Immunochromatography test strip detection device, immunochromatography kit and application thereof

By surrounding the sample loading area in the immunochromatography strip detection device, the limitations of detection speed and reagent consumption in the prior art are solved, and efficient detection of multiple markers and multiple samples is achieved.

CN119619494APending Publication Date: 2025-03-14ZHEJIANG ZHUNGE BIOTECHNOLOGY CO LTD
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Patent Information

Application Number
CN202411947484.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-27
Publication Date
2025-03-14

AI Technical Summary

Technical Problem

The existing in vitro diagnostic methods have limitations in detection speed, sample processing capacity and reagent consumption, and it is difficult to meet the demand for detecting multiple pathogens or markers simultaneously.

Method used

A cyclic immunochromatography test strip detection device and a kit are provided. By surrounding the sample loading area on the outer periphery of the liquid storage chamber, the space utilization rate of the test strip and the flexibility of the buffer solution are improved, and the detection of multiple markers and multiple samples is realized.

Benefits of technology

It improves the speed and sensitivity of detection, reduces sample loading errors and reagent consumption, and enhances the reliability of the detection results and the convenience of operation.

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Abstract

The invention discloses an immunochromatography test strip detection device, an immunochromatography kit and application of the immunochromatography test strip detection device and the immunochromatography kit, and relates to the technical field of immunochromatography. The immunochromatography test strip detection device provided by the invention can meet the detection requirements of multiple markers in a unified sample adding mode and the detection requirements of multiple markers of multiple samples in a single sample adding mode. The annular immunochromatography kit disclosed by the invention can be placed on a horizontal surface for detection. By means of the design, the mode that a traditional immunochromatography kit usually needs to be operated vertically is changed, the use convenience and safety are remarkably improved, and particularly, operation is more stable and reliable during reagent sample adding and result reading. Through the design that the sample adding area is arranged on the periphery of the liquid storage chamber in a surrounding mode, the reagent consumption is remarkably reduced through the improvement, and the burden of waste liquid treatment is reduced. The immunochromatography kit provided by the invention can be used for disease screening, pathogen detection, transgenic detection and biomarker analysis, and has a wide application prospect.
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Description

Technical Field

[0001] The present invention relates to the technical field of immunochromatography, and in particular to an immunochromatography test strip detection device, an immunochromatography kit and applications thereof. Background Art

[0002] Existing in vitro diagnostic methods usually use linear immunochromatography technology. However, this method has certain limitations in detection speed, sample processing capacity and reagent consumption, and cannot meet the needs of simultaneous detection of multiple pathogens or markers.

[0003] In view of this, the present invention is proposed. Summary of the invention

[0004] The object of the present invention is to provide an immunochromatographic test strip detection device, an immunochromatographic kit and applications thereof to solve the above technical problems.

[0005] The present invention is achieved in that:

[0006] In a first aspect, the present invention provides an immunochromatographic test strip detection device, comprising: a sample loading unit and a bottom plate, wherein the sample loading unit is located on the bottom plate, the sample loading unit comprises a liquid storage chamber and a sample loading area, and the sample loading area is arranged around the outer periphery of the liquid storage chamber; the sample loading area has a structure as shown in (1) or (2):

[0007] (1): A plurality of sample adding holes are arranged near the liquid storage chamber in the sample adding area, and a flow channel is provided under each sample adding hole in the sample adding area, and the flow channel extends toward the center and is connected to the liquid storage chamber, and the flow channel is used to insert the test strip;

[0008] (2): There is a flow channel in the sample addition area, and the flow channel extends toward the center and is connected to the liquid storage chamber. The flow channel is used to insert the test strip.

[0009] In a second aspect, the present invention further provides an immunochromatography kit, which comprises: a test strip and the above-mentioned immunochromatography test strip detection device, wherein the test strip is inserted into a flow channel of the immunochromatography test strip detection device.

[0010] In a third aspect, the present invention also provides an immunochromatographic test strip detection device or the above-mentioned immunochromatographic kit for use in the preparation of in vitro diagnostic products, transgenic detection products, environmental pollution detection, pesticide residue detection or pathogen detection products.

[0011] The present invention has the following beneficial effects:

[0012] The present invention provides a technical solution for circular flow immunoassay (CFIA); a sample addition area is arranged around the periphery of a liquid storage chamber. This helps to improve the utilization rate of test strips in space, and the distribution of test strips is more dense. The design of the liquid storage chamber can be adaptively selected according to the detection needs, which greatly improves the flexibility of buffer solution selection. The liquid storage chamber can be used to store buffer solution and / or lysis solution. When the sample to be tested is a solid sample or a sample with poor chromatographic performance, a buffer solution can be added to the liquid storage chamber to ensure that the sample is subjected to the best chromatographic environment.

[0013] On the one hand, the immunochromatographic test strip detection device provided by the present invention can meet the detection requirements of multiple markers in a unified loading mode, and the sample to be tested can be directly added to the liquid storage chamber, and the sample can evenly enter and diffuse to the flow channel of each test strip, avoiding loading errors and uneven situations, and facilitating rapid screening of multiple markers. On the other hand, the immunochromatographic test strip detection device provided by the present invention can meet the detection requirements of multiple markers of multiple samples in a single loading mode. In this mode, when loading samples, the samples are loaded one by one into the loading wells, and the loading wells are spaced apart from each other, avoiding the problem of inaccurate detection caused by mutual contamination.

[0014] The design of the annular immunochromatography kit of the present invention allows it to be placed stably on a horizontal surface (such as a desktop) for detection. This design changes the way traditional immunochromatography kits usually need to be operated upright, significantly improving the convenience and safety of use, especially when adding reagents and reading results, the operation is more stable and reliable. The flat-lying use design greatly reduces the risk of the kit tipping over or overturning due to external forces during the detection process. When traditional upright kits are in use, they are easily impacted or vibrated when unfolding solutions or moving samples, resulting in liquid leakage or contamination. The present invention effectively avoids these problems through a flat-lying design, ensuring the cleanliness of the experimental environment and the accuracy of detection.

[0015] Compared with the traditional immunochromatographic test kit design, the present invention greatly reduces the demand for buffer solution by surrounding the sample addition area on the periphery of the liquid storage chamber, and only a small amount of buffer solution is needed to achieve multiple immunochromatographic tests. This improvement significantly reduces reagent consumption, improves cost-effectiveness, and reduces the burden of waste liquid treatment.

[0016] The liquid adding area (liquid storage chamber and sample adding hole) of the present invention is concentrated in the central position of the reagent box, and the area is small, which can significantly reduce the possibility of solution exposure to the outside world and reduce the risk of contamination. The central liquid adding design combined with the flat use mode makes the reagent box more stable, reduces the possibility of solution diffusion or volatilization, and improves the reliability of the test results.

[0017] The immunochromatographic test strip detection device or immunochromatographic kit provided by the present invention also has the advantages of simple structure, convenient operation, high detection sensitivity, etc., and is suitable for disease screening, pathogen detection, transgenic detection and biomarker analysis, and has broad application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments are briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without creative work.

[0019] Figure 1 A physical picture of the multiple immunochromatography kit provided in Example 1;

[0020] Figure 2 A schematic diagram of the multiple immunochromatography kit provided in Example 1;

[0021] Figure 3 for Figure 2 Detailed schematic diagram of the flow channel and the liquid storage chamber;

[0022] Figure 4 A physical picture of the multiple immunochromatography kit provided in Example 2;

[0023] Figure 5 A schematic diagram of the multiple immunochromatography kit provided in Example 2;

[0024] Figure 6 A schematic side view of the test kit of Example 2;

[0025] Figure 7 It is a schematic diagram of the structure of a single test strip;

[0026] Figure 8 Schematic diagram of the joint testing of 11 sources of infection.

[0027] Figure numerals: 1-bottom plate; 2-test strip; 3-liquid storage chamber; 4-sample loading area; 5-test strip numbering area; 6-sample loading hole; 7-flow channel; 8-sample loading unit; 100-test kit. DETAILED DESCRIPTION

[0028] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the technical scheme in the embodiments of the present invention will be described clearly and completely below. If the specific conditions are not specified in the embodiments, they are carried out according to conventional conditions or conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be purchased commercially.

[0029] The features and performance of the present invention are further described in detail below in conjunction with the embodiments.

[0030] In a first aspect, the present invention provides an immunochromatographic test strip 2 detection device, which comprises: a sample loading unit 8 and a bottom plate 1, wherein the sample loading unit 8 is located on the bottom plate 1, and the sample loading unit 8 comprises a liquid storage chamber 3 and a sample loading area 4, wherein the sample loading area 4 is arranged around the outer periphery of the liquid storage chamber 3; the sample loading area 4 has a structure as shown in (1) or (2) below:

[0031] (1): The sample adding area 4 is provided with a plurality of sample adding holes 6 near the liquid storage chamber 3. The sample adding area 4 is also provided with a flow channel 7 below each sample adding hole 6. The flow channel 7 extends toward the center and is connected to the liquid storage chamber 3. The flow channel 7 is used to insert the test strip 2;

[0032] (2): A flow channel 7 is provided in the sample adding area 4, and the flow channel 7 extends toward the center and is connected to the liquid storage chamber 3, and the flow channel 7 is used for inserting the test strip 2.

[0033] The present invention provides a technical solution for circular flow immunoassay (CFIA); a sample addition area 4 is arranged around the periphery of a liquid storage chamber 3. This helps to improve the utilization rate of the test strip 2 in space, and the distribution of the test strip 2 is more dense. The design of the liquid storage chamber 3 can be adaptively selected according to the detection needs, which greatly improves the flexibility of buffer solution selection. The liquid storage chamber 3 can be used to store buffer solution and / or lysis solution. When the sample to be tested is a solid sample or a sample with poor chromatographic performance, a buffer solution can be added to the liquid storage chamber 3 to ensure that the sample is subjected to the best chromatographic environment.

[0034] When it is necessary to detect multiple markers or targets in the same sample, the sample addition area 4 shown in (1) or the sample addition area 4 shown in (2) can be used. When the sample addition area 4 shown in (1) is used, the sample to be tested is directly added to the liquid storage chamber 3, and there is no need to add samples to the sample addition holes 6 one by one. The liquid can flow evenly to the flow channels 7 of each test strip 2, thereby realizing immunochromatographic detection. When the sample addition area 4 shown in (2) is used, the sample to be tested is directly added to the liquid storage chamber 3, and the liquid can flow evenly to the flow channels 7 of each test strip 2, thereby realizing immunochromatographic detection.

[0035] When one or more markers (or targets) in multiple samples need to be detected, the samples to be tested are loaded one by one into the sample loading holes 6 by means of the sample loading area 4 shown in (1) for immunochromatographic detection.

[0036] Therefore, on the one hand, the immunochromatographic test strip 2 detection device provided by the present invention can meet the detection requirements of multiple markers in a unified loading mode, and the sample to be tested can be directly added to the liquid storage chamber 3, and the sample can be evenly diffused into the flow channel 7 of each test strip 2, avoiding loading errors and uneven situations, and facilitating rapid screening of multiple markers. On the other hand, the immunochromatographic test strip 2 detection device provided by the present invention can meet the detection requirements of multiple markers of multiple samples in a single loading mode. In this mode, when loading samples, the samples are loaded one by one into the loading holes 6, and the loading holes 6 are spaced apart from each other, avoiding the problem of inaccurate detection caused by mutual contamination.

[0037] The design of the annular immunochromatography kit 100 of the present invention allows it to be placed stably on a horizontal surface (such as a desktop) for detection. This design changes the way in which the traditional immunochromatography kit 100 usually needs to be operated upright, significantly improving the convenience and safety of use, especially when adding reagents and reading results, the operation is more stable and reliable. The flat-lying use design greatly reduces the risk of the kit 100 tipping over or overturning due to external forces during the detection process. When the traditional upright kit 100 is in use, it is easily hit or vibrated when unfolding the solution or moving the sample, resulting in liquid leakage or contamination. The present invention effectively avoids these problems through a flat design, ensuring the cleanliness of the experimental environment and the accuracy of the detection.

[0038] Compared with the design of the conventional immunochromatographic test kit 100, the present invention greatly reduces the demand for buffer solution by surrounding the sample addition area 4 on the periphery of the liquid storage chamber 3, and only a small amount of buffer solution is needed to achieve multiple immunochromatographic detection. This improvement significantly reduces reagent consumption, improves cost-effectiveness, and reduces the burden of waste liquid treatment.

[0039] The liquid adding area (liquid storage chamber 3 and sample adding hole 6) of the present invention is concentrated in the central position of the reagent box 100, and the area of ​​the liquid storage chamber 3 and the sample adding hole 6 is relatively small, which can significantly reduce the possibility of the solution being exposed to the outside world and reduce the risk of contamination. The central liquid adding design combined with the flat use mode makes the reagent box 100 more stable, reduces the possibility of solution diffusion or volatilization, and improves the reliability of the test results.

[0040] The cross-section of the flow channel 7 includes but is not limited to a U-shape, a V-shape, a square, a circle, or an ellipse, as long as it can meet the insertion requirements of the test strip 2.

[0041] The material of the bottom plate 1 is preferably plastic material, which is durable and cost-effective.

[0042] When the bottom plate 1 is circular, the diameter of the bottom plate 1 and the diameter of the sample loading unit 8 can be adjusted according to the number of channels.

[0043] A plurality of flow channels 7 are arranged at equal angular intervals on the periphery of the liquid storage chamber 3; preferably, the number of the flow channels 7 is a natural number between 2 and 100;

[0044] When the sample adding area 4 is annular, a plurality of flow channels 7 are arranged on the circumference at equal angular intervals. For example, the number of flow channels 7 is N, and the angular interval between two adjacent flow channels 7 is 360° / N.

[0045] For example, N is 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 16, 20, 30, 40, 50, 60, 70, 80, 90 or 100, or any value selected from the above point values.

[0046] The design requirements of flow channel 7 are as follows:

[0047] Width: Ensures sufficient space for testing reagents and samples.

[0048] Length: Sufficient to provide the necessary reaction distance and facilitate reagent flow.

[0049] Depth: Optimized to prevent evaporation and ensure reagent stability.

[0050] Channel spacing: Design reasonable spacing to prevent cross contamination and enhance detection reliability.

[0051] In a preferred embodiment of the present invention, the depth of the liquid storage chamber 3 is lower than the minimum depth of the sample addition hole 6. In other embodiments, the depth of the liquid storage chamber 3 is equal to or higher than the minimum depth of the sample addition hole 6, and the liquid storage chamber 3 also has a liquid storage side wall.

[0052] In a preferred embodiment of the present invention, a plurality of sample addition holes 6 are arranged in a ring array on the periphery of the liquid storage chamber 3. Such an arrangement helps to improve the space utilization of the test strips 2, and the distribution of the test strips 2 is more dense.

[0053] In a preferred embodiment of the present invention, the surface of the sample loading hole 6 is modified with a hydrophobic group or a hydrophilic group.

[0054] In a preferred embodiment of the present invention, the size of the plurality of sample addition holes 6 is smaller than or equal to the size of the sample pad of the test strip 2 .

[0055] In a preferred embodiment of the present invention, the liquid storage chamber 3 is circular, square, rectangular, diamond, heart-shaped, fan-shaped, trapezoidal or polygonal.

[0056] In a preferred embodiment of the present invention, a test strip numbering area 5 is provided on the periphery of the sample loading unit 8 or the outer edge of the bottom plate 1 .

[0057] In a preferred embodiment of the present invention, the test strip number area 5 has a barcode and a label.

[0058] In a preferred embodiment of the present invention, the thickness of the outer edge of the bottom plate 1 is greater than the thickness in the middle of the bottom plate 1;

[0059] In a preferred embodiment of the present invention, the immunochromatographic test strip 2 detection device further includes a cover or a sealing film, the cover is buckled on the sample loading unit 8, and the sealing film is arranged on the surface of the sample loading unit 8;

[0060] In a preferred embodiment of the present invention, the bottom of the sample loading unit 8 is sealed with the bottom plate 1 .

[0061] In a second aspect, the present invention further provides an immunochromatographic test kit 100, which comprises: a test strip 2 and the above-mentioned immunochromatographic test strip 2 detection device, wherein the test strip 2 is inserted into the flow channel 7 of the immunochromatographic test strip 2 detection device.

[0062] In a preferred embodiment of the present invention, the kit 100 further comprises at least one of the following solutions: a buffer solution and a lysis solution.

[0063] The buffer includes but is not limited to PBS buffer, Tris-HCl buffer, DPBS buffer, hepes-buffered HTF buffer or other cell culture buffer, such as phosphate buffer (PBS) with a pH of 5.0 to 8.0 and a concentration of 0.005M to 0.1M, and Tris-HCl buffer with a pH of 7.0 to 9.0 and a concentration of 0.005M to 1M.

[0064] The lysate is, for example, selected from biological lysate of plants, animals or microorganisms, and the lysate is used to directly detect biomarkers without extraction. The biological lysate can be selected from commercially available cell lysate, such as containing substances such as proteinase K and EDTA.

[0065] Buffer and / or lysis solution are used for solid samples or samples to be tested with poor chromatography performance. Buffer can be added to the liquid storage chamber 3 to ensure that the sample is tested under the best chromatography environment. When testing liquid samples or samples to be tested with good chromatography performance, buffer may not be added.

[0066] In a third aspect, the present invention also provides an immunochromatographic test strip 2 detection device or the above-mentioned immunochromatographic kit 100 for use in preparing in vitro diagnostic products, transgenic detection products, environmental pollution detection, pesticide residue detection or pathogen detection products.

[0067] In vitro diagnostics for at least one of the following indications: cancer, autoimmune disease, cardiovascular disease, diabetes, and infectious disease.

[0068] The samples to be tested are blood, body fluids, urine, saliva, reproductive tract secretions or other liquid samples or viscous samples from clinical or non-clinical sources. Non-clinical samples include samples from food testing, environmental pollution testing, pesticide residue testing, GMO testing, biological agent testing, veterinary testing, and drug testing.

[0069] Example 1

[0070] This embodiment provides an immunochromatographic test strip 2 detection device and a multiple immunochromatographic kit 100. The actual image of the kit 100 is shown in FIG. Figure 1 As shown, the structural diagram refers to Figure 2 shown.

[0071] The reagent kit 100 comprises: a sample loading unit 8 and a bottom plate 1, wherein the sample loading unit 8 is located on the bottom plate 1, and the sample loading unit 8 is divided into a liquid storage chamber 3 and a sample loading area 4, wherein the sample loading area 4 is arranged around the outer periphery of the liquid storage chamber 3; the sample loading area 4 is provided with a plurality of sample loading holes 6 near the liquid storage chamber 3 to facilitate sample loading or spotting, and the sample loading area 4 is provided with a flow channel 7 below each sample loading hole 6, and the flow channel 7 extends toward the center and communicates with the liquid storage chamber 3 (refer to Figure 3 As shown in FIG. 1 , the other end of the flow channel 7 extends outward. The flow channel 7 is used to insert the test strip 2.

[0072] In this embodiment, the sample loading unit 8 is integrally formed or assembled, and is made of plastic.

[0073] In this embodiment, 23 flow channels 7 are provided, corresponding to 23 sample addition holes 6 and 23 test strips 2. Figure 2 Only a portion of the test strip 2 is shown. 23 flow channels 7 are arranged on the circumference at equal angular intervals, and the angular interval between adjacent flow channels 7 is 15.6°.

[0074] When designing the flow channel 7, the width should be ensured to accommodate a sufficient amount of detection reagents and samples.

[0075] The length of the flow channel 7 should be sufficient to provide the necessary reaction distance and promote the flow of reagents.

[0076] Depth of flow channel 7: should be set appropriately to prevent evaporation and ensure reagent stability.

[0077] Channel 7 spacing: Design reasonable spacing to prevent cross contamination and enhance detection reliability.

[0078] In this embodiment, the liquid storage chamber 3 and the sample adding area 4 are both circular. In other embodiments, the shapes can be adjusted as needed.

[0079] The sample addition hole 6 is in the shape of a long strip in this embodiment, and can also be a round or square hole in other embodiments, which is optimized according to the detection sensitivity and type. Capacity: The hole capacity is optimized according to the reagent volume and detection sensitivity.

[0080] In order to enhance the reagent retention or the adhesion performance of specific cells, the surface of the sample addition hole 6 is also modified in this embodiment by using hydrophobic groups.

[0081] The outer periphery of the sample loading unit 8 is provided with a test strip numbering area 5; the test strip numbering area 5 has a barcode and a label. This is conducive to the unique identification of the flow channel 7 to be tested: each flow channel 7 is combined with a two-dimensional barcode for sample tracking and management. Clear label: used to identify each flow channel 7 and its corresponding test item, ensuring the accurate positioning of the sample and the result.

[0082] The immunochromatographic test strip 2 detection device also includes a cover or a sealing film, which is buckled on the sample loading unit 8 and the sealing film is arranged on the surface of the sample loading unit 8 to prevent the sample and reagent from evaporating and being contaminated. The bottom of the sample loading unit 8 is sealed with the bottom plate 1.

[0083] This embodiment is an independent sample addition mode. Each reagent strip can be selected according to the actual detection needs. It can be used for general screening or selective screening. Figure 7 As shown, the schematic diagram of the joint detection of 11 sources of infection is shown in Figure 8 shown.

[0084] The design of the reagent kit 100 provided in this embodiment meets the requirements of the automated dispensing system, ensuring efficient and accurate reagent dispensing.

[0085] Example 2

[0086] This embodiment provides another immunochromatographic test strip 2 detection device and a multiple immunochromatographic kit 100. The actual picture of the kit 100 is shown in FIG. Figure 4 As shown, the structural diagram refers to Figure 5 shown.

[0087] The reagent kit 100 comprises: a sample loading unit 8 and a bottom plate 1, wherein the sample loading unit 8 is located on the bottom plate 1, and the sample loading unit 8 is divided into a liquid storage chamber 3 and a sample loading area 4, wherein the sample loading area 4 is arranged around the outer periphery of the liquid storage chamber 3; a flow channel 7 is provided in the sample loading area 4, and the flow channel 7 extends toward the center and communicates with the liquid storage chamber 3, and the flow channel 7 is used to insert the test strip 2, and the flow channel 7 extends toward the center and communicates with the liquid storage chamber 3 (refer to Figure 3 As shown), the other end of the flow channel 7 extends outward. The flow channel 7 is used to insert the test strip 2. A test strip numbering area 5 is provided on the outer edge of the bottom plate 1. Figure 6 shown.

[0088] This embodiment is a unified sample addition mode. The sample is directly added to the central liquid storage chamber 3 and then evenly diffused to each reagent strip flow channel 7, avoiding sample addition errors and unevenness, and is more suitable for general screening of multiple markers. Figure 8 shown.

[0089] The kit 100 provided in this embodiment can be used for imaging and detection.

[0090] Imaging system compatibility: Designed for compatibility with fluorescence imaging or colorimetric imaging systems. Aperture and layout can be optimized as needed to improve image quality and analysis accuracy.

[0091] The present invention provides a technical solution for circular flow immunoassay (CFIA); a sample addition area 4 is arranged around the periphery of a liquid storage chamber 3. This helps to improve the utilization rate of the test strip 2 in space, and the distribution of the test strip 2 is more dense. The design of the liquid storage chamber 3 can be adaptively selected according to the detection needs, which greatly improves the flexibility of buffer solution selection. The liquid storage chamber 3 can be used to store buffer solution and / or lysis solution. When the sample to be tested is a solid sample or a sample with poor chromatographic performance, a buffer solution can be added to the liquid storage chamber 3 to ensure that the sample is subjected to the best chromatographic environment.

[0092] On the one hand, the immunochromatographic test strip 2 detection device provided by the present invention can meet the detection requirements of multiple markers in a unified loading mode, and the sample to be tested can be directly added to the liquid storage chamber 3, and the sample can be evenly diffused into the flow channel 7 of each test strip 2, avoiding loading errors and uneven situations, and facilitating rapid screening of multiple markers. On the other hand, the immunochromatographic test strip 2 detection device provided by the present invention can meet the detection requirements of multiple markers of multiple samples in a single loading mode. In this mode, when loading samples, the samples are loaded one by one into the loading holes 6, and the loading holes 6 are spaced apart from each other, avoiding the problem of inaccurate detection caused by mutual contamination.

[0093] The design of the annular immunochromatography kit 100 of the present invention allows it to be placed stably on a horizontal surface (such as a desktop) for detection. This design changes the way in which the traditional immunochromatography kit 100 usually needs to be operated upright, significantly improving the convenience and safety of use, especially when adding reagents and reading results, the operation is more stable and reliable. The flat-lying use design greatly reduces the risk of the kit 100 tipping over or overturning due to external forces during the detection process. When the traditional upright kit 100 is in use, it is easily hit or vibrated when unfolding the solution or moving the sample, resulting in liquid leakage or contamination. The present invention effectively avoids these problems through a flat design, ensuring the cleanliness of the experimental environment and the accuracy of the detection.

[0094] Compared with the design of the conventional immunochromatographic test kit 100, the present invention greatly reduces the demand for buffer solution by surrounding the sample addition area 4 on the periphery of the liquid storage chamber 3, and only a small amount of buffer solution is needed to achieve multiple immunochromatographic detection. This improvement significantly reduces reagent consumption, improves cost-effectiveness, and reduces the burden of waste liquid treatment.

[0095] The liquid adding area (liquid storage chamber 3 and sample adding hole 6) of the present invention is concentrated in the central position of the reagent box 100, and the area is small, which can significantly reduce the possibility of solution exposure to the outside world and reduce the risk of contamination. The central liquid adding design combined with the flat use mode makes the reagent box 100 more stable, reduces the possibility of solution diffusion or volatilization, and improves the reliability of the test results.

[0096] The immunochromatographic test strip 2 detection device or immunochromatographic kit 100 provided by the present invention also has the advantages of simple structure, convenient operation, high detection sensitivity, etc., and is suitable for disease screening, pathogen detection, transgenic detection and biomarker analysis, and has broad application prospects.

[0097] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. An immunochromatographic test strip detection device, characterized in that: It includes: A sample loading unit and a bottom plate, wherein the sample loading unit is located on the bottom plate, and the sample loading unit comprises a liquid storage chamber and a sample loading area, wherein the sample loading area is arranged around the outer periphery of the liquid storage chamber; the sample loading area has a structure as shown in (1) or (2): (1): The sample adding area is provided with a plurality of sample adding holes near the liquid storage chamber, and the sample adding area is provided with a flow channel below each of the sample adding holes, and the flow channel extends toward the center and is connected to the liquid storage chamber, and the flow channel is used to insert a test strip; (2): The sample adding area has a flow channel, and the flow channel extends toward the center and is connected to the liquid storage chamber, and the flow channel is used to insert a test strip.

2. The immunochromatographic test strip detection device according to claim 1, characterized in that: A plurality of flow channels are arranged at equal angular intervals on the periphery of the liquid storage chamber; preferably, the number of the flow channels is a natural number between 2 and 100; Preferably, the depth of the liquid storage chamber is lower than the minimum depth of the sample loading hole.

3. The immunochromatographic test strip detection device according to claim 1, characterized in that: The plurality of sample addition holes are arranged in a ring-shaped array on the periphery of the liquid storage chamber; Preferably, the surface of the sample loading well is modified with a hydrophobic group or a hydrophilic group.

4. The immunochromatographic test strip detection device according to claim 3, characterized in that: The size of the plurality of sample addition holes is smaller than or equal to the size of the sample pad of the test strip.

5. The immunochromatographic test strip detection device according to claim 1, characterized in that: The liquid storage chamber is circular, square, rectangular, diamond, heart-shaped, fan-shaped, trapezoidal or polygonal.

6. The immunochromatographic test strip detection device according to claim 1, characterized in that: A test strip numbering area is provided on the periphery of the sample loading unit or the outer edge of the bottom plate; Preferably, the test strip number area has a barcode and a label.

7. The immunochromatographic test strip detection device according to claim 1, characterized in that: The thickness of the outer edge of the bottom plate is greater than the thickness in the middle of the bottom plate; Preferably, the immunochromatographic test strip detection device further comprises a cover or a sealing film, wherein the cover is buckled on the sample loading unit, and the sealing film is arranged on the surface of the sample loading unit; Preferably, the bottom of the sample loading unit is sealed with the bottom plate.

8. An immunochromatography kit, characterized in that: It includes: A test strip and the immunochromatographic test strip detection device according to any one of claims 1 to 7, wherein the test strip is inserted into the flow channel of the immunochromatographic test strip detection device.

9. The immunochromatography kit according to claim 8, characterized in that The kit further comprises at least one of the following solutions: a buffer solution and a lysis solution.

10. Use of the immunochromatographic test strip detection device according to any one of claims 1 to 7 or the immunochromatographic kit according to any one of claims 8 to 9 in the preparation of in vitro diagnostic products, transgenic detection products, environmental pollution detection, pesticide residue detection or pathogen detection products.