JP2019203811A - Inspection tool and method for mixing agent - Google Patents

Abstract

To provide an inspection tool that can simplify the processes and can be reduced in size.SOLUTION: An inspection tool 1 comprises an inspection tool body 2, has a first introduction part 3 provided in the inspection tool body 2 for introducing a first liquid, a mixing part 5 arranged inside the inspection tool body 2 for mixing the first liquid, a second liquid, and a third liquid, and an agent tank 13 provided in the inspection tool body 2 as a liquid tank storing the third liquid, and has a first channel 4 connecting the first introduction part 3 and mixing part 5 and a third channel 12 connecting the agent tank 13 and mixing part 5.SELECTED DRAWING: Figure 1

Description

  The present invention relates to an inspection tool capable of mixing a plurality of liquids and a reagent mixing method using the inspection tool.

  Patent Document 1 below discloses a small apparatus that can automate the measurement of hemoglobin A1c. In the measurement method using the apparatus described in Patent Document 1, blood is centrifuged and blood cells are separated from plasma. Water is added to the separated blood cells to crush the blood cells. Next, a latex solution having latex particles and a sample obtained by crushing blood cells are mixed. Thereby, hemoglobin A1c is adsorbed on the latex particle surface. Next, anti-hemoglobin A1c antibody is mixed, and latex particles are aggregated. Bound anti-hemoglobin A1c antibody is measured. In this way, hemoglobin A1c is quantified.

  On the other hand, Patent Document 2 below discloses a small microchip that makes it possible to separate plasma and blood cells.

JP2008-76256 JP2010-145314

  In the measuring apparatus and the measuring method as described in Patent Document 1, many steps are required for measuring hemoglobin A1c as a measurement target. Therefore, it is complicated and the apparatus is complicated and large.

  In the microchip described in Patent Document 2, the process for separating plasma and blood cells is simplified, and the system can be miniaturized. However, even when this microchip is used, in order to use it in the measurement method as described in Patent Document 1, it is necessary to perform a plurality of mixing steps. For this reason, there is a possibility that the flow path becomes long and the liquid remains in the flow path. As a result, it has been difficult to sufficiently increase the measurement accuracy.

  An object of the present invention is to provide an inspection tool capable of simplifying and downsizing the structure of the inspection tool.

  Another object of the present invention is to provide a reagent mixing method for mixing the first to third liquids, which can simplify the mixing process.

  The inspection tool according to the present invention is an inspection tool capable of mixing the first to third liquids, includes an inspection tool body, is provided in the inspection tool body, and the first liquid A first introduction part for introducing the first liquid, a mixing part for mixing the first liquid, the second liquid and the third liquid, provided in the inspection tool body, A liquid tank containing the third liquid, provided in the inspection tool main body, provided in the inspection tool main body, and connecting the first introduction portion and the mixing portion; And a third flow path connecting the liquid tank and the mixing section.

  In the inspection tool according to the present invention, the second liquid may be contained in the mixing unit.

  In the inspection tool according to the present invention, preferably, the inspection tool main body further includes a second introduction part for introducing the second liquid, and the second introduction part and the mixing part are connected to each other. A second flow path is provided.

  In the test tool according to the present invention, the first liquid may be a blood sample, the second liquid may be a latex reagent liquid, and the third liquid is an antigen in the blood sample. Alternatively, it may be an antibody or an antigen reagent that reacts with the antibody.

  In the test tool according to the present invention, the third liquid may be an anti-hemoglobin A1c antibody reagent.

  In the inspection tool according to the present invention, the first liquid may be a measurement sample, the second liquid may be a reaction liquid that reacts with the measurement sample, and the third liquid is a measurement reagent. It may be.

  In the reagent mixing method according to the present invention, the step of introducing the first liquid into the mixing unit, the step of introducing the second liquid into the mixing unit, the first liquid and the second liquid are accommodated. And a step of introducing a third liquid into the mixing part. The reagent mixing method in the inspection tool includes the mixing part provided in the inspection tool, and the mixing part includes the first part. When the first liquid and the second liquid are stored, the first liquid and the second liquid are stored so that the first liquid and the second liquid are positioned downward in the vertical direction.

  In the reagent mixing method according to the present invention, it is preferable to introduce the third liquid from the lower side in the vertical direction of the mixing unit when the third liquid is introduced into the mixing unit.

  In the reagent mixing method according to the present invention, the first liquid may be a blood sample, the second liquid may be a latex reagent liquid, and the third liquid is contained in the blood sample. It may be an antibody or antigen reagent that reacts with the antigen or antibody.

  The third liquid may be an anti-hemoglobin A1c antibody reagent when measuring hemoglobin A1c.

  In the reagent mixing method according to the present invention, a measurement sample may be used as the first liquid, a reaction liquid may be used as the second liquid, or a measurement reagent may be used as the third liquid. good.

  According to the test tool and the reagent mixing method of the present invention, the first liquid, the second liquid, and the third liquid can be mixed by a simplified process. Therefore, simplification of the mixing process and downsizing of the inspection tool can be achieved.

It is a schematic diagram for demonstrating the mixing method of the reagent using the test | inspection tool which concerns on 1st Embodiment, and this test | inspection tool. It is a perspective view which shows the external appearance of the inspection tool which concerns on the 1st Embodiment of this invention. It is a schematic diagram for demonstrating the mixing method of the reagent using the test | inspection tool of the 1st Embodiment of this invention. It is a schematic diagram for demonstrating the mixing method of the reagent using the test | inspection tool of the 1st Embodiment of this invention. It is a schematic diagram for demonstrating the mixing method of the reagent using the test | inspection tool of the 1st Embodiment of this invention. It is a schematic diagram for demonstrating the mixing method of the reagent using the test | inspection tool of the 1st Embodiment of this invention. It is a typical partial notch front sectional drawing for demonstrating the inspection tool which concerns on the 2nd Embodiment of this invention.

  Hereinafter, the present invention will be clarified by describing specific embodiments of the present invention with reference to the drawings.

  FIG. 1 is a schematic diagram for explaining a test tool according to a first embodiment of the present invention and a reagent mixing method using the test tool, and FIG. 2 is a perspective view showing an appearance of the test tool.

  As shown in FIG. 2, the inspection tool 1 has a rectangular card shape. However, the shape of the inspection tool 1 is not limited to this, and it may have a disk shape or may not have a card shape.

  As such a card-type inspection tool 1, there is known a microchip having a micro flow path provided therein. In addition, although a microchannel is a channel which has the dimension mentioned later, the channel provided in the inspection tool in this invention is not limited to a microchannel.

  The inspection tool 1 has an inspection tool body 2. The inspection tool main body 2 can be composed of various materials such as a synthetic resin laminate, a structure in which a resin film is laminated on a synthetic resin plate, or a glass plate.

  As shown in FIG. 1, a first introduction unit 3 for introducing a blood sample as a first liquid is provided in the inspection tool body 2. One end of the first flow path 4 is connected to the first introduction part 3. A mixing unit 5 is connected to the other end of the first flow path 4.

  The blood introduction tool 21 is used together with the test tool 1. The blood introduction device 21 is not particularly limited, but a blood introduction device having an appropriate structure capable of supplying a blood sample from the first introduction unit 3 to the first flow path 4 is used. In the present embodiment, the blood introduction tool 21 has a capillary 21a. The capillary 21a is made of glass or plastic. By using the capillary 21a, it is possible to easily collect a certain amount of blood sample using capillary action.

  A gas flow path 6 is connected to the first introduction part 3. A pump 7 is connected to the gas flow path 6. The pump 7 has a gas generating material that generates gas by light irradiation. Gas is generated by irradiating light from the outside, and this gas is supplied into the first introduction part 3 through the gas flow path 6. Thereby, the blood sample is sent to the first flow path 4 by the gas supplied to the blood introduction tool 21.

  The mixing unit 5 contains a second liquid in advance. A latex reagent solution 32 is used as the second liquid. The latex reagent liquid 32 is a liquid containing latex particles. As latex particles, polystyrene, acrylic resin, or the like can be used.

  A gas flow path 8 is connected to the mixing unit 5. A pump 9 is connected to the gas flow path 8. The pump 9 is configured in the same manner as the pump 7. By driving the pump 9, the generated gas can be supplied to the mixing unit 5 and the mixing in the mixing unit 5 can be promoted.

  An exhaust passage 10 is connected to the mixing unit 5. An air hole 11 is connected to the exhaust path 10. The air hole 11 opens to the outside of the inspection tool main body 2.

  Furthermore, a third flow path 12 is connected to the mixing unit 5. A reagent tank 13 as a liquid tank is connected to the third flow path 12. In the reagent tank 13, an anti-hemoglobin A1c antibody reagent 33 as a third liquid is accommodated. A gas flow path 14 is connected to the reagent tank 13. A pump 15 is connected to the gas flow path 14. The pump 15 is configured similarly to the pump 7 and the pump 9.

  Preferably, the gas flow path 8 and the third flow path 12 are connected to the mixing unit 5 below the vertical direction. Thereby, the mixing efficiency in the mixing unit 5 can be increased.

  Next, a measurement method using the inspection tool 1 will be described.

  First, as shown in FIG. 3, the blood introduction tool 21 is inserted into the test tool 1. Next, the pump 7 is driven to supply the blood sample 31 into the mixing unit 5 as shown in FIG. And the pump 9 is driven, gas is sent into the mixing part 5, and it mixes with the latex reagent liquid 32, crushing the blood sample 31. FIG.

  Next, the pump 15 is driven, and the anti-hemoglobin A1c antibody reagent 33 accommodated in the reagent tank 13 is fed to the mixing unit 5. As shown in FIG. 5, although not shown, the anti-hemoglobin A1c antibody reagent 33 and the crushed blood sample and the latex reagent solution 32 are mixed in the mixing unit 5. Also in this mixing, it is preferable to drive the second pump 9 and feed the gas into the mixing unit 5. Thereby, the mixing efficiency can be increased.

  As described above, hemoglobin A1c in the blood is adsorbed on the surface of the latex particles in the latex reagent solution 32, and the anti-hemoglobin A1c antibody reagent 33 is further bound to hemoglobin A1c. Therefore, latex particles aggregate. Therefore, as shown in FIG. 6, the latex aggregate 34 is located in the mixing unit 5. In this state, for example, light is irradiated to a portion surrounded by a circle A, and the intensity of transmitted light is measured. The concentration of hemoglobin A1c can be determined from the intensity of the transmitted light.

  In the measurement method having the reagent mixing method using the inspection tool 1 in the embodiment, the steps up to mixing can be simplified. That is, the mixing unit 5 can mix the first liquid, the second liquid, and the third liquid. Conventionally, when three or more liquids are mixed, two or more mixing parts are required. On the other hand, if the inspection tool 1 of this embodiment is used, the mixing process can be simplified and the inspection tool 1 can be downsized.

  In the above embodiment, the blood sample 31 is used as the first liquid, the latex reagent liquid 32 is used as the second liquid, and the anti-hemoglobin A1c antibody reagent 33 is used as the third liquid. The first to third liquids are not limited to this. The third liquid may be an antibody or antigen reagent that reacts with an antigen or antibody in a blood sample other than hemoglobin A1c.

  In addition to the measurement using the blood sample, the first liquid may be a measurement sample other than the blood sample, and the second liquid may be a reaction liquid that reacts with the measurement sample. The liquid may be a measuring reagent. That is, the inspection tool in the present invention can be widely used in an inspection method including a step of mixing the first to third liquids.

  Furthermore, in addition to the first liquid, the second liquid, and the third liquid, one kind or two or more kinds of liquids may be mixed in one mixing unit 5.

  Further, in the inspection tool 1, the latex reagent liquid 32 is previously stored in the mixing unit 5 as the second liquid. Instead, as shown in FIG. 1, for example, a reagent tank X in which the latex reagent solution 32 is stored may be provided in the middle of the gas flow path 8. In that case, the latex reagent solution 32 can be supplied to the mixing unit 5 by driving the pump 9. In this case, the latex reagent solution 32 may be supplied to the mixing unit 5 prior to supplying the blood sample 31 to the mixing unit 5.

  Further, in order to supply the latex reagent solution 32, a flow path different from the gas flow path 8 may be connected to the mixing unit 5.

  FIG. 7 is a partially cutaway front sectional view for explaining an inspection tool according to the second embodiment.

  The inspection tool 41 shown in FIG. 7 has an inspection tool body 42. The inspection tool main body 42 has a card shape and has a first main surface 42a and a second main surface 42b. The card-type inspection tool main body 42 is used horizontally. That is, the inspection tool 41 is used so that the first and second main surfaces 42a and 42b face the horizontal direction. Here, the first flow path 4 is connected to a part of the side wall of the mixing unit 5. The first liquid is supplied from the first flow path 4 to the mixing unit 5 as in the first embodiment. In the mixing unit 5, a latex reagent solution 32 as a second reagent is stored in advance as in the first embodiment. Then, it is mixed with the blood sample 31 supplied from the first flow path 4. Further, an anti-hemoglobin A1c antibody reagent 33 as a third liquid is supplied from the third flow path 12 to the mixing unit 5. Thereby, a latex aggregate 34 is formed in the mixing unit 5.

  Like the inspection tool 41, the inspection tool according to the present invention may be a card-type inspection tool used in a horizontal position.

  The flow path in the inspection tool main body 2 including the first flow path 4 is a micro flow path. Here, the micro flow path refers to a fine flow path in which a micro effect is generated when liquid is transported. In such a microchannel, the fluid is strongly influenced by the surface tension and behaves differently from a fluid flowing through a normal large-sized channel.

  The cross-sectional shape and size of the micro flow path are not particularly limited as long as the micro flow effect is generated. For example, when using a pump or gravity when flowing a fluid through the microchannel, from the viewpoint of further reducing the channel resistance, if the cross-sectional shape of the microchannel is generally rectangular (including a square) The dimension of the smaller side is preferably 20 μm or more, more preferably 50 μm or more, and even more preferably 100 μm or more. Further, from the viewpoint of further miniaturizing the microfluidic device, it is preferably 5 mm or less, more preferably 1 mm or less, and further preferably 500 μm or less.

  Further, when the cross-sectional shape of the microchannel is almost circular, the diameter (in the case of an ellipse, the short diameter) is preferably 20 μm or more, more preferably 50 μm or more, and even more preferably 100 μm or more. From the viewpoint of further miniaturizing the microfluidic device, the diameter (in the case of an ellipse, the short diameter) is preferably 5 mm or less, more preferably 1 mm or less, and further preferably 500 μm or less.

  On the other hand, for example, when flowing a liquid into a microchannel, when the capillary phenomenon is used more effectively, if the cross-sectional shape of the microchannel is generally rectangular (including a square), the smaller side The dimension is preferably 5 μm or more, more preferably 10 μm or more, and further preferably 20 μm or more. The smaller side dimension is preferably 200 μm or less, and more preferably 100 μm or less.

In addition, the flow path formed in the inspection tool main body in the present invention is not limited to a minute one like a micro flow path, and has a cross-sectional area of about 0.25 to 1.5 mm ² larger than the micro flow path. It may be a flow path.

  The first liquid may be a biological sample such as a body fluid sample other than a blood sample. The measurement sample is not limited to a biological sample, and may be a chemical substance-containing sample. In addition, chemical substances and biochemical substances can be appropriately used for the reaction solution and the measurement reagent according to the measurement sample.

DESCRIPTION OF SYMBOLS 1,41 ... Inspection tool 2,42 ... Inspection tool main body 3 ... 1st introduction part 4 ... 1st flow path 5 ... Mixing part 6, 8, 14 ... Gas flow path 7, 9, 15 ... Pump 10 ... Exhaust Channel 11 ... Air hole 12 ... Third channel 13 ... Reagent tank 21 ... Blood introducer 21a ... Capillary 31 ... Blood sample 32 ... Latex reagent solution 33 ... Anti-hemoglobin A1c antibody reagent
34 ... Latex aggregate 42a, 42b ... 1st, 2nd main surface

Claims (11)

An inspection tool capable of mixing the first to third liquids,
It has an inspection tool body,
A first introduction part provided in the inspection tool main body for introducing the first liquid;
Provided in the inspection tool main body, and a mixing section for mixing the first liquid, the second liquid, and the third liquid;
A liquid tank that is provided in the inspection tool main body and contains the third liquid;
A third flow path provided in the inspection tool main body, connecting a first flow path connecting the first introduction part and the mixing part, and connecting the liquid tank and the mixing part; An inspection tool having a flow path.   The inspection tool according to claim 1, wherein the second liquid is accommodated in the mixing unit.   The inspection tool main body further includes a second introduction part for introducing the second liquid, and a second flow path connecting the second introduction part and the mixing part is provided. The inspection tool according to claim 1.   The first liquid is a blood sample, the second liquid is a latex reagent liquid, and the third liquid is an antibody or antigen reagent that reacts with an antigen or antibody in the blood sample. The inspection tool according to any one of 1 to 3.   The test tool according to claim 4, wherein the third liquid is an anti-hemoglobin A1c antibody reagent.   4. The method according to claim 1, wherein the first liquid is a measurement sample, the second liquid is a reaction liquid that reacts with the measurement sample, and the third liquid is a measurement reagent. The inspection tool described. Introducing the first liquid into the mixing section;
Introducing a second liquid into the mixing section;
And a step of introducing a third liquid into the mixing part in which the first liquid and the second liquid are accommodated,
The mixing unit is provided in the inspection tool, and when the first liquid and the second liquid are stored in the mixing unit, the first liquid and the second liquid are vertically downward. A reagent mixing method of storing the first liquid and the second liquid so as to be positioned at each other.   The reagent mixing method according to claim 7, wherein when the third liquid is introduced into the mixing unit, the third liquid is introduced from a vertically lower side of the mixing unit.   The first liquid is a blood sample, the second liquid is a latex reagent liquid, and the third liquid is an antibody or antigen reagent that reacts with an antigen or antibody in the blood sample. Item 9. The reagent mixing method according to Item 7 or 8.   The reagent mixing method according to claim 9, wherein the third liquid is an anti-hemoglobin A1c antibody reagent.   The reagent mixing method according to claim 7, wherein a measurement sample is used as the first liquid, a reaction liquid is used as the second liquid, and a measurement reagent is used as the third liquid.

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