High-sensitivity quantitative detection kit for PLA2R-IgG4 antibody

Abstract

The invention relates to the technical field of detection, and discloses a high-sensitivity quantitative detection kit for a PLA2R-IgG4 antibody. The packaging box comprises a box body; the box cover is arranged at the top opening of the box body and can be opened and closed; the handle is arranged on the outer side of the box body; the interior of the kit body is divided into a pore plate area, a reagent area and a material area; the pore plate area is provided with at least one pore plate accommodating cavity; the reagent area is provided with at least one antibody positioning hole and at least one standard substance positioning hole; the material area is provided with at least one consumable accommodating cavity; drawable bottom boxes are respectively arranged at the bottoms of the pore plate area, the reagent area and the material area on the kit body; and cooling mechanisms and / or cooling materials are selectively accommodated in the three drawable bottom boxes. Through structural design optimization, the portability and stability of the kit are greatly improved.

Description

Technical Field

[0001] The present invention relates to the field of detection technology, and in particular to a high-sensitivity quantitative detection kit for PLA2R-IgG4 antibody. Background Art

[0002] In time-resolved fluorescence immunoassay (TRFIA) detection, the detection kit is a carrier for carrying key components such as detection reagents, reaction plates, and standards. The existing TRFIA detection kits for phospholipase A2 receptor immunoglobulin G4 antibody (PLA2R-IgG4) have many deficiencies in practical applications and need to be solved urgently.

[0003] For example: (1) Traditional kits mostly adopt a single cavity design, and each component lacks modular separation. Core components such as reagent bottles and reaction plates are stacked disorderly. During transportation, due to the lack of a buffer protection structure, problems such as reagent bottle breakage and cross-contamination are likely to occur, ultimately endangering the integrity of the detection system and the reliability of data; (2) The portability of the kit is insufficient. Most kits do not have a special carrying structure. When medical staff or testers carry it, they can only drag the bottom of the box by hand. Holding the box not only makes it inconvenient to walk, but also reduces the action efficiency; (3) The kit cannot be placed at room temperature. Most kits are not equipped with a cooling device. If the experiment process is long or there are many test samples, the activity of some antibodies and detection reagents will decline in the room temperature environment for a long time.

[0004] In view of the above defects in the prior art, there is an urgent need in the art for a TRFIA ultrasensitive detection kit for PLA2R-IgG4 with optimized structure and perfect functions to meet the requirements of the actual detection work for the portability, stability, etc. of the kit. Summary of the Invention

[0005] To solve the above technical problems, the present invention provides a high-sensitivity quantitative detection kit for PLA2R-IgG4 antibody. Through the optimization of the structural design, the portability and stability of the kit are greatly improved.

[0006] The specific technical solution of the present invention is: a high-sensitivity quantitative detection kit for PLA2R-IgG4 antibody, which includes: a box body; a box cover provided at the top opening of the box body and capable of being opened and closed; a handle provided on the outer side of the box body. Among them, the interior of the box body is divided into a well plate area, a reagent area, and a material area; the well plate area is provided with at least one well plate accommodating cavity; the reagent area is provided with at least one antibody positioning hole and at least one standard product positioning hole; the material area is provided with at least one consumable accommodating cavity. The bottom of the box body located in the well plate area, the reagent area, and the material area is respectively provided with a pull-out bottom box; three of the pull-out bottom boxes selectively accommodate a cooling mechanism and / or cooling material.

[0007] First, the box body of the kit of the present invention is designed as an independently partitioned well plate area, reagent area, and material area, which can be used to position and accommodate different substances, and can play a protective role during transportation, avoiding problems such as reagent bottle breakage and cross-contamination. Secondly, the present invention is provided with a handle on the box body of the kit, and the design of the handle greatly increases the portability of the kit. Finally, the present invention is provided with a cooling mechanism and / or cooling material inside the box body, which can avoid the problem of the decline in the activity of antibodies and detection reagents in a normal temperature environment for a long time.

[0008] Preferably, the bottoms of the well plate area, reagent area, and material area and the pull-out bottom box are separated by a heat-conducting partition; more preferably, the heat-conducting partition is made of stainless steel.

[0009] The function of the heat-conducting partition is to separate the well plate area, reagent area, and material area at its top from the pull-out bottom box at its bottom. And since the pull-out bottom box contains a cooling mechanism and / or cooling material, and it is necessary to cool the contents in the well plate area, reagent area, and material area, it is necessary for the heat-conducting partition to have good heat conductivity. Therefore, the present invention further preferably uses a heat-conducting partition made of stainless steel.

[0010] Preferably, the well plate accommodating cavity is cubic in shape; the antibody positioning holes and standard product positioning holes are circular; the consumable accommodating cavity is cylindrical in shape.

[0011] Preferably, an elastic buffer layer is provided at the bottom inside the antibody positioning holes and standard product positioning holes.

[0012] The elastic buffer layer can absorb vibration energy, ensuring that the displacement of the contents during transportation is controlled within a very small range. Even if it experiences bumpy road conditions or handling collisions, the internal contents can remain stable, avoiding mutual extrusion, tipping, or breakage.

[0013] Preferably, the cooling mechanism is a refrigerator; the cooling material is an ice pack.

[0014] Preferably, a handle is provided on the outside of the pull-out bottom box.

[0015] Preferably, the handle is a flip-up handle and is fixed to the box body through a fixing mechanism.

[0016] Preferably, a concave-shaped configuration structure is provided on the front of the outside of the box body.

[0017] Preferably, a plurality of buckles for cooperating with the box body are provided on the box cover; the box cover is connected to the box body through a folding page.

[0018] Compared with the prior art, the beneficial effects of the present invention are:

[0019] (1) The cassette of the kit of the present invention is designed as an independently partitioned well plate area, reagent area, and material area, which can be used to locate and accommodate different substances, and can play a protective role during transportation to avoid problems such as reagent bottle breakage and cross - contamination.

[0020] (2) Secondly, the present invention is provided with a handle on the cassette of the kit, and the design of the handle greatly increases the portability of the kit.

[0021] (3) Finally, the present invention is provided with a cooling mechanism and / or cooling material inside the cassette to avoid the problem of the decline in the activity of antibodies and detection reagents in a normal - temperature environment for a long time. Description of the Drawings

[0022] Figure 1 is a schematic diagram of the internal structure of the cassette in the kit of the present invention;

[0023] Figure 2 is a schematic diagram of an appearance of the kit of the present invention;

[0024] Figure 3 is a schematic diagram of a front - side structure of the kit of the present invention.

[0025] The reference numerals are: 1 cassette; 2 cassette cover; 3 fixing mechanism; 4 handle; 5 concave - shaped configuration structure; 6 pull - out bottom box; 7 pull - handle; 8 folding page; 9 ice pack; 10 antibody positioning hole; 11 well plate accommodation cavity; 12 consumable accommodation cavity; 13 buckle; 14 standard product positioning hole. Detailed Embodiments

[0026] The present invention will be further described below in conjunction with embodiments.

[0027] Embodiment 1

[0028] A highly sensitive quantitative detection kit for PLA2R - IgG4 antibody, as Figures 1-3 shown, which includes:

[0029] Box body 1: Injection molded with ABS material, wall thickness 3mm, balancing lightweight and compressive strength, 35cm (length) × 15cm (width) × 25cm (height), thickness 3mm. There is a concave configuration structure 5 on the front side of the outer side of the box body. Specifically, the interior of the box body is divided into a well plate area, a reagent area, and a material area; there is 1 well plate accommodation cavity 11 (cubic shape) in the well plate area; there are 4 antibody positioning holes 10 and 4 standard product positioning holes 14 (round) in the reagent area; there are 3 consumable accommodation cavities 12 (cylindrical shape) in the material area. There is an elastic buffer layer (5mm silicone buffer layer) at the bottom inside the antibody positioning holes and the standard product positioning holes. At the bottom of the box body corresponding to the well plate area, the reagent area, and the material area, there are respectively pull-out bottom boxes 6; there are handles 7 on the outer sides of the 3 pull-out bottom boxes; at the same time, ice packs 9 can be accommodated in the pull-out bottom boxes according to actual needs. The spacer material between the well plate area, the reagent area, and the material area is polystyrene material, and the bottom of the well plate area, the reagent area, and the material area and the pull-out bottom boxes are separated by a heat-conducting partition (316 stainless steel material, 0.8mm thickness). The above materials can well transfer the low temperature of the ice packs in the pull-out bottom boxes and provide a good storage environment for the reagents.

[0030] Box cover 2: Set at the top opening of the box body and designed to be openable and closable. The box cover is made of polystyrene material, and the surface is matte-treated. Labels can be pasted in the middle part to mark the name of the reagent kit, the detection item, the expiration date, etc., which is convenient for identification and management. There are buckles 13 (acrylonitrile-butadiene-styrene copolymer (ABS) plastic material) on the box cover that cooperate with the box body; the box cover is connected to the box body through a folding page 8 (stainless steel material), and the rotation angle > 180°.

[0031] Handle 4: Set on the outer side of the box body, with a flip-up design, adopting a medical-grade ABS plastic arc structure, and fixed to the box body through a fixing mechanism 3. The fixing mechanism includes a metal bearing, a rotating shaft, and a fixing bolt. A ball bearing is embedded in the side mounting hole of the box body (interference fit), the outer ring is embedded in the mounting hole of the box body, the inner ring is tightly sleeved on the rotating shaft, and the bolt fixes the handle and the connecting part rotating shaft. There are access ports at both ends of the handle and can be sleeved on the threaded rotating shaft. Tighten the fixing bolt and debug the rotating function to ensure free folding, and it can bear 8kg without deformation. The handle is vertical when carrying and fits against the side of the box body when not in use.

[0032] The usage process of the reagent kit in this embodiment is as follows:

[0033] Preparation stage: When in use, press the handle against the side of the box body, open the box cover with a rotation angle > 180°, take out the 96-well plate in the well plate area in the order from left to right, place it horizontally on the table, and then take out the standard products in the reagent area in the order of standard product concentration. At the same time, take out Eu 3+Take out the labeled antibody solution from the antibody positioning holes, and then take out the enhancement solution, analysis buffer, and washing solution from the material area, keeping the ice pack in the drawer stationary. Finally, cover the box lid and lift the handle vertically.

[0034] Detection operation steps: First, add 100 μL of the sample to be tested into the coated PLA2R polystyrene 96-well plate, shake and react for 1 hour, and then wash with Tris-HCl washing solution to remove the unbound sample. Then add the Eu 3+ -labeled detection antibody into the operated polystyrene 96-well plate for incubation reaction. The incubation conditions are shaking at room temperature for 1 hour to obtain the fluorescent immune complex of coated antigen-antibody-Eu 3+ -labeled secondary antibody. Wash again with Tris-HCl washing solution. Subsequently, add the enhancement solution, shake for 5 min, and then detect the fluorescence intensity on the machine to determine the content of the detection index.

[0035] In summary, the kit of this embodiment has the following beneficial effects: The humanized handle design improves the carrying comfort. A foldable handle is configured on the side of the kit, made of ABS plastic, which is light in weight and high in strength. The handle is connected to the box body through a rotating connector with a bearing, and the angle can be flexibly adjusted: when carrying, it is lifted vertically, which conforms to ergonomics, and the force is evenly distributed to the palm, reducing the pressure on the hand; when not in use, it can be folded and attached to the side of the box body to avoid occupying extra space and facilitate stacking, transportation or storage. The box body size is optimized to meet the accommodation requirements of internal components while controlling the overall volume. With the foldable handle, the kit can be easily placed in containers such as medical boxes and backpacks during vehicle transportation, air consignment or manual handling. The interior of the kit is clearly divided into: well plate area, reagent area (14), and material area. The well plate area can accommodate the 96-well plate used for detection and can be placed well, optimizing the space utilization. The size of the middle reagent area is designed to match the bottle body size of the detection reagent. An elastic buffer layer is added to the inner wall of the positioning hole, and the storage positions of the standard product and the detection antibody are distinguished by the size of the pore diameter. The right material area is used to store materials with a large usage amount. During transportation, the reagent bottle is tightly wrapped after being inserted into the positioning hole, and the buffer layer absorbs the vibration energy to ensure that the displacement of the components is controlled within a very small range (such as within ±2 mm). Even after experiencing bumpy road conditions or handling collisions, the internal components can remain stable and avoid mutual extrusion, tipping or breakage.

[0036] In the present invention, the raw materials and equipment used, unless otherwise specified, are common raw materials and equipment in the art; the methods used in the present invention, unless otherwise specified, are conventional methods in the art.

[0037] The above are only preferred embodiments of the present invention and do not impose any limitations on the present invention. Any simple modifications, changes, and equivalent transformations made to the above embodiments according to the technical essence of the present invention still fall within the protection scope of the technical solution of the present invention.

Claims

1. A highly sensitive quantitative detection kit for PLA2R-IgG4 antibody, characterized in that Comprising: A box body; A box cover provided at the top opening of the box body and capable of being opened and closed; A handle provided on the outer side of the box body; The interior of the box body is divided into a well plate area, a reagent area and a material area; at least one well plate accommodation cavity is provided in the well plate area; at least one antibody positioning hole and at least one standard product positioning hole are provided in the reagent area; at least one consumable accommodation cavity is provided in the material area; Pull-out bottom boxes are respectively provided at the bottoms of the box body corresponding to the well plate area, the reagent area and the material area; a cooling mechanism and / or cooling materials are selectively accommodated in the three pull-out bottom boxes.

2. The kit according to claim 1, characterized in that, The bottoms of the well plate area, the reagent area and the material area and the pull-out bottom boxes are separated by heat-conducting partition plates.

3. The kit according to claim 2, characterized in that, The heat-conducting partition plates are made of stainless steel.

4. The kit according to any one of claims 1-3, wherein The well plate accommodation cavity is cubic in shape; The antibody positioning holes and the standard product positioning holes are circular; The consumable accommodation cavity is cylindrical in shape.

5. The kit according to claim 1, wherein Elastic buffer layers are provided at the bottoms of the antibody positioning holes and the standard product positioning holes.

6. The kit according to claim 1, characterized in that, The cooling mechanism is a refrigerator; the cooling material is an ice pack.

7. The kit according to claim 1, wherein A handle is provided on the outer side of the pull-out bottom box.

8. The kit according to claim 1, wherein, The handle is a flip-up handle and is fixed to the box body through a fixing mechanism.

9. The kit according to claim 1, characterized in that, A concave configuration structure is provided on the front side of the outer side of the box body.

10. The kit according to claim 1, wherein A plurality of buckles for cooperating with the box body are provided on the box cover; The box cover is connected to the box body through a folding page.

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