Diagnostic cartridge with improved flowability of solution

Abstract

The present invention relates to a diagnostic cartridge having improved flowability of a solution, and more particularly, to a diagnostic cartridge comprising a structure that adjusts whether or not the solution is discharged according to the volume of the solution injected into an injection part of the diagnostic cartridge, thereby improving the effectiveness and accuracy thereof when performing a diagnosis using the diagnostic cartridge. According to the present invention, when the diagnostic cartridge of the present invention is used, the discharge condition of the solution can be adjusted according to the volume of the solution injected by the injection part, thereby improving the accuracy of an antigen-antibody reaction and reducing the loss rate of the solution, thereby improving the effectiveness and accuracy of diagnosis by the kit.

Description

Technical Field

[0001] The present invention relates to a diagnostic card box with improved fluidity of a solution or improved flow regulation of a solution. More specifically, it is characterized in that the discharge of the solution is regulated according to the volume of the solution injected into the injection portion of the diagnostic card box, so that when the above-mentioned diagnostic card box is used for diagnosis, the discharge of the solution can be easily regulated, and the convenience, effectiveness and accuracy of the diagnosis can be improved. Background Art

[0002] Enzyme-Linked Immunosorbent Assay (ELISA) is a general term for methods that use enzymes as markers to measure the amount of antigens or antibodies by antigen-antibody reaction. Conventional ELISA plates use well-shaped reaction containers. An immune reaction based on an antigen-antibody reaction is carried out on the surface of a well or reaction chamber on a substrate having such a container shape. The immune reaction caused by the antigen-antibody reaction on the surface of the container is measured by changes in fluorescence or absorbance, and an analysis solution, a washing solution, and a reaction solution are added in sequence to carry out the immune reaction caused by the antigen-antibody reaction. The reaction result can also be analyzed by detecting the color change of the solution in the container using a colorimetric enzyme.

[0003] However, this reaction vessel type well plate has the disadvantage of requiring the sequential addition and removal of analytical solution, washing solution and reaction solution, and the use of a pipette to repeatedly add and remove washing solution during the washing process, which is cumbersome and may cause residues to remain in the well plate. Since a pipette is used to add and discharge the solution, there is a disadvantage that the solution volume may change.

[0004] Therefore, there is an urgent need to develop a diagnostic cartridge that can improve effectiveness and accuracy while maintaining solution capacity. Summary of the invention

[0005] Technical issues The present invention aims to solve the problems in the above-mentioned prior art and provides a diagnostic cartridge with improved fluidity of a solution, and a diagnostic method using the diagnostic cartridge which can easily adjust the fluidity according to whether the solution is discharged or not.

[0006] Technical Solution In order to solve the above problems, the present invention provides a diagnostic card box with improved solution discharge regulation and fluidity, and a diagnostic method using the diagnostic card box to easily regulate solution discharge and improve solution fluidity or solution flow regulation.

[0007] Effects of the Invention According to the present invention, when using the diagnostic card box with improved solution discharge regulation and fluidity of the present invention, it is possible to easily adjust whether the solution is discharged according to the volume of the solution injected into the injection part, thereby improving the accuracy of the antigen-antibody reaction while reducing the loss rate of the solution, thereby improving the effectiveness and accuracy of diagnosis through the kit. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 is a partial cross-sectional view of a diagnostic cartridge having improved fluidity of a solution according to an embodiment of the present invention.

[0009] FIG. 2 shows the effect of the solution volume on whether the solution is discharged or not according to an embodiment of the present invention. Figure 2a This indicates that when 30 μl of a sample solution for detecting a target substance is injected through the injection portion, the sample solution exists only in the reaction portion, and the sample solution is not discharged through the discharge tube. Figure 2b Indicated in Figure 2a After that, when 70 ul of the washing solution was injected through the injection portion, the washing solution was discharged through the discharge tube.

[0010] Figure 3a This means that when the diagnostic cartridge of the present invention does not include an absorbent portion, solution residues may remain in the discharge tube, or the discharge of the solution to the outside may not be stably regulated due to surface tension at the end of the discharge tube.

[0011] Figure 3b This means that when the diagnostic cartridge of the present invention includes the absorbent portion, no solution residue exists in the discharge tube, and the effect of the surface tension at the end of the discharge tube is offset, so that the discharge flow of the solution can be easily adjusted.

[0012] Best Mode for Carrying Out the Invention The present invention relates to a diagnostic card box, which comprises the following structure: whether the solution is discharged or not is regulated according to the volume of the solution injected into the injection part of the diagnostic card box, so that the effectiveness and accuracy of the diagnosis can be improved when the diagnostic card box is used for diagnosis. DETAILED DESCRIPTION

[0013] The language used in this specification and claims should not be limited to general or dictionary meanings. The inventor can appropriately define the terminology in principle to explain his invention in the best way, so it should be interpreted according to the meaning and concept that conforms to the technical idea of ​​the invention. Therefore, the embodiments and the like recorded in this specification constitute only the most preferred embodiment of the present invention and do not represent all the technical ideas of the present invention. It should be understood that there may be various equivalent solutions and variations that can replace these from the perspective of this application.

[0014] The terms used in the present invention are currently widely used general terms selected in consideration of the functions of the present invention, but they may vary according to the intentions of technicians in the relevant field, precedents, or the emergence of new technologies. In addition, in certain cases, there may be terms selected by the applicant himself, in which case their meanings will be explained in detail in the relevant specification section. Therefore, the terms used in the present invention should be defined according to their meanings and based on the overall content of the present invention, rather than just simple term names.

[0015] Terms including ordinal numbers such as 1st, 2nd, etc. may be used to describe various structural elements, but these structural elements are not limited by such terms. These terms are only used to distinguish one structural element from another structural element.

[0016] When it is mentioned that a certain structural element is "connected" or "contacting" another structural element, it should be understood that the structural element can be directly connected or contacting the other structural element, but other structural elements may also exist in between. On the contrary, when it is mentioned that a certain structural element is "directly connected" or "directly contacting" another structural element, it should be understood that there are no other structural elements in between.

[0017] The terms used in this application are only for describing specific embodiments and are not intended to limit the present invention. Singular expressions shall include plural expressions unless the context clearly does not refer to the plural. In this application, the terms "including" or "having" refer to the existence of features, numbers, steps, actions, structural elements, components or combinations thereof recorded in the specification, and do not preclude the existence or additional possibility of one or more other features, numbers, steps, actions, structural elements, components or combinations thereof.

[0018] The embodiments of the present invention will be described in detail below with reference to the accompanying drawings so that a person skilled in the art can easily implement the present invention. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. In addition, in order to clearly illustrate the present invention, parts not related to the description have been omitted from the drawings, and similar parts are marked with similar reference numerals throughout the specification.

[0019] The diagnostic card box with improved solution discharge regulation and fluidity of the present invention is characterized by comprising: an injection part, which injects a sample solution for detecting a target substance; a reaction part, which is located below the above-mentioned injection part and includes a micro-well for accommodating micro-beads for immune reaction; a hinge part, which connects the above-mentioned injection part and the reaction part so that the solution injected through the above-mentioned injection part flows into the reaction part; a discharge tube, which is connected to the hinge part on one side and to the absorption part on the other side, and can discharge the solution to the absorption part; and an absorption part, which is used to absorb the above-mentioned discharged solution.

[0020] In one embodiment of the present invention, the injection portion is a portion for flowing in a solution to be detected or a sample solution for detecting a target substance, and specifically, a sample solution, an analysis solution, a washing solution, a reaction solution, etc. The injection portion has an upper surface diameter, a lower end diameter, and a height from the upper surface to the lower end within a specified range, so that whether the solution is discharged or not can be adjusted according to the volume of the injected solution.

[0021] In one embodiment of the present invention, preferably, the injection portion has a structure in which the upper and lower ends are fully or partially open, and is characterized in that the open area of ​​the lower end is smaller than the open area of ​​the upper surface.

[0022] In one embodiment of the present invention, the reaction part contains or includes a substance for detecting a target substance included in the reaction solution flowing in or injected through the injection part 10, and the substance for detecting the target substance may include a substance selected from the group consisting of antibodies, antigens, enzymes, peptides, proteins, DNA, RNA, peptide nucleic acids (PNA, peptide nucleic acids), protein-binding nucleotides and aptamers. In addition, the present invention is characterized in that the reaction part is located below the injection part and includes a microwell for containing microbeads for immune reaction, and the microbeads include a substance for detecting the target substance. In addition, when the volume of the solution flowing in through the injection part is 10 to 60ul, the solution will flow into the reaction part through the hinge part, the injected solution will not be discharged through the discharge pipe, and the solution flowing into the reaction part will react immune with the microbead-shaped substance for detecting the target substance. However, when the volume of the solution flowing in through the injection part is 70ul, the substance that is not bound to the magnetic microbeads through the immune reaction can be discharged to the absorption part 15 through the discharge pipe 14. The present invention is characterized in that the reaction part may include a micro-well for fixing magnetic micro-beads, and the micro-well has a porous structure or porous holes, so that the micro-beads are fixed in the porous structure or porous holes of the micro-well.

[0023] In one embodiment of the present invention, the total length of the hinged portion may be 0.5 mm to 2 mm, specifically 1.2 mm, so that the solution injected into the injection portion can flow into the reaction portion. As an example, the hinged portion may have a branch structure connected to the reaction portion on one side and connected to the absorption portion through a discharge pipe on the other side. In this case, when a solution of a specified volume or more flows into the injection portion, the solution can be discharged to the absorption portion through the discharge pipe. In this case, the volume of the solution injected for discharging the solution may be 70 ul or more.

[0024] When the volume of the solution flowing through the injection part is between 10 and 60ul, the solution flowing into the injection part will not be discharged to the absorption part through the discharge tube, but will exist in the reaction part. When the volume of the solution flowing through the injection part reaches 70ul or more, the solution flowing into the injection part can be discharged from the reaction part through the discharge tube and the pressure of the absorption part. When the volume of the solution flowing through the injection part is less than 10ul, the reaction part may not be fully wetted, resulting in the inability of immune response, etc. Moreover, when the total volume of the solution flowing through the injection part reaches 70ul, the solution flowing in can be discharged from the reaction part through the discharge tube and the pressure of the absorption part.

[0025] In one embodiment of the present invention, when a sample solution for detecting a target substance or a substance for detecting the target substance is injected through the injection portion, the solution flows from the injection portion into the reaction portion through the hinge portion, and the target substance and the substance for detecting the target substance present in the solution in the reaction portion will not dry out during reaction or combination.

[0026] In one embodiment of the present invention, it is characterized in that the above-mentioned structure may also include a sensor part, which calculates the amount of target substance present in the solution by measuring the impedance change generated when the microbead-shaped substance for detecting target substance combines or reacts with the target substance present in the solution by immune reaction, or by measuring the presence of a substance that specifically binds to the microbead-shaped substance for detecting target substance when the microbead-shaped substance for detecting target substance combines or reacts with the target substance present in the solution by immune reaction.

[0027] In one embodiment of the present invention, the absorption part includes an absorption pad for absorbing unbound target molecules, washing liquid and other impurities in the reaction part. The absorption pad may include a material with strong absorption properties or may be composed of the above-mentioned material, specifically including paper (non-woven fabric), polymer chemical substances (super absorbent polymer) or natural super absorbent material (super absorbent cellulose, Supre absorbent cellulose) and the like.

[0028] Furthermore, the absorption part includes an absorption pad, and the absorption pad absorbs the solution discharged through the discharge tube, thereby constantly maintaining the surface tension and pressure conditions at the end of the discharge tube, so that the solution continuously moves along the discharge tube to the absorption part, which can easily adjust the solution discharge of the cartridge of the present invention and improve its fluidity. Specifically, the amount of the sample solution, reaction solution, washing solution, analysis solution, etc. injected by the injection part can be absorbed by the absorption pad, and can be discharged to the absorption part through the discharge tube in a prescribed manner, and the discharge and discharge flow of the discharged solution can be easily adjusted.

[0029] The solution injected through the injection part controls the flow from the hinge part to the discharge pipe according to its volume, which is determined by the water level of the volume injected into the injection part (the water level of the solution flowing in with the lower end of the reaction part as the reference). The surface tension generated between the hinge part and the discharge pipe will prevent the solution from flowing into the discharge pipe. When the solution with a specified volume and a water level above the specified volume flows into the injection part, the solution will flow through the discharge pipe. Therefore, the diagnostic card box with improved solution discharge regulation and fluidity of the present invention can adjust the volume of the solution flowing in through the injection part to adjust the flow of the solution discharged through the discharge pipe, and can discharge the solution flowing to the discharge pipe through the absorption part.

[0030] Hereinafter, the present invention will be described in detail with reference to the accompanying drawings.

[0031] Figure 1 is a partial cross-sectional view of a diagnostic cartridge having improved fluidity of a solution according to an embodiment of the present invention.

[0032] As shown in the figure, the diagnostic cartridge with improved fluidity of the solution of the present invention comprises an injection portion 10 , a reaction portion 11 , a hinge portion 12 , a sensor portion 13 , a discharge tube 14 and an absorption portion 15 .

[0033] The diagnostic cartridge with improved discharge regulation and fluidity of the solution of the present invention can be used for diagnosis of neuropsychiatric diseases such as dementia, diabetes, myocardial infarction, Parkinson's disease, Alzheimer's disease, cancer diagnosis, and protein detection based on immune response, etc. Specifically, the target substances required for inspection or detection for dementia diagnosis may include Tau, β-amyloid protein, α-synuclein, neurofilament light chain (NFL, Neurofilament light), troponin (Troponin), PSA protein, and other diagnostic target substances based on immune response.

[0034] In one embodiment of the present invention, when a sample solution for detecting a target substance, a reaction solution including a substance for detecting the target substance, a washing solution, and an analysis solution are injected through the injection part, the solution flows into the reaction part from the injection part through the hinge part, and the sample solution, reaction solution, washing solution, analysis solution, and the like other than the amount required for the reaction can be discharged to the absorption part through the discharge pipe connected to the hinge part, and removed through the absorption part. In this case, the reaction part may contain an appropriate amount required for the target substance in the sample solution to react or bind with the substance for detecting the target substance. Furthermore, even if the solution flowing into the reaction part is removed through the discharge pipe by the pressure of the absorption part, the target substance in the sample solution and the substance for detecting the target substance will not dry out so as to react or bind.

[0035] On the other hand, the sample solution in the present invention is a solution including a target substance that needs to be detected, and it may refer to a solution of processed blood, plasma, urine, tears and sweat including the target substance. The analysis solution includes substances (microbeads and antibodies, etc.) for detecting the target substance present in the above sample solution, and may refer to a solution of microbeads, etc. for antibody reaction, or a solution for activating antibodies attached to the sensor part when microbeads are not used. The above antibody in the labeled manner may refer to a first antibody. The washing solution refers to a solution for removing the residues left after the reaction of the antibody with the target substance (antigen) in order to remove the residual target substance and impurities other than the amount required for the reaction in the solution flowing into the reaction part. The reaction solution refers to a solution including a second antibody that reacts with the target substance to induce an enzyme reaction, a fluorescent reaction, etc.

[0036] On the other hand, the non-labeling method directly measures the target substance bound to the antibody, while the labeling method measures the target substance bound to the first antibody. The diagnostic cartridge of the present invention can be applied to both the labeling method and the non-labeling method.

[0037] The injection portion 10 can flow in or inject a solution to be detected (a sample solution for detecting a target substance), a reaction solution including a substance for detecting a target substance, a washing solution for removing substances that are not specifically bound or reacted between the substance for detecting the target substance and the solution for detecting the target substance, or a reaction solution, etc.

[0038] The diagnostic cartridge of the present invention is characterized in that the residual solution discharged through the discharge tube and the fluidity of the residual solution discharged can be improved according to the volume of the solution flowing in through the injection part 10. According to one embodiment of the present invention, when the amount of the injected solution is between 10 and 60 ul, the solution will not be discharged through the discharge tube 14, but will induce an immune response in the reaction part 11, but when the amount of the injected solution reaches 70 ul or more, the solution can be discharged to the absorption part 15 through the discharge tube 14.

[0039] The shape or material of the injection part 10 is not particularly limited, and may include shapes or materials known to ordinary technicians. Preferably, it has a U-shaped or V-shaped reaction well shape, preferably has a structure in which the upper and lower ends are fully or partially open, preferably, the open area of ​​the lower end is smaller than the open area of ​​the upper surface, and is connected to a discharge pipe to facilitate the discharge of the solution.

[0040] As an example, preferably, the diameter of the open upper surface of the above-mentioned injection part 10 is 3mm to 5.5mm, preferably, the diameter of the lower end of the above-mentioned injection part 10 is 1mm to 3mm, the diameter of the above-mentioned upper surface should be equal to or smaller than the diameter of the upper surface, preferably, the height from the upper surface to the lower end of the above-mentioned injection part is 5mm to 25mm, so as to facilitate the adjustment of the water level of the solution.

[0041] When the diameter of the lower end of the injection part 10 exceeds 3 mm, the discharge speed of the solution is too fast and may not fully induce an immune response in the reaction part 11 and be discharged to the absorption part 15 through the discharge tube 14. When the diameter of the lower end of the injection part 10 is less than 1 mm, the solution may not be discharged to the reaction part after flowing into the injection part, thereby making it difficult to carry out the immune reaction used for detection.

[0042] The reaction part 11 is located below the injection part and may include a microwell for accommodating microbeads for immune reaction, and the microbeads may include a substance for detecting the target substance. The substance for detecting the target substance preferably reacts selectively or specifically with the target substance or the analyte substance present in the sample solution for detecting the target substance, and as an example, may include one or more selected from the group consisting of antibodies, antigens, enzymes, peptides, proteins, DNA, RNA, peptide nucleic acids (PNA), protein-binding nucleotides and aptamers.

[0043] The diagnostic card box of the present invention is characterized in that the microbead-shaped substance for detecting the target substance contained in or present in the reaction part selectively or specifically reacts and binds with the target substance or the analyte substance included in the sample solution for detecting the target substance, thereby determining the amount of the target substance or the analyte substance present in the sample solution.

[0044] On the other hand, the present invention is characterized in that, when the microbead-shaped substance for detecting the target substance is an antibody, the target substance present in the sample solution injected through the injection part and the antibody included in the microbead are combined or reacted by immune reaction. Furthermore, when the substance for detecting the target substance is an antibody, the reaction part can accommodate a second antibody sample including a signal substance (gold nanoparticles, fluorescent substances, electrochemiluminescent substances, etc.) to measure the amount of the target substance or the analyte substance, i.e., the antigen, present in the sample solution, and the second antibody sample can detect the substance (antibody) for detecting the target substance.

[0045] The microbeads may be magnetic, but are not limited thereto.

[0046] The present invention is characterized in that the reaction part may include a micro-well for fixing magnetic micro-beads including a substance for detecting a target substance, and the micro-well has a porous structure or porous pores, so that the magnetic micro-beads are fixed in the porous structure or porous pores of the micro-well.

[0047] According to an embodiment of the present invention, when the volume of the solution flowing in through the injection part 10 is between 10 and 60 ul, the solution can flow into the reaction part 11 through the hinge part 12 and induce an immune response.

[0048] As an example, the reaction part 11 can contain a second antibody sample including a signal substance such as gold nanoparticles, fluorescent substances, and electrochemiluminescent substances. As an embodiment, if the above-mentioned signal substance is gold nanoparticles, it can usually be analyzed by using an optical reader that uses the 532nm light absorption characteristics of a green light source. If the signal substance is a fluorescent substance, it can be analyzed using a fluorescence optical reader for detecting light emitted from an excitation light source or a signal substance, but this is not limited to this and can include all contents known to ordinary technicians in this technical field (hereinafter referred to as "ordinary technicians"). In addition, if the signal substance is a reaction substance based on an electrochemical sensor, it can be analyzed using an electrochemical sensor electrode structure and an electric signal measurement reader generated between the electrode and the reaction substance.

[0049] The present invention is characterized in that the hinged part 12 connects the injection part and the reaction part so that the solution injected through the injection part can flow into the reaction part, and has a branch structure with one side connected to the reaction part and the other side connected to the absorption part through a discharge pipe.

[0050] The present invention is characterized in that one side of the discharge tube 14 is connected to the hinge part, and the other side is connected to the absorption part, so that the solution can be discharged to the absorption part. Through the pressure of the absorption part, etc., the discharge tube can remove the sample solution, reaction solution, washing solution and analysis solution, etc., other than the amount required for the reaction in the solution flowing into the reaction part. In addition, the discharge tube can make a specified amount of the solution flowing into the reaction part exist in the reaction part, and move the specified amount to the direction of the absorption part to remove the specified amount, thereby ensuring that there is an appropriate amount in the reaction part for the target substance present in the sample solution and the substance detecting it to react or combine, and preventing the solution in the reaction part from drying up, which makes it impossible for the target substance present in the sample solution to react or combine with the substance detecting it.

[0051] The sensor portion 13 is used to measure the amount of the target substance or the analyte substance present in the sample solution. If the microbeads present in the above-mentioned reaction portion are magnetic, the amount of the target substance present in the solution can be calculated by measuring the impedance change generated when the microbead-shaped substance for detecting the target substance binds or reacts with the target substance present in the sample solution through an immune reaction, or by measuring the presence of a substance that specifically binds to the microbead-shaped substance for detecting the target substance (including a second antibody sample of the signal substance, etc.) when the microbead-shaped substance for detecting the target substance binds or reacts with the target substance present in the sample solution through an immune reaction.

[0052] The sensor portion may include an impedance measuring reader, an optical reader, or the like.

[0053] In one embodiment of the present invention, when the target substance present in the above-mentioned sample solution is combined with the antibody sample of the above-mentioned magnetic microbeads and captured on the above-mentioned microwells, the substance in the above-mentioned sample solution that is not combined with the magnetic microbeads can be discharged to the absorption part 15 through the discharge tube 14 when more than 70ul of washing solution is injected.

[0054] In one embodiment of the present invention, 30ul of analytical solution (about 5mm with the lower end of the reaction part as the reference water level) is injected through the injection part 10, and after the magnetic microbeads including the antibody are placed in the microwell of the sensor part, more than 70ul of washing solution (15mm with the lower end of the reaction part as the reference water level) is injected to remove the magnetic microbeads not placed in the microwell. Then, 30ul of sample solution is injected to induce immune reaction between the magnetic microbeads including the above-mentioned antibody and the target substance, and the target substance bound to the above-mentioned magnetic microbeads through the immune reaction is fixed on the microwell through the magnetic microbeads, and then more than 70ul of washing solution is injected into the injection part 10, and the substance that is not bound to the above-mentioned magnetic microbeads through the immune reaction is discharged to the absorption part through the discharge pipe, and because residual target substances may remain, two more washing solutions of 70ul each are injected to remove the residual target substances. Then, after injecting 30ul of analytical solution that can induce enzyme reaction to carry out enzyme reaction, impedance (or current) is measured to quantify the target substance. It can be confirmed that by injecting specific volumes of reaction solution, sample solution, washing solution and analysis solution through this method, there is no need to inject the analysis solution, sample solution, washing solution and reaction solution in sequence and then remove them from the injection part. The target substance present in the sample solution can be detected and the amount of the target substance can be quantitatively analyzed simply by injecting each solution.

[0055] In one embodiment, in order to detect the immune reaction binding between the target substance present in the above-mentioned sample solution and the antibody included in the above-mentioned magnetic microbeads, the sensor part may also include: a detector module that can measure impedance changes, or a detector module inserted with an electrochemical sensor that can measure electrochemical reactions.

[0056] In one embodiment, the present invention is characterized in that the micro-well has a porous structure or porous pores, and the porous structure or porous pores have pores smaller than the particles bound to the magnetic micro-beads and the target substance, but larger than the size of the substance not bound to the magnetic micro-beads, but not limited to this. The reaction part including the micro-well has a porous structure or a porous pore structure, and the magnetic micro-beads including antibodies are fixed. Through the principle of immune reaction or specific reaction between biological substances, the target substance as the object to be detected is bound and captured by the magnetic micro-beads including the antibodies, and if the target substance is not captured by the magnetic micro-beads including the antibodies, a washing solution of more than a specified amount can be injected through the injection part 10, so that the residue of the sample solution is discharged through the discharge tube. As an example, the washing solution can be a phosphate buffered saline (PBS), and the washing solution can be injected more than 70ul, but it is not limited to this.

[0057] In one embodiment, when a solution below a specified volume (10 to 60ul) is injected through the injection part and reaches below a specified water level (5-8mm) in the reaction part, the above solution cannot be continuously discharged to the absorption part through the discharge pipe 14 due to the surface tension generated at the inlet of the discharge pipe. However, if a solution above a specified volume (70ul or more) is injected through the injection part to exceed the specified water level (10mm or more) in the reaction part, the above solution can be discharged through the discharge pipe 14, and the solution flows continuously due to the pressure of the suction force of the absorption part, thereby improving the discharge and flow of the solution. At this time, the substances that do not cause the immune reaction as described above are discharged in one direction, so the unnecessary by-products and biological substances that do not cause the immune reaction are washed along the flow direction of the solution and discharged through the discharge pipe 14.

[0058] Therefore, the diagnostic card box of the present invention has improved solution discharge regulation and fluidity, and can easily regulate whether the solution is discharged and the flow of the solution during discharge by the volume of the solution flowing into or injected into the injection part, so that the sample solution, reaction solution, washing solution and analysis solution present in the reaction part are discharged through the discharge tube.

[0059] Furthermore, by changing the position, size and type of the discharge tube 14, or changing the negative pressure or the amount of solution injected into the injection portion, the flow rate and flow rate of the solution passing therethrough can be controlled. For example, the solution can be moved slowly during an immune reaction and can be moved quickly during washing, thereby improving the reaction sensitivity.

[0060] The absorption part 15 is used to make the discharge flow of the solution continuous and stable, and may include an absorption pad, which may include a material having a strong absorption property of the solution or be composed of the above-mentioned material, specifically, paper (non-woven fabric), a polymer chemical (Super Absorbent Polymer) or a natural super absorbent material (Supre Absorbent Cellulose). As an example, the polymer chemical may be a thermoplastic resin, nitrocellulose or a synthetic hydrogel-forming polymer, but is not limited thereto.

[0061] The absorption part includes an absorption pad, which absorbs the solution discharged through the discharge tube, thereby constantly maintaining the surface tension and pressure conditions at the end of the discharge tube, so that the solution can continuously move along the discharge tube to the absorption part. Through the absorption part, the amount of the sample solution, reaction solution, washing solution and analysis solution injected into the absorption part can be kept constant, and the discharge of the solution can be easily adjusted.

[0062] Due to the absorption part, the above-mentioned unbound substances are discharged unidirectionally through the discharge pipe 14, while the unnecessary byproducts and biological substances that have not undergone immune reactions are washed along the flow direction of the solution and absorbed into the absorption pad included in the absorption part through the discharge pipe 14. In addition, by changing the position, size and type of the absorption pad, or applying negative pressure, the flow rate and flow rate of the solution through the orifice plate can be controlled, and due to the discharge flow of the solution as described above, the flow of the solution can be continuously adjusted under specified conditions.

[0063] According to one embodiment of the present invention, when the above-mentioned absorption part is not present, Figure 3a As shown, after a solution smaller than a specific volume is injected through the injection portion ( Figure 3a of (1)), which is not expelled due to surface tension ( Figure 3a (2)), however, when the volume of the additional injection solution reaches a certain volume or more ( Figure 3a (3)), the solution moves through the discharge tube and is discharged to the outside of the reagent box, but because there is no absorption part, the solution that moves to the discharge tube drips at the end of the discharge tube and is discharged, resulting in the solution that moves to the discharge tube not being completely discharged, and there is some residue in the discharge tube ( Figure 3a (4)). Then, if additional solution is injected ( Figure 3a (5)), there is some residue in the discharge pipe, which is similar to the above Figure 3a (1) to (4) different surface tension and pressure conditions, in order to discharge the solution, it is necessary to discharge more Figure 3a (1) to (4) are questions of volume more than the specific volume of solution required.

[0064] On the other hand, when there is an absorbing part, e.g. Figure 3bAs shown, when the solution is injected through the injection portion ( Figure 3b (1)), the absorbent pad in the absorbent part absorbs the solution flowing to the discharge pipe, so that the solution continuously flows from the discharge pipe to the absorbent part and is discharged, thereby no residual solution exists in the discharge pipe ( Figure 3b (2) to (4)). Even if the solution flows through the discharge tube to the absorbent pad of the absorbent portion, there is still an appropriate amount of solution in the reaction portion for the target substance in the sample solution and the substance to be detected to react or bind, because there is a step difference of more than a specified height between the reaction portion and the discharge tube. In addition, there is a solution of more than a specified amount to prevent the reaction portion from drying up and causing the target substance in the sample solution and the substance to be detected to be unable to react or bind, so that the reaction can proceed ( Figure 3b (4)). Then, if the solution is injected again ( Figure 3b (5)), and Figure 3a The difference is that there will be no residual solution in the discharge pipe, so the surface tension and pressure conditions remain the same as before the solution was injected, so the same Figure 3b The same volume adjustment solution as shown in (1) to (4) is discharged.

[0065] Therefore, by the absorption section, the amounts of the sample solution, reaction solution, washing solution, analysis solution, and the like injected into the injection section can be uniformly adjusted, while the discharge of the solution can be easily adjusted.

[0066] FIG. 2 shows the discharge of an injected solution according to an embodiment of the present invention.

[0067] As shown in the figure, in one embodiment of the present invention, when the target substance present in the solution injected through the above-mentioned injection part 10 is combined with the antibody sample of the magnetic microbeads included in the above-mentioned reaction part 11 and is captured in the microwells of the above-mentioned reaction part 11, the substance not combined with the magnetic microbeads in the above-mentioned solution composition is discharged through the discharge tube 14.

[0068] As an example, Figure 2a As shown, when the amount of the solution injected through the injection part 10 is 10 to 60ul, the solution will not be discharged to the absorption part 15 through the discharge tube 14, but will induce an immune reaction in the reaction part 11. Therefore, firstly, 10 to 60ul of a sample solution for detecting a target substance including a target substance is injected into the injection part 10, and then the magnetic microbeads containing antibodies pre-placed in the microwells of the above-mentioned reaction part 11 are made to react immune to the target substance. The target substance present in the sample solution combined with the above-mentioned magnetic microbeads through the immune reaction is fixed to the microwells included in the reaction part through the magnetic microbeads. Subsequently, as shown in FIG. Figure 2bAs shown, by injecting a washing solution into the injection part 10, the total volume of the sample solution and the washing solution reaches more than 70ul, so that the substances that are not bound to the above-mentioned magnetic microbeads through the immune reaction are discharged to the absorption part 15 through the discharge tube 14, and the target substance present in the sample solution can be specifically detected.

[0069] Furthermore, the present invention provides a diagnostic method using a diagnostic cartridge with improved discharge regulation and fluidity of a solution, the method comprising the following steps: A step of injecting a first volume of an analytical solution including microbeads for immune reaction through the injection portion of the diagnostic cartridge having improved discharge regulation and fluidity of the solution of the present invention; A step of injecting a second volume of the sample solution for detecting the target substance through the injection portion to allow the sample solution for detecting the target substance to specifically bind or react with the microbead-shaped substance for detecting the target substance; and A step of injecting a third volume of the washing solution through the injection portion to remove residual substances that have not specifically bound to or reacted with the sample solution for detecting the target substance.

[0070] The above-mentioned diagnostic method may also include a step of measuring the amount of the target substance or the analyte substance present in the sample solution by the sensor part. The present invention is characterized in that in the above-mentioned measuring step, when the microbeads present in the reaction part are magnetic, the impedance change generated when the microbead-shaped substance for detecting the target substance binds or reacts with the target substance present in the sample solution by immunoreaction is measured, or when the microbead-shaped substance for detecting the target substance binds or reacts with the target substance present in the sample solution by immunoreaction, the presence of a substance specifically binding to the microbead-shaped substance for detecting the target substance (including a second antibody sample of a signal substance, etc.) is measured, thereby calculating the amount of the target substance present in the solution.

[0071] The present invention is characterized in that, when the above-mentioned diagnostic method is used, the fluidity of the solution injected through the injection portion can be adjusted by injecting a specific volume of the solution.

[0072] Specifically, the first volume of the solution including the microbeads for immune reaction and the second volume of the sample solution for detecting the target substance, or the total volume of the first volume and the second volume should be 10 to 60ul, so that the injected solution will not be discharged through the discharge tube and the solution will not dry in the reaction part, so that the microbead-shaped substance for detecting the target substance can be immune-reacted and combined or reacted with the target substance in the sample solution, and the total volume of the solution volume remaining in the first volume and the second volume and the third volume can be adjusted to be more than 70ul, so that the substance that is not bound to the magnetic microbeads through the immune reaction is discharged to the absorption part 15 through the discharge tube 14. If multiple washing operations are required, more than 70ul of washing solution can be injected each time to perform additional washing operations.

[0073] In one embodiment, in the step of injecting a first volume of a solution including microbeads for immune reaction through the above-mentioned injection part, when the volume of the solution injected through the injection part is 10 to 60ul, the solution flows into the reaction part through the hinge part, and the solution flowing in through the injection part will not be discharged to the absorption part through the discharge tube, so that an immune reaction can be triggered when a sample solution including a target substance is subsequently injected.

[0074] As an example, the microbeads may be injected through the injection portion and placed in the reaction portion through the hinge portion.

[0075] When the second volume of the sample solution for detecting the target substance is injected through the injection portion, the second volume injected in the step of causing the sample solution for detecting the target substance to specifically bind or react with the microbead-shaped substance for detecting the target substance, and the first volume injected in the step of injecting the first volume of the solution including the microbeads for immune reaction through the injection portion of the diagnostic cartridge totals 10 to 60ul, the injected solution will not be discharged through the discharge tube and the solution will not dry in the reaction portion, so that the microbead-shaped substance for detecting the target substance and the target substance present in the sample solution can undergo an immune reaction to bind or react.

[0076] In the step of removing residual substances that have not specifically bound to or reacted with the sample solution for detecting the target substance by injecting the third volume of the washing solution through the above-mentioned injection part, the substances that have not bound to the magnetic microbeads through the immune reaction are discharged to the absorption part 15 through the discharge tube 14. The third volume should make the total volume of the residual solution volume in the above-mentioned first volume and second volume and the third volume (the whole residual solution) reach more than 70ul, so as to ensure that the substances that have not bound to the magnetic microbeads through the immune reaction are discharged to the absorption part 15 through the discharge tube 14.

[0077] As an example, the washing solution may be PBS, but is not limited thereto.

[0078] The present invention is characterized in that, in the step of injecting the washing solution through the above-mentioned injection part to remove the residual substances that have not specifically bound to or reacted with the substance used to detect the target substance, the specified reaction part is made to reach above the specified water level by injecting a washing solution of more than a specified volume, thereby removing the residual substances that have not specifically bound to or reacted with the washing solution and the solution used to detect the target substance without using an additional pipette.

[0079] The present invention is characterized in that the diagnostic method of the diagnostic card box with improved solution fluidity of the present invention can adjust whether the solution is discharged according to the volume of the solution flowing in through the injection part. According to one embodiment of the present invention, when the amount of solution injected through the injection part of the diagnostic card box with improved solution fluidity of the present invention is 10 to 60ul, the solution will not be discharged through the discharge tube, but will induce an immune response in the reaction part. When the amount of the injected solution reaches more than 70ul, the solution can be discharged to the absorption part through the discharge tube.

[0080] Furthermore, the diagnostic method using the diagnostic cartridge with improved discharge regulation and fluidity of the solution of the present invention can be used for the diagnosis of neuropsychiatric diseases such as dementia, diabetes, myocardial infarction, Parkinson's disease, Alzheimer's disease, cancer diagnosis, and protein detection based on immune response.

[0081] The above description of the present invention is only an example, and those skilled in the art to which the present invention belongs can understand that it can be easily changed to other specific modes without changing the technical ideas or essential features of the present invention. Therefore, the embodiments described above should be understood as being exemplary and non-restrictive in all aspects. For example, each structural element described in a single form can be implemented in a dispersed manner, and similarly, the structural elements described as dispersed can also be implemented in a combined form.

[0082] The scope of the present invention is determined by the following claims rather than the above detailed description, and all modifications or variations derived from the meaning and scope of the claims and their equivalents should be interpreted as being included in the scope of the present invention.

[0083] Description of Reference Numerals 10: Injection 11: Reaction section 12: Articulation 13: Sensor unit 14: Discharge pipe Industrial Applicability According to the technical concept of the present invention, the fluidity of the solution is improved in the diagnostic card box, and the discharge of the solution is adjusted according to the volume of the solution injected into the injection part of the diagnostic card box, so that the efficiency and accuracy of diagnosis when the diagnostic card box is used can be improved. Therefore, the accuracy of the antigen-antibody reaction can be improved while the loss rate of the solution can be reduced, thereby improving the efficiency and accuracy of diagnosis through the test kit, and having certain industrial practicality.

Claims

1. A diagnostic cartridge having improved discharge regulation and fluidity of a solution, characterized in that: include: An injection part, for injecting a sample solution for detecting a target substance; The reaction part is located below the injection part and includes a micro-well for receiving micro-beads for immune reaction; A hinge part, connecting the injection part and the reaction part, so that the solution injected through the injection part flows into the reaction part; a discharge tube, one side of which is connected to the hinged part and the other side of which is connected to the absorption part, and capable of discharging the solution to the absorption part; and The absorption part is used for absorbing the discharged solution.

2. The diagnostic cartridge with improved discharge regulation and fluidity of the solution according to claim 1, characterized in that: The hinged part is a branch structure with one side connected to the reaction part and the other side connected to the absorption part through the discharge pipe.

3. The diagnostic cartridge with improved discharge regulation and fluidity of the solution according to claim 1, characterized in that: The reaction part includes microbeads including a substance for detecting a target substance.

4. The diagnostic cartridge with improved discharge regulation and fluidity of the solution according to claim 3, characterized in that: The substance used to detect the target substance includes at least one selected from the group consisting of antibodies, antigens, enzymes, peptides, proteins, DNA, RNA, peptide nucleic acids (PNA), protein-binding nucleotides, and aptamers.

5. The diagnostic cartridge with improved discharge regulation and fluidity of the solution according to claim 4, 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 part and the antibody included in the microbeads undergo an immune reaction to bind or react.

6. The diagnostic cartridge with improved discharge regulation and fluidity of the solution according to claim 5, characterized in that: In order for the immune reaction to occur, the reaction portion is not dried.

7. The diagnostic cartridge with improved discharge regulation and fluidity of the solution according to claim 1, characterized in that: The microbeads in the reaction part are magnetic.

8. The diagnostic cartridge with improved discharge regulation and fluidity of the solution according to claim 1, characterized in that: The absorption part includes an absorption pad that absorbs the solution discharged through the discharge pipe so that the solution continuously flows along the discharge pipe to the absorption part.

9. The diagnostic cartridge with improved discharge regulation and fluidity of the solution according to claim 1, characterized in that: A sensor portion is also included.

10. The diagnostic cartridge with improved discharge regulation and fluidity of the solution according to claim 9, characterized in that: The sensor portion calculates the amount of target substance present in the solution by measuring the impedance change generated when the microbead-shaped substance for detecting target substance binds or reacts with the target substance present in the sample solution by immune reaction, or by measuring the presence of a substance that specifically binds to the microbead-shaped substance for detecting target substance when the microbead-shaped substance for detecting target substance binds or reacts with the target substance present in the sample solution by immune reaction.

11. The diagnostic cartridge with improved discharge regulation and fluidity of a solution according to claim 1, characterized in that: Whether or not the solution flowing into the discharge pipe is discharged can be adjusted by the volume of the solution flowing into the injection portion.

12. A diagnostic method using a diagnostic cartridge with improved discharge regulation and fluidity of a solution, characterized in that: include: A step of injecting a first volume of a solution including microbeads for immune reaction through the injection portion of the diagnostic cartridge having improved discharge regulation and fluidity of the solution according to claim 1; A step of injecting a second volume of a sample solution for detecting a target substance through the injection portion to allow the sample solution for detecting a target substance to specifically bind or react with the microbead-shaped substance for detecting a target substance; A step of injecting a third volume of a washing solution through the injection portion to remove residual substances that have not specifically bound to or reacted with the sample solution for detecting the target substance.

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