KR102526986B1 - A rapid diagnostic kit using immunochromatography - Google Patents

Abstract

The present invention relates to a diagnostic kit for rapidly detecting an analyte using immunochromatography. Specifically, the rapid diagnosis kit according to the present invention includes a strip including a sample pad, an intermediate pad, a conjugate pad, a membrane, and an absorbent pad, and a portion where the sample pad and the intermediate pad overlap and an intermediate pad and the conjugate pad overlap By adjusting the portion to a certain ratio, the presence or absence of the analyte can be more accurately and conveniently diagnosed in a short time.

Description

A rapid diagnostic kit using immunochromatography}

The present invention relates to a diagnostic kit for rapidly detecting an analyte using immunochromatography. Specifically, the present invention relates to a rapid diagnostic kit using an immunochromatography strip, including a sample pad, an intermediate pad, a conjugate pad, a membrane, and an absorbent pad.

Immunochromatographic analysis is a method capable of qualitatively or quantitatively analyzing a small amount of an analyte in a short time using an antigen-antibody reaction, and is widely used for diagnosis or examination of various diseases. In such an immunochromatographic analysis, a strip containing a reactant capable of reacting with a target analyte to be detected and exhibiting a change or an analyzer in the form of a device equipped with the strip in a plastic case is generally used. A typical strip includes a sample pad accommodating a liquid sample, a conjugate pad containing a conjugate in which a label generating a signal detectable by the naked eye or a sensor is conjugated to a ligand such as an antigen or an antibody, It consists of a porous membrane pad immobilized with a binding agent (antibody or antigen) that specifically binds to the analyte and/or the conjugate in the sample, and an absorbent pad that finally accommodates the liquid sample. These functional pads are some of them in the order listed above. They are connected in an overlapping form and attached to a solid support so as to be continuously arranged. When the strip is installed inside a plastic case and used, a sample inlet for dropping a sample into the sample pad is formed in the upper case, and a result confirmation window is formed at the location where the binder of the porous membrane pad is fixed to check the test results. do.

As described above, in the immunochromatographic analysis method using the strip, when a liquid sample is dropped onto the sample pad, the liquid sample moves through the conjugate pad and the porous membrane pad by capillary action, and is finally accommodated in the absorbent pad. At this time, the conjugate contained in the conjugate pad also moves along with the liquid sample, and if a substance to be analyzed exists in the sample, the conjugate binds to the binder fixed to the porous membrane pad through the medium of the analyte (usually, a "sandwich"). (referred to as "sandwich reaction"), the conjugate and the analyte competitively bind to the binder (generally referred to as "competition reaction"), the presence or absence of the analyte in the sample can be determined visually or using a sensor. can detect it.

In the prior art, in the immunochromatography method using a strip, since a liquid sample moves on a functional pad by lateral flow, accurately controlling the flow of the sample is important for the accuracy of diagnostic results, that is, specificity and sensitivity, and the sample is a functional pad. Depending on the speed at which it passes through, the time for the test result to appear varies. However, since liquid samples differ in fluidity depending on their type, the rate at which the sample meets the conjugate in the conjugate pad is different for each sample, and the degree of reaction of the analyte contained in the sample with the conjugate in the conjugate pad is different. There is a problem that the accuracy and reproducibility of the deterioration.

Accordingly, the present inventors have made intensive research efforts to improve the accuracy and reproducibility of sample analysis, and as a result, an intermediate pad is placed between the sample pad and the conjugate pad, and the portion where the sample pad and the intermediate pad overlap and the intermediate pad and the conjugate pad overlap each other. By controlling the part to be treated at a certain ratio, it is possible to reduce the difference in fluidity according to the sample and adjust the flow rate, so that the performance of the immunodiagnostic kit can be maintained at a constant rate, as well as more accurate and rapid immunodiagnosis results can be obtained. gave

Accordingly, an object of the present invention is to provide a diagnostic kit using immunochromatography capable of rapidly diagnosing with improved accuracy and reproducibility.

In order to achieve the above object, the present invention

(a) an upper case equipped with a sample inlet and a window for confirming results;

(b) a lower case provided to be assembled to correspond to the upper case; and

(c) a strip comprising a sample pad, a conjugate pad containing a labeling material, a membrane, and an absorption pad in this order

As a rapid diagnostic kit using immunochromatography, including,

An intermediate pad is disposed between the sample pad and the conjugate pad, one end of the intermediate pad overlaps the sample pad, and the other end of the intermediate pad overlaps the conjugate pad for rapid diagnosis using immunochromatography. kits are provided.

In addition, in the rapid diagnosis kit using the immunochromatography of the present invention, the length of the portion where the sample pad and the intermediate pad overlap and the length of the portion where the intermediate pad and the conjugate pad overlap each other are 0.1 with respect to the total length of the intermediate pad. To provide a rapid diagnostic kit using immunochromatography, within a ratio of 0.3.

According to the present invention, an immunodiagnostic kit in which the length of the overlapping portion of the sample pad and the intermediate pad and the length of the overlapping portion of the intermediate pad and the conjugate pad are adjusted at a ratio of 0.1 to 0.3 with respect to the total length of the intermediate pad, respectively, has improved accuracy. Since the color development level of the analyte appears high, the color signal value can be easily read with the naked eye or with a sensor.

In addition, in one embodiment of the present invention, the rapid diagnosis kit using immunochromatography may further include one or more ribs disposed inside the upper case or the lower case. The one or more ribs may press against the intermediate pad and/or the conjugate pad. For example, the one or more ribs may press the upstream portion of the intermediate pad and/or the downstream portion of the conjugate pad based on the traveling direction of the specimen. An overflow phenomenon may be prevented by controlling the flow of the sample in the strip through one or more ribs.

In the rapid diagnostic kit according to the present invention, an intermediate pad is placed between the sample pad and the conjugate pad, and the portion where the sample pad and the intermediate pad overlap and the portion where the intermediate pad and the conjugate pad overlap are adjusted at a certain ratio (0.1 to 0.3). As a result, the presence or absence of the analyte can be more accurately and conveniently diagnosed in a short time. In addition, by placing a rib on the inside of the upper case or the lower case to press the middle pad and/or the conjugate pad, the analyte in the sample sufficiently reacts with the conjugate in the conjugate pad, and errors in test results due to sample overflow can reduce

1 illustrates the structure of a strip used in a rapid diagnostic kit according to the present invention. The strip includes a sample pad (1), an intermediate pad (2), a conjugate pad (3), and a membrane (4) (first test line). (5), the second inspection line (6) and control line (7), and an absorbent pad (8).
Figure 2 shows the ratio (L2/L0 = 0.1 to 0.3) of the overlapping portion (L2) of the sample pad and the middle pad with respect to the total length (L0) of the middle pad in the strip constituting the rapid diagnostic kit according to the present invention, and the middle It shows the ratio (L1/L0 = 0.1 to 0.3) of the portion (L1) where the pad and the conjugate pad overlap.
3 shows an example of an upper case used in a rapid diagnosis kit using immunochromatography according to the present invention.
4 shows an example of a lower case used in a rapid diagnosis kit using immunochromatography according to the present invention.

Hereinafter, the present invention will be described in more detail.

In the present invention, the term "immunochromatography" combines the principle of immunoreaction based on antigen-antibody reaction and the principle of chromatography in which a sample containing an analyte moves along with a mobile phase by capillary action through a porous medium. is an analysis method. Briefly, the antibody or antigen to be analyzed is previously dispensed and fixed on a porous membrane, and a sample is spread from one end of the membrane toward the immobilized antibody or antigen to observe the reaction with the antigen or antibody in the blood. .

As used herein, the term "sample" refers to an analyte compound or composition including an analyte, and a sample usable in the present invention is a liquid or liquid-like material because it must be able to move through a medium for development. For example, the specimen may be a blood sample such as whole blood, plasma, or serum, or a secretion collected from the nasal cavity or throat.

In the present invention, the term "analyte" refers to a compound or composition to be detected or measured that has one or more epitopes, binding sites, or ligands, as a substance to be analyzed in a sample. . Analytes include antibodies, antigens, nucleic acid aptamers, haptens, antigenic proteins, DNA, DNA-binding proteins, SARS-CoV-2 virus, hormones, and tumor-specific markers. (tumor-specific marker) and tissue-specific marker (tissue-specific marker), but is not limited thereto. For example, the analyte may be a SARS-CoV-2 antibody such as SARS-CoV-2 IgG and SARS-CoV-2 IgM.

Immunochromatography uses the principle of chromatography in which a mobile phase containing an analyte moves along a medium. Therefore, for immunoassay using an immunochromatographic strip, a mobile phase is required to move a sample containing an analyte along the strip. Accordingly, the immunoassay kit of the present invention may further include a buffer. The buffer serves not only as a mobile phase for moving a specimen along the immunochromatography strip, but also as a solvent for dissolving the conjugate and, if necessary, as a diluent for diluting the specimen. In addition, when whole blood is used as a specimen, a component for lysing blood cell components such as red blood cells may be further included for whole blood analysis. As the buffer solution, a conventional buffer solution such as a phosphate buffered solution (PBS) at a concentration of 10 mM to 1 M, a nonionic or amphoteric surfactant, or a mixture thereof may be used without limitation, and a desired reaction such as an antigen-antibody reaction may be used. It can be appropriately selected according to the type of

the present invention

(a) an upper case equipped with a sample inlet and a window for confirming results;

(b) a lower case provided to be assembled to correspond to the upper case; and

(c) a strip comprising a sample pad, a conjugate pad containing a labeling material, a membrane, and an absorption pad in this order

As a rapid diagnostic kit using immunochromatography, including,

An intermediate pad is disposed between the sample pad and the conjugate pad, one end of the intermediate pad overlaps the sample pad, and the other end of the intermediate pad overlaps the conjugate pad for rapid diagnosis using immunochromatography. kits are provided.

The specimen pad is a place where the specimen and the specimen dilution solution are injected, and in the case of whole blood, red blood cell separation occurs here. The sample pad is made of a material having porosity sufficient to receive and contain the sample to be analyzed and is placed on a support. The specimen pad can be constructed of any suitable porous absorbent material. These materials include fibrous paper, microporous membranes of paper-like cellulosic materials, cellulose, cellulose derivatives such as cellulose acetate, nitrocellulose, glass fibers, naturally occurring fabrics such as cotton, nylon, or porous gels. It is not limited to this.

In the strip constituting the rapid diagnostic kit according to the present invention, a middle pad is disposed between the sample pad and the conjugate pad, one end of the middle pad overlaps the sample pad, and the other end of the middle pad overlaps the conjugate pad.

In manufacturing the strip, the types of materials that can be used for mass production on a commercial scale are limited, and when the material has a low water content, there is a problem in that control of chromatographic development is limited. The rapid immunodiagnosis kit according to the present invention increases the water content by inserting an intermediate pad between the sample pad and the conjugate pad, thereby increasing the volume of the sample and the conjugate, so that the antigen-antibody reaction can occur sufficiently to improve test results. can make it The middle pad may be made of polyethylene, nitrocellulose-glass fiber mixture, etc., but is not limited thereto.

On the other hand, when the specimen is blood, whole blood, plasma, and serum have different flow velocities on the medium, so that the time the specimen stays on the conjugate pad also varies depending on the type of specimen. In addition, when a secretion collected from the nasal cavity or throat is used as a sample, since the viscosity of the secretion differs from person to person, the rate at which the sample flows into the immunodiagnostic kit varies. As such, it is not easy to maintain constant performance of the immunodiagnostic kit due to the difference in flow rate for each sample. In this way, if the speed at which the sample meets the zygote is not adjusted, there is a problem in that the number of false negative test results increases.

In order to solve this problem, in the present invention, it is necessary to secure an appropriate absorption capacity in order to minimize the difference in fluidity according to the type of specimen, and by adjusting the length of the intermediate pad to adjust the flow rate of the specimen, the speed at which the specimen meets the conjugate is increased. It becomes controllable, reducing the possibility of false negative test results and maintaining uniform quality of mass production of immunodiagnostic kits.

2 shows a part (L2) where the sample pad and the middle pad overlap and a part (L1) where the middle pad and the conjugate pad overlap in the strip constituting the rapid diagnostic kit according to the present invention. When the length of the overlapping portion of the sample pad and the middle pad (L2) and the length of the portion of the middle pad and the conjugate pad (L1) are adjusted to a ratio of 0.1 to 0.3 with respect to the total length of the middle pad (L0), respectively, color development degree has been improved.

L1/L0=0.1~0.3

L2/L0=0.1~0.3

L0: Overall length of the middle pad

L1: the length of the overlapping portion of the middle pad and the conjugate pad

L2: the length of the overlapping portion of the sample pad and the intermediate pad

In the strip constituting the rapid diagnostic kit according to the present invention, the conjugate pad is disposed between the intermediate pad and the membrane. A diffusively attached conjugate permeates into the conjugate pad, and the conjugate includes a ligand and a label that are specifically attached to an analyte.

In the present invention, a label is used to easily confirm the antigen-antibody reaction with the naked eye or using a sensor. In addition, a ligand capable of specifically binding to an analyte may be linked to a label so that the label may bind to the analyte to be analyzed. The term "conjugate" of the present invention refers to a conjugate in which the label and the ligand are linked. The labeling substance and the ligand may be physically or chemically linked. That is, the label and the ligand may be linked by passive adsorption, and the label may be modified to have a reactive group so as to be linked to the ligand through a covalent bond, but is not limited thereto, and the label is not limited thereto. Connection of the ligand may be performed using a method known in the art.

The term "marker" of the present invention refers to a substance that generates a signal that can be detected with the naked eye or using a sensor. As the labeling material, latex particles, gold particles, colored polystyrene microparticles, enzymes, fluorescent dyes, conductive polymers, or magnetic particles may be used, but are not limited thereto. In addition, the signal may be generated by itself due to intrinsic characteristics of the labeling material, such as light emission, or may be generated by an external stimulus such as fluorescence. As an example of the labeling material, gold nanoparticles, a color-developing enzyme, or a fluorescent material may be used.

As used herein, the term "ligand" refers to substances that specifically bind to each other. For example, an antibody that specifically binds to an antigen, an antigen that specifically binds to an antibody, a ligand that specifically binds to a specific receptor, and the like act as ligands for each other. In addition, the ligand in the present invention may be used without limitation as long as it is a material exhibiting the above-defined characteristics. The term "ligand" used throughout this specification refers to substances that specifically bind to each other as defined above, unless specifically indicated as a ligand that specifically binds to a specific receptor.

The conjugate may be prepared by preparing a solution of a labeling substance and a ligand at known concentrations, mixing them, and then allowing them to react for a certain period of time. At this time, the concentration and mixing ratio of each solution can be determined in consideration of the binding ratio between the label and the ligand. The binding between the label and the ligand may be a case in which one ligand is bound to one label, a plurality of ligands are bound to one label, or a plurality of labels are bound to one ligand. . The specific binding ratio is not critical, but a preferred aspect may be to maintain a constant ratio. The binding ratio may vary depending on the types of labeling substances and ligands, and may be predicted in consideration of their relative sizes and the number of binding sites.

As described above, a conjugate solution of a known concentration can be obtained by mixing and reacting the labeling substance and the ligand at known concentrations. The conjugate solution is in the form of a dispersion in which conjugate molecules of a certain concentration are uniformly dispersed in the solution.

The conjugate dispersion may additionally contain another conjugate molecule including a ligand that reacts with a labeling material for signal detection and a reporter molecule immobilized on a control line so as to be used as an internal control. The additional conjugate may be prepared in the form of a uniform dispersion by the same method as the conjugate preparation method mentioned above and then mixed with the conjugate solution. The label used for the additional conjugate molecule may be the same as or different from that used for the conjugate.

The strip constituting the rapid diagnostic kit according to the present invention may include a porous membrane pad on which a test line is formed to capture an analyte in a sample, and an absorbent pad that provides a driving force for sample transfer to one end of the porous membrane pad. there is. The absorbent pad may partially overlap the porous membrane pad. As the membrane, a nitrocellulose membrane, a glass fiber membrane, a polyethersulfone (PES) membrane, a cellulose membrane, a nylon membrane, and combinations thereof may be used, Preferably, a nitrocellulose membrane having pores of 5 to 15 μm may be used, but is not limited thereto.

The absorbent pad may be made of a material capable of absorbing an excess of a sample or a buffer solution. The absorbent pad induces continuous fluid movement by absorbing and removing an excessive amount of a sample or sample developing solution, and plays a role of not disturbing the test result of the kit provided in the present invention. The material of the absorbent pad is not particularly limited thereto, but preferably cotton, liquid absorbent gel, or the like can be used.

The strip constituting the rapid diagnosis kit according to the present invention may be manufactured by additionally including a solid backing card at the bottom. As such a solid support, a support made of plastic can be used, and by attaching a strip to the solid support, durability can be increased and handling and storage can be facilitated. In addition, it is possible to facilitate the mounting of an additional external case. A plastic material that can be used as the solid support may include, but is not limited to, a polypropylene film, a polyester film, a polycarbonate film, an acrylic film, and the like.

The strip constituting the rapid diagnosis kit according to the present invention may be additionally fixed in the case. A plurality of guides and/or strip supports may be provided inside the lower case to place the immunochromatography strip at an appropriate position and fix or press the strip. Optionally, guides and strip supports may also be provided in the upper case at locations corresponding to the guides and strip supports provided in the lower case. That is, the guide and/or the strip support may be formed in the lower case, or both the upper case and the lower case, if necessary. In addition, a result confirmation window for detecting a signal from a marker may be provided in the upper case at a position corresponding to the sample inlet and the test line. The sample inlet may be formed in the form of a hole or slit at one end of the porous membrane, that is, at a point sufficiently spaced apart from the test line to the opposite end where the absorbent pad is located so that the test line and the sample can spread along the membrane. there is. The result confirmation window may be formed in a size sufficient to be visually identified from the outside or through a sensor, including the point where the test line is located on the porous membrane and/or the control line if an additional control line is formed in some cases. . As long as the test line and/or control line can be confirmed, the size and shape may be formed without limitation.

The upper and lower cases may be manufactured using a common plastic material, and for example, materials such as polycarbonate and acrylonitrile butadiene styrene (ABS) may be used, but are not limited thereto. The upper and lower cases may be separately manufactured, provided with coupling grooves, coupling protrusions, and the like, and coupled by conventional means, or may be integrally manufactured in some cases.

As one embodiment, the present invention provides a rapid diagnosis kit using immunochromatography, further comprising one or more ribs disposed inside the upper case or the lower case. One or more of the ribs may be spaced apart from each other, arranged side by side (Fig. 3), or may cross one another perpendicularly. The one or more ribs may press against the intermediate pad and/or the conjugate pad. For example, the one or more ribs may press the upstream portion of the intermediate pad and/or the downstream portion of the conjugate pad based on the traveling direction of the specimen.

The analyte contained in the sample reacts with the conjugate in the conjugate pad, and at this time, the time the sample stays in the conjugate pad is one of the main factors determining the performance of the immunodiagnostic kit. In the present invention, a rib is placed on the upper case or lower case of the rapid diagnostic kit so that the rib presses the middle pad and/or the conjugate pad, thereby securing sufficient time for the analyte to react with the conjugate on the conjugate pad, thereby providing an immunodiagnostic kit can increase the accuracy of Since the rib serves to control the flow of the sample by compression, it also has an effect of preventing the overflow phenomenon.

[Example]

Hereinafter, the present invention will be described in more detail through examples, and these examples are for illustration of the present invention, and the scope of the present invention is not limited by these examples.

Example 1: Synthesis of Gold Nanoparticle-Antibody Conjugates

Add 0.1 mL of 0.1 M borate buffer (pH 8.5) to 1 mL of gold nanoparticle colloidal solution (BBInternational, 20 nm), and 10 μL of 1 mg/mL second anti-SARS-CoV-2 IgG antibody was added and reacted for 30 minutes. After the reaction, 0.1 mL of a solution of 1% (w/v) BSA (Bovine serum albumin, Sigma) dissolved in phosphate buffered saline (PBS) was added and reacted at room temperature for 15 minutes. After the above reaction, centrifugation was performed at 10,000 rpm and 4°C for 20 minutes, and 1 mL of a BSA (Bovine serum albumin, Sigma) solution dissolved at a concentration of 1 mg/mL in 10 mM PBS was added three times, purified, and recovered to obtain gold nanoparticles. Particle-antibody conjugates were synthesized.

Example 2: Preparation of a strip for immunochromatography

After dispensing 0.4 μg of the first anti-SARS-CoV-2 IgG antibody as a capture antibody on a 4 x 25 mm ² membrane, drying and coating, 1 OD (Optical density) gold nanoparticles 10 mL were coated with a second 5 μL of the conjugate solution conjugated with 400 ng of anti-SARS-CoV-2 IgG antibody was impregnated into a 4 x 10 mm ² conjugate pad and dried.

Example 3: Assessment of color development level of diagnostic kit according to the overlapping ratio of the sample pad and the intermediate pad and the overlapping ratio of the intermediate pad and the conjugate pad

Intermediate pads made of 4x4 mm ² , 4x6 mm ² , 4x8 mm ² , and 4x10 mm ² (L0=4/6/8/10 mm) overlap ratio (L2/L0) with the specimen pad and overlap ratio with the conjugate pad (L1/L0) from 0.05 to 0.45, each strip was prepared in increments of 0.05, and the heat-treated SARS-CoV-2 virus was diluted at 10,000 TCID ₅₀ /mL in a developing solution and developed for 15 minutes, The level of color development was evaluated using the color development standard table (Table 1). The color development evaluation results are shown in Table 2 below.

Evaluation of the color development level of the diagnostic kit according to the overlapping ratio between the sample pad and the middle pad (L2/L0) and the overlapping ratio between the middle pad and the conjugate pad (L1/L0) result L0 = 4 mm L1/L0 0.05 0.10 0.15 0.20 0.25 0.30 0.35 0.40 0.45 L2/L0 0.05 3 5 6 6 5 5 3 2 2 0.10 5 7 8 8 7 7 5 4 4 0.15 6 8 9 9 8 7 6 5 4 0.20 6 8 9 9 8 7 6 5 4 0.25 6 8 9 9 8 8 6 5 3 0.30 6 8 9 9 8 7 6 5 4 0.35 5 7 8 8 7 7 5 4 4 0.40 3 5 6 6 5 5 3 2 2 0.45 2 4 5 5 4 4 2 One One L0 = 6 mm L1/L0 0.05 0.10 0.15 0.20 0.25 0.30 0.35 0.40 0.45 L2/L0 0.05 4 6 7 7 6 6 4 3 3 0.10 6 8 9 9 8 8 6 5 5 0.15 7 9 10 10 9 8 7 6 5 0.20 7 9 10 10 9 8 7 6 6 0.25 7 9 10 10 9 9 7 6 6 0.30 7 9 10 10 9 8 7 6 5 0.35 6 8 9 9 8 8 6 5 5 0.40 4 6 7 7 6 6 4 3 3 0.45 3 5 6 6 5 5 3 2 2 L0= 8mm L1/L0 0.05 0.10 0.15 0.20 0.25 0.30 0.35 0.40 0.45 L2/L0 0.05 5 7 8 8 7 7 5 4 4 0.10 7 9 10 10 9 9 7 6 6 0.15 8 10 11 11 10 10 8 7 7 0.20 8 10 11 11 10 10 8 7 7 0.25 8 10 11 11 10 10 8 7 7 0.30 8 10 11 11 10 10 8 7 6 0.35 7 9 10 10 9 9 7 6 6 0.40 5 7 8 8 7 7 5 4 4 0.45 4 6 7 7 6 6 4 3 3 L0 = 10 mm L1/L0 0.05 0.10 0.15 0.20 0.25 0.30 0.35 0.40 0.45 L2/L0 0.05 5 7 8 8 7 7 5 4 4 0.10 7 9 10 10 9 9 7 6 6 0.15 8 10 11 11 10 10 8 7 7 0.20 9 10 11 12 11 10 9 8 7 0.25 8 10 11 11 10 10 9 8 7 0.30 8 10 11 11 10 10 8 7 7 0.35 7 9 10 10 9 9 7 6 6 0.40 5 7 8 8 7 7 5 4 4 0.45 4 6 7 7 6 6 4 3 3

From the above experimental results, the overlapping ratio between the sample pad and the intermediate pad and the overlapping ratio between the intermediate pad and the zygote pad showing a high color development level of the top 20% ranged from 0.1 to 0.3, respectively, and the adjustment of the ratio and the length of the intermediate pad (L0 ), it is possible to adjust the color development level of the diagnostic kit to a desired color signal value.

1: Sample pad
2: middle pad
3: conjugate pad
4: Membrane
5: first inspection line
6: second inspection line
7: control line
8: absorbent pad
9: support
The above description of the present invention is for illustrative purposes, and those skilled in the art can understand that it can be easily modified into other specific forms without changing the technical spirit or essential features of the present invention. will be. Therefore, the embodiments described above should be understood as illustrative in all respects and not limiting.

Claims (11)

(a) an upper case equipped with a sample inlet and a window for confirming results;
(b) a lower case provided to be assembled to correspond to the upper case; and
(c) a strip comprising a sample pad, a conjugate pad containing a labeling material, a membrane, and an absorption pad in this order
A rapid diagnostic kit for a sample containing an analyte using immunochromatography, comprising:
An intermediate pad is disposed between the sample pad and the conjugate pad, one end of the intermediate pad overlaps the sample pad, the other end of the intermediate pad overlaps the conjugate pad, and the sample pad and the intermediate pad overlap. A rapid diagnosis kit using immunochromatography, wherein the length of the portion and the length of the overlapping portion of the intermediate pad and the conjugate pad are within a ratio of 0.1 to 0.3 with respect to the total length of the intermediate pad, respectively.
delete According to claim 1,
By adjusting the length of the overlapping portion of the sample pad and the intermediate pad and the length of the overlapping portion of the intermediate pad and the conjugate pad at a ratio of 0.1 to 0.3 with respect to the total length of the intermediate pad, respectively, visually through the result confirmation window. Or a rapid diagnosis kit using immunochromatography configured to read the color signal value with a sensor.
According to claim 1,
A rapid diagnosis kit using immunochromatography, further comprising at least one rib disposed inside the upper case or the lower case.
According to claim 4,
A rapid diagnostic kit using immunochromatography in which one or more ribs press against the intermediate pad and/or the zygotic pad.
According to claim 5,
A rapid diagnostic kit using immunochromatography in which one or more ribs press the upstream part of the intermediate pad and/or the downstream part of the conjugate pad based on the traveling direction of the sample.
According to claim 4,
A rapid diagnostic kit using immunochromatography in which the overflow phenomenon is prevented by controlling the flow of a sample in a strip through one or more ribs.
According to claim 1,
A rapid diagnostic kit using immunochromatography using gold nanoparticles, color-developing enzymes, or fluorescent substances as labels.
According to claim 1,
A rapid diagnostic kit using immunochromatography, wherein the intermediate pad is composed of polyethylene or nitrocellulose-glass fiber mixture.
According to claim 1,
Analyte is antibody, antigen, nucleic acid aptamer, hapten, antigen protein, DNA, DNA-binding protein, SARS-CoV-2 virus, hormone, tumor-specific marker A rapid diagnostic kit using immunochromatography, which is selected from the group consisting of (tumor-specific marker) and tissue-specific marker.
According to claim 1,
A rapid diagnostic kit using immunochromatography, wherein the membrane has a test line and a control line.

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