KR20220068788A - Diagnosis strip using solution supply device - Google Patents

Abstract

The present invention relates to a diagnostic strip, comprising: a housing, the interior of which has an accommodation space, and the upper surface of which has a first inlet and a second inlet arranged so as to communicate between the accommodation space and an external space and be spaced apart from each other; a membrane pad exposed to the second inlet and arranged in the accommodation space; a sample pad arranged in the accommodation space so as to come into contact with at least one surface of the membrane pad, thereby absorbing a sample solution injected into the first inlet; a solution supply apparatus which is arranged into the second inlet in an integrated or separable form, which accommodates a washing solution and a reaction solution, and which injects the washing solution and the reaction solution into the second inlet at a predetermined time interval; an absorbing pad interposed between the first inlet and the second inlet such that one side surface thereof comes into contact with an upper surface of the interior of the housing and the other side surface thereof is spaced apart from the membrane pad; and a sliding member which includes a gripping part for gripping the sample pad and an extending part for extending from the absorbing pad in a horizontal direction, so as to have at least a portion penetrating through the side surface of the housing and protruding outwardly.

Description

Diagnostic strip using solution supply device

The present invention relates to a diagnostic strip, and to a solution supplying device that automatically injects a washing solution and a reaction solution at an appropriate time, which can be easily used by users, and which enables quick and simple analysis in the field, and a diagnostic strip using the same.

Many diagnostic strips have been developed and used to quickly and accurately measure the concentration or presence of analytes in bodily fluids such as blood and urine. This has been recently developed.

The diagnostic strip using nanoparticles based on the lateral flow immunoassay method is the most common disposable point-of-care diagnostic strip, and the nanoparticles are aggregated by antigen binding to form a band, and positive/negative can be visually determined. However, when analyzing a low concentration of antigen, there is a limit in assay sensitivity that occurs in the process of visually observing band formation. There is a way to improve the sensitivity so that bands can be visually distinguished at low concentrations, but there are limitations in terms of materials. In addition, there is a method of improving the sensitivity by analyzing an image through fluorescence or light emission, but there is a problem that an additional image analysis device is required, which is not suitable for a disposable point-of-care diagnostic kit. In addition, although the colored band can be analyzed as a general optical or fluorescent image and the result can be digitized, there is a problem in that an additional apparatus for image analysis is required.

In order to analyze a low concentration of antigen, high-sensitivity electrochemical analysis was applied to the lateral flow immunoassay. For this purpose, quantitative analysis of the reacted substrate through the catalytic role of the enzyme bound to the detection antibody is important. It is necessarily accompanied by a washing step to remove it and then a step of dispensing a certain amount of substrate. This process is similar to the enzyme-linked immunosorbent assay (ELISA) performed in the laboratory, and there are limitations in the complexity of the analysis process in several steps, making it difficult for general users to use.

Therefore, there was a need for a diagnostic strip that can be easily used by general users and can be used as a point-of-care diagnostic kit by improving the sensitivity limit that occurs in the visual observation method.

Japanese Patent Application Laid-Open No. 6190395 (“Method and composition for detecting multiple subjects with a single signal,” Invisible Central, 2017 08 10) Republic of Korea Patent Registration No. 10-1768876 (“A device for detecting antigen and its use”, Invisible Centennial, 2017 08 10) Republic of Korea Patent Registration No. 10-1742958 (“Strip sensor module, strip sensor-based molecular diagnostic on-site inspection device using it”, Genetbio Co., Ltd., 2017 05 29)

The technical problem to be achieved by the present invention is to solve this problem, and relates to a diagnostic strip that can be easily used by general users and can be analyzed quickly and easily in the field.

The diagnostic strip of the present invention includes a housing having an accommodating space therein, and a housing forming a first inlet and a second inlet spaced apart from the receiving space and communicating with the external space on the upper surface, and integrally or separated from the second inlet. It is mounted in a possible form, accommodates the washing solution and the reaction solution, and may include a solution supply device that sequentially puts the washing solution and the reaction solution into the membrane pad through the second inlet at an interval.

1 is a perspective view of a diagnostic strip according to a first embodiment of the present invention.
FIG. 2 is an exploded perspective view of FIG. 1 .
3 is a cross-sectional view taken along the line A-A' of the diagnostic strip of FIG. 1;
4 is a block diagram of a solution supply device applied to the present invention.
FIG. 5 is a view showing an absorbent pad of the diagnostic strip of FIG. 1 .
6 to 11 are operational diagrams illustrating an operation process of a diagnostic strip according to an embodiment of the present invention.
12 is an exemplary view of the configuration for breaking the solution supply device 70 of the present invention.
13 is a configuration diagram of an embodiment of the first accommodating part.
14 is a perspective view of a diagnostic strip according to a second embodiment of the present invention.
15 is a cross-sectional view of the diagnostic strip of FIG. 14 taken along line B-B'.
16 to 20 are operational diagrams illustrating an operation process of a diagnostic strip according to a second embodiment of the present invention.
21 is a diagram illustrating a state of use of a diagnostic strip according to a second embodiment of the present invention.
22 is a cross-sectional view of a diagnostic strip according to a third embodiment of the present invention.
23 to 27 are operational diagrams illustrating an operation process of a diagnostic strip according to a third embodiment of the present invention.

Advantages and features of the present invention and methods for achieving them will become apparent with reference to the embodiments described below in detail in conjunction with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below, but may be implemented in various different forms, and only these embodiments allow the disclosure of the present invention to be complete and those of ordinary skill in the art to which the present invention pertains. It is provided to fully inform the person of the scope of the invention, and the present invention is only defined by the claims. Like reference numerals refer to like elements throughout.

Hereinafter, a diagnostic strip according to a first embodiment of the present invention will be described with reference to FIGS. 1 to 11 .

After the configuration of the diagnostic strip according to the first embodiment of the present invention will be described in detail with reference to FIGS. 1 to 5 , the operation process will be described with reference to FIGS. 6 to 11 .

1 is a perspective view of a diagnostic strip according to a first embodiment of the present invention, FIG. 2 is an exploded perspective view of FIG. 1, and FIG. 3 is a cross-sectional view of the diagnostic strip of FIG. 1 taken along line A-A', and FIG. 4 is a perspective view of the supply unit, and FIG. 5 is a view showing a second pad of the diagnostic strip of FIG. 1 .

1 to 5 , the diagnostic strip 1 of the present invention allows general users to conveniently measure the concentration or presence of an analyte in bodily fluids such as blood and urine, and to quickly and accurately analyze in the field. diagnostic kit for

The diagnostic strip 1 of the present invention includes a housing 10 , a membrane pad 20 , a sample pad 30 , an absorbent pad 40 , and a sliding member 50 positioned inside the housing 10 . . Specifically, in the diagnostic strip 1 of the present invention, the receiving space 11 is formed therein, and the first inlet 12 and the second inlet are spaced apart from each other to communicate with the receiving space 11 and the external space on the upper surface. At least one surface of the housing 10 forming the housing 10 , the membrane pad 20 exposed to the second inlet 13 and disposed in the accommodation space 11 , and the membrane pad 20 in the accommodation space 11 . is disposed in contact with the sample pad 30 for absorbing the sample solution (L1) injected into the first inlet 12, and disposed between the first inlet 12 and the second inlet 13, one side The absorbent pad 40 is in contact with the inner upper surface of the housing 10 and the other side is spaced apart from the membrane pad 20 , the gripper 51 for gripping the sample pad 30 , and the gripper 51 . The sliding member 50 is formed to extend in the horizontal direction, and at least a part of the sliding member 50 includes an extension part 52 protruding outwardly through the side surface of the housing 10, and the second inlet 13 is integrally or detachable. and a solution supply device 70 capable of sequentially supplying the washing solution W1 and the reaction solution L2 by being coupled to each other, and the sliding member 50 slides in the horizontal direction so that the sample pad 30 is a membrane pad ( 20 ), and the other side of the absorbent pad 40 is in contact with the membrane pad 20 .

The housing 10 forms the main body of the diagnostic strip 1 , and may be formed in a rectangular parallelepiped shape to form an accommodating space 11 therein. As shown in the drawing, the housing 10 is extended in the z-axis direction and described as an example that a cross-section cut in a horizontal line is formed in a rectangular shape, but is not limited thereto, and a cross-sectional shape cut in a horizontal line is a rectangular shape It may be formed in an elliptical shape other than this. The housing 10 accommodates the membrane pad 20 , the sample pad 30 , the absorbent pad 40 , and the sliding member 50 in the receiving space 11 . The housing 10 may be formed vertically so that each component accommodated in the accommodating space 11 can be easily disposed, and the first member 110 and the second member 120 that are formed separately to be coupled are included. may include The first member 110 and the second member 120 form the upper and lower portions of the housing 10 separated up and down, respectively, and may include an upper surface and a lower surface of the housing 10, respectively, and the surfaces facing each other It can be separated and coupled to each other by a coupling groove (not shown) and the protrusion 121 formed in the . In the first member 110 including the upper surface of the housing 10, a first inlet 12 and a second inlet 13 communicating with the receiving space 11 and the external space are formed to be spaced apart from each other, and the first inlet ( 12) and the second inlet 13, the arrival confirmation port 14 may be formed. The first inlet 12 and the second inlet 13 are through holes for introducing the sample solution L1, the washing solution W1, and the reaction solution L2 into the receiving space 11, respectively, and the first member 110 It is formed through the upper and lower surfaces of the housing 10 may be spaced apart along the longitudinal direction of the z-axis of the housing (10).

The solution supply device 70 may be coupled or integrally fixed to the second inlet 13 . The solution supply device 70 includes a cylindrical housing 71 for coupling with the second inlet 13 , and a first accommodating part 72 positioned in an upper portion of the housing 71 to receive the washing solution W1 . ) and a second accommodating part 73 positioned on the upper side of the housing 71 and on the side of the first accommodating part 72 to accommodate the reaction solution L2.

Although the embodiment of the present invention is described as including a cylindrical housing 71 , the first accommodating part 72 and the second accommodating part 73 are attached to the second guide surface 13a of the second inlet 13 . It can be installed in direct contact.

As will be described in detail later, the first accommodating part 72 and the second accommodating part 73 each receive a washing solution (W1) accommodated by a method such as breakage, breakage, cutting, pressurization, etc. at an appropriate timing during the analysis process. ) and the reaction solution L2 may be injected through the second inlet 13 .

That is, by breaking the first accommodating part 72 and injecting the washing solution (W1) to proceed with the washing step, the second accommodating part 72 is broken and the reaction solution (L2) is injected to analyze the reactivity of HRP, , the washing solution (W1) and the reaction solution (L2) may be injected into the second inlet in stages.

In the present specification, the washing solution (W1) may include a washing buffer partially containing a surfactant such as tween, and the reaction solution (L2) is a substrate that reacts with an enzyme (peroxidase, phosphatase, etc.) bound to the detection antibody. A solution containing this can be given as an example. The sample solution L1 , the washing solution W1 , and the reaction solution L2 may be introduced to be opposite to each other through the first inlet 12 and the second inlet 13 . The first inlet 12 and the second inlet 13 have a feature that can minimize non-specific reactions by implementing the input directions in which the sample solution (L1), the washing solution (W1), and the reaction solution (L2) are put in opposite directions. have. The arrival confirmation hole 14 is a through hole for confirming that the sample solution L1 injected into the first inlet 12 has reached a specific position riding on the membrane pad 20, and connects the upper and lower surfaces of the first member 11 . It may be formed through, and may be formed in parallel between the first inlet 12 and the second inlet 13 and along the z-axis. The arrival confirmation port 14 may be formed to be spaced apart from the first inlet 12 and the second inlet 13 , and be formed at a position adjacent to the second inlet 13 than the first inlet 12 .

Meanwhile, the housing 10 may include a first guide surface 12a extending from an inner upper surface, a second guide surface 13a, and a recess 19 .

3, the housing 10 has a first guide surface 12a extending downward from the lower surface of the first member 110, a second guide surface 13a, and a recess ( 19) and a pressing member (not shown).

The first guide surface 12a and the second guide surface 13a move the sample solution L1, the washing solution W1, and the reaction solution L2 injected into the first inlet 12 and the second inlet 13. It may be formed to extend downward from the first inlet 12 and the second inlet 13 toward the accommodating space 11 to guide the . The first guide surface 12a and the second guide surface 13a may be formed to have a diameter of an end portion smaller than a diameter of the first inlet 12 and the second inlet 13 to be inclined downward. The first guide surface 12a and the second guide surface 13a are formed to be inclined toward the lower portion, and the sample solution L1 and the washing solution W1 are introduced into the first inlet 12 and the second inlet 13, and The reaction solution L2 may be guided to be introduced into specific positions of the sample pad 30 and the membrane pad 20 . In addition, a portion of the first guide surface 12a is formed to have a longer length than other portions, so that the membrane pad 20 can be closely fixed to the upper surface of the second member 120 .

The indentation 19 forms a space in which the absorbent pad 40 to be described later is inserted and guides the movement of the absorbent pad 40 , and may be formed to extend downward from the inner upper surface of the housing 10 . The indentation 19 may be formed to extend downwardly from the lower surface of the first member 110 between the first inlet 12 and the second inlet 13 .

The indentation 19 may be disposed closer to the first inlet 12 between the arrival confirmation port 14 and the first inlet 12 to form a space into which the absorbent pad 40 is inserted. The indentation 19 accommodates the absorbent pad 40 in the inner space, and the opened lower side can be opened and closed by the sliding member 50, which will be described later in detail in the operation process.

The pressing member is for pressing the electrode unit 60 disposed in the receiving space 11 , and may be formed to extend downward from the inner upper surface of the housing 10 . The pressing member may be formed to extend downwardly from the lower surface of the first member 110 between the first inlet 12 and the second inlet 13 . The pressing member may be formed at a position facing the electrode part 60 between the arrival confirmation port 14 and the indentation part 19 to press the electrode part 60 .

The membrane pad 20 is disposed in the accommodation space 11 of the housing 10 including the first member 110 and the second member 120 .

The membrane pad 20 is disposed in the inner receiving space 11 of the housing 10 .

The membrane pad 20 may be disposed on the upper surface of the second member 120 and may be disposed to be exposed by the second inlet 13 . Membrane pad 20 may include a nitrocellulose (NC, Nitrocellulose) pad 21, is formed to extend along the longitudinal direction of the housing 10, the second inlet 13, the arrival confirmation port 14, press member, may face the indentation (19). At least a portion of the membrane pad 20 is pretreated with a capture antibody that specifically binds to a specific target antigen, and the detection antibody and capture material secondary to the antigen bound to the capture antibody are not limited to the antibody. , proteins, carbohydrates, nucleotides, aptamers, and the like.

The membrane pad 20 may be formed by combining a cover capable of reducing the interaction between the fluid in the nitrocellulose pad 21 and the second member 120 , for example, the nitrocellulose pad 21 and Polyethylene terephthalate (PET, polyethylene terephthalate) 22 may be formed by bonding. The membrane pad 20 may be formed of a member that minimizes interaction, such as a corrosion reaction by a fluid, and may be a member having an adhesive formed thereon.

One end of the membrane pad 20 can absorb the sample solution L1 injected from the first inlet 12 from the sample pad 30, and the sample solution L1 moves in the longitudinal direction to reach the arrival confirmation port 14 ), the washing solution W1 and the reaction solution L2 injected from the other end into the second inlet 13 can be absorbed. The reaction solution absorbed by the membrane pad 20 is transferred to the electrode part 60 , and the electrode part 60 may generate an electric signal, which will be described in detail during the operation process. The membrane pad 20 is characterized in that one side is pre-treated with a capture antibody that specifically binds to a predetermined antigen. The membrane pad 20 is not limited to the detection antibody and the capture material that binds secondary to the antigen bound to the capture antibody, and may be composed of proteins, carbohydrates, nucleotides, aptamers, and the like. The membrane pad 20 may be described as an example in which capture is coated in advance on one side, and capture and detector may not be limited to a material called an antibody.

Membrane pad 20 can quantitatively analyze the reaction generated on the surface through the electrode unit 60 by electrochemical analysis. Meanwhile, the electrode part 60 is disposed on the upper surface of the membrane pad 20 , and the sample pad 30 that is in contact with and separated from the membrane pad 20 is disposed on one side of the membrane pad 20 .

The electrode unit 60 obtains a signal from a reaction in which the reaction solution that is input into the second inlet 13 and absorbed by the membrane pad 20 is oxidized/reduced by the enzyme of the detection antibody, and the second inlet 13 and It may be disposed in close contact with the upper surface of the membrane pad 20 positioned between the absorbent pads 40 . The electrode unit 60 includes a substrate on which electrodes are patterned, and two electrodes or three electrodes may be patterned. For example, the electrode unit 60 includes a counter electrode, a working electrode, and a reference electrode, and is disposed on the upper surface of the membrane pad 20 to face the pressing member. can be Such an electrode unit 60 reacts with the solution injected into the first inlet 12 and the second inlet 13 to cause an oxidation/reduction reaction to analyze the concentration or presence of an analyte contained in the solution. .

Meanwhile, the diagnostic strip 1 according to the first embodiment of the present invention is described as an example of measuring the antigen concentration by oxidation/reduction reaction, but the present invention is not limited thereto, and the electrode part 60 is not formed and the membrane is not formed. By confirming that the pad 40 is discolored, the concentration or presence of the analyte may be analyzed. In order to analyze the signal of the presence or absence of binding of the detection antibody, the enzymes used in combination with the detection antibody are peroxidase and phosphatase, and typically horseradish peroxidase and alkaline phosphatase may be used. As a substrate thereof, TMB, dianisidine, phenylenediamine, NBT/BCIP, and pNPP may be used for electrochemical and discoloration reactions, and lumino, CSPD, 1,2-dioxetane, etc. may be used for luminescence reaction. In addition, fluorescence can be analyzed by attaching a fluorescent dye to the detection antibody.

The sample pad 30 is a pad that absorbs the sample solution L1 injected into the first inlet 12 . The sample pad 30 may be disposed under the first guide surface 12a so as to be exposed through the first inlet 12 , and disposed in contact with at least one surface of the membrane pad 20 in the receiving space 11 . 1 The sample solution L1 input from the inlet 12 may be absorbed and delivered to the membrane pad 20 . As shown in FIG. 3 , the lower surface of the sample pad 30 may contact the upper surface and one side of the membrane pad 20 at the same time, but the present invention is not limited thereto. It may be in contact with one side or may be disposed in the receiving space 11 so as to be in contact with at least part of it. The sample pad 30 arranged in this way can be slidably moved in the horizontal direction, which is the longitudinal direction of the housing 10 , by the sliding member 50 , so that it can be contacted and separated from the membrane pad 20 .

The sliding member 50 is for contacting and separating the sample pad 30 from the membrane pad 20 , and is formed of a soft material and disposed in the receiving space 11 . The sliding pad includes a gripper 51 for gripping the sample pad 30 , and an extension portion extending horizontally from the gripper 51 , at least a portion of which penetrates the side surface of the housing 10 and is disposed to protrude to the outside ( 52 , the sample pad 30 may be in contact with and separated from the membrane pad 20 while sliding in the horizontal direction by pulling the extension 52 protruding from the outside of the housing 10 .

The gripper 51 is for gripping the sample pad 30 , and may include an upper plate 510 and a lower plate 511 that are vertically spaced apart from each other. The grip part 51 is formed in a 'C' shape to form a separation space in which the sample pad 30 is accommodated between the upper plate 510 and the lower plate 511 , and penetrates the upper surface of the upper plate 510 . A through hole 512 for communicating with the separation space and the first inlet 12 may be formed. The gripper 51 forms a through hole 512 communicating with the first inlet 12 so that the sample pad 30 disposed in the spaced apart space passes through the sample solution L1 introduced into the first inlet 12 . It can be absorbed through the ball 512 . The grip part 51 may form a refracting part 513 in which an end of the upper plate 510 is bent downward. The refraction part 513 is to prevent the sample pad 30 from being separated from the separation space when the sliding member 50 slides.

The extension part 52 forms a handle for moving the grip part 51 , and extends from the end of the grip part 51 in the horizontal direction. The extension part 52 is formed to extend along the -z-axis direction from the grip part 51 , and the end part penetrates the side surface of the housing 10 and is disposed to protrude outside the housing 10 . At least a portion of the extension 52 is disposed on the outside of the housing 10, and the user pulls the end of the extension 52 to slide the sliding pad in the z-axis and -z-axis directions while the sample pad 30 may be in contact with and separated from the membrane pad 20 .

On the other hand, although the sliding pad slides in the horizontal direction, the extension part 52 is formed to extend in the z-axis and -z-axis directions and slides along the longitudinal direction of the housing 10 as an example, but is not limited thereto. Alternatively, the sample pad 30 may be contacted and separated from the membrane pad 20 while slidingly formed to extend in the x-axis or -x-axis direction.

Subsequently, the grip part 51 may be formed so that the upper plate 510 is longer than the lower plate 511 . The grip portion 51 may be positioned below the indentation portion 19 when the upper plate 510 is formed longer than the lower plate 511 and the sliding pad slides in the z-axis direction. The upper plate 510 of the gripping part 51 is positioned below the indentation part 19 while sliding the sliding pad in the z-axis direction and the -z-axis direction, or is positioned so that it is completely deviated from the lower side of the indentation part 19 . While the lower side of the indentation portion 19 can be opened and closed. In this way, the sliding pad opens and closes the open lower side of the indentation portion 19 so that the absorbent pad 40 accommodated in the indentation portion 19 is completely accommodated inside the indentation portion 19, or at least a part of the indentation portion 19 ) and may come into contact with the membrane pad 20 . This will be described later in detail through the operation process after the absorbent pad 40 is described.

The absorbent pad 40 is for absorbing the washing solution W1 that is input through the second inlet 13 and absorbed into the membrane pad 20 , and is formed of a material that expands in volume when the solution is absorbed. For example, the absorbent pad 40 may be formed of a material such as glass fiber or cotton, and may be disposed between the first inlet 12 and the second inlet 13 . The absorbent pad 40 has a thickness, material, volume, etc. according to the amount of the washing solution W1 injected through the second inlet 13 in a state where the first receiving part 72 of the solution supply device 70 is broken. This can be adjusted. Referring to FIG. 5A , the absorbent pad 40 may be formed of a thin pad capable of absorbing a solution. The absorbent pad 40 may be formed by being cut to a size that can be inserted into the indentation 19 , and the cut and formed thin pad may be formed by folding in different directions multiple times as shown in FIG. 5B . The absorbent pad 40 is described as an example that it is folded to form five layers as shown in the drawings, but is not limited thereto, and the area and volume of each layer according to the amount of the washing solution injected into the second inlet 13 . , the number of folds, thickness, material, etc. can be adjusted.

The absorbent pad 40 may be folded a plurality of times in opposite directions to form a stacked structure, one side of which is in contact with the inner upper surface of the housing 10 and the other side of which is spaced apart from the membrane pad 20 . The absorbent pad 40 may have different elasticity depending on the area, volume, thickness, number of times of folding, material, and the like. The absorbent pad 40 may be stacked as shown in FIG. 5c when pressure is applied up and down after being folded a number of times as in FIG. 5b, and when no pressure is applied to the upper or lower surfaces, each layer as shown in FIG. 5b As this spaced apart, it can open up and down. The absorbent pad 40 according to the first embodiment of the present invention is compressed and restored by elasticity and is formed in a structure that can absorb a solution, but is not limited thereto. The absorbent member may be separately formed and disposed in close contact or may be formed by bonding, which will be described in detail with reference to the diagnostic strip 1a of the second embodiment.

The absorbent pad 40 is inserted into the indentation portion 19 so that the lower side of the indentation portion 19 is closed by the sliding member 50 to be spaced apart from the membrane pad 20, and the sliding member 50 is When the lower side of the indentation portion 19 is opened by sliding movement, a portion may be separated from the indentation portion 19 due to elasticity and may come into contact with the upper surface of the membrane pad 20 on the other side thereof.

That is, before the sliding member 50 slides, the gripper 51 closes the lower side of the indentation portion 19 so that the absorbent pad 40 is completely inserted into the indentation portion 19 so that the membrane pad Spaced apart from 20 , the sample pad 30 may be disposed to contact the membrane pad 20 , and the through hole 512 may be disposed to communicate with the first inlet 12 .

In addition, when the extended portion 52 of the sliding member 50 slides outwardly of the housing 10 , the gripping portion 51 opens the lower side of the indentation portion 19 so that the absorbent pad 40 is disposed on the other side. In contact with the membrane pad 20, the sample pad 30 moves away from the membrane pad 20, and the upper surface of the gripper 51 can close the end of the first guide surface 12a, and the operation process is Please refer to the description in more detail.

Hereinafter, an operation process of the diagnostic strip according to the first embodiment of the present invention will be described with reference to FIGS. 6 to 11 .

Although the drawing shows that the first accommodating part 72 and the second accommodating part 73 protrude to the outside of the housing 10, they may be in a retracted form.

6 to 11 are operational diagrams illustrating an operation process of a diagnostic strip according to a first exemplary embodiment of the present invention.

Referring to FIG. 6 , FIG. 6 is a diagram illustrating a sample solution L1 being introduced into the first inlet 12 . For the sample solution (L1), a detection antibody-horseradish peroxide (HRP) solution pre-bound with the antigen sample to be analyzed is used. Peroxidase enzymes such as HRP can oxidize specific substrates, and the degree of this enzyme-substrate oxidation/reduction reaction can be measured through optical measurement methods such as discoloration, luminescence, and fluorescence analysis as well as high-sensitivity electrochemical measurement methods. It can be measured quantitatively. Accordingly, the sample solution (L1) in which the detection antibody and HRP are combined is introduced into the first inlet 12 . At this time, the sample pad 30 must be exposed through the first inlet 12 , and the sample solution L1 is introduced into the first inlet 12 while the sample pad 30 is in contact with the membrane pad 20 . should be The sample solution L1 injected into the first inlet 12 may be absorbed into the sample pad 30 .

Referring to FIG. 7 , FIG. 7 shows that the sample solution L1 injected into the first inlet 12 falls on the sample pad 30 , and the sample pad 30 absorbs the sample solution L1 to the sample pad 30 . It shows a view that the membrane pad 20 in contact with the wet entering.

The sample pad 30 absorbs the sample solution L1 introduced from the first inlet 12 , and at least a part of it is in contact with the membrane pad 20 , so that the absorbed sample solution L1 is transferred to the membrane pad 20 . do. The membrane pad 20 can absorb the sample solution L1 from one end in contact with the sample pad 30 , and the sample solution L1 absorbed from the sample pad 30 is wetted from one end to the other end. can go in It can be seen that the sample solution L1 is wetted from one end of the membrane pad 20 through the sample pad 30 to the other end through the electrode unit 60 . At this time, it can be confirmed that the sample solution L1 is absorbed from the arrival confirmation port 14 to the other end of the membrane pad 20, and when the sample solution L1 reaches the lower side of the arrival confirmation port 14, The sample pad 30 is separated from the membrane pad 20 .

Referring to FIG. 8 , FIG. 8 shows a diagram of sliding the sliding pad so that the sample pad 30 and the membrane pad 20 are separated. When the sample solution L1 is absorbed by the membrane pad 20 and reaches the lower side of the arrival confirmation hole 14 , the extension part 52 of the sliding pad is pulled from the outside of the housing 10 . When the extension part 52 is pulled, the grip part 51 integrally formed with the extension part 52 can slide and move, and at the same time, the sample pad 30 is separated from the membrane pad 20 . When the gripper 51 slides while the sliding pad is pulled to the outside of the housing 10, the sample pad 30 is separated from the membrane pad 20, and the upper plate 510 of the gripper 51 moves into the indentation ( 19) can be opened. As the lower side of the indentation portion 19 is opened, the absorbent pad 40 inserted and disposed in the indentation portion 19 may at least partially protrude from the indentation portion 19 by elasticity.

Referring to FIG. 9 , FIG. 9 shows a view in which a portion of the absorbent pad 40 protrudes outwardly of the indentation portion 19 due to elasticity. When the lower side of the indentation portion 19 is opened, the absorbent pad 40 may protrude to the outside of the indentation portion 19 by elasticity and the other end may contact the upper surface of the membrane pad 20 . One end of the absorbent pad 40 may be in contact with the inner upper surface of the indentation portion 19 due to elasticity, and the other end may be disposed so as to be in contact with the upper surface of the membrane pad 20 . At this time, one end of the absorbent pad 40 may be fixed to the inner upper surface of the indentation portion 19 , but may not be fixed and may be in close contact by applying a force to the inner upper surface of the indentation portion 19 by elasticity.

Continuingly, referring to FIG. 10 , FIG. 10 shows a view in which the washing solution W1 is introduced into the second inlet 13 . In a state in which the membrane pad 20 is in contact with the absorbent pad 40 and separated from the sample pad 30, the first accommodating part 72 is broken and the washing solution accommodated in the first accommodating part 72 ( W1) may be put into the second inlet (13).

The material of the first accommodating part 72 may be vinyl or resin material, and the washing solution W1 accommodated by applying pressure manually or automatically or by breaking a part or all of the bottom surface flows out, the second inlet 13 ) to allow input through

Examples of breaking the first accommodating part 72 will be described later in more detail.

The washing solution flows into the receiving space 11 through the second inlet 13, falls on the upper surface of the membrane pad 20, is absorbed along the longitudinal direction of the membrane pad 20, and comes into contact with the electrode unit 60, The remainder may be absorbed by the absorbent pad 40 .

Next, as shown in FIG. 11 , the second accommodating part 73 is broken to supply the reaction solution L2 to the accommodating space 11 through the second inlet 13 .

In this case, the electrode unit 60 may induce an electrochemical reaction of the reaction solution. TMB is oxidized by HRP enzyme to generate TMB radicals, hydrogen ions, and electrons. The process of reducing TMB oxidized according to Equation (2) by an electrochemical reaction at the working electrode is cyclically repeated. . Using this principle, the current difference at which the maximum instantaneous current for oxidation of TMB occurs can be checked by cyclic voltammetry, and the antigen concentration can be measured by the amperometric method. Accordingly, there is an advantage in that an amplified signal can be obtained even with a low concentration of antigen while the oxidation reaction by the enzyme and the reduction reaction by the electrode are continuously cycled.

12 is an exemplary view of the configuration for breaking the solution supply device 70 of the present invention.

Referring to FIG. 12 , a breaking part 80 for sequentially breaking each of the first accommodating part 72 and the second accommodating part 73 of the solution supply device 70 may be provided. The breaking part 80 includes a sensor 81 for detecting the position of the extension part 52, and after a set time elapses after the sensor 81 detects the movement of the extension part 52, an operation control signal is provided. It operates by the outputting control unit 82 to break the first accommodating part 72 and the second accommodating part 73 . After the first accommodating part 72 is broken, it also has a predetermined delay time until the second accommodating part 73 is broken.

The housing 71 has a partition wall formed between the lower ends of the first accommodating part 72 and the second accommodating part 73, so that the washing solution W1 and the reaction solution L2 do not mix with each other, This can be applied to the entire drawing described.

In this case, the breaking part 80 may be installed on the diagnostic strip, provided on an analysis device using the diagnostic strip, or separately provided outside.

The breaking part 80 includes two awls, and the first accommodating part 72 and the second accommodating part 73 are perforated by the movement of the awl, respectively, so that the first accommodating part 72 and the second accommodating part are drilled. The washing solution W1 and the reaction solution L2 accommodated in the unit 73 may be introduced into the lower second inlet 13 by gravity.

In the above example, the first accommodating part 72 and the first accommodating part 72 and the first accommodating part 72 and the first accommodating part 72 and the first accommodating part 72 and the first accommodating part 72 and the first accommodating part 72 have been described. 2 Examples of breaking the accommodating part 73 can be implemented in various ways.

For example, the bottom surface of each of the first accommodating part 72 and the second accommodating part 73 may be broken with a time difference using a sliding cutter.

The cutter may be of a rotary type.

13 is a configuration diagram of another embodiment of the first accommodating part 72 .

Referring to FIG. 13 , the bottom surface of the first accommodating part 72 may have a breaking line 74 that is weaker in strength than other parts, and the breaking part 80 presses the upper part of the first accommodating part 72 . By causing the breaking line 74 to break, the washing solution W1 accommodated therein can be introduced into the second inlet 13 .

As such, the present invention can supply the washing solution (W1) and the reaction solution (L2) at a set time through a wide variety of means, thereby improving the convenience of use.

Hereinafter, a diagnostic strip according to a second embodiment of the present invention will be described with reference to FIGS. 14 to 21 .

The diagnostic strip 1 according to the second embodiment of the present invention is substantially the same as the first embodiment described above except for the housing 10a and the absorbent pad 40a. Accordingly, the same reference numerals are attached to the components already described, and detailed descriptions thereof will be omitted.

The configuration of the second embodiment of the present invention will be described in detail with reference to FIGS. 14 and 15 , and the operation process will be described with reference to FIGS. 16 to 20 , and then the diagnosis according to the second embodiment with reference to FIG. 21 . Let us explain the use condition of the strip.

14 is a perspective view of a diagnostic strip according to a second embodiment of the present invention;

15 is a cross-sectional view taken along the line B-B' of the diagnostic strip of FIG. 14;

14 and 15 , the diagnostic strip 1a according to the second embodiment of the present invention includes a first color change confirmation hole 16 , a second color change confirmation hole 17 , and a code display unit in a housing 10a. 18 is formed, and an absorbent pad 40a to which the elastic member 41 and the absorbent member 42 are coupled is disposed inside the housing 10a.

The housing 10a includes a first color change confirmation hole 16 and a second color change confirmation hole 17 formed through the upper surface between the first inlet 12 and the second inlet 13 .

The first discoloration confirmation hole 16 and the second color change confirmation hole 17 are through-holes for confirming the discoloration of the membrane pad 20 , and the first member is disposed between the first inlet 12 and the second inlet 13 . It is formed through the upper and lower surfaces of the 110a, so that at least a portion of the membrane pad 20 may be exposed to the outside of the housing 10a. The first discoloration confirmation hole 16 and the second color change confirmation hole 17 are formed to be spaced apart from the first member 110 of the housing 10a by a predetermined interval, and the second inlet 13 and the absorbent pad 40a are disposed It can be formed spaced apart between the indentation (19). The membrane pad 20 may include one or more reaction units coated with a capture antibody to induce a reaction at positions corresponding to the first color change confirmation sphere 16 and the second color change confirmation sphere 17 . Since the reaction part is pre-treated with the capture antibody, the antigen-detecting antibody-enzyme complex included in the sample solution (L1) can be bound. Thereafter, when the reaction solution is introduced, the substrate included in the reaction solution may undergo an oxidation reaction by the bound enzyme, and as a result, a luminescence or fluorescence reaction may occur or the color may change.

The solution supply device 70 of the embodiment described above is applied to the second inlet 13 . At this time, the solution supply device 70 is also broken by the breaking part 80 in various ways, so that the washing solution W1 and the reaction solution L2 can be sequentially supplied.

The reaction unit includes a reagent that changes color by reacting with the detection antibody contained in the sample solution (L1) in the fluid, and the degree of reaction such as color development, luminescence, and fluorescence may vary depending on the concentration of antigen in the sample solution (L1). , the degree of color development may vary depending on the concentration of antigen. It is possible to check whether the reaction part is discolored through the first discoloration confirmation sphere 16 and the second discoloration confirmation sphere 17 to determine whether it is positive or negative.

A code display unit 18 is formed on the outer upper surface of the housing 10a.

The code display unit 18 may display a code that can read information through a device, such as a QR code, a Quick Response code, or a bar code, on the outer upper surface of the housing 10 . The code display unit 18 may be printed and formed on the upper surface of the first pad or may be manufactured and attached in the form of a sticker, and a diagnostic strip using a camera provided in the user's portable terminal (not shown) and an application stored in the portable terminal. It can be used for the purpose of confirming the diagnosis result of (1a). However, the code display unit 18 is not applied only to the diagnostic strip 1a of the second embodiment, but is applied to the housing 10 of the diagnostic strip 1 in the first embodiment and analyzed measured by the electrode unit 60 . It can also be used to confirm the concentration and detection of a substance.

The absorbent pad 40a is inserted into the indentation 19, and when the indentation 19 is opened by the sliding member 50 movement, it comes into contact with the membrane pad 20 and absorbs the washing solution in the first embodiment. It is the same as, but is slightly different from the absorbent pad 40a in the first embodiment in that it includes an elastic member 41 and an absorbent member 42 .

The absorbent pad 40a includes an elastic member 41 in contact with the inner upper surface of the housing 10a and an absorbent member 42 disposed below the elastic member 41 . The elastic member 41 is made of an elastically deformable material, and may include, for example, rubber, a spring, and the like. One side of the elastic member 41 may be disposed in close contact with the inner upper surface of the housing 10a and the absorption member 42 may be disposed in close contact with the other side thereof. The elastic member 41 is inserted and disposed inside the indentation part 19, and is compressed and restored as the sliding member 50 opens and closes the lower side of the indentation part 19, and the absorption member 42 disposed on the other side is indented. It can be pushed out of the part 19 . The absorbent member 42 may be made of a material that expands in volume when it absorbs liquid, such as glass fiber or cotton, which can absorb liquid, and one side of the absorbent member 42 may be disposed in close contact with the elastic member 41 . When the elastic member 41 is compressed, the absorbent member 42 is inserted into the indentation portion 19 together with the elastic member 41 , and the upper plate 510 of the gripping portion 51 is inserted into the indentation portion 19 . It may be disposed on the inside of the indentation 19 together with the elastic member 41 when disposed on the lower side of the. In addition, when the sliding member 50 slides and the lower side of the indentation part 19 is opened, it is pushed out of the indentation part 19 by the restoring force of the elastic member 41 and the end of the membrane pad 20 is It can be in contact with the upper surface.

The elastic member 41 and the absorbent member 42 may be integrally formed, formed separately and disposed so that one side thereof is in contact with each other, or one side thereof may be disposed to be fixed to each other.

On the other hand, in the diagnostic strip 1a according to the second embodiment, when the indentation portion 19 is formed on the inner surface of the housing 10a and the lower side of the indentation portion 19 is opened, the indentation portion 19 is the absorbent pad. The movement of (40a) can be guided. However, the present invention is not limited thereto, and the indentation 19 is not necessarily formed.

The diagnostic strip 1a in the second embodiment of the present invention will be described by taking as an example that the absorbent pad 40a includes an elastic member 41 and an absorbent member 42 . However, the absorbent pad 40a including the elastic member 41 and the absorbent member 42 is not limited to being applied to the diagnostic strip 1a of the second embodiment, and the absorbent pad 40a is used in the first embodiment. It can also be applied to the diagnostic strip 1 of , and the diagnostic strip in the third embodiment to be described later.

In addition, the housing 10a in which the first discoloration confirmation sphere 16, the second discoloration confirmation sphere 17 and the code display unit 18 of the present invention are formed, the elastic member 41 and the absorbing member 42 are coupled The used absorbent pad 40a may be applied to the diagnostic strip 1 in this first embodiment and the diagnostic strip 1b in the third embodiment.

Hereinafter, an operation process of the diagnostic strip according to the second embodiment of the present invention will be described with reference to FIGS. 16 to 20 .

16 to 20 are operational diagrams illustrating an operation process of a diagnostic strip according to a second exemplary embodiment of the present invention.

Referring to FIG. 16 , a diagram for introducing a sample solution L1 into the first inlet 12 is shown. As for the sample solution (L1), as described in the first embodiment, a solution obtained by pre-reacting an antigen with an enzyme-bound detection antibody is introduced into the first inlet 12 . The sample solution L1 injected into the first inlet 12 may be absorbed into the sample pad 30 .

Referring to FIG. 17 , the sample solution L1 introduced into the first inlet 12 falls on the sample pad 30 , and the sample pad 30 absorbs the sample solution L1 so that the membrane pad 20 is the sample pad. (30) The drawing is shown in the drawing wet from one end in contact. The sample pad 30 absorbs the sample solution L1 introduced from the first inlet 12 , and at least a part of it is in contact with the membrane pad 20 , so that the absorbed sample solution L1 is transferred to the membrane pad 20 . do. It can be confirmed that the sample solution L1 is wetted from one end to the other end of the membrane pad 20 through the sample pad 30 , and reaches the lower part of the arrival confirmation port 14 from the arrival confirmation port 14 . it can be seen that When the sample solution L1 is confirmed from the arrival confirmation port 14 , the sample pad 30 is separated from the membrane pad 20 .

Referring to FIG. 18 , there is shown a diagram of sliding the sliding pad so that the sample pad 30 and the membrane pad 20 are separated. When the sample solution L1 is absorbed by the membrane pad 20 and reaches the lower side of the arrival confirmation hole 14 , the extension part 52 of the sliding pad is pulled from the outside of the housing 10 . When the extension part 52 is pulled, the grip part 51 integrally formed with the extension part 52 can slide and move, and at the same time, the sample pad 30 is separated from the membrane pad 20 . When the gripper 51 slides while the sliding pad is pulled to the outside of the housing 10a, the sample pad 30 is separated from the membrane pad 20, and the upper plate 510 of the gripper 51 is indented ( 19), the lower side can be opened. As the lower side of the indentation portion 19 is opened, the absorbent pad 40a inserted into the indentation portion 19 can have the absorbent member 42 protrude from the indentation portion 19 by elasticity.

Referring to FIG. 19 , there is shown a view in which the absorbent member 42 protrudes outwardly from the indentation portion 19 and contacts the membrane pad 20 . When the lower side of the indentation portion 19 is opened, the absorbent member 42 is pushed out of the indentation portion 19 by the restoring force of the elastic member 41 so that the lower side of the absorbent member 42 is the membrane pad 20 . It can be in contact with the upper surface. When the absorbent member 42 is in contact with the upper surface of the membrane pad 20 , the washing solution W1 and the reaction solution L2 may be sequentially introduced into the second inlet 13 .

In FIG. 20 , the configuration of the solution supply device 70 is omitted to avoid duplication of description, but the washing solution W1 and the reaction solution L2 may be supplied from the solution supply device 70 . The washing solution W1 is a washing buffer containing a part of surfactant such as tween, and it falls on the upper surface of the membrane pad 20 through the second inlet 13 and is absorbed along the length direction of the membrane pad 20. Contact with the reagent pad and the remaining solution may be absorbed by the absorbent pad (40a). In addition, a portion of the membrane pad 20 exposed to the first color change confirmation port 16 and the second color change confirmation port 17 by the supply of the reaction solution L2 is an enzyme of the detection antibody contained in the sample solution L1. and the substrate included in the reaction solution react, resulting in color development, luminescence and fluorescence reactions, and through this, it is possible to immediately check whether the user is negative or positive.

21 is a state diagram of the diagnostic strip 1a according to the second embodiment of the present invention, in which it can be confirmed that the membrane pad 20 is discolored in the first discoloration confirmation sphere 16 and the second discoloration confirmation sphere 17 . have. As shown in FIG. 21A , when color change is confirmed in at least one of the first discoloration confirmation sphere 16 and the second discoloration confirmation sphere 17, it can be known that the result is a negative result, and as shown in FIG. 21B , the first discoloration confirmation sphere 16 ) and the second discoloration confirmation sphere 17, when the discoloration is confirmed, it can be seen that the result is positive. In addition, the QR code of the code display unit 18 may be photographed through the portable terminal, and a more accurate diagnosis result of the diagnostic strip 1a may be checked using an application stored in the portable terminal. In this way, the diagnostic strip 1a of the present invention can quickly and accurately confirm a diagnostic result.

Hereinafter, a diagnostic strip according to a third embodiment of the present invention will be described with reference to FIGS. 22 to 27 .

The diagnostic strip 1b according to the third embodiment of the present invention is substantially the same as the first embodiment described above except for the sliding member 50a. Accordingly, the same reference numerals are attached to the components already described, and detailed descriptions thereof will be omitted.

22 is a cross-sectional view of a diagnostic strip according to a third embodiment of the present invention.

Referring to FIG. 22 , in the diagnostic strip 1b according to the third embodiment of the present invention, the sliding member 50a includes a gripping part 51 and an extension part 52 , and is formed to extend from the gripping part 51 . It may further include an absorbent pad receiving portion 514 .

The absorbent pad receiving part 514 is for separating and contacting the absorbent pad 40b from the membrane pad 20 and may be integrally formed with the sliding member 50a. The absorbent pad receiving part 514 is formed to extend upwardly from the upper surface of the upper plate 510 of the gripping part 51 , and the other end is bent in a direction opposite to the extended part 52 , and the absorbent pad 40b is formed inside. ) can be accommodated. In other words, one end of the absorbent pad receiving portion 514 is fixed to the upper surface of the upper plate 510 , is formed to extend upward from one end, and the other end is formed in a direction opposite to the direction in which the extension 52 is formed. It may be refracted and formed. The absorbent pad receiving part 514 may be formed in a 'L' shape on the upper surface of the upper plate 510, and an inclined surface 514a having an end inclined toward the bottom may be formed. The absorbent pad 40b is inserted into the inner space of the absorbent pad receiving portion 514 and spaced apart from the membrane pad 20 or moved along the inclined surface 514a to absorb the absorbent pad 40b depending on whether the sliding member 50a slides. It may be separated from the inner space of the pad receiving unit 514 and disposed on the upper surface of the membrane pad 20 , which will be described in detail through the operation process. On the other hand, the absorbent pad receiving portion 514 may be formed to extend from the grip portion 51 to be integrally formed with the grip portion 51 , but may be formed separately to be engageable with the grip portion 51 so that the grip portion 51 is formed separately. It may be coupled to the upper plate 510 . In addition, the sliding member 50a on which the absorbent pad receiving portion 514 is formed may be applied to the diagnostic strip 1 in the first embodiment and the diagnostic strip 1a in the second embodiment.

Hereinafter, an operation process of the diagnostic strip according to the third embodiment of the present invention will be described with reference to FIGS. 23 to 27 .

23 to 27 are operational diagrams illustrating an operation process of a diagnostic strip according to a third embodiment of the present invention.

It is the same as the operation process of the first embodiment described above, except that the shape of the sliding member 50a is deformed and moved to accommodate and discharge the absorbent pad 40b. Accordingly, the previously described operation process will be briefly described and the operation process of the sliding member will be described in detail.

23 is a diagram illustrating a sample solution L1 is introduced into the first inlet 12 , and FIG. 24 is a diagram in which the sample pad 30 absorbs the sample solution L1 and is transferred to the membrane pad 20 . FIG. 25 shows the sliding pad sliding movement by pulling the extension part 52, and FIG. 26 shows the absorbent pad 40b detaching from the absorbent pad receiving part 514 and the membrane pad ( 20) is shown, and FIG. 27 shows that the washing solution W1 and the reaction solution L2 of the solution supply device 70 are introduced into the second inlet 13, and the absorbent pad 40b absorbs them. The drawing is shown.

23 to 27 , the sample solution L1 is introduced into the first inlet 12 from the outside of the housing 10 . The sample solution L1 injected into the first inlet 12 is absorbed by the sample pad 30 , and the sample pad 30 comes into contact with the membrane pad 20 and absorbs the sample solution L1 into the sample pad 30 . It is transferred to the membrane pad 20 . When absorption of the sample solution L1 from the upper portion of the housing 10 through the arrival confirmation port 14 to the lower side of the arrival confirmation port 14 is confirmed, the extension part 52 is pulled.

When the extension part 52 of the sliding member 50a is pulled from the outside of the housing 10 , the grip part 51 and the absorbent pad receiving part 514 may also slide in a direction in which the extension part 52 is pulled. The absorbent pad accommodating part 514 may move downward of the first guide surface 12a, and may be formed of a soft material so as to be slidably deformed in shape. At this time, the absorbent pad 40b in which the absorbent pad receiving part 514 is accommodated inside by the first guide surface 12a may be discharged to the outside along the inclined surface 514a. As the sliding member 50 slides, the absorbent pad 40b may gradually protrude from the absorbent pad receiving portion 514 and be seated on the upper surface of the membrane pad 20 . In this case, the absorbent pad 40b may be disposed in close contact with the upper surface of the membrane pad 20 while pressing the absorbent pad 40b from the upper portion of the inclined surface 514a of the absorbent pad receiving part 514 . In the diagnostic strip 1 according to the third embodiment, the sliding member 50a includes the absorbent pad receiving portion 514 and does not require a separate elastic member 41, and the absorbent pad 40b is attached to the membrane pad 20 ) may be spaced apart from the upper surface or placed in close contact with the upper surface of the membrane pad 20 .

27 is a cross-sectional view of a process in which the washing solution W1 and the reaction solution L2 are sequentially supplied, and the first and second accommodating parts 72 and 73 are omitted for convenience of explanation.

When the sliding member 50a slides to move the sample pad 30 away from the membrane pad 20 and the absorbent pad 40b is in close contact with the upper surface of the membrane pad 20, the washing solution ( W1) and the reaction solution (L2) may be added. The washing solution injected from the second inlet 13 is absorbed by the membrane pad 20 and transferred to the electrode unit 60 , and the antigen concentration can be measured by oxidation/reduction reaction.

The diagnostic strip (1) of the present invention is applied to various sensors through an optical analysis method that analyzes discoloration, luminescence, and fluorescence according to the selection of an enzyme bound to a detection antibody and a substrate according to the enzyme, and an electrochemical analysis method that analyzes a redox reaction. can be

In addition, the diagnostic strip 1 of the present invention can be applied to optical analysis and electrochemical analysis of discoloration, luminescence, and fluorescence depending on the enzyme and substrate used.

Although embodiments of the present invention have been described above with reference to the accompanying drawings, those of ordinary skill in the art to which the present invention pertains will realize that the present invention can be implemented in other specific forms without changing the technical spirit or essential features. you will understand Therefore, it should be understood that the embodiments described above are illustrative in all respects and not restrictive.

1, 1a, 1b: diagnostic strip 10, 10a: housing
11: accommodation space 12: first inlet
12a: first guide surface 13: second inlet
13a: 2nd guide surface 14: arrival confirmation hole
16: first discoloration confirmation sphere 17: second discoloration confirmation sphere
18: code display part 19: indentation part
20: membrane pad 21: nitrocellulose pad
22: polyethylene terephthalate 30: sample pad
40, 40a, 40b: absorbent pad 41: elastic member
42: absorption member 50, 50a: sliding member
51: grip portion 52: extension portion
60: electrode 70: solution supply device
71: housing 72: first receiving part
73: second receiving unit 74: broken line
80: break part 110: first member
120: second member 121: protrusion
510: upper plate 511: lower plate
512: through hole 513: refractive part
514: absorbent pad receiving portion 514a: inclined surface

Claims (16)

a housing forming an accommodating space therein, and forming a first inlet and a second inlet spaced apart from each other in communication with the accommodating space and the external space on an upper surface; and
It is mounted integrally or detachably to the second inlet, and accommodates the washing solution and the reaction solution, and includes a solution supply device that sequentially puts the washing solution and the reaction solution into the membrane pad through the second inlet at an interval. diagnostic strips. According to claim 1,
The solution supply device,
a first housing coupled to the second inlet;
a first accommodating part located in an upper part of the first housing, accommodating the washing solution, and breaking by the action of the breaking part to put the washing solution into the second inlet;
Diagnosis comprising an upper portion of the first housing and a second accommodating part located on the side of the first accommodating part to receive the reaction solution, and to be broken by the action of the breaking part to put the washing solution into the second inlet strip. 3. The method of claim 2,
The breaking part,
The diagnostic strip, characterized in that the first and second accommodating parts are sequentially punctured or pressurized to break them. 4. The method of claim 3,
The first accommodating part and the second accommodating part,
A diagnostic strip, characterized in that a breaking line is formed on the bottom surface and the breaking line is broken by the pressure of the breaking part. According to claim 1,
It further comprises an absorbent pad disposed in the receiving space between the first inlet and the second inlet, one side contacting the inner upper surface of the housing and the other side being spaced apart from the membrane pad,
The diagnostic strip, characterized in that the absorbent pad is formed by folding a plurality of times in opposite directions. According to claim 1,
It further comprises an absorbent pad disposed in the receiving space between the first inlet and the second inlet, one side contacting the inner upper surface of the housing and the other side being spaced apart from the membrane pad,
wherein the absorbent pad includes an elastic member in contact with an inner upper surface of the housing, and an absorbent member disposed below the elastic member. 7. The method according to claim 5 or 6,
In the absorbent pad, the area, the number of folds, and the volume of each layer are adjusted according to the amounts of the washing solution and the reaction solution injected into the second inlet. 8. The method of claim 7,
a sample pad disposed in the receiving space in contact with at least one surface of the membrane pad and absorbing the sample solution injected into the first inlet;
Further comprising: a gripper for gripping the sample pad; and a sliding member extending from the gripper in a horizontal direction, at least a portion of which extends through a side surface of the housing to protrude to the outside;
The sliding member slides in a horizontal direction so that the sample pad is spaced apart from the membrane pad, and the other side of the absorbent pad is in contact with the membrane pad,
The gripper includes an upper plate and a lower plate spaced up and down to form a space in which the sample pad is accommodated, and a through hole passing through the upper surface of the upper plate to communicate the sample pad and the first inlet, wherein the The diagnostic strip, characterized in that the gripping portion forms a refracting portion in which both ends of the upper plate are bent downward. 9. The method of claim 8,
and an absorbent pad accommodating part extending upward from the upper surface of the upper plate and having the other end bent in a direction opposite to the extended part to accommodate the absorbent pad therein. According to claim 1,
The membrane pad is a diagnostic strip, characterized in that pre-treated with a capture antibody that specifically binds to a predetermined antigen on one side. 10. The method of claim 9,
The absorbent pad accommodating part forms an inclined surface with an end inclined toward the bottom,
The absorbent pad moves along the inclined surface when the sliding member slides and is seated on an upper surface of the membrane pad. 10. The method of claim 9,
and an electrode positioned between the second inlet and the absorbent pad and disposed in close contact with an upper surface of the membrane pad. 13. The method of claim 12,
and a pressing member extending downward from the inner upper surface of the housing to face the electrode and pressing the electrochemical sensor. According to claim 1,
and a first discoloration confirmation sphere and a second discoloration confirmation sphere formed through the upper surface between the first inlet and the second inlet to confirm discoloration of the membrane pad. 15. The method of claim 14,
The housing includes a code display unit for displaying a code that can read information through the device on the upper outer surface of the diagnostic strip. 10. The method of claim 9,
A diagnostic strip extending downward from the inner upper surface of the housing between the first inlet and the second inlet to form a space into which the absorbent pad is inserted, and a lower portion of the diagnostic strip to form an indentation that can be opened and closed by the sliding member.

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