquid flowing into the capillary channel 5 flows out to the outside of the capillary channel 5. The liquid feeding operation can be performed.

  Thereby, in inspection device 1D1, 1D2 of this embodiment, it is possible to perform liquid feeding operation with respect to the capillary flow path 5 using gravity, without using a pump. Further, in the inspection devices 1D1 and 1D2 of the present embodiment, the liquid L can be retained in the first flow path 3 by the flow path trap portions 50A and 50B.

  Here, as shown in FIGS. 13A to 13C, the flow of the liquid L in the flow path trap section 50A, and in the flow path trap section 50B as shown in FIGS. 14A to 14C. The flow of the liquid L in FIG. FIGS. 13A and 14A are plan views showing the state of the liquid L in the flow path trap portions 50A and 50B when the inspection device 1D is held in the direction along the gravity. FIG. 13B and FIG. 14B show the inside of the flow path trap portions 50A and 50B when the inspection device 1D is tilted to one side (clockwise with respect to the Z axis) with respect to the direction along gravity. 3 is a plan view showing a state of a liquid L. FIG. FIG. 13C and FIG. 14C show the inside of the channel trap portions 50A and 50B when the inspection device 1D is tilted to the other side (counterclockwise with respect to the Z axis) with respect to the direction along the gravity. It is a top view which shows the state of the liquid L in.

  First, as shown in FIGS. 13A and 14A, when the inspection device 1D is held in the direction along gravity, the liquid L in the flow path trap portions 50A and 50B is liquid level on the inflow side. And the liquid level on the outflow side stay in the flow path trap portions 50A and 50B so that they have the same horizontal height. At this time, the liquid level on the inflow side is located below the plurality of capillary channels 5. Strictly speaking, the liquid level on the inflow side becomes slightly higher than the liquid level on the outlet side due to the tension of the liquid L applied when the liquid L flows out to the liquid recovery unit 18.

  Next, as shown in FIGS. 13B and 14B, when the inspection device 1D is tilted to one side with respect to the direction along the gravity, the liquid L in the channel trap portions 50A and 50B is The liquid flows into the first flow path 3 while being connected to the plurality of capillary flow paths 5 (flow path linear portion 3A). Thereby, the liquid L flows in from the one end side opening part 5a of each capillary flow path 5. FIG. Therefore, by repeating the state shown in FIGS. 13 (A) and 14 (A) and the state shown in FIGS. 13 (B) and 14 (B), the liquid feeding operation to the capillary channel 5 is repeatedly performed. Is possible.

  Next, as shown in FIGS. 13C and 14C, when the inspection device 1D is tilted to the other side with respect to the direction along the gravity, the liquid L in the flow path trap portions 50A and 50B is Then, it flows into the liquid recovery unit 18. Thereby, the liquid L staying in the flow path trap units 50A and 50B can be discharged and recovered to the liquid recovery unit 18 side.

  As described above, in the inspection device 1D of the present embodiment, the liquid feeding operation with respect to the capillary channel 5 can be repeatedly performed using the liquid L staying in the channel trap unit 50. Further, the amount and flow rate of the liquid fed to the capillary channel 5 can be easily controlled.

  In addition, about the flow-path trap part 50, not only the structure arrange | positioned at the 1st flow path 3 side mentioned above but the structure arrange | positioned at the 2nd flow path 4 side is also possible. In that case, the air holes 19 are preferably located in the upper space opposite to the upper space communicating with the flow path trap portion 50. Alternatively, the protective wall 20 may block the liquid L that has flowed out of the flow path trap unit 50 so as not to enter the air hole 19.

  The flow path trap unit 50 is not limited to the configuration added to the inspection device 1A, but may be configured to be added to the inspection devices 1B and 1C. Furthermore, by appropriately changing the structure of the flow path trap section 50 and the arrangement of the plurality of capillary flow paths 5, the inspection device 1D is held in the direction along gravity as shown in FIGS. 13 (A) and 14 (A). In this case, the liquid level on the inflow side can be set higher than the plurality of capillary channels 5.

[Fifth Embodiment]
Next, an inspection device 1E shown in FIG. 15 will be described as a fifth embodiment of the present invention. FIG. 15 is a cross-sectional view showing the configuration of the inspection device 1E. Moreover, in the following description, about the site | part equivalent to the said test | inspection device 1A, while omitting description, the same code | symbol shall be attached | subjected in drawing.

  The inspection device 1E includes a first cartridge half (first base) 2c and a second cartridge half (second base) 2d that constitute the cartridge body 2. The cartridge body 2 is joined and integrated in a state where the butting surfaces of the first cartridge half 2c and the second cartridge half 2d are butted against each other.

  On one surface of the first cartridge half 2c that faces the second cartridge half 2d, a first recess 3a that constitutes the first flow path 3 and a second that constitutes the second flow path 4 are provided. A recess 4a is formed. A plurality of capillary channels 5 are formed in the second cartridge half 2d. In addition, the one end side opening 5a and the other end side opening 5b of each capillary channel 5 are provided so as to open on one surface of the second cartridge half 2d facing the first cartridge half 2d. Yes. That is, each capillary channel 5 is provided extending in the width direction of the second cartridge half 2d in a state of being parallel to the length direction of the second cartridge half 2d, and both sides in the width direction are provided. It is bent toward the one end side opening 5a and the other end side opening 5b.

  In the inspection device 1E, the first channel 3, the second recess 4a, and each capillary channel 5 between the first recess 3a and the surface on which the one end opening 5a of each capillary channel 5 is formed. The second flow path 4 is formed between the other end side opening 5b and the surface on which the other end side opening 5b is formed.

  Further, in the inspection device 1E, although not shown, the first liquid injection unit 8a and the second injection unit 8b (injection source 9 and injection port 10), the first flow path expansion unit 16 and the second flow The path enlargement portion 17, the liquid recovery portion 18, the air hole 19, and the protective wall 20 may be formed using one or both sides of the first cartridge half 2c and the second cartridge half 2d. it can. Furthermore, in the inspection device 1E, a chip mounting portion can be provided in the second cartridge half 2d, and a chip portion in which a plurality of capillary channels 5 are formed can be detachably attached to the chip mounting portion. is there. The rest of the configuration is basically the same as that of the inspection device 1A.

  In the testing device 1E having the above-described configuration, the capillary channel 5 can be used as a reaction field for immunoassay, as in the case of the testing device 1A. Specifically, when the capillary channel 5 is used as a reaction field for immunoassay, the first channel 3 and the second flow from either the first liquid injection part 8a or the second liquid injection part 8b. Liquid is injected into any of the channels 4. At this time, the inspection device 1B is held so that the length direction (one direction) of the cartridge body 2 is the direction along the gravity. Thereby, a liquid can be distribute | circulated from the upper end side of either the 1st flow path 3 and the 2nd flow path 4 to a lower end side using gravity.

  In the inspection device 1E of the present embodiment, a part of the liquid is flowing while the liquid is circulated from the upper end side to the lower end side of either the first flow path 3 or the second flow path 4 by gravity. After flowing into the capillary channel 5 by capillary action, the liquid flowing into the capillary channel 5 is discharged to the outside of the capillary channel 5, and is sent to the capillary channel 5. Liquid operation can be performed.

  Thereby, in the test | inspection device 1E of this embodiment, it is possible to perform liquid feeding operation with respect to the capillary flow path 5 using gravity, without using a pump. The configuration of the inspection device 1E is not limited to the configuration of the inspection device 1A, and can be applied to the configurations of the inspection devices 1B to 1D.

[Other Embodiments]
The inspection device to which the present invention is applied is not necessarily limited to the configuration of the above-described embodiment, and various modifications can be made without departing from the spirit of the present invention.

  Specifically, the capillary channel 5 has a configuration as shown in FIGS. 16A to 16D, for example. 16A to 16D are cross-sectional views of the plurality of capillary channels 5 along the line segment X-X ′ shown in FIG. 1.

  The plurality of capillary channels 5 illustrated in FIG. 16A have a rectangular (including rectangular or square) cross-sectional shape. The plurality of capillary channels 5 shown in FIG. 16B have a circular (including oval or elliptical) cross-sectional shape. Each capillary channel 5 shown in FIGS. 16A and 16B has a long shape in the thickness direction (Z-axis direction) of the cartridge body 2, but the length direction of the cartridge body 2. You may have a long shape in (X-axis direction).

  The cross-sectional shape of the plurality of capillary channels 5 shown in FIG. 16C is a configuration in which the plurality of capillary channels 5 are arranged in parallel in the length direction (X-axis direction) and the thickness direction (Z-axis direction) of the cartridge body 2. It is. Thus, it is also possible to arrange a plurality of capillary channels 5 three-dimensionally.

  The cross-sectional shape of the plurality of capillary channels 5 shown in FIG. 16D is a configuration having a cross-sectional shape extended in the thickness direction (Z-axis direction) of the cartridge body 2.

  About the 1st flow path 3 and the 2nd flow path 4, the structure as shown to FIG. 17 (A)-(E) is mentioned, for example. 17A to 17E are plan views showing modifications of the first flow path 3 and the second flow path 4.

  The first flow path 3 and the second flow path 4 shown in FIG. 17A sandwich the flow path straight line portions 3A and 4A where the cross-sectional area in the width direction is minimum, and flow from the upper end thereof. It is the structure which has the taper parts 34 and 44 where the flow-path cross-sectional area of the width direction becomes small continuously toward linear part 3A, 4A. The tapered portions 34 and 44 are formed on the inner inner wall surfaces 34a and 44a inclined with respect to the inner inner wall surfaces of the first channel 3 and the second channel 4, and the first channel 3 and the second channel. Outer inner wall surfaces 34 b and 44 b are inclined with respect to the outer inner wall surface of the road 4.

  The first flow path 3 and the second flow path 4 shown in FIG. 17B sandwich the flow path straight line portions 3A and 4A where the cross-sectional area of the flow direction in the width direction is the minimum, and flow paths from the upper end thereof. Tapered portions 34 and 44 in which the cross-sectional area in the width direction continuously decreases toward the straight portions 3A and 4A, and the cross-sectional area in the width direction continues from the straight line portions 3A and 4A toward the lower end. This is a configuration having reverse tapered portions 35 and 45 that become larger in size. The tapered portions 34 and 44 are formed on the inner inner wall surfaces 34a and 44a inclined with respect to the inner inner wall surfaces of the first channel 3 and the second channel 4, and the first channel 3 and the second channel. Outer inner wall surfaces 34 b and 44 b are inclined with respect to the outer inner wall surface of the road 4. The reverse taper portions 35 and 45 include inner inner wall surfaces 35a and 45a that are inclined with respect to the inner inner wall surfaces of the first channel 3 and the second channel 4, and the first channel 3 and the second channel. It has outer inner wall surfaces 35b and 45b inclined with respect to the outer inner wall surface of the flow path 4.

  The first flow path 3 and the second flow path 4 shown in FIG. 17C sandwich the flow path straight line portions 3A and 4A where the cross-sectional area of the flow direction in the width direction is the minimum, and the flow paths from the upper end thereof. It is the structure which has the taper parts 36 and 46 in which the flow-path cross-sectional area of the width direction becomes small continuously toward linear part 3A, 4A. The tapered portions 36 and 46 are formed on the inner inner wall surfaces 36a and 46a inclined with respect to the inner inner wall surfaces of the first flow path 3 and the second flow path 4, and the first flow path 3 and the second flow path. Outer inner wall surfaces 36 b and 46 b that are flush with the outer inner wall surface of the road 4 are provided.

  The first flow path 3 and the second flow path 4 shown in FIG. 17D sandwich the flow path straight line portions 3A and 4A where the cross-sectional area in the width direction is minimum, and flow from the upper end thereof. Tapered portions 36, 46 in which the cross-sectional area in the width direction continuously decreases toward the straight portions 3A, 4A, and the cross-sectional area in the width direction continues from the straight line portions 3A, 4A toward the lower end. This is a configuration having reverse tapered portions 37 and 47 that become larger in size. The tapered portions 36 and 46 are formed on the inner inner wall surfaces 36a and 46a inclined with respect to the inner inner wall surfaces of the first flow path 3 and the second flow path 4, and the first flow path 3 and the second flow path. Outer inner wall surfaces 36 b and 46 b that are flush with the outer inner wall surface of the road 4 are provided. The reverse taper portions 37 and 47 include inner inner wall surfaces 37 a and 47 a that are inclined with respect to inner inner wall surfaces of the first flow path 3 and the second flow path 4, and the first flow path 3 and the second flow path 3. Outer inner wall surfaces 37 b and 47 b that are flush with the outer inner wall surface of the flow path 4 are provided.

  The first flow path 3 and the second flow path 4 shown in FIG. 17 (E) have a taper in which the cross-sectional area in the width direction continuously decreases from the upper end portion toward the cross-sectional area minimum portions 31 and 41. Along with the portions 38 and 48, there are reverse tapered portions 39 and 49 in which the cross-sectional area in the width direction continuously increases from the cross-sectional area minimum portions 31 and 41 toward the lower end portion. The cross-sectional area minimum portions 31 and 41 are located substantially in the middle of the plurality of capillary channels 5 arranged in parallel in the length direction. The taper portions 38 and 48 and the inverse taper portions 39 and 49 have a symmetrical shape with the cross-sectional area minimum portions 32 and 42 interposed therebetween. In the tapered portions 38 and 48, inner inner wall surfaces 38a and 48a and outer inner wall surfaces 38b and 48b are inclined. In the reverse taper portions 39 and 49, inner inner wall surfaces 39a and 49a and outer inner wall surfaces 39b and 49b are inclined.

  The plurality of capillary channels 5 are divided into a plurality of capillary channel groups 5A between the first channel 3 and the second channel 4 as shown in FIG. 18, for example. It is good also as a structure. FIG. 18 is a plan view showing a configuration in which a plurality of capillary channel groups 5A are arranged in the inspection device 1A.

  Moreover, about the some capillary flow path 5, as shown to FIG. 19 (A), (B), for example, the structure which connects between the 1st flow path expansion part 16 and the 2nd flow path expansion part 17 It is good. FIG. 19A is a plan view in which the positions of the plurality of capillary channels 5 in the inspection device 1A are changed. FIG. 19B is a plan view in which the positions of the plurality of capillary channels 5 in the inspection device 1D are changed.

  In the configuration shown in FIGS. 19A and 19B, the first flow path expanding portion 16 and the second flow path expanding portion 17 function as the first flow path 3 and the second flow path 4. The lengths of the first channel 3 and the second channel 4 can be shortened. Thereby, the total length of the cartridge body 2 can be shortened, and the inspection devices 1A and 1D can be downsized.

  For the production of an inspection device to which the present invention is applied, for example, when the above-described resin material is used, for example, an injection molding method, a molding method in which a fine pattern produced using a soft lithography technique is transferred, and an imprint The method etc. can be used suitably. On the other hand, when a glass material is used, it can be produced using, for example, dry etching, wet etching, laser drilling, machining, or the like.

  Moreover, when performing nano (nm) scale fine processing, it is preferable to perform processing combining an ultra-short pulse laser and wet etching. For example, when a short pulse laser such as a femtosecond laser is focused and focused on a portion to be processed on the glass substrate, the focal portion is modified. The modified portion is preferentially removed by immersing in the etching solution. Using this principle, a fine modified pattern is formed while controlling the position of the modified portion with a precision stage or the like. Then, a fine pattern such as the capillary channel 5 can be formed by immersing in an etching solution such as hydrofluoric acid or KOH for an arbitrary time.

  In addition, when forming micropores directly inside the resin material, focused irradiation with a femtosecond laser is effective. By condensing and irradiating femtosecond laser, a gap can be provided in the condensing part. Moreover, it is possible to make a fine flow path by connecting gaps continuously.

(Inspection method)
Next, an inspection method according to an embodiment of the present invention will be described. In the inspection method of the present embodiment, the inspection method using the inspection device 1A is exemplified, but any inspection device can be used as long as the inspection device is applied with the present invention.

  In the inspection method using the inspection device 1A, the capillary channel 5 is used as a reaction field for immunoassay. Specifically, when the capillary channel 5 is used as a reaction field for immunoassay, a polymer that specifically binds to a specific substance M on the inner wall surface of the capillary channel 5 as schematically shown in FIG. P is fixed. Examples of the type of the polymer P include antibodies, peptides, DNA aptamers, RNA aptamers, sugar chains, and the like.

  In this case, the distance between the substance M and the polymer P in the capillary channel 5 becomes very short. For this reason, in an immune reaction using a normal well or the like as a reaction field, a reaction time that takes several hours to several tens of hours is reduced to several minutes to several tens of minutes in an immune reaction using the inside of the capillary channel 5 as a reaction field. Can be shortened.

  Further, in the inspection method using the inspection device 1A, the number of detection samples is increased by the plurality of capillary channels 5, so that the detection accuracy can be improved. Furthermore, a plurality of immunoassays can be performed in parallel. In that case, the type of the polymer P fixed to the inner wall surface of each capillary channel 5 may be changed. As a result, the inspection time is further shortened, and it is advantageous in comparing the detection targets.

  Further, in the inspection method using the inspection device 1A, the first flow path 3 and the second flow path 4 from any one of the first liquid injection section 8a and the second liquid injection section 8b described above. The inspection device 1A is held so that the length direction (one direction) of the cartridge body 2 is in the direction along the gravity when the liquid is injected into any of them. Thereby, a liquid can be distribute | circulated from the upper end side of either the 1st flow path 3 and the 2nd flow path 4 to a lower end side using gravity.

  In the inspection method using the inspection device 1A, while the liquid is circulated from the upper end side to the lower end side of one of the first flow path 3 and the second flow path 4 by gravity, After a part of the liquid flows into the capillary channel 5 due to a capillary phenomenon, the liquid flowing into the capillary channel 5 flows out of the capillary channel 5, and the inspection device 1 </ b> A is used. A liquid feeding operation is performed on the capillary channel 5.

  The test method of the present embodiment includes a step of feeding a liquid containing a specimen to be examined (including a case where the specimen itself is a liquid), and a primary antibody that specifically binds to a specific antigen in the specimen. A step of feeding a liquid containing, a step of feeding a liquid containing a blocking agent, a step of feeding a liquid containing a secondary antibody labeled with an enzyme or a luminescent substance, and color development or luminescence by reacting with the enzyme One of the steps of feeding a liquid containing the reagent to be carried out. Further, the method includes a step of feeding a liquid for cleaning the inside of the flow channel after feeding any one of the above liquids.

  In the inspection method of this embodiment, in any of the above steps, it is possible to perform a liquid feeding operation on the capillary channel 5 using gravity without using a pump.

[Immunoassay]
Next, an example of immunoassay using the test device 1A will be described with reference to FIGS. 21 to 29 are plan views for sequentially explaining each step of the immunoassay using the test device 1A.

  In the immunoassay using the test device 1A, first, as shown in FIG. 21, the liquid L1 containing the primary antibody Ab1 is fed from the first flow path 3 side. Accordingly, the liquid L1 is circulated from the upper end side to the lower end side of the first flow path 3 while the liquid L1 fills the first flow path 3. Further, while the liquid L1 is circulated from the upper end side to the lower end side of the first flow path 3, a part of the liquid L1 flows into the capillary flow paths 5 by capillary action. Thereafter, as shown in FIG. 22, the liquid L <b> 1 that has flowed into the capillary channels 5 flows out of the capillary channels 5. By this liquid feeding operation, as shown in FIG. 23, the primary antibody Ab1 contained in the liquid L1 adheres to and is fixed to the inner wall surface of each capillary channel 5.

  After feeding the liquid L1, for example, a liquid containing a blocking agent such as skim milk or albumin is fed, and the blocking agent is fixed to the inner wall surface of the capillary channel 5 other than the portion where the primary antibody Ab1 is fixed. A process (hereinafter referred to as a blocking process), a process of feeding a cleaning liquid and cleaning the inside of the flow path (hereinafter referred to as a cleaning process) are performed.

  Next, as shown in FIG. 24, the liquid L2 containing the specimen to be examined is fed from the first flow path 3 side. It is assumed that the specimen contains an antigen Ag that specifically binds to the primary antibody Ab1. Thereby, the liquid L2 flows from the upper end side to the lower end side of the first flow path 3 while the liquid L2 fills the first flow path 3. Further, while the liquid L2 is circulated from the upper end side to the lower end side of the first flow path 3, a part of the liquid L2 flows into each capillary flow path 5 by capillary action. Thereafter, as shown in FIG. 25, the liquid L <b> 2 that has flowed into the capillary channels 5 flows out of the capillary channels 5. By this liquid feeding operation, as shown in FIG. 26, the antigen Ag contained in the specimen in the liquid L2 is bound and captured by the primary antibody Ab1 by the antigen-antibody reaction. Thereafter, excess antigen Ag that has not reacted with the primary antibody Ab1 is washed away by a washing step (referred to as B / F separation).

  Next, as shown in FIG. 27, the liquid L3 containing the secondary antibody Ab2 labeled with the fluorescent substance is fed from the second flow path 4 side. As a result, the liquid L3 flows from the upper end side to the lower end side of the second flow path 4 while the liquid L3 fills the second flow path 4. Further, while the liquid L3 is circulated from the upper end side to the lower end side of the second flow path 4, a part of the liquid L3 flows into the capillary flow paths 5 by capillary action. Thereafter, as shown in FIG. 28, the liquid L <b> 1 that has flowed into the capillary channels 5 flows out of the capillary channels 5. By this liquid feeding operation, as shown in FIG. 29, the secondary antibody Ab2 contained in the liquid L3 is specifically bound to the antigen Ag by the antigen-antibody reaction. Thereafter, excess secondary antibody Ab2 that has not reacted with antigen Ag is washed away by a washing step (referred to as B / F separation).

  Since the secondary antibody Ab2 is pre-labeled with a fluorescent substance, for example, when the capillary channel 5 is irradiated with excitation light, the fluorescent substance of the secondary antibody Ab2 bound to the antigen Ag emits fluorescence. become. Therefore, in the immunoassay using the test device 1A, the amount or concentration of the antigen Ag contained in the specimen is quantitatively measured by measuring the fluorescence emission intensity when the capillary channel 5 is irradiated with the excitation light. It is possible to detect.

  The secondary antibody Ab2 is not limited to one labeled with a luminescent substance such as a fluorescent luminescent substance, and a secondary antibody Ab2 labeled with an enzyme can be used. In this case, a step of feeding a liquid containing a substrate (reagent) that develops or emits light by reacting with the enzyme of the secondary antibody Ab2 is further added to the capillary channel 5 after the above step. Thereby, it is possible to quantitatively detect the amount and concentration of the antigen Ag contained in the specimen by measuring the emission intensity of the substrate that develops or emits light.

  Examples of the luminescent substance include green fluorescent protein (GFP) and quantum dots. On the other hand, examples of the enzyme include peroxidase, luciferase, aequorin and the like. Examples of the enzyme substrate include 3- (p-hydroxyphenol) propionic acid and analogs thereof, luciferin and luciferin analogs, coelenterazine and coelenterazine analogs, and the like. Further, at least one or two or more of these labeling substances can be used. In addition, examples of the non-luminescent labeling substance include radioactive labeling substances used in known radioimmunoassay methods. The method for binding the labeling substance to the secondary antibody Ab2 is not particularly limited, and a known method can be applied.

  The type of antigen Ag is not particularly limited and is appropriately selected according to the purpose of biochemical examination. Specific examples of the antigen Ag include proteins, peptides, nucleic acids, lipids, sugar chains and the like derived from pathogens such as viruses and bacteria that cause colds, hepatitis, acquired immune deficiency, and the like.

  For the primary antibody Ab1 and the secondary antibody Ab2, it is necessary to prepare in advance a specimen that specifically binds to a specific antigen Ag. Such an antibody is appropriately selected from known ones and used. It is possible.

  In addition, when there is a place where it is not desired to adsorb the antigen Ag, the primary antibody Ab1, the secondary antibody Ab2, etc. in the flow path, by performing a surface treatment such as a coating for improving the water repellency of the place in advance, Unnecessary adsorption can be prevented.

  In the immunoassay using the test device 1A, the presence or absence of the antigen Ag in the sample to be tested is qualitatively detected, and the amount or concentration of the antigen Ag contained in the sample is quantitatively detected. Is possible.

  In addition, as an immunoassay using the test device 1A, for example, a known immunoassay method such as a sandwich immunoassay method, an indirect antibody immunoassay method, or a bridging immunoassay method can be employed. It is not limited.

(Inspection equipment)
Next, an inspection apparatus according to an embodiment of the present invention will be described. In the inspection apparatus of the present embodiment, an inspection apparatus using the inspection device 1A is exemplified, but any inspection device can be used as long as the inspection device is applied with the present invention.

  The inspection apparatus according to the present embodiment includes a device holding unit 101 that holds an inspection device 1A as shown in FIGS. 30A and 30B, for example, and a device inspection unit 102 that inspects the inspection device 1A. Can be mentioned. Note that FIG. 30A is a block diagram illustrating a configuration in which the device inspection unit 102 includes a light emitting unit 103 and a light receiving unit 104. FIG. 30B is a block diagram illustrating a configuration in which the light receiving unit 104 is provided as the device inspection unit 102.

  The device holding unit 101 holds the inspection device 1A so that the length direction (one direction) of the cartridge main body 2 is a direction along gravity. The mechanism for holding the inspection device 1A is not particularly limited, and a conventionally known mechanism can be used.

  In this state, the inspection apparatus according to the present embodiment can perform a liquid feeding operation on the capillary channel 5 using the above-described gravity without using a pump. In this state, it is possible to perform immunoassay using the above-described test device 1A. Therefore, in the inspection apparatus of this embodiment, the apparatus configuration can be simplified, the entire apparatus can be downsized, the cost can be reduced, and the maintainability can be improved by simplifying the apparatus configuration.

  In the device inspection unit 102 shown in FIG. 30A, the capillary light channel 5 of the inspection device 1A is irradiated with excitation light emitted from the light emitting unit 103. On the other hand, the light receiving unit 104 receives light from a luminescent material that emits light when excited in the capillary channel 5 (hereinafter referred to as detection light). Thus, it is possible to qualitatively detect the presence or absence of an antigen contained in the specimen from the emission intensity of the detection light, and to quantitatively detect the amount or concentration of the antigen.

  On the other hand, in the device inspection unit 102 shown in FIG. 30B, the light receiving unit 104 receives light from a luminescent substance that emits light within the capillary channel 5 (hereinafter referred to as detection light). Thus, it is possible to qualitatively detect the presence or absence of an antigen contained in the specimen from the emission intensity of the detection light, and to quantitatively detect the amount or concentration of the antigen.

  In addition, the inspection apparatus according to the present embodiment may be configured to further include an injection driving unit 105 as shown in FIGS. 31A and 31B, for example. FIG. 31A is a block diagram illustrating a configuration in which the injection driving unit 105 is added to the configuration illustrated in FIG. FIG. 31B is a block diagram illustrating a configuration in which an injection driving unit 105 is added to the configuration illustrated in FIG.

  In the configuration shown in FIGS. 30A and 30B, the liquid injection operation is manually performed on the first liquid injection unit 8a and the second liquid injection unit 8b of the inspection device 1A, whereas FIG. In the configurations shown in (A) and (B), the injection operation can be automatically performed by the injection driving unit 105.

  Specifically, the injection driving unit 105 presses the diaphragm valve 12b from the rear surface side of the main body 2a against the injection source 9, thereby pumping the liquid stored in the liquid storage unit 11 to the outlet channel 13. To do. The mechanism for pressing the diaphragm valve 12b is not particularly limited, and a conventionally known mechanism can be used. Moreover, in the structure which packaged the liquid storage part 11, it is good also as a structure which performs operation which opens a part of seal | sticker of a package.

  The injection drive unit 105 is not limited to a configuration in which a plurality of operation mechanisms are provided in accordance with the number of injection sources 9, but is configured to selectively operate the plurality of injection sources 9 while changing the position with one operation mechanism. Also good. In addition, about the timing which operates each injection source 9, it is necessary to provide a time difference.

  In addition, the inspection apparatus according to the present embodiment may further include an injection device driving unit 106 as shown in FIGS. 32A and 32B, for example. FIG. 32A is a block diagram illustrating a configuration in which the device driver 106 is added to the configuration illustrated in FIG. FIG. 32B is a block diagram illustrating a configuration in which the device driver 106 is added to the configuration illustrated in FIG.

  The device driving unit 106 is configured to be added to an inspection apparatus using the inspection device 1D instead of the inspection device 1A. Specifically, the device driving unit 106 moves the device holding unit 101 that holds the inspection device 1D to tilt the inspection device 1D to one side (clockwise) with respect to the direction along the gravity, The inspection device 1D can be tilted to the other side (clockwise) with respect to the direction along the direction. A mechanism for moving the device holding unit 101 is not particularly limited, and the moving operation can be performed by a mechanism using a drive motor such as a stepping motor or a servo motor.

  In the inspection apparatus according to the present embodiment, in addition to the above configuration, for example, a calculation unit that performs a calculation based on a result detected by a control unit that controls driving of each unit, a power supply unit that supplies power, or the device inspection unit 102 And an output unit that outputs the result of the calculation by the calculation unit as a signal.

[Detection optics]
Next, an example of the detection optical system constituting the device inspection unit 102 shown in FIGS. 30A, 31A, and 32A will be described with reference to FIG. FIG. 33 is a cross-sectional view showing the configuration of the detection optical system.

  In the detection optical system shown in FIG. 33, a light emitting unit 103 and a light receiving unit 104 are arranged with an inspection device 1A held by the device holding unit 101 interposed therebetween. In the light emitting unit 103, a light emitting element 107 and a collimating lens 108 are sequentially arranged on the optical axis AX1 toward the inspection device 1A. In the light receiving unit 104, a collimating lens 109, an optical filter 110, a condensing lens 111, and a light receiving element 112 are arranged in order on the optical axis AX2 toward the side opposite to the inspection device 1A. Yes.

  The optical axis AX1 on the light emitting unit 103 side has an angle inclined with respect to the main surface of the detection unit (corresponding to the chip units 7A and 7B) 113 in which the plurality of capillary channels 5 of the inspection device 1A are arranged. . On the other hand, the optical axis AX2 on the light receiving unit 104 side has an angle perpendicular to the main surface of the detection unit 113. That is, the optical axis AX1 and the optical axis AX2 intersect each other in the detection unit 113 so that the optical path of the excitation light emitted from the light emitting unit 103 and the optical path of the detection light received by the light receiving unit 104 do not coincide.

  The light emitting element 107 is made of, for example, a semiconductor laser and irradiates excitation light toward the detection unit 113. The collimator lens 108 collimates the excitation light toward the detection unit 113. The collimating lens 109 collimates detection light toward the light receiving element 112. Further, instead of the collimating lens 109, a lens that collects the detection light toward the light receiving element 112 may be used. The optical filter 110 cuts light other than the detection light (excitation light or light from the outside) and improves the S / N ratio of the detection light incident on the light receiving element. The condensing lens 111 condenses the detection light toward the light receiving element 112. The light receiving element 112 includes, for example, a photomultiplier tube, a solid-state imaging device (CCD), an avalanche photodiode, a photodiode, or the like, and receives detection light.

  The light emitting unit 103 includes a light shielding path 114 that shields an optical path between the light emitting element 107 and the detecting unit 113. Accordingly, it is possible to shield the excitation light from leaking out and the external light from entering the detection unit 113.

  In addition, the light emitting unit 103 has a light shielding path 115 that shields the optical path on the extension of the optical axis AX1 on the opposite side across the inspection device 1A. Thereby, it is possible to shield the excitation light from entering the light receiving unit 104 side.

  The light receiving unit 104 includes a light blocking path 116 that blocks the optical path between the detecting unit 113 and the light receiving element 112. Accordingly, it is possible to shield the detection light from leaking out and preventing the external light from entering the light receiving element 112.

  The device holding unit 101 is provided with an opening 101a on the light emitting unit 103 side through which excitation light passes and an opening 101b on the light receiving unit 104 side through which detection light passes. The opening 101b on the light receiving unit 104 side functions as a stop. Thereby, the spot size of the detection light received by the light receiving element 112 can be made constant, and the detection light received by the light receiving unit 104 can be quantified.

  The device inspection unit 102 is not necessarily limited to the configuration of the detection optical system described above, and can be implemented with appropriate modifications. For example, the device holding unit 101 may be provided with a heater (not shown) for heating the inspection device 1A. Thereby, 1 A of test | inspection devices can be hold | maintained at specific temperature.

  DESCRIPTION OF SYMBOLS 1A-1E ... Inspection device 2 ... Cartridge main body 2a ... Main-body part (1st base material) 2b ... Panel part (2nd base material) 2c ... 1st cartridge half body 2d ... 2nd cartridge half body 3 ... 1st flow path 3a ... 1st recessed part 3A ... Flow path linear part 3B ... Flow path changing part (taper shape) 3C ... Flow path changing part (constricted shape) 4 ... 2nd flow path 4a ... 2nd recessed part 4A: Channel linear portion 4B: Channel changing portion (tapered shape) 4C ... Channel changing portion (constricted shape) 5A ... Capillary channel group 5 ... Capillary channel 5a ... One end side opening portion 5b ... Other end side opening portion 6A, 6B ... Chip mounting part 7A, 7B ... Chip part 8a ... First liquid injection part 8b ... Second liquid injection part 9 ... Injection source 10 ... Inlet 11 ... Liquid storage part 12 ... Liquid feeding part 13 ... Outlet Channel 14 ... Liquid container 15 ... Outlet channel 16 ... First channel Most part 17 ... 2nd flow-path expansion part 18 ... Liquid recovery part 19 ... Air hole 20 ... Protective wall 21 ... Absorbent material 31 ... Cross-sectional area minimum part 32 ... Tapered part 33 ... Reverse taper part 34 ... Tapered part 35 ... Reverse Tapered portion 36 ... Tapered portion 37 ... Reverse tapered portion 38 ... Tapered portion 39 ... Reverse tapered portion 41 ... Minimum cross-sectional area 42 ... Tapered portion 43 ... Reverse tapered portion 44 ... Tapered portion 45 ... Reverse tapered portion 46 ... Tapered portion 47 ... Tapered portion 48 ... Tapered portion 49 ... Reverse tapered portion 50A, 50B ... Flow path trap portion 51 ... First bent flow path 52 ... Upward flow path 53 ... Second bent flow path 54 ... Downward flow path 101 ... Device Holding unit 102 ... Device inspection unit 103 ... Light emitting unit 104 ... Light receiving unit 105 ... Injection driving unit 106 ... Device driving unit L, L1, L2, L3 ... Liquid Ab1 ... primary antibody Ab2 ... secondary antibody Ag ... antigen

Claims (20)

A first channel and a second channel extended in one direction in a state of being aligned with each other;
A plurality of capillary channels that connect between the first channel and the second channel in a state of being parallel to the one direction;
A liquid injection part for injecting liquid from one end side of either the first flow path or the second flow path;
An inspection device comprising: a liquid recovery unit that recovers liquid flowing out from the other end of either the first flow path or the second flow path.   The first flow path and the second flow path have a flow path straight line portion in which a flow path cross-sectional area while being connected to at least the plurality of capillary flow paths is constant in the one direction. The inspection device according to claim 1.   The first flow path and the second flow path have a flow path changing portion in which a flow path cross-sectional area while being connected to at least the plurality of capillary flow paths changes in the one direction. The inspection device according to claim 1.   The inspection device according to claim 3, wherein the flow path changing portion has a tapered shape in which the flow path cross-sectional area continuously decreases or increases in the one direction.   The flow path changing section has a continuous flow cross-sectional area from one end side in the one direction toward the minimum cross-sectional area with the cross-sectional area minimum section having the minimum flow path cross-sectional area in the one direction interposed therebetween. The inspection device according to claim 3, wherein the inspection device has a constricted shape in which the flow path cross-sectional area continuously increases from the minimum cross-sectional area portion toward the other end side in the one direction. .   A part of the flow path between the other end side of the first flow path and the second flow path and the liquid recovery part is directed from the other end side in the one direction to the one end side. The inspection device according to any one of claims 1 to 5, further comprising a flow path trap portion that is folded back in a direction.   The flow path expansion part which expanded a part of flow path between either one end side of the said 1st flow path and the said 2nd flow path, and the said liquid injection part is provided. The inspection device according to any one of 1 to 6.   8. The liquid injection unit according to claim 1, wherein the liquid injection unit includes any one of an injection source for injecting a liquid previously contained in the interior and an injection port for injecting a liquid from the outside. The inspection device described.   The inspection device according to claim 1, wherein the liquid recovery unit is provided with an absorbing material that absorbs the liquid. A first base material in which a first recess that constitutes the first flow path and a second recess that constitutes the second flow path are formed on one surface;
A plurality of capillary channels are formed, and each capillary channel has a second base provided with one end side opening and the other end side opening opened on one surface, respectively,
By abutting one surface of the first base material and one surface of the second base material between each other, between the first recess and the surface where the one end side opening of each capillary channel is formed. The second flow path is configured between the first flow path, the second recess, and a surface on which the other end side opening of each capillary flow path is formed. The inspection device according to any one of claims 1 to 9. A tip portion including at least the plurality of capillary channels;
The inspection device according to claim 1, further comprising: a main body provided with a chip mounting portion to which the chip portion is detachably attached.   The inspection device according to any one of claims 1 to 11, wherein a polymer that specifically binds to a specific substance is fixed to an inner wall surface of the capillary channel. An inspection method using the inspection device according to any one of claims 1 to 12,
When the capillary channel is used as a reaction field for immunoassay, when the liquid is injected from the liquid injection part to one end side of the first channel or the second channel, An inspection method, wherein the inspection device is held such that the direction is in a direction along gravity.   While the liquid is circulated from one end side to the other end side of either the first flow path or the second flow path by gravity, a part of the liquid flows by the capillary phenomenon. The liquid flow into the capillary channel is performed using the fact that the liquid flowing into the capillary channel flows out to the outside of the capillary channel after flowing into the capillary channel. The inspection method according to claim 13.   A step of feeding a liquid containing a specimen to be examined, a step of feeding a liquid containing a primary antibody that specifically binds to a specific antigen in the specimen, and a step of feeding a liquid containing a blocking agent And a step of feeding a liquid containing a secondary antibody labeled with an enzyme or a luminescent substance, and a step of feeding a liquid containing a reagent that develops color or emits light by reacting with the enzyme. The inspection method according to claim 13 or 14, characterized by comprising:   The inspection method according to claim 15, further comprising a step of supplying a liquid for cleaning the inside of the flow path after supplying any one of the liquids. An inspection apparatus using the inspection device according to any one of claims 1 to 12,
A device holding unit for holding the inspection device;
The device holding unit is configured such that when the liquid is injected from the liquid injection unit to one end side of the first flow path and the second flow path, the one direction is a direction along gravity. The inspection device is characterized by holding the inspection device.   The inspection apparatus according to claim 17, further comprising a device inspection unit that inspects the inspection device.   The inspection apparatus according to claim 17, further comprising an injection drive unit that operates to inject liquid from the liquid injection unit.   The inspection apparatus according to any one of claims 17 to 19, further comprising a device drive unit that moves and operates the inspection device.

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