Multi-item combined immunochromatography detection kit

Abstract

The utility model discloses a multi-item joint immunochromatography detection kit, which relates to the technical field of instant detection and comprises a test strip, a clamping groove bottom plate and an upper cover, a sample pad sample adding area is arranged in the middle of the clamping groove bottom plate, a plurality of test strip fixing grooves which are independently arranged are distributed on the periphery of the sample pad sample adding area in the circumferential direction, and the upper cover is arranged in the test strip fixing grooves. The test strip is arranged in the test strip fixing groove; the upper cover can be buckled on the top of the clamping groove bottom plate, a detection result observation window and a sample application hole are formed in the upper cover, the detection result observation window is opposite to the NC film on the test strip, and the sample application hole is opposite to the sample adding area of the sample pad; the multi-pathogen synchronous detection of a single sample can be realized, the flowing path of the sample can be controlled by the independent groove body structure, the isolation of each detection area is realized, and the detection accuracy is ensured.

Description

Technical Field

[0001] This invention relates to the field of point-of-care testing technology, and in particular to a multi-component combined immunochromatographic assay kit. Background Technology

[0002] Lateral flow assay (LFA), as a core method for point-of-care testing (POCT), has been widely applied in medical diagnostics, food safety, and environmental monitoring due to its speed, simplicity, and cost-effectiveness. Traditional LFA test strips mostly employ a linear stacked structure, driving sample flow through capillary action and relying on a single detection line for target identification. However, with increasingly complex clinical and public health needs, the demand for simultaneous detection of multiple pathogens (such as respiratory viruses and enteric pathogens) has significantly increased, revealing the following key shortcomings in existing technologies:

[0003] Insufficient multi-line detection capability: Traditional test strips require multiple test lines to be set in parallel on the same NC membrane, which can easily lead to uneven sample distribution. The sensitivity of the test lines near the sample pad decreases due to excessive sample consumption, while the test lines at the far end may produce false negatives due to flow rate attenuation.

[0004] Risk of cross-interference: When multiple antibodies coexist, non-specific binding or signal crosstalk (such as diffusion of fluorescent markers) may cause false positives, especially when detecting targets with similar structures (such as influenza virus subtypes).

[0005] Operational complexity and space constraints: Existing multi-piece test strips usually require multiple sample additions or rely on complex microfluidic structures, which increases the number of operation steps and costs, and the linear layout limits the expansion of detection throughput.

[0006] In recent years, some studies have attempted to improve detection throughput through multi-channel or array-based designs. However, such solutions often rely on precision manufacturing techniques (such as microfluidic chips), resulting in high production costs and large sample volume requirements, making it difficult to meet the rapid screening needs in resource-constrained scenarios. In addition, while circular or disk-shaped structures have potential in terms of uniform diffusion and space utilization, problems such as uncontrollable sample flow paths and poor isolation of detection areas remain unresolved in existing technologies, limiting their practical application. Utility Model Content

[0007] The purpose of this invention is to provide a multi-pathogen combined immunochromatographic assay kit to solve the problems existing in the prior art. It can realize the simultaneous detection of multiple pathogens in a single sample. The independent tank structure can control the sample flow path, realize the isolation of each detection area, and ensure the accuracy of detection.

[0008] To achieve the above objectives, this utility model provides the following solution:

[0009] This invention provides a multi-component combined immunochromatographic assay kit, comprising a test strip, a slot base plate, and a top cover. The center of the slot base plate is a sample pad application area, and multiple independently arranged test strip fixing slots are distributed circumferentially around the sample pad application area. The test strip is placed in the test strip fixing slot. The top cover can be fastened to the top of the slot base plate. The top cover is provided with a test result observation window and a sample application hole. The test result observation window is opposite to the NC membrane on the test strip, and the sample application hole is opposite to the sample pad application area.

[0010] Preferably, the test strip consists of a sample pad, a conjugate pad, an NC membrane, and absorbent paper from one end to the other, and the sample pad overlaps with the sample pad provided on the sample pad application area.

[0011] Preferably, the test strip fixing groove is provided with 8 grooves and is evenly distributed around the outer periphery of the sample pad sample application area.

[0012] Preferably, each of the fixing slots includes two slot walls arranged radially along the slot base plate, the slot walls protruding from the slot base plate.

[0013] Preferably, the upper cover has eight rows of test strip positioning parts corresponding to the eight test strip fixing slots. Each row of test strip positioning parts includes three straight protrusions. The three straight protrusions are arranged radially on the inner side of the test result observation window. When the upper cover is fastened to the card slot bottom plate, the straight protrusions can abut against the test strip in the test strip fixing slot, thereby fixing the position of the test strip.

[0014] Preferably, both the card slot base plate and the top cover are circular.

[0015] Preferably, the outer and inner rings of the card slot base plate are respectively provided with a ring of positioning pin one and a ring of positioning pin hole one, and the corresponding outer and inner rings of the upper cover are respectively provided with a ring of positioning pin hole two and a ring of positioning pin two. When the card slot base plate and the upper cover are fastened together, the positioning pin one is inserted into the positioning pin hole two and the positioning pin two is inserted into the positioning pin hole one to achieve fastening.

[0016] Preferably, the positioning pin and the positioning pin hole are evenly distributed circumferentially on the card slot bottom plate.

[0017] Preferably, the second positioning pin and the second positioning pin hole are evenly distributed circumferentially on the upper cover.

[0018] The present invention achieves the following technical advantages over the prior art:

[0019] This invention relates to a multi-pathogen combined immunochromatographic assay kit, which features multiple independent test strip fixing slots arranged circumferentially within the kit body. Each test strip is fixed in a different slot, enabling simultaneous detection of multiple pathogens in a single sample. The independent slot structure controls the sample flow path, isolating each detection area and ensuring detection accuracy. The circumferential distribution of the test strip fixing slots ensures uniform sample distribution, overcomes the throughput limitations of traditional linear structures, and guarantees the sensitivity of each test strip. A single sample application well allows for simultaneous detection of multiple pathogens with a single application, improving operational convenience. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 This is a three-dimensional structural diagram of the card slot base plate in this utility model;

[0022] Figure 2 This is a schematic diagram of the front structure of the card slot base plate in this utility model;

[0023] Figure 3 This is a three-dimensional structural diagram of the upper cover in this utility model;

[0024] Figure 4 This is a front view of the upper cover in this utility model.

[0025] Figure 5 This is a schematic diagram of the back structure of the upper cover in this utility model;

[0026] Figure 6 This is a distribution diagram of the test paper strips on the card slot bottom plate of this utility model;

[0027] In the diagram: 1. Test strip; 2. Card slot base plate; 3. Top cover; 4. Sample pad application area; 5. Test strip fixing slot; 6. Observation window for test results; 7. Sample spotting hole; 8. Sample pad; 9. Binding pad; 10. NC membrane; 11. Absorbent paper; 12. Slot wall; 13. I-shaped boss; 14. Positioning pin one; 15. Positioning pin hole one; 16. Positioning pin hole two; 17. Positioning pin two. Detailed Implementation

[0028] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0029] The purpose of this invention is to provide a multi-component combined immunochromatographic assay kit to address the problems existing in the prior art.

[0030] To make the above-mentioned objectives, features and advantages of this utility model more apparent and understandable, the utility model will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0031] The multiple combined immunochromatographic assay kits in this embodiment, such as Figures 1-6 As shown, the system includes a test strip 1, a card slot base plate 2, and a top cover 3. The center of the card slot base plate 2 is the sample pad application area 4. Multiple independently positioned test strip fixing slots 5 are distributed circumferentially around the sample pad application area 4, and the test strip 1 is placed within each of these slots. The top cover 3 can be fastened to the top of the card slot base plate 2. The top cover 3 has a test result observation window 6 and a sample application hole 7. The test result observation window 6 is opposite to the NC membrane 10 on the test strip 1, and the sample application hole 7 is opposite to the sample pad application area 4. The sample pad 8 serves as the initial reaction position, homogenizing the sample, filtering out sample impurities, and regulating the sample liquid flow rate. The sample pad 8 is made of glass fiber pretreated with a pretreatment solution, which optimizes the physicochemical properties of the sample, such as pH and viscosity, promotes the stable release of the target analyte antigen, and homogenizes the liquid to suit subsequent chromatography reactions.

[0032] In this specific embodiment, the test strip 1 consists of a sample pad 8, a conjugate pad 9, an NC membrane 10, and absorbent paper 11 from one end to the other. The sample pad 8 overlaps with the sample pad provided on the sample pad application area 4.

[0033] Binding pad 9 serves as the marker release interface and is crucial for the binding of the antigen and latex microsphere-labeled antibody complex. Binding pad 9 uses a polyester membrane as a carrier, loading antibodies (the markers) containing latex microspheres. During sample chromatography, the sample permeates from sample pad 8 to binding pad 9, where the target analyte antigen binds to the antibody valently coupled to the latex microspheres on binding pad 9, forming an "antigen-antibody-latex microsphere" complex.

[0034] NC membrane 10, serving as the core reaction carrier, is the final reaction site for the double-antibody sandwich. NC membrane 10 balances capillary flow rate and reaction time through its micron-sized pores, and its surface is pre-coated with a detection line (T-line) and a control line (C-line). The detection line (T-line) consists of a fixed, coated capture antibody that binds a second time to the complex that has chromatographically migrated from conjugate pad 9 to NC membrane 10, forming an "antibody-antigen-antibody-latex microsphere" double-antibody sandwich structure. If the target analyte concentration in the sample is sufficient, the latex microspheres aggregate and develop color, ultimately forming a red reaction line. The control line (C-line) consists of a fixed, coated secondary antibody, goat anti-mouse IgG, which captures free markers that have not bound to the T-line antibody, forming a red reaction line to verify the chromatographic reaction process.

[0035] The absorbent paper 11 maintains the unidirectional capillary action of the liquid flow through its highly absorbent material, preventing back osmosis. The liquid flows from the NC membrane 10 to the absorbent paper 11, and the chromatography ends.

[0036] In this specific embodiment, eight test strip fixing slots 5 are provided and are evenly distributed circumferentially around the outer periphery of the sample pad application area 4. Each fixing slot includes two slot walls 12 arranged radially along the slot base plate 2, and the slot walls 12 protrude from the slot base plate 2. The arrangement of the slot walls 12 makes each test strip fixing slot 5 independent, controls the sample flow path, and achieves isolation of each detection area.

[0037] In this specific embodiment, the upper cover 3 is provided with 8 rows of test strip 1 positioning parts corresponding to 8 test strip fixing slots 5. Each row of test strip 1 positioning parts includes three straight protrusions 13. The three straight protrusions 13 are arranged radially in sequence on the inner side of the test result observation window 6. When the upper cover 3 is fastened to the card slot bottom plate 2, the straight protrusions 13 can abut against the test strip 1 in the test strip fixing slot 5 and thus fix the position of the test strip 1.

[0038] In this specific embodiment, both the card slot base plate 2 and the top cover 3 are circular. The outer and inner rings of the card slot base plate 2 are respectively provided with a ring of positioning pin 14 and a ring of positioning pin hole 15. The corresponding outer and inner rings of the top cover 3 are respectively provided with a ring of positioning pin hole 26 and a ring of positioning pin 27. When the card slot base plate 2 and the top cover 3 are fastened together, the positioning pin 14 is inserted into the positioning pin hole 26 and the positioning pin 27 is inserted into the positioning pin hole 15 to achieve fastening.

[0039] In this specific embodiment, positioning pin 14 and positioning pin hole 15 are evenly distributed circumferentially on the card slot bottom plate 2; positioning pin 2 17 and positioning pin hole 2 16 are evenly distributed circumferentially on the upper cover 3.

[0040] This utility model uses specific examples to illustrate its principles and implementation methods. The above description of the embodiments is only for the purpose of helping to understand the method and core idea of ​​this utility model. At the same time, for those skilled in the art, there will be changes in the specific implementation methods and application scope based on the idea of ​​this utility model. In summary, the content of this specification should not be construed as a limitation of this utility model.

Claims

1. A multi-component combined immunochromatographic assay kit, characterized in that: The device includes a test strip, a slot base plate, and a top cover. The center of the slot base plate is a sample pad application area. Multiple independently arranged test strip fixing slots are distributed circumferentially around the sample pad application area, and the test strips are placed in the test strip fixing slots. The top cover can be fastened to the top of the slot base plate. The top cover is provided with a test result observation window and a sample application hole. The test result observation window is opposite to the NC film on the test strip, and the sample application hole is opposite to the sample pad application area.

2. The multi-factor combined immunochromatographic assay kit according to claim 1, characterized in that: The test strip consists of a sample pad, a conjugate pad, an NC membrane, and absorbent paper, arranged sequentially from one end to the other. The sample pad overlaps with the sample pad placed on the sample pad application area.

3. The multi-factor combined immunochromatographic assay kit according to claim 1, characterized in that: The test strip fixing groove is provided with 8 grooves and is evenly distributed around the outer periphery of the sample pad sample application area.

4. The multi-factor combined immunochromatographic assay kit according to claim 3, characterized in that: Each of the fixing slots includes two slot walls arranged radially along the slot base plate, the slot walls protruding from the slot base plate.

5. The multi-factor combined immunochromatographic assay kit according to claim 3, characterized in that: The upper cover has eight rows of test strip positioning parts corresponding to the eight test strip fixing slots. Each row of test strip positioning parts includes three straight protrusions. The three straight protrusions are arranged radially on the inner side of the test result observation window. When the upper cover is fastened to the card slot bottom plate, the straight protrusions can abut against the test strip in the test strip fixing slot, thereby fixing the position of the test strip.

6. The multi-factor combined immunochromatographic assay kit according to claim 1, characterized in that: Both the card slot base plate and the top cover are circular.

7. The multi-factor combined immunochromatographic assay kit according to claim 1, characterized in that: The outer and inner rings of the card slot base plate are respectively provided with a ring of positioning pin one and a ring of positioning pin hole one. Correspondingly, the outer and inner rings of the upper cover are respectively provided with a ring of positioning pin hole two and a ring of positioning pin two. When the card slot base plate and the upper cover are fastened together, positioning pin one is inserted into positioning pin hole two and positioning pin two is inserted into positioning pin hole one to achieve fastening.

8. The multi-factor combined immunochromatographic assay kit according to claim 7, characterized in that: The positioning pin and the positioning pin hole are evenly distributed circumferentially on the bottom plate of the slot.

9. The multi-factor combined immunochromatographic assay kit according to claim 7, characterized in that: The second positioning pin and the second positioning pin hole are evenly distributed circumferentially on the upper cover.

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