Viral antigen detection stick and manufacturing method thereof

Abstract

The present invention discloses a virus antigen detection stick and a manufacturing method thereof. An antibody attachment layer, a water-soluble protective film, a colloidal gold attachment layer, and an outer water-soluble protective film are sequentially superimposed and attached to the surface of an ellipsoid core body. During detection, saliva can melt the water-soluble protective film and the outer water-soluble protective film, and the colloidal gold captures the virus antigens in the saliva and simultaneously marks them. The marked antigens are captured by the specific antibody attachment layer attached to the surface of the core body to form a combination of antibodies, antigens, and colloidal gold particles. A large number of such combined particles accumulate on the surface of the core body and present a color surface layer visible to the naked eye. With this design, specific antigens in saliva in the oral cavity are directly labeled with colloidal gold, without the need for swab sampling, and the operation is simple. Moreover, the marked specific antigens are captured by the specific antibodies attached to the core sphere in the oral cavity and then accumulate on the sphere surface, making the presentation more obvious, easy to identify, and having high detection accuracy.

Description

Technical Field

[0001] The present invention relates to the technical field of viral antigen detection, and more particularly to a viral antigen detection stick and a manufacturing method thereof. Background Art

[0002] An antigen is a substance that can stimulate the body to produce an immune response and bind to the immune response products, antibodies, and sensitized lymphocytes, to produce an immune effect. For example, nucleic acid testing detects the genetic material RNA within the new coronavirus, while antigen testing detects proteins on the surface of the virus. For example, the structural proteins of the new coronavirus include S protein, N protein, M protein, and E protein. Once the human body is infected with the virus, these structural proteins can act as immunogens to stimulate plasma cells to produce specific antibodies. These proteins contain multiple antigenic epitopes, and the principle of specific binding between antigens and antibodies can be utilized to detect the presence of antigens through antibodies, thereby proving the presence of a specific virus in the sample. Antigen testing is mainly performed on samples from saliva, throat swabs, nasal mucus, and nasal swabs.

[0003] Currently, a variety of test kits using colloidal gold technology are available on the market to detect different types of viruses. These kits generally use colloidal gold as a marker. While colloidal gold spheres are larger and less sensitive than smaller markers such as fluorescent and latex microspheres, making them unsuitable for quantitative testing, virus detection kits using colloidal gold technology do not require specialized instrumentation, unlike fluorescent and latex microspheres, which require specialized instrumentation for reading and interpretation of test results. They also offer a fast reaction time, typically only 15 to 20 minutes, and intuitive reading of test results, eliminating the need for complex expertise.

[0004] Current virus detection kits using colloidal gold technology (such as the current mainstream COVID-19) have the aforementioned advantages, but they also suffer from the following significant drawbacks: 1. Sampling with a nasal swab is limited due to the relatively small swab area, limiting the amount of sample that can be attached to the cotton ball during swabbing; 2. The swab head must remain in the preservation solution for a sufficient amount of time to allow the sample to be eluted into the preservation solution; and 3. When the sample volume in the preservation solution is small and the amount of preservation solution dripped into the sample well of the kit is small, fewer samples can be labeled with gold, resulting in less pronounced color development. These three factors can all lead to test failure.

[0005] Furthermore, existing test kits require swab sampling, sample elution, and sample placement on a test card. These steps can easily lead to errors in self-testing for untrained individuals. In practice, a significant proportion of test failures are caused by incorrect sampling and handling techniques.

[0006] Therefore, it is necessary to design a virus antigen detection stick that is simple and easy for the general public to use. Summary of the Invention

[0007] The purpose of the present invention is to address the above-mentioned shortcomings and provide a virus antigen detection stick and a method for manufacturing the same, in order to solve the technical problems in the prior art such as the lack of obvious color development of the detection kit and the high operational requirements for use by the general public.

[0008] In order to solve the above technical problems, the present invention adopts the following technical solutions:

[0009] The present invention provides a virus antigen detection stick, comprising a handheld stick and a detection portion fixed to the front end of the handheld stick, wherein the detection portion comprises a core body, an antibody attachment layer, a water-soluble protective film, a colloidal gold attachment layer, and an outer water-soluble protective film. The core body is an ellipsoid with microporous high molecular polymer on the surface and is fixed to the front end of the handheld stick, the antibody attachment layer is attached and fixed to the entire surface of the core body, the water-soluble protective film is attached and fixed to the surface of the antibody attachment layer, the colloidal gold attachment layer is attached and fixed to the surface of the water-soluble protective film, and the outer water-soluble protective film is attached and fixed to the surface of the colloidal gold attachment layer.

[0010] Furthermore, the core polymer is food-grade silica gel, the micropore diameter of the food-grade silica gel surface is about 8-10 nm, and the specific surface area is 300-500 m² / g.

[0011] Furthermore, the core ellipsoid has a major axis diameter of 1.2-1.5 cm and a minor axis diameter of 0.8-1 cm.

[0012] Furthermore, the water-soluble protective film is made of polyvinyl alcohol.

[0013] Furthermore, the outer water-soluble protective film is made of polyvinyl alcohol.

[0014] A method for manufacturing a viral antigen detection stick comprises the following steps:

[0015] Step 1: Use plastic to make a cylindrical stick by injection molding, with a length of 10-15 cm and a diameter of 1-2 mm, to obtain a handheld stick;

[0016] Step 2: Using a microporous polymer, a spheroid is injection molded into a core body. The diameter of the major axis of the spheroid is 1.2-1.5 cm, the diameter of the minor axis is 0.8-1 cm, and a mounting hole corresponding to one end of the handheld stick in step 1 is left. The spheroid is then fixed to the front end of the handheld stick through the mounting hole.

[0017] Step 3: After remelting, the specific detection antibody corresponding to the virus is evenly sprayed onto the surface of the core body by spraying. After dehydration and drying, the antibody is tightly attached to the surface of the core body to form an antibody attachment layer;

[0018] Step 4: spraying a water-soluble polymer liquid evenly on the surface of the antibody attachment layer, and forming a water-soluble protective film after drying;

[0019] Step 5: Take the colloidal gold solution and spray it evenly on the surface of the water-soluble protective film by spraying, and form a colloidal gold adhesion layer after drying;

[0020] Step six: take a water-soluble polymer liquid and spray it evenly on the surface of the colloidal gold attachment layer by a spraying method, and form an outer water-soluble protective film after drying.

[0021] Furthermore, the microporous polymer in step 2 is food grade silica gel, and the micropore diameter of the food grade silica gel surface is about 8-10 nm, and the specific surface area is 300-500 m² / g.

[0022] Furthermore, the water-soluble polymer in step 4 and step 6 is polyvinyl alcohol.

[0023] Compared with the prior art, the present invention has the following beneficial effects: an antibody attachment layer, a water-soluble protective film, a colloidal gold attachment layer, and an outer water-soluble protective film are sequentially superimposed and attached to the surface of the ellipsoid core. During detection, saliva can melt the water-soluble protective film and the outer water-soluble protective film, allowing the colloidal gold to capture and label viral antigens in the saliva. The labeled antigens are captured by the specific antibody attachment layer attached to the core surface, forming a combination of antibody, antigen, and colloidal gold particles. A large number of these combined particles accumulate on the core surface, presenting a visible color surface layer. This design allows colloidal gold to directly label specific antigens in oral saliva, eliminating the need for swab sampling, making the operation simple. Moreover, the labeled specific antigens are captured by the specific antibodies attached to the core sphere in the mouth and then accumulate on the sphere surface, making the detection effect more obvious, easy to identify, and achieving high detection accuracy. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 This is a schematic structural diagram of a viral antigen detection stick according to an embodiment of the present invention;

[0025] Figure 2 Schematic diagram of the local structure of the surface of the detection part of the viral antigen detection stick in an embodiment of the present invention.

[0026] The following are the descriptions of the reference numerals:

[0027] 1 is a handheld stick, 2 is a detection part, 201 is a core body, 202 is an antibody attachment layer, 203 is a water-soluble protective film, 204 is a colloidal gold attachment layer, and 205 is an outer water-soluble protective film. DETAILED DESCRIPTION

[0028] The present invention will be further described below with reference to the accompanying drawings.

[0029] refer to Figure 1 and Figure 2 As shown, an embodiment of the present invention is a virus antigen detection stick, comprising a handheld stick 1, a detection portion 2 fixed to the front end of the handheld stick 1;

[0030] Importantly, the detection portion 2 includes a core body 201, an antibody attachment layer 202, a water-soluble protective film 203, a colloidal gold attachment layer 204, and an outer water-soluble protective film 205. The core body 201 is a microporous polymer ellipsoid fixed to the front end of the handheld stick 1. The antibody attachment layer 202 is attached to the entire surface of the core body 201, the water-soluble protective film 203 is attached to the surface of the antibody attachment layer 202, the colloidal gold attachment layer 204 is attached to the surface of the water-soluble protective film 203, and the outer water-soluble protective film 205 is attached to the surface of the colloidal gold attachment layer 204.

[0031] The antibody attachment layer 202, water-soluble protective film 203, colloidal gold attachment layer 204, and outer water-soluble protective film 205 are sequentially superimposed and attached to the surface of the ellipsoid core 201. During testing, saliva can melt the water-soluble protective film 203 and the outer water-soluble protective film 205, allowing the colloidal gold to capture and label viral antigens in the saliva. The labeled antigens are captured by the specific antibody attachment layer 202 attached to the surface of the core 201, forming a combination of antibody, antigen, and colloidal gold particles. A large number of these combined particles accumulate on the surface of the core 201, presenting a visible color surface. This design allows colloidal gold to directly label specific antigens in oral saliva, eliminating the need for swab sampling, making the operation simple. Furthermore, the labeled specific antigens are captured by the specific antibodies attached to the core sphere 201 in the mouth and then accumulate on the sphere surface, making the effect more obvious, easy to identify, and achieving high detection accuracy.

[0032] The core polymer 201 is food-grade silica gel, an inorganic polymer colloidal material formed by the polycondensation of silicic acid. Its primary component is SiO2·nH2O, exceeding 98%. It is non-toxic, odorless, and chemically stable. Under normal conditions, it does not react with any acids, bases, or salts except caustic soda and hydrofluoric acid. Due to its colloidal structure, it possesses numerous micropores and a large specific surface area. The pore size of food-grade silica gel is approximately 8-10 nm, with a specific surface area of ​​300-500 m² / g. Its hydrophilic surface strongly absorbs reconstituted specific antibodies and is non-toxic, odorless, highly transparent, and non-yellowing. It is also soft, elastic, and kink-resistant.

[0033] The core body 201 ellipsoid has a major axis diameter of 1.2-1.5 cm and a minor axis diameter of 0.8-1 cm, and the size should be convenient for users to use in the mouth.

[0034] Both the water-soluble protective film 203 and the outer water-soluble protective film 205 are made of polyvinyl alcohol (PVA). Polyvinyl alcohol (PVA) is a water-soluble polymer characterized by good density, high crystallinity, strong adhesion, and the resulting film is flexible, smooth, abrasion-resistant, and gas-barrier. PVA is non-toxic, odorless, and harmless to the human body, has good affinity with the natural environment, and does not accumulate or pollute.

[0035] In addition, a method for manufacturing a viral antigen detection stick is provided, which is used to manufacture the viral antigen detection stick, and specifically comprises the following steps:

[0036] Step 1: Use plastic to form a cylindrical stick with a length of 10-15 cm and a diameter of 1-2 mm to obtain a handheld stick 1;

[0037] Step 2: Using a polymer with microporous surfaces, an ellipsoid is injection molded into a core body 201. The ellipsoid has a major axis diameter of 1.2-1.5 cm and a minor axis diameter of 0.8-1 cm. The core body 201 is provided with a mounting hole corresponding to one end of the handheld stick in step 1. The ellipsoid is then fixed to the front end of the handheld stick 1 through the mounting hole.

[0038] Step 3: After remelting, the specific antibody for virus detection is evenly sprayed onto the surface of the core body by spraying. After dehydration and drying, the antibody is tightly attached to the surface of the core body to form an antibody attachment layer 202;

[0039] Step 4: spray a water-soluble polymer liquid evenly onto the surface of the antibody attachment layer 202, and form a water-soluble protective film 203 after drying;

[0040] Step 5: Take a colloidal gold solution and spray it evenly on the surface of the water-soluble protective film 203 by spraying, and form a colloidal gold adhesion layer 204 after drying;

[0041] Step six: take a water-soluble polymer liquid and spray it evenly on the surface of the colloidal gold adhesion layer 204 by a spraying method, and form an outer water-soluble protective film 205 after drying.

[0042] Among them, the microporous polymer in step 2 is food-grade silica gel, and the micropore diameter of the food-grade silica gel surface is about 8-10nm, and the specific surface area is 300-500m² / g.

[0043] Wherein, the water-soluble polymer in step 4 and step 6 is polyvinyl alcohol.

[0044] Specific usage:

[0045] 1. Remove the outer packaging of the test stick;

[0046] 2. Hold the handle of the test stick and insert the end with the olive-shaped structure deep into the mouth and throat;

[0047] 3. Keep rotating and moving the olive. Rotate 3 to 5 times to make the olive touch every part of the mouth as much as possible.

[0048] 4. Squeeze the handle and remove the olive at one end of the handle;

[0049] 5. Observe the color of the olive surface. If the surface is visible, it means that the test is positive for the specific antigen. If there is no color, it means it is negative.

[0050] In addition to the above, it should be noted that references to "one embodiment," "another embodiment," "an embodiment," and the like in this specification refer to specific features, structures, or characteristics described in conjunction with that embodiment as included in at least one embodiment generally described in this application. The appearance of the same expression in multiple places in the specification does not necessarily refer to the same embodiment. Furthermore, when a specific feature, structure, or characteristic is described in conjunction with any embodiment, it is intended that such feature, structure, or characteristic, when implemented in conjunction with other embodiments, also falls within the scope of the present invention.

[0051] Although the present invention has been described herein with reference to a number of illustrative embodiments thereof, it will be understood that numerous other modifications and implementations may be devised by those skilled in the art that fall within the scope and spirit of the principles disclosed herein. More specifically, within the scope of the present disclosure, the drawings, and the claims, numerous variations and modifications may be made to the components and / or layout of the subject combination arrangement. In addition to variations and modifications to the components and / or layout, other uses will also be apparent to those skilled in the art.

Claims

1. A viral antigen detection stick, comprising a handheld stick and a detection portion fixed to the front end of the handheld stick, characterized in that: The detection part includes a core body, an antibody attachment layer, a water-soluble protective film, a colloidal gold attachment layer, and an outer water-soluble protective film. The core body is a microporous polymer ellipsoid fixed to the front end of the handheld stick. The antibody attachment layer is attached to the entire surface of the core body, the water-soluble protective film is attached to the surface of the antibody attachment layer, the colloidal gold attachment layer is attached to the surface of the water-soluble protective film, and the outer water-soluble protective film is attached to the surface of the colloidal gold attachment layer. The core body is food grade silica gel, the micropore diameter of the food grade silica gel surface is 8-10nm, and the specific surface area is 300-500m² / g.

2. The viral antigen detection stick according to claim 1, characterized in that: The core body ellipsoid has a major axis diameter of 1.2-1.5 cm and a minor axis diameter of 0.8-1 cm.

3. The viral antigen detection stick according to claim 1, wherein: The material of the water-soluble protective film is polyvinyl alcohol.

4. The viral antigen detection stick according to claim 1, wherein: The outer water-soluble protective film is made of polyvinyl alcohol.

5. A method for manufacturing a viral antigen detection stick, characterized in that: The steps include: Step 1: Use plastic to make a cylindrical stick by injection molding, with a length of 10-15 cm and a diameter of 1-2 mm, to obtain a handheld stick; Step 2: Using a microporous polymer, a spheroid is injection molded into a core body. The diameter of the major axis of the spheroid is 1.2-1.5 cm, the diameter of the minor axis is 0.8-1 cm, and a mounting hole corresponding to one end of the handheld stick in step 1 is left. The spheroid is then fixed to the front end of the handheld stick through the mounting hole. Step 3: After remelting, the specific detection antibody corresponding to the virus is evenly sprayed onto the surface of the core body by spraying. After dehydration and drying, the antibody is tightly attached to the surface of the core body to form an antibody attachment layer; Step 4: spraying a water-soluble polymer liquid evenly on the surface of the antibody attachment layer, and forming a water-soluble protective film after drying; Step 5: Take the colloidal gold solution and spray it evenly on the surface of the water-soluble protective film by spraying, and form a colloidal gold adhesion layer after drying; Step 6: spraying a water-soluble polymer liquid evenly on the surface of the colloidal gold attachment layer, and forming an outer water-soluble protective film after drying; The microporous high molecular polymer in step 2 is food grade silica gel, and the micropore diameter of the food grade silica gel surface is 8-10 nm, and the specific surface area is 300-500 m² / g.

6. The method for manufacturing a viral antigen detection stick according to claim 5, wherein: The water-soluble polymer in step 4 and step 6 is polyvinyl alcohol.

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