Sample extraction and detection device

By designing a fully sealed sample extraction and detection device, the combination of the kit body, lid body, reaction container and magnetic casing assembly is used to solve the complex and contaminated sample extraction and detection operations, and the detection results with high accuracy and reliability are achieved.

CN222795603UActive Publication Date: 2025-04-25GUANGZHOU DRIPNANO BIOTECH CO LTD
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Patent Information

Application Number
CN202421300641.4
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-06-07
Publication Date
2025-04-25
Estimated Expiration
2034-06-07

AI Technical Summary

Technical Problem

In medical examination, sample extraction and detection operations are complex, and the sample transfer process is susceptible to external pollution, resulting in sample pollution or detection environmental pollution.

Method used

A sample extraction and detection device is designed, which completes nucleic acid extraction, amplification and detection in a fully sealed environment, and uses the combination of the kit body, the lid body, the reaction container and the magnetic sleeve assembly to achieve seamless connection between sample extraction, amplification and detection.

Benefits of technology

The overall structure is simplified, the probability of sample contamination is reduced, the accuracy of sample extraction and detection is improved, the reliability of detection results is ensured, and biohazards are reduced.

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Abstract

The utility model relates to a sample extraction and detection device which is characterized in that a kit body is provided with a plurality of cavities arranged along a first direction, one of the cavities is a penetrating cavity with openings at two ends, the rest of the cavities are reagent cavities with openings at one ends, and a cover body and a reaction container are movably connected to two opposite ends of the kit body respectively; the cover body and the reaction container can move along a first direction relative to the kit body, so that the insertion hole in the cover body is opposite to the opening of any cavity, the opening of the reaction cavity of the reaction container is opposite to the opening of the insertion cavity, the cover body can seal the openings of the plurality of cavities at the same end, and the reaction container is in sealing fit with the kit body; the magnetic sleeve assembly can be inserted into or withdrawn from the cavity and the reaction cavity which are communicated with the insertion hole through the insertion hole, can be in sealing fit with the hole wall of the insertion hole, and is used for magnetic attraction, magnetic release, liquid suction and liquid injection. The sample extraction and detection device can complete extraction, amplification and detection of nucleic acid in a fully-sealed environment.
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Description

Technical Field

[0001] The present application relates to the technical field of sample detection, and in particular to a sample extraction and detection device. Background Art

[0002] In medical testing, molecular testing is mainly used in the detection of pathogenic microorganisms and other aspects. The mainstream technology of molecular testing is fluorescent quantitative PCR (polymerase chain reaction) technology. The process of testing samples using PCR technology is generally divided into three steps: sample extraction, amplification and detection.

[0003] Since sample extraction and testing operations are mostly carried out in an open experimental environment, and each step requires independent equipment to complete, the sample needs to be moved to the equipment of the subsequent step after the previous step is completed during a test. The experimental steps are numerous and the operations are complicated. In addition, the sample transfer process is easily contaminated by the external environment or may cause the sample to contaminate the testing environment. Summary of the invention

[0004] Based on this, it is necessary to provide a sample extraction and detection device to address the above problems. The sample extraction and detection device can complete the entire process of nucleic acid extraction, amplification and detection in a fully sealed environment, simplify the overall structure, reduce the probability of sample contamination, and improve the accuracy of sample extraction and detection.

[0005] The technical solution is as follows:

[0006] A sample extraction and detection device, comprising:

[0007] A reagent box body, the reagent box body having a first end and a second end opposite to each other, the reagent box body being provided with a plurality of chambers arranged at intervals along a first direction, one of the chambers being a through chamber penetrating a first end surface of the first end and a second end surface of the second end, and the remaining plurality of chambers being reagent chambers penetrating the first end surface, and different reagent chambers being used to store different reagents;

[0008] a cover body, the cover body being movably connected to the first end of the reagent box body, the cover body being capable of sealing the openings of the plurality of chambers located at the first end surface, the cover body being provided with an insertion hole, the reagent box body and the cover body being capable of relative movement along the first direction so that the insertion hole is opposite to the opening of any chamber on the first end surface;

[0009] a reaction container, the reaction container being movably connected to the second end of the reagent box body and being sealed with the reagent box body, the reaction container being provided with a reaction chamber with one end being open, the reagent box body and the reaction container being relatively movable along the first direction so that the opening of the reaction chamber is opposite to the opening of the interpenetrating chamber located at the second end face;

[0010] A magnetic sleeve assembly, which can be inserted into or withdrawn from the chamber and the reaction chamber connected to the through hole through the through hole, and the magnetic sleeve assembly can be sealed with the hole wall of the through hole, and the magnetic sleeve assembly is used to cooperate with the magnetic rod to attract and release magnetism to the magnetic part, and to absorb liquid in the chamber or inject liquid into the chamber.

[0011] In the above-mentioned sample extraction detection device, since a plurality of chambers arranged along the first direction and penetrating the first end surface are formed in the reagent box body, different reagent chambers in the plurality of chambers are used to hold different reagents, the cover body is movably connected to the first end of the reagent box body and is formed with an insertion hole, the cover body and the reagent box body can move relative to each other along the first direction so that the insertion hole is opposite to the opening of any chamber on the first end, so the magnetic sleeve assembly inserted in the insertion hole can inject or absorb liquid and / or adsorb or release magnetic parts in different reagent chambers. Therefore, the magnetic sleeve assembly can be used to transfer liquid and / or magnetic parts between different reagent chambers to complete the extraction of nucleic acid in the reagent box body. Since the reaction container is movably connected to the second end of the test kit body, and the reaction container is provided with a reaction chamber, the reaction container and the test kit body can move relative to each other along the first direction, so that the opening of the reaction chamber is connected to the interpenetrating chambers in the plurality of chambers that penetrate the second end surface, so the magnetic sleeve assembly can inject the nucleic acid extracted from the test kit body into the reaction chamber through the interpenetrating chamber, so that the extracted nucleic acid can react with the reactant in the reaction chamber to achieve amplification and detection of the sample to be tested. Therefore, through the cooperation of the cover body, the test kit body, the reaction container and the magnetic sleeve assembly, the extraction, amplification and detection of the sample to be tested can be integrated into the sample extraction and detection device, achieving seamless docking of the entire process, reducing the different equipment required for sample detection, and simplifying the overall structure. In addition, since the cover body can seal the openings of multiple chambers on the first end surface, the magnetic sleeve assembly is sealed with the hole wall of the through hole, and the reaction container is sealed with the reagent box body, during the experiment, the samples to be tested can be prepared and tested in a fully sealed environment, reducing the probability of contamination of the samples to be tested, improving the accuracy of extraction and testing of the samples to be tested, ensuring the reliability of the test results, and at the same time reducing biological hazards.

[0012] The technical solution is further described below:

[0013] In one embodiment, the first direction is the circumference of the reagent box body, the reagent box body is rotatably connected to the cover body and the reaction container, the reagent box body and the cover body can rotate relative to each other along the first direction so that the through hole is opposite to the opening of any of the chambers on the first end face, and the reagent box body and the reaction container can rotate relative to each other along the first direction so that the opening of the reaction chamber is opposite to the opening of the through cavity located on the second end face.

[0014] In one embodiment, the magnetic sleeve assembly includes a piston, an elastic member, and a main body and a suction part connected thereto. The main body forms a through main body cavity, and the suction part forms a through connecting channel. The main body cavity is connected to the connecting channel to form a sampling space. The piston is slidably disposed in the sampling space, and the piston is sealed and matched with the side wall of the connecting channel. The elastic member is disposed in the main body cavity, one end of the elastic member is connected to the piston, and the other end is connected to the main body. One end of the suction part can be inserted into or withdrawn from the chamber connected to the through hole through the through hole; the opening in the sampling space away from the connecting channel is used for the magnetic rod to penetrate into or withdraw from the sampling space, and the magnetic rod is used to drive the piston to move toward one end of the suction part away from the main body and to absorb the magnetic member;

[0015] And / or, the reaction container includes a shell and a reactor body, the shell is formed with a receiving groove, a first matching portion is provided in the receiving groove, the reactor body is provided with a second matching portion, the reactor body is arranged in the receiving groove, and the second matching portion is snap-fitted with the first matching portion, the reactor body is sealed with the side wall of the receiving groove, the reaction chamber is formed in the reactor body, the opening of the reaction chamber is connected with the opening of the receiving groove, and the shell is rotatably sealed with the reagent box body.

[0016] In one embodiment, the cover body is provided with a through sample loading hole, the sample loading hole and the through hole are arranged in the first direction, the sample loading hole is used to add a sample to be tested into one of the chambers, and a sealing cover is provided on the end surface of the cover body away from the first end, the sealing cover is used to close the sample loading hole, and the sealing cover is provided with a tube hole corresponding to and connected with the through hole;

[0017] And / or, a first sealing member is provided between the cover body and the reagent box body, and the cover body is sealed and matched with the reagent box body through the first sealing member.

[0018] In one embodiment, the first direction is the length direction of the reagent box body, the reagent box body is slidably connected to the cover body and the reaction container, the reagent box body and the cover body can slide relative to each other along the first direction so that the through hole is opposite to the opening of any of the chambers on the first end face, and the reagent box body and the reaction container can slide relative to each other along the first direction so that the opening of the reaction chamber is opposite to the opening of the through cavity located on the second end face.

[0019] In one embodiment, the magnetic sleeve assembly includes a piston, an elastic member, and a main body and a suction part connected thereto. The main body forms a through main body cavity, and the suction part forms a through connecting channel. The main body cavity is connected to the connecting channel to form a sampling space. The piston is slidably disposed in the sampling space, and the piston is sealed and matched with the side wall of the connecting channel. The elastic member is disposed in the main body cavity, one end of the elastic member is connected to the piston, and the other end is connected to the main body. One end of the suction part can be inserted into or withdrawn from the chamber connected to the through hole through the through hole; the opening in the sampling space away from the connecting channel is used for the magnetic rod to penetrate into or withdraw from the sampling space, and the magnetic rod is used to drive the piston to move toward one end of the suction part away from the main body and to absorb the magnetic member;

[0020] Or, the insertion hole includes a first hole and a second hole arranged along the first direction, the reagent box body and the cover body can slide relative to each other along the first direction, so that the first hole is opposite to the opening of any chamber on the first end face, and the second hole is opposite to the opening of any reagent chamber, the magnetic sleeve assembly includes an injection tube and a magnetic suction tube, the injection tube is a hollow tube body with openings at both ends, a slidable second piston is arranged inside the injection tube, the second piston is sealed with the injection tube, the injection tube can be inserted into or withdrawn from the chamber and the reaction chamber connected to the first hole through the first hole, the injection tube can be sealed with the hole wall of the first hole, the magnetic suction tube is a hollow tube body with one end closed and the other end open, the closed end of the magnetic suction tube can be inserted into or withdrawn from the reagent chamber connected to the second hole through the second hole, the open end of the magnetic suction tube is used for the magnetic rod to be inserted or withdrawn, so that the magnetic suction tube adsorbs or releases the magnetic part, and the magnetic suction tube can be sealed with the hole wall of the second hole.

[0021] In one embodiment, the cover body is provided with a first sealing member, the first sealing member is provided with a penetrating sealing hole, the sealing hole corresponds to and is connected with the insertion hole, the first sealing member is slidably fitted with the first end surface, and the first sealing member can seal the openings of the multiple chambers;

[0022] And / or, the cover body is provided with a through sample loading hole, the sample loading hole and the interpenetrating hole are arranged in the first direction, the interpenetrating hole and the interpenetrating cavity are located on the same side of the sample loading hole, the reagent box body has a first position and a second position, in the first position, the opening of the reagent cavity located on the side of the interpenetrating hole close to the sample loading hole and farthest from the interpenetrating hole among the multiple reagent cavities is arranged opposite to the sample loading hole, in the second position, the multiple chambers are all located on the side of the sample loading hole close to the interpenetrating hole, and the reagent box body can slide between the first position and the second position by sliding relative to the cover body along the first direction.

[0023] In one embodiment, there are multiple reaction chambers, and the multiple reaction chambers are arranged at intervals along the first direction. The reagent box body and the cover body can move relative to each other along the first direction, so that the opening of the interpenetrating cavity located at the second end surface is opposite to the opening of any of the reaction chambers, and the magnetic sleeve assembly can be inserted into or withdrawn from the reaction chamber connected to the interpenetrating cavity through the interpenetrating hole;

[0024] And / or, the multiple reagent chambers include a lysis chamber, a cleaning chamber, an elution chamber and a magnetic component chamber, the lysis chamber is used to store lysis solution, the cleaning chamber is used to store cleaning solution, the elution chamber is used to store elution solution, and the magnetic component chamber is used to store magnetic components.

[0025] In one embodiment, the sample extraction detection device includes a first sealing cover, the first sealing cover is provided on the first end surface, the first sealing cover is provided with a plurality of first puncture portions, the plurality of first puncture portions are provided in one-to-one correspondence with the openings of the plurality of chambers, and the magnetic sleeve assembly can puncture the first puncture portion so that the magnetic sleeve assembly can be inserted into or withdrawn from the chamber corresponding to the first puncture portion;

[0026] And / or, the sample extraction and detection device includes a second sealing cover, which is arranged on the end surface of the opening of the reaction chamber in the reaction container, and the second sealing cover is provided with a plurality of second puncture portions, and the plurality of second puncture portions are arranged one-to-one corresponding to the openings of the plurality of reaction chambers, and the magnetic sleeve assembly can puncture the second puncture portion so that the magnetic sleeve assembly can be inserted into or withdrawn from the reaction chamber corresponding to the second puncture portion.

[0027] In one embodiment, the reagent box body is further provided with a receiving cavity penetrating the first end surface, the receiving cavity and the plurality of chambers are arranged in a first direction, the receiving cavity is used to place the magnetic sleeve assembly, and the opening of the receiving cavity can be opposite to the insertion hole when the reagent box body and the cover body move relative to each other along the first direction;

[0028] And / or, a second sealing member is provided in the through hole, and the magnetic sleeve assembly can pass through the second sealing member and seal with the hole wall of the through hole through the second sealing member;

[0029] And / or, the reagent box body is provided with a third sealing member, and the reagent box body is sealed and matched with the reaction container through the third sealing member. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 FIG. 4 is a schematic diagram of the three-dimensional structure of a sample extraction and detection device in an embodiment.

[0031] Figure 2 for Figure 1 Schematic diagram of the exploded structure of the structure shown.

[0032] Figure 3 FIG. 4 is a schematic diagram of the three-dimensional structure of a sample extraction and detection device in another embodiment.

[0033] Figure 4 for Figure 2 Schematic diagram of the exploded structure of the structure shown.

[0034] Figure 5 It is a schematic cross-sectional structural diagram of a magnetic sleeve assembly in one embodiment.

[0035] Figure 6 FIG. 4 is a schematic diagram of the three-dimensional structure of a sample extraction and detection device in another embodiment.

[0036] Figure 7 for Figure 6 Schematic diagram of the exploded structure of the structure shown.

[0037] Figure 8 It is a schematic diagram of the cross-sectional structure of the injection tube in one embodiment.

[0038] Fig. 9 It is a schematic diagram of the cross-sectional structure of the magnetic attraction tube in one embodiment.

[0039] Description of reference numerals:

[0040] 100. Sample extraction and detection device; 1. Cover; 11. Insertion hole; 111. First insertion hole; 212. Second insertion hole; 12. Sample addition hole; 13. First sliding part; 2. Reagent box body; 21. Reagent chamber; 211. Lysis chamber; 212. Magnetic chamber; 213. Cleaning chamber; 214. Elution chamber; 22. Insertion chamber; 23. Accommodation chamber; 231. First chamber; 232. Second chamber; 24. First end; 241. First end surface; 25. Second end; 251. Second end surface; 2b. Second sliding part; 2c, third sliding part; 3, reaction container; 3a, reaction chamber; 3b, fourth sliding part; 31, reactor body; 32, shell; 32a, accommodating groove; 321, first matching part; 4, sealing cover; 41, tube hole; 5, magnetic sleeve assembly; 5a, sampling space; 51, main body; 51a, main body cavity; 52, piston; 521, head; 522, rod; 53, elastic member; 54, suction part; 54a, connecting channel; 55, injection tube; 57, second piston; 56, magnetic suction tube; 6, first sealing member. DETAILED DESCRIPTION

[0041] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0042] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0043] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0044] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0045] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0046] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation method.

[0047] See also Figures 1 to 4 , a sample extraction and detection device 100 provided in one embodiment of the present application includes a reagent box body 2, a cover body 1, a reaction container 3 and a magnetic sleeve assembly 5, wherein:

[0048] The reagent box body 2 has a first end 24 and a second end 25 opposite to each other. The reagent box body 2 is provided with a plurality of chambers arranged at intervals along a first direction, wherein one of the chambers is a through cavity 22 that passes through a first end surface 241 of the first end 24 and a second end surface 251 of the second end 25, and the remaining plurality of chambers are reagent chambers 21 that pass through the first end surface 241. Different reagent chambers 21 are used to store different reagents. The cover body 1 is movably connected to the first end 24 of the reagent box body 2. The cover body 1 can seal the openings of the plurality of chambers located at the first end surface 241. The cover body 1 is provided with a through hole 11. The reagent box body 2 and the cover body 1 can move relative to each other along the first direction so that the through hole 11 and any chamber are in the first The openings on one end face 241 are opposite to each other, the reaction container 3 can be movably connected to the second end 25 of the reagent box body 2 and is sealed with the reagent box body 2. The reaction container 3 is provided with a reaction chamber 3a with an opening at one end. The reagent box body 2 and the reaction container 3 can move relative to each other along a first direction so that the opening of the reaction chamber 3a is opposite to the opening on the second end face 251 in the insertion cavity 22. The magnetic sleeve assembly 5 can be inserted into or withdrawn from the chamber and the reaction chamber 5a connected to the insertion hole 11 through the insertion hole 11, and the magnetic sleeve assembly 5 can be sealed with the hole wall of the insertion hole 11. The magnetic sleeve assembly 5 is used to cooperate with the magnetic rod to attract and release magnetism to the magnetic part, and to absorb liquid in the chamber or inject liquid into the chamber.

[0049] In the above-mentioned sample extraction detection device 100, since a plurality of chambers arranged along the first direction and penetrating the first end surface 241 are formed in the reagent box body 2, different reagent chambers 21 in the plurality of chambers are used to hold different reagents, the cover body 1 is movably connected to the first end 24 of the reagent box body 2 and is formed with an insertion hole 11, the cover body 1 and the reagent box body 2 can move relative to each other along the first direction so that the insertion hole 11 is opposite to the opening of any chamber on the first end 24, so the magnetic sleeve assembly 5 that can be inserted into the insertion hole 11 can inject or absorb liquid and / or adsorb or release magnetic components in different reagent chambers 21. Therefore, the magnetic sleeve assembly can be used to transfer liquid and / or magnetic components between different reagent chambers 21 to complete the extraction of nucleic acids in the reagent box body 2. Since the reaction container 3 is movably connected to the second end 25 of the reagent box body 2, and the reaction container 3 is provided with a reaction chamber 3a, the reaction container 3 and the reagent box body 2 can move relative to each other along the first direction, so that the opening of the reaction chamber 3a is connected to the interpenetrating chamber 22 that passes through the second end surface 251 in the multiple chambers, so the magnetic sleeve assembly 5 can inject the nucleic acid extracted from the reagent box body 2 into the reaction chamber 3a through the interpenetrating chamber 22, so that the extracted nucleic acid can react with the reactant in the reaction chamber 3a, and realize the amplification and detection of the sample to be tested. Therefore, through the cooperation of the cover body 1, the reagent box body 2, the reaction container 3 and the magnetic sleeve assembly 5, the extraction, amplification and detection of the sample to be tested can be integrated into the sample extraction and detection device 100, realizing seamless docking of the entire process, reducing the different equipment required for sample detection, and simplifying the overall structure. In addition, since the cover body 1 can seal the openings of multiple chambers on the first end surface 241, the magnetic sleeve assembly 5 is sealed with the hole wall of the through hole 11, and the reaction container 3 is sealed with the reagent box body 2, during the experiment, the samples to be tested can be prepared and tested in a fully sealed environment, reducing the probability of contamination of the samples to be tested, improving the accuracy of extraction and testing of the samples to be tested, ensuring the reliability of the test results, and at the same time reducing biological hazards.

[0050] It should be noted that when the magnetic sleeve assembly 5 is used to move liquids and / or magnetic parts between different chambers, it is necessary to ensure that the magnetic sleeve assembly 5 is always inserted in the through hole 11, so that during the process of extracting and detecting nucleic acids, the magnetic sleeve assembly 5 can always be sealed with the hole wall of the through hole 11, thereby avoiding exposure of the sample to be tested to the external environment and ensuring the sealing during the operation.

[0051] In one embodiment, Figure 1 and Figure 2As shown, the first direction is the circumferential direction of the reagent box body 2, the reagent box body 2 is rotatably connected to the cover body 1 and the reaction container 3, the reagent box body 2 and the cover body 1 can rotate relative to each other along the first direction, so that the insertion hole 11 is opposite to the opening of any chamber on the first end face 241, and the reagent box body 2 and the reaction container 3 can rotate relative to each other along the first direction, so that the opening of the reaction chamber 3a is opposite to the opening located on the second end face 251 in the insertion chamber 22. In this way, the insertion hole 11 can be opposite to the opening of any chamber on the first end face 241 by the relative rotation of the reagent box body 2 and the cover body 1 along the first direction, so as to realize the movement of liquid and / or magnetic parts between different reagent chambers 21, thereby completing the extraction and purification of the sample to be tested in the reagent box body 2. It is also possible to make the insertion chamber 22 and the opening of the reaction chamber 3a relative to each other by the relative rotation of the reagent box body 2 and the reaction container 3 along the first direction, so that the magnetic sleeve assembly 5 can inject the extracted and purified nucleic acid into the reaction chamber 3a, so as to complete the amplification and detection in the reaction container 3.

[0052] Further, in one embodiment, Figure 5As shown, the magnetic sleeve assembly 5 includes a piston 52, an elastic member 53, and a main body 51 and an absorption portion 54 connected thereto. The main body 51 is formed with a penetrating main body cavity 51a, and the absorption portion 54 is formed with a penetrating connecting channel 54a. The main body cavity 51a is connected to the connecting channel 54a to form a sampling space 5a. The piston 52 is slidably disposed in the sampling space 5a, and the piston 52 is sealed with the side wall of the connecting channel 54a. The elastic member 53 is disposed in the main body cavity 51a, one end of the elastic member 53 is connected to the piston 52, and the other end is connected to the main body 51. One end of the absorption portion 54 can be inserted into or withdrawn from the chamber connected to the insertion hole 11 through the insertion hole 11. The opening in the sampling space 5a away from the connecting channel 54a is used for the magnetic rod to penetrate into or withdraw from the sampling space 5a. The magnetic rod is used to drive the piston 52 to move toward one end of the absorption portion 54 away from the main body 51 and to absorb the magnetic member. In this way, when the magnetic rod is inserted into the body cavity 51a and applies a force toward the suction part 54 to the piston 52, the piston 52 can be moved toward the side close to the suction part 54, and when the magnetic rod cancels the force applied to the piston 52, the piston 52 can be moved to the side away from the suction part 54 under the action of the elastic member 53 to reset. Therefore, when the magnetic sleeve assembly 5 is inserted into the chamber, the gas in the connecting channel 54a can be discharged when the magnetic rod presses the piston 52 toward the end where the suction part 54 is located, and then when the magnetic rod is withdrawn and the elastic member 53 drives the piston 52 to move away from the suction part 54 to reset, the liquid in the chamber can be sucked into the connecting channel 54a under the action of negative pressure; and when the magnetic rod presses the piston 52 toward the end where the suction part 54 is located, the magnetic sleeve assembly 5 can inject liquid into the chamber. In addition, when the magnetic rod presses down the piston 52, the distance between the end of the magnetic rod and the end of the absorption part 54 away from the main body 51 will gradually decrease. Therefore, when the magnetic rod and the magnetic sleeve assembly 5 are inserted into the chamber containing the magnetic part, and the magnetic rod presses down the piston 52 so that the above distance reaches the distance that the magnetic rod can absorb the magnetic part, the magnetic part in the chamber can be adsorbed on the outer periphery of the absorption part 54 under the action of magnetic force, so as to realize the magnetic absorption of the magnetic sleeve assembly 5. When the magnetic rod is withdrawn from the sampling space 5a outward so that the distance between the magnetic rod and the end of the absorption part 54 away from the main body 51 is greater than the distance that the magnetic rod can absorb the magnetic part, the magnetic attraction of the magnetic rod to the magnetic part is small or the magnetic part is not affected by the magnetic force, so the magnetic part will be separated from the surface of the absorption part 54 under the action of gravity, so as to realize the magnetic release of the magnetic sleeve assembly 5. Therefore, the magnetic sleeve assembly 5 can integrate the functions of liquid transfer and magnetic bead transfer, which is conducive to improving the automation of the experiment.

[0053] Optional, such as Figure 5As shown, the piston 52 includes a rod 522 and a head 521 connected to each other, the head 512 is disposed in the body cavity 51a, and one end of the rod 522 away from the head 512 is slidably inserted in the connecting channel 512a and sealed with the side wall of the connecting channel 512a. One end of the elastic member 53 is connected to the head 521, and the other end is connected to one end of the body 51 near the injection and suction portion 54.

[0054] Further, in one embodiment, Figure 2 As shown, the reaction vessel 3 includes a shell 32 and a reactor body 31, the shell 32 is formed with a receiving groove 32a, a first matching portion 321 is provided in the receiving groove 32a, the reactor body 31 is provided with a second matching portion, the reactor body 31 is arranged in the receiving groove 32a, and the second matching portion is engaged with the first matching portion 321, the reactor body 31 is sealed with the side wall of the receiving groove 32a, the reaction chamber 3a is formed in the reactor body 31, the opening of the reaction chamber 3a is connected with the opening of the receiving groove 32a, and the shell 32 is rotatably sealed with the reagent box body 2. In this way, the shell 32 and the reactor body 31 can be conveniently disassembled and assembled, so that when the reactor body 31 fails, the reactor body 31 can be conveniently replaced, so as to ensure the reliability of the body extraction detection device. In addition, the reaction vessel 3 and the reagent box body 2 are sealed and connected by the shell 32, which is conducive to ensuring the sealing performance of the device.

[0055] Further, in one embodiment, Figure 1 and Figure 2 As shown, the cover body 1 is provided with a through-hole 12, and the sample adding hole 12 and the insertion hole 11 are arranged in a first direction. The sample adding hole 12 is used to add the sample to be tested into one of the chambers. A cover 4 is provided on the end surface of the cover body 1 away from the first end 24, and the cover 4 is used to close the sample adding hole 12. The cover 4 is provided with a tube hole 41 corresponding to and connected with the insertion hole 11. Among them, the cover 4 can be rotatably connected with the cover body 1. When the sample to be tested is added into one of the chambers through the sample adding hole 12, the cover 4 can be rotated to leak out of the sample adding hole 12. After the addition of the sample to be tested is completed, the cover 4 can be rotated relative to the cover body 1 to close the sample adding hole 12, to ensure the sealing of the sample adding hole 12, so that the sample to be tested can be extracted and purified in a closed space, the probability of contamination of the sample to be tested is reduced, the accuracy of nucleic acid extraction and purification of the sample to be tested is improved, the reliability of the test results is ensured, and biological hazards can also be reduced. At the same time, since the tube hole 41 provided on the sealing cover 4 is correspondingly connected to the insertion hole 11, the magnetic sleeve assembly 5 can move relative to the cover body 1 through the tube hole 41 to move closer to or away from the reagent box body 2 to realize the corresponding operation process.

[0056] Optionally, in one embodiment, in combination Figure 1 and Figure 2As shown, a first sealing member is provided between the cover body 1 and the reagent box body 2, and the cover body 1 is sealed with the reagent box body 2 through the first sealing member. In this way, the sealing performance of the device can be effectively guaranteed during the experiment, so that the sample to be tested can be prepared and tested in a fully sealed environment, the probability of contamination of the sample to be tested is reduced, the accuracy of extraction and testing of the sample to be tested is improved, the reliability of the test results is guaranteed, and biological hazards can also be reduced.

[0057] Optionally, the first sealing member may be disposed in a ring shape on the cover body 1 or on the reagent box body 2 .

[0058] In another embodiment, Figure 3 and Figure 4 As shown, the first direction is the length direction of the reagent box body 2, the reagent box body 2 can be slidably connected to the cover body 1 and the reaction container 3, the reagent box body 2 and the reaction container 3 can slide relative to each other along the first direction, so that the insertion hole 11 is opposite to the opening of any chamber on the first end face 241, and the reagent box body 2 and the cover body 1 can slide relative to each other along the first direction, so that the opening of the reaction chamber 3a is opposite to the opening located at the second end face 251 in the insertion chamber 22. In this way, the insertion hole 11 can be opposite to the opening of any chamber on the first end face 241 by the relative sliding of the reagent box body 2 and the cover body 1 along the first direction, so as to realize the movement of liquid and / or magnetic parts between different reagent chambers, thereby completing the extraction and purification of the sample to be tested in the reagent box body 2. It is also possible to make the insertion hole 11 opposite to the opening of the reaction chamber 3a by the relative sliding of the reagent box body 2 and the reaction container 3 along the first direction, so that the magnetic sleeve assembly 5 can inject the extracted and purified nucleic acid into the reaction chamber 3a, so as to complete the amplification and detection in the reaction container 3.

[0059] Optional, such as Figure 4 As shown, the cover body 1 is provided with a first sliding portion 13, and the reagent box body 2 is provided with a second sliding portion 2b, and the first sliding portion 13 and the second sliding portion 2b are slidably matched. In this way, it can be ensured that the cover body 1 and the reagent box body 2 can be reliably slidably connected, which is conducive to ensuring the reliability of the sample extraction and detection device 100.

[0060] Optionally, one of the first sliding portion 13 and the second sliding portion 2b is a sliding groove, and the other is a sliding rail.

[0061] Optional, such as Figure 4 As shown, the reagent box body 2 is provided with a third sliding portion 2c, and the reaction container 3 is provided with a fourth sliding portion 3b, and the third sliding portion 2c and the fourth sliding portion 3b are slidably matched. In this way, it can be ensured that the reagent box body 2 and the reaction container 3 can be reliably slidably connected, which is conducive to ensuring the reliability of the sample extraction and detection device 100.

[0062] Optionally, one of the third sliding portion 2c and the fourth sliding portion 3b is a sliding groove, and the other one is a sliding rail.

[0063] Further, in one embodiment, the magnetic sleeve assembly 5 includes a piston 52, an elastic member 53, and a main body 51 and an absorption portion 54 connected thereto. The main body 51 is formed with a penetrating main body cavity 51a, and the absorption portion 54 is formed with a penetrating connecting channel 54a. The main body cavity 51a is connected to the connecting channel 54a to form a sampling space 5a. The piston 52 is slidably disposed in the sampling space 5a, and the piston 52 is sealed with the side wall of the connecting channel 54a. The elastic member 53 is disposed in the main body cavity 51a, one end of the elastic member 53 is connected to the piston 52, and the other end is connected to the main body 51. One end of the absorption portion 54 can be inserted into or withdrawn from the chamber connected to the insertion hole 11 through the insertion hole 11. The opening in the sampling space 5a away from the connecting channel 54a is used for the magnetic rod to penetrate into or withdraw from the sampling space 5a. The magnetic rod is used to drive the piston 52 to move toward one end of the absorption portion 54 away from the main body 51 and to absorb the magnetic member. In this way, the magnetic sleeve assembly 5 can integrate the functions of liquid transfer and magnetic bead transfer, which is beneficial to improving the automation of the experiment.

[0064] In another embodiment, Figure 6 , Figure 7 , Figure 8 and Fig. 9 As shown, the insertion hole 11 includes a first insertion hole 111 and a second insertion hole 212 arranged along a first direction, the reagent box body 2 and the cover body 1 can slide relative to each other along the first direction, so that the first insertion hole 111 is opposite to the opening of any chamber on the first end surface 241, and the second insertion hole 212 is opposite to the opening of any reagent chamber 21, the magnetic sleeve assembly 5 includes an injection tube 55 and a magnetic absorption tube 56, the injection tube 55 is a hollow tube body with openings at both ends, and a slidable second piston 57 is arranged inside the injection tube 55, and the second piston 57 is sealed with the injection tube 55, and the injection tube 55 is injected. The tube 55 can be inserted into or withdrawn from the chamber and reaction chamber connected to the first plug hole 111 through the first plug hole 111, and the injection tube 55 can be sealed with the hole wall of the first plug hole 111. The magnetic tube 56 is a hollow tube body with one end closed and the other end open. The closed end of the magnetic tube 56 can be inserted into or withdrawn from the reagent chamber 21 connected to the second plug hole 212 through the second plug hole 212. The open end of the magnetic tube 56 is used for the magnetic rod to be inserted or withdrawn, so that the magnetic tube 56 can absorb or release the magnetic part, and the magnetic tube 56 can be sealed with the hole wall of the second plug hole 212. In this way, the liquid can be moved between different chambers through the cooperation of the injection tube 55 and the second piston 57, and the magnetic part can be moved between different reagent chambers 21 through the cooperation of the magnetic tube 56 and the magnetic rod, so that the sample to be tested can realize the extraction and purification of nucleic acid in the reagent box body 2, and then the injection tube 55 can inject the extracted nucleic acid into the reaction chamber 3a to realize the detection operation of nucleic acid.

[0065] In some other embodiments, the magnetic sleeve assembly 5 may also be only the injection tube 55 , or may also be only the magnetic attraction tube 56 .

[0066] Further, in one embodiment, Figure 4 As shown, the cover body 1 is provided with a first sealing member 6, and a through sealing hole is provided on the first sealing member 6, and the sealing hole corresponds to and is connected with the insertion hole 11, and the first sealing member 6 is slidably fitted with the first end face 241, and the first sealing member 6 can seal the openings of multiple chambers. In this way, the cover body 1 can reliably seal the openings of each chamber on the first end face 241 through the first sealing member 6, thereby ensuring that the sample extraction and detection device 100 can complete extraction and detection in a fully sealed environment, thereby reducing the probability of contamination of the sample to be tested, improving the accuracy of the extraction of the sample to be tested, ensuring the reliability of the results, and protecting the physiological health of the operator.

[0067] Further, in one embodiment, Figure 3 and Figure 4 As shown, a through sample loading hole 12 is provided on the cover body 1, and the sample loading hole 12 and the interpenetrating hole 11 are arranged in a first direction, and the interpenetrating hole 11 and the interpenetrating cavity 22 are located on the same side of the sample loading hole 12. The reagent box body 2 has a first position and a second position. In the first position, the opening of the reagent cavity 21 located on the side of the interpenetrating hole 11 close to the sample loading hole 12 and farthest from the interpenetrating hole 11 among the multiple reagent cavities 21 is arranged opposite to the sample loading hole 12. In the second position, the multiple chambers are all located on the side of the sample loading hole 12 close to the interpenetrating hole 11, and the reagent box body 2 can slide between the first position and the second position by sliding relative to the cover body 1 along the first direction. In this way, when the reagent box body 2 is in the first position, the sample to be tested can be injected into the corresponding chamber through the sample injection hole 12, and when the reagent box body 2 is in the second position, the opening of each chamber can always be offset with the sample injection hole 12, that is, the sample injection hole 12 is not opposite to the opening of any chamber, so in the second position, when the reagent box body 2 slides relative to the cover body 1, the opening of each chamber on the first end surface 241 can be sealed by the cover body 1 to ensure that the experimental operation can be carried out in a sealed environment.

[0068] Among them, Figure 4 As shown, when the cover body 1 is provided with a first sealing member 6, the first sealing member 6 is also provided with a sample adding port, which corresponds to and is connected with the sample adding hole 12. In this way, the cover body 1 can not only seal the openings of each chamber on the first end surface 241 through the first sealing member 6, but also add a sample to one of the chambers through the sample adding hole 12.

[0069] In one embodiment, Figure 2 and Figure 4As shown, the number of reaction chambers 3a is multiple, and the multiple reaction chambers 3a are arranged at intervals along the first direction. The reagent box body 2 and the cover body 1 can move relative to each other along the first direction, so that the opening located at the second end face 251 in the interlaced cavity 22 is opposite to the opening of any reaction chamber 3a, and the magnetic sleeve assembly 5 can be inserted into or withdrawn from the reaction chamber 3a connected to the interlaced cavity 22 through the interlaced hole 11. In this way, it is possible to conveniently operate in each reaction chamber 3a by moving the magnetic sleeve assembly 5 up and down relative to the reaction container 3 and the reagent box body 2 and the reaction container 3 relative to each other along the first direction. Therefore, different reaction solutions stored in different reaction chambers 3a can be used to process nucleic acids, thereby realizing the amplification and detection of nucleic acid in the reaction container 3, thereby ensuring the sealing of the experimental process.

[0070] In one embodiment, Figure 2 and Figure 4 As shown, the multiple reagent chambers 21 include a lysis chamber 211, a cleaning chamber 213, an elution chamber 214 and a magnetic chamber 212. The lysis chamber 211 is used to store a lysis solution, the cleaning chamber 213 is used to store a cleaning solution, the elution chamber 214 is used to store an elution solution, and the magnetic chamber 212 is used to store a magnetic component. In this way, the lysis chamber 211, the cleaning chamber 213, the elution chamber 214 and the magnetic chamber 212 can be conveniently operated by moving the magnetic sleeve assembly 5 up and down relative to the reagent box body 2 and the reagent box body 2 and the cover body 1 relative to each other along the first direction, so as to complete the extraction and purification of nucleic acids using the reagents stored in the lysis chamber 211, the cleaning chamber 213, the elution chamber 214 and the magnetic chamber 212, so as to facilitate the next step of nucleic acid detection.

[0071] It should be noted that when the reagent box body 2 is slidably connected to the cover body 1, in the first position, the sample adding hole 12 should correspond to the opening of the lysis chamber 211, so that the sample to be tested can be added to the lysis chamber 211 through the sample adding hole 12, thereby completing the lysis of the nucleic acid in the lysis chamber 211. At the same time, it can also ensure that during the experiment, each chamber can be staggered with the sample adding hole 12 to ensure the sealing during the experiment.

[0072] Optionally, the plurality of reagent chambers 21 may further include a sample chamber, which is used to hold the sample to be tested. In this way, before the experiment begins, the sample to be tested can be added to the sample chamber through the sample adding hole 12. It should be noted that when the reagent box body 2 is provided with chambers such as the sample chamber, the lysis chamber 211 and the magnetic component chamber 212, in the scheme where the reagent box body 2 is slidably connected to the cover body 1, in the first position, the opening of the sample chamber is opposite to the sample adding hole 12.

[0073] Optionally, the number of the cleaning chambers 213 can be set as required, for example, it can be one, two or more.

[0074] In one embodiment, in combination Figure 2 and Figure 4 As shown, the sample extraction detection device 100 includes a first sealing cover, which is arranged on the first end face 241. The first sealing cover is provided with a plurality of first puncture parts, and the plurality of first puncture parts are arranged one by one with the openings of the plurality of chambers. The magnetic sleeve assembly 5 can puncture the first puncture part so that the magnetic sleeve assembly 5 can be inserted into or withdrawn from the chamber corresponding to the first puncture part. In this way, during the experiment, when the magnetic sleeve assembly 5 does not puncture the first puncture part corresponding to the chamber, the first sealing cover can seal the opening of the chamber on the first end face 241, which is conducive to ensuring the sealing during the experiment, helping to reduce biological hazards and protecting the physiological health of the operator. Among them, the first puncture part is a membrane body that can be penetrated by the magnetic sleeve assembly 5, so that the magnetic sleeve assembly 5 can quickly puncture the first sealing cover. Optional. The material of the first puncture part can be plastic or aluminum, etc.

[0075] Among them, combined Figure 4 As shown, in the scheme in which the reagent kit body 2 and the reaction container 3 are slidably connected, when both a first sealing member and a first sealing cover are provided, the first sealing member and the first sealing cover are slidably fitted together to ensure that after the first sealing cover is punctured, the first sealing member can reliably seal the opening of the chamber on the first end surface 241.

[0076] In one embodiment, in combination Figure 2 and Figure 4 As shown, the sample extraction detection device 100 includes a second sealing cover, which is arranged on the end face where the opening of the reaction chamber 3a in the reaction container 3 is located, and the second sealing cover 4 is provided with a plurality of second puncture parts, and the plurality of second puncture parts are arranged one by one with the openings of the plurality of reaction chambers 3a, and the magnetic sleeve assembly 5 can puncture the second puncture part so that the magnetic sleeve assembly 5 can be inserted into or withdrawn from the reaction chamber 3a corresponding to the second puncture part. In this way, during the experiment, when the magnetic sleeve assembly 5 does not puncture the second puncture part corresponding to the reaction chamber 3a, the second sealing cover can seal the reaction chamber 3a, which is conducive to ensuring the sealing during the experiment, helping to reduce biological hazards and protecting the physiological health of the operator. Among them, the second puncture part is a membrane that can be penetrated by the magnetic sleeve assembly 5, so that the magnetic sleeve assembly 5 can quickly puncture the second sealing cover. Optional. The material of the second puncture part can be plastic or aluminum.

[0077] Optionally, the first sealing cover and the second sealing cover can be at least one of a plastic cover and an aluminum film cover; in this way, the first sealing cover and the second sealing cover can not only play a sealing and isolating role, but also facilitate the rapid puncture of the magnetic sleeve assembly 5.

[0078] Optionally, the first sealing cover is sealed and connected to the reagent box body 2 by heat sealing welding. The second sealing cover is sealed and connected to the reaction container 3 by heat sealing welding.

[0079] Optionally, the first puncture portion is recessed toward the side close to the second end 25. The second puncture portion is recessed toward the bottom of the corresponding reaction chamber 3a. In this way, the magnetic sleeve assembly 5 can be prevented from deviating from the puncture portion during the puncture process, ensuring that the magnetic sleeve assembly 5 can smoothly and quickly puncture the puncture portion.

[0080] Optional, such as Figure 5 As shown, the suction portion 54 in the magnetic sleeve assembly 5 can be in an inverted cone shape. In this way, it is beneficial to quickly pierce the first sealing cover and the second sealing cover, so that the magnetic sleeve assembly 5 can move in each chamber or each reaction chamber 3a.

[0081] In one embodiment, Figure 2 and Figure 4 As shown, the reagent box body 2 is also provided with a receiving cavity 23 that passes through the first end surface 241. The receiving cavity 23 and the multiple chambers are arranged in the first direction. The receiving cavity 23 is used to place the magnetic sleeve assembly 5. The opening of the receiving cavity 23 can be opposite to the insertion hole 11 when the reagent box body 2 and the cover body 1 move relative to each other along the first direction. In this way, before the nucleic acid extraction process is carried out, the magnetic sleeve assembly 5 can be conveniently placed in the sample extraction and detection device 100. When the experiment begins, the magnetic sleeve assembly 5 can be taken out of the receiving cavity 23 through the insertion hole 11, and then the magnetic sleeve assembly 5 can be used to complete the extraction and detection of nucleic acids, etc., which effectively ensures the reliability of the sample extraction and detection device 100.

[0082] Among them, Figure 7 As shown, in the scheme in which the reagent box body 2 and the cover body 1 are slidably connected, when the magnetic sleeve assembly 5 includes an injection tube 55 and a magnetic attraction tube 56, the accommodating cavity 23 includes a first cavity 231 and a second cavity 232 arranged along a first direction, the first cavity 231 is used to place the injection tube 55, and the second cavity 232 is used to place the magnetic attraction tube 56, and the opening of the first cavity 231 and the opening of the second cavity 232 can be opposite to the first hole 111 and the second hole 212 respectively when the reagent box body 2 and the cover body 1 slide relative to each other along the first direction.

[0083] In one embodiment, a second seal is provided in the insertion hole 11, and the magnetic sleeve assembly 5 can pass through the second seal and seal with the hole wall of the insertion hole 11 through the second seal. In this way, a gap between the magnetic sleeve assembly 5 and the hole wall of the insertion hole 11 during the movement of the magnetic sleeve assembly 5 relative to the cover body 1 is effectively avoided, the probability of contamination of the sample to be tested is reduced, the reliability of the test results is ensured, and biological hazards can also be reduced.

[0084] Optionally, the second seal includes a sealing ring, the outer surface of the sealing ring is in close contact with the hole wall of the insertion hole 11, and the inner side of the sealing ring is in close contact with the outer surface of the magnetic sleeve assembly 5. Of course, in other embodiments, the second seal may also be other components with the same function, without limitation thereto.

[0085] Among them, Figure 7 As shown, in the scheme in which the reagent box body 2 and the cover body 1 are slidably connected, when the magnetic sleeve assembly 5 includes an injection tube 55 and a magnetic attraction tube 56, a second sealing member that is sealed with the hole wall is provided in the first hole 111 and the second hole 212, and the injection tube 55 can pass through the second sealing member in the first hole 111, and the magnetic attraction tube 56 can pass through the second hole 212.

[0086] In one embodiment, the reagent box body 2 is provided with a third sealing member, and the reagent box body 2 is sealed with the reaction container 3 through the third sealing member. In this way, the sealing performance of the device during the experiment can be effectively guaranteed, so that the sample to be tested can be prepared and tested in a fully sealed environment, the probability of contamination of the sample to be tested is reduced, the accuracy of extraction and testing of the sample to be tested is improved, the reliability of the test results is guaranteed, and biological hazards can also be reduced.

[0087] Among them, combined Figure 4 As shown, in the scheme where the reagent box body 2 and the reaction container 3 are slidably connected, the third sealing member can be arranged on the second end surface 251, and the second sealing member has an insertion opening, which corresponds to and communicates with the opening of the insertion cavity 22 on the second end surface 251, thereby ensuring that the magnetic sleeve assembly 5 can be inserted into the reaction cavity corresponding to the insertion cavity 22. In addition, when both the third sealing member and the second sealing cover are provided, the third sealing member and the second sealing cover can be slidably fitted to ensure that after the second sealing cover is punctured, the third sealing member can reliably seal the opening of the reaction cavity 3a.

[0088] Combination Figure 2 As shown, in the scheme where the reagent box body 2 and the reaction container 3 are rotatably connected, the third sealing member can be disposed between the reagent box body 2 and the reaction container 3, so that the reaction container 3 can be sealed with the reagent box body 2 through the third sealing member. Optionally, the third sealing member can be disposed around the reagent box body 2 or around the reaction container 3.

[0089] In summary, combined Figure 1 and Figure 2 Taking the scheme in which the reagent box body 2 is rotatably connected to the cover body 1 and the reaction container 3 as an example, the working process of an embodiment of the sample extraction and detection device 100 in the present application is described, which may specifically include the following steps:

[0090] S1: Add sample

[0091] Open the cover 4, add the sample to be tested into the lysis chamber 211 through the sample adding hole 12, and then close the cover 4 to seal the sample adding hole 12, so that the sample extraction and detection device 100 can maintain a sealed state. Put the sample extraction and detection device 100 into the automatic operation instrument according to the predetermined position.

[0092] S2: Nucleic acid extraction and PCR detection

[0093] S21: Sample lysis: The automatic operating instrument pulls the magnetic sleeve assembly 5 upward from the accommodating chamber 23 through the insertion hole 11, and then rotates the cover body 1 to rotate the magnetic sleeve assembly 5 to the top of the lysis chamber 211, and then moves the magnetic sleeve assembly 5 downward. The magnetic sleeve assembly 5 pierces the first sealing cover at the opening of the lysis chamber 211 and extends into the lysis chamber 211. The magnetic sleeve assembly 5 moves up and down or rotates in the lysis chamber 211 to mix the lysis solution in the lysis chamber 211 with the sample to be tested, thereby completing the sample lysis and releasing the nucleic acid.

[0094] S22: Nucleic Acid Capture

[0095] The magnetic sleeve assembly 5 is pulled out from the lysis chamber 211 and the cover body 1 is rotated to rotate the magnetic sleeve assembly 5 to the top of the magnetic component chamber 212, and then the magnetic sleeve assembly 5 is moved downward to pierce the first sealing cover and then inserted into the magnetic component chamber 212. The magnetic sleeve assembly 5 moves up and down or rotates in the magnetic component chamber 212 to achieve mixing of the magnetic components in the magnetic component chamber 212; then the magnetic stand on the automated instrument is inserted downward into the magnetic sleeve assembly 5 to adsorb the magnetic components onto the magnetic sleeve assembly 5; then, The magnetic sleeve assembly 5 together with the magnetic rod is pulled out from the magnetic component cavity 212, and the cover body 1 is rotated to rotate the magnetic sleeve assembly 5 to the top of the lysis chamber 211, and then the magnetic sleeve assembly 5 together with the magnetic rod is inserted downward into the lysis chamber 211; then the magnetic rod is moved upward to release the magnetic component adsorbed on the magnetic sleeve assembly 5, and finally the magnetic sleeve assembly 5 is driven to move up and down or rotate in the lysis chamber 211 to fully mix the lysis solution containing nucleic acid and the magnetic component, so that the nucleic acid in the sample is adsorbed on the magnetic component.

[0096] S22: Nucleic acid cleaning

[0097] The magnetic rod on the automated instrument is inserted downward into the magnetic sleeve assembly 5 again to adsorb the magnetic parts adsorbed with nucleic acid in the lysis chamber 211 onto the magnetic sleeve assembly 5; then the magnetic sleeve assembly 5 together with the magnetic rod is pulled out of the lysis chamber 211 and the cover body 1 is rotated to rotate the magnetic sleeve assembly 5 to above the cleaning chamber 213, and then the magnetic sleeve assembly 5 together with the magnetic rod is inserted downward into the cleaning chamber 213, and then the magnetic rod is moved upward to release the magnetic parts adsorbed on the magnetic sleeve assembly 5, and then the magnetic sleeve assembly 5 is driven to move up and down or rotate in the cleaning chamber 213 to mix the cleaning solution and magnetic parts in the cleaning chamber 213, and wash away impurities such as cell walls and proteins remaining on the surface of the magnetic parts.

[0098] S23: Nucleic acid elution

[0099] The magnetic rod is inserted downward into the magnetic sleeve assembly 5 again to adsorb the magnetic parts in the cleaning chamber 213 to the magnetic sleeve assembly 5; then the magnetic sleeve assembly 5 is pulled upward together with the magnetic rod, and the cover body 1 is rotated to rotate the magnetic sleeve assembly 5 to the top of the elution chamber 214, and then the magnetic sleeve assembly 5 is inserted downward into the elution chamber 214 together with the magnetic rod, and then the magnetic stand is moved upward to release the magnetic parts adsorbed on the magnetic sleeve assembly 5, and then the magnetic sleeve assembly 5 is driven to move up and down or rotate in the elution chamber 214 to mix the eluent and the magnetic parts in the elution chamber 214, and elute the nucleic acid from the magnetic parts into the eluent.

[0100] S24: Magnetic beads discard

[0101] The magnetic stand is inserted downward into the magnetic sleeve assembly 5 again to adsorb the magnetic part in the elution chamber 214 onto the magnetic sleeve assembly 5; then the magnetic sleeve assembly 5 together with the magnetic rod is moved upward out of the elution chamber 214 and the cover 1 is rotated to rotate the magnetic sleeve assembly 5 to the top of the cleaning chamber 213, and then the magnetic sleeve assembly 5 together with the magnetic rod is inserted downward into the cleaning chamber 213, and then the magnetic rod is moved upward to release the magnetic part into the cleaning chamber 213. It is understandable that in other embodiments, the magnetic part can also be discarded in the lysis chamber 211 and the magnetic part chamber 212, which is not limited here.

[0102] S25: Reaction solution mixing

[0103] Move the magnetic sleeve assembly 5 upward out of the cleaning chamber 213 and rotate the cover body 1 to rotate the magnetic sleeve assembly 5 to above the elution chamber 214, then insert the magnetic sleeve assembly 5 downward into the elution chamber 214, and then insert the magnetic sleeve assembly 5 downward into the elution chamber 214, and then insert the magnetic rod on the automated instrument downward into the magnetic sleeve assembly 5 to press the piston 52 in the magnetic sleeve assembly 5 downward, and then move the magnetic rod upward to suck the eluent into the magnetic sleeve assembly 5; then lift the magnetic sleeve assembly 5 upward and rotate the cover body 1 to rotate the magnetic sleeve assembly 5 to above the interlaced chamber 22, and then insert the magnetic sleeve assembly 5 downward through the interlaced chamber 22 into the reaction chamber 3a of the reaction container 3; then move the magnetic rod downward to allow the eluent containing nucleic acid sucked into the magnetic sleeve assembly 5 to flow into the reaction chamber 3a to mix with the reaction reagent to form an amplification reagent.

[0104] S26: Nucleic acid testing

[0105] The magnetic sleeve assembly 5 is moved upward out of the reaction chamber 3a and the reaction container 3 is rotated to seal the reaction chamber 3a. Then the automated instrument starts the PCR program to perform nucleic acid detection on the amplification reagent in the reaction chamber 3a.

[0106] It should be noted that in step S2, when the magnetic sleeve assembly 5 moves upward out of the chamber and the cover body 1 is rotated, the magnetic sleeve assembly 5 is always inserted in the insertion hole 11, so that the magnetic sleeve assembly 5 can maintain a sealed connection with the hole wall of the insertion hole 11, thereby ensuring the sealing of the device during the nucleic acid extraction and detection process, so that the sample to be tested can be extracted and detected in a closed space, reducing the probability of contamination of the sample to be tested, improving the accuracy of extraction and detection of the sample to be tested, ensuring the reliability of the test results, and at the same time reducing biological hazards.

[0107] S3: Device discarded

[0108] After the PCR is completed, the sample extraction and detection device 100 is taken out from the automated instrument for waste biological treatment.

[0109] Illustratively, in this embodiment, the movement and plugging and unplugging of the magnetic sleeve assembly and the magnetic rod are performed by automated instruments. In other embodiments, the movement and plugging and unplugging of the magnetic sleeve assembly and the magnetic rod can also be performed manually, which is not limited here.

[0110] The technical features of the above embodiments may be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0111] The above embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A sample extraction and detection device, characterized in that: include: A reagent box body, the reagent box body having a first end and a second end opposite to each other, the reagent box body being provided with a plurality of chambers arranged at intervals along a first direction, one of the chambers being a through chamber penetrating a first end surface of the first end and a second end surface of the second end, and the remaining plurality of chambers being reagent chambers penetrating the first end surface, and different reagent chambers being used to store different reagents; a cover body, the cover body being movably connected to the first end of the reagent box body, the cover body being capable of sealing the openings of the plurality of chambers located at the first end surface, the cover body being provided with an insertion hole, the reagent box body and the cover body being capable of relative movement along the first direction so that the insertion hole is opposite to the opening of any chamber on the first end surface; a reaction container, the reaction container being movably connected to the second end of the reagent box body and being sealed with the reagent box body, the reaction container being provided with a reaction chamber with one end being open, the reagent box body and the reaction container being relatively movable along the first direction so that the opening of the reaction chamber is opposite to the opening of the interpenetrating chamber located at the second end face; A magnetic sleeve assembly, which can be inserted into or withdrawn from the chamber and the reaction chamber connected to the through hole through the through hole, and the magnetic sleeve assembly can be sealed with the hole wall of the through hole, and the magnetic sleeve assembly is used to cooperate with the magnetic rod to attract and release magnetism to the magnetic part, and to absorb liquid in the chamber or inject liquid into the chamber.

2. The sample extraction and detection device according to claim 1, characterized in that: The first direction is the circumferential direction of the reagent box body, the reagent box body is rotatably connected to the cover body and the reaction container, the reagent box body and the cover body can rotate relative to each other along the first direction so that the through hole is opposite to the opening of any of the chambers on the first end face, and the reagent box body and the reaction container can rotate relative to each other along the first direction so that the opening of the reaction chamber is opposite to the opening of the through cavity located on the second end face.

3. The sample extraction and detection device according to claim 2, characterized in that: The magnetic sleeve assembly includes a piston, an elastic member, and a main body and a suction part connected thereto. The main body forms a through main body cavity, and the suction part forms a through connecting channel. The main body cavity is connected to the connecting channel to form a sampling space. The piston is slidably disposed in the sampling space, and the piston is sealed and matched with the side wall of the connecting channel. The elastic member is disposed in the main body cavity, one end of the elastic member is connected to the piston, and the other end is connected to the main body. One end of the suction part can be inserted into or withdrawn from the chamber connected to the through hole through the through hole; the opening in the sampling space away from the connecting channel is used for the magnetic rod to penetrate into or withdraw from the sampling space, and the magnetic rod is used to drive the piston to move toward one end of the suction part away from the main body and to absorb the magnetic member; And / or, the reaction container includes a shell and a reactor body, the shell is formed with a receiving groove, a first matching portion is provided in the receiving groove, the reactor body is provided with a second matching portion, the reactor body is arranged in the receiving groove, and the second matching portion is snap-fitted with the first matching portion, the reactor body is sealed with the side wall of the receiving groove, the reaction chamber is formed in the reactor body, the opening of the reaction chamber is connected with the opening of the receiving groove, and the shell is rotatably sealed with the reagent box body.

4. The sample extraction and detection device according to claim 2, characterized in that: The cover body is provided with a through sample adding hole, the sample adding hole and the insertion hole are arranged in the first direction, the sample adding hole is used to add a sample to be tested into one of the chambers, and a sealing cover is provided on the end surface of the cover body away from the first end, the sealing cover is used to close the sample adding hole, and the sealing cover is provided with a tube hole corresponding to and connected with the insertion hole; And / or, a first sealing member is provided between the cover body and the reagent box body, and the cover body is sealed and matched with the reagent box body through the first sealing member.

5. The sample extraction and detection device according to claim 1, characterized in that: The first direction is the length direction of the reagent box body, and the reagent box body is slidably connected to the cover body and the reaction container. The reagent box body and the cover body can slide relative to each other along the first direction so that the through hole is opposite to the opening of any chamber on the first end face, and the reagent box body and the cover body can slide relative to each other along the first direction so that the opening of the reaction chamber is opposite to the opening of the through cavity located on the second end face.

6. The sample extraction and detection device according to claim 5, characterized in that: The magnetic sleeve assembly includes a piston, an elastic member, and a main body and a suction part connected thereto. The main body forms a through main body cavity, and the suction part forms a through connecting channel. The main body cavity is connected to the connecting channel to form a sampling space. The piston is slidably disposed in the sampling space, and the piston is sealed and matched with the side wall of the connecting channel. The elastic member is disposed in the main body cavity, one end of the elastic member is connected to the piston, and the other end is connected to the main body. One end of the suction part can be inserted into or withdrawn from the chamber connected to the through hole through the through hole; the opening in the sampling space away from the connecting channel is used for the magnetic rod to penetrate into or withdraw from the sampling space, and the magnetic rod is used to drive the piston to move toward one end of the suction part away from the main body and to absorb the magnetic member; Or, the insertion hole includes a first hole and a second hole arranged along the first direction, the reagent box body and the cover body can slide relative to each other along the first direction, so that the first hole is opposite to the opening of any chamber on the first end face, and the second hole is opposite to the opening of any reagent chamber, the magnetic sleeve assembly includes an injection tube and a magnetic suction tube, the injection tube is a hollow tube body with openings at both ends, a slidable second piston is arranged inside the injection tube, the second piston is sealed with the injection tube, the injection tube can be inserted into or withdrawn from the chamber and the reaction chamber connected to the first hole through the first hole, the injection tube can be sealed with the hole wall of the first hole, the magnetic suction tube is a hollow tube body with one end closed and the other end open, the closed end of the magnetic suction tube can be inserted into or withdrawn from the reagent chamber connected to the second hole through the second hole, the open end of the magnetic suction tube is used for the magnetic rod to be inserted or withdrawn, so that the magnetic suction tube adsorbs or releases the magnetic part, and the magnetic suction tube can be sealed with the hole wall of the second hole.

7. The sample extraction and detection device according to claim 6, characterized in that: The cover body is provided with a first sealing member, the first sealing member is provided with a penetrating sealing hole, the sealing hole corresponds to and is in communication with the insertion hole, the first sealing member is slidably fitted with the first end surface, and the first sealing member can seal the openings of the plurality of chambers; And / or, the cover body is provided with a through sample loading hole, the sample loading hole and the interpenetrating hole are arranged in the first direction, the interpenetrating hole and the interpenetrating cavity are located on the same side of the sample loading hole, the reagent box body has a first position and a second position, in the first position, the opening of the reagent cavity located on the side of the interpenetrating hole close to the sample loading hole and farthest from the interpenetrating hole among the multiple reagent cavities is arranged opposite to the sample loading hole, in the second position, the multiple chambers are all located on the side of the sample loading hole close to the interpenetrating hole, and the reagent box body can slide between the first position and the second position by sliding relative to the cover body along the first direction.

8. The sample extraction and detection device according to any one of claims 1 to 7, characterized in that: There are multiple reaction chambers, and the multiple reaction chambers are arranged at intervals along the first direction. The reagent box body and the cover body can move relative to each other along the first direction, so that the opening of the interpenetrating cavity located at the second end surface is opposite to the opening of any of the reaction chambers, and the magnetic sleeve assembly can be inserted into or withdrawn from the reaction chamber connected to the interpenetrating cavity through the interpenetrating hole; And / or, the multiple reagent chambers include a lysis chamber, a cleaning chamber, an elution chamber and a magnetic component chamber, the lysis chamber is used to store lysis solution, the cleaning chamber is used to store cleaning solution, the elution chamber is used to store elution solution, and the magnetic component chamber is used to store magnetic components.

9. The sample extraction and detection device according to claim 8, characterized in that: The sample extraction and detection device comprises a first sealing cover, the first sealing cover is provided on the first end surface, the first sealing cover is provided with a plurality of first puncture portions, the plurality of first puncture portions are provided in one-to-one correspondence with the openings of the plurality of chambers, the magnetic sleeve assembly can puncture the first puncture portion so that the magnetic sleeve assembly can be inserted into or withdrawn from the chamber corresponding to the first puncture portion; And / or, the sample extraction and detection device includes a second sealing cover, which is arranged on the end surface of the opening of the reaction chamber in the reaction container, and the second sealing cover is provided with a plurality of second puncture portions, and the plurality of second puncture portions are arranged one-to-one corresponding to the openings of the plurality of reaction chambers, and the magnetic sleeve assembly can puncture the second puncture portion so that the magnetic sleeve assembly can be inserted into or withdrawn from the reaction chamber corresponding to the second puncture portion.

10. The sample extraction and detection device according to claim 1, characterized in that: The reagent box body is further provided with a receiving cavity penetrating the first end surface, the receiving cavity and the plurality of chambers are arranged in a first direction, the receiving cavity is used to place the magnetic sleeve assembly, and the opening of the receiving cavity can be opposite to the insertion hole when the reagent box body and the cover body move relative to each other along the first direction; And / or, a second sealing member is provided in the through hole, and the magnetic sleeve assembly can pass through the second sealing member and seal with the hole wall of the through hole through the second sealing member; And / or, the reagent box body is provided with a third sealing member, and the reagent box body is sealed and matched with the reaction container through the third sealing member.