A rapid test strip for viral antigens

Abstract

The utility model provides a kind of virus antigen rapid detection test paper, it is related to biological detection technical field, multi-dimensional gradient compound synergistic component, integrate dendritic flow guide groove and nano microporous structure on sample pad, it can promote processing liquid and sample to be radially evenly distributed in diffusion process, on the one hand, effectively avoid the detection interference caused by local liquid concentration too high, on the other hand, significantly shorten the liquid infiltration time of detection starting stage, improve chromatography efficiency, set up gradient distribution's antigen line on NC membrane, its virus specificity antigen concentration is increasing distribution from the end close to binding pad to bibulous pad, accurately adapt the detection requirement of different virus load sample, low virus load sample because of less combined compound, can flow to bibulous pad end high concentration antigen area sufficient combination and produce strong signal, avoid missed detection, high virus load sample because of compound sufficiency, preferentially and binding pad end low concentration antigen area quickly combine, effectively avoid signal inhibition or false negative problem.

Description

Technical Field

[0001] This utility model relates to the field of biological detection technology, and in particular to a rapid test strip for viral antigen detection. Background Technology

[0002] Viral antigens are substances contained in viruses that can induce an immune response and stimulate antibody formation. They are exogenous complete antigens with immunogenicity and immunoreactivity. These antigens can exist in different parts of the virus, such as the surface, middle or core. Different viruses may contain multiple antigens. After the virus enters the human body, it is recognized by immunoglobulins on B cells and processed by antigen-presenting cells, thereby activating T cells and triggering an immune response.

[0003] A rapid viral antigen test strip is a diagnostic tool based on immunochromatography technology used to detect the presence of a specific viral antigen. These test strips typically contain specific antibodies that can bind to the target antigen to form a complex, thereby enabling rapid detection of the virus.

[0004] The existing rapid test strip for viral antigens has the following shortcomings:

[0005] Sample pads often use linear flow channels or no flow channel structure, causing liquid to accumulate at the edges or center, resulting in insufficient wetting and leading to local concentrations that are too high or too low. Furthermore, anti-interference treatment solutions usually need to be added manually, which results in large errors in dosage control and inaccurate drop position. On the other hand, NC membranes are only set to a single concentration antigen line, which cannot be adapted to a wide viral load range, leading to weak signals due to insufficient antigen-antibody binding and thus inaccurate test results. Utility Model Content

[0006] This invention proposes a multi-dimensional gradient composite enhancement component, which utilizes a sample pad with a tree-like guide groove and nanopores to promote radial and uniform diffusion of the treatment liquid and sample. This avoids excessively high local concentrations and shortens the liquid immersion time at the beginning of the detection process, thereby solving the problems mentioned in the background art.

[0007] To achieve the above objectives, the present invention adopts the following technical solution: a rapid test strip for viral antigens, comprising a base plate, a multidimensional gradient composite enhancement component disposed on the top of the base plate, and a pressing and puncturing component disposed on the top of the multidimensional gradient composite enhancement component;

[0008] The multidimensional gradient composite enhancement component includes a flow channel and a composite labeling part. The flow channel is in a tree-shaped radial pattern and is used to make the treatment liquid and sample diffuse evenly. Four treatment liquid capsules are provided on the outer periphery of the flow channel. The interior of the four treatment liquid capsules is filled with anti-interference treatment liquid. The composite labeling part is made of fluorescent microspheres and superparamagnetic gold nanocomposite.

[0009] The press-and-puncture assembly includes a press plate with four pins connected to its bottom, the four pins being used to puncture the treatment fluid capsule upon pressing.

[0010] Preferably, the top of the base plate has a groove, and a top plate is embedded between the inner surfaces of the groove.

[0011] Preferably, the multidimensional gradient composite enhancement component further includes a base pad, the flow channel is formed on the top of the base pad, the bottom of each of the four processing liquid capsules is connected to a microchannel, the bottom of each of the four microchannels is connected to the flow channel, and the base pad, the flow channel, the four processing liquid capsules, and the four microchannels constitute a sample pad, which is used for uniform mixing and diffusion of the sample and the processing liquid. A support substrate is connected to one side of the outer wall of the base pad, the top of the support substrate is connected to the bottom of the composite labeling part, and the bottom of the support substrate is connected to the top of the base plate, and the support substrate and the composite labeling part constitute a binding pad, which is used to achieve specific binding of viral antigens and labeling materials in the sample.

[0012] Preferably, a membrane substrate is connected to one side of the outer wall of the supporting substrate. A coating is applied to the top of the membrane substrate, and a set of antigen lines are installed on the top of the coating. The bottom of the membrane substrate is connected to the bottom of the base plate. The membrane substrate, the coating, and the set of antigen lines constitute an NC detection membrane. The NC detection membrane is used to visualize the detection signal. An inner layer is connected to one side of the outer wall of the membrane substrate. An outer layer is connected to the top of the inner layer. A set of trapezoidal serrations are formed on the edge of the outer layer. The bottom of the inner layer is connected to the bottom of the base plate. The inner and outer layers constitute an absorbent pad. The absorbent pad drives the liquid to flow in a directional manner. The concentration of virus-specific antigens in the set of antigen lines increases from the conjugate pad end to the absorbent pad end, and is uniformly diffused by the tree-like guide grooves and directionally driven by the inner and outer layers in the absorbent pad.

[0013] Preferably, the bottom of the pressing plate is fixedly connected to four solid rods, and the outer surfaces of the four solid rods are all fixedly fitted with sliders, and the bottoms of the four sliders are all elastically connected with springs.

[0014] Preferably, the pressing and puncturing component further includes four holes, the inner surfaces of the four holes are symmetrically provided with grooves, and each set of grooves is slidably connected to a corresponding slider. The bottom of the inner wall of each of the four holes is elastically connected to a corresponding spring, and the four holes are all located at the top of the top plate.

[0015] Compared with the prior art, the advantages and positive effects of this utility model are as follows:

[0016] 1. In this invention, by setting up a multi-dimensional gradient composite enhancement component, a tree-like guide channel and a nanoporous structure are integrated on the sample pad. This promotes a radial and uniform distribution of the processing liquid and sample during diffusion. On the one hand, it effectively avoids detection interference caused by excessively high local liquid concentrations; on the other hand, it significantly shortens the liquid immersion time at the beginning of detection, improving chromatography efficiency. A gradient distribution of antigen lines is set on the NC membrane, with the virus-specific antigen concentration increasing from near the binding pad end to the absorbent pad end. This precisely adapts to the detection needs of samples with different viral loads. Low viral load samples, due to fewer binding complexes, can flow to the absorbent pad end. The high-concentration antigen region at the end of the water pad fully binds and generates a strong signal, avoiding missed detections. Samples with high viral loads, due to sufficient complexes, preferentially bind to the low-concentration antigen region at the end of the binding pad, effectively avoiding signal inhibition or false negatives caused by an imbalance in the antigen-antibody ratio. At the same time, serrated cuts are set at the edge of the absorbent pad to break up air bubbles generated during chromatography, ensuring uniform and continuous signal bands. The absorbent pad adopts a double-layer composite structure. The inner layer is a large-pore cellulose filter paper, which can quickly absorb liquid to form a continuous chromatographic driving force. The outer layer is a small-pore glass fiber, which ensures sufficient antigen-antibody reaction by precisely controlling the liquid flow rate.

[0017] 2. In this utility model, by setting up a pressing and puncturing component, the pressure plate is connected to the slider through four corner springs. When pressing, the springs are compressed evenly, avoiding the tilting of the pressure plate caused by pressing on one side, and ensuring that the four needles at the bottom puncture the capsule simultaneously. This solves the drawback of needing to rely on external parts or puncturing if necessary. At the same time, after pressing is completed, the spring drives the pressure plate to automatically reset. At this time, the needles are disengaged from the capsule, which can prevent the needles from being stuck and causing leakage of the treatment liquid or the entry of external contaminants. This design provides a fundamental guarantee for the stability and accuracy of the entire detection process. Attached Figure Description

[0018] Figure 1 This is a three-dimensional view of the main structure of a rapid viral antigen test strip proposed in this utility model;

[0019] Figure 2 This is a three-dimensional side view of the structure of a rapid viral antigen test strip proposed in this utility model;

[0020] Figure 3 This is a three-dimensional cross-sectional view of a rapid viral antigen test strip proposed in this utility model;

[0021] Figure 4 An exploded view of the multidimensional gradient composite enhancement component in a rapid viral antigen test strip proposed in this utility model;

[0022] Figure 5 This invention proposes a rapid test strip for viral antigen detection. Figure 4 Enlarged view of the structure at point A in the image;

[0023] Figure 6 This is a diagram showing the positional relationship between the pressure-puncture component and the multi-dimensional gradient composite enhancement component in a rapid viral antigen test strip proposed in this utility model.

[0024] Figure 7 This invention proposes a rapid test strip for viral antigen detection. Figure 6 Enlarged view of the structure at point B in the image.

[0025] Legend: 1. Base plate; 2. Top plate; 3. Pressing and puncturing assembly; 301. Pressing plate; 302. Ejector pin; 303. Solid rod; 304. Slider; 305. Spring; 306. Hole; 4. Multidimensional gradient composite enhancement assembly; 401. Base pad; 402. Guide channel; 403. Processing fluid capsule; 404. Microchannel; 405. Supporting substrate; 406. Composite marking section; 407. Membrane substrate; 408. Coating; 409. Antigen line; 410. Inner layer; 411. Outer layer. Detailed Implementation

[0026] To better understand the above-mentioned objectives, features, and advantages of this utility model, the present utility model will be further described below with reference to the accompanying drawings and embodiments. It should be noted that, unless otherwise specified, the embodiments and features described in these embodiments can be combined with each other.

[0027] Many specific details are set forth in the following description in order to provide a full understanding of the present invention. However, the present invention may also be implemented in other ways different from those described herein. Therefore, the present invention is not limited to the specific embodiments disclosed in the following specification.

[0028] In the embodiments, please refer to the appendix. Figure 1 - Appendix Figure 3 As shown, this utility model provides a technical solution: a rapid test strip for viral antigens, including a base plate 1, a multidimensional gradient composite enhancement component 4 and a press-to-puncture component 3, all of which are installed on the top of the base plate 1, and the press-to-puncture component 3 is installed on the top of the multidimensional gradient composite enhancement component 4.

[0029] The top of the base plate 1 has a groove, and the top plate 2 is embedded between the inner surfaces of the groove.

[0030] Specifically: First, check the appearance of the base plate 1 for any damage. Then, align the top plate 2 with one side of the outer wall of the base plate 1 to see if the dimensions allow for complete insertion. The base plate 1 provides effective support for the entire rapid test strip and protects it from damage or contamination due to external forces. When the rapid test strip is needed for testing, the operator first places the entire test strip flat on the table and manually presses the pressing plate 301. Under the force, the pressing plate 301 drives the ejector pin 302 to puncture the processing liquid capsule 403, releasing the anti-interference processing liquid. At this time, the liquid is guided to flow through the tree-like guide grooves 402 on the sample pad surface and quickly and evenly wets the sample. The entire sample pad, after the secretions or serum are dripped in, is mixed with the sample and the processing solution and spread evenly in the tree-shaped guide channel 402, avoiding local accumulation. The processed sample then flows sequentially along the rear end of the sample pad into the binding pad, which is composed of the support substrate 405 and the composite labeling part 406. The binding pad is used to achieve specific binding between the viral antigen in the sample and the labeling material. The NC detection membrane is composed of the membrane substrate 407, the coating 408, and a set of antigen lines 409. The NC detection membrane is used to visualize the detection signal. The absorbent pad is composed of the inner layer 410 and the outer layer 411, and the absorbent pad drives the liquid to flow in a directional manner, thereby completing the entire detection process.

[0031] In some embodiments, according to Figures 3-5 As shown, the multidimensional gradient composite enhancement component 4 includes a flow channel 402 and a composite labeling part 406. The flow channel 402 is in a tree-shaped radial pattern and is used to make the processing liquid and sample diffuse evenly. Four processing liquid capsules 403 are provided on the outer periphery of the flow channel 402. The interior of the four processing liquid capsules 403 is filled with anti-interference processing liquid. The composite labeling part 406 is made of fluorescent microspheres and superparamagnetic gold nanocomposite.

[0032] The multidimensional gradient composite enhancement component 4 also includes a base layer 401, a flow channel 402 on the top of the base layer 401, and microchannels 404 connected to the bottom of each of the four processing liquid capsules 403. The bottom of each of the four microchannels 404 is connected to the flow channel 402. The base layer 401, the flow channel 402, the four processing liquid capsules 403, and the four microchannels 404 together form a sample pad. The sample pad is used for uniform mixing and diffusion of the sample and the processing liquid. A support substrate 405 is connected to one side of the outer wall of the base layer 401. The top of the support substrate 405 is connected to the bottom of the composite labeling part 406, and the bottom of the support substrate 405 is connected to the top of the base plate 1. The support substrate 405 and the composite labeling part 406 together form a binding pad. The binding pad is used to achieve specific binding of viral antigens and labeling materials in the sample.

[0033] A membrane substrate 407 is connected to one side of the outer wall of the support substrate 405. A coating 408 is coated on the top of the membrane substrate 407. A set of antigen lines 409 are installed on the top of the coating 408. The bottom of the membrane substrate 407 is connected to the bottom of the base plate 1. The membrane substrate 407, the coating 408, and the set of antigen lines 409 constitute an NC detection membrane. The NC detection membrane is used to visualize the detection signal. An inner layer 410 is connected to one side of the outer wall of the membrane substrate 407. An outer layer 411 is connected to the top of the inner layer 410. A set of trapezoidal serrations are opened on the edge of the outer layer 411. The bottom of the inner layer 410 is connected to the bottom of the base plate 1. The inner layer 410 and the outer layer 411 constitute an absorbent pad. The absorbent pad drives the liquid to flow in a directional manner. The concentration of virus-specific antigens of the set of antigen lines 409 increases from the conjugate pad end to the absorbent pad end. The concentration is uniformly diffused by the tree-shaped guide groove 402 and driven directionally by the inner layer 410 and the outer layer 411 in the absorbent pad.

[0034] The overall effect of this embodiment is as follows: The staff first places the test paper flat on the table and manually presses the pressing plate 301. Under pressure, the pressing plate 301 drives the pin 302 to puncture the treatment liquid capsule 403, releasing the anti-interference treatment liquid. This treatment liquid can pre-wash the sample pad composed of the base pad layer 401, the guide groove 402, the treatment liquid capsule 403, and the microchannel 404. Then, secretions or serum are manually dripped in. The tree-shaped radial guide groove 402 and the microchannel 404 in the sample pad work together to make the sample and treatment liquid fully mixed and evenly spread, avoiding local accumulation. The treated sample flows from the rear end of the sample pad into the binding pad composed of the supporting substrate 405 and the composite labeling part 406. The fluorescent microspheres added to the composite labeling part 406 can emit light under ultraviolet light excitation, making it easy to observe the signal with the naked eye or instruments. The superparamagnetic gold nanocomposite enriches low concentrations of virus by magnetic properties, improving the detection rate of trace viruses. After the viral antigens in the sample bind to the labeling material, they flow with the liquid towards the NC detection membrane. The NC detection membrane consists of a membrane substrate 407, a coating 408, and a set of antigen lines 409. The membrane substrate 407 is made of porous PVDF membrane, which has higher mechanical strength and a faster liquid flow rate than traditional NC membranes. This characteristic reduces excessive dilution of the sample during flow, ensuring that low viral load samples can effectively flow through the gradient antigen lines 409 and reach the downstream area. The set of antigen lines 409 are distributed in a gradient on the membrane, with the antigen concentration increasing from near the binding pad end to the absorbent pad end. When the viral antigens flow through the gradient antigen lines 409, low viral load samples, due to the smaller number of bound complexes, can smoothly reach the absorbent pad end under the rapidly flowing liquid, fully bind with the high concentration of antigen there, and emit a strong signal, effectively avoiding excessive dilution of the sample. The problem of weak signals caused by small sample volume and dilution during flow is addressed. High viral load samples, due to sufficient complexes, will preferentially bind to low-concentration antigens at the binding pad end. By utilizing the matching between low-concentration antigens and excess complexes, the detection signal inhibition caused by antigen excess is avoided. During the detection process, the inner layer 410 of the absorbent pad quickly absorbs the liquid on the NC membrane, forming a continuous and stable sample flow dynamic. Combined with the rapid flow rate of the PVDF membrane, this further ensures that the sample flows efficiently through the gradient antigen line 409. The outer layer 411 is made of glass fiber, which controls the liquid flow rate to avoid signal band blurring. Its trapezoidal serrations can break air bubbles in the flow, and the hydrophilic nanofibers in the serrations guide the liquid in the air bubbles back, effectively eliminating the obstruction of the detection line by air bubbles, and ultimately achieving accurate detection of viral samples with a wide viral load range.

[0035] according to Figures 1-3 as well as Figures 6-7 As shown, the press-and-puncture assembly 3 includes a press plate 301, and four ejector pins 302 are connected to one side of the outer wall of the press plate 301. The four ejector pins 302 are used to puncture the treatment fluid capsule 403.

[0036] Four solid rods 303 are fixedly connected to one side of the outer wall of the pressing plate 301. Slider 304 is fixedly sleeved on the outer surface of each of the four solid rods 303. Springs 305 are elastically connected to one side of the outer wall of each of the four sliders 304.

[0037] The pressing and puncturing component 3 also includes four holes 306. The inner surfaces of the four holes 306 are symmetrically provided with grooves, and each set of grooves is slidably connected to a corresponding slider 304. The bottom of the inner wall of each of the four holes 306 is elastically connected to a corresponding spring 305. All four holes 306 are opened on the outer surface of the top plate 2.

[0038] The overall effect of this embodiment is as follows: When performing rapid viral antigen detection, the staff first places the test strip flat on the table. The four holes 306 on the outer surface of the top plate 2 are each equipped with an elastic mechanism consisting of a spring 305 and a slider 304. The slider 304 slides with the inner wall of the hole 306 through a groove structure, and its inner side is fixedly sleeved with a solid rod 303. The upper end of the solid rod 303 is rigidly connected to the pressing plate 301, and the lower end is coaxially fixed with four ejector pins 302. When the staff manually presses the pressing plate 301, the mechanical force is transmitted to the ejector pins 302 through the solid rod 303, which simultaneously drives the slider 304 to slide downward in the hole 306, compressing the spring 305 at the bottom. When the tip of the ejector pin 302 contacts the processing liquid capsule 403, the concentrated pressure punctures the capsule, releasing the anti-interference processing liquid. The processing liquid diffuses along the tree-shaped guide groove 402 on the surface of the sample pad, starting the subsequent detection process. After the pressing plate 301 is released, the compressed spring 305 releases its elastic potential energy, pushing the slider 304 to return to its original position along the inner wall of the hole 306. This causes the pressing plate 301 and the ejector pin 302 to rise back to their initial positions synchronously. Through the mechanical linkage design of the spring 305 and the slider 304, this structure achieves one-way triggering and automatic reset of the pressing and puncturing action, ensuring the stability, accuracy and convenience of the operation.

[0039] The above description is merely a preferred embodiment of the present utility model and is not intended to limit the present utility model in any other way. Any person skilled in the art may make changes or equivalent variations to the above-disclosed technical content and apply them to other fields. However, any simple modifications, equivalent variations and alterations made to the above embodiments based on the technical essence of the present utility model without departing from the technical solution of the present utility model shall still fall within the protection scope of the technical solution of the present utility model.

Claims

1. A rapid test strip for viral antigens, comprising a substrate (1), characterized in that: The multidimensional gradient composite enhancement component (4) is located on the top of the base plate (1), and the pressing and puncturing component (3) is located on the top of the multidimensional gradient composite enhancement component (4); The multidimensional gradient composite enhancement component (4) includes a flow channel (402) and a composite labeling part (406). The flow channel (402) is in a tree-shaped radial pattern and is used to make the processing liquid and sample diffuse evenly. Four processing liquid capsules (403) are provided on the outer periphery of the flow channel (402). The interior of the four processing liquid capsules (403) is filled with anti-interference processing liquid. The composite labeling part (406) is made of fluorescent microspheres and superparamagnetic gold nanocomposite. The press-and-puncture assembly (3) includes a press plate (301) with four pins (302) connected to the bottom of the press plate (301), the four pins (302) being used to puncture the treatment fluid capsule (403) upon pressing.

2. The rapid viral antigen test strip according to claim 1, characterized in that: The top of the base plate (1) has a groove, and the top plate (2) is embedded between the inner surfaces of the groove.

3. The rapid viral antigen test strip according to claim 1, characterized in that: The multidimensional gradient composite enhancement component (4) also includes a base layer (401), the flow channel (402) is opened on the top of the base layer (401), the bottom of the four processing liquid capsules (403) are all connected to microchannels (404), the bottom of the four microchannels (404) are all connected to the flow channel (402), and the base layer (401), the flow channel (402), the four processing liquid capsules (403), and the four microchannels (404) form a sample pad, which is used for uniform mixing and diffusion of the sample and the processing liquid. The outer wall of the base layer (401) is connected to a support substrate (405), the top of the support substrate (405) is connected to the bottom of the composite labeling part (406), the bottom of the support substrate (405) is connected to the top of the base plate (1), and the support substrate (405) and the composite labeling part (406) form a binding pad, which is used to achieve specific binding of viral antigens and labeling materials in the sample.

4. The rapid viral antigen test strip according to claim 3, characterized in that: The outer wall of the supporting substrate (405) is connected to a membrane substrate (407). A coating (408) is applied to the top of the membrane substrate (407), and a set of antigen lines (409) is mounted on the top of the coating (408). The bottom of the membrane substrate (407) is connected to the bottom of the base plate (1). The membrane substrate (407), coating (408), and set of antigen lines (409) constitute an NC detection membrane. The NC detection membrane is used to visualize the detection signal. An inner layer (410) is connected to the outer wall of the membrane substrate (407). The top of the inner layer (410) is connected to the outer layer (411), and the edge of the outer layer (411) is provided with a set of trapezoidal serrations. The bottom of the inner layer (410) is connected to the bottom of the base plate (1), and the inner layer (410) and the outer layer (411) form an absorbent pad. The absorbent pad drives the liquid to flow in a directional manner. The concentration of virus-specific antigens of a set of antigen lines (409) increases from the conjugate pad end to the absorbent pad end, and is uniformly diffused by the tree-shaped guide groove (402) and directionally driven by the inner layer (410) and the outer layer (411) in the absorbent pad.

5. The rapid viral antigen test strip according to claim 1, characterized in that: The bottom of the pressing plate (301) is fixedly connected to four solid rods (303), and the outer surfaces of the four solid rods (303) are all fixedly fitted with sliders (304), and the bottoms of the four sliders (304) are all elastically connected with springs (305).

6. The rapid test strip for viral antigens according to claim 1, characterized in that: The pressing and puncturing component (3) also includes four holes (306). The inner surfaces of the four holes (306) are symmetrically provided with grooves, and each set of grooves is slidably connected to a corresponding slider (304). The bottom of the inner wall of each of the four holes (306) is elastically connected to a corresponding spring (305). The four holes (306) are all located on the top of the top plate (2).

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