Nucleic acid detection card box
By designing a nucleic acid detection box, using isothermal amplification technology and a dual-cavity structure, the problem of large size and long detection time of traditional PCR equipment is solved, and fast and accurate home and bedside nucleic acid detection is achieved, reducing costs and equipment dependence.
Patent Information
- Application Number
- CN202422453735.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-11
- Publication Date
- 2025-09-02
- Estimated Expiration
- 2034-10-11
AI Technical Summary
In the prior art, traditional PCR nucleic acid detection equipment is large in size and heavy in weight, cumbersome in sample processing, long detection time, and mobile detection methods are not yet mature, and antigen detection sensitivity is low, which cannot meet the needs of rapid detection at home and bedside.
A nucleic acid detection card box is designed, using isothermal amplification technology, including a shell, reaction tube scaffold and reagent strip, and the rapid mixing and detection of samples and reaction reagents are achieved through a dual-cavity structure, simplifying the operation process, and is suitable for home and bedside testing.
It realizes fast and accurate nucleic acid detection, reduces detection costs, eliminates the need for large instruments and standard laboratories, and is suitable for mobile detection, improving the sensitivity and applicability of detection.
Smart Images
Figure CN223292546U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the field of isothermal nucleic acid detection, in particular to a nucleic acid detection card box. Background Art
[0002] Isothermal amplification technology is a general term for a type of in vitro nucleic acid amplification technology. The reaction process is always maintained at a constant temperature, and the purpose of rapid nucleic acid amplification is achieved by adding enzymes with different activities and their respective specific primers (or not).
[0003] In the existing technology, traditional PCR nucleic acid detection equipment is large in size and weight, the sample processing process is cumbersome, and the detection time is long (usually the detection time is more than three hours). It is only suitable for high-throughput nucleic acid detection in standard laboratories. Due to the characteristics of PCR nucleic acid detection equipment such as high sample processing conditions, difficulty in miniaturizing fluorescence detection technology, and high sample transportation costs (cold chain transportation is required), mobile nucleic acid detection methods are still in the research and development stage. The mature in vitro diagnostic technology is still the antigen detection method, but antigen detection has lower sensitivity than nucleic acid detection and poor detection effect. For clinical in vitro diagnosis, it can only be used as an auxiliary screening method and cannot be used as a diagnostic gold standard.
[0004] Therefore, there is an urgent need for a nucleic acid detection cartridge based on isothermal technology to solve the above technical problems. Utility Model Content
[0005] Based on the above, the purpose of the present invention is to provide a nucleic acid detection card box to realize rapid amplification and detection of samples and reaction reagents, which can be used for mobile detection such as home self-testing and bedside testing. It has simple operation, low detection cost and high detection accuracy.
[0006] To achieve this purpose, the present invention adopts the following technical solutions:
[0007] Nucleic acid detection cartridge, including:
[0008] A housing, wherein a receiving chamber and an observation chamber are provided within the housing, a liquid inlet and a liquid outlet are respectively provided on the housing, and a sample injection sealing plug is installed at the liquid inlet; the liquid outlet is connected to the observation chamber, a reagent strip is provided in the observation chamber, and a reagent strip viewing window is provided on the observation chamber; a sealing member is further provided on the outside of the housing for sealing a first end of the receiving chamber, and a reagent sealing plug is installed at a second end of the receiving chamber;
[0009] A reaction tube holder is movably disposed in the accommodating chamber, wherein a reaction chamber is provided in the reaction tube holder, and a pre-filled substance is provided in the reaction chamber; a holder sealing plug and a reagent piston are respectively installed at both ends of the reaction tube holder; a second reagent is provided between the reagent sealing plug and the reagent piston; and the liquid outlet is located between the holder sealing plug and the sealing member;
[0010] When the reaction tube holder is in the first position, the liquid inlet is connected to the reaction chamber, and the pre-filled substance can react with the sample to form a first reagent; when the reaction tube holder is in the second position, a gap is formed between the reagent piston and the accommodating chamber, and the second reagent can enter the reaction chamber along the gap and react with the first reagent to form a third reagent; when the reaction tube holder is in the third position, the reaction chamber is connected to the liquid outlet.
[0011] In some possible embodiments, the accommodating chamber includes a first chamber and a second chamber connected in a step-like manner, the inner diameter of the first chamber is smaller than the inner diameter of the second chamber, the reaction tube holder and the holder sealing plug are located in the second chamber, and the bottom of the reaction tube holder is provided with an opening connected to the reaction chamber; when the reagent piston is located in the first chamber, it is sealed with the first chamber, and when the reagent piston is located in the second chamber, it is clearance-matched with the second chamber.
[0012] In some possible implementations, the injection sealing plug is located above the liquid inlet, and the injection sealing plug is connected to the housing via threads.
[0013] In some possible implementations, the sealing member is connected to the shell through a heat sealing process.
[0014] In some possible implementations, the reagent strip window is connected to the housing via a snap-fit structure.
[0015] In some possible implementations, both ends of the reaction tube holder are respectively connected to the holder sealing plug and the reagent piston via a snap-fit structure.
[0016] In some possible implementations, the reagent strip is fixed in the observation cavity via a snap-fit structure.
[0017] In some possible implementations, the support sealing plug is tightly sealed against the second chamber by extrusion, and the reagent piston and the reagent sealing plug are tightly sealed against the first chamber by extrusion, respectively.
[0018] In some possible embodiments, the pre-filled material includes isothermal amplification reaction unit lyophilized beads.
[0019] In some possible embodiments, the nucleic acid detection cartridge further includes a push rod, the reagent sealing plug is provided with a mounting groove, and one end of the push rod is mounted in the mounting groove.
[0020] Beneficial effects of the utility model:
[0021] The nucleic acid detection cartridge provided by the present invention can add a pre-treated sample from the liquid inlet by opening the sample injection sealing plug; then the sample injection sealing plug is replaced, and the sample liquid flows into the reaction chamber of the reaction tube holder, and is fully mixed and reacted with the pre-filled substance therein to form a first reagent; then the sealing piece is punctured using a tooling fixture or a specific sharp object, and force is applied from the outside to push the reagent sealing plug, thereby driving the second reagent pre-filled in the accommodating chamber to gradually enter the reaction chamber along the gap between the reagent piston and the accommodating chamber, and the second reagent and the first reagent are quickly mixed and reacted to form a third reagent; the external thrust continues to push the reagent sealing plug until the reaction chamber of the reaction tube holder is connected to the liquid outlet of the shell, at which time the third reagent in the reaction chamber flows along the liquid outlet onto the reagent strip, and the operator observes the test result of the reagent strip through the reagent strip window.
[0022] The nucleic acid detection card box provided by the present invention arranges a pre-filled substance in the reaction chamber and a second reagent in the receiving chamber, and adopts the working principle of a double-chamber syringe to realize the detection of the sample to be detected. It has a simple structure and is easy to operate. It does not require large instruments and standard laboratories. It can be used for mobile detection such as home self-testing and bedside testing, reduces the detection cost, solves the problem of poor sealing of traditional nucleic acid detection card boxes, and has high detection accuracy and good applicability. BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Figure 1 This is a schematic structural diagram of the nucleic acid detection cartridge provided by an embodiment of the present utility model;
[0024] Figure 2 This is a top view of the nucleic acid detection cartridge provided by an embodiment of the present utility model;
[0025] Figure 3 yes Figure 2 Cross-sectional view along AA direction;
[0026] Figure 4 yes Figure 3 Schematic diagram of the middle accommodating cavity and the injection sealing plug;
[0027] Figure 5 yes Figure 2 Cross-sectional view along direction BB.
[0028] In the picture:
[0029] 10. Shell; 11. Liquid inlet; 12. Liquid outlet; 13. Receiving chamber; 131. First chamber; 132. Second chamber; 14. Observation chamber; 15. Second reagent; 20. Injection sealing plug; 30. Sealing member; 40. Reagent strip window; 50. Reaction tube holder; 51. Pre-filled substance; 52. Reaction chamber; 60. Holder sealing plug; 70. Reagent piston; 80. Reagent strip; 90. Reagent sealing plug; 91. Mounting slot. DETAILED DESCRIPTION
[0030] The present invention will be further described in detail below with reference to the accompanying drawings and examples. It should be understood that the specific embodiments described herein are intended only to illustrate the present invention and are not intended to limit the present invention. It should also be noted that, for ease of description, the accompanying drawings only illustrate portions relevant to the present invention, not all of its components.
[0031] In the description of this utility model, unless otherwise expressly specified or limited, the terms "connected," "connected," and "fixed" should be understood in a broad sense. For example, they may refer to fixed connection, detachable connection, or integration; mechanical connection or electrical connection; direct connection or indirect connection through an intermediate medium; internal communication between two components or interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in this utility model based on specific circumstances.
[0032] In the present invention, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may include the first feature being in direct contact with the second feature, or may include the first feature being in contact with the second feature through another feature between them instead of being in direct contact. Moreover, a first feature being "above," "above," and "above" a second feature may include the first feature being directly above or obliquely above the second feature, or may simply mean that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature may include the first feature being directly below or obliquely below the second feature, or may simply mean that the first feature is lower in level than the second feature.
[0033] In the description of this utility model, the terms "upper," "lower," "left," and "right," etc., regarding orientations or positions, are based on the orientations or positions shown in the accompanying drawings and are intended solely for ease of description and simplified operation. They are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on this utility model. Furthermore, the terms "first" and "second" are used solely for descriptive purposes and have no special meaning.
[0034] like Figures 1 to 5As shown, this embodiment provides a nucleic acid detection cartridge for performing nucleic acid detection on a sample to be detected. The nucleic acid detection cartridge includes a housing 10, a sample injection seal plug 20, a sealing member 30, a reagent strip window 40, a reaction tube holder 50, a holder seal plug 60, a reagent piston 70, a reagent strip 80, and a reagent seal plug 90. The housing 10 specifically includes a main housing and an observation housing, wherein a accommodating chamber 13 is provided in the main housing, and a liquid inlet 11 and a liquid outlet 12 respectively connected to the accommodating chamber 13 are provided on the main housing, wherein the liquid inlet 11 is used to install the sample injection seal plug 20; an observation chamber 14 is provided in the observation housing, and the liquid outlet 12 is connected to the observation chamber 14, and a reagent strip 80 is provided in the observation chamber 14 for displaying the nucleic acid detection result; the reagent strip window 40 is provided above the observation chamber 14 and directly opposite to the reagent strip 80, and the reagent strip window 40 is made of a transparent material to facilitate observation of the reagent strip 80. Preferably, the main housing of this embodiment is tubular, with a circular cross-section channel forming a receiving chamber 13. The observation housing is rectangular and disposed parallel to one side of the main housing. The top of the observation housing is open, and a reagent strip viewing window 40 is fixedly mounted in the open area. A sealing member 30 is fixed to the outside of the housing 10 and seals the first end of the receiving chamber 13. A reagent sealing plug 90 is sealed at the second end of the receiving chamber 13.
[0035] The reaction tube holder 50 is movably disposed within the accommodating chamber 13. A reaction chamber 52 is provided within the reaction tube holder 50, and a pre-filled substance 51 is provided within the reaction chamber 52. A reagent piston 70 is mounted on the side of the reaction tube holder 50 near the reagent sealing plug 90, and a holder sealing plug 60 is mounted on the side of the reaction tube holder 50 near the sealing member 30. Both the reagent piston 70 and the holder sealing plug 60 are sealedly connected to the accommodating chamber 13. A second reagent 15 is pre-filled between the reagent sealing plug 90 and the reagent piston 70, and a liquid outlet 12 is disposed between the holder sealing plug 60 and the sealing member 30. When the reaction tube holder 50 is in the first position, the liquid inlet 11 is connected to the reaction chamber 52, and the sample to be tested entering through the liquid inlet 11 can react with the pre-filled substance 51 to form a first reagent; when the reaction tube holder 50 is in the second position, a gap is formed between the reagent piston 70 and the accommodating chamber 13, and the second reagent 15 can enter the reaction chamber 52 along the gap. The second reagent 15 reacts with the first reagent to form a third reagent; when the reaction tube holder 50 is in the third position, the reaction chamber 52 is connected to the liquid outlet 12, and the third reagent can flow into the observation chamber 14.
[0036] In the initial state of the nucleic acid detection cartridge provided in this embodiment, the reaction tube holder 50 is in the first position (eg Figure 3As shown), at this time, the injection sealing plug 20 is opened, and the pre-treated sample is added from the liquid inlet 11; then the injection sealing plug 20 is replaced, and the sample liquid flows into the reaction chamber 52 of the reaction tube holder 50, and is fully mixed with the pre-filled substance 51 therein to react to form the first reagent; then, a tool or a specific sharp object is used to pierce the sealing member 30, and a force is applied from the left side of the accommodating chamber 13 to push the reagent sealing plug 90, so that the reagent sealing plug 90, the second reagent 15, the reagent piston 70, the reaction tube holder 50 and the holder sealing plug 60 are moved to the right as a whole, until there is a gap between the reagent piston 70 and the accommodating chamber 13, at which time the reaction tube holder 50 is in the second position; then continue to push The reagent sealing plug 90 is moved, so that the second reagent 15 pre-filled in the accommodating chamber 13 gradually enters the reaction chamber 52 along the gap between the reagent piston 70 and the accommodating chamber 13, and the second reagent 15 and the first reagent quickly mix and react to form a third reagent; then the external thrust continues to push the reagent sealing plug 90, and the reaction tube holder 50 continues to move right until the reaction chamber 52 of the reaction tube holder 50 is connected to the liquid outlet 12 of the shell 10. At this time, the reaction tube holder 50 is in the third position, and the third reagent in the reaction chamber 52 can flow along the liquid outlet 12 onto the reagent strip 80. The test result can be displayed through the reaction between the reagent strip 80 and the third reagent, and the operator can observe the test result through the reagent strip window 40.
[0037] This embodiment arranges a pre-filled substance 51 in the reaction chamber 52 and a second reagent 15 in the accommodating chamber 13, and adopts the working principle of a double-chamber syringe to realize the detection of the sample to be detected. It has a simple structure and is easy to operate. It does not require large instruments and standard laboratories. It can be used for mobile detection such as home self-testing and bedside testing, which reduces the detection cost and solves the problem of poor sealing of traditional nucleic acid detection cartridges. It also has high detection accuracy and good applicability.
[0038] refer to Figure 3 and Figure 4 The accommodating chamber 13 of this embodiment includes a first chamber 131 and a second chamber 132 connected in a stepped manner. The inner diameter of the first chamber 131 is smaller than the inner diameter of the second chamber 132. The reaction tube holder 50 and the holder sealing plug 60 are both located in the second chamber 132. The bottom of the reaction tube holder 50 is provided with an opening communicating with the reaction chamber 52. When the reaction tube holder 50 is in the first position, the reagent piston 70 is located in the first chamber 131 and the reagent piston 70 and the first chamber 131 are sealed. When the reaction tube holder 50 moves to the second position, the reagent piston 70 is located in the second chamber 132 and the reagent piston 70 and the second chamber 132 are loosely matched, so that the second reagent 15 can enter the reaction chamber 52 along the gap between the reagent piston 70 and the second chamber 132 and the opening at the bottom of the reaction tube holder 50. The above-mentioned accommodating chamber 13 has a simple structure and is easy to process.
[0039] Optionally, the sample injection plug 20 of this embodiment is located above the liquid inlet 11 to facilitate the addition of sample liquid. The sample injection plug 20 is provided with an external thread on its periphery, and the liquid inlet 11 is provided with an internal thread. The sample injection plug 20 and the liquid inlet 11 are connected by a threaded connection, which is reliable and easy to install and remove.
[0040] Optionally, the sealing member 30 of this embodiment is connected to the shell 10 by a heat sealing process to achieve the effect of sealing the first end of the accommodating cavity 13. A puncture portion is provided on the sealing member 30, and the sealing member 30 can be punctured by a tool or a specific sharp object to connect the accommodating cavity 13 with the outside atmosphere, so that the reagent sealing plug 90 can be pushed by an external force from the second end of the accommodating cavity 13. Preferably, the nucleic acid detection cartridge of this embodiment further includes a push rod (not shown in the figure), and the reagent sealing plug 90 is provided with a mounting groove 91, and one end of the push rod is installed in the mounting groove 91. This embodiment pushes the reagent sealing plug 90 to move in the accommodating cavity 13 by the push rod, and the operation is simpler and more convenient.
[0041] Optionally, the reagent strip window 40 of this embodiment is connected to the housing 10 via a snap-fit structure, and the reagent strip 80 is also fixed in the observation chamber 14 via the snap-fit structure. The snap-fit structure allows for convenient and rapid connection, greatly improving the production efficiency of the nucleic acid detection cartridge. When the operator needs to observe the detection information of the sample to be tested, the reagent strip 80 can be directly observed through the reagent strip window 40, thereby improving the convenience of observation. It should be noted that the detection principle and display principle of the reagent strip 80 are both prior art and will not be further described in detail in this embodiment.
[0042] In this embodiment, the two ends of the reaction tube support 50 are respectively connected to the support sealing plug 60 and the reagent piston 70 by a snap-fit structure, which is reliable and easy to assemble and disassemble. Furthermore, the support sealing plug 60 of this embodiment is tightly sealed with the second chamber 132 by extrusion to ensure the sealing performance of the support sealing plug 60 and the second chamber 132, thereby preventing the liquid in the reaction chamber 52 from flowing out of the housing 10; the reagent sealing plug 90 is tightly sealed with the first chamber 131 by extrusion to ensure the sealing performance of the reagent sealing plug 90 and the first chamber 131, thereby preventing the second reagent 15 from leaking from the reagent sealing plug 90; the reagent piston 70 is tightly sealed with the first chamber 131 by extrusion to ensure the sealing performance of the reagent piston 70 and the first chamber 131, thereby preventing the second reagent 15 from entering the reaction chamber 52 in advance when the reaction tube support 50 is in the first position, thereby ensuring the orderly progress of each reaction.
[0043] Optionally, the pre-filled material 51 of this embodiment is an isothermal amplification reaction unit freeze-dried ball. The freeze-dried ball is mixed with the sample to be tested to form a test liquid, which solves the problem of storage and transportation of the test liquid at room temperature, eliminates the cold chain transportation cost of the test liquid, and further reduces the cost of testing. It should be noted that the isothermal amplification reaction unit freeze-dried ball includes primer probes, magnesium acetate and other substances to ensure the fusion reaction amplification of the sample to be tested and the reagent. The specific composition and reaction principle of the isothermal amplification reaction unit freeze-dried ball are all prior art and will not be repeated in this embodiment.
[0044] Obviously, the above-described embodiments of the present invention are merely examples for the purpose of clearly illustrating the present invention and are not intended to limit the manner in which the present invention is to be implemented. A person skilled in the art would be able to make various obvious changes, readjustments, and substitutions without departing from the scope of protection of the present invention. It is not necessary and impossible to enumerate all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the claims of the present invention.
Claims
1. A nucleic acid detection cartridge, characterized in that: include: A housing (10) is provided with a receiving chamber (13) and an observation chamber (14) in the housing (10); a liquid inlet (11) and a liquid outlet (12) respectively connected to the receiving chamber (13) are provided on the housing (10); a sample injection sealing plug (20) is installed at the liquid inlet (11); the liquid outlet (12) is connected to the observation chamber (14); a reagent strip (80) is provided in the observation chamber (14), and a reagent strip viewing window (40) is provided on the observation chamber (14); a sealing member (30) is further provided on the outside of the housing (10) for sealing a first end of the receiving chamber (13); a reagent sealing plug (90) is installed at the second end of the receiving chamber (13); A reaction tube holder (50) is movably arranged in the accommodating chamber (13); a reaction chamber (52) is provided in the reaction tube holder (50); a pre-filled substance (51) is provided in the reaction chamber (52); a holder sealing plug (60) and a reagent piston (70) are respectively installed at both ends of the reaction tube holder (50); a second reagent (15) is provided between the reagent sealing plug (90) and the reagent piston (70); and the liquid outlet (12) is located between the holder sealing plug (60) and the sealing member (30); When the reaction tube holder (50) is in the first position, the liquid inlet (11) is connected to the reaction chamber (52), and the pre-filled substance (51) can react with the sample to form a first reagent; when the reaction tube holder (50) is in the second position, there is a gap between the reagent piston (70) and the accommodating chamber (13), and the second reagent (15) can enter the reaction chamber (52) along the gap and react with the first reagent to form a third reagent; when the reaction tube holder (50) is in the third position, the reaction chamber (52) is connected to the liquid outlet (12).
2. The nucleic acid detection cartridge according to claim 1, wherein The accommodating chamber (13) comprises a first chamber (131) and a second chamber (132) connected in a stepped manner, wherein the inner diameter of the first chamber (131) is smaller than the inner diameter of the second chamber (132), the reaction tube holder (50) and the holder sealing plug (60) are located in the second chamber (132), and the bottom of the reaction tube holder (50) is provided with an opening communicating with the reaction chamber (52); when the reagent piston (70) is located in the first chamber (131), it is in sealing engagement with the first chamber (131), and when the reagent piston (70) is located in the second chamber (132), it is in clearance engagement with the second chamber (132).
3. The nucleic acid detection cartridge according to claim 1, wherein: The injection sealing plug (20) is located above the liquid inlet (11), and the injection sealing plug (20) is connected to the housing (10) through threads.
4. The nucleic acid detection cartridge according to claim 1, wherein The sealing member (30) is connected to the housing (10) through a heat sealing process.
5. The nucleic acid detection cartridge according to claim 1, wherein: The reagent strip window (40) is connected to the housing (10) via a snap-fit structure.
6. The nucleic acid detection cartridge according to claim 1, wherein: The two ends of the reaction tube support (50) are respectively connected to the support sealing plug (60) and the reagent piston (70) through a snap-fit structure.
7. The nucleic acid detection cartridge according to claim 1, wherein: The reagent strip (80) is fixed in the observation cavity (14) via a snap-fit structure.
8. The nucleic acid detection cartridge according to claim 2, wherein: The bracket sealing plug (60) is pressed and sealed against the second chamber (132), and the reagent piston (70) and the reagent sealing plug (90) are respectively pressed and sealed against the first chamber (131).
9. The nucleic acid detection cartridge according to claim 1, wherein: The pre-filled material (51) includes isothermal amplification reaction unit freeze-dried beads.
10. The nucleic acid detection cartridge according to any one of claims 1 to 9, characterized in that: The nucleic acid detection cartridge further comprises a push rod, and a mounting groove (91) is provided on the reagent sealing plug (90), and one end of the push rod is mounted in the mounting groove (91).