Puncture negative pressure nucleic acid detection consumables

Abstract

The application discloses a kind of puncture negative pressure nucleic acid detection consumables, belong to nucleic acid detection field.It includes swab tube assembly and negative pressure tube assembly, the swab tube assembly can be threadedly connected with negative pressure tube assembly, linkage cooperation between components is realized by rotation and the quantitative transfer and sealing of sample;The swab tube assembly includes swab tube, swab tube cover and swab tube plug, the swab tube cover can be detachably connected to the top end of swab tube, for sealing the internal space of swab tube, the swab tube plug is arranged inside the bottom end of swab tube;Realize integrated design and operation, by the thread connection cooperation of swab tube assembly and negative pressure tube assembly, swab tube, negative pressure tube, PCR tube and freeze-drying reagent ball are integrated, without separately setting independent lysis tube, dilution tube and reaction tube, substantially reduce the space occupied by consumables, and it is convenient to carry and on-site detection, solve the problem that traditional dispersed consumables occupy large space, inconvenient to carry.

Description

Technical Field

[0001] This invention relates to the field of nucleic acid testing, and in particular to a puncture negative pressure nucleic acid testing consumable. 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. Furthermore, relevant personnel must possess PCR certification, placing strict demands on both the experimental environment and personnel qualifications. Therefore, while molecular diagnostic laboratories can meet throughput requirements, they necessitate separate setups for nucleic acid extraction, amplification, detection, and other auxiliary equipment. This results in complex equipment, large space requirements, hinders automation, and poses a risk of aerosol contamination during nucleic acid extraction transfer, compromising detection accuracy. With the development of molecular detection technology, nucleic acid detection technology has been widely used. The nucleic acid detection 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 is used to dilute the sample lysis mixture. The reaction tube holds the reaction solution. The specific process of nucleic acid detection 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 sample lysis mixture → The sample is lysed in the lysis tube → Open the cap of the dilution tube → Quantitatively squeeze the sample lysis mixture from the lysis tube into the dilution tube → Mix the sample lysis mixture with the diluent in the dilution tube → Open the cap of the reaction tube → Quantitatively squeeze the diluted sample lysis mixture from the dilution tube into the reaction tube → Mix the diluted sample 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 separate and independently configured, frequent handling of these tubes is required during nucleic acid testing, necessitating frequent opening of the caps and addition of substances. This results in numerous experimental steps, increased operational difficulty, and extreme inconvenience. Furthermore, frequent handling and addition of substances to the lysis and reaction tubes increases the chance of sample solution contact with the external environment, leading to sample contamination and reduced detection accuracy. Moreover, the separate lysis and reaction tubes occupy a large amount 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 address the problems of complex equipment, large space occupation, low automation, and high risk of aerosol contamination in existing molecular diagnostic laboratories. It also overcomes the issues of cumbersome operation, easy contamination, and inconvenience caused by separate lysis tubes, dilution tubes, and reaction tubes. This invention achieves integrated and automated nucleic acid detection, reducing manual intervention, lowering the risk of contamination, improving detection accuracy and ease of operation, and reducing the space occupied by equipment and consumables, making it convenient for portability and on-site testing. Another purpose of this invention is to provide a matching integrated nucleic acid detection consumable. By integrating the lysis chamber, dilution chamber, and reaction chamber into one unit, frequent opening and closing of tube caps and sample transfer are eliminated, simplifying the detection steps, reducing operational difficulty, and minimizing the contact between samples and the external environment, further ensuring detection accuracy. Simultaneously, the consumable structure is optimized, reducing space occupation and improving portability and ease of use, adapting to the automated operation requirements of integrated detection devices.

[0004] Technical solution: A puncture negative pressure nucleic acid testing consumable, including a swab tube assembly and a negative pressure tube assembly, wherein the swab tube assembly and the negative pressure tube assembly can be threadedly connected, and the linkage between the components and the quantitative transfer and sealing of the sample can be achieved by rotation; The swab tube assembly includes a swab tube, a swab tube cap, and a swab tube plug. The swab tube cap is detachably connected to the top of the swab tube and is used to seal the internal space of the swab tube. The swab tube plug is located inside the bottom of the swab tube. The bottom of the swab tube has a sharp end for piercing the sealing structure. The negative pressure tube assembly includes a negative pressure tube, a negative pressure tube plug, a PCR tube, and a lyophilized reagent bulb. The negative pressure tube plug is located inside the top of the negative pressure tube, the PCR tube is connected to the bottom of the negative pressure tube, and the lyophilized reagent bulb is placed inside the PCR tube. The inside of the negative pressure tube is under negative pressure to achieve quantitative aspiration and temporary storage of samples. The bottom of the negative pressure tube is provided with a plug that can be opened to control the flow of temporarily stored samples into the PCR tube.

[0005] Furthermore, the connection between the swab tube and the negative pressure tube is provided with a matching threaded structure, and the swab tube can be moved axially towards the negative pressure tube by rotating the swab tube clockwise.

[0006] Furthermore, both the swab tube plug and the negative pressure tube plug are made of silicone material, which has the flexibility to be pierced by the sharp end of the bottom of the swab tube, while ensuring the sealing performance before piercing.

[0007] Furthermore, the volume of the negative pressure tube is pre-designed, and in conjunction with the internal negative pressure intensity, it can achieve quantitative aspiration of the sample in the swab tube, with a quantitative range of 50-200 μL.

[0008] Furthermore, the sealing structure at the bottom of the negative pressure tube is an elastic sealing flap. When the swab tube continues to be screwed into the negative pressure tube, the elastic sealing flap is pushed open, and the temporary sample flows into the PCR tube. At this time, the inner tip of the swab tube is pushed up by the bottom of the negative pressure tube to achieve sealing.

[0009] Furthermore, the lyophilized reagent spheres are lyophilized spheres containing reagents required for PCR amplification, which can quickly dissolve after sample inflow and fully mix with the sample to form a reaction system.

[0010] Furthermore, the inner wall of the swab tube is provided with anti-slip texture, making it easy for operators to hold and rotate the swab tube.

[0011] Furthermore, the PCR tube and the negative pressure tube are integrally molded or detachably sealed to ensure no leakage during sample flow.

[0012] Beneficial effects: It achieves integrated design and operation. By connecting the swab tube assembly and the negative pressure tube assembly with a threaded connection, the swab tube, negative pressure tube, PCR tube and lyophilized reagent ball are integrated into one unit. There is no need to set up separate lysis tubes, dilution tubes and reaction tubes. It significantly reduces the space occupied by consumables and is easy to carry and test on site. It solves the problems of large space occupation and inconvenience of traditional distributed consumables. The operation process is simplified and the operation difficulty is reduced. The sealing puncture, sample quantitative aspiration, sealing and plugging and sample transfer can be completed in sequence by simply rotating the swab tube clockwise. There is no need to frequently open and close the tube cap or manually transfer the sample. The entire operation process is simple. With the anti-slip texture on the inner wall of the swab tube, it is easy for the operator to hold and control it stably. It is suitable for quick use in non-professional scenarios and overcomes the defects of cumbersome steps and high operation difficulty in traditional testing. To improve testing accuracy and reduce the risk of contamination, the swab tube stopper and negative pressure tube stopper are made of silicone, ensuring a tight seal before puncture. The negative pressure inside the tube allows for quantitative sample aspiration, and the entire transfer is sealed, preventing direct contact between the sample and the external environment. At the same time, the tip of the swab tube is blocked by the bottom of the negative pressure tube, preventing sample backflow or leakage. The sealed connection structure between the PCR tube and the negative pressure tube further prevents leakage, effectively reducing aerosol contamination and the probability of sample contamination, and ensuring the accuracy of test results. Optimizing reaction efficiency and compatibility, the lyophilized reagent balls in the PCR tube can quickly dissolve and fully mix with the sample after sample inflow to form a reaction system, eliminating the need for additional reagent steps. It is compatible with subsequent amplification and detection processes, and the pre-designed negative pressure tube volume and negative pressure intensity enable accurate sample quantification and improve the stability and repeatability of detection results. With a reasonable and practical structural design, all components work together closely. The sharp end at the bottom of the swab tube can efficiently pierce the sealing structure, and the elastic sealing flap at the bottom of the negative pressure tube can accurately control the timing of sample release. The overall structure is simple and reliable, taking into account both the potential for automation and the convenience of manual operation. It is suitable for various nucleic acid testing scenarios. Compared with traditional laboratory testing equipment and distributed consumables, it significantly reduces the requirements for the operating environment and the professional skills of personnel. Attached Figure Description

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

[0014] In the diagram: 1. Swab tube; 2. Swab tube cap; 3. Swab tube stopper; 4. Negative pressure tube; 5. Negative pressure tube stopper; 6. PCR tube; 7. 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. Example

[0016] like Figures 1-3As shown, a puncture negative pressure nucleic acid testing consumable is provided, including a swab tube assembly and a negative pressure tube assembly. The swab tube assembly and the negative pressure tube assembly can be threadedly connected, and the linkage between the components and the quantitative transfer and sealing of the sample can be achieved by rotation. The swab tube assembly includes a swab tube 1, a swab tube cap 2, and a swab tube plug 3. The swab tube cap 2 is detachably connected to the top of the swab tube 1 and is used to seal the internal space of the swab tube 1. The swab tube plug 3 is located inside the bottom end of the swab tube 1. The bottom of the swab tube 1 is provided with a sharp end for piercing the sealing structure. The negative pressure tube assembly includes a negative pressure tube 4, a negative pressure tube plug 5, a PCR tube 6, and a lyophilized reagent ball 7. The negative pressure tube plug 5 is located inside the top of the negative pressure tube 4, the PCR tube 6 is connected to the bottom of the negative pressure tube 4, and the lyophilized reagent ball 7 is placed inside the PCR tube 6. The inside of the negative pressure tube 4 is under negative pressure, which is used to realize the quantitative aspiration and temporary storage of samples. The bottom of the negative pressure tube 4 is provided with a plug structure that can be opened to control the flow of the temporary sample into the PCR tube 6.

[0017] The connection between the swab tube 1 and the negative pressure tube 4 is provided with a matching threaded structure. By rotating the swab tube 1 clockwise, the swab tube 1 can be moved axially towards the negative pressure tube 4.

[0018] Both the swab tube plug 3 and the negative pressure tube plug 5 are made of silicone material, which has the flexibility to be pierced by the sharp end at the bottom of the swab tube 1, while ensuring the sealing performance before piercing.

[0019] The volume of the negative pressure tube 4 is pre-designed and, in conjunction with the internal negative pressure strength, enables quantitative aspiration of the sample in the swab tube 1, with a quantitative range of 50-200 μL.

[0020] The sealing structure at the bottom of the negative pressure tube 4 is an elastic sealing flap. When the swab tube 1 continues to be screwed into the negative pressure tube 4, the elastic sealing flap is pushed open, and the temporary sample flows into the PCR tube 6. At this time, the inner tip of the swab tube 1 is pushed up by the bottom of the negative pressure tube 4 to achieve sealing.

[0021] The lyophilized reagent ball 7 is a lyophilized ball containing the reagents required for PCR amplification. It can quickly dissolve after the sample is added and mix thoroughly with the sample to form a reaction system.

[0022] The inner wall of the swab tube 1 is provided with anti-slip texture, which makes it easy for the operator to hold and rotate the swab tube 1.

[0023] PCR tube 6 and negative pressure tube 4 are integrally molded or detachably sealed to ensure no leakage during sample flow; The usage instructions for this negative pressure nucleic acid testing consumable are as follows: First, hold the swab tube 1, unscrew the swab tube cap 2, put the swab containing the collected sample into the swab tube 1, and then screw the swab tube cap 2 back onto the top of the swab tube 1 to complete the initial sealing of the sample. The second step is to align the swab tube 1 containing the sample with the negative pressure tube 4 through its matching threaded structure and start rotating it clockwise, so that the swab tube 1 moves axially towards the negative pressure tube 4. During this process, the sharp end at the bottom of the swab tube 1 pierces the swab tube plug 3 and the negative pressure tube plug 5 in sequence. The third step is to use the negative pressure state inside the negative pressure tube 4 to quantitatively draw the sample from the swab tube 1 into the negative pressure tube 4 for temporary storage. Based on the preset volume and negative pressure intensity of the negative pressure tube 4, the accurate quantification of 50-200μL samples can be achieved. Fourth step, continue to rotate the swab tube 1 clockwise so that the inner tip of the swab tube 1 is pressed against the bottom of the negative pressure tube 4, thus completing the sealing of the swab tube 1 and preventing sample backflow or leakage. Fifth step, continue to screw in the swab tube 1, open the elastic sealing flap at the bottom of the negative pressure tube 4, so that the sample temporarily stored in the negative pressure tube 4 flows into the PCR tube 6. The sample comes into contact with the lyophilized reagent ball 7 in the PCR tube 6 and dissolves it quickly, and mixes thoroughly to form a reaction system. At this point, the sample transfer and pre-reaction preparation are completed, and the subsequent amplification and detection process can begin. Throughout the operation, the anti-slip texture on the inner wall of the swab tube 1 makes it easy for the operator to hold it stably and control the rotation amplitude precisely. The connection structure between the PCR tube 6 and the negative pressure tube 4 can effectively prevent leakage during sample transfer.

[0024] 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 puncture negative pressure nucleic acid testing consumable, comprising a swab tube assembly and a negative pressure tube assembly, characterized in that: The swab tube assembly and the negative pressure tube assembly can be threaded together, and the linkage between the components and the quantitative transfer and sealing of the sample can be achieved by rotation; The swab tube assembly includes a swab tube (1), a swab tube cap (2), and a swab tube plug (3). The swab tube cap (2) is detachably connected to the top of the swab tube (1) to seal the internal space of the swab tube (1). The swab tube plug (3) is located inside the bottom of the swab tube (1). The bottom of the swab tube (1) has a sharp end for piercing the sealing structure. The negative pressure tube assembly includes a negative pressure tube (4), a negative pressure tube plug (5), a PCR tube (6), and a lyophilized reagent ball (7). The negative pressure tube plug (5) is located inside the top of the negative pressure tube (4). The PCR tube (6) is connected to the bottom of the negative pressure tube (4). The lyophilized reagent ball (7) is placed inside the PCR tube (6). The inside of the negative pressure tube (4) is under negative pressure, which is used to realize the quantitative aspiration and temporary storage of the sample. The bottom of the negative pressure tube (4) is provided with a plug structure that can be opened, which is used to control the flow of the temporary sample into the PCR tube (6).

2. The puncture negative pressure nucleic acid testing consumable according to claim 1, characterized in that: The connection between the swab tube (1) and the negative pressure tube (4) is provided with a matching thread structure. By rotating the swab tube (1) clockwise, the swab tube (1) can be moved axially toward the negative pressure tube (4).

3. The puncture negative pressure nucleic acid testing consumable according to claim 1, characterized in that: Both the swab tube plug (3) and the negative pressure tube plug (5) are made of silicone material, which has the flexibility to be pierced by the sharp end of the bottom of the swab tube (1) while ensuring the sealing performance before piercing.

4. The puncture negative pressure nucleic acid testing consumable according to claim 1, characterized in that: The volume of the negative pressure tube (4) is pre-designed and, in conjunction with the internal negative pressure strength, can achieve quantitative aspiration of the sample in the swab tube (1), with a quantitative range of 50-200 μL.

5. The puncture negative pressure nucleic acid testing consumable according to claim 1, characterized in that: The sealing structure at the bottom of the negative pressure tube (4) is an elastic sealing flap. When the swab tube (1) continues to be screwed into the negative pressure tube (4), the elastic sealing flap is pushed open, and the temporary sample flows into the PCR tube (6). At this time, the inner tip of the swab tube (1) is pushed up by the bottom of the negative pressure tube (4) to achieve sealing.

6. The puncture negative pressure nucleic acid testing consumable according to claim 1, characterized in that: The lyophilized reagent sphere (7) is a lyophilized sphere containing the reagents required for PCR amplification. It can be rapidly dissolved after the sample flows in and fully mixed with the sample to form a reaction system.

7. The puncture negative pressure nucleic acid testing consumable according to claim 1, characterized in that: The inner wall of the swab tube (1) is provided with anti-slip texture, which makes it easy for the operator to hold and rotate the swab tube (1).

8. The puncture negative pressure nucleic acid testing consumable according to claim 1, characterized in that: The PCR tube (6) and the negative pressure tube (4) are integrally formed or detachably sealed to ensure that there is no leakage during the sample flow process.

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