WO2023095965A1 - Diagnostic strip - Google Patents

Abstract

Provided is a diagnostic strip which can be easily used by general users and enables quick and simple on-site analyses. The diagnostic strip comprises: a housing within which an accommodation space is formed and which has first and second inlets formed at the upper surface thereof, spaced apart from each other, and allowing the accommodation space to communicate with an outside space; a membrane pad which is exposed to the second inlet and disposed in the accommodation space; a sample pad which is arranged in the accommodation space to come into contact with at least one surface of the membrane pad and absorbs a sample solution introduced through the first inlet; an absorption pad which is disposed between the first inlet and the second inlet, one side of which comes into contact with the upper inner surface of the housing, and the other side of which is spaced apart from the membrane pad; a holding part which holds the sample pad; and a sliding member including an extension portion which is formed to extend in the horizontal direction from the holding part and at least a part of which passes through and protrudes out of a side surface of the housing, wherein sliding of the sliding member in the horizontal direction causes the sample pad to be spaced apart from the membrane pad and causes the other side of the absorption pad to be brought into contact with the membrane pad.

Description

diagnostic strips

The present invention relates to a diagnostic strip, which can be easily used by general users and enables rapid and simple analysis in the field.

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, in the field. Immunosensor strips and DNA sensor strips based on biospecific binding This has recently been developed.

The diagnostic strip using nanoparticles based on the lateral flow immunoassay method is the most common disposable point-of-care diagnostic strip. Nanoparticles agglomerate by antigen binding to form a band, so positive/negative can be judged with the naked eye. However, there is a limit in the sensitivity of the analysis that occurs in the process of visually observing the formation of bands in the case of low concentration antigen analysis. 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 sensitivity by analyzing images through fluorescence or light emission, but there is a problem that is not suitable for a disposable point-of-care diagnostic kit because an additional image analysis device is required. In addition, the colored band can be analyzed as a general optical or fluorescence image and the result can be digitized, but there is a problem in that an additional image analysis device is required.

In order to analyze low-concentration antigens, high-sensitivity electrochemical analysis was attempted to be grafted onto lateral flow immunoassay. is necessarily accompanied by a washing step to remove and a certain amount of substrate dispensing step thereafter. This process is similar to the enzyme-linked immunosorbent assay (ELISA) performed in the laboratory, and it is difficult for general users to use it due to the complex limitations of the multi-step analysis process.

Therefore, there is 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.

[Prior art literature]

[Patent Literature]

(Patent Document 0001) Japanese Unexamined Patent Publication No. 6190395 (“Method and composition for detecting multiple subjects with a single signal”, Invisible Central, 2017 08 10)

(Patent Document 0002) Republic of Korea Patent Registration No. 10-1768876 (“Antigen Detection Device and Use thereof”, Invisible Central, 2017 08 10)

(Patent Document 0003) Republic of Korea Patent Registration No. 10-1742958 (“Strip sensor module, strip sensor-based molecular diagnostic field inspection device using it”, Genet Bio Co., Ltd., 2017 05 29)

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

The diagnostic strip of the present invention includes a housing having an accommodation space formed therein, and a first inlet and a second inlet spaced apart from each other on an upper surface of the housing, which are exposed to the second inlet and the outer space is in communication with the outer space. A membrane pad disposed in the accommodation space, a sample pad disposed in the accommodation space in contact with at least one surface of the membrane pad and absorbing the sample solution injected into the first inlet, the first inlet and the second inlet an absorbent pad disposed between, one side of which is in contact with the inner upper surface of the housing and the other side of which is spaced apart from the membrane pad; a gripper for gripping the sample pad; A sliding member including an extension part of which protrudes outwardly through a side surface of the housing, and 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 A side surface is in contact with the membrane pad.

The absorbent pad may be formed by being folded multiple times in different and opposite directions.

The absorbent pad may include an elastic member in contact with an inner upper surface of the housing and an absorbent member disposed below the elastic member.

The absorbent pad may be characterized in that the area, number of folds, and volume of each layer are adjusted according to the amount of the washing and reaction solutions introduced into the second inlet.

The gripping part includes an upper plate and a lower plate spaced apart vertically to form a spaced space in which the sample pad is accommodated, and includes a through hole penetrating an upper surface of the upper plate and communicating between the sample pad and the first inlet, The holding part may form a bent part in which both ends of the upper plate are refracted downward.

One side of the membrane pad may be pre-treated with a capture antibody that specifically binds to a predetermined antigen.

The gripping part may include an absorption pad accommodating part that extends upward from the top surface of the top plate and has an other end bent in a direction opposite to the extension part to accommodate an absorbent pad therein.

The absorbent pad accommodating part may form an inclined surface with an end inclined downward, and the absorbent pad may move along the inclined surface when the sliding pad slides and be seated on the upper surface of the membrane pad.

It may include an electrode unit positioned between the second inlet and the absorbent pad and closely attached to an upper surface of the membrane pad.

It may include a pressing member that extends downward from an inner upper surface of the housing to face the electrode unit and presses the electrochemical sensor unit.

A first discoloration checker and a second discoloration checker may be formed through the upper surface between the first inlet and the second inlet to check discoloration of the membrane pad.

The housing may include a code display unit displaying a code capable of reading information through a device on an outer upper surface.

A space may be formed between the first inlet and the second inlet that extends downward from the inner upper surface of the housing to form a space into which the absorbent pad is inserted, and a lower side may form a recess that can be opened and closed by the sliding pad.

The diagnostic strip of the present invention can be used as a point-of-care diagnostic kit by improving the sensitivity limit that occurs in the visual observation method. In addition, it can be easily used by general users and has the characteristics of quick and convenient analysis in the field.

1 is a perspective view of a diagnostic strip according to a first embodiment of the present invention.

Figure 2 is an exploded perspective view of Figure 1;

3 is a cross-sectional view of the diagnostic strip of FIG. 1 taken along line A-A'.

4 is a view showing an absorbent pad of the diagnostic strip of FIG. 1;

5 to 9 illustrate the operation of a diagnostic strip according to an embodiment of the present invention.

It is also a timed operation diagram.

10 is a perspective view of a diagnostic strip according to a second embodiment of the present invention.

11 is a cross-sectional view of the diagnostic strip of FIG. 10 taken along line BB'.

12 to 16 show the operation process of the diagnostic strip according to the second embodiment of the present invention.

It is an operation diagram shown.

17 is a diagram illustrating a state of use of a diagnostic strip according to a second embodiment of the present invention.

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

19 to 23 show the operating process of the diagnostic strip according to the third embodiment of the present invention.

It is an operation diagram shown.

- Description of code -

1, 1a, 1b: diagnostic strip 10, 10a: housing

11: receiving space 12: first inlet

12a: first guide surface 13: second inlet

13a: second guide surface 14: reach confirmation tool

16: first color change confirmation sphere 17: second color change 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: absorbent member 50, 50a: sliding member

51: holding part 52: extension part

60: electrode unit 110: first member

120: second member 121: protrusion

510: upper plate 511: lower plate

512: through hole 513: bent part

514: absorbent pad accommodating portion 514a: inclined surface

Advantages and features of the present invention and methods for achieving them will become clear with reference to the detailed description of the following embodiments 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 the present embodiments make the disclosure of the present invention complete and those skilled in the art in the art to which the present invention belongs It is provided to fully inform the person of the scope of the invention, and the invention is defined only by the claims. Like reference numerals designate like elements throughout the specification.

Hereinafter, a diagnostic strip according to a first embodiment of the present invention will be described with reference to FIGS. 1 to 10 .

After the configuration of the diagnostic strip according to the first embodiment of the present invention is described in detail with reference to FIGS. 1 to 4 , the operation process will be described with reference to FIGS. 5 to 9 .

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, FIG. 3 is a cross-sectional view of the diagnostic strip of FIG. 1 taken along line A-A', and FIG. is a diagram showing the second pad of the diagnostic strip of FIG. 1 .

1 to 4, the diagnostic strip 1 of the present invention is intended for general users to conveniently measure the concentration or presence of an analyte present in bodily fluids such as blood or urine and quickly and accurately analyze it in the field. It is a diagnostic kit.

The diagnostic strip 1 of the present invention includes a housing 10, a membrane pad 20 located inside the housing 10, a sample pad 30, an absorbent pad 40, and a sliding member 50. . Specifically, in the diagnostic strip 1 of the present invention, an accommodation space 11 is formed inside, and a first inlet 12 and a second inlet are spaced apart from each other by communicating the accommodation space 11 and the external space on the upper surface. The housing 10 forming the housing 13, the membrane pad 20 exposed to the second inlet 13 and disposed in the accommodating space 11, and at least one surface of the membrane pad 20 in the accommodating space 11 A sample pad 30 disposed in contact with and absorbing the sample solution L1 introduced into the first inlet 12, and disposed between the first inlet 12 and the second inlet 13, one side The absorbent pad 40 in contact with the inner upper surface of the housing 10 and spaced apart from the membrane pad 20 on the other side, the gripping part 51 for holding the sample pad 30, and the gripping part 51 It includes a sliding member 50 extending in the horizontal direction and including an extension portion 52 at least partially penetrating the side surface of the housing 10 and protruding outwardly, wherein the sliding member 50 slides in the horizontal direction. By moving, the sample pad 30 is spaced apart from the membrane pad 20 and the other surface of the absorbent pad 40 comes into 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 accommodation space 11 therein. As shown in the drawing, the housing 10 is described as being extended in the z-axis direction and having a cross section cut in a horizontal line formed in a rectangular shape as an example, but is not limited thereto, and a cross section cut in a horizontal line has a rectangular shape. It may be formed in a non-elliptical shape. The housing 10 accommodates the membrane pad 20 , the sample pad 30 , the absorbent pad 40 and the sliding member 50 in the accommodation space 11 . The housing 10 may be separated vertically so that each component accommodated in the accommodation space 11 can be easily disposed, and the first member 110 and the second member 120 are separated so as to be coupled. can include The first member 110 and the second member 120 form the upper and lower portions of the housing 10 separated vertically, and may include the upper and lower surfaces of the housing 10, respectively, and face each other. It can be separated from and coupled to each other by a coupling groove (not shown) formed in and the protrusion 121 . In the first member 110 including the upper surface of the housing 10, the first inlet 12 and the second inlet 13 communicating with the receiving space 11 and the external space are formed at a distance 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 injecting the sample solution L1 and the washing and reaction solutions L2 into the receiving space 11, respectively, and pass through the upper and lower surfaces of the first member 110. Doedoe is formed, it may be formed spaced apart along the z-axis, which is the longitudinal direction of the housing (10). After the washing step is performed by injecting the washing solution into the second inlet 13, the HRP reactivity can be analyzed using the reaction solution, and the washing and reaction solution L2 can be injected into the second inlet in stages. The washing solution in the present specification may be a washing buffer partially containing a surfactant such as tween, and the reaction solution may be a solution containing a substrate that reacts with an enzyme (peroxidase, phosphatase, etc.) bound to the detection antibody as an example. can be heard The sample solution L1 and the washing and reaction solution L2 may be introduced through the first inlet 12 and the second inlet 13 to be opposite to each other. The first inlet 12 and the second inlet 13 are characterized in that non-specific reactions can be minimized by implementing the input directions in which the sample solution L1 and the washing and reaction solutions are introduced in opposite directions. The arrival check hole 14 is a through-hole for confirming that the sample solution L1 injected into the first inlet 12 has reached a specific position along the membrane pad 20, and the upper and lower surfaces of the first member 11 It may be formed through, and may be formed side by side between the first inlet 12 and the second inlet 13 and along the z-axis. The arrival check hole 14 may be formed at a position adjacent to the second inlet 13 rather than the first inlet 12 and spaced apart from the first inlet 12 and the second inlet 13 .

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

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

The first guide surface 12a and the second guide surface 13a are for guiding the movement of the sample solution L1 and the washing and reaction solution L2 introduced into the first inlet 12 and the second inlet 13. As such, it may be formed extending downward toward the accommodation space 11 from the first inlet 12 and the second inlet 13. The first guide surface 12a and the second guide surface 13a may have end diameters that are smaller than diameters of the first inlet 12 and the second inlet 13 so as to be inclined downward. The first guide surface 12a and the second guide surface 13a are inclined downward, and the sample solution L1 and the washing and reaction solution L2 introduced into the first inlet 12 and the second inlet 13 ) may be guided to be put 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 be longer than other portions, so that the membrane pad 20 can be tightly fixed to the upper surface of the second member 120 .

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

The recess 19 may be disposed closer to the first inlet 12 between the arrival check hole 14 and the first inlet 12 to form a space into which the absorbent pad 40 is inserted. The recessed portion 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 in detail later in the operation process.

The pressing member is for pressing the electrode unit 60 disposed in the accommodating space 11 and may be formed extending downward from the inner upper surface of the housing 10 . The pressing member may extend downward 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 hole 14 and the recessed part 19 to press the electrode part 60 .

The membrane pad 20 is disposed in the accommodating 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 accommodating space 11 of the housing 10 . The membrane pad 20 is disposed on the upper surface of the second member 120 and may be disposed to be exposed to the second inlet 13 . The membrane pad 20 may include a nitrocellulose (NC) pad 21, and is formed extending along the longitudinal direction of the housing 10 to include a second inlet 13, a reach checker 14, and a press The member may face the indentation 19 . At least a portion of the membrane pad 20 is pre-treated with a capture antibody that specifically binds to a specific target antigen, and the detection antibody and capture material that secondarily bind to the antigen bound to the capture antibody are not limited to antibodies. , 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 It may be formed by combining polyethylene terephthalate (PET) 22. The membrane pad 20 may be formed of a member that minimizes an interaction such as a corrosion reaction by a fluid, and may be a member having an adhesive formed on its lower surface.

The membrane pad 20 has one end capable of absorbing the sample solution L1 injected from the first inlet 12 from the sample pad 30, and the sample solution L1 moves along the longitudinal direction so that the arrival confirmation port 14 ), it is possible to absorb the washing and reaction solution (L2) introduced from the other end into the second inlet (13). The reaction solution absorbed by the membrane pad 20 is transmitted to the electrode unit 60 so that the electrode unit 60 can generate an electrical signal, which will be described in detail in 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 antibodies, and may be composed of proteins, carbohydrates, nucleotides, aptamers, and the like. Membrane pad 20 can be described as an example in which capture is pre-coated on one side, and capture and detector may not be limited to materials called antibodies.

The reaction occurring on the surface of the membrane pad 20 through the electrode unit 60 can be quantitatively analyzed by electrochemical analysis. Meanwhile, the electrode unit 60 is disposed on the upper surface of the membrane pad 20 , and the sample pad 30 contacting and separated from the membrane pad 20 is disposed on one side of the membrane pad 20 .

The electrode part 60 obtains a signal from a reaction in which the reaction solution injected through 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 placed 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 may have two or three electrodes patterned thereon. 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 The electrode unit 60 reacts with the solution introduced through the first inlet 12 and the second inlet 13 to cause an oxidation/reduction reaction to analyze the concentration or presence of the analyte contained in the solution. .

On the other hand, the diagnostic strip 1 according to the first embodiment of the present invention will be described by taking an example of measuring the concentration of an antigen by an oxidation/reduction reaction, but it is not limited thereto, and the electrode unit 60 is not formed and the membrane is not formed. The presence or concentration of the analyte may be analyzed by confirming that the pad 40 is discolored. In order to analyze the signal of whether the detection antibody is bound or not, the enzymes used in combination with the detection antibody are peroxidase and phosphatase, and representatively horseradish peroxidase and alkaline phosphatase can be used. TMB, dianisidine, phenylenediamine, NBT/BCIP, and pNPP may be used as substrates for electrochemical and discoloration reactions, and lumino, CSPD, 1,2-dioxetane, and the like may be used for luminescence reactions. 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 to the first inlet 12, and is disposed in the accommodation space 11 to contact at least one surface of the membrane pad 20. 1 The sample solution L1 injected from the inlet 12 may be absorbed and transferred 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 surface of the membrane pad 20 at the same time, but is not limited thereto, and one side surface of the end portion may be in contact with the top surface and one side surface of the membrane pad 20 at the same time. It may be in contact with one side or may be disposed in the accommodation space 11 so as to be in contact with at least a portion thereof. The sample pad 30 disposed as described above can be slid in the horizontal direction, which is the lengthwise direction of the housing 10, by the sliding member 50, so that it can come into contact with and be 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 accommodation space 11. The sliding pad includes a gripping part 51 for gripping the sample pad 30, and an extension extending from the gripping part 51 in the horizontal direction and having at least a portion protruding outwardly through the side surface of the housing 10 ( 52), the sample pad 30 may come into contact with and separate from the membrane pad 20 while sliding in a horizontal direction by pulling the extension part 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 spaced apart from each other vertically. The gripper 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 top surface of the upper plate 510. A through hole 512 for communication between the spaced 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 space passes through the sample solution L1 injected into the first inlet 12. It can be absorbed through the ball 512. The gripping portion 51 may form a bent portion 513 in which an end portion of the top plate 510 is bent downward. The bending part 513 is to prevent the sample pad 30 from being separated from the separation space during the sliding movement of the sliding member 50, and in FIG. 3 it is shown that it is formed adjacent to the extension part 52. As shown in FIG. 19 to be described later, both ends of the upper plate 510 may be bent downward.

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

On the other hand, the sliding pad slides in the horizontal direction, but the extension 52 extends in the z-axis and -z-axis directions to slide along the longitudinal direction of the housing 10, but is not limited thereto. Alternatively, the sample pad 30 may come in contact with and separate from the membrane pad 20 while extending and sliding in the x-axis or -x-axis direction.

Subsequently, the upper plate 510 of the gripping portion 51 may be formed longer than the lower plate 511 . The gripping portion 51 may be positioned below the indented portion 19 when the sliding pad slides in the z-axis direction since the upper plate 510 is longer than the lower plate 511 . The upper plate 510 of the gripping part 51 is located at the lower side of the recessed part 19 while the sliding pad slides in the z-axis direction and the -z-axis direction, or is positioned so as to completely deviate from the lower side of the recessed part 19. It is possible to open and close the lower side of the indented portion 19 while doing so. In this way, the sliding pad opens and closes the open lower side of the indented portion 19 so that the absorbent pad 40 accommodated in the indented portion 19 is completely accommodated inside the indented portion 19 or at least part of it is accommodated in the indented portion 19 ) and may come into contact with the membrane pad 20 . This will be described in detail later through an operation process after the absorbent pad 40 is described.

The absorbent pad 40 is for absorbing the washing solution introduced through the second inlet 13 and absorbed into the membrane pad 20, and is formed of a material whose volume expands 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 thickness, material, and volume of the absorbent pad 40 may be adjusted according to the amount of the washing solution injected through the second inlet 13. Referring to FIG. 4A , 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 portion 19, and the cut thin pad may be folded multiple times in different opposite directions as shown in FIG. 4B. Although the absorption pad 40 is described as an example of being formed by being folded to form five layers as shown in the drawing, the area and volume of each layer are not limited thereto, and the area and volume of each layer depend on 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 multiple times in opposite directions to form a stacked structure, one side of which is in contact with the upper inner 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 area, volume, thickness, number of times of folding, material, and the like. When the absorbent pad 40 is folded multiple times as shown in FIG. 4B and then applied upward and downward pressure, each layer may be stacked as shown in FIG. 4C. As it is spaced apart, it can open up and down. The absorbent pad 40 according to the first embodiment of the present invention is formed in a structure capable of being compressed and restored by elasticity and absorbing a solution, but is not limited thereto, and is a compressible and restorable elastic member (41 in FIG. 11 ). Reference) and the absorbent member (see 42 in FIG. 11) for absorbing the solution may be separately formed and closely disposed or bonded to each other, which will be described in detail through the diagnostic strip 1a of the second embodiment.

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

That is, before the sliding member 50 slides, the gripping part 51 closes the lower side of the indented part 19 so that the absorbent pad 40 is completely inserted into the indented part 19 and disposed as a membrane pad. It is spaced apart from (20), the sample pad (30) is 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 indented portion 19, and the absorbent pad 40 is removed from the other side surface. In contact with the membrane pad 20, the sample pad 30 moves away from the membrane pad 20, the upper surface of the gripping part 51 can close the end of the first guide surface 12a, and the operation process Please refer to it for a more detailed explanation.

Hereinafter, the operating process of the diagnostic strip according to the first embodiment of the present invention will be described with reference to FIGS. 5 to 9 .

5 to 9 are operation diagrams showing the operating process of the diagnostic strip according to the first embodiment of the present invention.

Referring to FIG. 5 , FIG. 5 shows a view in which a sample solution L1 is injected into the first inlet 12 . As the sample solution (L1), a detection antibody-HRP (horseradish peroxide) solution pre-combined with the antigen sample to be analyzed is used. Peroxidase enzymes such as HRP can oxidize specific substrates, and the degree of such enzyme-substrate oxidation/reduction reactions can be measured by measuring the amount of antigen through high-sensitivity electrochemical measurements as well as optical measurements such as discoloration, luminescence, and fluorescence analysis. can be measured quantitatively. Thus, 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 is necessarily exposed through the first inlet 12 and the sample solution L1 is injected into the first inlet 12 while the sample pad 30 is in contact with the membrane pad 20. It should be. The sample solution L1 injected into the first inlet 12 may be absorbed by the sample pad 30 .

Referring to FIG. 6, FIG. 6 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 form the sample pad 30. It shows a view in which the membrane pad 20 in contact with gets wet.

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 the absorbed sample solution L1 is delivered to the membrane pad 20. do. The membrane pad 20 can absorb the sample solution L1 at 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 enter It can be confirmed that the sample solution L1 wets from one end of the membrane pad 20 through the sample pad 30 to the other end through the electrode part 60 . At this time, it can be confirmed that the sample solution L1 is absorbed to the other end of the membrane pad 20 from the arrival confirmation port 14, and when the sample solution L1 reaches the lower part of the arrival confirmation port 14, The sample pad 30 is separated from the membrane pad 20.

Referring to FIG. 7 , FIG. 7 shows a view in which the sliding pad is slid 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 reach confirmation port 14, the extended portion 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 together, and at the same time, the sample pad 30 is separated from the membrane pad 20 . When the gripping part 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 gripping part 51 is moved to the indented portion ( 19) can be opened. As the lower side of the indented portion 19 is opened, at least a portion of the absorbent pad 40 inserted into and disposed in the indented portion 19 may protrude from the indented portion 19 by elasticity.

Referring to FIG. 8 , FIG. 8 shows a view in which a portion of the absorbent pad 40 protrudes outward from the indented portion 19 due to elasticity. When the lower side of the indented portion 19 is opened, the absorbent pad 40 protrudes outward from the indented portion 19 by elasticity, and the other end may come into contact with the upper surface of the membrane pad 20 . The absorbent pad 40 may have one end in contact with the inner upper surface of the indented portion 19 and the other end in contact with the upper surface of the membrane pad 20 due to elasticity. At this time, although one end of the absorbent pad 40 may be fixed to the inner upper surface of the indented part 19, it may not be fixed and may be brought into close contact by applying force to the inner upper surface of the indented part 19 by elasticity.

Continuing to refer to FIG. 9 , FIG. 9 shows a view in which the washing solution is injected into the second inlet 13 . The washing solution may be introduced into the second inlet 13 while the membrane pad 20 is in contact with the absorbent pad 40 and separated from the sample pad 30 .

The washing solution is an individual solution of Washing Buffer and TMB (Tetramethylbenzidine) or a mixed solution of Washing Buffer and TMB (Tetramethylbenzidine). The washing solution flows into the accommodation 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 contacts the electrode unit 60, The rest may be absorbed by the absorbent pad 40 . At this time, the electrode unit 60 may induce an electrochemical reaction of the reaction solution. TMB is oxidized by the HRP enzyme to generate TMB radicals, hydrogen ions, and electrons, and the TMB oxidized according to Formula (2) is reduced by an electrochemical reaction at the working electrode, which occurs cyclically. . Using this principle, it is possible to check the current difference in which the maximum instantaneous current of TMB oxidation is generated by cyclic voltammetry, and measure the concentration of the antigen by amperometric method. Therefore, there is an advantage in that an amplified signal can be obtained even at a low concentration of antigen while the reduction reaction by the electrode of the oxidation reaction mass by the enzyme is continuously cycled.

Hereinafter, a diagnostic strip according to a second embodiment of the present invention will be described with reference to FIGS. 10 to 17 .

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

After explaining the configuration of the second embodiment of the present invention in detail with reference to FIGS. 10 and 11 and explaining the operation process with reference to FIGS. 13 to 16, diagnosis according to the second embodiment with reference to FIG. 17 Describe the state of use of the strip.

10 is a perspective view of a diagnostic strip according to a second embodiment of the present invention, and FIG. 11 is a cross-sectional view of the diagnostic strip of FIG. 10 taken along line BB'.

10 and 11, the diagnostic strip 1a according to the second embodiment of the present invention includes a first discoloration checker 16, a second discoloration checker 17 and a code display unit in the housing 10a. 18 is formed, and an absorbent pad 40a in which an elastic member 41 and an absorbent member 42 are combined is disposed inside the housing 10a.

The housing 10a includes a first discoloration checker 16 and a second discoloration checker 17 formed through an upper surface between the first inlet 12 and the second inlet 13 .

The first discoloration checking hole 16 and the second discoloration checking hole 17 are through-holes for checking discoloration of the membrane pad 20, and the first member is placed between the first inlet 12 and the second inlet 13. It is formed to penetrate the upper and lower surfaces of 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 checker 16 and the second discoloration checker 17 are spaced apart at regular intervals on the first member 110 of the housing 10a, and the second inlet 13 and the absorbent pad 40a are disposed. It may be formed spaced apart between the indentations 19 to be. The membrane pad 20 may include one or more reaction parts coated with a capture antibody to induce a reaction at positions corresponding to the first color change checker 16 and the second color change checker 17 . Since the reaction unit is pre-treated with the capture antibody, the antigen-detection 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 is oxidized by the bound enzyme, and as a result, light emission or fluorescence may occur or the color may change.

The reaction unit may vary the degree of reaction such as color development, luminescence, and fluorescence according to the concentration of the antigen in the sample solution (L1), including a reagent that changes color by reacting with the detection antibody included in the sample solution (L1) in the fluid, , the degree of color development can vary depending on the concentration of the antigen. Through the first discoloration checker 16 and the second color change checker 17, it is possible to check whether the reaction part has changed color, and 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 capable of reading information through a device, such as a QR code (Quick Response code) or a bar code, on the outer upper surface of the housing 10 . The code display unit 18 may be formed by being printed on the upper surface of the first pad or manufactured and attached in the form of a sticker, and may be attached 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 by the electrode unit 60. It can also be used to confirm the concentration and detection of a substance.

In the first embodiment, the absorbent pad 40a is inserted into the indentation portion 19 and absorbs the washing solution in contact with the membrane pad 20 when the indentation portion 19 is opened by the movement of the sliding member 50. Same as, but slightly different from the absorbent pad 40a in the first embodiment in that it includes the elastic member 41 and the 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 or a spring. One side of the elastic member 41 may be disposed in close contact with the inner upper surface of the housing 10a and the absorbent member 42 may be closely disposed on the other side. The elastic member 41 is inserted and disposed inside the indented portion 19 and is compressed and restored as the sliding member 50 opens and closes the lower side of the indented portion 19 to indent the absorbent member 42 disposed on the other side. It can be pushed outward of the part 19. The absorbent member 42 may be made of a material that expands in volume when liquid is absorbed, such as glass fiber or cotton capable of absorbing liquid, and one side thereof 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 recessed part 19 together with the elastic member 41, and the upper plate 510 of the gripping part 51 is inserted into the recessed part 19. When disposed on the lower side of the elastic member 41 may be disposed on the inside of the indentation portion 19. In addition, when the sliding member 50 slides and the lower side of the indented portion 19 is opened, the restoring force of the elastic member 41 pushes the indented portion 19 outward so that the end portion of the membrane pad 20 It can come into contact with the upper surface.

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

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

The diagnostic strip 1a in the second embodiment of the present invention will be described with an example in which the absorbent pad 40a includes the elastic member 41 and the 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 in the first embodiment It can also be applied to the diagnostic strip 1 of and the diagnostic strip (see 1b in Fig. 18) in a third embodiment to be described later.

In addition, the housing 10a in which the first discoloration checker 16, the second discoloration checker 17, and the code display unit 18 of the present invention are formed, the elastic member 41 and the absorbing member 42 are combined. The 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, the operating process of the diagnostic strip according to the second embodiment of the present invention will be described with reference to FIGS. 12 to 16 .

12 to 16 are operation diagrams showing the operation process of the diagnostic strip according to the second embodiment of the present invention.

Referring to FIG. 12 , FIG. 12 shows a view in which a sample solution L1 is injected into the first inlet 12 . As the sample solution L1, as described above in the first embodiment, a solution in which an antigen is pre-reacted with an enzyme-coupled detection antibody is introduced into the first inlet 12. The sample solution L1 injected into the first inlet 12 may be absorbed by the sample pad 30 .

Referring to FIG. 13, FIG. 13 shows that the sample solution L1 injected into the first inlet 12 is dropped onto the sample pad 30, and the sample pad 30 absorbs the sample solution L1 to form the membrane pad 20. It shows a drawing that gets wet from one end in contact with the sample pad 30. 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 the absorbed sample solution L1 is delivered 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 sphere 14 from the arrival confirmation sphere 14. can know that When the sample solution L1 is confirmed from the reach confirmation port 14, the sample pad 30 is separated from the membrane pad 20.

Referring to FIG. 14 , FIG. 14 shows a view in which the sliding pad is slid 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 reach confirmation port 14, the extended portion 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 together, and at the same time, the sample pad 30 is separated from the membrane pad 20 . When the gripping part 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 top plate 510 of the gripping part 51 is placed in the indented portion ( 19) can be opened. As the lower side of the indented portion 19 is opened, the absorbent pad 40a inserted into the indented portion 19 may cause the absorbent member 42 to protrude from the indented portion 19 due to elasticity.

Referring to FIG. 15 , FIG. 15 shows a view in which the absorbent member 42 protrudes outward from the recessed portion 19 and is in contact with the membrane pad 20 . When the lower side of the indented portion 19 is opened, the absorbent member 42 is pushed out of the indented portion 19 by the restoring force of the elastic member 41, and the lower surface of the absorbent member 42 is formed of the membrane pad 20. It can come into contact with the upper surface. When the absorbent member 42 comes into contact with the upper surface of the membrane pad 20, the washing and reaction solution L2 may be injected into the second inlet 13.

Referring to FIG. 16, FIG. 16 shows a view of injecting a washing solution into the second inlet 13. The washing solution is a washing buffer containing a portion of a surfactant such as tween, which falls on the upper surface of the membrane pad 20 through the second inlet 13 and is absorbed along the longitudinal direction of the membrane pad 20 to form a reagent pad and Contact and the remaining solution may be absorbed by the absorbent pad 40a. A portion of the membrane pad 20 exposed by the first discoloration checker 16 and the second color change checker 17 reacts with the enzyme of the detection antibody included in the sample solution L1 and the substrate included in the reaction solution. As a result, color development, luminescence, and fluorescence reactions appear, and through this, it is possible to immediately check whether the user is negative or positive.

FIG. 17 is a state diagram of the diagnostic strip 1a according to the second embodiment of the present invention, and it can be confirmed that the membrane pad 20 is discolored in the first discoloration checker 16 and the second discoloration checker 17. there is. As shown in FIG. 17A, when color change is confirmed in at least one of the first color change checker 16 and the second color change checker 17, it can be seen that the result is negative, and as shown in FIG. 17B, the first color change checker 16 ) and the second discoloration checker 17, it can be seen that the result is positive when discoloration is confirmed. In addition, it is possible to photograph the QR code of the code display unit 18 through the portable terminal and check the more accurate diagnosis result of the diagnostic strip 1a using an application stored in the portable terminal. As such, the diagnostic strip 1a of the present invention can quickly and accurately confirm diagnostic results.

Hereinafter, a diagnostic strip according to a third embodiment of the present invention will be described with reference to FIGS. 18 to 23 .

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

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

Referring to FIG. 18 , in the diagnostic strip 1b according to the third embodiment of the present invention, a sliding member 50a includes a gripping portion 51 and an extension portion 52, and extends from the gripping portion 51. An absorbent pad accommodating part 514 may be further included.

The absorbent pad accommodating portion 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 absorption pad accommodating portion 514 extends from the upper surface of the top plate 510 of the gripping portion 51 toward the top, and the other end is bent toward the direction opposite to the extension portion 52 so that the absorption pad 40b is formed inside. ) can be accommodated. In other words, the absorbent pad accommodating portion 514 has one end fixed to the upper surface of the top plate 510, extending from one end toward the top, and the other end extending in a direction opposite to the direction in which the extension part 52 is formed. It can be bent and formed. The absorbent pad accommodating portion 514 may be formed in an 'L' shape on the top surface of the top plate 510, and may form an inclined surface 514a with an end inclined downward. Depending on whether the sliding member 50a slides, the absorbent pad 40b is inserted into the inner space of the absorbent pad accommodating part 514 and spaced apart from the membrane pad 20, or moves along the inclined surface 514a to absorb water. It may be separated from the inner space of the pad accommodating part 514 and disposed on the upper surface of the membrane pad 20, and this will be described in detail through an operation process. On the other hand, the absorbent pad accommodating portion 514 may extend from the holding portion 51 and be formed integrally with the holding portion 51, but may be formed separately so as to be coupled with the holding portion 51 so that the holding portion 51 It may also be coupled to the top plate 510 . In addition, the sliding member 50a having the absorbent pad accommodating portion 514 may be applied to the diagnostic strip 1 in the first embodiment and the diagnostic strip 1a in the second embodiment.

Hereinafter, the operating process of the diagnostic strip according to the third embodiment of the present invention will be described with reference to FIGS. 19 to 23.

19 to 23 are operation diagrams showing the operating process of the diagnostic strip according to the third embodiment of the present invention.

Referring to FIGS. 19 to 23 , the operation process is the same as the previously described first embodiment except that the shape of the sliding member 50a is deformed and slides to receive and discharge the absorbent pad 40b. Therefore, the previously described operation process will be briefly described and the operation process of the sliding member will be described in detail.

FIG. 19 shows a view of injecting the sample solution L1 into the first inlet 12, and FIG. 20 is a view of the sample pad 30 absorbing the sample solution L1 and transferring it to the membrane pad 20. 21 shows a view in which the sliding pad slides by pulling the extension part 52, and FIG. 22 shows that the absorbent pad 40b is separated from the absorbent pad accommodating part 514 and the membrane pad ( 20), and FIG. 23 shows a view in which the washing and reaction solution L2 is injected into the second inlet 13 and absorbed by the absorbent pad 40b.

Referring to FIGS. 19 to 23 , a sample solution L1 is injected 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 contacts the membrane pad 20 to obtain the sample solution L1 absorbed by the sample pad 30 It is transferred to the membrane pad (20). When absorption of the sample solution L1 from the top of the housing 10 to the lower side of the arrival confirmation opening 14 through the arrival confirmation opening 14 is confirmed, the extension part 52 is pulled.

When the extended portion 52 of the sliding member 50a is pulled from the outside of the housing 10, the gripping portion 51 and the absorbent pad accommodating portion 514 may slide in the direction of pulling the extended portion 52. The absorbent pad accommodating portion 514 can move to the lower side of the first guide surface 12a, and can slide while being deformed in shape because it is made of a soft material. At this time, the absorbent pad 40b in which the absorbent pad accommodating portion 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 gradually protrudes from the absorbent pad accommodating portion 514 and can be seated on the upper surface of the membrane pad 20 . At this time, the absorbent pad 40b may be placed in close contact with the upper surface of the membrane pad 20 while the inclined surface 514a of the absorbent pad accommodating portion 514 presses the absorbent pad 40b from the top. In the diagnostic strip 1 according to the third embodiment, the sliding member 50a includes the absorbent pad accommodating portion 514 so that a separate elastic member 41 is not required and the absorbent pad 40b is attached to the membrane pad 20. ) or placed in close contact with the upper surface of the membrane pad 20. As shown in FIG. 22, when the sliding member 50a slides and the sample pad 30 moves away from the membrane pad 20 and the absorbent pad 40b comes into close contact with the upper surface of the membrane pad 20, the second inlet 13 The washing and reaction solution (L2) may be introduced through. The washing solution injected from the second inlet 13 is absorbed by the membrane pad 20 and delivered to the electrode unit 60, and the concentration of the antigen 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 enzyme bound to the detection antibody and the substrate selected according to the enzyme, and an electrochemical analysis method that analyzes redox reactions. It 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 the embodiments of the present invention have been described with reference to the accompanying drawings, those skilled in the art to which the present invention pertains know that the present invention can be implemented in other specific forms without changing the technical spirit or essential features. You will understand. Therefore, the embodiments described above should be understood as illustrative in all respects and not limiting.

The present invention provides a structure of a diagnostic strip that is easy to use and can immediately use detection results in the field by using natural laws, and has industrial applicability.

Claims (13)

1. A housing including a first inlet and a second inlet that form an accommodation space therein and are spaced apart from each other by communicating the accommodation space and the external space on an upper surface thereof;

   a membrane pad exposed through the second inlet and disposed in the accommodating space;

   a sample pad disposed in the receiving space in contact with at least one surface of the membrane pad and absorbing the sample solution introduced into the first inlet;

   an absorbent pad disposed between the first inlet and the second inlet and having one side in contact with the inner upper surface of the housing and the other side spaced apart from the membrane pad; and

   a sliding member including a gripping part gripping the sample pad and an extension part extending in a horizontal direction from the gripping part and protruding outwardly through at least a portion of a side surface of the housing;

   The diagnostic strip of claim 1 , wherein the sliding member slides in a horizontal direction so that the sample pad is spaced apart from the membrane pad, and the other surface of the absorbent pad contacts the membrane pad.
2. According to claim 1,

   The diagnostic strip, characterized in that the absorbent pad is formed by folding a plurality of times in different and opposite directions.
3. According to claim 1,

   The diagnostic strip of claim 1 , 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.
4. According to claim 1,

   The diagnostic strip according to claim 1 , wherein the area, number of folds, and volume of each layer of the absorbent pad are adjusted according to the amount of the washing and reaction solutions injected into the second inlet.
5. According to claim 1,

   The holding part is vertically spaced apart to form a spaced space in which the sample pad is accommodated.

   It includes an upper plate and a lower plate, and includes a through hole through which the sample pad communicates with the first inlet through the upper surface of the upper plate,

   The diagnostic strip of claim 1 , wherein the holding portion forms a bent portion in which both ends of the top plate are refracted downward.
6. According to claim 5,

   The diagnostic strip of claim 1 , wherein the gripping portion includes an absorbent pad accommodating portion that extends from an upper surface of the top plate toward an upper portion, and the other end is bent in a direction opposite to the extending portion to accommodate an absorbent pad therein.
7. According to claim 1,

   The diagnostic strip, characterized in that one side of the membrane pad is pre-treated with a capture antibody that specifically binds to a predetermined antigen.
8. According to claim 6,

   The absorbent pad accommodating portion forms an inclined surface at an end inclined downward,

   The diagnostic strip of claim 1 , wherein the absorbent pad moves along the inclined surface when the sliding pad slides and is seated on the upper surface of the membrane pad.
9. According to claim 1,

   The diagnostic strip is located between the second inlet and the absorbent pad, and includes an electrode part closely disposed on an upper surface of the membrane pad.
10. According to claim 8,

    and a pressing member extending downward from an inner upper surface of the housing to face the electrode unit and pressurizing the electrochemical sensor unit.
11. According to claim 1,

    A diagnostic strip comprising a first discoloration checker and a second discoloration checker formed through the upper surface between the first inlet and the second inlet to check discoloration of the membrane pad.
12. According to claim 10,

    The diagnostic strip includes a code display unit displaying a code for reading information through the device on an outer upper surface of the housing.
13. According to claim 1,

    A diagnostic strip extending from an upper inner surface of the housing to a lower portion between the first inlet and the second inlet, forming a space into which the absorbent pad is inserted, and having a lower side forming a recess that can be opened and closed by the sliding pad.

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