Plug-in reagent tube assembly and nucleic acid self-testing device used therewith

Abstract

The present invention provides a plug-in reagent tube assembly and a nucleic acid self-testing device used therewith, wherein the reagent tube assembly includes: a sample tube for containing samples and reagents, a first end of which has a sealing cover and a second end which is a closed end; a base having a positioning hole for inserting the second end of the sample tube and at least one reaction hole, a puncture head having a hollow flow channel being arranged in the positioning hole; when the sample tube is inserted in the positioning hole, the puncture head can puncture the closed end so that the contents contained in the sample tube can flow into the reaction hole through the hollow flow channel. The sample tube of the present invention can be connected to the base in a plug-in manner, and the reaction hole is a component of the reagent tube assembly, which is no longer in the reaction device of the detection device, and will not cause pollution to the main body of the detection device. The main body of the detection device can be reused. During use, the user only needs to replace the plug-in reagent tube assembly, which greatly reduces the user's detection and use costs.

Description

Technical Field

[0001] The present invention belongs to the technical field of nucleic acid detection equipment design, and specifically relates to a plug-in reagent tube assembly and a nucleic acid self-testing device used in conjunction with the assembly. Background Art

[0002] With the improvement of people's living standards and the development of biotechnology, people's pursuit and concern for health have become more and more prominent. At the same time, with the acceleration of people's pace of life, time, cost, privacy, etc. have become aspects of people's concern, whether in work or life, especially in medical testing. The cumbersome examinations in hospitals, the long waiting time for results, the high testing costs, and even some private testing items are all troubling people; in order to overcome the aforementioned shortcomings, a portable nucleic acid testing device has appeared in the prior art, which is small in size and compact in structure. It can be purchased by users for self-testing at home. After the corresponding reagent tube is loaded with the sample, it is inserted into the reaction device with the detection device. The sample flows into each reaction well in turn through the flow channel. After the reaction is completed, the result is read. Since each reaction well is in the reaction device of the detection device, after completing the nucleic acid test of the user, the reaction device is contaminated, resulting in the detection device cannot be reused, which increases the user's detection cost. Summary of the invention

[0003] Therefore, the technical problem to be solved by the present invention is to provide a plug-in reagent tube assembly and a nucleic acid self-testing device used therewith, so as to overcome the shortcomings of the prior art that the reaction hole is in the reaction device of the detection equipment and is contaminated after completing a nucleic acid test, resulting in the detection equipment being unable to be reused, thereby increasing the user's detection cost.

[0004] In order to solve the above problems, the present invention provides a plug-in reagent tube assembly, comprising:

[0005] A sample tube, used to hold samples and reagents, with a sealing cap at the first end and a closed end at the second end;

[0006] A base having a positioning hole for inserting the second end of the sample tube and at least one reaction hole, wherein a puncture head having a hollow flow channel is arranged in the positioning hole;

[0007] When the sample tube is inserted into the positioning hole, the puncture head can pierce the closed end to allow the content contained in the sample tube to flow into the reaction hole through the hollow flow channel.

[0008] In some embodiments, the base comprises:

[0009] A fixed plate and a reaction seat, wherein the fixed plate and the reaction seat are interlocked and connected, the positioning hole is constructed on the fixed plate, and also includes a liquid separation plate, the puncture head is connected to the liquid separation plate, and the liquid separation plate has a liquid separation channel, one end of the liquid separation channel is connected to the hollow channel, and the other end of the liquid separation channel is connected to the reaction hole.

[0010] In some embodiments, the liquid separation plate further has a guide column extending into the reaction hole, and the liquid separation channel is connected to the reaction hole via the guide column.

[0011] In some embodiments, the liquid separation channel is an open groove constructed on the bottom surface of the liquid separation plate, and the base also includes a sealing film, which is clamped between the reaction seat and the bottom surface of the liquid separation plate to seal the opening of the open groove.

[0012] In some embodiments, the sealing membrane is a silicone membrane, and there are multiple liquid separation channels. The first ends of the multiple liquid separation channels are connected to the hollow channel, and the second ends are respectively connected to a reaction hole. The first ends of the liquid separation channels can be controllably blocked or opened by the silicone membrane.

[0013] In some embodiments, a first hemispherical groove is constructed at the central position of the liquid separation plate, the first ends of the plurality of liquid separation channels are located on the groove wall of the first hemispherical groove, the silicone membrane has a second hemispherical groove, the second hemispherical groove is arranged opposite to the first hemispherical groove, and a through hole is constructed at the position of the reaction seat corresponding to the second hemispherical groove.

[0014] In some embodiments, a first elastic clip is provided on the top surface of the fixed plate, at least two of the first elastic clips are spaced apart around the positioning hole, and the outer circumferential wall of the second end of the sample tube has a first groove that cooperates with the first elastic clip; and / or, a second elastic clip is provided on the bottom surface of the fixed plate, at least two of the second elastic clips are spaced apart around the fixed plate, and the outer circumferential wall of the reaction seat has a second groove that cooperates with the second elastic clip.

[0015] In some embodiments, the liquid separation plate is configured with ventilation holes, the number of which is the same as the number of the reaction holes and corresponds one to one, the fixed plate is configured with air holes, and air plugs are provided in the air holes; and / or, there are positioning pins between the fixed plate and the reaction seat.

[0016] In some embodiments, the reaction seat also has an anti-foolproof structure; and / or, the fixed plate has an upwardly protruding plug-in column, on which the puncture head is fixedly connected, and the second end of the sample tube has a plug-in hole that is plugged into and cooperates with the plug-in column; and / or, the reaction hole protrudes from the seat body plane of the reaction seat and extends downward.

[0017] The present invention also provides a nucleic acid self-testing device for use with the above-mentioned plug-in reagent tube assembly.

[0018] The present invention provides a plug-in reagent tube assembly and a nucleic acid self-testing device used therewith, wherein the sample tube can be connected to the base in a plug-in manner. During the plug-in process of the two, the puncture head can pierce the closed end of the sample tube so that the contents in the sample tube flow into a reaction hole of a certain volume. Since the reaction hole is a component of the reagent tube assembly, it is no longer in the reaction device of the detection device and will not cause pollution to the main body of the detection device. The main body of the detection device can be reused. During use, the user only needs to replace the plug-in reagent tube assembly, which greatly reduces the user's detection and use cost. It should be particularly noted that the plug-in reagent tube assembly of the present invention only requires the user to collect samples by himself and then place the sample into the sample tube and then plug and connect the sample tube to the base in a specific application, so as to realize the quantitative transfer of the sample to the reaction hole. Finally, the plug-in reagent tube assembly is placed on the main body of the detection device for subsequent heating amplification, detection and other steps. No special pipetting and quantification processes are required. The operation is very simple and convenient, and is particularly suitable for home self-testing scenarios, thereby meeting the user's privacy protection purpose and saving a lot of waiting time. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 A schematic diagram of the internal structure of a plug-in reagent tube assembly according to an embodiment of the present invention;

[0020] Figure 2 for Figure 1 Schematic diagram of the structure of the sample tube;

[0021] Figure 3 for Figure 1 A schematic diagram of the three-dimensional structure of the fixed disk in FIG.

[0022] Figure 4 for Figure 1 Schematic diagram of the three-dimensional structure of the reaction seat;

[0023] Figure 5 for Figure 1 Schematic diagram of the internal structure of the distribution plate.

[0024] The reference numerals are as follows:

[0025] 1. Sample tube; 11. Sealing cover; 12. First card slot; 13. Plug-in hole; 21. Piercing head; 22. Fixing plate; 221. First elastic buckle; 222. Second elastic buckle; 223. Air hole; 23. Reaction seat; 231. Reaction hole; 232. Through hole; 233. Second card slot; 234. Positioning pin; 235. Foolproof structure; 24. Separation plate; 241. Guide column; 242. First hemispherical groove; 243. Plug-in column; 244. Air hole; 25. Sealing membrane; 251. Second hemispherical groove. DETAILED DESCRIPTION

[0026] See also Figures 1 to 5 As shown, according to an embodiment of the present invention, there is provided a plug-in reagent tube assembly, comprising: a sample tube 1 for containing samples and reagents, a first end of which has a sealing cover 11, and a second end which is a closed end; a base, which has a positioning hole for inserting the second end of the sample tube 1 and at least one reaction hole 231, and a puncture head 21 (which may be a puncture needle) having a hollow flow channel is arranged in the positioning hole; when the sample tube 1 is inserted in the positioning hole, the puncture head 21 can puncture the closed end to allow the content contained in the sample tube 1 (that is, the aforementioned mixed liquid of the sample and the reagent) to flow into the reaction hole 231 via the hollow flow channel. In this technical solution, the sample tube 1 can be connected to the base in a plug-in manner. During the plug-in process of the two, the puncture head 21 can pierce the closed end of the sample tube 1 so that the contents of the sample tube 1 flow into the reaction hole 231 of a certain volume. Since the reaction hole 231 is a component of the reagent tube assembly, it is no longer in the reaction device of the detection equipment and will not cause pollution to the main body of the detection equipment. The main body of the detection equipment can be reused. During use, the user only needs to replace the plug-in reagent tube assembly, which greatly reduces the user's detection and use cost. It should be particularly noted that the plug-in reagent tube assembly of the present invention only requires the user to collect samples by himself and then place the sample into the sample tube 1 and then plug and connect the sample tube 1 to the base in a specific application, so as to realize the quantitative transfer of the sample to the reaction hole 231. Finally, the plug-in reagent tube assembly is placed on the main body of the detection equipment for subsequent heating amplification, detection and other steps. No special pipetting and quantitative processes are required. The operation is very simple and convenient, especially suitable for home self-testing scenarios, thereby meeting the user's privacy protection purpose and saving a lot of waiting time. It should be noted that the sealing cover 11 is provided with an air hole and covered with an air-permeable membrane by ultrasonic or hot-melt method to ensure that the contents of the sample tube 1 can smoothly enter the reaction hole 231 through the puncture head 21 when the sample tube 1 is in a sealed state (that is, the sealing cover 11 is in a sealed state).

[0027] See also Figure 1The base includes a fixed plate 22 and a reaction seat 23, the fixed plate 22 and the reaction seat 23 are mutually buckled and connected, that is, they are assembled in an integral manner by stacking up and down, so as to realize the assembly and corresponding operation of the components (such as the liquid separation plate 24) arranged inside the fixed plate 22, the positioning hole is constructed on the fixed plate 22, and the liquid separation plate 24 is also included, the puncture head 21 is connected to the liquid separation plate 24, and the liquid separation plate 24 has a liquid separation flow channel, one end of the liquid separation flow channel is connected to the hollow flow channel, and the other end of the liquid separation flow channel is connected to the reaction hole 231, so as to realize the smooth transfer and guidance of the contents in the sample tube 1 to the reaction hole 231. Furthermore, the liquid separation plate 24 also has a guide column 241 extending into the reaction hole 231, and the liquid separation flow channel is connected to the reaction hole 231 via the guide column 241. In this technical solution, the guide column 241 extends into the reaction hole 231, preferably into the bottom of the reaction hole 231, which can prevent the sample solution droplets from forming a pressure difference between the entrance and the bottom of the reaction hole 231, resulting in the liquid being unable to fill the entire reaction hole 231 and unable to achieve the quantitative purpose.

[0028] In a specific embodiment, see Figure 5 As shown, the liquid separation channel is an open groove constructed on the bottom end surface of the liquid separation plate 24, and the base also includes a sealing film 25, which is clamped between the reaction seat 23 and the bottom end surface of the liquid separation plate 24 to form a seal for the opening of the open groove. The liquid separation channel is formed by an open groove, which can reduce the difficulty of processing the liquid separation channel, and the sealing film 25 can ensure the sealing of the liquid separation channel.

[0029] In some embodiments, the sealing film 25 is a silicone film, so that the sealing film 25 has elastic deformation ability, there are multiple liquid separation channels, the first ends of the multiple liquid separation channels are connected to the hollow channel, and the second ends are each connected to a reaction hole 231. The first end of the liquid separation channel can be controllably blocked or connected by the silicone film, that is, the blocking and connection of the liquid separation channel can be achieved by controlling the deformation of the silicone film, so as to achieve the internal sealed environment during the amplification or detection of the sample liquid in the reaction hole 231, and prevent the pollution of the external environment. In a specific embodiment, the central position of the liquid separation disk 24 is configured with a first hemispherical groove 242, whose opening faces downward, and the first ends of the multiple liquid separation channels are located on the groove wall of the first hemispherical groove 242. The silicone film has a second hemispherical groove 251, whose opening faces upward, and the second hemispherical groove 251 is arranged opposite to the first hemispherical groove 242, and the position corresponding to the second hemispherical groove 251 of the reaction seat 23 is configured with a through hole 232. In this technical solution, a roughly spherical accommodating space is formed between the first hemispherical groove 242 and the second hemispherical groove 251, and freeze-dried reagents can be pre-placed in this accommodating space. When subsequent operations such as nucleic acid amplification are required, the ejection components such as the ejector rod on the corresponding detection equipment body can apply force to the bottom surface of the second hemispherical groove 251 to deform it upward and finally fit with the groove wall of the first hemispherical groove 242, thereby achieving the blocking of the liquid separation channel. It can be understood that when blocking is not required and conduction is required, the force applied by the ejection component to the second hemispherical groove 251 should be released, and under the action of the elastic force of the silicone membrane itself, it will be recessed downward, thereby achieving the conduction of the diversion channel.

[0030] See Figure 3 As shown, a first elastic buckle 221 is provided on the top surface of the fixed disk 22, and at least two first elastic buckles 221 are arranged at intervals around the positioning hole. A first card groove 12 that cooperates with the first elastic buckle 221 is provided on the outer circumferential wall of the second end of the sample tube 1. The first card groove 12 can be, for example, an annular groove arranged around the tube body of the sample tube 1, or it can be a single multiple grooves. The present invention is not particularly limited to this. Through the buckle connection relationship between the first elastic buckle 221 and the first card groove 12, a quick, convenient and reliable connection between the sample tube 1 and the base is achieved.

[0031] A second elastic clip 222 is provided on the bottom surface of the fixed disk 22, and at least two second elastic clips 222 are arranged at intervals around the fixed disk 22. The outer circumferential wall of the reaction seat 23 has a second slot 233 that cooperates with the second elastic clip 222 to achieve fast and reliable assembly between the reaction seat 23 and the fixed disk 22.

[0032] See also Figure 5As shown, the liquid separation plate 24 is constructed with air holes 244, and the number of the air holes 244 is the same as the number of the reaction holes 231 and corresponds one to one. The fixed plate 22 is constructed with air holes 223, and the air holes 223 are provided with air plugs (not shown in the figure). The air plugs are of an air-permeable and water-tight structure, thereby achieving smooth discharge of the gas in the reaction hole 231, thereby ensuring that the contents in the sample tube 1 can smoothly enter the reaction hole 231.

[0033] There is a positioning pin 234 between the fixing plate 22 and the reaction seat 23. Figure 4 As shown, there are two positioning pins 234, and the two positioning pins 234 are integrally formed with the reaction seat 23. At this time, corresponding positioning holes are constructed on the bottom surface of the corresponding liquid separation plate 24. The positioning pins 234 are inserted and matched with the positioning holes to realize the position determination of the reaction hole 231 on the liquid separation plate 24 and the reaction seat 23.

[0034] In some embodiments, the reaction seat 23 also has an anti-fool structure 235, which is, for example, a protrusion protruding from the outer circumferential wall of the reaction seat 23, which can cooperate with corresponding components on the detection device body, such as a heating module, to achieve positioning purposes.

[0035] See also Figure 5 As shown, the fixed disk 22 has an upwardly protruding plug-in column 243, on which the puncture head 21 is fixedly connected, and the second end of the sample tube 1 has a plug-in hole 13 that is plugged into and cooperates with the plug-in column 243. Through the plug-in hole 13, accurate and rapid positioning with the puncture head 21 can be achieved, and the connection of the sample tube 1 can be ensured to be more reliable.

[0036] See also Figure 1 As shown, the reaction hole 231 protrudes from the seat body plane of the reaction seat 23 and extends downward, so that it can be placed in the corresponding heating groove of the heating module to achieve multi-faceted wrapping, thereby ensuring the temperature adjustment and heat preservation effect.

[0037] According to an embodiment of the present invention, a nucleic acid self-testing device is also provided for use with the above-mentioned plug-in reagent tube assembly.

[0038] It is easy for those skilled in the art to understand that, under the premise of no conflict, the above-mentioned advantageous methods can be freely combined and superimposed.

[0039] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention shall be included in the protection scope of the present invention. The above are only preferred embodiments of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and variations can be made without departing from the technical principles of the present invention, and these improvements and variations should also be regarded as the protection scope of the present invention.

Claims

1. A plug-in reagent tube assembly, characterized in that: include: A sample tube (1) is used to contain samples and reagents, and has a sealing cap (11) at its first end and a closed end at its second end; a base having a positioning hole for inserting the second end of the sample tube (1) and at least one reaction hole (231), wherein a puncture head (21) having a hollow flow channel is arranged in the positioning hole; When the sample tube (1) is inserted into the positioning hole, the puncture head (21) can puncture the closed end to allow the contents contained in the sample tube (1) to flow into the reaction hole (231) through the hollow flow channel; The base comprises: a fixed plate (22) and a reaction seat (23), the fixed plate (22) and the reaction seat (23) being mutually buckled and connected, the positioning hole being formed on the fixed plate (22), and further comprising a liquid separation plate (24), the puncture head (21) being connected to the liquid separation plate (24), the liquid separation plate (24) being provided with a liquid separation flow channel, one end of the liquid separation flow channel being in communication with the hollow flow channel, and the other end of the liquid separation flow channel being in communication with the reaction hole (231); The sealing cover (11) is provided with an air hole.

2. The plug-in reagent tube assembly according to claim 1, characterized in that: The liquid separation plate (24) further comprises a guide column (241) extending into the reaction hole (231), and the liquid separation flow channel is connected to the reaction hole (231) via the guide column (241).

3. The plug-in reagent tube assembly according to claim 1, characterized in that: The liquid separation channel is an open groove constructed on the bottom end surface of the liquid separation plate (24), and the base further comprises a sealing film (25), wherein the sealing film (25) is sandwiched between the reaction seat (23) and the bottom end surface of the liquid separation plate (24) to form a seal for the opening of the open groove.

4. The plug-in reagent tube assembly according to claim 3, characterized in that: The sealing membrane (25) is a silicone membrane, and the liquid separation flow channels are multiple, and the first ends of the multiple liquid separation flow channels are connected to the hollow flow channel, and the second ends are respectively connected to a reaction hole (231), and the first ends of the liquid separation flow channels can be controllably blocked or opened by the silicone membrane.

5. The plug-in reagent tube assembly according to claim 4, characterized in that: A first hemispherical groove (242) is constructed at the central position of the liquid separation plate (24); the first ends of the plurality of liquid separation channels are located on the groove wall of the first hemispherical groove (242); a second hemispherical groove (251) is provided on the silicone membrane; the second hemispherical groove (251) is arranged opposite to the first hemispherical groove (242); and a through hole (232) is constructed at a position of the reaction seat (23) corresponding to the second hemispherical groove (251).

6. The plug-in reagent tube assembly according to claim 1, characterized in that: The top surface of the fixed disk (22) is provided with a first elastic buckle (221), at least two of the first elastic buckles (221) are arranged at intervals around the positioning hole, and the outer circumferential wall of the second end of the sample tube (1) has a first clamping groove (12) that cooperates with the first elastic buckle (221) to be clamped; and / or, the bottom surface of the fixed disk (22) is provided with a second elastic buckle (222), at least two of the second elastic buckles (222) are arranged at intervals around the fixed disk (22), and the outer circumferential wall of the reaction seat (23) has a second clamping groove (233) that cooperates with the second elastic buckle (222).

7. The plug-in reagent tube assembly according to claim 1, characterized in that: The liquid separation plate (24) is provided with ventilation holes (244), the number of the ventilation holes (244) being the same as the number of the reaction holes (231) and corresponding one to one, the fixed plate (22) is provided with ventilation holes (223), and the ventilation holes (223) are provided with ventilation plugs; and / or, a positioning pin (234) is provided between the fixed plate (22) and the reaction seat (23).

8. The plug-in reagent tube assembly according to claim 1, characterized in that: The reaction seat (23) also has an anti-foolproof structure (235); and / or, the fixed plate (22) has an upwardly protruding plug-in column (243), the plug-in column (243) is fixedly connected to the puncture head (21), and the second end of the sample tube (1) has a plug-in hole (13) that is plugged into and cooperates with the plug-in column (243); and / or, the reaction hole (231) protrudes from the seat body plane of the reaction seat (23) and extends downward.

9. A nucleic acid self-testing device, characterized in that: Used in conjunction with the plug-in reagent tube assembly described in any one of claims 1 to 8.

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