KR101806167B1 - Hybrid immune reaction diagonostic kit - Google Patents

Abstract

A hybrid immune response diagnostic kit is disclosed. The hybrid immune response diagnostic kit according to an embodiment of the present invention includes: an upper substrate on which a sample injecting unit is injected; A lower substrate coupled to the upper substrate, the lower substrate including a sample loading part on which sample samples having passed through the sample injection part are accumulated, and at least one fine channel channel part extending from the sample loading part; And at least one membrane strip disposed in the inner space between the upper substrate and the lower substrate to be in contact with the microchannel channel portions, respectively.

Description

[0001] HYBRID IMMUNE REACTION DIAGONOSTIC KIT [0002]

TECHNICAL FIELD The present invention relates to an immunological response diagnostic kit, and more particularly, to a hybrid immune response diagnostic kit to which a microfluidic technique is applied to a membrane-based immune response diagnostic kit.

Measurement of disease indicator substances (e.g., metabolites, proteins, cells, etc.) existing in the body fluids (e.g., blood, urine, etc.) of the body is generally performed using biological reactions such as enzyme reaction and antigen-antibody attachment. However, the above-described methods for detecting disease indicator substances are labor-intensive and take a long time to obtain results because they are subjected to various processes such as cell culture, PCR, and enzyme immunoassay. In addition, the need for self-diagnosis as well as in the medical field has greatly increased recently. This is why research and development of point-of-care (POC) that enables quick and easy diagnosis of immune response is active.

In connection with such field-of-care devices, membrane-type diagnostic kits are mainly used. Membrane-based diagnostic kits utilize the capillary action of microporous membranes. For example, analytes contained in sample samples are separated from other compounds, which is due to their affinity for binding to capture molecules immobilized on a fixed solid phase.

However, in the case of such a membrane type diagnostic kit, the wettability of the sample (liquid) is different and the rate at which the fluid is absorbed and moved is not constant. This is why it is difficult to predict the flow rate of the fluid. In addition, the membrane-type diagnostic kit includes a plurality of pads formed on the main membrane. In the sample loading pad, a sample transfer pad is loaded with the sample sample first. This is because the sample fluid takes a relatively long time to sufficiently wet the sample loading pad.

In addition, in order to perform multiple diagnoses (detection) in one kit, a branch channel through which the fluid can move must be formed. However, in the membrane type diagnostic kit, it is difficult to form such a branch channel. Therefore, it is general that a plurality of single channels are arranged in one case. For example, in order to perform three types of diagnosis in one kit, three membrane strip sensors of the same type are arranged in one case, and the sample sample must be injected three times.

This is why many researches have been conducted to improve the disadvantages of the above-described membrane type diagnostic kit, in particular, the inefficiency of analytical diagnosis.

Patent Document 1: Korean Patent No. 10-0599420 (published on November 4, 2004) Patent Document 2: Korean Patent No. 10-1184322 (published on October 26, 2011)

The present invention provides a diagnostic kit capable of detecting an immune response more efficiently by reducing the time required for diagnosing an immune response and the amount of a necessary sample, compared with a membrane type diagnostic kit.

According to an aspect of the present invention, there is provided a plasma display panel comprising: an upper substrate on which a sample injecting unit is injected; A sample loading part coupled to the upper substrate and formed in a groove shape (a part of the rim is opened) so that the sample samples passed through the sample injection part are collected; A lower substrate including at least one microchannel channel section (each microchannel channel width is smaller than a width of a membrane strip below) having a plurality of microchannel channels extended in a flat shape and surface-treated with hydrophilicity; And at least one membrane strip disposed in an inner space between the upper substrate and the lower substrate so as to be in contact with the ends of the microchannel channel part, respectively.

At this time, the hydrophilic surface treatment of the microchannel channel is preferably carried out using a compound having an amine, hydroxy, carbonyl or epoxy functional group, a monomer having a functional group, a dimer and a polymer At least one organic material; At least one inorganic substance selected from gold, silver, silicon, aluminum, nickel, iron, copper, manganese, silicon, titanium, chromium and oxides thereof is applied to the surface of the microchannel channel have.

The upper substrate and the lower substrate may be formed of a material selected from the group consisting of polyester, polyethylene (PE), polypropylene (PP), polyimide (PI), polystyrene (PS), polycarbonate (PC), polyurethane, polyvinylidene fluoride, (PMMA), polyvinyl chloride (PVC), cyclic olefin copolymer (COC), polyamide (PA), poly (phenylene ether) (PPE), polyoxymethylene (PEEK), polyethersulfone (PES), polytetrafluoroethylene (PTFE), or an acrylic based resin.

Also, at least one opening may be formed on the upper substrate so as to observe the immune reaction in the membrane strip.

The lower substrate may be provided with a plurality of protruding members for preventing the membrane strip from moving right and left.

In addition, the membrane strip may include a main membrane on which the sample is transferred and an immune reaction result can be confirmed, and a conjugation pad and an absorption pad disposed on the main membrane.

In addition, when the microchannel channel portion is two or more, the sample sample accumulated in the sample loading portion may be branched from the sample loading portion to the microchannel channel portions.

In the hybrid immunoassay kit according to embodiments of the present invention, the sample sample accumulated in the sample loading unit moves directly to the membrane strip along the microchannel channel, thereby reducing the time required to diagnose the immune response as compared with the membrane type diagnostic kit.

Further, when two or more microchannel channels are formed, since a plurality of immune reactions can be detected by one sample sample injection, the amount of the required sample is reduced as compared with the membrane type diagnostic kit.

In addition, the hybrid immunoassay kit according to the embodiments of the present invention can be manufactured through injection molding, which is simpler to manufacture than the membrane type diagnostic kit and can be shortened in manufacturing time, thereby facilitating mass production.

1 is a perspective view of a hybrid immune response diagnostic kit according to an embodiment of the present invention.
2 is an exploded perspective view of the hybrid immune response diagnostic kit of FIG.
FIG. 3 is a view showing the back surface of the upper substrate in the hybrid immune response diagnostic kit of FIG. 1; FIG.
4 is an enlarged view of IV shown in Fig.
Figure 5 is a view showing the membrane strip of Figure 2;
6 is a perspective view of a hybrid immune response diagnostic kit according to another embodiment of the present invention.
FIG. 7 is an exploded perspective view of the hybrid immune response diagnostic kit of FIG. 6; FIG.
Fig. 8 is a view showing the back surface of the upper substrate in the hybrid immune response diagnostic kit of Fig. 6; Fig.
9 is an enlarged view of IX shown in FIG.

Hereinafter, the present invention will be described in detail with reference to the accompanying drawings. It is to be understood that the following description is illustrative of the present invention, and the technical spirit of the present invention is not limited to the following description. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this application, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention.

FIG. 1 is a perspective view of a hybrid immune response diagnostic kit 100 according to an embodiment of the present invention, FIG. 2 is an exploded perspective view, and FIG. 3 is a rear view of an upper substrate 110.

In the drawings attached hereto, the hybrid immune response diagnostic kit 100 is shown to have a streamlined body as a whole, but is not limited thereto. For example, the hybrid immune response diagnostic kit 100 may have a rectangular shape or an unformed shape as a whole.

The term "hybrid" immune response diagnostic kit 100 as used herein means that the immune response test kit according to the present invention is not a complete membrane type immune response test kit as will be described below, It is not an immunological reaction diagnostic kit.

1 to 3, a hybrid immune response diagnostic kit 100 (hereinafter referred to as an immune response diagnostic kit) may include an upper substrate 110, a lower substrate 120, and a membrane strip 130 have.

The upper substrate 110 and the lower substrate 120 may be coupled up and down, respectively, to form one case. At this time, the coupling method of the upper substrate 110 and the lower substrate 120 is not specified. In an embodiment, as shown in the drawings attached to the present specification, pillars (not shown) protruding upwardly are formed on at least a part of the upper edge of the lower substrate 120, The upper substrate 110 and the lower substrate 120 can be coupled in an interference fit manner by forming the receiving members (untraded members) for receiving the pillar members at positions opposite to the pillar members, And the housing member may be integrally formed with the upper substrate and the lower substrate, respectively). In other embodiments, the upper substrate 110 and the lower substrate 120 may be coupled in a conventional bolt-nut manner. In yet another embodiment, the upper substrate 110 and the lower substrate 120 may be bonded via an adhesive. Examples of the adhesive include rubber adhesives, acrylic resin adhesives, silicone adhesives, optical adhesives, and heat-resistant adhesives, and are not limited to those listed above.

The upper substrate 110 and the lower substrate 120 may be formed of a plastic material. Examples of the plastic material include polyesters, polyethylene (PE), polypropylene (PP), polyimide (PI), polystyrene (PS), polycarbonate (PC), polyurethane, polyvinylidene fluoride, nylon (PMMA), polyvinyl chloride (PVC), cyclic olefin copolymer (COC), polyamide (PA), poly (phenylene ether) (PPE), polyoxymethylene (PEEK), polyether sulfone (PES), polytetrafluoroethylene (PTFE), acrylic resin, and the like, but are not limited to those listed above. In one embodiment, the upper substrate 110 and the lower substrate 120 may be formed of polycarbonate (PC). In other embodiments, the upper substrate 110 and the lower substrate 120 may be formed of different plastic materials. In another embodiment, the upper substrate 110 and the lower substrate 120 are formed of the same plastic material, and the physical properties of the upper substrate 110 and the lower substrate 120 may be different.

The upper substrate 110 and the lower substrate 120 may be manufactured by a conventional injection molding method. For example, it may be a method of injecting a polymer into a mold at a high temperature using a mold and / or a mold, cooling the mold, and then separating the mold from the mold.

One or more membrane strips 130 may be disposed in the inner space of the upper substrate 110 and the lower substrate 120. In one embodiment, the membrane strips 130 may be disposed on the lower substrate 120. The membrane strip 130 serves as a passage through which the injected sample is transferred, and at the same time exerts a function of confirming the desired chemical and biological reaction results from the outside. The membrane strip 130 will be described later in detail.

Hereinafter, the upper substrate 110 will be described in detail.

The upper substrate 110 may have a sample injection unit 111 and an opening 112 formed therein. A sample sample can be injected into the sample injecting section 111. Here, the "sample sample" is not particularly limited as long as it can contain the substance to be analyzed. For example, a "sample sample" may be a biological sample or a biological fluid. More specific examples of the biological sample and the biological fluid include urine (urine), blood, plasma, serum, saliva, semen, sputum, cerebrospinal fluid, tears, mucus, amniotic fluid and the like. The sample sample may consist of a sample in liquid form.

The sample injecting unit 111 may have an open form so that the sample can be injected, and its shape, size and the like are not limited. In the drawings attached hereto, the sample injection unit 111 is shown in a circular opening form, but the present invention is not limited thereto. For example, the sample injecting unit 111 may be formed in a polygonal shape such as a triangle, a square, or the like other than a circular shape or other unformed shapes.

The openings 112 may be formed in the upper substrate 110 to allow observation of chemical and biological immune reactions in the membrane strip 130 from the outside. The openings 112 may be a plurality of openings and may be formed to correspond to the respective regions of the membrane strip 130 (conjugation pad, main membrane, absorbent pad) (112a, 112b, 112c in FIGS. 1 and 3) Respectively. The shape, shape, and size of the opening 112 are not limited and may be formed in various types. In connection with the drawings attached hereto, the opening 112 is shown in a slit form.

Hereinafter, the lower substrate 120 will be described in detail. 4 is an enlarged view of IV shown in Fig. 2, and the lower substrate 120 will be described with reference to Figs. 1, 2 and 4. Fig.

The lower substrate 120 may include a sample loading unit 121 and at least one micro channel channel unit 122.

The sample loading unit 121 may collect sample samples injected or dropped through the sample injection unit 111 of the upper substrate 110. Specifically, the sample loading unit 121 may be formed in the shape of a groove having a predetermined depth so that the sample samples can be accumulated. For example, as shown in FIG. 4, a space is formed in the front surface of the lower substrate 120 so as to protrude upward, and a groove having a predetermined depth is formed in the center of the space The sample loading part 121 can be formed. In the drawings attached hereto, the shape of the sample loading part 121 is shown in a circular shape, but it is not limited thereto, and it may be formed in various shapes such as a polygonal shape and an unformed shape.

The fine channel channel portion 122 extends from the sample loading portion 121, and one or more of the fine channel channel portions 122 may be formed. In this embodiment, one microchannel channel part 122 is formed. The fine flow channel portion 122 may include a plurality of fine flow channel portions. In the drawings attached hereto, the fine channel channel portion 122 includes three fine channel channels, but the present invention is not limited thereto and may include more or fewer fine channel channels. Also, in the drawings attached hereto, the fine channel channel part 122 includes fine channel channels having a linear pattern, but the present invention is not limited thereto. For example, the microchannel channels may be formed in a curved pattern (spiral, serpentine, zigzag).

One end of the fine flow channel part 122 is connected to the sample loading part 121. For example, a part of the rim of the sample loading part 121 may be formed as an open type having no depth, and the micro channel channel part 122 may be extended from the opened part. The sample sample accumulated in the sample loading part 121 is transferred to the micro channel channel part 122 through the opened part by a capillary force and is then transferred continuously to the other end direction of the micro channel channel part 122 Lt; / RTI > The other end of the microchannel channel 122 is connected to the membrane strip 130.

For example, there are a laser cutting method, a cutting floating processing method, a cutting printing method, a lathe processing method (using CNC milling, etc.), and the like. The methods are well known and the detailed description of each method is omitted. In addition, the microchannel channel portion 122 including the microchannel channels may be formed together when the lower substrate 120 is formed. As described above, the lower substrate 120 may be formed using a conventional injection molding method, and a method of injecting the fine channel channels together during the injection molding of the lower substrate 120 may be used. In this case, it is possible to omit the step of separately manufacturing the micro channel unit 122, which is advantageous in simplifying the process.

The width and depth of the microchannel channel are not specified. For example, the width and / or depth of the microchannel channel may be formed in nanometer, micrometer, or millimeter. In one embodiment, the depth and / or width of the microchannel channel may be suitably selected within the range of about 20 microns to 1 mm, specifically about 20 to 300 microns, and more specifically about 50 to 100 microns, It is not limited to the above range because it can be changed depending on the specific application. In another embodiment, the width and / or depth of the microchannel channel may be suitably selected within the range of several tens nanometers to several hundred nanometers.

An organic material and / or an inorganic material for imparting hydrophilicity may be applied to the micro channel channel part 122. As described above, the upper substrate 110 and the lower substrate 120 are formed of a plastic material, and generally exhibit hydrophobic (or non-polar) or weak hydrophilic properties. Since the hydrophilic surface is typically a surface that draws moisture, the sample (fluid) may flow better on this hydrophilic surface. Therefore, the hydrophilic surface treatment can be performed by applying an organic substance and / or an inorganic substance to the micro channel channel portion 122 exhibiting hydrophobic or weakly hydrophilic properties. At this time, the organic material and / or the inorganic material may be more preferably a material which is not reactive with the sample sample.

Examples of the organic material include at least one selected from the group consisting of amine, hydroxy, carbonyl or epoxy functional groups, monomers having the functional groups, dimers and polymers, and the like . Examples of the inorganic material may include a metal or a nonmetal, specifically, at least one metal selected from gold, silver, silicon, aluminum, nickel, iron, copper, manganese, silicon, titanium and chromium or an oxide thereof. In addition, the organic and inorganic materials may be mixed. In one embodiment, the micro channel channel portion 122 can be surface-treated with hydrophilic properties by applying silica (SiO ₂ ).

The organic material and / or the inorganic material may be formed by thermal evaporation, E-beam deposition, sputtering, chemical vapor deposition (CVD), sol-gel method, plasma treatment, liquid phase chemical treatment, And these methods are well known, and detailed description of each method is omitted.

Meanwhile, the lower substrate 120 may be provided with a plurality of protrusion members 123 for preventing the membrane strip 130 from moving in the lateral direction. The protrusion member 123 is for fixing the position of the membrane strip 130 disposed in the space in the upper substrate 110 and the lower substrate 120. The protrusion member 123 is formed in a virtual frame formed by the plurality of protrusion members 123, A strip 130 may be disposed. Specifically, in Fig. 2, two pairs of rectangular parallelepiped projection members 123 and a projection member 123 of a reverse "-shaped " shape are formed on the lower substrate 120. The two pairs of protrusion members 123 are spaced apart from each other to face each other, and the interval may correspond to a width of the membrane strip 130. The spacing existing in the "C" shaped protrusion member 123 may also correspond to the width of the membrane strip 130. Therefore, when the membrane strip 130 is disposed in the virtual frame made up of the protruding members 123, the protruding members 123 are blocked by the protruding members 123, so that the membrane strips 130 can not move leftward and rightward. The shape of the projection member 123 is not limited, and may be formed in various shapes. The size of the projection member 123 is not limited, but it is preferable that the height of the projection member 123 is at least half the height of the membrane strip 130.

Hereinafter, the membrane strip 130 will be described in detail. In this regard, FIG. 5 is a diagram illustrating the membrane strip 130 of FIG. 2.

5, the membrane strip 130 may include a main membrane 131 and a conjugation pad 132 and an absorption pad 133 disposed on the main membrane 131. Specifically, the conjugation pad 132 may be disposed at one end of the main membrane 131, and the absorption pad 133 may be disposed at the other end of the main membrane 131. Based on the fact that the membrane strip 130 has been placed in the immune reaction diagnostic kit 100, the conjugation pad 132 has a sample loading portion 121 of the lower substrate 120 (see FIG. 4) and a micro channel channel portion 122 , And the absorption pad 133 may be disposed on the opposite side.

The main membrane 131 may be formed of any material in the form of a membrane capable of lateral flow of the sample sample, which serves to transport the sample sample and to confirm the result of the immune reaction. For example, the main membrane 131 may be formed of a material selected from nitrocellulose, nylon, polysulfone, polyethersulfone, and polyvinylidene fluoride, but is not limited thereto.

A detection antibody or the like for detecting an analyte of a sample sample may be fixed to the main membrane 131. Such detection antibodies include antibodies against hepatitis A virus (HAV), hepatitis B virus (HBV) or hepatitis C virus (HCV) antigen such as IgM antibody-HA, IgM antibody-HBc, HBsAg, , HBeAg, antibody-HBeAb and antibody-HCVAb; Ferritin; Creatinine kinase MB (CK-MB); Digoxin; Phenytoin; Phenobarbitol; Carbamazepine; Vancomycin; Gentamicin; Theophylline; Valproic acid; Quinidine; Luteinizing hormone (LH); Vesicle stimulating hormone (FSH); Estradiol, progesterone; C-reactive protein (CRP); Lipocalin; IgE antibodies; Cytokine; Vitamin B2 micro-globulin; Glycated hemoglobin (Gly.Hb); Cortisol; Digoxin; N-acetyl procainamide (NAPA); Procainamide; Antibodies against rubella such as rubella-IgG and rubella IgM, for example, toxoplasmosis such as tox (Toxo-IgG) and toxoplasmosis IgM; Testosterone; Salicylate; Acetaminophen; Human immunodeficiency virus 1 and 2 (HIV 1 and 2); Human T-cell leukemia viruses 1 and 2 (HTLV); Influenza virus; Thyroid stimulating hormone (TSH); Thyroxine (T4); Total triiodothyronine (total T3); Free triiodothyronine (free T3); Carcinoembryonic antigen (CEA); Lipid proteins, cholesterol, and triglycerides; And alpha-fetoprotein (AFP), but are not limited thereto.

The conjugation pad 132 may be treated with a signal generating material, or a conjugate of a signal generating material with a substance that specifically binds to the sample sample, such as a detection antibody. The signal generating material may be a metal nanoparticle (for example, gold, silver or copper nanoparticles), a quantum dot nanoparticle, a magnetic nanoparticle, an enzyme, an enzyme substrate, an enzyme reaction product, a light absorbing substance, Lt; / RTI > More specifically, the signal generating material may be a fluorescent material such as umbelliferone, fluorescein, fluorescein isothiocyanate (FITC), rhodamine, TAMRA Fluorescein including fluorescein, dichlorotriazinylamine fluorescein, dansyl chloride, quantum dots, phycoerythrin, FAM (fluorecein amidite) and the like, Alexa fluorine and cyanine, including Cy3, Cy5, Cy7, indocyanine green, and the like. The conjugation pad 132 may be made of a material such as cellulose, polyester, polypropylene or glass fiber or a membrane material such as nitrocellulose, nylon, polysulfone, polyethersulfone and polyvinylidene fluoride as well as the main membrane 131 As shown in FIG.

The absorption pad 133 may serve to absorb a sample sample developed through the main membrane 132. The absorption pad 133 is not particularly limited as long as it is capable of absorbing a liquid sample sample. For example, the absorbent pad 133 may be formed of a material such as cellulose, polyester, polypropylene, or glass fiber.

The membrane strip 130 in this embodiment may be in the form of a sample loading pad omitted when compared to a membrane strip in a conventional membrane type diagnostic kit. Accordingly, the technical and non-technical description herein relating to the membrane strip 130 and the chemical or biological reactions that occur as the sample sample flows through the membrane strip 130 may be addressed in the context of the technical aspects of the membrane strip in the conventional membrane- They may be the same or similar, and a detailed description thereof will be omitted.

In the conventional membrane type diagnostic kit, a sample loading pad, a membrane, a conjugation pad, an absorbent pad, and the like are generally composed of four membranes and pads. Among them, the sample loading pad is formed by firstly injecting sample samples, To develop the sample sample. At this time, there was a disadvantage that the sample fluid took a relatively long time to sufficiently wet the sample loading pad. However, in the immunoassay kit 100 according to the present embodiment, the membrane strip 130 is omitted from the membrane strip in the conventional membrane type diagnostic kit, and instead the sample loading pad 121 of the lower substrate 120 And the fine channel channel portion 122, thereby greatly reducing the time taken for the sample fluid to wet the sample loading pad, as described above. That is, in the immunoassay kit 100 according to the present embodiment, the sample sample accumulated in the sample loading unit 121 can be directly transferred to the membrane strip 130 along the microchannel channels without any time delay, The entire immune response diagnostic time can be reduced.

In this regard, the inventors of the present invention produced a prototype of the immune response diagnostic kit 100 according to this embodiment. The inventors of the present invention measured the time for the sample to reach from the sample loading portion to the conjugation pad of the membrane strip through the microchannel channel portion with respect to the prototype and the time was measured using the membrane strip used in the conventional membrane- Of the sample loading pad to the conjugation pad.

Hereinafter, a hybrid immune response diagnostic kit according to another embodiment of the present invention will be described. In the following description, the description of the same or similar parts as those of the above-described embodiment will be omitted, and the differences from the above-described embodiment will be mainly described. The hybrid immune response diagnostic kit according to this embodiment accommodates a plurality of membrane strips, and is capable of detecting an immune response multiplex.

FIG. 6 is a perspective view of a hybrid immune response diagnostic kit 200 according to another embodiment of the present invention, FIG. 7 is an exploded perspective view, and FIG. 8 is a rear view of the upper substrate 210.

In the drawings attached hereto, the hybrid immune response diagnostic kit 200 is shown to have a streamlined body as a whole, but is not limited thereto. For example, the hybrid immune response diagnostic kit 200 may have a rectangular shape or an unformed shape as a whole.

6 to 8, a hybrid immune response diagnostic kit 200 (hereinafter referred to as an immune response diagnostic kit) may include an upper substrate 210, a lower substrate 220, and a membrane strip 230 have.

A sample injection unit 211 and an opening 222 may be formed in the upper substrate 210. The sample injecting portion 211 and the opening portion 222 are the same as or similar to those in the above-described embodiment, so that redundant description will be omitted. However, this embodiment differs from the above-described embodiment in that the openings 222 are formed in a plurality of lines. This is to observe the chemical and biological immune responses in the membrane strips disposed in each line through the openings 222 of each line. The openings 222 of one line may be plural and may be respectively formed corresponding to the respective regions (conjugation pad, main membrane, absorption pad) of the corresponding membrane strip (denoted by 212a, 212b, 212c in FIG. 8) ). The upper substrate 210 of this embodiment is the same as or similar to the upper substrate of the above-described embodiment, so that redundant description will be omitted.

A sample loading part 221 and at least one fine channel channel part 222 may be formed on the lower substrate 220. Referring to Fig. 9, which is an enlarged view of Fig. 7, it is referred to together.

The sample loading unit 221 may perform the function of collecting sample samples injected or dropped through the sample injection unit 211 of the upper substrate 210, as in the above-described embodiment. In this embodiment, unlike the above-described embodiment, three microchannel channel sections 222 are formed (denoted by 222a, 222b and 222c in FIGS. 7 and 9). Each of the microchannel channel sections 222 may include a plurality of microchannel channels. In the drawings attached hereto, the fine channel channel portions 222 each include three fine channel channels, but the present invention is not limited thereto and may include more or fewer fine channel channels . Also, in the drawings attached hereto, the micro channel channel portion 222 includes micro channel channels having a linear pattern, but the present invention is not limited thereto. For example, the microchannel channels may be formed in a curved pattern (spiral, serpentine, zigzag). In the drawings attached hereto, the three micro channel channel portions 222 are formed to have an inclination angle of about 30 degrees with the adjacent micro channel channel portions 222, but the present invention is not limited thereto.

As in the above-described embodiment, one end of the microchannel channel part 222 is connected to the sample loading part 221. The sample sample accumulated in the sample loading section 221 is transferred to the microchannel channel section 222 through the open part by a capillary force and specifically to the sample loading section 221 The sample can be branched and transported to the three microchannel channel sections 222 and then continuously transported in the other end direction of each microchannel channel section 222. Since the other end of each microchannel channel part 222 is connected to each of the membrane strips 230, it is possible to perform multiple detection as many times as the number of the membrane strips 230 by injecting or dropping a sample sample (Three kinds of detection are possible in this embodiment). That is, in the immune response diagnostic kit 200 according to the present embodiment, when a sample is injected or dripped into a single sample injection unit 211 formed on the upper substrate 210, the sample is formed on the lower substrate 220 Can be transferred to the membrane strips 230 which are accumulated in the sample loading part 221 and then branched and transported to the microchannel channel parts 222 and further contacted with the microchannel channel parts 222 respectively.

Conventional membrane type diagnostic kits have been designed to perform multiple detection, but since it is difficult to make a branch channel with a membrane material, it is common that a plurality of single channels are arranged in one case. For example, as in this embodiment, in order to perform three types of diagnoses in one kit, three membrane strip sensors are provided in one case, and three sample injection units for injecting sample samples are also present in the three cases Respectively. However, in the immunoassay kit 200 according to the present embodiment, the sample sample injected or dropped through one sample injection unit 211 is branched into three micro channel channel units 222 via the sample loading unit 221 So that the amount of the sample to be sampled is inevitably lower than in the conventional membrane type diagnostic kit. That is, since a plurality of immune reactions can be detected by one sample injection, a more efficient immune response diagnosis is possible in the conventional membrane type diagnostic kit.

On the other hand, an organic substance and / or an inorganic substance for imparting hydrophilicity may be applied to the micro channel channel portion 222. The lower substrate 220 may be provided with a plurality of protrusion members 223 for preventing the membrane strips 230 from moving left and right. This has been described in the above embodiment, and redundant description will be omitted.

In this embodiment, a plurality of membrane strips 230 are disposed (denoted by 230a, 230b, and 230c in FIG. 7), and the configuration of each membrane strip 230 is the same as or similar to that in the above- Duplicate descriptions shall be omitted. Each of the membrane strips 230 can be immobilized with different detection antibodies, so that one or more analytes in a sample sample can be individually subjected to an immune reaction diagnosis, thereby enabling multiple detection.

As described above, in the hybrid immune response diagnostic kit according to embodiments of the present invention, the sample sample accumulated in the sample loading unit moves directly to the membrane strip along the microchannel channel. As a result, Diagnostic time is reduced. Further, when two or more microchannel channels are formed, since a plurality of immune reactions can be detected by one sample sample injection, the amount of the required sample is reduced as compared with the membrane type diagnostic kit. In addition, the hybrid immunoassay kit according to the embodiments of the present invention can be manufactured through injection molding, which is simpler to manufacture than the membrane type diagnostic kit and can be shortened in manufacturing time, thereby facilitating mass production.

In addition, the present invention can additionally provide a method of analyzing a biological specimen for measuring an analyte by injecting a sample into a hybrid immune response diagnostic kit according to embodiments of the present invention described above. The biological sample analysis method is the same as or similar to the known biological sample analysis method except for the use of the hybrid immune response diagnostic kit according to the embodiments of the present invention, so a detailed description thereof will be omitted.

Embodiments of the present invention have been described above. However, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the present invention as defined by the appended claims. It will be understood that various modifications may be made in the invention, and that such modifications are also included within the scope of the present invention.

100, 200: Hybrid immune response diagnostic kit
110, 210: upper substrate
111 and 211:
112, 212: opening
120, 220: Lower substrate
121, 221: sample loading section
122 and 222:

Claims (8)

An upper substrate on which a sample injecting unit to inject sample samples is formed;
A sample loading part coupled to the upper substrate and formed in a groove shape (a part of the rim is opened) so that the sample samples passed through the sample injection part are collected; A lower substrate including at least one microchannel channel section (each microchannel channel width is smaller than a width of a membrane strip below) having a plurality of microchannel channels extended in a flat shape and surface-treated with hydrophilicity; And
And at least one membrane strip disposed in an inner space between the upper substrate and the lower substrate so as to be in contact with the ends of the microchannel channel part, respectively. The method according to claim 1,
The hydrophilic surface treatment of the microchannel channel may be carried out by using a compound having an amine, hydroxy, carbonyl or epoxy functional group, a monomer having a functional group, a dimer and a polymer Organic matter; Wherein at least one material selected from the group consisting of gold, silver, silicon, aluminum, nickel, iron, copper, manganese, silicon, titanium, chromium and oxides thereof is applied to the surface of the microchannel channel, Immune response diagnostic kit. The method of claim 2,
Wherein the upper substrate and the lower substrate are made of a material selected from the group consisting of polyester, polyethylene (PE), polypropylene (PP), polyimide (PI), polystyrene (PS), polycarbonate (PC), polyurethane, polyvinylidene fluoride, (PMMA), polyvinyl chloride (PVC), cyclic olefin copolymer (COC), polyamide (PA), poly (phenylene ether) (PPE), polyoxymethylene A hybrid immune response diagnostic kit formed of a resin such as polyethylene terephthalate (PET), polyether sulfone (PES), polytetrafluoroethylene (PTFE), or acrylic resin. The method according to any one of claims 1 to 3,
Wherein at least one opening is formed in the upper substrate so as to observe the immune reaction in the membrane strip. The method according to any one of claims 1 to 3,
Wherein the lower substrate is provided with a plurality of protrusion members for preventing the membrane strip from moving right and left. The method according to any one of claims 1 to 3,
Wherein the membrane strip comprises a main membrane to which the sample sample is transferred and an immune reaction result can be confirmed, and a conjugation pad and an absorption pad disposed on the main membrane. The method according to any one of claims 1 to 3,
And the sample sample accumulated in the sample loading part is branched from the sample loading part to the micro channel channel part when the micro channel channel part is two or more. A method for analyzing a biological sample, comprising the steps of: injecting a sample into a hybrid immune response diagnostic kit according to any one of claims 1 to 3;

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