Kit for nucleic acid detection

The limit component design of the upper and lower split structures solves the problem of misplacement of sample solution filling during nucleic acid testing, ensures the accuracy of the test results and the integrity of the test process, and achieves accuracy and pollution-freeness in the sample transfer and testing process within the test kit.

CN223421290UActive Publication Date: 2025-10-10黄广平
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Patent Information

Application Number
CN202423080720.1
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-12-13
Publication Date
2025-10-10
Estimated Expiration
2034-12-13

AI Technical Summary

Technical Problem

During the nucleic acid testing process, the position of the detection slot in the test kit may move or change due to external force or other factors, resulting in the wrong position of adding the sample solution, affecting the accuracy of the test results.

Method used

It adopts an upper and lower split structure, and the position of the lower split is locked by a limit component to ensure that the sample addition port is aligned with the reagent position where the sample needs to be added. The sample is added using a sample addition device, and the lower split is driven to rotate by an external mechanism during the test, so that the transfer of the reagent solution and the detection process are completed inside the test kit.

Benefits of technology

It effectively prevents misplacement of sample solution filling, ensures the accuracy of test results, and completes nucleic acid extraction and PCR amplification inside the kit to reduce the risk of contamination.

✦ Generated by Eureka AI based on patent content.

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Abstract

The utility model discloses a kit for nucleic acid detection, and relates to the technical field of nucleic acid detection.The kit comprises an upper split body, a lower split body and a detection unit, and the upper split body is provided with a sample adding opening; the lower split body is rotationally connected with the upper split body, and a plurality of reagent positions are arranged in the lower split body; a limiting assembly used for limiting the position of the lower split body is arranged on the upper split body. During use, before a sample is added, the limiting assembly locks the position of the lower split body and prevents the lower split body from rotating, at the moment, a reagent position needing to be added with the sample right faces the sample adding opening, at the moment, the sample adding device extends into the sample adding opening, the sample in the sample adding device is added into the corresponding reagent position, sample adding is completed, sample solution injection dislocation is effectively prevented, and the sample adding efficiency is improved. The accuracy of a detection result is ensured.
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Description

Technical Field

[0001] The present application relates to the technical field of nucleic acid detection, and in particular to a kit for nucleic acid detection. Background Art

[0002] Nucleic acid testing is widely used in various fields of biomedicine, especially in the detection of infectious disease pathogens. The nucleic acid test result is an important criterion for diagnosis. The nucleic acid testing process includes sample lysis, washing, nucleic acid elution, PCR amplification, and result detection.

[0003] The bottom of the test kit is usually equipped with several test slots or test tubes for holding reagent solutions. During the test, the sample needs to be added to the corresponding test slots or test tubes in the test kit in advance. However, if the position of the test slot in the test kit moves or changes due to external force or other factors, it is easy to cause the sample solution to be added in the wrong position, thereby affecting the accuracy of the test results. Summary of the Invention

[0004] In order to prevent the sample solution from being misplaced during filling, the present application provides a nucleic acid detection kit.

[0005] On the one hand, the present application provides a nucleic acid detection kit, which adopts the following technical solution:

[0006] A kit for nucleic acid detection, comprising:

[0007] An upper body, wherein the upper body is provided with a sample addition port;

[0008] A lower body, the lower body being rotatably connected to the upper body, and the lower body being provided with a plurality of reagent positions;

[0009] The upper body is provided with a limiting component for limiting the position of the lower body.

[0010] By adopting the above technical solution, before adding the sample, the limit assembly locks the position of the lower body to prevent it from rotating. At this time, the reagent position where the sample needs to be added is facing the sample injection port. At this time, the sample injection device is inserted into the sample injection port and the sample in the sample injection device is added to the corresponding reagent position. The sample injection is completed, effectively preventing the sample solution from being misplaced and ensuring the accuracy of the test results. During the test, the limit assembly releases the restriction on the lower body, allowing the external instrument to drive the lower body to rotate.

[0011] Optionally, the lower body includes a mounting portion, the mounting portion includes a rotating platform and a receiving platform, the rotating platform is rotatably arranged in the upper body, and the bottom of the upper body is used to abut against the receiving platform.

[0012] Optionally, a sealing ring is provided between the rotating platform and the upper split body.

[0013] Optionally, the limit assembly includes a limit pin and an elastic member, the limit pin is slidably arranged in the upper body along the axial direction of the test kit, the top wall of the rotating table is provided with a limit hole for inserting the limit pin, and the elastic member is arranged in the upper body to drive the limit pin to move closer to the lower body.

[0014] Optionally, a first mark is provided on the upper body, and a second mark is provided on the lower body, and when the first mark is opposite to the second mark, the limit pin is opposite to the limit hole.

[0015] Optionally, the reagent positions are configured as a plurality of detection tanks, wherein the detection tanks include one or more of a cleaning tank, a lysis tank, an elution tank, and a PCR tank.

[0016] Optionally, the test kit further includes a pipette, which is disposed in the upper body and is used to transfer the solution in the detection tank to other detection tanks.

[0017] Optionally, the upper body is provided with at least two positioning planes, and the positioning planes extend along the height direction of the upper body.

[0018] In summary, this application includes at least one of the following beneficial technical effects:

[0019] 1. During use, before adding the sample, the limit assembly locks the position of the lower split to prevent it from rotating. At this time, the reagent position where the sample needs to be added is facing the sample injection port. At this time, insert the sample injection device into the sample injection port and add the sample in the sample injection device to the corresponding reagent position to complete the sample injection, effectively preventing the sample solution from being misplaced and ensuring the accuracy of the test results.

[0020] 2. Multiple reagent positions are set up in the lower body. Reagent solutions and / or cleaning solutions are preset in the corresponding reagent positions before the experiment. During the test, the lower body is driven to rotate by an external mechanism, and the sample solution in the reagent position is transferred to other reagent positions by a pipette to complete nucleic acid extraction and purification and / or PCR amplification detection. The entire process is carried out inside the test kit, effectively preventing contamination. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a schematic diagram of the overall structure of an embodiment of the present application;

[0022] Figure 2 This is a schematic structural diagram of the lower split body of the card box in an embodiment of the present application;

[0023] Figure 3 is a top view of the card box according to an embodiment of the present application;

[0024] Figure 4 This is an embodiment of the present application Figure 3 Middle AA section view;

[0025] Figure 5 This is a schematic diagram of the structure of the pipette mainly embodied in the embodiment of the present application.

[0026] Figure 6 This is an embodiment of the present application Figure 4 Enlarged view of part B in the middle.

[0027] Explanation of reference numerals: 1. Upper body; 11. Positioning plane; 111. Positioning groove; 12. Sealing tube; 121. End plug; 122. Limiting ring; 2. Lower body; 21. Rotating table; 211. Embedding groove; 22. Receiving table; 23. Limiting hole; 3. Pipette; 31. Pipette; 311. Boss; 312. First filter element; 32. Needle; 33. Reset member; 4. Sample loading cover; 41. Cover body; 411. Accommodating tank; 412, second filter element; 42, cover plate; 421, air pressure balance hole; 5, detection tank; 51, cleaning tank; 52, lysis tank; 53, elution tank; 54, PCR tank; 55, combining tank; 56, small hole slot; 6, limiting assembly; 61, limiting pin; 611, limiting platform; 612, tip; 613, handheld platform; 62, elastic part; 7, sleeve; 81, first identification; 82, second identification. DETAILED DESCRIPTION

[0028] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0029] It should be noted that all directional indications in the embodiments of the present invention (such as up, down, left, right, front, back, etc.) are only used to explain the relative position relationship, movement status, etc. between the various components under a certain specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indication will also change accordingly.

[0030] In the present invention, unless otherwise specified or limited, the terms "connection" and "fixation" should be understood in a broad sense. For example, "fixation" can mean fixed connection, detachable connection, or integration; mechanical connection or electrical connection; direct connection or indirect connection through an intermediate medium; internal communication between two elements or interaction between two elements, unless otherwise specified. Those skilled in the art will be able to understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0031] In addition, if there are descriptions involving "first", "second", etc. in the embodiments of the present invention, the descriptions of "first", "second", etc. are only for descriptive purposes and cannot be understood as indicating or suggesting their relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of such features. In addition, the meaning of "and / or" appearing throughout the text includes three parallel schemes. Taking "A and / or B" as an example, it includes scheme A, or scheme B, or a scheme in which A and B are satisfied at the same time. In addition, the technical solutions between the various embodiments can be combined with each other, but it must be based on the ability of ordinary technicians in this field to implement. When the combination of technical solutions is mutually contradictory or cannot be implemented, it should be deemed that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0032] The embodiments of the present application disclose a kit for nucleic acid detection.

[0033] Reference Figure 1 A nucleic acid detection kit comprises an upper body 1, a pipette 3, and a lower body 2. The lower body 2 is rotatably connected to the upper body 1. The cross-sections of the lower body 2 and the upper body 1 are circular to facilitate rotation. The lower body 2 and the upper body 1 form an integrally molded housing structure. The ends of the upper and lower bodies 1 and 2 that are closer to each other are open and the ends that are farther away from each other are closed, forming a relatively sealed housing for the kit.

[0034] Reference Figure 1 The upper body 1 is provided with a first mark 81, and the lower body 2 is provided with a second mark 82. When the first mark 81 and the second mark 82 are aligned, the limit pin 61 is aligned with the limit hole 23. The first mark 81 and the second mark 82 can be configured as labels. In this embodiment, the first mark 81 and the second mark 82 are configured as vertical grooves. When the two grooves overlap, it indicates that the lower body 2 is correctly positioned.

[0035] Reference Figure 2 The lower body 2 includes a mounting portion, which includes a rotating platform 21 and a receiving platform 22. The rotating platform 21 and the receiving platform 22 are integrally formed. The outer diameter of the rotating platform 21 is slightly smaller than the inner diameter of the upper body 1. The rotating platform 21 is rotatably arranged in the upper body 1, and the bottom of the upper body 1 is used to abut against the receiving platform 22. After the upper and lower bodies 1 and 2 are installed, the rotating platform 21 extends into the upper body 1 and abuts against the inner wall of the upper body 1, while the bottom end of the upper body 1 abuts against the upper surface of the receiving platform 22, playing the role of supporting the upper body 1.

[0036] Further, refer to Figure 2To reduce the diffusion of aerosols from the reagent chamber to the outside of the reagent chamber, a sealing ring (not shown) is provided between the rotating platform 21 and the upper body 1. Specifically, an embedding groove 211 is formed along the circumference of the rotating platform 21 on the outer sidewall of the rotating platform 21, and the sealing ring is embedded in the embedding groove 211. In this embodiment, the sealing ring is configured as an O-ring made of rubber. The sealing ring contacts the inner wall of the upper body 1, thereby sealing the connection between the upper body 1 and the lower body 2.

[0037] Reference Figure 1 The upper body 1 is provided with at least two positioning flats 11 extending along its height. During testing, it is installed in the mounting cavity of a test instrument. The mounting cavity of the instrument contains a positioning plate that matches the positioning flats 11. The positioning flats 11 abut against the positioning plate, thereby achieving the purpose of defining the position of the upper body 1 and maintaining the position of the upper body 1 stable during the process of driving the lower body 2 to rotate.

[0038] Further, refer to Figure 1 Positioning plane 11 is provided with a positioning groove 111, which is arranged perpendicular to the axis of the reagent container. Positioning groove 111 can be a V-shaped groove, a T-shaped groove, or a groove of another shape. In this embodiment, positioning groove 111 is configured as a V-shaped groove. The instrument is provided with a positioning portion for inserting into positioning groove 111, thereby limiting the vertical freedom of the reagent container.

[0039] Optionally, refer to Figure 2 , a number of reagent positions are provided in the lower body 2, and a number of the reagent positions are provided as a number of detection tanks 5, and the detection tank 5 includes one or more of a cleaning tank 51, a lysis tank 52, an elution tank 53 and a PCR tank 54. In this embodiment, the detection tank 5 includes a cleaning tank 51, a binding tank 55, a lysis tank 52, an elution tank 53 and a PCR tank 54. Specifically, it includes an elution tank 53, a lysis tank 52, a binding tank 55, three cleaning tanks 51, and a number of PCR tanks 54. The elution tank 53 is provided with a nucleic acid elution solution, the lysis tank 52 is provided with a lysis solution, the binding tank 55 is reserved with an incubation buffer solution, the cleaning tank 51 is provided with a cleaning solution, and the PCR tank 54 is a position for PCR primers and probes for different targets. The PCR tank 54 is a circular tank, and protrudes from the bottom of the lower body 2 to form a number of cylindrical structures extending downward; the cleaning tank 51 and the binding tank 55 are fan-shaped tanks, and protrude from the bottom of the lower body 2. Each of the detection slots 5 protrudes downward from the bottom of the lower body 2, forming a protruding structure corresponding to the detection slot 5, which is compatible with the driving mechanism of the detection device, thereby enabling the driving mechanism of the detection device to drive the detection slot 5 and the lower body 2 to rotate. Furthermore, in this embodiment, the detection slot 5 also includes four small hole slots 56, each of which is provided with proteinase K, magnetic beads, paraffin oil, and PCR enzyme freeze-dried pellets.

[0040] Reference Figure 3 and Figure 4 The upper body 1 is provided with a sample loading port, and a sample loading cover 4 is provided at the sample loading port. When loading, the sample loading cover 4 is opened, the sample solution is drawn into the upper body 1 through the sample loading device, and the sample solution is added to the detection tank 5, and then the sample loading cover 4 is closed. The sample loading cover 4 includes a cover body 41 and a cover plate 42. The cover body 41 and the cover plate 42 are integrally formed. When the sample loading cover 4 is closed, the cover body 41 is inserted into the sample loading port, and the cover plate 42 abuts against the top wall of the upper body 1. The size of the cover plate 42 is larger than the sample loading port.

[0041] Reference Figure 3 and Figure 4 The cover 41 has a receiving groove 411, and the cover plate 42 has a pressure balancing hole 421. The pressure balancing hole 421 is connected to the receiving groove 411. The provision of the pressure balancing hole 421 ensures that the internal and external air can be connected, ensuring the normal operation of the test. To prevent contamination, a second filter element 412 is provided at the sample inlet. Specifically, the second filter element 412 is embedded in the receiving groove 411, effectively preventing aerosols from diffusing from the pressure balancing hole 421.

[0042] Reference Figure 4 The pipette 3 is arranged in the upper body 1 and is used to transfer the solution in the detection tank 5 to other detection tanks 5. The pipette 3 includes: a pipette 31, a needle 32 and a reset member 33.

[0043] Optionally, a sealing tube 12 is fixedly disposed in the axial direction of the cartridge within the upper body 1. The top of the sealing tube 12 is open and extends through the top wall of the upper body 1. The top wall of the upper body 1 refers to the end face of the upper body 1 away from the lower body 2. That is, during the test, the top wall is the uppermost wall of the upper body 1. A pipette 31 is slidably disposed within the upper body 1 along the central axis of the cartridge. The central axis of the cartridge is the vertical axis when the cartridge is in use. The pipette 31 is open at the end away from the lower body 2.

[0044] Reference Figure 4 and Figure 5 The pipette 31 is slidably arranged in the sealing tube 12. A boss 311 is provided on the pipette 31 for contacting the inner wall of the sealing tube 12. The boss 311 is circular. In order to increase the sealing effect, the side wall of the boss 311 is adapted to the inner wall of the sealing tube 12 and fits each other.

[0045] Reference Figure 4 and Figure 5The bottom of the sealing tube 12 is provided with an end plug 121, which can be fixed to the sealing tube 12 by welding, bonding, or threading. The end plug 121 has a perforation for a needle 32 to pass through. The needle 32 is connected to the end of the pipette 31 near the lower body 2 of the cartridge, and the needle 32 is in communication with the pipette 31. The needle 32 is used to pierce the sealing membrane and insert into the detection tank 5, where the needle 32 is in contact with the inner wall of the perforation.

[0046] Optionally, a reset member 33 is disposed within the upper cartridge body 1 to force the pipette 31 to move away from the lower cartridge body 2, thereby disengaging the needle 32 from the detection tank 5. In this embodiment, the reset member 33 is configured as a reset spring, which is located within the sealing tube 12 and sleeved onto the pipette 31. One end of the reset spring abuts against the boss 311, and the other end abuts against the end plug 121. After the needle 32 is inserted into the detection tank 5 and aspirates the solution, the elastic force of the reset spring automatically resets the pipette 31 and needle 32 upward, disengaging the needle 32 from the detection tank 5.

[0047] Reference Figure 5 A limiting ring 122 for abutting against the boss 311 is provided at the tube mouth of the sealing tube 12. The limiting ring 122 is integrally formed with the upper split body 1 of the card box. Under the action of the reset spring, the pipette 31 has a tendency to move upward. When the boss 311 abuts against the limiting ring 122, the position of the pipette 31 is limited to prevent the pipette 31 from escaping from the sealing tube 12.

[0048] Reference Figure 5 A first filter element 312 is disposed within the pipette 31. The first filter element 312 is in contact with the inner wall of the pipette 31 and is located at the upper end of the pipette 31 to increase the effective pipetting volume of the pipette. The effective pipetting volume is the volume of the cavity between the first filter element 312 and the bottom of the pipette 31. The first filter element 312 allows gas to pass through while effectively blocking aerosols, preventing aerosols inside the cartridge from diffusing outside the cartridge and causing aerosol contamination.

[0049] Optional, see Figure 4 and Figure 6 The upper body 1 is provided with a limit assembly 6 for limiting the position of the lower body 2. The limit assembly 6 includes a limit pin 61 and an elastic member 62. The limit pin 61 is slidably disposed within the upper body 1 along the axial direction of the reagent cartridge. The top wall of the rotating platform 21 is provided with a limit hole 23 for receiving the limit pin 61. When the limit pin 61 is aligned with the limit hole 23, the detection slot 5 to which the sample is to be added is aligned with the sample injection port.

[0050] Reference Figure 4 and Figure 6A sleeve 7 is fixedly provided in the upper body 1 along the axial direction of the reagent box. The top wall of the sleeve 7 extends through the top wall of the upper body 1. A limit pin 61 is slidably provided in the sleeve 7, and one end of the limit pin 61 passes through the top wall of the sleeve 7 and extends out of the upper body 1. A limit platform 611 is fixedly provided on the limit pin 61. An elastic member 62 is provided in the upper body 1 to drive the limit pin 61 to move closer to the lower body 2. The elastic member 62 is configured as a compression spring, which is sleeved on the limit pin 61. One end of the compression spring abuts against the top wall of the sleeve 7, and the other end abuts against the limit platform 611. In order to facilitate the insertion of the limit pin 61 into the limit hole 23, a tip portion 612 is provided at the bottom of the limit pin 61. The tip portion 612 is configured as a smooth hemispherical structure to reduce wear on the top wall of the rotating table 21. In order to facilitate the upward pulling out of the limiting pin 61 , a handheld platform 613 is fixedly provided on the top of the limiting pin 61 , and a groove is provided on the side wall of the handheld platform 613 to facilitate the pulling out of the limiting pin 61 .

[0051] The above are all preferred embodiments of the present application, and are not intended to limit the scope of protection of the present application. Therefore, any equivalent changes made based on the structure, shape, and principle of the present application should be included in the scope of protection of the present application.

Claims

1. A nucleic acid detection kit, characterized in that: The kit comprises: An upper body (1), wherein the upper body (1) is provided with a sample addition port; A lower body (2), the lower body (2) is rotatably connected to the upper body (1), and a plurality of reagent positions are provided in the lower body (2); The upper body (1) is provided with a position limiting component (6) for limiting the position of the lower body (2).

2. A nucleic acid detection kit according to claim 1, characterized in that: The lower body (2) includes a mounting portion, and the mounting portion includes a rotating platform (21) and a receiving platform (22). The rotating platform (21) is rotatably arranged in the upper body (1), and the bottom of the upper body (1) is used to abut against the receiving platform (22).

3. A nucleic acid detection kit according to claim 2, characterized in that: A sealing ring is provided between the rotating platform (21) and the upper body (1).

4. A nucleic acid detection kit according to claim 2, characterized in that: The limiting assembly (6) includes a limiting pin (61) and an elastic member (62). The limiting pin (61) is slidably provided in the upper body (1) along the axial direction of the reagent box. The top wall of the rotating table (21) is provided with a limiting hole (23) for inserting the limiting pin (61). The elastic member (62) is provided in the upper body (1) to drive the limiting pin (61) to move toward the lower body (2).

5. A nucleic acid detection kit according to claim 4, characterized in that: The upper body (1) is provided with a first mark (81), and the lower body (2) is provided with a second mark (82). When the first mark (81) and the second mark (82) are facing each other, the limit pin (61) and the limit hole (23) are facing each other.

6. A nucleic acid detection kit according to claim 1, characterized in that: The plurality of reagent positions are configured as a plurality of detection slots (5), wherein the detection slots (5) include one or more of a cleaning slot (51), a lysis slot (52), an elution slot (53) and a PCR slot (54).

7. A nucleic acid detection kit according to claim 1, characterized in that: The test kit further comprises a pipette (3), which is arranged in the upper body (1) and is used to transfer the solution in the detection tank (5) to other detection tanks (5).

8. A nucleic acid detection kit according to claim 1, characterized in that: The upper body (1) is provided with at least two positioning planes (11), and the positioning planes (11) extend along the height direction of the upper body (1).