Nucleic acid purification kit and testing device

By using shell components, liquid storage components and transmission components in the nucleic acid purification kit, combined with automatic transfer technology of magnetic rod components, the problems of cumbersome operations and unstable results in the prior art are solved, and the complete sealing is achieved nucleic acid extraction and PCR detection improve the stability and automation of detection.

WO2024254900A1PCT designated stage expired Publication Date: 2024-12-19SHENZHEN INST OF ADVANCED TECH

Patent Information

Application Number
PCT/CN2023/102714
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-06-14
Filing Date
2023-06-27
Publication Date
2024-12-19

AI Technical Summary

Technical Problem

In the prior art, nucleic acid extraction and detection operations are cumbersome, the results are unstable, and the implementation of large-scale detection is difficult, mainly due to the instability and complexity caused by manual transfer steps.

Method used

A nucleic acid purification kit is designed, including a housing assembly, a liquid storage assembly and a transmission assembly. The automatic transfer and purification of nucleic acids between the liquid storage spaces is realized through the magnetic rod assembly, and a fully enclosed nucleic acid extraction and PCR detection process is realized. Reduce external interference and manual operations.

Benefits of technology

The nucleic acid extraction and expansion process is achieved, the stability and automation of the test results are improved, the operation process is simplified, and the difficulty of implementing a large number of tests is reduced.

✦ Generated by Eureka AI based on patent content.

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Abstract

Disclosed in the present application are a nucleic acid purification kit and a testing device. The nucleic acid purification kit comprises: a housing assembly having an accommodating space; a liquid storage assembly located in the accommodating space and provided with a plurality of liquid storage spaces arranged in a preset direction, wherein the plurality of liquid storage spaces are configured to purify nucleic acid; a transmission assembly fixedly arranged above the liquid storage assembly and configured to drive the liquid storage assembly to move in a reciprocating manner in the preset direction; and a magnetic bar assembly located above the liquid storage assembly and configured to attract magnetic beads. The transmission assembly drives the liquid storage assembly to move in such a way that different liquid storage spaces move below the magnetic bar assembly, and the magnetic bar assembly attracts lower magnetic beads to different liquid storage spaces. In the present application, the magnetic bar assembly can attract the magnetic beads to enter and exit from the plurality of liquid storage spaces, respectively, so that nucleic acid extraction and testing can be automatically carried out, thereby facilitating the operation, achieving a stable testing result, and lowering the implementation difficulty of mass testing.
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Description

A nucleic acid purification kit and detection device Technical Field

[0001] The present application relates to the technical field of nucleic acid detection, and in particular to a nucleic acid purification kit and a detection device. Background Art

[0002] As the types and number of diseases increase, rapid and accurate disease detection is crucial to maximizing crisis management efficiency, treatment effectiveness, and economic stability in order to minimize their impact on human life. However, disease testing is currently centralized in centralized laboratories, where patient samples are typically taken to hospitals or clinics for testing, with test results provided within a few days. For areas farther from disease detection sites, disease detection often takes longer due to a lack of skilled personnel and medical infrastructure. Consequently, the demand for portable, easy-to-use, and point-of-care diagnostic tests (POCTs) is rapidly increasing.

[0003] In the existing technology, it is necessary to use the centrifugal column method or the magnetic bead method for nucleic acid extraction, which generally requires steps such as lysis, binding, and elution. At present, the manual transfer method is generally adopted, that is, after the lysis step, it is manually transferred to the corresponding test tube for the binding step. After the binding is completed, it is manually transferred to the corresponding test tube for the elution step. The manual transfer in sequence is carried out to achieve nucleic acid extraction. Not only is the operation cumbersome, time-consuming and labor-intensive, but it is also difficult to transfer the sample fully and efficiently. Manual operation makes the operation process unstable, which can easily lead to unstable test results, making it difficult to implement large-scale testing.

[0004] Summary of the Invention

[0005] In view of this, the present application provides a nucleic acid purification kit and detection device to solve the problems in the prior art of manual transfer for nucleic acid extraction and detection, which bring about cumbersome operation, unstable detection results, and difficulty in implementing large-scale detection.

[0006] This application proposes a nucleic acid purification kit, comprising:

[0007] A housing assembly having an accommodating space;

[0008] A liquid storage component is located in the accommodating space, and the liquid storage component has a plurality of liquid storage spaces arranged along a preset direction, and the plurality of liquid storage spaces are used for purifying nucleic acids;

[0009] A transmission assembly is fixedly arranged above the liquid storage assembly, and is used to drive the liquid storage assembly to reciprocate along the preset direction;

[0010] A magnetic rod assembly is located above the liquid storage assembly and is used to absorb magnetic beads;

[0011] The transmission assembly drives the liquid storage assembly to move, so that different liquid storage spaces move to the bottom of the magnetic bar assembly, and the magnetic bar assembly absorbs or moves the magnetic beads below to different liquid storage spaces.

[0012] Optionally, the liquid storage component includes a sealing film, and the sealing film is used to seal the multiple liquid storage spaces.

[0013] Optionally, a first through hole is provided on the housing assembly;

[0014] The magnetic rod assembly includes a driving mechanism and a magnetic rod sleeve, the magnetic rod sleeve is electrically connected to the driving mechanism, a first boss is provided at one end of the magnetic rod sleeve, the other end of the magnetic rod sleeve passes through the first through hole and extends toward the accommodating space, and the first boss is embedded outside the first through hole.

[0015] Optionally, the magnetic rod sleeve includes a first countersunk hole, and the first countersunk hole is located at one end facing the first boss;

[0016] The magnetic bar assembly includes a magnetic bar piece, the driving mechanism is electrically connected to the magnetic bar piece, the magnetic bar piece is sleeved in the first countersunk hole, and the magnetic bar piece is used to absorb magnetic beads.

[0017] Optionally, the magnetic rod sleeve includes a vibration component, which is located in the magnetic rod sleeve and is arranged away from the first countersunk hole, and the vibration component is electrically connected to the driving mechanism.

[0018] Optionally, the plurality of liquid storage spaces include a first liquid storage chamber, a second liquid storage chamber, a third liquid storage chamber, a fourth liquid storage chamber, and a fifth liquid storage chamber arranged in parallel, and the magnetic bar assembly can reciprocate toward the first liquid storage chamber, the second liquid storage chamber, the third liquid storage chamber, the fourth liquid storage chamber, and the fifth liquid storage chamber respectively;

[0019] The first liquid storage chamber is used to store lysis solution, the second liquid storage chamber is used to store magnetic bead preservation solution, the third liquid storage chamber is used to store first cleaning solution, the fourth liquid storage chamber is used to store second cleaning solution, and the fifth liquid storage chamber is used to store pure water.

[0020] Optionally, the nucleic acid purification kit includes a heating component, which is located at the bottom of the first liquid storage chamber and is used to heat the first liquid storage chamber.

[0021] Optionally, racks are provided on both sides of the openings of the plurality of liquid storage spaces;

[0022] The transmission assembly includes a gear, which is engaged with the rack so that the rack drives the liquid storage assembly to reciprocate.

[0023] Optionally, the transmission assembly includes a gear shaft, both ends of which are connected to the nucleic acid detection instrument, the gear is passed through the gear shaft, and the gear shaft drives the gear to rotate;

[0024] The gear shaft is provided with a film opening portion, and the film opening portion opens the sealing film during the movement of the liquid storage component.

[0025] This application also proposes a nucleic acid detection device, comprising:

[0026] The nucleic acid purification kit as described above, wherein the housing component is provided with a second through hole;

[0027] A PCR reaction assembly, comprising a reaction chamber and a needle tube, wherein the reaction chamber is used to place freeze-dried balls and solid paraffin, one end of the needle tube is connected to the reaction chamber, and the other end of the needle tube passes through the second through hole and is connected to the fifth liquid storage chamber;

[0028] A detection probe is located on one side of the PCR reaction component, and is used to emit detection fluorescence;

[0029] The reaction liquid in the fifth liquid storage chamber enters the reaction chamber to perform PCR reaction, and the detection probe is used to emit detection fluorescence for detection.

[0030] The beneficial effects of the present application are: different from the existing technology, the present application provides a housing space for the liquid storage component, the transmission component and the magnetic rod component by setting up a shell component, so that the nucleic acid purification process is completed in the shell component, and the shell component makes the nucleic acid purification detection environment completely closed, and realizes the sample nucleic acid lysis, nucleic acid binding, cleaning, elution and PCR detection in a completely closed state, thereby ensuring the airtightness of the nucleic acid extraction and expansion process, reducing the interference of external aerosols on the test results, and preventing the infection hazard of samples to the test personnel, and realizing a fully automated detection process of sample input and result output; secondly, the present application sets up multiple liquid storage spaces in the liquid storage component, so that multiple liquid storage spaces are used for nucleic acid purification, and completes the processes of nucleic acid lysis, nucleic acid binding, nucleic acid cleaning and nucleic acid elution in the liquid storage space, without the need for manual transfer, reducing operation. The operation is less complicated, the stability of the test results is increased, and a large number of tests are facilitated; in addition, the present application fixes the transmission component above the liquid storage component, and the transmission component can drive the liquid storage component to reciprocate, and the transmission component can move any position of the liquid storage component to the bottom of the magnetic rod component. When a step needs to be completed for the nucleic acid in the corresponding liquid storage space, the magnetic rod assembly can be used to transfer the nucleic acid between multiple liquid storage spaces; in addition, the present application sets a magnetic rod assembly for adsorbing magnetic beads, and the magnetic beads adsorb nucleic acids to achieve the transfer of nucleic acids between multiple liquid storage spaces, that is, when the transmission component drives the corresponding liquid storage space to move to the bottom of the magnetic rod assembly, the magnetic rod assembly can adsorb magnetic beads in and out of the liquid storage space to implement various steps of nucleic acid purification, so that nucleic acid extraction and detection can be automatically performed, the operation is simple and convenient, the test results are stable, and the difficulty of implementing large-scale tests is reduced.

[0031] It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0033] FIG1 is a schematic structural diagram of a housing assembly of the present application;

[0034] FIG2 is a schematic structural diagram of the nucleic acid purification kit of the present application;

[0035] FIG3 is a schematic structural diagram of the liquid storage assembly and the magnetic rod assembly of the present application;

[0036] FIG4 is a schematic structural diagram of the sealing film and rolling mechanism of the present application.

[0037] Among them, the figure marks in the figure are: 10, shell assembly; 11, accommodating space; 13, first shell; 14, second shell; 15, snap-fit ​​structure; 20, liquid storage assembly; 21, liquid storage space; 22, sealing film; 23, rack; 24, first liquid storage chamber; 25, second liquid storage chamber; 26, third liquid storage chamber; 27, fourth liquid storage chamber; 28, fifth liquid storage chamber; 30, transmission assembly; 31, gear; 32, gear shaft; 34, spike; 35, scrolling mechanism; 40, magnetic rod assembly; 42, magnetic rod sleeve; 43, first boss; 44, first countersunk hole; 50, PCR reaction assembly; 52, needle tube. DETAILED DESCRIPTION

[0038] To help those skilled in the art better understand the technical solutions of this application, the nucleic acid purification kit and detection device provided by this application are further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be understood that the described embodiments are only some of the embodiments of this application, and not all of them. All other embodiments derived by those of ordinary skill in the art based on the embodiments in this application without inventive effort are within the scope of protection of this application.

[0039] The terms "first," "second," and the like in this application are used to distinguish between different objects, not to describe a particular order. Furthermore, the terms "including," "having," and any variations thereof, are intended to cover non-exclusive inclusions. For example, a process, method, system, product, or apparatus comprising a series of steps or elements is not limited to the listed steps or elements, but may optionally include steps or elements not listed, or may optionally include other steps or elements inherent to the process, method, product, or apparatus.

[0040] The present application provides a nucleic acid purification kit and a detection device to solve the problems in the prior art of manual transfer for nucleic acid extraction and detection, which result in cumbersome operation, unstable detection results, and difficulty in implementing large-scale detection.

[0041] Please refer to Figures 1 to 4, Figure 1 is a structural schematic diagram of the shell assembly of the present application; Figure 2 is a structural schematic diagram of the nucleic acid purification kit of the present application; Figure 3 is a structural schematic diagram of the liquid storage assembly and the magnetic rod assembly of the present application; Figure 4 is a structural schematic diagram of the sealing film and rolling mechanism of the present application.

[0042] In one embodiment, as shown in Figures 1 to 4, the present application proposes a nucleic acid purification kit that can be used in a nucleic acid detection instrument. The nucleic acid purification kit includes a housing component 10, a liquid storage component 20, a transmission component 30 and a magnetic rod component 40. Among them, the shell component 10 may have a accommodating space 11, the liquid storage component 20 may be located in the accommodating space 11, the liquid storage component 20 may have multiple liquid storage spaces 21 arranged along a preset direction, and multiple liquid storage spaces 21 can be used to purify nucleic acids. The preset direction can be set to a row, a column or other shapes. The transmission component 30 can be fixedly arranged above the liquid storage component 20. The transmission component 30 can be used to drive the liquid storage component 20 to reciprocate along the preset direction. The magnetic rod assembly 40 can be located above the liquid storage component 20 and can be located on one side of the transmission component 30. The magnetic rod assembly 40 can be used to adsorb magnetic beads, and the magnetic beads can be used to transfer nucleic acids between multiple liquid storage spaces 21. When the transmission component 30 drives the corresponding liquid storage space 21 to move to the bottom of the magnetic rod assembly 40, the magnetic rod assembly 40 adsorbs or the magnetic beads below enter and exit different liquid storage spaces 21.

[0043] In the embodiment of the present application, the present application adopts the principle of extracting sample nucleic acid by the traditional magnetic rod method, and places the reaction liquid of each process of purifying nucleic acid in multiple liquid storage spaces 21 respectively. The magnetic beads adsorb the nucleic acid, and the magnetic rod assembly 40 adsorbs the magnetic beads with nucleic acid to complete the transfer of nucleic acid between the multiple liquid storage spaces 21, so that the nucleic acid can complete the processes of nucleic acid cleavage, nucleic acid binding, nucleic acid cleaning and nucleic acid elution in the fully enclosed liquid storage space 21, and fully integrates the complex sample from nucleic acid extraction and purification to PCR detection, saves the pre-processing time of the detection, and does not require manual transfer, reduces the tediousness of the operation, increases the stability of the detection results, and facilitates the realization of large-scale detection; secondly, the present application fixes the transmission assembly 30 above the liquid storage assembly 20, and the transmission assembly The component 30 can drive the liquid storage component 20 to move back and forth, and the transmission component 30 can move any position of the liquid storage component 20 to the bottom of the magnetic rod component 40. When it is necessary to complete a step for the nucleic acid in the corresponding liquid storage space 21, the magnetic rod component 40 can be used to transfer the nucleic acid between multiple liquid storage spaces 21; in addition, the present application sets a magnetic rod component 40 for adsorbing magnetic beads, and the magnetic beads adsorb nucleic acids to achieve the transfer of nucleic acids between multiple liquid storage spaces 21, that is, when the transmission component 30 drives the corresponding liquid storage space 21 to move to the bottom of the magnetic rod component 40, the magnetic rod component 40 can adsorb magnetic beads in and out of the liquid storage space 21 to implement various steps of nucleic acid purification, so that nucleic acid extraction and detection can be automatically performed, the operation is simple and convenient, the test results are stable, and the difficulty of implementing a large number of tests is reduced.

[0044] In some embodiments, as shown in Figures 2 to 3, racks 23 may be provided on both sides of the openings of multiple liquid storage spaces 21, and the transmission assembly 30 may include a gear 31. The gear 31 may be engaged with the rack 23, and the gear 31 rolls, thereby driving the rack 23 to move forward and backward, so that the rack 23 drives the liquid storage assembly 20 to reciprocate.

[0045] Optionally, the transmission assembly 30 may include a gear shaft 32, both ends of which may be connected to the nucleic acid detection instrument, the gear 31 may be passed through the gear shaft 32, the gear shaft 32 may drive the gear 31 to rotate, and the nucleic acid detection instrument transmits power to the gear shaft 32, and the gear 31 rotates with the gear shaft 32, so that the gear 31 drives the rack 23 to reciprocate.

[0046] Among them, through the meshing transmission design of the gear 31 and the rack 23, the liquid storage component 20 for storing the reagent is driven to move horizontally through the rotation of the transmission shaft, thereby realizing the switching of different solutions in the multiple liquid storage spaces 21 directly below the magnetic rod assembly 40.

[0047] In some embodiments, as shown in FIG4 , the liquid storage assembly 20 may include a sealing film 22 , which may be used to seal the multiple liquid storage spaces 21 to reduce the contact between the reaction liquid and nucleic acid in the multiple liquid storage spaces 21 and the outside air.

[0048] Optionally, the sealing film 22 can be set as an aluminum film, and the aluminum film is sealed at the opening of the liquid storage space 21 by heat sealing.

[0049] In some embodiments, a film opening portion may be provided on the gear shaft 32 , and the film opening portion may open the sealing film 22 during the movement of the liquid storage assembly 20 , so as to facilitate the magnetic rod assembly 40 to enter and exit the liquid storage space 21 .

[0050] Optionally, as shown in FIG2 , a spike 34 may be provided on the gear shaft 32 , and the spike 34 is integrally connected to the gear shaft 32 . The spike 34 can rotate along with the gear shaft 32 . The spike 34 is used to pierce the sealing film 22 during the rotation process, so that the magnetic rod sleeve 42 directly above can enter the liquid storage space 21 to transfer the magnetic beads under the drive of the magnetic rod.

[0051] There can be multiple spikes 34 , which are distributed around the gear shaft 32 , so that during the rotation of the gear shaft 32 , there are always spikes 34 piercing the sealing film 22 , reducing the resistance of the magnetic rod assembly 40 entering and exiting the liquid storage space 21 .

[0052] Optionally, as shown in FIG4 , the transmission assembly 30 may further include a rolling mechanism 35 , which may be located between the two gears 31 and connected to the gear shaft 32 . The sealing films 22 at some of the first liquid storage chambers 24 are manually torn open, and the starting ends of the sealing films 22 are rolled up on the gear shaft 32 . During the rotation of the gear shaft 32 , the rolling mechanism 35 follows and rolls up the sealing films 22 , thereby opening a plurality of liquid storage spaces 21 . During the rotation of the gear shaft 32 , when a certain liquid storage space 21 is no longer needed, the rolling mechanism 35 may loosen the corresponding sealing film 22 and temporarily cover the liquid storage space 21 , thereby reducing the contact between the reaction liquid in the liquid storage space 21 and the air, while also preserving the integrity of the sealing film 22 .

[0053] In some embodiments, a first through hole may be provided on the shell assembly 10, and the magnetic rod assembly 40 may include a driving mechanism and a magnetic rod sleeve 42. The magnetic rod sleeve 42 may be electrically connected to the driving mechanism. A first boss 43 may be provided at one end of the magnetic rod sleeve 42, and the other end of the magnetic rod sleeve 42 may extend toward the accommodating space 11 through the first through hole, and the first boss 43 may be embedded outside the first through hole so that the magnetic rod sleeve 42 will not completely fall into the accommodating space 11. The magnetic rod sleeve 42 has a retractable function, and the driving mechanism can electrically control the drive magnetic rod sleeve 42 to retract and retract in and out of the liquid storage space 21.

[0054] Optionally, the magnetic rod sleeve 42 can be made of silicone material, which will not interfere with the magnetism of the magnetic rod.

[0055] In some embodiments, the magnetic rod sleeve 42 may include a first countersunk hole 44, and the first countersunk hole 44 may be set at one end facing the first boss 43, that is, the first countersunk hole 44 is located in the upper half of the magnetic rod sleeve 42. The magnetic rod assembly 40 may include a magnetic rod piece, the driving mechanism may be electrically connected to the magnetic rod piece, the magnetic rod piece may be sleeved in the first countersunk hole 44, and the magnetic rod piece may be used to adsorb magnetic beads.

[0056] It can be understood that the driving mechanism electrically controls the movement of the magnetic rod sleeve 42 and the magnetic rod piece. The driving mechanism can electrically drive the magnetic rod piece in and out of the first countersunk hole 44. When the magnetic rod piece is located in the first countersunk hole 44, the upper half of the magnetic rod sleeve 42 is magnetic and can absorb magnetic beads; when the magnetic rod piece leaves the first countersunk hole 44, the upper half of the magnetic rod sleeve 42 is not magnetic and cannot absorb magnetic beads.

[0057] Optionally, the magnetic rod piece can be set as an electromagnetic piece, or a magnetic core can be set in the magnetic rod piece, so that the magnetic rod piece has an adsorption function when entering the first countersunk hole 44.

[0058] In some embodiments, the magnetic rod sleeve 42 may include a vibrating member, which may be located inside the magnetic rod sleeve 42 and may be arranged away from the first sink hole 44, that is, located at the bottom of the magnetic rod sleeve 42. The vibrating member may be electrically connected to the driving mechanism. When the magnetic rod sleeve 42 enters the liquid storage space 21, it activates the switch of the driving mechanism, causing the magnetic rod sleeve 42 to vibrate, thereby making the nucleic acid purification reaction in the liquid storage space 21 more complete.

[0059] Optionally, the vibration element can be set as an ultrasonic component, or a vibration element with a vibration period on the same order of magnitude as the sound wave frequency, as long as it can meet the needs, which will not be described in detail here.

[0060] In some embodiments, the nucleic acid purification kit may further include a heating component, which may be disposed at the bottom of the first liquid storage chamber 24 . When nucleic acid lysis is performed, the heating component is used to heat the nucleic acid lysis process in the first liquid storage chamber 24 .

[0061] In some embodiments, as shown in FIG3 , the plurality of liquid storage spaces 21 may include a first liquid storage chamber 24, a second liquid storage chamber 25, a third liquid storage chamber 26, a fourth liquid storage chamber 27, and a fifth liquid storage chamber 28, arranged in parallel. The magnetic rod assembly 40 may reciprocate within the first liquid storage chamber 24, the second liquid storage chamber 25, the third liquid storage chamber 26, the fourth liquid storage chamber 27, and the fifth liquid storage chamber 28, respectively. The first liquid storage chamber 24 may be located away from the second through hole so that the fifth liquid storage chamber 28 is located at the second through hole, facilitating the needle 52 from penetrating the rubber-made fifth liquid storage chamber 28. The first liquid storage chamber 24 may be used to hold a lysis solution, the second liquid storage chamber 25 may be used to hold a magnetic bead storage solution, the third liquid storage chamber 26 may be used to hold a first cleaning solution, the fourth liquid storage chamber 27 may be used to hold a second cleaning solution, and the fifth liquid storage chamber 28 may be used to hold pure water or other eluents.

[0062] Optionally, the nucleic acid purification kit of the present application can be used to detect samples including but not limited to sputum, tissue, blood, and feces. The nucleic acid purification kit of the present application can be configured with different reaction solutions for different types of samples and set different processing methods, such as chemical lysis solution guanidine isothiocyanate, biological enzyme lysis solution proteinase K, as well as heating and mechanical shearing, etc.

[0063] The working process of sample lysis: manually tear open the sealing film 22 above the first liquid storage chamber 24, add the sample into the first liquid storage chamber 24, cover the second shell 14, and under the action of the lysis liquid in the first liquid storage chamber 24, the sample is lysed. During the lysis process, the heating component can be used to heat the outside of the first liquid storage chamber 24 to 70 degrees Celsius to better promote the lysis of the sample.

[0064] The working process of nucleic acid binding: When the sample is in the lysis process in the first liquid storage chamber 24, power can be provided by an external nucleic acid detection instrument at the same time, so that the gear shaft 32 drives the second liquid storage chamber 25 containing the magnetic bead preservation liquid to move to the bottom of the magnetic rod sleeve 42. The driving mechanism of the nucleic acid detection instrument applies a driving force to the magnetic rod, aligning the magnetic rod with the magnetic rod sleeve 42 and moving it downward to the bottom of the second liquid storage chamber 25. Under the action of the magnetic field of the magnetic rod, all the magnetic beads are adsorbed on the top of the magnetic rod sleeve 42.

[0065] After the magnetic attraction of the magnetic beads is completed, the magnetic rod piece and the magnetic rod sleeve 42 slowly move upward until the magnetic rod sleeve 42 returns to its initial position and then stops moving. Next, the nucleic acid detection instrument drives the gear shaft 32 to rotate, so that the first liquid storage chamber 24 is displaced to just below the magnetic rod sleeve 42. The magnetic rod piece and the magnetic rod sleeve 42 begin to slowly move downward to the bottom of the first liquid storage chamber 24. The driving mechanism drives the magnetic rod piece to return to its initial position, but the magnetic rod sleeve 42 remains in its original position. Since there is no magnetic rod piece in the magnetic rod sleeve 42, the magnetic rod sleeve 42 loses its magnetic field. Under the oscillation action of the magnetic rod sleeve 42, the magnetic beads are evenly dispersed in the lysate of the first liquid storage chamber 24. At this time, the driving mechanism starts the vibrating piece, so that the vibrating piece vibrates the lysate in the first liquid storage chamber 24. The vibrating piece continues to maintain an oscillating state, promoting the binding of the magnetic beads and each nucleic acid in the lysate.

[0066] The working process of nucleic acid cleaning: After the magnetic beads complete the adsorption of nucleic acid in the first liquid storage chamber 24, the vibrating part is turned off, and the magnetic rod part moves downward into the magnetic rod sleeve 42. Under the action of the magnetic field of the magnetic rod part, the magnetic beads in the lysate are adsorbed to the top position of the magnetic rod sleeve 42, and the magnetic rod part and the magnetic rod sleeve 42 move upward together to the initial state position of the magnetic rod assembly 40.

[0067] Next, the nucleic acid detection instrument drives the gear shaft 32 to rotate, and moves the third liquid storage chamber 26 containing the first cleaning liquid to a position directly below the magnetic rod assembly 40. The magnetic rod piece and the magnetic rod sleeve 42 move downward together into the first cleaning liquid. The magnetic rod leaves the magnetic rod sleeve 42, and the vibration piece is turned on. The magnetic beads on the top of the magnetic rod sleeve 42 are completely dispersed into the first cleaning liquid under the oscillation action of the magnetic rod sleeve 42. After the cleaning is completed, the vibration piece is turned off, and the magnetic rod piece moves downward into the magnetic rod sleeve 42 to adsorb the magnetic beads in the first cleaning liquid to the top of the silicone sleeve. After the adsorption of the magnetic beads is completed, the magnetic rod piece and the magnetic rod sleeve 42 rise together to the initial position and stay there.

[0068] The nucleic acid detection instrument continues to drive the gear shaft 32 to rotate, and moves the fourth liquid storage chamber 27 where the second cleaning liquid is placed to a position directly below the magnetic rod assembly 40. The magnetic rod and the magnetic rod sleeve 42 move downward into the second cleaning liquid. The magnetic rod piece leaves the magnetic rod sleeve 42, and the magnetic beads on the top of the magnetic rod sleeve 42 lose their magnetic attraction. The vibrating piece is started, and the magnetic beads are completely dispersed into the second cleaning liquid under the oscillation action of the magnetic rod sleeve 42. After completing the secondary cleaning, the vibrating piece is turned off, and the magnetic rod piece moves downward into the magnetic rod sleeve 42, and the magnetic beads in the second cleaning liquid are adsorbed to the top of the magnetic rod sleeve 42. After completing the adsorption of the magnetic beads, the magnetic rod piece and the magnetic rod sleeve 42 rise to the initial position together and stay there. They can remain suspended in the air for 1-5 minutes to allow the organic solution attached to the magnetic beads to evaporate.

[0069] The working process of nucleic acid elution: After the magnetic beads are dried, the nucleic acid detection instrument drives the gear shaft 32 to place the fifth liquid storage chamber 28 containing the eluent directly below the elastic magnetic rod sleeve 42. The magnetic rod and the magnetic rod sleeve 42 move downward into the eluent, and the vibration element is started to vibrate the magnetic rod sleeve 42 to fully disperse the magnetic beads into the eluent. After waiting for 1-5 minutes, the vibration element is turned off, and the magnetic rod element moves downward. After completing the magnetic absorption, the magnetic rod element and the magnetic rod sleeve 42 move upward to leave the eluent, completing the extraction of nucleic acid.

[0070] The nucleic acid purification kit of the present application is suitable for a variety of clinical samples, such as urine, blood, nasopharyngeal swabs, sputum, tissue, feces and other samples. It is compatible with various forms of samples and can also adjust the reagent formula and increase or decrease the processing steps according to the specific sample, or pre-set different positions of the liquid storage space 21. The number and shape of the liquid storage space 21 can be changed and adjusted according to specific needs.

[0071] The nucleic acid purification kit integrates nucleic acid extraction and detection reagents. Once the sample is added, fully enclosed automated processing is achieved without any connection to the outside air. This greatly reduces the impact of the external environment on the test results and protects the health of testers, achieving a "sample in, result out" automated device.

[0072] Optionally, a third through hole may be provided on the side wall of the fifth liquid storage chamber 28 away from the first liquid storage chamber 24. The third through hole may be sealed with a rubber stopper to keep the fifth liquid storage chamber 28 in a closed state. The rubber stopper can facilitate the needle tube 52 to pierce the rubber stopper during the PCR reaction and then enter the fifth liquid storage chamber 28 to take out the nucleic acid purification liquid.

[0073] Optionally, the housing assembly 10 may include a first housing 13 and a second housing 14. The first housing 13 is disposed at the bottom and has a first platform. The rack 23 is placed on the first platform so that the liquid storage assembly 20 is suspended with the first platform as support, facilitating the removal and placement of the liquid storage assembly 20. The second housing 14 is disposed at the top and fits in with the first housing 13. A snap-fit ​​structure 15 is provided between the first housing 13 and the second housing 14, thereby making the seal between the first housing 13 and the second housing 14 more tight, isolating the outside world and achieving a fully sealed environment for the nucleic acid extraction process.

[0074] Among them, the external dimensions of the nucleic acid purification kit can be set to 120 mm in length, 65 mm in height, and 24 mm in width, respectively, to make the nucleic acid purification kit more compact and portable.

[0075] Optionally, the nucleic acid purification kit of the present application can be processed by injection molding, which can achieve batch production and has the advantages of high output and low cost.

[0076] The present application also proposes a nucleic acid detection device, including a nucleic acid purification kit as described in any of the above embodiments, a PCR reaction assembly 50 (Polymerase Chain Reaction) and a detection probe. A second through hole may be provided on the housing assembly 10, and the PCR reaction assembly 50 may include a reaction chamber and a needle tube 52. The reaction chamber may be used to place freeze-dried balls and solid paraffin wax. One end of the needle tube 52 may be connected to the reaction chamber, and the other end of the needle tube 52 may pass through the second through hole and be connected to the fifth liquid storage chamber 28. The detection probe may be provided on one side of the PCR reaction assembly 50. The detection probe is used to emit detection fluorescence. Under the action of external thrust, the needle tube 52 may pierce the fifth liquid storage chamber 28 of the magnetic rod assembly 40. The reaction liquid in the fifth liquid storage chamber 28 enters the reaction chamber and mixes with the freeze-dried balls to perform a PCR reaction, and the detection probe is used to emit detection fluorescence for detection.

[0077] In some embodiments, the nucleic acid detection device may further include a PCR reaction heating unit, which is disposed on one side of the PCR reaction component 50 and is used to heat the PCR reaction component 50 to meet the conditions for the PCR reaction.

[0078] Working process of PCR reaction assembly 50:

[0079] First, in the process of preparing the PCR reaction solution, the PCR reaction component 50 contains freeze-dried balls of reagents required for the PCR reaction. With the assistance of a matching nucleic acid detection instrument, the needle 52 of the PCR reaction component 50 penetrates into the nucleic acid purification liquid through the rubber stopper on the inner wall of the fifth liquid storage chamber 28. Under the action of external pressure, the nucleic acid purification liquid enters the PCR reaction chamber along the injection needle to re-melt the freeze-dried balls.

[0080] Again, during the PCR reaction and detection process, with the assistance of the supporting nucleic acid detection instrument, when the temperature rises, the solid paraffin in the PCR reaction chamber will dissolve and float to the upper layer of the liquid in the reaction chamber, which can prevent the liquid from evaporating. The PCR reaction heating part is used for heating. During the PCR reaction, the probe fluorescence detection is performed according to the reaction.

[0081] Optionally, the freeze-dried balls of the present application can also be modified as needed. They can be used not only in nucleic acid detection devices, but also in nucleic acid detection instruments, and can also be used in RPA (Robotic Process Automation) and other PCR methods. The reagent system and probe system used are all within the scope of protection of this application.

[0082] The freeze-dried balls of the present application are used to store PCR reagents, which solves the problem that conventional PCR reagents need to be frozen for storage. In addition, the present application uses a needle 52 for puncture sampling to realize the transfer and preparation of PCR reaction liquid, which solves the liquid transfer problem between the liquid storage of nucleic acid purification liquid and the preparation of PCR reaction liquid.

[0083] In summary, the present application provides a shell component 10 with a accommodating space 11, and a liquid storage component 20 is arranged in the accommodating space 11, so that the liquid storage component 20 has multiple liquid storage spaces 21, and multiple liquid storage spaces 21 are arranged for purifying nucleic acids, and the transmission component 30 is fixedly arranged above the liquid storage component 20, so that the transmission component 30 is used to drive the liquid storage component 20 to reciprocate, and the magnetic rod assembly 40 is arranged above the liquid storage component 20 and on one side of the transmission component 30, so that the magnetic rod assembly 40 is used to adsorb magnetic beads, and the magnetic beads are used to transfer nucleic acids between multiple liquid storage spaces 21, and the nucleic acids are placed in corresponding liquid storage spaces 21. When the transmission component 30 drives the corresponding liquid storage space 21 to move to the bottom of the magnetic rod assembly 40, the magnetic rod assembly 40 can adsorb magnetic beads in and out of the liquid storage space 21 to implement various purification steps for the nucleic acid, so that nucleic acid extraction and detection can be automatically performed, the operation is simple and convenient, the test results are stable, and the difficulty of implementing a large number of tests is reduced. Secondly, by providing a liquid storage assembly 20 including a sealing membrane 22, the sealing membrane 22 is used to seal the multiple liquid storage spaces 21, thereby reducing the contact between the reaction liquid and nucleic acid in the multiple liquid storage spaces 21 and the outside air, thereby increasing the stability of nucleic acid detection. In addition, by providing a PCR reaction assembly 50 and a detection probe on one side of the nucleic acid purification kit, the problem of conventional PCR reagents requiring frozen storage is solved, and the needle tube 52 puncture sampling method realizes the transfer and preparation of the PCR reaction solution, solving the liquid transfer problem between the liquid storage of the nucleic acid purification solution and the preparation of the PCR reaction solution.

[0084] It should be noted that the various optional implementation methods introduced in the embodiments of the present application can be implemented in combination with each other or can be implemented separately, and the embodiments of the present application do not limit this.

[0085] In the description of this application, it should be understood that the terms "upper", "lower", "left", "right", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, and a specific orientation structure and operation. Therefore, it cannot be understood as a limitation on this application. In addition, "first" and "second" are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of this application, unless otherwise specified, "multiple" means two or more.

[0086] In the description of this application, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on the specific circumstances.

[0087] The above embodiments are described with reference to the accompanying drawings. Other different forms and embodiments are also possible without departing from the principles of the present application, and therefore the present application should not be construed as limiting the embodiments presented herein. Rather, these embodiments are provided so that the present application will be perfect and complete, and will convey the scope of the present application to those skilled in the art. In the accompanying drawings, component sizes and relative sizes may be exaggerated for clarity. The terms used herein are for the purpose of describing specific embodiments only and are not intended to be limiting. The terms "comprising" and / or "including" when used in this specification indicate the presence of the features, integers, components and / or components, but do not exclude the presence or increase of one or more other feature integers, components, components and / or their groups. Unless otherwise indicated, when stated, a numerical range includes the upper and lower limits of the range and any sub-ranges therebetween.

[0088] The above descriptions are only some embodiments of the present application and do not limit the scope of protection of the present application. Any equivalent device or equivalent process transformation made using the contents of the description and drawings of this application, or directly or indirectly applied in other related technical fields, are also included in the scope of patent protection of this application.

Claims

1. A nucleic acid purification kit, characterized in that: include: A housing assembly having an accommodating space; A liquid storage component is located in the accommodating space, and the liquid storage component has a plurality of liquid storage spaces arranged along a preset direction, and the plurality of liquid storage spaces are used for purifying nucleic acids; A transmission assembly is fixedly arranged above the liquid storage assembly, and is used to drive the liquid storage assembly to reciprocate along the preset direction; A magnetic rod assembly is located above the liquid storage assembly and is used to absorb magnetic beads; The transmission assembly drives the liquid storage assembly to move, so that different liquid storage spaces move to the bottom of the magnetic bar assembly, and the magnetic bar assembly absorbs or moves the magnetic beads below to different liquid storage spaces.

2. The nucleic acid purification kit according to claim 1, characterized in that The housing assembly is provided with a first through hole; The magnetic rod assembly includes a driving mechanism and a magnetic rod sleeve, the magnetic rod sleeve is electrically connected to the driving mechanism, a first boss is provided at one end of the magnetic rod sleeve, the other end of the magnetic rod sleeve passes through the first through hole and extends toward the accommodating space, and the first boss is embedded outside the first through hole.

3. The nucleic acid purification kit according to claim 2, characterized in that The magnetic rod sleeve includes a first countersunk hole, and the first countersunk hole is located at one end facing the first boss; The magnetic bar assembly includes a magnetic bar piece, the driving mechanism is electrically connected to the magnetic bar piece, the magnetic bar piece is sleeved in the first countersunk hole, and the magnetic bar piece is used to absorb magnetic beads.

4. The nucleic acid purification kit according to claim 3, characterized in that The magnetic rod sleeve includes a vibration component, which is located in the magnetic rod sleeve and is arranged away from the first countersunk hole. The vibration component is electrically connected to the driving mechanism.

5. The nucleic acid purification kit according to claim 1, characterized in that The plurality of liquid storage spaces include a first liquid storage chamber, a second liquid storage chamber, a third liquid storage chamber, a fourth liquid storage chamber, and a fifth liquid storage chamber arranged in parallel, and the magnetic rod assembly can reciprocate toward the first liquid storage chamber, the second liquid storage chamber, the third liquid storage chamber, the fourth liquid storage chamber, and the fifth liquid storage chamber respectively; The first liquid storage chamber is used to store lysis solution, the second liquid storage chamber is used to store magnetic bead preservation solution, the third liquid storage chamber is used to store first cleaning solution, the fourth liquid storage chamber is used to store second cleaning solution, and the fifth liquid storage chamber is used to store pure water.

6. The nucleic acid purification kit according to claim 5, characterized in that The nucleic acid purification kit includes a heating component, which is located at the bottom of the first liquid storage chamber and is used to heat the first liquid storage chamber.

7. The nucleic acid purification kit according to claim 1, characterized in that The liquid storage component includes a sealing film, and the sealing film is used to seal the multiple liquid storage spaces.

8. The nucleic acid purification kit according to claim 7, characterized in that Racks are provided on both sides of the openings of the plurality of liquid storage spaces; The transmission assembly includes a gear, which is engaged with the rack so that the rack drives the liquid storage assembly to reciprocate.

9. The nucleic acid purification kit according to claim 8, characterized in that The transmission assembly includes a gear shaft, both ends of which are connected to the nucleic acid detection instrument, and the gear is installed on the gear shaft, and the gear shaft drives the gear to rotate; The gear shaft is provided with a film opening portion, and the film opening portion opens the sealing film during the movement of the liquid storage component.

10. A nucleic acid detection device, characterized in that: include: The nucleic acid purification kit according to any one of claims 1 to 9, wherein the housing assembly is provided with a second through hole; A PCR reaction assembly includes a reaction chamber and a needle tube, wherein the reaction chamber is used to place freeze-dried balls and solid paraffin, one end of the needle tube is connected to the reaction chamber, and the other end of the needle tube passes through the second through hole and is connected to the fifth liquid storage chamber; A detection probe is located on one side of the PCR reaction component, and is used to emit detection fluorescence; The reaction liquid in the fifth liquid storage chamber enters the reaction chamber to perform PCR reaction, and the detection probe is used to emit detection fluorescence for detection.

Citation Information

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