A combined nucleic acid detection device

Abstract

The present invention discloses a combined nucleic acid detection device, including an amplification reaction tube and a detection card box, wherein a sealed solution cavity for accommodating an amplification reaction system is provided in the amplification reaction tube, the amplification reaction tube includes a first end wall, a side wall and a second end wall, the first end wall and the side wall are integrally formed, and a first matching portion is provided on the side wall; the detection card box includes a box shell and a detection test paper located in the box shell, the upper surface of the box shell is provided with a receiving port, a broken tube assembly and a second matching portion that matches the first matching portion are provided in the receiving port, when the amplification reaction tube is inserted into the receiving port from the end where the second end wall is located, the amplification reaction tube and the detection card box can be sealed and connected through the first matching portion and the second matching portion. By adopting the above technical solution, there is no need to set an additional fixed bracket when heating in a water bath. During the entire detection process, the amplification reaction tube and the detection card box are in a sealed connection state, which can effectively prevent the leakage of the amplification product.

Description

Technical Field

[0001] The present invention relates to the field of detection, and in particular to a combined nucleic acid detection device. Background Art

[0002] Nucleic acid diagnostics is one of the most dynamic segments of the IVD (in vitro diagnostic) industry in the future. The main drivers of my country's growth are the increased efforts in infectious disease prevention and control, the promotion of blood screening nucleic acid testing, and the development of personalized medicine. Driven by these factors, nucleic acid diagnostics in China are expected to grow at a rate of 25-30% in the future, significantly exceeding the average growth rate of the domestic IVD industry. Nucleic acid diagnostics will benefit large medical centers by enabling early, rapid, specific, and high-throughput detection of pathogens and genetic diseases.

[0003] Point-of-care testing (POCT), also known as "instant testing" in Chinese, is an emerging sub-sector of in vitro diagnostics (IVD). It enables analysis immediately at the point of sampling, eliminating the complex sample handling required for laboratory testing and providing rapid results. Key criteria for POCT are the lack of a fixed testing location, the portable reagents and instruments, and the ability to operate instantly. POCT assumes the functions of a laboratory without the traditional equipment of a hospital laboratory, providing comprehensive 24-hour patient service regardless of time or location.

[0004] However, these nucleic acid amplification methods are susceptible to cross-contamination of amplified products. This can cause false positive signals, leading to misinterpretation of test results. Cross-contamination between samples is common during target nucleic acid amplification procedures. This can originate from known or unknown positive substances introduced during the processing of negative samples, which can cause false positive reactions through airborne contamination or aerosols. Therefore, nucleic acid testing must be performed in specialized, closed laboratories, making it difficult to conduct immediate testing in certain impoverished or underdeveloped areas.

[0005] A series of methods have been developed in the prior art to prevent cross-contamination of amplification products. For example, Reference 1 (CN105199940A) discloses a contamination-resistant portable genetic testing method and device. This device allows a PCR tube containing amplification products to be placed in the device, sealed, and then punctured to perform testing. This prevents contamination of nucleic acid amplification products and avoids false positives. Furthermore, Reference 2 (CN203241416U) discloses a sealed plastic card box for test strips, and Reference 3 (CN205574438U) discloses a sealed test tube assembly containing a tube piercing assembly. These devices allow for immediate nucleic acid testing without the need for a dedicated, closed laboratory. Summary of the Invention

[0006] Although various detection devices that can conveniently implement instant testing have been disclosed in the prior art, nucleic acid samples must be placed in a constant temperature water bath for nucleic acid amplification before nucleic acid testing, and a dedicated fixed bracket is required to secure the amplification reaction tubes. This increases the amount of equipment required when performing testing outside the laboratory, making instant testing inconvenient.

[0007] The present invention aims to address the inconvenient operation of existing enclosed detection devices. To address this issue, the present invention discloses a novel modular nucleic acid detection device. This device, when used in a water bath, eliminates the need for additional fixed supports, conveniently enabling nucleic acid amplification reactions. It also effectively prevents the diffusion of amplification products into the air, which could result in false positive reactions.

[0008] The present invention discloses a combined nucleic acid detection device, comprising an amplification reaction tube and a detection cartridge.

[0009] A sealed solution cavity for accommodating the amplification reaction system is provided in the amplification reaction tube. The amplification reaction tube includes a first end wall, a side wall, and a second end wall. The first end wall and the side wall are integrally formed, and a first mating portion is provided on the side wall.

[0010] The detection card box includes a box shell and a detection test paper located in the box shell. A receiving port is provided on the upper surface of the box shell. A tube breaking assembly and a second matching portion that cooperates with the first matching portion are provided in the receiving port. The tube breaking assembly is used to pierce the second end wall of the amplification reaction tube. When the amplification reaction tube is inserted into the receiving port from the end where the second end wall is located, the amplification reaction tube is sealed and connected to the detection card box through the first matching portion and the second matching portion.

[0011] Using the above technical solution, the amplification reaction tube is inverted so that the second end wall is facing upward. After the amplification reaction system is injected from the second end wall through the needle, the second end wall of the amplification reaction tube is maintained facing upward, and the amplification reaction tube is inserted into the receiving port, so that the amplification reaction tube and the detection cartridge are sealed. At this time, the amplification reaction tube and the detection cartridge jointly form a sealed state, and the end where the first end wall of the amplification reaction tube is located is immersed in water. Since the first end wall and the side wall of the amplification reaction tube are integrally formed, the amplification reaction tube can be directly placed in a constant temperature water bath, and the reaction system will not leak into the water bath. The detection cartridge will float on the water surface due to buoyancy, which can serve as a fixed bracket, and no additional fixed bracket is required. After the amplification reaction is completed, the modular nucleic acid detection device is flipped over, and the amplification reaction tube is continued to be pushed toward the receiving port. The broken tube assembly punctures the amplification reaction tube, and the amplification product after the amplification reaction flows into the cartridge shell, and the amplification product can be detected. Throughout the entire process, the amplification reaction tube and the detection cartridge are in a sealed connection state, which can effectively prevent the amplification product from leaking.

[0012] According to another specific embodiment of the present invention, a cut is provided on the second end wall of the amplification reaction tube.

[0013] According to another specific embodiment of the present invention, the thickness of the second end wall of the amplification reaction tube is thinner than the thickness of the side wall.

[0014] According to another specific embodiment of the present invention, the second end wall is a cover, which is detachably sealed to the side wall.

[0015] According to another specific embodiment of the present invention, the end of the amplification reaction tube close to the first end wall is a tapered tube.

[0016] According to another specific embodiment of the present invention, a cleaning liquid storage portion is further provided in the box shell, in which a nucleic acid cleaning reagent is placed. The cleaning liquid storage portion can be opened to allow the nucleic acid cleaning reagent to flow into the box shell.

[0017] According to another specific embodiment of the present invention, the first matching portion is an external thread, and the second matching portion is an internal thread. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments:

[0019] Figure 1 This is a schematic structural diagram of an amplification reaction tube provided by the present invention;

[0020] Figure 2 This is a cross-sectional schematic diagram of an amplification reaction tube provided by the present invention;

[0021] Figure 3 This is a cross-sectional schematic diagram of another amplification reaction tube provided by the present invention;

[0022] Figure 4 This is a schematic structural diagram of the combined nucleic acid detection device provided by the present invention in a coordinated state;

[0023] Figure 5 This is a cross-sectional schematic diagram of the combined nucleic acid detection device provided by the present invention in a mating state;

[0024] Figure 6 This is a schematic diagram of the explosion of the combined nucleic acid detection device provided by the present invention.

[0025] Reference numerals:

[0026] Amplification reaction tube 100

[0027] Side wall 110

[0028] Conical tube 111

[0029] First end wall 120

[0030] Second end wall 130

[0031] Recess 131

[0032] First height indicator 150

[0033] Second height indicator 160

[0034] Box shell 200

[0035] Cleaning liquid storage portion 220

[0036] Sealing film 230

[0037] Test paper 240

[0038] Broken pipe assembly 250

[0039] Spike 251

[0040] Fixing portion 252

[0041] Receiving port 260

[0042] Test result observation area 270

[0043] Elastic downward pressure structure 280

[0044] Baffle 290 DETAILED DESCRIPTION

[0045] The following is an explanation of the embodiments of the present invention by specific specific examples. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. Although the description of the present invention will be introduced in conjunction with the preferred embodiment, this does not mean that the features of this invention are limited to this embodiment. On the contrary, the purpose of introducing the invention in conjunction with the embodiment is to cover other options or modifications that may be extended based on the claims of the present invention. In order to provide a deep understanding of the present invention, the following description will contain many specific details. The present invention can also be implemented without using these details. In addition, in order to avoid confusion or blurring the focus of the present invention, some specific details will be omitted in the description. It should be noted that the embodiments of the present invention and the features in the embodiments can be combined with each other without conflict.

[0046] In the description of this embodiment, it should be noted that the terms "upper", "lower", "inner", "bottom", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, or are the orientations or positional relationships in which the inventive product is usually placed when in use. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, they cannot be understood as limitations on the present invention.

[0047] The terms “first”, “second”, etc. are only used for distinguishing descriptions and should not be understood as indicating or implying relative importance.

[0048] In the description of this embodiment, it should be noted that, unless otherwise specified or limited, the terms "disposed," "connected," and "connected" should be understood broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and internal connections between two components. Those skilled in the art will understand the specific meanings of the above terms in this embodiment based on specific circumstances.

[0049] like Figure 1-6 As shown, the present invention discloses a combined nucleic acid detection device, including an amplification reaction tube 100 and a detection cartridge.

[0050] The amplification reaction tube 100 is provided with a sealed solution chamber for accommodating the amplification reaction system. The amplification reaction tube 100 includes a first end wall 120, a side wall 110, and a second end wall 130. The first end wall 120 and the side wall 110 are integrally formed. The side wall 110 is provided with a first mating portion.

[0051] The detection cartridge includes a cartridge shell 200 and a detection test paper 240 located inside the cartridge shell 200. A receiving port 260 is provided on the upper surface of the cartridge shell 200. A tube-breaking assembly and a second mating portion that cooperates with the first mating portion are provided inside the receiving port 260. The tube-breaking assembly is used to pierce the second end wall 130 of the amplification reaction tube 100. When the amplification reaction tube 100 is inserted into the receiving port 260 from the end where the second end wall 130 is located, the amplification reaction tube 100 and the detection cartridge can be sealed and connected through the first mating portion and the second mating portion.

[0052] Using the above technical solution, the amplification reaction tube 100 is inverted with the second end wall 130 facing upward. After the amplification reaction system is injected through the second end wall 130 via a needle, the second end wall 130 of the amplification reaction tube 100 is maintained facing upward, and the amplification reaction tube 100 is inserted into the receiving port 260, thereby sealing the amplification reaction tube 100 and the detection cartridge. At this point, the amplification reaction tube 100 and the detection cartridge are together sealed. The end of the amplification reaction tube 100 where the first end wall 120 is located is immersed in water. Since the first end wall 120 and the side wall 110 of the amplification reaction tube 100 are integrally formed, the amplification reaction tube 100 can be directly placed in a constant temperature water bath. The reaction system will not leak into the water bath. The detection cartridge will float on the water surface due to buoyancy, thus serving as a fixed bracket, eliminating the need for an additional fixed bracket. After the amplification reaction is complete, the combined nucleic acid detection device is flipped over and the amplification reaction tube 100 is continuously pushed toward the receiving port. The tube piercing assembly 250 punctures the amplification reaction tube 100, allowing the amplification product to flow into the cartridge housing 200 for detection. Throughout this process, the amplification reaction tube 100 and the detection cartridge are sealed, effectively preventing leakage of the amplification product.

[0053] Furthermore, the detection cartridge is preferably made of a material with a relatively low density to ensure that the detection cartridge at least partially floats on the water surface. The specific material can be the same as that of conventional plastic cartridges, such as PVC, PP, and PET.

[0054] According to another specific embodiment of the present invention, the first mating portion is an external thread, and the second mating portion is an internal thread. The internal and external threads are configured such that when the amplification reaction tube 100 is first screwed in, the amplification reaction tube 100 and the detection cartridge are sealed by the threaded fit. At this point, the amplification reaction tube 100 can be placed in a water bath for an amplification reaction. After the reaction is complete, as the amplification reaction tube 100 continues to be screwed in, the tube breaker assembly 250 punctures the bottom wall of the amplification reaction tube 100, allowing the amplification product to flow into the cartridge housing 200, and detection can begin.

[0055] According to another specific embodiment of the present invention, a first height indicator 150 and a second height indicator 160 are further provided on the side wall 110, and the second height indicator 160 is closer to the first end wall 120 than the first height indicator 150. The first height indicator 150 and the second height indicator 160 can be any visible structure, for example, they can be colored coatings or indicators formed of materials with different refractive indices, or indicator structures formed by uneven surfaces, such as concave rings, etc.

[0056] In which, the first height indicator 150 is configured so that when the first height indicator 150 is flush with the height of the receiving port, the amplification reaction tube 100 is sealed and connected to the detection card box, and the amplification reaction tube 100 is not punctured by the tube-breaking component 250; when the second height indicator 160 is flush with the height of the receiving port, the amplification reaction tube 100 is punctured by the tube-breaking component 250.

[0057] Furthermore, to facilitate puncturing of the amplification reaction tube 100 by the tube piercing assembly 250 , a notch is provided on the second end wall 130 of the amplification reaction tube 100 , or the thickness of the second end wall 130 of the amplification reaction tube 100 is thinner than the thickness of the side wall 110 .

[0058] Furthermore, since the second end wall 130 of the amplification reaction tube 100 is relatively thin or there are cuts on the second end wall 130, it is easy to break during the process of taking and placing. Therefore, according to another specific embodiment of the present invention, the second end wall 130 of the amplification reaction tube 100 is recessed into the amplification reaction tube 100 to form a recess 131, and only the inner wall of the recess 131 is relatively thin, which can effectively prevent the amplification reaction tube 100 from being damaged during the process of taking and placing.

[0059] Further, if Figure 1 and Figure 2 As shown, the second end wall 130 can be integrally formed with the side wall 110, and the reaction system can be injected into the amplification reaction tube 100 through the cutout or thin-walled area on the second end wall 130 through a syringe, and then the rupture is sealed with a sealing film or a high-melting-point wax drop. Or as Figure 3 As shown, the second end wall 130 is a lid, and is detachably sealed to the side wall 110. In this way, the lid can be opened, the reaction system can be directly injected, and the lid can be closed afterwards.

[0060] Furthermore, for the purpose of improving the water bath heating efficiency, the end of the amplification reaction tube 100 close to the first end wall 120 is a tapered tube 111 , and below the tapered tube 111 is a cylindrical tube, the outer wall of the cylindrical tube is provided with the aforementioned external thread.

[0061] Furthermore, a cleaning liquid storage section 220 is provided within the cartridge housing 200. A nucleic acid cleaning reagent is placed within the cleaning liquid storage section 220, and the cleaning liquid storage section 220 is openable. After the reaction is complete, the cleaning liquid storage section 220 can be opened to allow the nucleic acid cleaning reagent to flow into the cartridge housing 200, reacting all the samples to be tested within the cartridge housing 200. This prevents accidental separation of the amplification reaction tube 100 and the test cartridge during subsequent processing, which could cause leakage of the test sample and contaminate the environment.

[0062] According to another embodiment of the present invention, the first height indicator 150 and the second height indicator 160 may be independently scale lines formed by colored paint or an uneven surface.

[0063] According to another specific embodiment of the present invention, the tube breaking assembly includes a spike portion 251 and a fixing portion 252, the spike portion 251 is fixedly connected to the receiving port 260 through the fixing portion 252, the cleaning liquid storage portion 220 is arranged below the test paper 240, and the upper surface of the cleaning liquid storage portion 220 is provided with an opening and is sealed by a sealing film 230, wherein the fixing portion 252 is configured so that when the amplification reaction tube 100 is screwed into the receiving port and the second height indicator 160 is flush with the upper end of the receiving port, the spike portion 251 pierces the second end wall 130 of the amplification reaction tube 100, and the amplification product flows into the box shell 200; when the amplification reaction tube 100 continues to be screwed in, the fixing portion 252 breaks, and the tube breaking assembly pierces the sealing film 230.

[0064] Specifically, the breaking strength of the fixing portion 252 should be moderate. From the time the amplification reaction tube 100 is inserted into the receiving port 260 to the time the amplification reaction tube 100 is screwed in until the second height indicator 160 is flush with the upper end of the receiving port 260, and the spike portion 251 pierces the second end wall 130 of the amplification reaction tube 100, the fixing portion 252 will not break during this process. Then, the amplification reaction tube 100 continues to be screwed in. At this time, as the pressure on the fixing portion 252 increases, as the amplification reaction tube 100 continues to be screwed in, the fixing portion 252 breaks, and the amplification reaction tube 100 pushes the tube rupture assembly to pierce the sealing film 230, causing the test paper 240 to react with the destructive liquid in the cleaning liquid storage portion 220, and completely removing the amplification product in the box shell 200.

[0065] According to another embodiment of the present invention, the fixing portion 252 may be provided with a cut, or a portion of the fixing portion 252 may be thinner, so that the connection portion is easily broken along the position of the cut or the thinner area. Figure 3 and Figure 4 As shown, the end of the connecting portion connected to the receiving port 260 can be set to be thinner, so that when the reaction tube continues to be screwed inward, it can be broken along the thinner area.

[0066] There are no specific limitations on the structure of the sealing film 230, as long as the sealing film 230 can seal the cleaning liquid storage portion 220 and can be punctured by the tube piercing assembly. For example, the sealing film 230 can be any of the various waterproof sealing films commonly used in laboratories, such as inherently weak sealing films that randomly rupture when squeezed; or it can have localized cuts that rupture along the cuts when squeezed; or it can be a direct wax seal, etc.

[0067] According to another embodiment of the present invention, an elastic pressing structure 280 is provided above the test paper 240 . When the sealing film 230 is opened, the elastic pressing structure 280 presses at least a portion of the test paper 240 into the cleaning liquid storage portion 220 .

[0068] According to another specific embodiment of the present invention, a baffle 290 is provided between the sealing film 230 and the rupture tube assembly 250. The baffle 290 can be moved from a first position to a second position. When the baffle 290 is in the first position, the baffle 290 prevents the rupture tube assembly 250 from moving downward. When the baffle 290 moves to the second position, as the amplification reaction tube 100 is screwed in, the rupture tube assembly 250 can pierce the sealing film 230.

[0069] According to another specific embodiment of the present invention, a sealing ring made of an elastomer is provided at the insertion end of the receiving port 260 , or a sealing ring made of an elastomer is provided on the outside of the side wall 110 of the amplification reaction tube 100 .

[0070] According to another specific embodiment of the present invention, a test result observation area 270 made of a transparent material is further provided on the box shell 200 .

[0071] According to another embodiment of the present invention, the cleaning liquid storage portion 220 stores a nucleic acid destroying agent, such as sodium hypochlorite solution or a commercial DNA detergent.

[0072] Although the present invention has been illustrated and described with reference to certain preferred embodiments thereof, it should be understood by those skilled in the art that the above description is provided as a further detailed description of the present invention in conjunction with specific embodiments thereof, and that the specific implementation of the present invention is not limited to these descriptions. Those skilled in the art may make various changes in form and details, including simple deductions or substitutions, without departing from the spirit and scope of the present invention.

Claims

1. A combined nucleic acid detection device, characterized in that: Including amplification reaction tubes and detection cartridges, The amplification reaction tube is provided with a sealed solution chamber for accommodating the amplification reaction system. The amplification reaction tube includes a first end wall, a side wall, and a second end wall. The first end wall and the side wall are integrally formed, and the side wall is provided with a first mating portion. The end of the amplification reaction tube near the first end wall is a tapered tube, and the lower portion of the tapered tube is a cylindrical tube. The side wall is also provided with a first height indicator and a second height indicator, and the second height indicator is closer to the first end wall than the first height indicator. The detection cartridge comprises a cartridge housing and a test strip located within the cartridge housing. A receiving port is provided on an upper surface of the cartridge housing. A tube-breaking assembly and a second mating portion that mates with the first mating portion are provided within the receiving port. The tube-breaking assembly is configured to puncture the second end wall of the amplification reaction tube. When the amplification reaction tube is inserted into the receiving port from the end where the second end wall is located, the amplification reaction tube is sealedly connected to the detection cartridge via the first mating portion and the second mating portion. The tube-breaking assembly includes a spike portion and a fixing portion, and the spike portion is fixedly connected to the receiving port through the fixing portion; a cleaning liquid storage portion is also provided in the box shell, and the cleaning liquid storage portion is arranged below the test paper. An opening is provided on the upper surface of the cleaning liquid storage portion and is sealed by a sealing film; wherein the fixing portion is configured so that when the amplification reaction tube is screwed into the receiving port and the second height indicator is flush with the upper end of the receiving port, the spike portion pierces the second end wall of the amplification reaction tube, and the amplification product flows into the box shell; when the amplification reaction tube continues to be screwed in, the fixing portion breaks, and the tube-breaking assembly pierces the sealing film.

2. The combined nucleic acid detection device according to claim 1, wherein: A notch is provided on the second end wall of the amplification reaction tube.

3. The combined nucleic acid detection device according to claim 1, wherein: The thickness of the second end wall of the amplification reaction tube is thinner than the thickness of the side wall.

4. The combined nucleic acid detection device according to claim 1, wherein: The second end wall is a cover, which is detachably sealed to the side wall.

5. The combined nucleic acid detection device according to claim 1, wherein: A cleaning liquid storage portion is further provided in the box shell, in which a nucleic acid cleaning reagent is placed. The cleaning liquid storage portion can be opened to allow the nucleic acid cleaning reagent to flow into the box shell.

6. The combined nucleic acid detection device according to claim 1, wherein: The first matching portion is an external thread, and the second matching portion is an internal thread.

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