Nucleic acid test cartridge

Abstract

A nucleic acid test cartridge, provided with a plurality of chambers (10) and at least one air vent (20). The air vent (20) is in communication with the chambers (10). The air vent (20) is used for driving a fluid in a cartridge (100) to flow among the plurality of chambers (10) when a positive pressure or a negative pressure is introduced. In addition, a water-absorbing air-permeable membrane (30) is disposed between the air vent (20) and the chambers (10) in communication therewith, and the water-absorbing air-permeable membrane (30) is used for preventing moisture from entering the cartridge (100) and eliminating air bubbles. By means of the described method, in one aspect, external moisture can be prevented from entering the cartridge (100) by means of the air vent (20) to affect test results, and in another aspect, air bubbles generated in the ultrasonic mixing process can be prevented from entering the external environment by means of the air vent (20) to cause environmental pollution.

Description

Nucleic acid test kit Technical Field

[0001] This application relates to the field of in vitro medical diagnostic devices, specifically to a nucleic acid detection cartridge. Background Technology

[0002] Nucleic acid test cartridges typically have multiple chambers. During the nucleic acid testing process, the nucleic acid sample needs to be transferred to different chambers according to the testing steps, and then processed by corresponding reagents within each chamber. Therefore, at least some of the chambers need to be connected to the outside environment through vents, and positive or negative pressure needs to be introduced into the chambers through these vents to allow the fluid inside the cartridge to flow between the multiple chambers, thereby enabling the transfer of the sample between them.

[0003] When processing nucleic acid samples, it is also necessary to mix the nucleic acid samples and reagents in the cavity by ultrasonic vibration. Due to the high energy of ultrasonic vibration, the reagents in the cavity will splash and produce bubbles. These bubbles can easily enter the channel between the pores and the cavity and enter the external environment through the pores, causing reagent leakage and environmental pollution. Summary of the Invention

[0004] In view of the above problems, this application provides a nucleic acid testing cartridge to solve the problem that when existing cartridges process nucleic acid samples, the air bubbles generated by ultrasonic vibration mixing can easily enter the external environment through the pores and cause environmental pollution.

[0005] According to one aspect of the embodiments of this application, a nucleic acid detection cartridge is provided, the cartridge having multiple cavities and at least one vent, the vent communicating with the cavities, the vent being used to drive fluid within the cartridge to flow between the multiple cavities when positive or negative pressure is introduced; a water-absorbing and breathable membrane is provided between the vent and the communicating cavity, the water-absorbing and breathable membrane being used to prevent moisture from entering the interior of the cartridge and to eliminate air bubbles.

[0006] In one alternative approach, the pores are covered with a waterproof and breathable membrane to prevent leakage of aerosols and vaporized reagents from inside the cartridge.

[0007] In one alternative embodiment, the card holder includes a card holder body and a cover. The side of the card holder body has several grooves. The cover is attached to the side of the card holder body and seals the groove openings, so that the grooves form cavities and channels connecting the cavities and vents. The channels have receiving grooves with enlarged bottom areas, and water-absorbing and breathable membranes are filled in the receiving grooves.

[0008] In one alternative embodiment, the plurality of cavities include an elution chamber, the pores include a first pore communicating with the elution chamber, and the absorbent breathable membrane includes a first absorbent breathable membrane disposed between the first pore and the elution chamber; a microvalve is disposed in the channel between the first absorbent breathable membrane and the elution chamber, the microvalve being used to reduce the volume of the bubbles.

[0009] In one alternative embodiment, the channel between the first absorbent and breathable membrane and the elution chamber includes a first channel and a second channel; one end of the first channel is connected to the first absorbent and breathable membrane, and one end of the second channel is connected to the elution chamber. A valve groove is provided on the cartridge body, which is connected to the other end of the first channel and the other end of the second channel, respectively. A blocking element is provided in the valve groove to block air bubbles; the valve groove and the blocking element together form a micro-valve.

[0010] In one alternative approach, there is a gap between the blocking element and the inner wall of the valve groove.

[0011] In one alternative approach, the blocking element includes an elastic pad.

[0012] In one alternative embodiment, the two opposite ends of the first absorbent and breathable membrane are respectively connected to the elution chamber and the first pore via channels.

[0013] In one alternative approach, the first absorbent and breathable membrane is positioned at the edge or corner of the card holder.

[0014] In one alternative embodiment, the plurality of cavities include a sample cavity and a lysis cavity, the sample cavity being in communication with the lysis cavity; the pores include a second pore communicating with at least one of the sample cavity and the lysis cavity, and the absorbent breathable membrane includes a second absorbent breathable membrane disposed between the second pores and the cavity communicating therewith.

[0015] In one alternative embodiment, the second pore is connected to the sample chamber and is used to drive the sample from the sample chamber into the lysis chamber when positive pressure is introduced; a second absorbent and breathable membrane is disposed between the second pore and the sample chamber.

[0016] This embodiment of the application provides an air vent on the cartridge that communicates with the cavity, and uses positive or negative pressure through the air vent to drive the fluid inside the cartridge, making the process of driving the sample liquid to flow within the cartridge highly efficient and controllable. Furthermore, a water-absorbing and breathable membrane is placed between the air vent and the communicating cavity. On the one hand, the membrane absorbs moisture that enters the cartridge through the air vent, preventing moisture from entering the cartridge and affecting the accuracy of the detection structure when positive pressure is applied to the air vent. On the other hand, air bubbles generated during ultrasonic vibration mixing will burst when they encounter the water-absorbing and breathable membrane, thus preventing air bubbles from carrying reagents to the external environment and causing environmental pollution.

[0017] The above description is only an overview of the technical solution of this application. In order to better understand the technical means of this application and to implement it in accordance with the contents of the specification, and to make the above and other objects, features and advantages of this application more obvious and understandable, the following are specific embodiments of this application. Attached Figure Description

[0018] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the scope of this application. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings:

[0019] Figure 1 shows a perspective view of one side of the nucleic acid test kit provided in the embodiment of this application;

[0020] Figure 2 shows a perspective view of the nucleic acid test kit provided in the embodiment of this application from another side;

[0021] Figure 3 shows a perspective view of the nucleic acid detection cartridge provided in the embodiment of this application from the frontal view;

[0022] Figure 4 shows a perspective view of a nucleic acid detection cartridge provided in another embodiment of this application from a frontal view.

[0023] Figure 5 shows an exploded view of one side of the nucleic acid test kit provided in the embodiment of this application;

[0024] Figure 6 shows an exploded view of the nucleic acid test kit provided in the embodiment of this application from another side;

[0025] Figure 7 shows an enlarged schematic diagram of point A in Figure 6.

[0026] The reference numerals in the detailed embodiments are as follows: 100, Card box; 10, Cavity; 20, Vent; 30, Water-absorbing and breathable membrane; 40, Waterproof and breathable membrane; 50, Card box body; 60, Cover; 70, Channel; 80, Sample inlet; 11, Sample chamber; 12, Magnetic bead chamber; 13, Pyrolysis chamber; 14, Elution chamber; 15, Reaction chamber; 21, First vent; 22, Second vent; 31, First water-absorbing and breathable membrane; 32, Second water-absorbing and breathable membrane; 71, Receptacle; 72, Microvalve; 73, First channel; 74, Second channel; 75, Third channel; 721, Valve groove; 722, Blocking element; 723, Micropore. Detailed Implementation

[0027] The embodiments of the technical solution of this application will now be described in detail with reference to the accompanying drawings. These embodiments are only used to more clearly illustrate the technical solution of this application and are therefore merely examples, and should not be used to limit the scope of protection of this application.

[0028] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains; the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the application; the terms “comprising” and “having”, and any variations thereof, in the specification, claims, and foregoing description of the drawings are intended to cover non-exclusive inclusion.

[0029] In the description of the embodiments of this application, technical terms such as "first" and "second" are used only to distinguish different objects and should not be construed as indicating or implying relative importance or implicitly specifying the number, specific order, or primary and secondary relationship of the indicated technical features. In the description of the embodiments of this application, "multiple" means two or more, unless otherwise explicitly defined.

[0030] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0031] In the description of the embodiments in this application, the term "and / or" is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent three cases: A exists, A and B exist simultaneously, and B exists. In addition, the character " / " in this document generally indicates that the related objects before and after it have an "or" relationship.

[0032] In the description of the embodiments of this application, the term "multiple" refers to two or more (including two), similarly, "multiple sets" refers to two or more (including two sets), and "multiple pieces" refers to two or more (including two pieces).

[0033] In the description of the embodiments of this application, the technical terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and other indications of orientation or positional relationships are based on the orientation or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the embodiments of this application and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the embodiments of this application.

[0034] In the description of the embodiments of this application, unless otherwise expressly specified and limited, the technical terms such as "installation," "connection," "joining," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. For those skilled in the art, the specific meaning of the above terms in the embodiments of this application can be understood according to the specific circumstances.

[0035] Nucleic acid detection technology typically includes steps such as lysis, binding, washing, elution, and subsequent PCR (polymerase chain reaction, also known as in vitro DNA amplification) and optical detection. The lysis, binding, washing, and elution steps are used to process the sample to extract nucleic acids carried by bacteria and / or viruses, while PCR and optical detection are used to detect the extracted nucleic acids. To ensure the accuracy of nucleic acid detection, sample processing and nucleic acid detection are usually performed separately; that is, the cartridge typically has multiple chambers, each dedicated to separate sample processing and nucleic acid detection. Furthermore, to facilitate sample transfer, the cartridge also has vents connecting the external environment to the chambers, allowing positive or negative pressure to be introduced into the chambers, thereby driving the sample flow between the multiple chambers.

[0036] Furthermore, during sample processing, the samples and reagents (e.g., lysis agents, binding agents, detergents, eluents, etc.) within the chamber can be ultrasonically vibrated to thoroughly process the samples and extract nucleic acids with higher purity. However, due to the high energy of ultrasonic vibration, the reagents within the chamber can generate bubbles during sample processing. These bubbles can reach the pores through the channel between the chamber and the pores, and then enter the external environment, leading to leakage of the reagents carried by the bubbles and causing environmental pollution.

[0037] Based on this, this application provides a nucleic acid detection cartridge with a water-absorbing and breathable membrane placed between the pores and the cavity, requiring air bubbles to pass through the membrane before reaching the pores. However, the air bubble ruptures upon contact with the membrane, allowing the gas it carries to pass through while the liquid reagent it carries is absorbed, effectively preventing reagent leakage and environmental pollution. Furthermore, when positive pressure is introduced through the pores, the membrane can also absorb moisture entering the cartridge from the pores, thus preventing moisture from affecting the accuracy of the test results.

[0038] According to one aspect of the embodiments of this application, a nucleic acid detection cartridge is provided. Please refer to Figures 1 to 3 for details. Figures 1 and 2 show the three-dimensional structure of the two sides of the cartridge, respectively. Figure 3 shows the perspective structure of the cartridge from the front view. It should be noted that in the specific embodiment shown in Figure 3, each channel and cavity is formed by a groove opened on the cartridge, and the groove opening is covered with a film or baffle to seal the cavity and flow channel. The black solid line part in the figure represents the groove structure that can be seen from the front, and the gray dashed line part represents the groove structure that cannot be seen from the back. The slender extension part in the figure is the channel. The channels are interconnected by through holes that penetrate the cartridge at the position where the solid line and the dashed line meet. It can be understood that the figure is only an example of a cartridge provided by the embodiments of this application. In other embodiments, all the flow channels and cavities can be set on one side of the cartridge, or an integrally molded cartridge can be used, and the cavity and flow channel are formed inside the cartridge during the injection molding process.

[0039] As shown in Figure 3, the cartridge 100 is provided with multiple cavities 10 and at least one vent 20. The vent 20 communicates with the cavities 10 and is used to drive the fluid inside the cartridge 100 to flow between the multiple cavities 10 when positive or negative pressure is introduced. A water-absorbing and breathable membrane 30 is provided between the vent 20 and the cavity 10 it communicates with. The water-absorbing and breathable membrane 30 is used to prevent moisture from entering the interior of the cartridge 100 and to eliminate air bubbles.

[0040] The cavities 10 are various functional spaces on the cartridge 100, such as the sample cavity 11 for injecting sample solution, the magnetic bead cavity 12 for storing magnetic beads (i.e., lyophilized beads), the lysis cavity 13 and elution cavity 14 for processing samples, and the reaction cavity 15 for detecting nucleic acids. During nucleic acid detection, the sample needs to be transferred to the corresponding cavity 10 according to the detection steps. For example, when processing the sample, it needs to be transferred from the sample cavity 11 to the lysis cavity 13 or the elution cavity 14, and during the transfer, the sample needs to pass through the magnetic bead cavity 12 to allow the sample to adhere to the magnetic beads. When detecting nucleic acids, the sample needs to be transferred from the lysis cavity 13 or the elution cavity 14 to the reaction cavity 15. In some embodiments, the cartridge 100 may also have only one sample processing cavity, which performs the functions of the lysis cavity 13 and the elution cavity 14.

[0041] To facilitate sample transfer, the cartridge 100 is provided with at least one vent 20 communicating with the cavity 10. This vent 20 provides power to the fluid (e.g., sample solution) inside the cartridge 100, thereby driving the fluid to flow between the multiple cavities 10. Specifically, as an example, as shown in FIG3, the vent 20 includes a first vent 21 communicating with the elution chamber 14 on the cartridge 100. When positive pressure is introduced into the first vent 21, the pressure inside the elution chamber 14 increases, thereby driving the fluid inside the elution chamber 14 to exit the elution chamber 14 and enter other cavities 10, maintaining pressure balance between the elution chamber 14 and other cavities 10, and ensuring the stability of the cartridge 100. Similarly, when negative pressure is introduced into the first vent 21, the pressure inside the elution chamber 14 decreases, thereby driving the fluid in other cavities 10 to enter the elution chamber 14. Specifically, when performing nucleic acid testing, the cartridge 100 can be used in conjunction with a testing device. The testing device is equipped with a gas pipeline for connecting to the vent 20. Gas is blown into the vent 20 through the gas pipeline to achieve positive pressure access to the vent 20, and gas is extracted from the vent 20 through the gas pipeline to achieve negative pressure access to the vent 20.

[0042] The absorbent and breathable membrane 30 has the property of absorbing liquid and allowing gas to pass through. Specifically, when positive pressure is introduced into the vent 20, the moisture entering the cartridge 100 along with the gas is absorbed by the absorbent and breathable membrane 30, while the gas normally enters the cavity 10 connected to the vent 20. Of course, when drying the magnetic beads, the water vapor evaporated during drying is also absorbed by the absorbent and breathable membrane 30 when it passes through the membrane. Furthermore, when the sample and reagent in the cavity 10 are mixed by ultrasonic vibration, not only will the reagent splash and bubbles be generated, but the pressure inside the cavity 10 will also increase. At this time, the pressure at the air hole 20 on the cartridge 100 will be lower than the pressure inside the cavity 10, which will drive the bubbles to move toward the air hole 20. When the bubbles reach the water-absorbing and breathable membrane 30, the liquid on the surface of the bubbles will be absorbed by the water-absorbing and breathable membrane 30, which will cause the bubbles to burst. That is, the reagent carried by the bubbles will be absorbed by the water-absorbing and breathable membrane 30, while the gas continues to move toward the air hole 20.

[0043] The position of the absorbent breathable membrane 30 is determined by the position of the pores 20. That is, the absorbent breathable membrane 30 is positioned between the pore 20 and the cavity 10 it communicates with, preventing liquid (i.e., water or reagent) from flowing between the external environment and the inside of the cartridge 100 through the pores 20. Specifically, in the embodiment shown in Figure 3, the pores 20 include a first pore 21 communicating with the elution chamber 14 and a second pore 22 communicating with the lysis chamber 13. Therefore, a first absorbent breathable membrane 31 is positioned between the first pore 21 and the elution chamber 14, and a second absorbent breathable membrane 32 is positioned between the second pore 22 and the lysis chamber 13. Figure 4 shows a perspective view of a nucleic acid detection card box provided in another embodiment of this application from the frontal view. In this embodiment, the pore 20 also includes a first pore 21 communicating with the elution chamber 14 and a second pore 22 communicating with the sample chamber 11. The position of the first water-absorbing and breathable membrane 31 is the same as that in the embodiment shown in Figure 3, and the second water-absorbing and breathable membrane 32 is disposed between the second pore 22 and the sample chamber 11.

[0044] In the above embodiments, by providing an air hole 20 on the cartridge 100 that communicates with the cavity 10, and by applying positive or negative pressure to the air hole 20 to drive the fluid inside the cartridge 100, the process of driving the sample liquid to flow inside the cartridge 100 is made efficient and controllable. Furthermore, a water-absorbing and breathable membrane 30 is provided between the air hole 20 and the cavity 10 it communicates with. On the one hand, the water-absorbing and breathable membrane 30 can absorb moisture that enters the cartridge 100 through the air hole 20, preventing moisture from entering the cartridge 100 and affecting the accuracy of the detection structure when positive pressure is applied to the air hole 20; on the other hand, bubbles generated during ultrasonic vibration mixing will burst when they encounter the water-absorbing and breathable membrane 30, thereby preventing bubbles from carrying reagents into the external environment and causing environmental pollution.

[0045] To further reduce pollution to the testing environment, this application proposes an embodiment, as shown in Figures 3 and 5. Figure 5 shows the exploded structure of the cartridge from one side view. A waterproof and breathable membrane 40 covers the vent 20, preventing leakage of aerosols and vaporized reagents inside the cartridge 100. Specifically, the waterproof and breathable membrane 40 can cover the opening of the vent 20, as shown in Figures 3 and 5, or it can cover the channel between the vent 20 and the cavity 10. This structural arrangement allows the waterproof and breathable membrane 40 to seal the vent 20 connecting the internal and external spaces of the cartridge 100, thereby effectively preventing internal aerosol contamination of the testing environment.

[0046] Considering the complexity and high cost of the one-piece microchannel method inside the card holder 100, this application proposes a manufacturing method that facilitates mass production of the card holder 100 and can effectively reduce costs. Please refer to Figures 5 and 6 for details. Figure 6 shows the exploded structure of the card holder from another side view. The card holder 100 includes a card holder body 50 and a cover 60. Several grooves are formed on the side of the card holder body 50. The cover 60 is attached to the side of the card holder body 50 and seals the groove openings, so that the grooves form a cavity 10 and a channel 70 connecting the cavity 10 and the vent 20.

[0047] In the specific manufacturing process, to ensure structural strength, the card holder body 50 can be made of rigid material, while to ensure sealing performance, the cover 60 can be made of flexible material. The two can be assembled and fixed by means of bonding, heat fusion, etc. Compared with the method of integrally molding the channel 70 and cavity 10 inside, the method provided in this embodiment of opening a groove in the card holder body 50 and sealing the groove with the cover 60 is more convenient for the manufacturing of the card holder 100, which helps to improve manufacturing efficiency and reduce production costs.

[0048] Furthermore, it should be noted that the current absorbent and breathable membranes experience a significant decrease in permeability after absorbing a large amount of liquid. Considering that during the ultrasonic mixing of nucleic acid samples and reagents within cavity 10, liquid splashing may occur inside the cavity, as shown in Figures 3 and 4. Consequently, a considerable amount of liquid may pass through channel 70 to the absorbent and breathable membrane 30 and be absorbed by it, resulting in a decrease in the permeability of the absorbent and breathable membrane 30. Consequently, when air pressure is introduced through pore 20, the permeability of gas at the absorbent and breathable membrane 30 decreases, reducing its ability to drive the internal liquid. In severe cases, this may even prevent the normal flow of samples between cavity 10 and channel 70.

[0049] Therefore, as shown in Figures 3 to 5, the channel 70 has a receiving groove 71 with an enlarged bottom area, and the absorbent breathable membrane 30 is filled in the receiving groove 71. Specifically, as shown in the figures, the absorbent breathable membrane 30 is laid flat in the receiving groove 71, that is, the area of ​​the absorbent breathable membrane 30 is equal to the bottom area of ​​the receiving groove 71, so that the absorbent breathable membrane 30 has a large area, so that it can absorb a large amount of liquid without clogging.

[0050] The bubbles generated by ultrasonic vibration mixing are of different sizes. In channels of the same size, the air content in large bubbles is greater than that in small bubbles. Therefore, large bubbles are lighter than small bubbles. Under the same pressure, large bubbles move faster in channel 70 than small bubbles. This may cause large bubbles to pass through the surface of the absorbent breathable membrane 30 because the absorbent breathable membrane 30 cannot absorb them in time, and then reach the external environment through the pores, causing environmental pollution. Alternatively, the waterproof breathable membrane 40 covering the pores 20 may be wetted by the liquid carried by the bubbles and fail. Subsequently, when positive or negative pressure is introduced into the pores 20, the gas cannot pass through the waterproof breathable membrane 40, thus affecting the transfer of fluid.

[0051] Therefore, to prevent large air bubbles from passing through the surface of the absorbent breathable membrane 30, this application further proposes an embodiment, as shown in Figures 4 to 6, in which multiple cavities 10 include an elution chamber 14, and pores 20 include a first pore 21 communicating with the elution chamber 14. The absorbent breathable membrane 30 includes a first absorbent breathable membrane 31 disposed between the first pore 21 and the elution chamber 14. A micro-valve 72 is disposed in the channel 70 between the first absorbent breathable membrane 31 and the elution chamber 14. The micro-valve 72 is used to reduce the volume of air bubbles. The function of the micro-valve 72 is to eliminate large air bubbles or convert large air bubbles into small air bubbles when the elution chamber 14 is subjected to ultrasonic vibration mixing treatment, so that they are quickly absorbed when they reach the first absorbent breathable membrane 31, preventing large air bubbles from passing through the first absorbent breathable membrane 31 and reaching the first pore 21, thereby preventing environmental pollution or failure of the waterproof breathable membrane 40 covering the first pore 21.

[0052] Specifically, as shown in Figures 5 to 7, Figure 7 shows an enlarged schematic diagram of point A in Figure 6. The channel 70 between the first absorbent and breathable membrane 31 and the elution chamber 14 includes a first channel 73 and a second channel 74. One end of the first channel 73 is connected to the first absorbent and breathable membrane 31, and one end of the second channel 74 is connected to the elution chamber 14. A valve groove 721 is provided on the cartridge body 50. The valve groove 721 is connected to the other end of the first channel 73 and the other end of the second channel 74, respectively. A blocking member 722 is placed inside the valve groove 721 to block air bubbles. The valve groove 721 and the blocking member 722 together form a micro-valve 72.

[0053] During the ultrasonic vibration mixing process in the elution chamber 14, bubbles generated in the elution chamber 14 may splash into the second channel 74 and move along the second channel 74 to the micro valve 72 under pressure. When the bubbles enter the valve groove 721 from the second channel 74, they are blocked by the blocking member 722 and collide with the blocking member 722 and break. Specifically, the blocking member 722 may include an elastic pad.

[0054] Furthermore, there is a gap between the blocking member 722 and the inner wall of the valve groove 721. When a bubble reaches the micro valve 72, the smaller bubble can enter the first channel 73 through the gap between the blocking member 722 and the inner wall of the valve groove 721, so as to reach the first absorbent breathable membrane 31 through the first channel 73 and be absorbed by the first absorbent breathable membrane 31.

[0055] Large air bubbles, when entering the valve groove 721 through the second channel 74, may collide with the blocking member 722 and burst, or burst or transform into small air bubbles when passing through the gap between the inner wall of the valve groove 721 and the blocking member 722. In other words, large air bubbles, upon reaching the microvalve 72, can be eliminated or transformed into small air bubbles by impact with the blocking member 722 and by entering from a larger cross-section into a smaller gap cross-section, thus allowing them to be quickly absorbed when they reach the first absorbent and breathable membrane 31. Specifically, as shown in Figure 7, when the first channel 73 and the second channel 74 are respectively located on both sides of the card box 100, the second channel 74 can communicate with the side wall of the valve groove 721, while the first channel 73 communicates with the micropore 723 penetrating through the bottom of the valve groove 721. After the bubble enters the micro-valve 72 through the first channel 73, it first passes through the gap between the side wall of the valve groove 721 and the blocking member 722 to reach the bottom of the valve groove 721. Then it passes through the gap between the bottom inner wall of the valve groove 721 and the blocking member 722 to reach the micro-hole 723. Finally, it passes through the micro-hole 723 to enter the first channel 73. During this process, the large bubble is squeezed by the inner wall of the valve groove 721 and the blocking member 722 and is broken.

[0056] Of course, the microvalve 72 can also be set as a flow control valve. Before the sample in the elution chamber 14 is ultrasonically mixed, the microvalve 72 can be turned off in advance to ensure that the liquid will not splash onto the first absorbent and breathable membrane 31, thereby avoiding the first absorbent and breathable membrane 31 from absorbing too much liquid and affecting its breathability, and ensuring the driving ability of the sample when pressure is introduced into the first pore 21.

[0057] In the above embodiment, by setting a micro valve 72 between the elution chamber 14 and the first absorbent and breathable membrane 31, the large air bubbles generated during the ultrasonic mixing process can be eliminated or converted into small air bubbles through the micro valve 72, so as to prevent large air bubbles from passing through the surface of the first absorbent and breathable membrane 31 and causing environmental pollution or failure of the waterproof and breathable membrane 40 covering the first pore 21.

[0058] The absorbent and breathable membrane 30 primarily eliminates air bubbles by contacting them and absorbing liquid from their surface, causing the bubbles to burst. However, under pressure, after reaching the absorbent and breathable membrane 30, the bubbles continue to move along its surface. If the two locations on the absorbent and breathable membrane 30 that connect to the cavity 10 and the pore 20 are relatively close, the bubbles only need to move a short distance along the surface of the membrane to enter the channel 70 between the membrane 30 and the pore 20. This may result in the bubble's contact time with the membrane being too short for it to be absorbed by the membrane 30.

[0059] Therefore, to ensure sufficient contact between the air bubbles and the absorbent breathable membrane 30, this application further proposes an embodiment, as shown in Figures 3 and 4, in which the two opposite ends of the first absorbent breathable membrane 31 are connected to the elution chamber 14 and the first pore 21 respectively through channels 70. As shown in the figures, the right end of the first absorbent breathable membrane 31 is connected to the elution chamber 14 through channel 70, while the first pore 21 is connected to a position near the left end of the first absorbent breathable membrane 31 through channel 70. This ensures that after the air bubbles reach the first absorbent breathable membrane 31 from the elution chamber 14, they need to pass through the first absorbent breathable membrane 31 from right to left before entering the channel 70 between the first absorbent breathable membrane 31 and the first pore 21, thus ensuring sufficient contact between the air bubbles and the first absorbent breathable membrane 31 and their absorption by the first absorbent breathable membrane 31.

[0060] Of course, the upper and lower ends of the first absorbent breathable membrane 31 can also be connected to the elution chamber 14 and the first pore 21 respectively through the channel 70, so that the bubbles pass through the first absorbent breathable membrane 31 from bottom to top or from top to bottom after reaching it. In addition, in order to make the bubbles travel a longer distance on the first absorbent breathable membrane 31, the elution chamber 14 and the first pore 21 can be connected to two opposite corners of the first absorbent breathable membrane 31 respectively. For example, in Figure 4, the top right side of the first absorbent breathable membrane 31 is connected to the elution chamber 14, and the bottom left side of the first absorbent breathable membrane 31 is connected to the first pore 21.

[0061] In the above embodiment, by connecting the elution chamber 14 and the first pore 21 to the opposite ends of the first absorbent breathable membrane 31, bubbles can fully contact the first absorbent breathable membrane 31 after reaching it from the elution chamber 14. This effectively utilizes the liquid absorption properties of the first absorbent breathable membrane 31 to eliminate bubbles, preventing them from passing through the first absorbent breathable membrane 31 and reaching the first pore 21, thus avoiding environmental pollution or causing the waterproof breathable membrane 40 covering the first pore 21 to fail.

[0062] It should be noted that when the absorbent breathable membrane 30 includes other absorbent breathable membranes besides the first absorbent breathable membrane 31, the other absorbent breathable membranes can also be connected to the cavity 10 and the air hole 20 through the channel 70 at their opposite ends, so that the air bubbles can fully contact the other absorbent breathable membranes after reaching them from the cavity 10.

[0063] Considering that the central area of ​​the card holder 100 needs to integrate a large number of cavities 10 and channels 70, in order to make the first absorbent breathable membrane 31 have a larger area, this application further proposes an implementation method, as shown in Figures 4 and 5, in which the first absorbent breathable membrane 31 is disposed at the edge or corner of the card holder 100, ensuring that the area of ​​the first absorbent breathable membrane 31 can be set as large as possible. Comparing Figures 3 and 4, it can be seen that, compared with the embodiment shown in Figure 3, the embodiment shown in Figure 4 has a larger area because the first absorbent breathable membrane 31 is disposed at the edge or corner where there are fewer cavities 10 and channels 70. This better ensures that the first absorbent breathable membrane 31 does not become clogged when absorbing a large amount of liquid.

[0064] Of course, if the absorbent breathable membrane 30 also includes other absorbent breathable membranes besides the first absorbent breathable membrane 31, the other absorbent breathable membranes can be placed at the edge or corner of the card box 100 to ensure that the area of ​​the other absorbent breathable membranes can be set as large as possible, so that they can absorb more liquid without clogging.

[0065] Furthermore, to prevent reagents splashing into the channel 70 from reaching the first vent 21, this application proposes a further embodiment, as shown in FIG4, in which the first vent 21 is located in the middle of the cartridge 100, and the first absorbent breathable membrane 31 is connected to the first vent 21 through a curved channel 70 on the side opposite to the first vent 21, so as to ensure that the channel 70 between the first absorbent breathable membrane 31 and the first vent 21 can be set as long as possible.

[0066] Specifically, as shown in Figure 4, after the reagent splashed into channel 70 passes through the first absorbent and breathable membrane 31, it still needs to pass through channel 70 (i.e., third channel 75) between the first absorbent and breathable membrane 31 and the first pore 21 to reach the first pore 21. Since the third channel 75 is curved and the first absorbent and breathable membrane 31 is located at the edge or corner, while the first pore 21 is located in the middle, the third channel 75 can be made as long as possible. This can, to a certain extent, prevent the reagent and air bubbles from reaching the first pore 21, and prevent the reagent and air bubbles from passing through channel 70 to the first pore 21 and causing environmental pollution or failure of the waterproof and breathable membrane 40 covering the first pore 21.

[0067] To facilitate the control of fluid movement between multiple cavities, as shown in Figures 3 and 4, the multiple cavities 10 include a sample cavity 11 and a lysis cavity 13, with the sample cavity 11 and the lysis cavity 13 in communication. The vent 20 includes a second vent 22 that communicates with at least one of the sample cavity 11 and the lysis cavity 13. The water-absorbing and breathable membrane 30 includes a second water-absorbing and breathable membrane 32 disposed between the second vent 22 and the cavity 10 in communication with it.

[0068] As shown in Figure 3, the second pore 22 can communicate with the lysis chamber 13. The second water-absorbing and breathable membrane 32 is disposed between the second pore 22 and the lysis chamber 13. When the second pore 22 is connected to negative pressure, the pressure in the lysis chamber 13 decreases, thereby drawing the sample in the sample chamber 11 into the lysis chamber 13. When the second pore 22 is connected to positive pressure, the pressure in the lysis chamber 13 increases, thereby pumping the fluid in the lysis chamber 13 into the subsequent chamber 10.

[0069] To ensure convenient sample injection, the inlet 80 is generally set to be relatively large, and the volume of the sample chamber 11 is also set to be relatively large. Practical testing has shown that a larger volume of sample chamber 11 results in more sample liquid adhering to the inner wall of sample chamber 11, forming small droplets. Based on this, when the second vent 22 is connected to the lysis chamber 13 as shown in Figure 3, during the process of introducing negative pressure through the second vent 22 to draw the sample liquid from sample chamber 11 into lysis chamber 13, the small droplets adhering to the inner wall of sample chamber 11 cannot be effectively drawn into lysis chamber 13 due to the characteristics of negative pressure drive. As a result, these small droplets cannot participate in the subsequent sample processing process, thus affecting the sample processing capability of cartridge 100.

[0070] In view of the above problems, in addition to adopting the specific structure shown in Figure 3, the card holder 100 can also be used in other embodiments, such as the exploded structure and perspective structure shown in Figures 4 to 6, where the second vent 22 is connected to the sample chamber 11. The second vent 22 is used to drive the sample from the sample chamber 11 into the lysis chamber 13 when positive pressure is introduced. The second absorbent and breathable membrane 32 is disposed between the second vent 22 and the sample chamber 11.

[0071] When positive pressure is introduced through the second vent 22, the pressure inside the sample chamber 11 increases, thereby pumping the sample from the sample chamber 11 into the lysis chamber 13. During this process, the direction of gas flow from the second vent 22 to the sample chamber 11 is shown by the dashed arrow in Figure 4 located in the channel 70 between the second vent 22 and the sample chamber 11. Comparing Figures 3 and 4, it can be seen that the specific embodiments shown in the two figures are basically the same in structure except for the cavity 10 connected to the second vent 22.

[0072] By connecting the second vent 22 to the sample chamber 11 and using the positive pressure introduced through the second vent 22 to push the sample from the sample chamber 11 to the lysis chamber 13, the gas passing through the sample chamber 11 will push most of the small liquid droplets suspended on the inner wall of the sample chamber 11 into the lysis chamber 13 along the inner wall and the channel 70, so as to ensure that more samples participate in subsequent processing and detection, thereby improving sample processing capacity and detection effect.

[0073] Furthermore, during ultrasonic mixing of the sample and reagents within the lysis chamber 13, any bubbles or splashed reagents generated within the lysis chamber 13 must first enter the sample chamber 11 through the channel 70 between the lysis chamber 13 and the sample chamber 11 before reaching the second absorbent breathable membrane 32 through the channel 70 between the sample chamber 11 and the second absorbent breathable membrane 32. However, the reagents entering the sample chamber 11 will deposit at the bottom of the sample chamber 11 under gravity, and bubbles may collide with the wall of the channel 70 and rupture during their movement within the channel 70 between the lysis chamber 13 and the sample chamber 11. Therefore, this structural design effectively prevents the second absorbent breathable membrane 32 from losing its breathability due to excessive liquid absorption, and the liquid in the channel 70 between the lysis chamber 13 and the sample chamber 11, as well as the liquid in the sample chamber 11, can be re-pumped into the lysis chamber 13 by introducing positive pressure into the second vent 22.

[0074] Of course, in some other embodiments, at least two second vents 22 may be provided on the cartridge 100, at least one of which is connected to the sample chamber 11 and at least the other is connected to the lysis chamber 13. When driving the sample, positive pressure can be introduced into the second vent 22 connected to the sample chamber 11, and negative pressure can be introduced into the second vent 22 connected to the lysis chamber 13.

[0075] According to another aspect of the embodiments of this application, a nucleic acid detection system is also provided, the system including a detection device (not shown) and a nucleic acid detection cartridge 100 as described in any of the above embodiments, the detection device being used to fix and operate the nucleic acid detection cartridge for nucleic acid detection.

[0076] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application, and not to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. These modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application, and they should all be covered within the scope of the claims and specification of this application. In particular, as long as there is no structural conflict, the various technical features mentioned in the embodiments can be combined in any way. This application is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.

Claims

1. A nucleic acid testing cartridge, characterized by, The cartridge is provided with a plurality of cavities and at least one air hole communicating with the cavities, and the air hole is used to drive the fluid in the cartridge to flow between the cavities when a positive pressure or a negative pressure is introduced. A water-absorbing and air-permeable film is arranged between the air hole and the cavities communicating therewith, and the water-absorbing and air-permeable film is used to prevent moisture from entering the interior of the cartridge and eliminate air bubbles.

2. The nucleic acid testing cartridge of claim 1, wherein, A waterproof and air-permeable film is arranged on the air hole, and the waterproof and air-permeable film is used to prevent aerosol and reagent after vaporization in the interior of the cartridge from leaking.

3. The nucleic acid testing cartridge of claim 1 or 2, wherein, The cartridge comprises a cartridge body and a cover, a plurality of grooves are formed in the side surface of the cartridge body, and the cover is attached to the side surface of the cartridge body and seals the groove openings of the grooves, so that the grooves form the cavities and channels communicating the cavities and the air hole. The channel has a containing groove with an enlarged bottom area, and the water-absorbing and air-permeable film is filled in the containing groove.

4. The nucleic acid testing cartridge of claim 3, wherein, The plurality of cavities include an elution cavity, the air hole includes a first air hole communicating with the elution cavity, and the water-absorbing and air-permeable film includes a first water-absorbing and air-permeable film arranged between the first air hole and the elution cavity. A micro valve is arranged in the channel between the first water-absorbing and air-permeable film and the elution cavity, and the micro valve is used to reduce the volume of air bubbles.

5. The nucleic acid testing cartridge of claim 4, wherein, The channel between the first water-absorbing and air-permeable film and the elution cavity includes a first channel and a second channel. One end of the first channel communicates with the first water-absorbing and air-permeable film, one end of the second channel communicates with the elution cavity, a valve groove is arranged on the cartridge body and communicates with the other end of the first channel and the other end of the second channel, respectively, a blocking piece is arranged in the valve groove, and the blocking piece is used to block air bubbles. The valve groove and the blocking piece jointly form the micro valve.

6. The nucleic acid testing cartridge of claim 5, wherein, The blocking piece has a gap with the inner wall of the valve groove.

7. The nucleic acid testing cartridge of claim 5, wherein, The blocking piece includes an elastic pad.

8. The nucleic acid testing cartridge of claim 4, wherein, The first water-absorbing and air-permeable film communicates with the elution cavity and the first air hole through channels at opposite ends thereof, respectively.

9. The nucleic acid testing cartridge of claim 4, wherein, The first water-absorbing and air-permeable film is arranged at an edge or a corner position of the cartridge.

10. The nucleic acid testing cartridge of claim 1 or 2, wherein, The plurality of cavities include a sample cavity and a lysis cavity, and the sample cavity communicates with the lysis cavity. The air hole includes a second air hole communicating with at least one of the sample cavity and the lysis cavity, and the water-absorbing and air-permeable film includes a second water-absorbing and air-permeable film arranged between the second air hole and the cavities communicating therewith.

11. The nucleic acid testing cartridge of claim 10, wherein, The second air hole communicates with the sample cavity, and the second air hole is used to drive the sample from the sample cavity into the lysis cavity when a positive pressure is introduced. The second water-absorbing and air-permeable film is arranged between the second air hole and the sample cavity.

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