A blow sampling virus antigen detection kit and a method of using the same

Abstract

This invention discloses a blow-type sampling viral antigen detection kit and its usage method, including a sampler, a blow nozzle, a detection working column, and a equilibration liquid dropper. Sampling is performed by blowing air, a simple sampling method that reduces the probability of sampling errors in untrained individuals. Equilibration liquid is dripped into the funnel-shaped opening of the sampler's receiving tank through the equilibration liquid dropper, continuously eluting the biological sample. The operation is simple and effective. The equilibration liquid, along with the eluted biological sample, enters a colloidal gold filter. The colloidal gold is re-dissolved, captures and labels the viral antigen in the solution. The labeled antigen then enters an antibody filter impregnated with specific antibodies, where it is captured by those antibodies, forming a conjugate of antibody, antigen, and colloidal gold microparticles. A large number of these conjugate microparticles aggregate on the filter membrane above the absorbent cotton column, resulting in color development. The sample elution step is simple, the sampling method is reliable, and the detection and colorimetric observation are easy to perform, making it convenient for the general public to use.

Description

Technical Field

[0001] This invention relates to the field of viral antigen detection technology, and more specifically, to a blow-type sampling viral antigen detection kit and its usage method. Background Technology

[0002] Viruses cause harm to humans. The transmission routes of viruses are complex. Respiratory transmission is a very common mode of viral transmission. Using technological means to quickly identify and characterize the type and nature of viruses, and to promptly identify and treat infected individuals, are crucial methods for controlling the spread of related viruses.

[0003] Antigen detection technology is one of the main detection methods. Antigen detection measures proteins on the surface of viruses, primarily using saliva (pharyngeal swabs) and nasal mucus (nasal swabs). Utilizing the principle of specific binding between antigens and antibodies, the presence of antigens can be detected by antibodies, thus proving the presence of a specific virus in the sample. The antibodies used in virus detection are usually artificial antibodies, whose properties are similar to those of antibodies found in the human body. When testing for different viruses, artificial antibodies corresponding to that virus can be used. These are collectively referred to as specific antibodies. Currently, to detect different types of viruses, various test kits using colloidal gold technology are available on the market. These kits generally use colloidal gold as a marker and employ different artificial antibodies (specific antibodies) to capture the labeled antigens. Although colloidal gold spheres have a larger diameter and relatively lower sensitivity compared to other smaller-diameter markers such as fluorescent microspheres and latex microspheres, making them unsuitable for quantitative detection, viral detection kits using colloidal gold technology do not require specialized reading instruments, unlike fluorescent microspheres and latex microspheres which require specialized instruments to interpret the results. Furthermore, the reaction time is short, typically only 15–20 minutes, and the results are readily readable, requiring no complex professional knowledge from the testing personnel.

[0004] While current virus detection kits using colloidal gold technology have the advantages mentioned above, they also have the following significant drawbacks, as described below:

[0005] 1. When using nasal swabs for sampling, the number of samples adhering to the cotton ball during wiping is limited due to the relatively small wiping area;

[0006] 2. The swab head needs to be stored in the preservation solution for a sufficient time before the sample on the swab can be eluted into the preservation solution;

[0007] 3. When the sample volume in the preservation solution is relatively small, and the amount of preservation solution added to the sample well of the kit is also small, the amount of sample that can be labeled with gold is relatively small, and the color development is not obvious enough.

[0008] The above three factors can all lead to test failure. In addition, existing test kits involve steps such as swab sampling, sample elution, and sample placement on the test card. These processes are prone to errors for untrained individuals when performing self-testing. In practice, a significant proportion of test failures are due to incorrect sampling and operation methods. Therefore, further design of viral antigen detection kits is needed to facilitate use by the general public. Summary of the Invention

[0009] The purpose of this invention is to address the above-mentioned shortcomings by providing a blow-type sampling viral antigen detection kit and its usage method, in order to solve the technical problems of complex viral antigen detection steps and easy errors in the prior art.

[0010] To solve the above-mentioned technical problems, the present invention adopts the following technical solution:

[0011] This invention provides a blow-type sampling viral antigen detection kit, including a sampler, a blow nozzle, a detection working column, and a balance drop bottle;

[0012] The sampler includes a liquid receiving tank and a filter plate. The liquid receiving tank is a bell-shaped open cylinder. The filter plate is fixed inside the bottom opening of the liquid receiving tank. A detachable connection port is provided on the outside of the bottom opening of the liquid receiving tank.

[0013] The detection column includes a functional section and an observation section. The functional section is a cylinder with an open top and a closed bottom. A colloidal gold filter and an antibody filter are sequentially and fixedly attached to the inner side of the functional section cylinder from top to bottom. A detection fixing port corresponding to the detachable connection port of the sampler is provided on the inner side of the upper opening of the functional section cylinder. An observation section embedding edge is provided on the inner side of the lower opening of the functional section cylinder. The observation section is a cylinder with an open top and a closed bottom. A fixing edge corresponding to the observation section embedding edge is provided on the outer side of the upper opening of the observation section cylinder. A filter membrane and an absorbent cotton column are sequentially and fixedly attached to the inner side of the observation section cylinder from top to bottom.

[0014] The sampler is fixed to the detection working column functional section detection fixing port through the detachable connection port at the bottom of the liquid receiving tank, and the filter is tightly attached to the colloidal gold filter; the observation section is fixed through the upper opening and embedded in the lower side of the observation section along the rear filter membrane tightly attached to the antibody filter.

[0015] The air nozzle is a hollow cylinder with a sampling fixing port on the inner side of the front opening corresponding to the sampler liquid receiving tank detachable connection port. The sampler is fixed to the front sampling fixing port of the air nozzle through the detachable connection port at the bottom of the liquid receiving tank, and the filter sheet seals the front opening of the air nozzle.

[0016] The equilibrium liquid dropper is a separate, independent unit with an internal equilibrium liquid receiving chamber and a dropper at the top. After the sampler is fixed on the detection column, the equilibrium liquid is dripped into the sampler's liquid receiving tank.

[0017] Furthermore, the air-blowing sampling viral antigen detection kit also includes a snap-in insertion slot, which is set separately and independently, with a slot in the middle corresponding to the detection working column.

[0018] Furthermore, the detachable connection port at the bottom of the liquid receiving tank is an external thread located on the outside of the opening, the detection fixing port is an internal thread located on the inside of the opening at the upper end of the functional section cylinder corresponding to the external thread of the detachable connection port, and the sampling fixing port is an internal thread located on the inside of the external thread of the detachable connection port located on the front end opening of the air nozzle.

[0019] Furthermore, the filter sheet is made of fiber filter cotton with a thickness of 1-2 mm.

[0020] Furthermore, the colloidal gold filter is a circular sheet of fiber filter cotton impregnated with resolvable colloidal gold.

[0021] Furthermore, the antibody filter is a circular piece of fiber filter cotton impregnated with antibodies.

[0022] Furthermore, the filter membrane is a cellulose acetate membrane.

[0023] A method for using a breath-sampling viral antigen detection kit, the method comprising the following steps:

[0024] Step 1: Fix the sampler in the above device to the sampling port at the front end of the air nozzle through the detachable connection port at the bottom of the liquid receiving tank. Then, put the rear end of the air nozzle into the mouth, bring the air intake end close to the root of the tongue, purse your lips, and blow the air expelled from the lungs into the sampler evenly and forcefully. During the blowing process, some liquid in the mouth is allowed to enter the sampler with the airflow. Repeat 3-4 times.

[0025] Step 2: Remove the sampler and fix it to the detection fixing port of the functional section of the detection working column through the detachable connection port at the bottom of the liquid receiving tank. The filter should be tightly attached to the colloidal gold filter.

[0026] Step 3: Vertically insert the detection work column into the insertion slot of the above device and fix it in place;

[0027] Step 4: Take the equilibrium liquid dropper from the above device and evenly drip the equilibrium liquid into the funnel-shaped opening of the sampler's liquid receiving tank one drop at a time through the dropper nozzle. The amount of equilibrium liquid dripped in should be the upper limit of the water absorption capacity of the absorbent cotton column in the detection working column.

[0028] Step 5: Remove the functional segment of the detection work column from the observation segment;

[0029] Step 6: Observe the color displayed on the filter membrane in the observation section, record the detection result represented by the color, and complete the detection process.

[0030] Compared with existing technologies, the advantages of this invention are: it uses a blowing method for sampling, which is simple and eliminates the need for swab sampling at specific points, reducing the probability of sampling errors in untrained populations; in addition, by dripping equilibration solution into the funnel-shaped opening of the sampler's receiving tank through an equilibration solution dropper, the equilibration solution continuously washes off the biological sample from the sampler's filter by percolation. The equilibration solution, along with the washed-off biological sample, enters the colloidal gold filter. The colloidal gold impregnated on the filter is re-dissolved, and due to electrostatic interaction, the colloidal gold captures and labels the viral antigens in the solution. The labeled antigens enter the antibody filter impregnated with specific antibodies and are captured by the specific antibodies impregnated on the filter, forming a complex of antibody, antigen, and colloidal gold microparticles. A large number of these complex microparticles aggregate on the filter membrane above the absorbent cotton column, resulting in color development. The sample elution step is simple, the probability of error in dripping from the funnel opening is low, and the detection and color development are simple and convenient for the general public to use. Attached Figure Description

[0031] Figure 1 This is a cross-sectional schematic diagram of the air-blowing sampling viral antigen detection kit in an embodiment of the present invention;

[0032] Figure 2 This is a cross-sectional view of the sampler fixed on the air nozzle in an embodiment of the present invention;

[0033] Figure 3 This is a cross-sectional schematic diagram of the sampler fixed on the detection working column in an embodiment of the present invention.

[0034] The annotations in the attached figures are explained as follows:

[0035] 1 is a sampler, 2 is an air nozzle, 3 is a detection working column, 4 is a balance solution dropper, 101 is a liquid receiving tank, 102 is a filter, 103 is a detachable connection port, 201 is a sampling fixing port, 301 is a functional section, 302 is an observation section, 303 is a colloidal gold filter, 304 is an antibody filter, 305 is a detection fixing port, 306 is the inner edge of the observation section, 307 is the fixing edge, 308 is a filter membrane, 309 is an absorbent cotton column, 401 is a balance solution receiving chamber, 402 is a dropper, 5 is a cannula groove, and 501 is a slot. Detailed Implementation

[0036] The invention will now be further described with reference to the accompanying drawings.

[0037] refer to Figure 1 , Figure 2 and Figure 3As shown, an embodiment of the present invention is a blow-type sampling viral antigen detection kit, which, importantly, includes a sampler 1, a blow nozzle 2, a detection working column 3, and a balance drop bottle 4;

[0038] Sampler 1 includes a liquid receiving tank 101 and a filter 102. The liquid receiving tank 101 is a bell-shaped open cylinder. The filter 102 is fixed in the bottom opening of the liquid receiving tank. A detachable connection port 103 is provided on the outside of the bottom opening of the liquid receiving tank 101.

[0039] The detection column 3 includes a functional section 301 and an observation section 302. The functional section 301 is a cylinder with an open top and a closed bottom. Colloidal gold filter 303 and antibody filter 304 are sequentially and tightly fixed inside the cylinder from top to bottom. The inner side of the upper opening of the cylinder is provided with a detection fixing port 305 corresponding to the detachable connection port 103 of the sampler 1. The inner side of the lower opening of the cylinder is provided with an observation section embedded edge 306. The observation section 302 is a cylinder with an open top and a closed bottom. The outer side of the upper opening of the cylinder is provided with a fixing edge 307 corresponding to the observation section embedded edge 306. The inner side of the cylinder is sequentially and tightly fixed with a filter membrane 308 and absorbent cotton column 309 from top to bottom.

[0040] Sampler 1 is fixed to the functional section 301 of the detection working column 3 via the detachable connection port 103 at the bottom of the liquid receiving tank 101. After the detection fixing port 305, the filter 102 is tightly attached to the colloidal gold filter 303. The observation section 302 is embedded in the lower observation section of the functional section 301 via the upper opening fixing edge 307. After the observation section embedding edge 306, the filter membrane 308 is tightly attached to the antibody filter 304.

[0041] The mouthpiece 2 is a hollow cylinder. The front opening has a sampling fixing port 201 corresponding to the detachable connection port 103 of the sampler 1 liquid receiving tank 101. The sampler 1 is fixed to the front sampling fixing port 201 of the mouthpiece 2 through the detachable connection port 103 at the bottom of the liquid receiving tank 101. The filter 102 seals the front opening of the mouthpiece 2. The mouthpiece 2 is a hollow tubular body. Its air inlet part is a flat hollow tube, and the rear part gradually transitions to a hollow cylinder. The change in appearance is mainly to adapt to being placed in the mouth for blowing air. The mouthpiece 2 has a sampling fixing port 201 at the tail end. When sampling is required, the sampler 1 is fixed on the mouthpiece 2, the air inlet end is brought close to the root of the tongue, the lips are pursed, and the air expelled from the lungs is blown evenly and forcefully into the sampler 1. During the blowing process, some liquid in the oral cavity is allowed to enter the sampler 1 with the airflow. The sampling is repeated 3 to 4 times.

[0042] After sampling is completed, the sampler 1 is separated from the air nozzle 2. The sampler 1 is fixed to the detection fixing port 305 of the functional section 301 of the detection working column 3 through the detachable connection port 103 at the bottom of the liquid receiving tank 101. The filter 102 is tightly attached to the colloidal gold filter 303 before the next step of sample elution is carried out.

[0043] The equilibration solution dropper 4 is a separate, independent unit with an internal equilibration solution receiving chamber 401 and a dropper 402 at the top. After the sampler 1 is fixed on the detection column 3, the equilibration solution is dripped into the flared mouth of the sampler 1's receiving tank 101. The dripping method is simple, and the flared mouth has a large receiving opening, making it less prone to errors. The equilibration solution continuously washes off the biological sample on the filter 102 through percolation. The equilibration solution, along with the washed-off biological sample, enters the colloidal gold filter 303. The colloidal gold impregnated on the filter is re-dissolved. Due to electrostatic action, the colloidal gold captures the viral antigen in the solution and simultaneously labels it. The labeled antigen enters the antibody filter 304, which is impregnated with specific antibodies. It is captured by the specific antibodies impregnated on the filter, forming a complex of antibody, antigen, and colloidal gold microparticles. The solution carrying the complex continues to percolate downwards. A large number of these complex microparticles accumulate on the filter membrane 308 above the absorbent cotton column 309, exhibiting a visible detection color effect.

[0044] The advantages of this design are: Sampling is performed by blowing air, which is simple and eliminates the need for swab sampling, reducing the probability of sampling errors in untrained individuals; Furthermore, by dripping equilibration solution into the funnel-shaped opening of the sampler 1's receiving tank 101 through the equilibration solution dropper 4, the equilibration solution continuously washes away the biological sample from the sampler 1's filter 102 via percolation. The equilibration solution, along with the washed-off biological sample, enters the colloidal gold filter 303. The colloidal gold impregnated on the filter is re-dissolved, and due to electrostatic attraction, the colloidal gold captures and labels the viral antigens in the solution. The labeled antigens then enter the antibody filter 304, which is impregnated with specific antibodies, and are captured by these antibodies, forming a complex of antibody, antigen, and colloidal gold microparticles. A large number of these complex microparticles aggregate on the filter membrane 308 above the absorbent cotton column 309, resulting in color development. The sample elution process is simple, the probability of error from dripping through the funnel opening is low, and the detection and color development are easy to observe, making it convenient for the general public to use.

[0045] A further design feature is that the air-blowing sampling viral antigen detection kit also includes a snap-fit ​​insertion slot 5. The insertion slot 5 is a separate and independent unit with a corresponding slot 501 for the detection working column 3 in the middle. This slot is mainly used to fix the detection working column 3 during detection for ease of use.

[0046] More specifically, the detachable connection port 103 at the bottom of the liquid receiving tank 101 is an external thread located on the outside of the opening, the detection fixing port 305 is an internal thread located on the inside of the opening at the upper end of the cylindrical part of the functional section 301 corresponding to the external thread of the detachable connection port 103, and the sampling fixing port 201 is an internal thread located on the inside of the opening at the front end of the air nozzle 2. The threaded connection method is simple and easy to use.

[0047] More specifically, the filter 102 is a fiber filter cotton with a thickness of 1-2mm, which can trap saliva during the blowing process and facilitate sample elution.

[0048] More specifically, the colloidal gold filter 303 is a circular fiber filter cotton disc impregnated with resolvable colloidal gold. The synthetic fiber filter cotton disc is immersed in a colloidal gold aqueous solution. The synthetic fiber filter cotton disc that has been soaked in the colloidal gold aqueous solution is taken out and dried and dehydrated, and then used to become a colloidal gold filter 303 impregnated with a large amount of resolvable colloidal gold and with good permeability.

[0049] More specifically, antibody filter 304 is a circular fiber filter cotton disc impregnated with antibodies. The synthetic fiber filter cotton disc is impregnated in an aqueous solution of a specific antibody. The synthetic fiber filter cotton disc impregnated with the specific antibody aqueous solution is taken out and dried to remove water. It is then used to become a specific antibody filter 304 impregnated with a large amount of specific antibodies and with good permeability. The specific antibody aqueous solution can be selected according to the specific virus type to be detected.

[0050] More specifically, the filter membrane 308 is a cellulose acetate membrane. With the help of the capillary action of the absorbent cotton column 309 below it, the equilibration solution can pass through and be drawn into the absorbent cotton column 309, while the conjugates of antibodies, antigens and colloidal gold microparticles are trapped above the colorimetric filter membrane 308. The large amount of conjugates of antibodies, antigens and colloidal gold microparticles accumulates, making the colorimetric filter membrane appear red, indicating the virus detection result.

[0051] In addition, a method for using a breath-sampling viral antigen detection kit is designed. This method uses the aforementioned breath-sampling viral antigen detection kit and includes the following steps:

[0052] Step 1: Fix the sampler 1 in the above device to the sampling fixing port 201 at the front end of the air nozzle 2 through the detachable connection port 103 at the bottom of the liquid receiving tank 101. Then, put the rear end of the air nozzle 1 into the mouth, bring the air intake end close to the root of the tongue, purse your lips, and blow the air expelled from the lungs into the sampler 1 evenly and forcefully. During the blowing process, some liquid in the mouth is allowed to enter the sampler 1 with the airflow. Repeat 3-4 times to complete the sampling.

[0053] Step 2: Remove sampler 1 and fix sampler 1 to the detection fixing port 305 of functional section 301 of detection working column 3 through the detachable connection port 103 at the bottom of liquid receiving tank 101. Filter 102 is tightly attached to colloidal gold filter 303.

[0054] Step 3: Vertically insert the detection work column 3 into the insertion slot 5 of the above device and fix it in place;

[0055] Step 4: Take the balance liquid dropper 4 from the above device and evenly drip the balance liquid into the funnel-shaped opening of the liquid receiving tank 101 of the sampler 1 one drop at a time through the dropper 402. The amount of balance liquid dripped in is limited to the water absorption capacity of the absorbent cotton column 309 in the detection working column.

[0056] Step 5: Remove the functional segment 301 of the detection work column 3 from the observation segment 302;

[0057] Step 6: Observe the color displayed on the filter membrane 308 in observation section 302, record the detection result represented by the color, and complete the detection process.

[0058] In addition to the above, it should be noted that the terms "one embodiment," "another embodiment," and "embodiment" used in this specification refer to specific features, structures, or characteristics described in connection with that embodiment, which are included in at least one embodiment described in the general description of 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 connection with any embodiment, the intention is to suggest that implementing such a feature, structure, or characteristic in conjunction with other embodiments also falls within the scope of this invention.

[0059] Although the invention has been described herein with reference to several illustrative embodiments, it should be understood that many other modifications and implementations can be devised by those skilled in the art, which will fall within the scope and spirit of the principles disclosed herein. More specifically, various variations and modifications can be made to the components and / or layout of the subject matter combination within the scope of the disclosure, drawings, and claims. Besides variations and modifications to the components and / or layout, other uses will be apparent to those skilled in the art.

Claims

1. A blow-type sampling viral antigen detection kit, characterized in that: Includes sampler, air nozzle, detection column, and balance drop bottle; The sampler includes a liquid receiving tank and a filter plate. The liquid receiving tank is a bell-shaped open cylinder. The filter plate is fixed inside the bottom opening of the liquid receiving tank. A detachable connection port is provided on the outside of the bottom opening of the liquid receiving tank. The detection column includes a functional section and an observation section. The functional section is a cylinder with an open top and a closed bottom. A colloidal gold filter and an antibody filter are sequentially and fixedly attached to the inner side of the functional section cylinder from top to bottom. A detection fixing port corresponding to the detachable connection port of the sampler is provided on the inner side of the upper opening of the functional section cylinder. An observation section embedding edge is provided on the inner side of the lower opening of the functional section cylinder. The observation section is a cylinder with an open top and a closed bottom. A fixing edge corresponding to the observation section embedding edge is provided on the outer side of the upper opening of the observation section cylinder. A filter membrane and an absorbent cotton column are sequentially and fixedly attached to the inner side of the observation section cylinder from top to bottom. The sampler is fixed to the detection working column functional section detection fixing port through the detachable connection port at the bottom of the liquid receiving tank, and the filter is tightly attached to the colloidal gold filter; the observation section is fixed through the upper opening and embedded in the lower side of the observation section along the rear filter membrane tightly attached to the antibody filter. The air nozzle is a hollow cylinder with a sampling fixing port on the inner side of the front opening corresponding to the sampler liquid receiving tank detachable connection port. The sampler is fixed to the front sampling fixing port of the air nozzle through the detachable connection port at the bottom of the liquid receiving tank, and the filter sheet seals the front opening of the air nozzle. The equilibrium liquid dropper is a separate, independent unit with an internal equilibrium liquid receiving chamber and a dropper at the top. After the sampler is fixed on the detection column, the equilibrium liquid is dripped into the sampler's liquid receiving tank.

2. The air-blowing sampling viral antigen detection kit according to claim 1, characterized in that: The air-blowing sampling viral antigen detection kit also includes a cannula slot, which is set separately and independently, with a slot in the middle corresponding to the detection working column.

3. The air-blowing sampling viral antigen detection kit according to claim 1, characterized in that: The detachable connection port at the bottom of the liquid receiving tank is an external thread located on the outside of the opening. The detection fixing port is an internal thread located on the inside of the opening at the upper end of the functional section cylinder, corresponding to the external thread of the detachable connection port. The sampling fixing port is an internal thread located on the inside of the external thread of the detachable connection port located on the front end of the air nozzle opening.

4. The air-blowing sampling viral antigen detection kit according to claim 1, characterized in that: The filter sheet is made of fiber filter cotton with a thickness of 1-2 mm.

5. The air-blowing sampling viral antigen detection kit according to claim 1, characterized in that: The colloidal gold filter is a circular sheet of fiber filter cotton impregnated with resolvable colloidal gold.

6. The air-blowing sampling viral antigen detection kit according to claim 1, characterized in that: The antibody filter is a circular piece of fiber filter cotton impregnated with antibodies.

7. The air-blowing sampling viral antigen detection kit according to claim 1, characterized in that: The filter membrane is a cellulose acetate membrane.

8. A method for using a blow-type sampling viral antigen detection kit, characterized in that, The method uses the air-blowing sampling viral antigen detection kit according to any one of claims 1-7, and includes the following steps: Step 1: Fix the sampler to the sampling port at the front of the air nozzle through the detachable connection port at the bottom of the liquid collection tank. Then, put the rear end of the air nozzle into the mouth, bring the air intake end close to the root of the tongue, purse your lips, and blow the air expelled from the lungs into the sampler evenly and forcefully. During the blowing process, some liquid in the mouth is allowed to enter the sampler with the airflow. Repeat 3-4 times. Step 2: Remove the sampler and fix it to the detection fixing port of the functional section of the detection working column through the detachable connection port at the bottom of the liquid receiving tank. The filter should be tightly attached to the colloidal gold filter. Step 3: Vertically insert the detection work column into the insertion slot in claim 2 and fix it in place; Step 4: Take the equilibrium solution dropper bottle and evenly drip the equilibrium solution into the funnel-shaped opening of the sampler's liquid receiving tank one drop at a time through the dropper nozzle. The amount of equilibrium solution dripped in should be the upper limit of the water absorption capacity of the absorbent cotton column in the detection working column. Step 5: Remove the functional segment of the detection work column from the observation segment; Step 6: Observe the color displayed on the filter membrane in the observation section, record the detection result represented by the color, and complete the detection process.

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