Inner packing material suitable for in-vitro diagnostic reagent

Abstract

The utility model discloses an inner packing material suitable for an in-vitro diagnostic reagent, which comprises an upper U-shaped micro hole and a lower U-shaped micro tube which is tightly connected through a connecting groove, and the U-shaped micro hole and the U-shaped micro tube are isolated and communicated through six wedge-shaped micro holes. Therefore, an antigen-antibody incubation reaction environment is kept under the condition that no external force exists after a sample is added into the U-shaped micro hole at the upper part. And after centrifugation, the reacted antigen-antibody liquid flows into the U-shaped miniature tube below through the micropores to carry out next-step reaction. According to the device disclosed by the utility model, integrated operation of sample adding and incubation reaction in the same device is realized, the complexity of operation in an experiment process is reduced, and the risk of sample pollution in the operation process is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of in vitro diagnostic reagents, and specifically refers to an inner packaging material suitable for in vitro diagnostic reagents. Background Art

[0002] In vitro diagnostic reagents are usually divided into four categories according to the detection principles and methods: biochemical reagents; immunoassay; molecular diagnosis and microbiological diagnosis. Among them, immunoassay is to diagnose various diseases and determine the immune status by applying the theories, techniques and methods of immunology. Immunoassay reagents are the most diverse in diagnostic kits and are widely used in hospitals, blood stations, physical examination centers, disease control and prevention centers, etc., mainly for the detection of infectious diseases, blood type detection, tumor detection, pregnancy testing, etc. Among them, immunoassay techniques mainly include enzyme-linked immunosorbent assay (ELISA), chemiluminescence immunoassay, colloidal gold immunoassay, etc. Among them, chemiluminescence is suitable for the detection of endocrine, drugs, blood types, tumor markers, etc., and has the advantages of strong specificity, high sensitivity and high automation; ELISA is suitable for the detection of endocrine, tumors, drugs, blood types, etc., with mature technology and low cost. Chemiluminescence technology and ELISA mainly focus on medium and high-throughput sample detection, are suitable for large-scale sample detection, and account for more than 80% in the immunoassay market structure.

[0003] At present, the overall structure of the inner packaging materials on the market is not stably spliced, and sample addition and incubation need to be carried out separately. The entire test operation is relatively complex, and impurities are easily introduced during the separation process, resulting in reagent contamination. Therefore, there is an urgent need for an inner packaging material suitable for in vitro diagnostic reagents. Summary of the Invention

[0004] I. Technical Problems to be Solved

[0005] The technical problem to be solved by the present invention is various problems mentioned in the above background art, and an inner packaging material suitable for in vitro diagnostic reagents is provided.

[0006] II. Technical Solutions

[0007] To solve the above technical problems, the technical solution provided by the present invention is: an inner packaging material suitable for in vitro diagnostic reagents, including U-shaped micro-holes and U-shaped micro-tubes. There is 1 center at the inner bottom of the U-shaped micro-holes, and 5 wedge-shaped micro-holes with a diameter of 0.4 - 0.6 mm are provided at the edge of the U-shaped micro-holes. A connecting groove with a diameter of 6.58 ± 0.1 mm is provided at the outer bottom of the U-shaped micro-holes. A connecting block is provided between the U-shaped micro-holes, and the connecting block connects multiple U-shaped micro-holes. The center distance between every two U-shaped micro-tubes is 8.95 ± 0.1 mm and the centers are located on the same straight line. Support columns are provided at the bottom of the U-shaped micro-tubes, and connecting members are provided between the U-shaped micro-tubes, and the connecting members connect multiple U-shaped micro-tubes.

[0008] As an improvement, the six micro-holes of the U-shaped micro-hole can achieve the separation of the upper and lower parts.

[0009] As an improvement, the U-shaped micro-hole and the U-shaped micro-tube can be tightly connected through a connecting groove, and 4 exhaust holes are designed on the connecting groove.

[0010] As an improvement, the bottom support column of the U-shaped micro-tube can make the splicing structure of the U-shaped micro-hole and the U-shaped micro-tube stand stably on the plane, and the bottom of the U-shaped micro-tube is suspended without contacting the plane.

[0011] III. Beneficial Effects

[0012] The advantages of the present invention compared with the prior art are as follows: The utility model is applicable to the inner packaging material of medium and high-throughput immunoassay reagents. Its upper and lower parts are firmly connected. The upper U-shaped micro-hole forms an independent antigen / antibody incubation environment during sample addition, preventing liquid from leaking downward and allowing it to enter the lower U-shaped micro-tube during centrifugation. It realizes the integrated operation of sample addition-incubation reaction in the same device, with a simple structure and convenient operation, reducing the pollution risk during the test process and indirectly improving the product quality of the diagnostic reagent. Description of the Drawings

[0013] Figure 1 It is a structural diagram of a U-shaped micro-hole of an inner packaging material applicable to in vitro diagnostic reagents according to the present invention.

[0014] Figure 2 It is a structural diagram of a U-shaped micro-tube of an inner packaging material applicable to in vitro diagnostic reagents according to the present invention.

[0015] Figure 3 It is a combined structural diagram of an inner packaging material applicable to in vitro diagnostic reagents according to the present invention.

[0016] Figure 4 It is a cross-sectional view of an inner packaging material applicable to in vitro diagnostic reagents according to the present invention.

[0017] Figure 5 It is a structural diagram of the bottom of a U-shaped micro-hole of an inner packaging material applicable to in vitro diagnostic reagents according to the present invention.

[0018] Figure 6 It is a structural diagram of the bottom of a U-shaped micro-tube of an inner packaging material applicable to in vitro diagnostic reagents according to the present invention.

[0019] As shown in the figure: 01, micro-hole cavity; 02, connecting groove; 03, upper incision; 04, connecting block; 05, micro-hole; 06, ventilation channel; 07, reaction cavity; 08, lower incision; 09, support column; 10, spherical bottom; 11, connecting piece. Specific Embodiments

[0020] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts belong to the scope of protection of the present invention.

[0021] Combined with the attached Figure 1 —attached Figure 6 , An inner packaging material suitable for in vitro diagnostic reagents, including a U-shaped micro-hole and a U-shaped micro-tube. There is 1 center at the inner bottom of the U-shaped micro-hole. There are 5 wedge-shaped micro-holes with a diameter of 0.4 - 0.6 mm at the edge of the U-shaped micro-hole. There is a connecting groove with a diameter of 6.58 ± 0.1 mm at the outer bottom of the U-shaped micro-hole. There is a connecting block between the U-shaped micro-holes, and the connecting block connects multiple U-shaped micro-holes. The center distance between every two U-shaped micro-tubes is 8.95 ± 0.1 mm and the centers are located on the same straight line. There are support columns at the bottom of the U-shaped micro-tubes. There is a connecting piece between the U-shaped micro-tubes, and the connecting piece connects multiple U-shaped micro-tubes.

[0022] Each reaction unit is composed of two parts: a U-shaped micro-hole and a U-shaped micro-tube. Every 8 reaction units form an inner packaging material.

[0023] There are 6 micro-holes at the inner bottom of each U-shaped micro-hole cavity, with a diameter of 0.4 - 0.6 mm. 5 are at the edge of the cavity bottom and 1 is in the middle of the cavity bottom. These micro-holes can prevent the liquid in the U-shaped micro-hole from leaking into the U-shaped micro-tube without external force. Under certain centrifugal conditions, the liquid in the U-shaped micro-hole can enter the U-shaped micro-tube through the micro-holes to continue the reaction;

[0024] The two ends of the upper surface of the U-shaped micro-hole are designed differently and can be marked for writing, which is convenient for distinguishing directions;

[0025] The connecting groove at the outer bottom of the U-shaped micro-hole cavity fits with the interface of the lower U-shaped micro-tube, and is stably connected to form a complete detection device, and can also be disassembled for use;

[0026] The connecting groove of the U-shaped micro-hole contains 4 tiny air channels, which can avoid the formation of bubbles due to inconsistent internal and external pressures during centrifugation.

[0027] The U-shaped micro-tube is composed of 8 spherical bottom reaction tubes and two support columns at the bottom;

[0028] The two ends of the surface of the U-shaped micro-tube are designed differently and one end has a digital mark, and can also be marked for writing, which is convenient for distinguishing directions;

[0029] The side of the U-shaped micro-tube is a complete plane, which is not only beneficial to the beauty of the overall shape but also convenient for writing marks;

[0030] The spherical bottom of the U-shaped microtube has good adsorption property and can be pre-coated with protein, enabling the reaction solution after centrifugation to enter the reaction cavity and continue to react with the solid phase carrier.

[0031] The bottom support column of the U-shaped microtube can place the complete inner packaging material stably on the plane and the spherical bottom will not contact the plane, ensuring the cleanliness of the bottom surface and the presentation effect of the final interpretation result.

[0032] Example 1

[0033] As Figure 1 shown, it is the structural diagram of the U-shaped microhole (8 holes in a single strip) of the present utility model; the main body of the U-shaped microhole is composed of 8 independent microcavities 01, and each microcavity is connected by a connecting block 04 in the middle, increasing the overall stability, and the outer walls are connected to form a plane, which is beautiful and generous and can be used for writing marks. There are voids formed between the tubes, saving materials and having a stable structure that is not easily deformed. Above the top plane of the microcavity 01, there is an upper notch 03 for easy marking and distinction. On the inner surface of the bottom of the microcavity 01, there are 6 wedge-shaped micropores 05 with a diameter of 0.4 - 0.6 mm, 5 are located at the bottom edge of the cavity, and 1 is located in the middle of the bottom of the cavity. These micropores can prevent the liquid in the microcavity 01 from leaking when it is stable. When centrifugation operation is carried out, the liquid in the microcavity 01 can flow downward through the micropores 05 and enter the reaction cavity 07. On the outer surface of the bottom of the microcavity 01, there is a connecting groove 02, whose size matches the opening size of the U-shaped microtube. Through the connecting groove 02, the U-shaped microhole can be tightly combined with the U-shaped microtube. And there are 4 air channels 06 on the edge of the sample addition groove 02, which can avoid the formation of bubbles due to inconsistent upper and lower pressures between the microcavity 01 and the reaction cavity 07 during centrifugation.

[0034] As Figure 2 shown, it is the structural diagram of the U-shaped microtube (8 holes in a single strip) of the present utility model; the main body of the U-shaped microtube is composed of 8 independent reaction cavities 07, and the reaction cavity has the same structure as the microcavity. Each reaction cavity is connected by a connecting piece 11 in the middle, increasing the overall stability, and the outer wall is a complete plane, which is beautiful and generous and can be used for writing marks. There are voids formed between the tubes, saving materials and having a stable structure that is not easily deformed. Above the top plane of the reaction cavity 07, there is a lower notch 08 for easy marking and distinction of the direction. The bottom of the reaction cavity 07 is a spherical bottom 10 with a smooth inner surface, making the result more accurate and easier to interpret.

[0035] Combined with the attached Figure 3As shown, it is a structural diagram of the complete combination of a U-shaped micro-hole and a U-shaped micro-tube. When in use, the U-shaped micro-tube can be first coated with protein, and then the U-shaped micro-hole is installed. After incubating the protein to be detected with the corresponding antigen / antibody, it is centrifuged and captured by the protein at the bottom of the U-shaped micro-tube, and the result can be directly shown or shown by adding an indicator again to achieve visual result judgment. Compared with the inner packaging materials of traditional diagnostic reagents, it is more convenient, accurate and safe in operation;

[0036] It should be noted that in this article, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the term "comprising", "including" or any other variant thereof is intended to cover non-exclusive inclusion, so that a process, method, article or device comprising a series of elements not only includes those elements, but also includes other elements not expressly listed, or further includes elements inherent to such process, method, article or device.

[0037] Although the embodiments of the present invention have been shown and described, for those of ordinary skill in the art, it can be understood that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

[0038] The above describes the present invention and its embodiments, and this description is not restrictive. What is shown in the drawings is only one of the embodiments of the present invention, and the actual structure is not limited thereto. Generally speaking, if those of ordinary skill in the art are inspired by it and design similar structural ways and embodiments without creative work without departing from the purpose of the present invention, they shall fall within the protection scope of the present invention.

Claims

1. An inner packaging material suitable for in vitro diagnostic reagents, characterized in that: It includes a U-shaped micro hole and a U-shaped micro tube, wherein the inner bottom of the U-shaped micro hole is provided with a center, the edge of the U-shaped micro hole is provided with 5 wedge-shaped micro holes with a diameter of 0.4-0.6 mm, the outer bottom of the U-shaped micro hole is provided with a connecting groove with a diameter of 6.58±0.1 mm, and connecting blocks are provided between the U-shaped micro holes, and the connecting blocks connect multiple U-shaped micro holes; The center distance between every two U-shaped microtubes is 8.95±0.1mm and the centers are located in the same straight line. A support column is provided at the bottom of the U-shaped microtube. Connectors are provided between the U-shaped microtubes to connect multiple U-shaped microtubes.

2. The inner packaging material for in vitro diagnostic reagents according to claim 1, characterized in that: The six micropores of the U-shaped micropore can achieve separation of the upper and lower parts.

3. The inner packaging material for in vitro diagnostic reagents according to claim 1, characterized in that: The U-shaped micro hole and the U-shaped micro tube can be tightly connected through a connecting groove, and the connecting groove is designed with four exhaust holes.

4. The inner packaging material for in vitro diagnostic reagents according to claim 1, characterized in that: The U-shaped microtube bottom support column can make the U-shaped microhole and the U-shaped microtube splicing structure stand stably on a plane, and the bottom of the U-shaped microtube is suspended in the air and does not contact the plane.

Images