Improved detection cartridge with enhanced solution flow control.

Abstract

The present invention relates to a diagnostic cartridge with improved fluidity of a solution, and more particularly, to a diagnostic cartridge including a structure that can enhance the efficiency and accuracy of diagnosis using the diagnostic cartridge by adjusting the presence or absence of solution discharge according to the volume of the solution injected into the injection part of the diagnostic cartridge. According to the present invention, when using the diagnostic cartridge of the present invention, since the presence or absence of solution discharge can be adjusted according to the volume of the solution injected into the injection part, while increasing the accuracy of the antigen-antibody reaction, the loss rate of the solution can be reduced, and the efficiency and accuracy of diagnosis using the kit can be enhanced.

Description

Technical Field

[0001] The present invention relates to a diagnostic cartridge in which the fluidity of a solution is improved or the control of the flow of the solution is improved. More specifically, by adjusting the presence or absence of solution discharge according to the volume of the solution injected into the injection part of the diagnostic cartridge, when diagnosing using the diagnostic cartridge, the discharge of the solution can be easily adjusted, thereby enhancing the convenience, efficiency, and accuracy of the diagnosis.

Background Art

[0002] ELISA (Enzyme-Linked Immuno Sorbent Assay) refers to an enzyme immunoassay that collectively refers to methods for measuring the amount of an antigen or antibody using an antigen-antibody reaction with an enzyme as a label. Conventional ELISA plates use well-type reaction vessels. An immune reaction due to an antigen-antibody reaction proceeds on the surface of such a well or reaction chamber provided with a container-type substrate. The immune reaction due to the antigen-antibody reaction on the surface of the container is measured with changes in fluorescence or absorbance, and for such an immune reaction due to the antigen-antibody reaction, an analysis solution, a washing solution, and a reaction solution are put in this order. Here, the reaction product can also be analyzed by detecting a change in the color of the solution in the container using a colorimetric enzyme.

[0003] However, in such a reaction vessel-type well, there is a drawback that it is inevitable to put in and remove an analysis solution, a washing solution, and a reaction solution in this order, and the washing process is not only complicated because the process of putting in and removing the washing solution using a pipette has to be repeated, but there is also a problem that residues remain in the well as they are. Moreover, there is a drawback that the volume of the solution may vary because the solution is put in and taken out using a pipette.

[0004] Therefore, there is an urgent need to develop diagnostic cartridges that can improve efficiency and accuracy while preserving the volume of solution. [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] The present invention aims to solve the problems of the conventional technology described above, and its objective is to provide a diagnostic cartridge with improved solution flowability and a diagnostic method using the diagnostic cartridge that can easily adjust the flowability according to whether or not the solution is discharged. [Means for solving the problem]

[0006] To solve the above problems, the present invention provides a diagnostic cartridge with improved solution discharge control and flowability, and a diagnostic method using the diagnostic cartridge with improved solution flowability or improved solution flow control that allows for easy adjustment of solution discharge. [Effects of the Invention]

[0007] According to the present invention, when using a diagnostic cartridge with improved solution discharge control and flowability, the discharge of the solution can be adjusted according to the volume of solution injected into the injection port. This allows for increased accuracy of the antigen-antibody reaction while reducing the rate of solution loss, thereby improving the efficiency and accuracy of diagnosis using the kit. [Brief explanation of the drawing]

[0008] [Figure 1] This is a cross-sectional view of a part of a diagnostic cartridge with improved solution flow according to one embodiment of the present invention. [Figure 2a]According to one embodiment of the present invention, a device is used to indicate whether or not a solution is discharged according to the volume of the solution, and when 30 μl of a sample solution for detecting a target substance is injected through the injection port, the device shows that the sample solution is present only in the reaction port and is not discharged through the discharge tube. [Figure 2b] According to one embodiment of the present invention, the presence or absence of solution discharge depends on the volume of the solution, and after Figure 2a, when 70 μl of washing solution is injected through the injection port, the washing solution is discharged through the discharge pipe. [Figure 3a] This invention demonstrates that when the diagnostic cartridge of the present invention does not have an absorption section, solution residue may be present in the discharge pipe, or the discharge of the solution to the outside may not be stably regulated due to surface tension at the end of the discharge pipe. [Figure 3b] This invention demonstrates that, when the diagnostic cartridge of the present invention is equipped with an absorption section, there is no solution residue in the discharge pipe, and the effect of surface tension at the end of the discharge pipe can be canceled out, allowing for easy adjustment of the flow of solution discharge. [Modes for carrying out the invention]

[0009] The present invention relates to a diagnostic cartridge that includes a structure that can improve the efficiency and accuracy of diagnosis using a diagnostic cartridge by adjusting whether or not to discharge a solution according to the volume of solution injected into the injection section of the diagnostic cartridge.

[0010] The terms and words used herein and in the claims are not to be interpreted in their ordinary or dictionary sense, but rather in a sense corresponding to the technical idea of ​​the present invention, in accordance with the principle that the inventor may appropriately define the concept of a term in order to best describe the invention. Therefore, it should be understood that the embodiments and configurations shown in the drawings herein are merely preferred embodiments of the present invention and do not represent the entire technical idea of ​​the present invention, and that there may be a variety of equivalents and modifications that can be substituted for them at the time of filing this application.

[0011] In this invention, while considering the function of the invention, we have selected as many commonly used terms as possible. However, this may vary depending on the intentions of engineers in the field, precedents, and the emergence of new technologies. In certain cases, the applicant may have arbitrarily selected terms, in which case their meaning will be described in detail in the section describing the relevant invention. Therefore, the terms used in this invention should not be merely names of terms, but should be defined in light of the meaning of the terms and the overall content of the invention.

[0012] Phrases including ordinal numbers, such as "the first," "the second," etc., can be used to describe various components, but these components are not limited in any way by such phrasing. The above phrasing can only be used to distinguish one component from another.

[0013] When it is said that one component is "linked" or "connected" to another component, it should be understood that the first component is directly linked or connected to the other component, or that there may be other components between them. Conversely, when it is said that one component is "directly linked" or "directly connected" to another component, it should be understood that there are no other components between them.

[0014] The terms used in this application are used solely to describe specific embodiments and are not intended to limit the invention. Singular expressions include plural expressions unless the context clearly indicates otherwise. In this application, terms such as “equipped with,” “includes,” or “having” merely specify the existence of features, figures, stages, operations, components, parts, or combinations thereof described in the specification, and should be understood not to preclude the existence or addition of one or more other features, figures, stages, operations, components, parts, or combinations thereof.

[0015] Hereinafter, embodiments of the present invention will be described in detail based on the accompanying drawings, so that they can be easily implemented by a person with ordinary skill in the art to which the present invention pertains. However, the present invention can be embodied in various different forms and is not limited in any way to the embodiments described herein. In the drawings, parts unrelated to the description have been omitted in order to clearly illustrate the present invention, and similar parts are denoted by similar reference numerals throughout the specification.

[0016] The diagnostic cartridge of the present invention, which has improved solution discharge control and flowability, comprises an injection section into which a sample solution for detecting a target substance is injected, and a section located below the injection section that contains beads for an immunoassay. Microwells A reaction section containing the injection section and a connection between the injection section and the reaction section such that the solution injected through the injection section flows into the reaction section. Branch And one side Branch It is characterized by comprising a discharge pipe connected to one end and connected to an absorption section on the other end, allowing the solution to be discharged to the absorption section, and an absorption section that absorbs the discharged solution.

[0017] In one embodiment of the present invention, the injection section is a place into which a solution to be inspected or a sample solution for detecting a target substance flows, and specifically, a sample solution, analytical solution, washing solution, and reaction solution can flow into it, and the injection section has a certain diameter of the upper surface, a certain diameter of the lower end, and a certain height from the upper surface to the lower end, so that the discharge of the solution can be adjusted according to the volume of the flowing solution.

[0018] In one embodiment of the present invention, the injection portion preferably has a structure in which all or part of the upper and lower ends are open, and the lower end may be characterized in that it has an area even smaller than the open area of ​​the upper surface.

[0019] In one embodiment of the present invention, the reaction unit contains or includes beads to which a substance for detecting a target substance contained in a reaction solution flowing in or injected through the injection unit 10 is bound or linked, and the substance for detecting the target substance may include selected from the group consisting of antibodies, antigens, enzymes, peptides, proteins, deoxyribonucleic acid (DNA), ribonucleic acid (RNA), peptide nucleic acids (PNA), protein-binding nucleotides, and aptamers. Furthermore, the reaction unit is located below the injection unit and contains beads for the immunoreaction. Microwells The beads may be characterized by containing a substance for detecting the target substance. Furthermore, if the volume of solution flowing in through the injection port is 10 to 60 μl, the solution BranchIt flows into the reaction part through [the relevant part], and the injected solution cannot be discharged into the discharge pipe. The solution flowing into the reaction part can cause an immune reaction with the substance for detecting the bead-shaped target substance. However, when the volume (amount) of the solution flowing in through the injection part is 70 μl, substances not bound by the immune reaction with the magnetic beads may be discharged to the absorption part 15 through the discharge pipe 14. The reaction part may include Microwells and the Microwells may have a porous structure or porous pores, and the beads may be Microwells fixed to the porous structure or porous pores, which may be characterized as such.

[0020] In one embodiment of the present invention, the Branch may have a total length of 0.5 mm to 2 mm. Specifically, by having a length of 1.2 mm, the solution injected into the injection part can be made to flow into the reaction part. For example, the Branch may have a branched structure where one side is connected to the reaction part and the other side is connected to the absorption part through the discharge pipe. At this time, when a solution of a certain volume or more flows into the injection part, the solution may be discharged to the absorption part through the discharge pipe. At this time, the volume of the solution injected to discharge the solution may be 70 μl or more.

[0021] When the volume (amount) of the solution flowing in through the injection part is 10 to 60 μl, the solution flowing into the injection part will be present in the reaction part without being discharged to the absorption part through the discharge pipe. When the volume (amount) of the solution flowing in through the injection part is 70 μl or more, the solution flowing into the injection part may be discharged from the reaction part due to the pressure of the discharge pipe and the absorption part, etc. When the volume (amount) of the solution flowing in through the injection part is less than 10 μl, there is a risk that the reaction part will not be sufficiently immersed and an immune reaction, etc. will not occur. Also, when the total volume of the solution flowing in through the injection part is 70 μl or more, the solution flowing into the injection part may be discharged from the reaction part due to the pressure of the discharge pipe and the absorption part, etc.

[0022] In one embodiment of the present invention, when a sample solution for detecting a target substance or a substance for detecting it is injected through the injection unit, the Branch The solution flows from the injection section to the reaction section via a certain mechanism, and the reaction section may be characterized by not drying out in order for the target substance present in the solution to react or combine with the substance used to detect it.

[0023] In one embodiment of the present invention, the structure may further include a sensor unit, the sensor unit being characterized by calculating the amount of target substance present in the solution by measuring the change in impedance that occurs when a substance for detecting bead-shaped target substances binds or reacts with a target substance present in the sample solution by an immunoassay, or by measuring the presence of a substance that specifically binds to the substance for detecting bead-shaped target substances when the substance for detecting bead-shaped target substances binds or reacts with a target substance present in the solution by an immunoassay.

[0024] In one embodiment of the present invention, the absorbent portion may be characterized by comprising an absorbent pad for absorbing target molecules not bound in the reaction portion, washing solution, and other impurities. The absorbent pad may contain a substance having properties such as high absorbency, or may be composed of such a substance. Specific examples include paper (nonwoven fabric), super absorbent polymer, or super absorbent cellulose.

[0025] Furthermore, the absorbent section is equipped with an absorbent pad, which absorbs the solution discharged through the discharge pipe. By doing so, the surface tension and pressure conditions at the end of the discharge pipe remain constant, allowing the solution to move continuously along the discharge pipe to the absorbent section. This plays an important role in easily regulating the discharge of the solution from the cartridge of the present invention and improving its flowability. Specifically, the amount of sample solution, reaction solution, washing solution, analytical solution, etc., injected into the injection section via the absorbent section can be kept constant and discharged to the absorbent section via the discharge pipe, allowing for easy adjustment of the presence or absence of solution discharge and the discharge flow.

[0026] The solution injected into the injection port will, according to its volume, Branch The flow from the injection port to the discharge pipe is controlled by the water level of the volume injected into the injection port (the water level of the solution that has flowed in relative to the lower end of the reaction port). Branch The surface tension generated between the injection port and the discharge pipe prevents the solution from flowing into the discharge pipe. When a certain volume and a certain level of solution flow into the injection port, the solution will flow through the discharge pipe. Therefore, the diagnostic cartridge of the present invention, with its improved solution discharge control and flowability, can adjust the flow of solution discharged through the discharge pipe by adjusting the volume of solution injected or flowing in through the injection port, and the solution moving through the discharge pipe can be discharged via the absorption port.

[0027] The present invention will be described in detail below with reference to the attached drawings.

[0028] Figure 1 is a cross-sectional view of a portion of a diagnostic cartridge with improved solution flowability according to one embodiment of the present invention.

[0029] As shown in the figure, the diagnostic cartridge with improved solution flow according to the present invention comprises an injection section 10 and a reaction section 11, Branch It comprises 12, a sensor unit 13, a discharge pipe 14, and an absorption unit 15.

[0030] The diagnostic cartridge of the present invention, with its improved solution discharge control and flowability, can be used for the diagnosis of neuropsychiatric disorders such as dementia, diabetes, myocardial infarction, Parkinson's disease, and Alzheimer's disease, as well as for the diagnosis of cancer and the detection of proteins based on immune responses. Specifically, target substances for testing or detection for the diagnosis of dementia include Tau, amyloid-beta, α-synuclein neurofilament light chain (NfL), troponin, and prostate-specific antigen (PSA) protein, which are diagnostic target substances based on immune responses.

[0031] In the present invention, when a sample solution for detecting a target substance, a reaction solution containing a substance for detecting it, a washing solution, an analytical solution, etc. are injected through the injection unit, Branch The solution flows from the injection port to the reaction port via this mechanism, and sample solution, reaction solution, washing solution, analytical solution, etc., in amounts other than those required for the reaction are removed. Branch The solution can be removed via the absorption section through a discharge pipe connected to the reaction section, in which case the reaction section may contain an appropriate amount necessary for the target substance present in the sample solution and the substance for detecting it to react or combine. Furthermore, even if the solution that has flowed into the reaction section is removed via the discharge pipe due to the pressure of the absorption section, the reaction section may be characterized in that it does not dry out in order for the target substance present in the sample solution and the substance for detecting it to react or combine.

[0032] On the other hand, in the present invention, the sample solution is a solution containing a target substance to be detected, and may mean a solution obtained by processing blood, plasma, urine, tears, and sweat containing the target substance; the analytical solution contains a substance (such as beads and antibodies) for detecting the target substance present in the sample solution, and may mean a solution such as beads that have reacted with antibodies, or a solution for activating antibodies attached to the sensor when beads are not used; in the case of a labeling method, the antibody may mean a primary antibody; the washing solution may mean a solution used to remove residual target and impurities other than the amount required for the reaction from the solution that has flowed into the reaction section, and to eliminate the residue remaining after the reaction between the antibody and the target (antigen); and the reaction solution may mean a solution containing a secondary antibody that reacts with the target substance to cause an enzymatic reaction, a fluorescent reaction, etc.

[0033] On the other hand, the unlabeled method is a method that immediately measures the target substance bound to the antibody, while the labeled method is a method that measures the target substance bound to the primary antibody. The diagnostic cartridge of the present invention can employ both the labeled method and the unlabeled method.

[0034] A solution to be tested (a sample solution for detecting a target substance), a reaction solution containing a substance for detecting a target substance, a washing solution for removing substances that did not specifically bind or react with the substance for detecting the target substance and the solution for detecting the target substance, or a reaction solution may be flowed into or injected through the injection section 10.

[0035] The diagnostic cartridge of the present invention may be characterized in that it is possible to improve whether or not residual solution is discharged through the discharge pipe and the flowability of the discharge of said residual solution depending on the volume of solution flowing in through the injection section 10. According to one embodiment of the present invention, when the amount of solution injected is 10 to 60 μl, the solution can trigger an immune reaction in the reaction section 11 without being discharged through the discharge pipe 14, but when the amount of solution injected is 70 μl or more, the solution may be discharged to the absorption section 15 through the discharge pipe 14.

[0036] The shape and material of the injection section 10 are not particularly limited and encompass all things well known to those skilled in the art. Preferably, it has the shape of a reaction well with U-shaped or V-shaped pores, and preferably has a structure in which all or part of the upper and lower ends are open, with the lower end having an area even smaller than the open area of ​​the upper surface and being connected to a discharge pipe so that the solution can be discharged.

[0037] For example, the diameter of the open upper surface of the injection section 10 is preferably 3 mm to 5.5 mm, the diameter of the lower end of the injection section 10 is preferably 1 mm to 3 mm, equal to or smaller than the diameter of the upper surface, and the height from the upper surface to the lower end of the injection section is preferably 5 mm to 25 mm for adjusting the water level of the solution.

[0038] If the diameter of the lower end of the injection section 10 exceeds 3 mm, the discharge rate of the solution may be too fast, preventing a sufficient immune reaction from occurring using the reaction section 11, and the solution may be discharged to the absorption section 15 via the discharge tube 14. If the diameter of the lower end of the injection section 10 is less than 1 mm, the solution may not be discharged to the reaction section after flowing into the injection section, making it difficult for an immune reaction to occur for testing.

[0039] The reaction section 11 is located below the injection section and contains beads for the immune reaction. MicrowellsThe beads may contain a substance for detecting a target substance. The substance for detecting the target substance preferably reacts selectively or specifically with the target substance or analyte contained in the sample solution for detecting the target substance, and may include, for example, one or more selected from the group consisting of antibodies, antigens, enzymes, peptides, proteins, deoxyribonucleic acid (DNA), ribonucleic acid (RNA), peptide nucleic acids (PNA), protein-binding nucleotides, and aptamers.

[0040] The diagnostic cartridge of the present invention may be characterized in that a substance for detecting a bead-shaped target substance contained in or present in the reaction section selectively or specifically reacts and binds with the target substance or analyte contained in the sample solution for detecting the target substance, thereby measuring the amount of the target substance or analyte present in the sample solution.

[0041] On the other hand, if the substance used to detect the bead-shaped target substance is an antibody, the system may be characterized by the binding or reaction between the target substance present in the sample solution injected through the injection unit and the antibody contained in the beads via an immunoassay. Furthermore, if the substance used to detect the target substance is an antibody, the reaction unit can contain a secondary antibody sample containing a signaling substance (such as gold nanoparticles, fluorescent substances, or electrochemiluminescent substances) to measure the amount of the target substance or antigen present in the sample solution, and the secondary antibody sample can detect the substance (antibody) used to detect the target substance.

[0042] The aforementioned beads may, but are not limited to, being magnetic.

[0043] The reaction section is for fixing magnetic beads containing a substance for detecting the target substance. Microwells It may include the above Microwells The magnetic beads have a porous structure or porous pores, which allows them to Microwells It may also be characterized by being fixed to a porous structure or porous pore.

[0044] According to one embodiment of the present invention, when the volume (amount) of the solution flowing in through the injection unit 10 is 10 to 60 μl, the solution Branch The reaction can then flow into the reaction section 11 via 12, triggering an immune response.

[0045] For example, the reaction unit 11 can accommodate a secondary antibody sample containing signaling substances such as gold nanoparticles, fluorescent substances, and electrochemiluminescent substances. In one embodiment, when the signaling substance is gold nanoparticles, it is generally possible to analyze its optical properties using an optical reader with a 532 nm absorption characteristic using a green light source. When the signaling substance is a fluorescent substance, it can be analyzed using an excitation light source and a fluorescence optical reader that detects the light emitted from the signaling substance. However, the present invention is not limited thereto and may include anything that is well known to a person with ordinary skill in the art (hereinafter referred to as "a person skilled in the art"). Furthermore, when the signaling substance is a reactant based on an electrochemical sensor, it can be analyzed using an electrochemical sensor electrode structure and a measuring reader that detects the electrical signal generated between these electrodes and the reactant.

[0046] Branch 12 connects the injection section and the reaction section so that the solution injected through the injection section flows into the reaction section, and may be characterized by having a branched structure in which one side is connected to the reaction section and the other side is connected to the absorption section via a discharge pipe.

[0047] The discharge pipe 14 has one side BranchThe discharge pipe may be characterized by being connected to one side and the other side being connected to an absorption section so that the solution can be discharged to the absorption section. Using the pressure of the absorption section, the discharge pipe can remove the sample solution, reaction solution, washing solution, analytical solution, etc., from the solution that has flowed into the reaction section in amounts other than those required for the reaction. Furthermore, the discharge pipe can move a certain amount toward the absorption section in order to ensure that an appropriate amount of the solution that has flowed into the reaction section is present in the reaction section so as to be necessary for the target substance present in the sample solution to react or bind with the substance used to detect it, and so that the solution in the reaction section does not dry out and prevent the reaction or binding of the target substance present in the sample solution with the substance used to detect it from becoming impossible.

[0048] The sensor unit 13 measures the amount of target substance or analyte present in the sample solution. If the beads present in the reaction unit are magnetic, the sensor unit can calculate the amount of target substance present in the solution by measuring the change in impedance that occurs when the substance for detecting the bead-shaped target substance binds or reacts with the target substance present in the sample solution via an immunoassay, or by measuring the presence of a substance that specifically binds to the substance for detecting the bead-shaped target substance (such as a secondary antibody sample containing a signaling substance) when the substance for detecting the bead-shaped target substance binds or reacts with the target substance present in the sample solution via an immunoassay.

[0049] The sensor unit may include an impedance measurement reading unit, an optical reading unit, and the like.

[0050] In one embodiment of the present invention, the target substance present in the sample solution binds to the antibody sample of the magnetic beads and Microwells When captured on the surface, any substance that does not bind to the magnetic beads in the sample solution can be discharged to the absorption section 15 via the discharge pipe 14 when 70 μl or more of the washing solution is injected.

[0051] In one embodiment of the present invention, 30 μl of analytical solution (water level approximately 5 mm relative to the lower end of the reaction section) is injected through the injection section 10, and magnetic beads containing antibodies are injected into the sensor section Microwells After positioning it, inject 70 μl or more of washing solution (water level 15 mm relative to the lower end of the reaction section) Microwells Magnetic beads that were not in the correct position were removed. After this, 30 μl of the sample solution was injected so that the magnetic beads containing the antibody and the target substance would trigger an immunoreaction, and the target substance bound to the magnetic beads by the immunoreaction was then transferred to the magnetic beads. Microwells The magnetic beads were fixed on top of the sample, and then, by injecting 70 μl or more of the washing solution into the injection section 10, any substances that did not bind to the magnetic beads by immunoreaction were discharged to the absorption section via the discharge tube. Since residual target substances may remain, the washing solution was injected again in 70 μl increments twice to remove any remaining target substances. After this, 30 μl of an analytical solution capable of inducing an enzymatic reaction was injected to induce the enzymatic reaction, and then the impedance (or current) was measured to quantify the target substance. Using this method, it became clear that by injecting specific volumes of reaction solution, sample solution, washing solution, and analytical solution, it is possible to detect the target substance present in the sample solution and quantitatively analyze the amount of the target substance present in the sample solution simply by injecting each solution, without the inconvenience of having to add the analytical solution, sample solution, washing solution, and reaction solution in that order and then remove them from the injection section again.

[0052] In one embodiment, in order to sense the binding of a target substance present in the sample solution to an antibody contained in the magnetic beads via an immunoreaction, the sensor unit may further include a detector module into which a change in impedance is measured or an electrochemical sensor capable of measuring an electrochemical reaction is inserted.

[0053] In one embodiment, the above MicrowellsThe present invention is characterized by having a porous structure or porous pores, wherein the porous structure or porous pores are smaller than particles in which magnetic beads and target material are bonded, and larger than materials that are not bonded to the magnetic beads, but the present invention is not limited thereto. Microwells The reaction section, having a porous structure or porous pore structure, immobilizes magnetic beads containing antibodies, and, by the principle of immunoreaction or specific reaction with biomolecules, the target substance to be tested is captured by binding to the magnetic beads containing antibodies. If the target substance is not captured by the magnetic beads containing antibodies, a certain amount or more of washing solution can be injected through the injection section 10, and the sample solution residue can be discharged through the discharge tube. For example, the washing solution may be phosphate-buffered saline (PBS), and the amount of washing solution injected may be 70 μl or more, but the present invention is not limited thereto.

[0054] In one embodiment, if a certain volume or less (10-60 μl) of solution is injected through the injection port so that the water level in the reaction section is below a certain level (5-8 mm), the solution cannot be continuously discharged to the absorption section via the discharge pipe 14 due to the surface tension generated at the inlet of the discharge pipe. However, if a certain volume or more (70 μl) of solution is injected through the injection port so that the water level in the reaction section exceeds a certain level (10 mm or more), the solution will be discharged through the discharge pipe 14, and the solution will flow continuously due to the pressure such as the suction force of the absorption section, thereby improving the discharge and flow of the solution. In this case, substances that did not undergo the above-mentioned immune reaction are discharged in one direction, and therefore, unwanted by-products and biomolecules that did not undergo the immune reaction are both washed in the direction of the solution flow and discharged through the discharge pipe 14.

[0055] Therefore, the diagnostic cartridge of the present invention, with its improved solution discharge control and flowability, allows for easy adjustment of the presence or absence of discharge and the flow of the solution during discharge, by using the volume of solution flowing in or injected through the injection section to ensure that sample solution, reaction solution, washing solution, analytical solution, etc., present in the reaction section are discharged through the discharge pipe.

[0056] Furthermore, the flow rate and flow rate of the solution passing through the discharge pipe 14 can be controlled by varying its position, diameter, and type, or by varying the negative pressure or the amount of solution injected into the injection port. For example, the solution can be moved at a low speed during an immunoassay and at a high speed during washing to improve the sensitivity of the reaction.

[0057] The absorbent section 15 ensures a continuous and stable flow of solution discharge and may include an absorbent pad. The absorbent pad may contain a substance having strong solution absorption properties, or may be composed of such a substance. Specific examples include paper (nonwoven fabric), super absorbent polymer, or super absorbent cellulose. For example, the super absorbent polymer may be a thermoplastic resin, nitrocellulose, or synthetic hydrogel-forming polymer, but the present invention is not limited thereto.

[0058] The absorbent section is equipped with an absorbent pad, which absorbs the solution discharged through the discharge pipe, thereby maintaining constant surface tension and pressure conditions at the end of the discharge pipe, allowing the solution to move continuously along the discharge pipe to the absorbent section. The amount of sample solution, reaction solution, washing solution, analytical solution, etc., injected into the injection section via the absorbent section can be kept constant while the discharge of the solution can be easily controlled.

[0059] Substances that do not bind to the absorbent section are discharged in one direction via the discharge pipe 14. Unwanted by-products and biomolecules that do not trigger an immune response are washed in the direction of the solution flow and absorbed by the absorbent pads provided in the absorbent section via the discharge pipe 14. Furthermore, by varying the position, size, and type of absorbent pads, or by applying negative pressure, the flow rate and flow rate of the solution passing through the wells can be controlled, making it possible to continuously regulate the flow of the solution under certain conditions through the discharge flow of the solution as described above.

[0060] According to one embodiment of the present invention, if the absorbent part is absent, as shown in Figure 3a, after a solution below a certain volume is injected through the injection part (Figure 3a (1)), it is not discharged due to surface tension (Figure 3a (2)). However, when the solution is further injected to a volume greater than or equal to a certain volume (Figure 3a (3)), the solution moves through the discharge tube and is discharged to the outside of the kit. However, because there is no absorbent part, the solution moving to the discharge tube is discharged by dripping from the end of the discharge tube, so not all of the solution moving to the discharge tube is discharged, and some residue remains in the discharge tube (Figure 3a (4)). Subsequently, when the solution is further injected (Figure 3a (5)), some residue remains in the discharge tube, resulting in different surface tension and pressure conditions than those shown in Figure 3a (1) to (4). As a result, a problem arises in that a volume even larger than the specific volume required to discharge the solution in Figure 3a (1) to (4) is required to discharge the solution.

[0061] On the other hand, if an absorption section is present, as shown in Figure 3b, when the solution is injected through the injection section (Figure 3b (1)), the absorption pad in the absorption section absorbs the solution moving to the discharge tube, and the solution is continuously discharged from the discharge tube to the absorption section, so that no residual solution remains in the discharge tube (Figure 3b (2) to (4)). Even if the solution moves to the absorption pad in the absorption section via the discharge tube, the reaction section and the discharge tube are separated by a step of a certain height or more, so that the reaction section contains an appropriate amount of solution necessary for the target substance present in the sample solution and the substance for detecting it to react or bind, and that the reaction section contains a certain amount of solution or more so that the reaction section does not dry out and the reaction or binding of the target substance present in the sample solution and the substance for detecting it becomes impossible, thus allowing the reaction to occur (Figure 3b (4)). If the solution is injected again after this (Figure 3b (5)), unlike in Figure 3a, there is no solution residue in the discharge pipe, so the surface tension and pressure conditions are the same as before the solution was injected, and the discharge of the solution can be adjusted using the same volume as the specific volume required to discharge the solution in (1) to (4) shown in Figure 3b.

[0062] Therefore, the amount of sample solution, reaction solution, washing solution, analytical solution, etc., injected into the injection section via the absorption section can be kept constant, while the discharge of the solution can be easily controlled.

[0063] Figure 2 shows whether or not the injected solution was discharged according to one embodiment of the present invention.

[0064] As shown in the figure, in one embodiment of the present invention, the target substance present in the solution injected via the injection unit 10 binds to the antibody sample of the magnetic beads contained in the reaction unit 11 and the reaction unit 11 Microwells When captured by the system, any substance that does not bind to the magnetic beads in the solution composition is discharged through the discharge pipe 14.

[0065] For example, as shown in Figure 2a, if the amount of solution injected through the injection section 10 is 10 to 60 μl, it will not be discharged to the absorption section 15 via the discharge tube 14, and an immune reaction can be triggered in the reaction section 11. Therefore, after injecting 10 to 60 μl of the sample solution containing the target substance into the injection section 10, the reaction section 11 is prepared in advance. Microwells Magnetic beads containing antibodies positioned at a certain location are used to initiate an immunoreaction, and the target substance present in the sample solution bound to the magnetic beads by the immunoreaction is contained within the reaction area by the magnetic beads. Microwells The magnetic beads are fixed in place, and thereafter, as shown in Figure 2b, the washing solution is injected into the injection unit 10 so that the total volume of the sample solution and washing solution combined is 70 μl or more. This allows substances that did not bind to the magnetic beads by immunoreaction to be discharged to the absorption unit 15 via the discharge tube 14, thereby enabling the specific detection of target substances present in the sample solution.

[0066] Furthermore, the present invention provides a diagnostic method using a diagnostic cartridge with improved solution discharge control and flowability, comprising the steps of: injecting a first volume of solution containing beads for an immunoassay through an injection port of a diagnostic cartridge with improved solution discharge control and flowability; injecting a second volume of sample solution for detecting a target substance through the injection port to bind or react the sample solution for detecting the target substance with a substance for specifically detecting the bead-shaped target substance; and injecting a third volume of washing solution through the injection port to remove residual substances that did not specifically bind or react with the sample solution for detecting the target substance.

[0067] The diagnostic method may further include a step of measuring the amount of a target substance or analyte present in a sample solution via a sensor unit. The measurement step may be characterized by calculating the amount of the target substance present in the solution by measuring the change in impedance that occurs when a substance for detecting the bead-shaped target substance binds or reacts with the target substance present in the sample solution via an immunoassay, or by measuring the presence of a substance that specifically binds to the substance for detecting the bead-shaped target substance (such as a secondary antibody sample containing a signaling substance) when the substance for detecting the bead-shaped target substance binds or reacts with the target substance present in the sample solution via an immunoassay.

[0068] The diagnostic method described above may be characterized by the ability to inject a specific volume of solution and adjust the flow rate of the injected solution through the injection port.

[0069] Specifically, the volume of the first volume of solution containing beads for the immunoreaction and the second volume of sample solution for detecting the target substance, or the combined volume of the first and second volumes, can be adjusted so that the injected solution is not discharged into the discharge tube, the solution does not dry out in the reaction section, and the substance for detecting the bead-shaped target substance and the target substance present in the sample solution can bind or react by immunoreaction. The combined volume of the solution remaining in the first and second volumes plus the third volume can be adjusted to be 70 μl or more, so that any substance that did not bind to the magnetic beads by immunoreaction is discharged to the absorption section 15 via the discharge tube 14. If multiple washing operations are necessary, the washing operation may be further performed by injecting washing solution in increments of 70 μl or more.

[0070] In one embodiment, in the step of injecting a first volume of solution containing beads for an immunoassay through the injection port, if the volume (amount) of solution flowing in through the injection port is 10 to 60 μl, the solution Branch Since the solution flows into the reaction section via the injection section and is not discharged into the absorption section via the discharge tube, an immunoassay can occur when a sample solution containing the target substance is subsequently injected through the injection section.

[0071] For example, the beads are injected through the injection section. Branch It may be located in the reaction section via a diaphragm.

[0072] In the step of injecting a second volume of sample solution for detecting a target substance through the injection port to bind or react the sample solution for detecting a target substance with a substance for specifically detecting bead-shaped target substances, if the total volume of the injected second volume and the first volume of solution containing beads for an immunoreaction that flows in through the injection port of the diagnostic cartridge is 10 to 60 μl, the injected solution will not be discharged into the discharge tube, the solution will not dry out in the reaction section, and the substance for detecting bead-shaped target substances and the target substances present in the sample solution can bind or react by an immunoreaction.

[0073] The step of injecting a third volume of washing solution through the injection port to remove residual substances that did not specifically bind to or react with the sample solution for detecting the target substance involves discharging substances that did not bind to the magnetic beads by immunoreaction to the absorption port 15 via the discharge port 14. The third volume can be configured such that the total residual solution volume, which is the sum of the volume of solution remaining in the first and second volumes and the third volume, is 70 μl or more, so that substances that did not bind to the magnetic beads by immunoreaction are discharged to the absorption port 15 via the discharge port 14.

[0074] For example, the washing solution may be phosphate buffer solution (PBS), but the present invention is not limited thereto.

[0075] The step of injecting a washing solution through the injection port to remove residual substances that did not specifically bind to or react with the solution for detecting the target substance may be characterized in that a certain volume or more of washing solution is injected through the injection port so that it is above a certain water level in a certain reaction port, thereby enabling the removal of residual substances that did not specifically bind to or react with the washing solution and the solution for detecting the target substance without separate pipetting.

[0076] The diagnostic method using the diagnostic cartridge with improved solution flowability of the present invention may also be characterized in that the discharge of the solution can be adjusted according to the volume of solution flowing in through the injection section. According to one embodiment of the present invention, when the amount of solution injected into the injection section of the diagnostic cartridge with improved solution flowability of the present invention is 10 to 60 μl, the solution is not discharged through the discharge tube and an immune reaction can be triggered in the reaction section. However, when the amount of solution injected is 70 μl or more, the solution may be discharged through the discharge tube to the absorption section.

[0077] Furthermore, the diagnostic method using the diagnostic cartridge of the present invention, which has improved solution discharge control and flowability, can be used for the diagnosis of neuropsychiatric disorders such as dementia, diabetes, myocardial infarction, Parkinson's disease, and Alzheimer's disease, as well as for the diagnosis of cancer and the detection of proteins based on immune responses.

[0078] The above description of the present invention is for illustrative purposes only, and a person with ordinary skill in the art to which the invention pertains will understand that it can be easily modified into other specific forms without altering the technical idea or essential features of the invention. Therefore, the embodiments described above should be understood to be illustrative and not limiting in all respects. For example, each component described as a single type may be implemented in a distributed manner, and similarly, components described as distributed may be implemented in a combined manner.

[0079] The scope of the present invention is expressed more by the appended claims than by the above detailed description, and any modifications or alterations derived from the meaning and scope of the claims, as well as the concept of equivalents, should be interpreted as being included within the scope of the present invention. [Industrial applicability]

[0080] The diagnostic cartridge with improved solution flow based on the technical concept of the present invention can enhance the efficiency and accuracy of diagnosis using the diagnostic cartridge by adjusting whether or not the solution is discharged according to the volume of solution injected into the injection part of the diagnostic cartridge. This has industrial utility in that it can improve the accuracy of antigen-antibody reactions while reducing the rate of solution leakage, thereby improving the efficiency and accuracy of diagnosis using the kit. [Explanation of Symbols]

[0081] 10 Injection part 11 Reaction section 12 Branch 13 Sensor section 14 Discharge pipe

Claims

1. An injection section into which a sample solution for detecting the target substance is injected, A reaction section located below the injection section and containing microwells for accommodating beads for an immunoassay, A branching section is provided to connect the injection section and the reaction section so that the solution injected through the injection section flows into the reaction section, One end is connected to the branching section, and the other end is a discharge pipe that discharges the solution. An absorbent section is provided on the other side of the discharge pipe to absorb the discharged solution, Equipped with, The aforementioned branching section is The branched structure has one side connected to the reaction section and the other side connected to the absorption section via the discharge pipe. The flow of the solution injected into the injection section is controlled by the water level determined by the volume, from the branch section to the discharge pipe. When a solution below a certain water level is injected into the injection section, the surface tension generated between the branch section and the discharge pipe prevents the solution from flowing into the discharge pipe. When a solution above the certain water level is injected into the injection section, the solution is discharged through the discharge pipe and flows continuously to the absorption section. It is configured in such a way. A detection cartridge characterized by improved solution discharge control and flowability.

2. The detection cartridge according to claim 1, characterized in that the reaction section includes beads, and the beads contain a substance for detecting a target substance, thereby improving the control of solution discharge and flowability.

3. A detection cartridge with improved solution discharge control and flowability according to claim 2, characterized in that the substance for detecting the target substance comprises one or more selected from the group consisting of antibodies, antigens, enzymes, peptides, proteins, deoxyribonucleic acid (DNA), ribonucleic acid (RNA), peptide nucleic acid (PNA), protein-binding nucleotides, and aptamers.

4. The detection cartridge according to claim 3, characterized in that, when the substance for detecting the target substance is an antibody, the target substance present in the solution injected through the injection section and the antibody contained in the beads bind or react by an immunoreaction.

5. The detection cartridge according to claim 4, characterized in that the reaction section does not dry out in order for the aforementioned immune reaction to occur, thereby improving the control of solution discharge and flowability.

6. The detection cartridge according to claim 1, characterized in that the beads in the reaction section are magnetic, thereby improving the control of solution discharge and flowability.

7. The detection cartridge according to claim 1, characterized in that the absorbent section comprises an absorbent pad, the absorbent pad absorbs the solution discharged through the discharge pipe, and the solution moves continuously along the discharge pipe to the absorbent section, thereby improving the control of solution discharge and flowability.

8. A detection cartridge according to claim 1, further comprising a sensor unit, wherein the solution discharge control and flow characteristics are improved.

9. The detection cartridge according to claim 8, characterized in that the sensor unit calculates the amount of target substance present in the solution by measuring the change in impedance that occurs when a substance for detecting bead-shaped target substances binds or reacts with a target substance present in the sample solution by an immunoreaction, or by measuring the presence of a substance that specifically binds to the substance for detecting bead-shaped target substances when the substance for detecting bead-shaped target substances binds or reacts with a target substance present in the sample solution by an immunoreaction, thereby improving the discharge control and flowability of the solution.

10. The detection cartridge according to claim 1, characterized in that the discharge of solution into the discharge pipe can be adjusted using the volume of solution that has flowed into the injection section.

11. A step of injecting a first volume of solution containing beads for an immunoassay through the injection port of a detection cartridge with improved solution discharge control and flowability as described in claim 1, The steps include: injecting a second volume of sample solution for detecting the target substance through the injection port to bind or react the sample solution for detecting the target substance with a substance for specifically detecting the bead-shaped target substance; The steps include: injecting a third volume of washing solution through the injection port to remove residual substances that did not specifically bind to or react with the sample solution for detecting the target substance; Includes, During the injection of the first and second volumes, the injected solution falls below the certain water level, and the reaction is carried out in a state where the surface tension generated between the branch and the discharge pipe prevents the solution from flowing into the discharge pipe. When the third volume is injected, the accumulated solution rises above the certain water level, counteracting the surface tension, and the solution is discharged through the discharge pipe and flows continuously into the absorption section, thereby removing the residual substance. A detection method using a detection cartridge with improved solution discharge control and flow properties, characterized by the above.

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