A blood antibody detection kit

Abstract

This utility model belongs to the field of medical device technology and provides a blood antibody test kit, including a test box. The top of the test box is provided with an openable lid. The interior of the test box is provided with spaced-apart isolation plates, which divide the interior of the test box into a reagent storage chamber for storing reagents, a desiccant chamber for storing desiccant, a reaction chamber, and a buffer chamber. The reagent storage chamber and the desiccant chamber are isolated from each other. The top opening of the reagent storage chamber is covered with an easy-tear film, and the top opening of the desiccant chamber is covered with a breathable and dustproof film. This utility model protects the reagents pre-packaged in the reagent chamber, especially lyophilized reagents, from deliquescence and failure by designing moisture-proof and isolation components inside the test kit, thus ensuring reagent activity and detection stability.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, specifically a blood antibody detection kit. Background Technology

[0002] Cancer is one of the leading causes of death worldwide, and its early detection and accurate diagnosis are crucial for improving patient survival. Serological tests, especially blood tests for tumor-associated antigens (TAAs) or autoantibodies, play an important role in the auxiliary diagnosis, treatment monitoring, and prognostic assessment of cancer due to their non-invasiveness, relative simplicity, and cost-effectiveness. They are particularly suitable for large-scale screening and regular monitoring of high-risk populations.

[0003] Cancer-related antibody detection often relies on highly sensitive reaction systems, requiring high reagent activity. In particular, labeled antibodies or enzyme conjugates preserved using lyophilization technology are extremely sensitive to humidity and oxygen.

[0004] Existing reagent kits often expose key reagents directly on the test strip or are simply packaged in a bag, lacking effective physical isolation and drying protection mechanisms.

[0005] This structural design makes the reagents highly susceptible to moisture damage and failure during storage and transportation, leading to a decrease in detection sensitivity. In particular, it may fail to detect low-abundance, weakly positive cancer-related antibody signals (which are crucial in early cancer detection), resulting in a false negative risk and seriously affecting the reliability of early cancer screening. Utility Model Content

[0006] To address the aforementioned technical problems, this invention provides a blood antibody test kit to solve the problem in the prior art where reagents are easily affected by moisture and become ineffective during storage and transportation.

[0007] A blood antibody test kit includes a test box with an openable lid on top. The interior of the test box has spaced-apart partitions that divide the interior into a reagent storage chamber, a desiccant chamber, a reaction chamber, and a buffer chamber. The reagent storage chamber and the desiccant chamber are adjacent to each other but isolated from each other. The top opening of the reagent storage chamber is covered with an easy-tear film, and the top opening of the desiccant chamber is covered with a breathable and dustproof film.

[0008] Preferably, the lid is rotatably connected to the test box body, a magnetic strip is provided between the lid and the test box body to attract each other, the isolation plate is fixedly connected to the test box body, and suction cups are provided at the bottom of the test box body near the four corners.

[0009] Preferably, the reagent storage cavity is provided with a support strip fixedly connected to the side wall of the isolation plate. The support strips are distributed in multiple layers and the support strips on both sides are positioned opposite each other. The tops of two support strips at the same height overlap with a support plate. The reagents are placed on the support plate at intervals. The reagents are lyophilized antibodies or lyophilized enzymes, and the reagents are pre-packaged as lyophilized spheres.

[0010] Preferably, the interior of the reaction chamber is provided with a transparent mounting plate fixedly connected to the isolation plate, a transparent substrate is provided below the transparent mounting plate, a sample loading hole is provided on the transparent mounting plate, a one-way valve capillary channel is provided in the sample loading hole, a reaction zone is provided on the top of the transparent substrate, and the one-way valve capillary channel extends above the reaction zone.

[0011] Preferably, the transparent substrate is pre-covered with detection lines and quality control lines, and a reflector is provided below the transparent substrate, the reflector being white.

[0012] Preferably, the bottom of the lid is provided with a sealing flange that is fixedly connected. After the lid is closed on the test box, the sealing flange is tightly attached to the side wall of the reaction chamber. The inside of the sealing flange and the lid are provided with a result observation window.

[0013] Preferably, the buffer chamber has a liquid outlet on the side plate away from the reaction chamber, the liquid outlet is provided with a sealing plug, and the box cover is provided with spaced plastic clips above the buffer chamber.

[0014] Compared with the prior art, the present invention has the following beneficial effects:

[0015] 1. This utility model sets up multiple isolation plates inside the test box to divide it into two isolated reagent storage chambers and a drying chamber. The top opening of the reagent storage chamber is covered with an easy-tear film to seal the chamber, which can effectively prevent reagent leakage or contamination during storage. The desiccant chamber is filled with desiccant, and its top opening is covered with a breathable and dustproof film. This film allows water vapor to pass through and be absorbed by the desiccant, but prevents dust and microorganisms from entering, thereby continuously providing a dry environment for the reagent storage chamber and avoiding the situation where the reagent is placed inside the test box and becomes damp. Moreover, the adjacent design of the drying chamber and the reagent storage chamber can maximize the drying efficiency. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the structure of the blood antibody detection kit of this utility model;

[0017] Figure 2 This is a schematic diagram of the structure of the test box body and lid of this utility model;

[0018] Figure 3 This is a cross-sectional view of the internal structure of the test box of this utility model;

[0019] Figure 4 This is a schematic diagram of the internal structure of the reagent storage cavity of this utility model;

[0020] Figure 5 This is a schematic diagram showing the disassembled components of the present invention, including the transparent substrate and the transparent mounting plate.

[0021] In the picture:

[0022] 1. Test box body; 2. Box lid; 3. Isolation plate; 4. Reagent storage chamber; 5. Desiccant chamber; 6. Reaction chamber; 7. Buffer chamber; 8. Easy-tear film; 9. Breathable dustproof film; 10. Magnetic strip; 11. Suction cup; 12. Support strip; 13. Support plate; 14. Transparent mounting plate; 15. Transparent substrate; 16. Sample dispensing port; 17. One-way valve capillary channel; 18. Reaction zone; 19. Detection line; 20. Quality control line; 21. Reflector; 22. Sealing flange; 23. Result observation window; 24. Liquid outlet; 25. Sealing plug; 26. Plastic clip; 27. Reagent; 28. Desiccant. Detailed Implementation

[0023] The embodiments of this utility model will be described in further detail below with reference to the accompanying drawings and examples. The following examples are for illustrative purposes only and should not be construed as limiting the scope of this utility model.

[0024] As attached Figure 1 To be continued Figure 5 As shown:

[0025] Example 1: This utility model provides a blood antibody test kit 27, including a test box 1. The top of the test box 1 is provided with an openable lid 2. The interior of the test box 1 is provided with spaced-apart partitions 3. The partitions 3 divide the interior of the test box 1 into a reagent 27 storage cavity 4 for storing reagent 27, a desiccant 28 cavity 5 for storing desiccant 28, a reaction cavity 6, and a buffer cavity 7. The reagent 27 storage cavity and the desiccant 28 cavity 5 are adjacent to each other and isolated from each other. The top opening of the reagent 27 storage cavity is covered with an easy-tear film 8, and the top opening of the desiccant 28 cavity 5 is covered with a breathable dustproof film 9.

[0026] It should be noted that by setting multiple isolation plates 3 inside the test box 1, the isolation plates 3 divide the test box 1 into two isolated reagent 27 storage chambers and drying chambers. The top opening of the reagent 27 storage chamber 4 is covered with an easy-tear film 8 to seal the chamber, which can effectively prevent the reagent 27 from leaking or becoming contaminated during storage. The desiccant 28 chamber 5 is filled with desiccant 28, and its top opening is covered with a breathable and dustproof film 9. This film allows water vapor to pass through and be absorbed by the desiccant 28, but prevents dust and microorganisms from entering, thereby continuously providing a dry environment for the reagent 27 storage chamber 4 and preventing the reagent 27 from getting damp when placed inside the test box 1. Moreover, the adjacent design of the drying chamber and the reagent 27 storage chamber can maximize the drying efficiency.

[0027] Specifically, the easy-tear film 8 is made of aluminum foil composite film. When in use, the user can tear open the easy-tear film 8 to expose the reagent 27 storage cavity, so that the reagent 27 inside can be taken out. The desiccant 28 is made of silicone, which can effectively absorb moisture in the air. The breathable and dustproof film 9 is made of ePTFE film, which can allow water vapor to enter but can also effectively isolate dust and microorganisms.

[0028] In this embodiment, the lid 2 is rotatably connected to the test box body 1, and a magnetic strip 10 is provided between the lid 2 and the test box body 1 to attract each other. The isolation plate 3 is fixedly connected inside the test box body 1, and suction cups 11 are provided at the bottom of the test box body 1 near the four corners.

[0029] It should be noted that, by using the magnetic strips 10 positioned opposite each other on the lid 2 and the test box 1, the two can attract each other after the lid 2 is closed, preventing the lid 2 from opening automatically. The suction cup 11 designed at the bottom of the test box 1 can improve stability.

[0030] In this embodiment, the interior of the reagent 27 storage cavity is provided with a support strip 12 fixedly connected to the side wall of the isolation plate 3. The support strip 12 is distributed in multiple layers and the support strips 12 on both sides are opposite to each other. The tops of the two support strips 12 at the same height are connected to the support plate 13. The reagent 27 is placed on the support plate 13 at intervals. The reagent 27 is a lyophilized antibody or a lyophilized enzyme, and the reagent 27 is pre-packaged as a lyophilized sphere.

[0031] It should be noted that the support strip 12 is fixedly connected to the side plate. The support strip 12 can provide support for the support plate 13. The reagent 27 is placed on the support plate 13. The two are designed to be movable, so that after the upper layer of reagent 27 is taken out, the support plate 13 can be taken out to facilitate the access to the lower layer of reagent 27.

[0032] In this embodiment, the interior of the reaction chamber 6 is provided with a transparent mounting plate 14 fixedly connected to the isolation plate 3. A transparent substrate 15 is provided below the transparent mounting plate 14. A sample feeding hole 16 is provided on the transparent mounting plate 14. A one-way valve capillary channel 17 is provided in the sample feeding hole 16. A reaction zone 18 is provided on the top of the transparent substrate 15. The one-way valve capillary channel 17 extends above the reaction zone 18.

[0033] It should be noted that by setting a sample application port 16 on the transparent mounting plate 14, when blood antibody testing is required, the dropper can drip blood into the sample application port 16 after drawing blood. The blood will flow from the sample application port 16 into the one-way valve capillary channel 17. The one-way valve capillary channel 17 is made of hydrophobic plastic or has a hydrophobic coating on its inner wall. Its inner diameter design and hydrophobic properties work together to allow the liquid sample to flow smoothly to the reaction zone 18 under capillary action and external pressure. However, when the sample application stops or when negative pressure is present, the meniscus formed in the channel will generate a large capillary resistance, effectively preventing the liquid from flowing back into the application port.

[0034] In this embodiment, the transparent substrate 15 is also pre-covered with detection lines 19 and quality control lines 20, and a reflector 21 is provided below the transparent substrate 15. The reflector 21 adopts a white background.

[0035] It should be noted that by setting a detection line 19 and a control line 20 on the transparent substrate 15, the detection line 19 is coated with the target antigen and the control line 20 is coated with the anti-species secondary antibody, which is used to bind with the labeled antibody to form a color band. Thus, after the reagent 27 is fused with the blood, the detection line 19 and the control line 20 will react, and the test result can be determined according to the color of the detection line 19 and the control line 20.

[0036] In this embodiment, the bottom of the cover 2 is provided with a sealing flange 22 that is fixedly connected. After the cover 2 is closed on the test box 1, the sealing flange 22 is tightly attached to the side wall of the reaction chamber 6. The inside of the sealing flange 22 and the cover 2 are provided with a result observation window 23.

[0037] It should be noted that by setting a fixedly connected sealing flange 22 on the lid 2, when the user closes the lid 2 after adding the sample, the sealing flange 22 will be tightly pressed into the reaction chamber 6 to form an effective seal, preventing external dust, droplets and other contaminants from entering the reaction zone 18, and also helping to maintain the microenvironment within the reaction zone 18.

[0038] The result observation window 23 is made of transparent material, which makes it easy for the user to observe the reaction results.

[0039] In this embodiment, a liquid outlet 24 is provided on the side plate of the buffer chamber 7 away from the reaction chamber 6, and a sealing plug 25 is provided on the liquid outlet 24. Plastic clips 26 are provided at intervals on the cover 2 and above the buffer chamber 7.

[0040] It should be noted that buffer diluent is provided in buffer chamber 7. When blood needs to be tested, a reagent 27 is taken out from reagent 27 storage chamber. Since it is a lyophilized sphere, it is placed in buffer diluent to dissolve. After drawing up the appropriate liquid reagent 27 with a dropper, it is dripped into sample loading well 16. The liquid outlet 24 can discharge the unused liquid reagent 27 after the test is completed.

[0041] A plastic clip 26 is provided on the lid 2, which can hold the dropper or tweezers in place for easy handling.

[0042] The embodiments of this utility model are given for the purpose of illustration and description. Although embodiments of this utility model have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the utility model. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of this utility model.

Claims

1. A blood antibody test kit (27), characterized in that, include: The test box (1) has an openable lid (2) on the top. The test box (1) has spaced partitions (3) inside. The partitions (3) divide the test box (1) into a reagent (27) storage chamber (4) containing reagent (27), a desiccant (28) chamber (5) containing desiccant (28), a reaction chamber (6), and a buffer chamber (7). The reagent (27) storage chamber and the desiccant (28) chamber (5) are adjacent to each other and isolated from each other. The top opening of the reagent (27) storage chamber is covered with an easy-tear film (8), and the top opening of the desiccant (28) chamber (5) is covered with a breathable dustproof film (9).

2. The blood antibody test kit (27) as described in claim 1, characterized in that: The lid (2) is rotatably connected to the test box body (1). A magnetic strip (10) is provided between the lid (2) and the test box body (1) to attract each other. The isolation plate (3) is fixedly connected inside the test box body (1). A suction cup (11) is provided at the bottom of the test box body (1) near the four corners.

3. The blood antibody test kit (27) as described in claim 1, characterized in that: The interior of the reagent (27) storage cavity is provided with a support strip (12) fixedly connected to the side wall of the isolation plate (3). The support strip (12) is distributed in multiple layers and the support strips (12) on both sides are opposite to each other. The top of the two support strips (12) at the same height is connected to a support plate (13). The reagent (27) is placed on the support plate (13) at intervals. The reagent (27) is a lyophilized antibody or a lyophilized enzyme, and the reagent (27) is pre-packaged as a lyophilized sphere.

4. The blood antibody test kit (27) as described in claim 1, characterized in that: The reaction chamber (6) is provided with a transparent mounting plate (14) fixedly connected to the isolation plate (3). A transparent substrate (15) is provided below the transparent mounting plate (14). A sample loading hole (16) is provided on the transparent mounting plate (14). A one-way valve capillary channel (17) is provided in the sample loading hole (16). A reaction zone (18) is provided on the top of the transparent substrate (15). The one-way valve capillary channel (17) extends above the reaction zone (18).

5. The blood antibody test kit (27) as described in claim 4, characterized in that: The transparent substrate (15) is also pre-covered with detection lines (19) and quality control lines (20). A reflector (21) is provided below the transparent substrate (15), and the reflector (21) adopts a white background.

6. The blood antibody test kit (27) as described in claim 5, characterized in that: The bottom of the cover (2) is provided with a ring of fixed sealing flange (22). After the cover (2) is closed on the test box (1), the sealing flange (22) is tightly attached to the side wall of the reaction chamber (6). The inside of the sealing flange (22) and the cover (2) are provided with a result observation window (23).

7. The blood antibody test kit (27) as described in claim 1, characterized in that: The buffer chamber (7) has a liquid outlet (24) on the side plate away from the reaction chamber (6), and a sealing plug (25) is provided on the liquid outlet (24). The box cover (2) is provided with spaced plastic clips (26) above the buffer chamber (7).

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