Nucleic acid swab detection consumable

Abstract

The invention discloses a nucleic acid swab detection consumable, and belongs to the field of nucleic acid detection. Comprising a swab tube, a PCR tube, a piston push rod, a pressing push rod, a swab tube cover plug, a PCR tube plug and a freeze-drying reagent ball, the swab tube is used for containing a sample preservation solution and containing a swab sample, the freeze-drying reagent ball is arranged in the PCR tube, the PCR tube plug covers a tube opening of the PCR tube in a sealed mode, and the swab tube cover plug covers a tube opening of the swab tube in a sealed mode; the swab tube cover, the pressing push rod and the swab tube cover plug form an integrated assembly, the pressing push rod and the swab tube cover plug can be driven to be synchronously separated from the swab tube by unscrewing the swab tube cover, and the pressing push rod and the piston push rod are of a split structure. According to the kit, the detection process is integrated, the swab tube, the PCR tube and the pushing structure are integrated, and compared with a traditional split detection consumable, the kit has the advantages that the occupied space is greatly reduced, carrying and on-site rapid detection are facilitated, and the kit does not need to depend on a professional laboratory environment.

Description

A type of nucleic acid swab testing consumable Technical Field

[0001] This invention relates to the field of nucleic acid testing, and more particularly to a consumable for nucleic acid swab testing. Background Technology

[0002] PCR (Polymerase Chain Reaction) is a molecular biology technique that amplifies specific DNA (deoxyribonucleic acid) sequences in vitro. Due to its high specificity, high sensitivity, low purity requirements, simplicity, and speed, PCR is widely used in molecular biology detection and analysis. Conventional nucleic acid testing is performed either in molecular diagnostic laboratories or using sealed cartridges. In molecular diagnostic laboratories, national regulations require separate zones for reagent preparation, nucleic acid extraction, amplification, and detection. Personnel must also possess PCR certification, placing strict demands on both the experimental environment and personnel qualifications. Therefore, while molecular diagnostic laboratories can meet throughput requirements, they require separate setups for nucleic acid extraction, amplification, detection, and other auxiliary equipment, resulting in complex equipment, large space requirements, and hindering automation. Furthermore, there is a risk of aerosol contamination during nucleic acid extraction transfer, compromising accuracy. With the development of molecular detection technologies, nucleic acid detection has become widely used. The nucleic acid testing process requires the use of lysis tubes, dilution tubes, and reaction tubes. The lysis tube holds the lysis buffer and provides space for mixing the lysis buffer and the sample solution containing the sample. The dilution tube dilutes the lysis mixture, and the reaction tube holds the reaction solution. The specific process for nucleic acid testing is as follows: Open the cap of the lysis tube → Add the sample solution to the lysis tube containing the lysis buffer; the sample solution and lysis buffer mix to form a lysis mixture → The sample is lysed in the lysis tube → Open the cap of the dilution tube → Quantitatively squeeze the lysis mixture from the lysis tube into the dilution tube → Mix the lysis mixture with the diluent in the dilution tube → Open the cap of the reaction tube → Quantitatively squeeze the diluted lysis mixture from the dilution tube into the reaction tube → Mix the diluted lysis mixture with the reaction solution in the reaction tube → Sample amplification and fluorescence detection. Because the lysis tubes, dilution tubes, and reaction tubes are set up separately and independently, the nucleic acid testing process requires frequent handling of these tubes, as well as frequent opening and closing of the caps and addition of substances. This results in numerous experimental steps, high operational difficulty, and extreme inconvenience. Furthermore, frequent handling of lysis tubes and reaction tubes, along with frequent additions, can increase the chances of sample solution coming into contact with the external environment, leading to sample contamination and reduced detection accuracy. Moreover, separate lysis tubes and reaction tubes take up a lot of space and are inconvenient to carry. Summary of the Invention

[0003] Purpose of the Invention: The purpose of this invention is to provide an integrated nucleic acid detection device to solve the problems of cumbersome operation, high operational difficulty, poor portability, and sample contamination and reduced detection accuracy caused by the separate setting of lysis tubes, dilution tubes, and reaction tubes in existing nucleic acid detection methods. This device integrates sample processing, dilution, and reaction in the nucleic acid detection process, reducing manual intervention and the number of times the tubes are opened, improving detection convenience, contamination prevention, and detection accuracy. It also reduces the space occupied by the device, making it easy to carry and conduct on-site testing. Another purpose of this invention is to provide a nucleic acid detection method based on the above-mentioned integrated nucleic acid detection device, simplifying the nucleic acid detection process, reducing operational difficulty, avoiding aerosol contamination and contact with the external environment during sample transfer, ensuring detection accuracy, reducing the complexity of detection equipment, increasing the degree of automation, eliminating the need for specialized laboratory zoning environments and highly qualified operators, and expanding the application scenarios of nucleic acid detection.

[0004] Technical Solution: A nucleic acid swab testing consumable includes a swab tube, a PCR tube, a piston rod, a pressing rod, a swab tube cap, a PCR tube stopper, and a lyophilized reagent bulb. The swab tube is used to hold sample preservation solution and contain swab samples. The PCR tube contains the lyophilized reagent bulb. The PCR tube stopper seals the opening of the PCR tube, and the swab tube cap seals the opening of the swab tube. The swab tube cap, pressing rod, and swab tube cap form an integrated assembly. Unscrewing the swab tube cap activates the pressing rod. The swab tube cap detaches from the swab tube simultaneously. The pressing push rod and the piston push rod are separate structures. The piston push rod has a puncture needle structure at its front end. A side hole is opened at the connection between the puncture needle and the piston end of the piston push rod. The needle hole of the puncture needle is connected to the side hole. When the pressing push rod is pressed, it can push the piston push rod to move towards the PCR tube, so that the puncture needle punctures the PCR tube cap. The sample in the swab tube is quantitatively sprayed into the PCR tube through the side hole and the needle hole using the principle of an injection pump, and combines with the lyophilized reagent ball.

[0005] Furthermore, the swab tube cap is connected to the opening of the swab tube by a thread, and the swab tube cap plug is tightly fitted to the inner wall of the opening of the swab tube to achieve a seal.

[0006] Furthermore, the PCR tube stopper is made of silicone, and the tip of the puncture needle has a sharp structure, which can quickly puncture the PCR tube stopper and avoid generating debris that contaminates the sample.

[0007] Furthermore, the piston push rod slides and seals with the inner wall of the swab tube, and the piston push rod can generate negative or positive pressure when it moves, thereby realizing the quantitative delivery of the sample.

[0008] Furthermore, the inner wall of the pressing push rod is adapted to the outer wall of the rear end of the piston push rod, so that when the pressing push rod is pressed, it can form a rigid transmission engagement with the piston push rod.

[0009] Furthermore, the lyophilized reagent spheres are lyophilized versions of pre-set nucleic acid amplification reaction reagents, which can quickly dissolve and initiate the reaction process after the sample is sprayed in.

[0010] Furthermore, the puncture needle and the piston rod are integrally formed, the side hole is opened along the radial direction of the puncture needle, and the diameter of the side hole is smaller than the diameter of the needle hole of the puncture needle.

[0011] Furthermore, the swab tube and the PCR tube are coaxially arranged to ensure that the piston push rod drives the puncture needle to accurately align with the center of the PCR tube plug.

[0012] Beneficial effects: It achieves integrated testing process, combining swab tubes, PCR tubes, and the push mechanism into one unit. Compared to traditional separate testing consumables, this significantly reduces space requirements, making it easy to carry and perform rapid on-site testing without relying on a professional laboratory environment. It effectively reduces the risk of sample contamination. Sample transfer is achieved by puncturing the sealed PCR tube stopper with a puncture needle, eliminating the need for frequent opening of the cap and reducing the chance of sample contact with the external environment. Simultaneously, the silicone PCR tube stopper, combined with the sharp puncture needle, prevents debris from contaminating the sample during puncture, ensuring testing accuracy. It simplifies the operation process and reduces operational difficulty. The integrated component consisting of the swab tube cap, push rod, and swab tube cap stopper, as well as the separate design of the push rod and piston rod, are both convenient and easy to use. The device allows for easy insertion of swab samples and quantitative sample delivery via a simple pressing action, eliminating the need for professional operators and complex techniques, thus improving testing efficiency. Sample delivery is precise and reliable. Based on the principle of a syringe pump, the sliding seal between the piston rod and the swab tube enables quantitative sample transfer. The design of the side hole and needle hole of the puncture needle ensures that the sample is smoothly sprayed into the PCR tube and quickly and evenly mixed with the lyophilized reagent bulbs, guaranteeing the stability of the reaction system and providing a reliable foundation for subsequent amplification and detection. The device boasts a reasonable and durable structural design; the puncture needle and piston rod are integrally molded, enhancing structural strength and sealing. The lyophilized reagent bulbs can be pre-installed, eliminating the need for additional reaction reagents, further simplifying the testing process and expanding the applicable scenarios for consumables. Attached Figure Description

[0013] Figure 1 is a three-dimensional structural schematic diagram of the present invention; Figure 2 is an exploded structural schematic diagram of the present invention; Figure 3 is a cross-sectional structural schematic diagram of the present invention; Figure 4 is a cross-sectional structural schematic diagram of the present invention shown in Figure 2.

[0014] In the diagram: 1. Swab tube; 2. Swab tube cap; 3. PCR tube; 4. Piston pusher; 5. Press pusher; 6. Swab tube cap stopper; 7. PCR tube stopper; 8. Lyophilized reagent ball. Detailed Implementation

[0015] To make the technical solution of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0016] As shown in Figures 1-4, a nucleic acid swab testing consumable is provided, including a swab tube 1, a PCR tube 3, a piston push rod 4, a pressing push rod 5, a swab tube cap 6, a PCR tube stopper 7, and a lyophilized reagent bulb 8. The swab tube 1 is used to hold sample preservation solution and contain swab samples. The PCR tube 3 contains a lyophilized reagent bulb 8. The PCR tube stopper 7 seals the opening of the PCR tube 3, and the swab tube cap 6 seals the opening of the swab tube 1. The swab tube cap 2, the pressing push rod 5, and the swab tube cap 6 form an integrated assembly. Unscrewing the swab tube cap 2 causes the pressing push rod 5 and the swab tube cap 6 to simultaneously detach from the swab tube 1. The pressing push rod 5 and the piston push rod 4 are separate structures. The front end of the piston push rod 4 has a puncture needle structure, and the puncture needle... A side hole is provided at the piston end connection of the piston push rod 4, and the needle hole of the puncture needle is connected to the side hole. When the push rod 5 is pressed, it can push the piston push rod 4 towards the PCR tube 3, so that the puncture needle punctures the PCR tube stopper 7, and the sample in the swab tube 1 is quantitatively sprayed into the PCR tube 3 through the side hole and the needle hole via the principle of a syringe pump, and combined with the lyophilized reagent bulb 8. The swab tube cap 2 is connected to the opening of the swab tube 1 by threads, and the swab tube cap 6 is tightly fitted to the inner wall of the opening of the swab tube 1 to achieve a seal. The PCR tube stopper 7 is made of silicone material, and the needle tip of the puncture needle has a sharp structure, which can quickly puncture the PCR tube stopper 7 and avoid generating debris to contaminate the sample. The piston push rod 4 slides and seals with the inner wall of the swab tube 1. When rod 4 moves, it can create negative or positive pressure to achieve quantitative sample delivery; the inner wall of the push rod 5 is adapted to the outer wall of the rear end of the piston push rod 4, and when the push rod 5 is pressed, it can form a rigid transmission engagement with the piston push rod 4; the lyophilized reagent ball 8 is a lyophilized body of the preset nucleic acid amplification reaction reagent, which can quickly dissolve and start the reaction process after the sample is sprayed in; the puncture needle and the piston push rod 4 are integrally formed, with side holes opened along the radial direction of the puncture needle, and the diameter of the side holes is smaller than the diameter of the needle hole of the puncture needle; the swab tube 1 and the PCR tube 3 are set coaxially along the axis to ensure that the piston push rod 4 drives the puncture needle to accurately align with the center position of the PCR tube plug 7; the usage method of this nucleic acid swab testing consumable is as follows: First, load the sample, hold the swab tube cap 2, and along the screw... First, unscrew the integrated assembly in the direction of the screw thread. This causes the pressing push rod 5 and the swab tube cap 6 to simultaneously detach from the swab tube 1. Place the swab with the collected sample into the sample preservation solution inside the swab tube 1, stir thoroughly to release the sample into the preservation solution, and then remove the swab. Second, reseal the device by screwing the swab tube cap 2 back onto the opening of the swab tube 1, ensuring that the swab tube cap 6 fits tightly against the inner wall of the swab tube 1. At this point, the pressing push rod 5 is fitted onto the rear end of the piston push rod 4, completing the device reset. Third, push the sample by manually pressing down on the pressing push rod 5. With the help of rigid transmission, the piston push rod 4 moves along the axis of the swab tube 1 towards the PCR tube 3. The puncture needle at the front end of the piston push rod 4 precisely aligns with and punctures the silicone PCR tube cap 7.The fourth step is quantitative mixing. Continue pressing the plunger 5 to inject the sample from swab tube 1 into PCR tube 3 under positive pressure through the side hole and needle hole of the puncture needle. This rapidly mixes and dissolves the lyophilized reagent bulb 8 in PCR tube 3, forming the reaction system. The fifth step is subsequent reaction. Transfer PCR tube 3 containing the reaction system into the amplification and detection equipment, start the nucleic acid amplification and fluorescence detection process, and complete the entire nucleic acid detection.

[0017] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention. Therefore, the scope of protection of this patent should be determined by the appended claims.

Claims

1. A nucleic acid swab testing consumable, comprising a swab tube (1), a PCR tube (3), a piston push rod (4), a pressing push rod (5), a swab tube cap (6), a PCR tube stopper (7), and a lyophilized reagent ball (8), characterized in that: The swab tube (1) is used to hold the sample preservation solution and contain the swab sample. The PCR tube (3) contains the lyophilized reagent ball (8). The PCR tube stopper (7) is sealed to the opening of the PCR tube (3). The swab tube cap (6) is sealed to the opening of the swab tube (1). The swab tube cap (2), the push rod (5), and the swab tube cap (6) form an integrated assembly. Unscrewing the swab tube cap (2) can cause the push rod (5) and the swab tube cap (6) to simultaneously detach from the swab tube (1). The piston push rod (4) and the piston push rod (4) are separate structures; the front end of the piston push rod (4) is provided with a puncture needle structure, and a side hole is opened at the connection between the puncture needle and the piston end of the piston push rod (4). The needle hole of the puncture needle is connected to the side hole; when the pressing push rod (5) is pressed, the pressing push rod (5) can push the piston push rod (4) to move towards the PCR tube (3), so that the puncture needle punctures the PCR tube plug (7), and the sample in the swab tube (1) is quantitatively sprayed into the PCR tube (3) through the side hole and the needle hole by the principle of the injection pump, and combined with the lyophilized reagent ball (8).

2. The nucleic acid swab testing consumable according to claim 1, characterized in that: The swab tube cap (2) is connected to the opening of the swab tube (1) by a thread, and the swab tube cap plug (6) is tightly fitted to the inner wall of the opening of the swab tube (1) to achieve a seal.

3. The nucleic acid swab testing consumable according to claim 1, characterized in that: The PCR tube stopper (7) is made of silicone material, and the tip of the puncture needle has a sharp structure, which can quickly puncture the PCR tube stopper (7) and avoid generating debris to contaminate the sample.

4. The nucleic acid swab testing consumable according to claim 1, characterized in that: The piston push rod (4) slides and seals with the inner wall of the swab tube (1). When the piston push rod (4) moves, it can generate negative or positive pressure to realize the quantitative push of the sample.

5. The nucleic acid swab testing consumable according to claim 1, characterized in that: The inner wall of the pressing push rod (5) is adapted to the outer wall of the rear end of the piston push rod (4), and when the pressing push rod (5) is pressed, it can form a rigid transmission engagement with the piston push rod (4).

6. The nucleic acid swab testing consumable according to claim 1, characterized in that: The lyophilized reagent ball (8) is a lyophilized form of a pre-set nucleic acid amplification reaction reagent. After the sample is sprayed in, it can quickly dissolve and start the reaction process.

7. The nucleic acid swab testing consumable according to claim 1, characterized in that: The puncture needle and the piston rod (4) are integrally formed. The side hole is opened along the radial direction of the puncture needle, and the diameter of the side hole is smaller than the diameter of the needle hole of the puncture needle.

8. The nucleic acid swab testing consumable according to claim 1, characterized in that: The swab tube (1) and the PCR tube (3) are coaxially arranged to ensure that the piston rod (4) drives the puncture needle to accurately align with the center of the PCR tube plug (7).

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