WO2024254900A1 - 一种核酸纯化试剂盒及检测装置 - Google Patents

一种核酸纯化试剂盒及检测装置 Download PDF

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Publication number
WO2024254900A1
WO2024254900A1 PCT/CN2023/102714 CN2023102714W WO2024254900A1 WO 2024254900 A1 WO2024254900 A1 WO 2024254900A1 CN 2023102714 W CN2023102714 W CN 2023102714W WO 2024254900 A1 WO2024254900 A1 WO 2024254900A1
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WIPO (PCT)
Prior art keywords
liquid storage
nucleic acid
assembly
magnetic
storage chamber
Prior art date
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Ceased
Application number
PCT/CN2023/102714
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English (en)
French (fr)
Inventor
喻学锋
舒伟良
周文华
惠允
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Shenzhen Institute of Advanced Technology of CAS
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Shenzhen Institute of Advanced Technology of CAS
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Publication of WO2024254900A1 publication Critical patent/WO2024254900A1/zh
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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/10—Processes for the isolation, preparation or purification of DNA or RNA
    • C12N15/1003—Extracting or separating nucleic acids from biological samples, e.g. pure separation or isolation methods; Conditions, buffers or apparatuses therefor
    • C12N15/1006—Extracting or separating nucleic acids from biological samples, e.g. pure separation or isolation methods; Conditions, buffers or apparatuses therefor by means of a solid support carrier, e.g. particles, polymers
    • C12N15/1013—Extracting or separating nucleic acids from biological samples, e.g. pure separation or isolation methods; Conditions, buffers or apparatuses therefor by means of a solid support carrier, e.g. particles, polymers by using magnetic beads
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6806—Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6844—Nucleic acid amplification reactions
    • C12Q1/686—Polymerase chain reaction [PCR]

Definitions

  • 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.
  • a centrifugal column method or a magnetic bead method for nucleic acid extraction which generally requires steps such as lysis, binding, and elution.
  • a 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 achieve large-scale testing.
  • 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, such as cumbersome operation, unstable detection results, and difficulty in implementing large-scale detection.
  • nucleic acid purification kit comprising:
  • a housing assembly having a receiving 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 fixedly disposed above the liquid storage assembly, and used for driving the liquid storage assembly to reciprocate along the preset direction;
  • a magnetic bar assembly located above the liquid storage assembly, and used for adsorbing 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 rod assembly.
  • the magnetic rod assembly adsorbs or moves the magnetic beads below to different liquid storage spaces.
  • the liquid storage component includes a sealing film, and the sealing film is used to seal the plurality of liquid storage spaces.
  • a first through hole is provided on the housing assembly
  • 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 arranged 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.
  • 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 comprises 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.
  • the magnetic rod sleeve includes a vibrating member, the vibrating member is located inside the magnetic rod sleeve and is arranged away from the first countersunk hole, and the vibrating member is electrically connected to the driving mechanism.
  • 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;
  • 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
  • the fifth liquid storage chamber is used to store pure water.
  • 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.
  • racks are provided on both sides of the openings of the plurality of liquid storage spaces
  • the transmission assembly includes a gear, and the gear is meshed with the rack so that the rack drives the liquid storage assembly to reciprocate.
  • 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;
  • 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.
  • the present application also proposes a nucleic acid detection device, comprising:
  • the nucleic acid purification kit as described above, wherein the housing component is provided with a second through hole;
  • 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;
  • a detection probe located at one side of the PCR reaction component, and the detection probe 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.
  • 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;
  • 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 the processes of nucleic acid lysis, nucleic acid binding, nucleic acid cleaning and nucleic acid elution are completed in the liquid storage space, without
  • the present application fixes the transmission component above the liquid storage component, the transmission component can drive the liquid storage component to reciprocate, the transmission component can move any position of the liquid storage component to the bottom of the magnetic rod component, and when it is necessary to complete a step for the nucleic acid in the corresponding liquid storage space, the magnetic rod component can be used to transfer the nucleic acid between multiple liquid storage spaces; in addition, the present application arranges a magnetic rod component 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 component, the magnetic rod component 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,
  • FIG1 is a schematic structural diagram of a housing assembly of the present application.
  • FIG2 is a schematic diagram of the structure of the nucleic acid purification kit of the present application.
  • FIG3 is a schematic diagram of the structure of the liquid storage assembly and the magnetic rod assembly of the present application.
  • FIG. 4 is a schematic diagram of the structure of the sealing film and rolling mechanism of the present application.
  • 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 cavity; 25, second liquid storage cavity; 26, third liquid storage cavity; 27, fourth liquid storage cavity; 28, fifth liquid storage cavity; 30, transmission assembly; 31, gear; 32, gear shaft; 34, spike; 35, rolling mechanism; 40, magnetic rod assembly; 42, magnetic rod sleeve; 43, first boss; 44, first countersunk hole; 50, PCR reaction assembly; 52, needle tube.
  • nucleic acid purification kit and detection device provided by the present application are further described in detail below in conjunction with the accompanying drawings and specific embodiments. It is understood that the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in the field without creative work are within the scope of protection of the present application.
  • 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, such as cumbersome operation, unstable detection results, and difficulty in implementing large-scale detection.
  • 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.
  • the present application proposes a nucleic acid purification kit, which 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.
  • the housing 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 a plurality of liquid storage spaces 21 arranged along a preset direction
  • the plurality of liquid storage spaces 21 may be used to purify nucleic acids.
  • the preset direction may be arranged in a row, a column, or other shapes.
  • the transmission component 30 may be fixedly disposed above the liquid storage component 20, and the transmission component 30 may be used to drive the liquid storage component 20 to reciprocate along the preset direction.
  • the magnetic rod component 40 may be located above the liquid storage component 20 and may be located on one side of the transmission component 30.
  • the magnetic rod component 40 may be used to adsorb magnetic beads, and the magnetic beads may be used to transfer nucleic acids between a plurality of liquid storage spaces 21.
  • the transmission component 30 drives the corresponding liquid storage space 21 to move to
  • the magnetic bar assembly 40 adsorbs or the magnetic beads below enter and exit different liquid storage spaces 21 .
  • the present application adopts the principle of extracting sample nucleic acid by the traditional magnetic rod method, and the reaction liquid of each process of purifying nucleic acid is placed in a plurality of liquid storage spaces 21 respectively, and the nucleic acid is adsorbed by magnetic beads, and the magnetic rod assembly 40 adsorbs the magnetic beads with nucleic acid, and completes the transfer of nucleic acid between the plurality of 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, which reduces the cumbersomeness of the operation, increases the stability of the detection result, and facilitates the realization of a large number of detections; secondly, the present application fixes the transmission assembly 30 above the liquid storage assembly 20, and the transmission
  • 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.
  • racks 23 may be provided on both sides of the openings of the multiple liquid storage spaces 21, and the transmission assembly 30 may include a gear 31, which may be engaged with the rack 23.
  • the gear 31 rolls and drives the rack 23 to move forward and backward, so that the rack 23 drives the liquid storage assembly 20 to reciprocate.
  • 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, 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.
  • the liquid storage assembly 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.
  • the liquid storage component 20 may include a sealing film 22 , which may be used to seal the plurality of liquid storage spaces 21 , thereby reducing the contact between the reaction liquid and nucleic acid in the plurality of liquid storage spaces 21 and the outside air.
  • 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.
  • 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 component 20 , so as to facilitate the magnetic rod component 40 to enter and exit the liquid storage space 21 .
  • 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 may 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.
  • 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 end of the sealing films 22 is rolled up on the gear shaft 32.
  • the rolling mechanism 35 follows the rolling up of the sealing films 22 to open multiple liquid storage spaces 21.
  • the rolling mechanism 35 may loosen the corresponding sealing film 22, temporarily cover the liquid storage space 21, reduce the contact between the reaction liquid in the liquid storage space 21 and the air, and retain the integrity of the sealing film 22.
  • 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 through the first through hole toward the accommodating space 11, 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 of the magnetic rod sleeve 42 to retract and retract in and out of the liquid storage space 21.
  • the magnetic rod sleeve 42 can be made of silicone material, which will not interfere with the magnetism of the magnetic rod.
  • 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, and 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.
  • 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.
  • 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.
  • the magnetic bar member may be configured as an electromagnetic member, or a magnetic core may be disposed inside the magnetic bar member, so that the magnetic bar member has an adsorption function when entering the first countersunk hole 44 .
  • the magnetic rod sleeve 42 may include a vibrating member, which may be located inside the magnetic rod sleeve 42 and may be disposed away from the first sink hole 44, i.e., located at the bottom of the magnetic rod sleeve 42.
  • the vibrating member may be electrically connected to a driving mechanism.
  • the magnetic rod sleeve 42 enters the liquid storage space 21, it activates a 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.
  • the vibration element can be set as an ultrasonic component, and can also be set to have a vibration period of the same order of magnitude as the sound wave frequency.
  • a suitable vibration device can meet the needs and will not be elaborated here.
  • 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 .
  • the heating component is used to heat the nucleic acid cleavage process in the first liquid storage chamber 24 .
  • 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, and the magnetic rod assembly 40 may reciprocate toward 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 at a position away from the second through hole so that the fifth liquid storage chamber 28 is located at the second through hole, so that the needle tube 52 can penetrate the fifth liquid storage chamber 28 made of rubber.
  • the first liquid storage chamber 24 can be used to place a lysate
  • the second liquid storage chamber 25 can be used to place a magnetic bead preservation solution
  • the third liquid storage chamber 26 can be used to place a first cleaning solution
  • the fourth liquid storage chamber 27 can be used to place a second cleaning solution
  • the fifth liquid storage chamber 28 can be used to place pure water or other eluents.
  • 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.
  • the working process of sample lysis manually tear open a point of 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.
  • 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.
  • the working process of nucleic acid binding while the sample is being lysed 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.
  • 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.
  • 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.
  • the magnetic beads are evenly dispersed in the lysate of the first liquid storage chamber 24.
  • 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 to promote the binding of the magnetic beads and each nucleic acid in the lysate.
  • the working process of nucleic acid cleaning After the magnetic beads have completed the adsorption of nucleic acid in the first liquid storage chamber 24, the vibrating element is turned off and the magnetic rod The magnetic rod assembly 40 moves downward into the magnetic rod sleeve 42 , and under the action of the magnetic field of the magnetic rod assembly 42 , the magnetic beads in the lysate are adsorbed to the top position of the magnetic rod sleeve 42 , and the magnetic rod assembly 40 and the magnetic rod sleeve 42 move upward together to the initial state position of the magnetic rod assembly 40 .
  • the nucleic acid detection instrument drives the gear shaft 32 to rotate, and moves the third liquid storage chamber 26 containing the first cleaning solution to the 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 solution.
  • 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 solution under the oscillation action of the magnetic rod sleeve 42.
  • 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 solution to the top of the silicone sleeve.
  • the magnetic rod piece and the magnetic rod sleeve 42 rise together to the initial position and stay there.
  • the nucleic acid detection instrument continues to drive the gear shaft 32 to rotate, and moves the fourth liquid storage chamber 27 for placing the second cleaning solution to the position directly below the magnetic rod assembly 40.
  • the magnetic rod and the magnetic rod sleeve 42 move downward into the second cleaning solution at once, and the magnetic rod piece leaves the magnetic rod sleeve 42.
  • the magnetic beads on the top of the magnetic rod sleeve 42 lose their magnetic attraction, and the vibration piece is started.
  • the magnetic beads are completely dispersed into the second cleaning solution under the oscillation action of the magnetic rod sleeve 42.
  • the vibration piece After completing the secondary cleaning, 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 second cleaning solution 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, and can be suspended in the air for 1-5 minutes to allow the organic solution attached to the magnetic beads to evaporate.
  • 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, and the magnetic rod and the magnetic rod sleeve 42 move downward into the eluent, start the vibration element, and vibrate the magnetic rod sleeve 42 to make the magnetic beads fully dispersed in the eluent.
  • the magnetic rod element and the magnetic rod sleeve 42 move upward to leave the eluent, and the extraction of nucleic acid is completed.
  • the nucleic acid purification kit of the present application is suitable for a variety of clinical samples, such as urine, blood, nasopharyngeal swabs, sputum, tissues, feces and other samples, and is compatible with samples of various forms.
  • the reagent formula can be adjusted and the processing steps can be increased or decreased according to the specific samples, or different positions of the liquid storage spaces 21 can be preset. The number and shape of the liquid storage spaces 21 can be changed and adjusted according to specific needs.
  • the nucleic acid purification kit integrates nucleic acid extraction and detection reagents. After the sample is added, it can realize fully enclosed automatic processing without connecting to the outside air. This can greatly avoid the influence of the external environment on the test results and protect the health of the test personnel, realizing an automated device of "sample in, result out";
  • 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, and the third through hole may be closed with a rubber plug to keep the fifth liquid storage chamber 28 in a closed state.
  • the rubber plug may facilitate the needle tube 52 to pierce the rubber plug and enter the fifth liquid storage chamber 28 during the PCR reaction to take out the nucleic acid purification liquid.
  • 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.
  • 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 yield and low cost.
  • the present application also proposes a nucleic acid detection device, including a nucleic acid purification kit as in any of the above embodiments, a PCR reaction assembly 50 (Polymerase Chain Reaction) and a detection probe.
  • the housing assembly 10 may be provided with a second through hole
  • 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
  • one end of the needle tube 52 may be connected to the reaction chamber
  • 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
  • the detection probe is used to emit
  • the PCR reaction component 50 is equipped with freeze-dried balls of reagents required for the PCR reaction.
  • the needle 52 of the PCR reaction component 50 pierces the nucleic acid purification liquid through the rubber stopper on the inner wall of the fifth liquid storage chamber 28.
  • the nucleic acid purification liquid enters the PCR reaction chamber along the injection needle to re-melt the freeze-dried balls.
  • 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.
  • the detection probe fluorescence detection is performed according to the reaction.
  • freeze-dried ball of the present application can also be changed as needed, and can be applied not only to nucleic acid detection devices, but also to nucleic acid detection instruments, and can also be applied to RPA (Robotic Process Automation, i.e., robot Process automation) and other PCR methods used in the reagent system and probe system, all belong to the protection scope of this application.
  • RPA Robot Process Automation, i.e., robot Process automation
  • the present application arranges the shell component 10 with a accommodating space 11, arranges the liquid storage component 20 in the accommodating space 11, so that the liquid storage component 20 has multiple liquid storage spaces 21, and arranges multiple liquid storage spaces 21 for purifying nucleic acids, and fixes the transmission component 30 above the liquid storage component 20, so that the transmission component 30 is used to drive the liquid storage component 20 to reciprocate, and arranges the magnetic rod component 40 above the liquid storage component 20 and on one side of the transmission component 30, so that the magnetic rod component 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.
  • the magnetic rod component 40 can adsorb the magnetic beads in and out of the liquid storage space 21, so as to implement various purification steps for the nucleic acid, so that the nucleic acid extraction and detection can be automatically performed, the operation is simple and convenient, the detection results are stable, and the difficulty of implementing a large number of tests is reduced.
  • the sealing film 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.
  • the PCR reaction component 50 and the detection probe are provided on one side of the nucleic acid purification kit, the problem that conventional PCR reagents need to be stored frozen is solved, and the needle tube 52 punctures and samples to achieve the transfer and preparation of the PCR reaction liquid, thus solving the problem of liquid transfer between the liquid storage of the nucleic acid purification liquid and the preparation of the PCR reaction liquid.
  • the terms “installed”, “connected”, “connected” and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral 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, or it can be the internal communication of two components.
  • installed can be a fixed connection, a detachable connection, or an integral 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, or it can be the internal communication of two components.

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Abstract

本申请公开了一种核酸纯化试剂盒及检测装置，核酸纯化试剂盒包括：壳体组件，具有容置空间；储液组件，位于容置空间内，储液组件具有沿预设方向排列的多个储液空间，多个储液空间用于纯化核酸；传动组件，固定设置在储液组件的上方，传动组件用于带动储液组件沿预设方向进行往复运动；磁棒组件，位于储液组件的上方，磁棒组件用于吸附磁珠；传动组件驱动储液组件移动，使不同的储液空间运动至磁棒组件下方，磁棒组件吸附或者下方磁珠至不同的储液空间。本申请通过设置磁棒组件可吸附磁珠分别进出多个储液空间，使得能够自动进行核酸提取检测，操作简单方便、检测结果稳定、降低了大量检测的实现难度。

Description

一种核酸纯化试剂盒及检测装置 技术领域
本申请涉及核酸检测技术领域，特别是涉及一种核酸纯化试剂盒及检测装置。
背景技术
随着疾病种类和数量的增加，为了降低对人类生活的影响，快速和准确的疾病检测对于最大限度地提高危机管理效率、治疗效果和经济稳定至关重要。然而，目前疾病检测集中在中央实验室，通常病人的样本会被带到医院或诊所进行检测，检测结果会在几天内反馈，对于一些距离疾病检测点较远的地区，由于缺乏熟练的人员和医疗基础设施，疾病检测往往会更久。因此，对便携、易于使用和即时诊断检测(POCT，即Point-Of-Care Testing)的需求正在迅速增加。
在现有技术中，需要使用离心柱法或磁珠法进行核酸提取，一般需要进行裂解、结合、洗脱等步骤，目前一般采用的是手动转移的方式，即进行完裂解步骤后，再手动转移至对应的试管内，进行结合步骤，结合完成后，再手动转移至对应的试管内，进行洗脱步骤，如此依次手动转移，实现核酸提取，不仅操作繁琐、费时费力，且样本很难充分、高效的转移，人工操作使得作业过程不稳定，进而极易导致检测结果不稳定，使得大量检测实现难度大。
发明内容
有鉴于此，本申请提供了一种核酸纯化试剂盒及检测装置，以解决现有技术中手动转移进行核酸提取检测，带来的操作繁琐、检测结果不稳定、大量检测实现难度大的问题。
本申请提出一种核酸纯化试剂盒，包括：
壳体组件，具有容置空间；
储液组件，位于所述容置空间内，所述储液组件具有沿预设方向排列的多个储液空间，多个所述储液空间用于纯化核酸；
传动组件，固定设置在所述储液组件的上方，所述传动组件用于带动所述储液组件沿所述预设方向进行往复运动；
磁棒组件，位于所述储液组件的上方，所述磁棒组件用于吸附磁珠；
所述传动组件驱动所述储液组件移动，使不同的所述储液空间运动至所述磁棒组件下 方，所述磁棒组件吸附或者下方所述磁珠至不同的所述储液空间。
可选地，所述储液组件包括封口膜，所述封口膜用于封闭多个所述储液空间。
可选地，所述壳体组件上设置有第一通孔；
所述磁棒组件包括驱动机构和磁棒套，所述磁棒套电连接于所述驱动机构，所述磁棒套一端设置有第一凸台，所述磁棒套另一端穿过所述第一通孔朝向所述容置空间延伸，且所述第一凸台卡嵌于所述第一通孔外。
可选地，所述磁棒套包括第一沉孔，所述第一沉孔位于朝向所述第一凸台的一端；
所述磁棒组件包括磁棒件，所述驱动机构电连接于所述磁棒件，所述磁棒件套设在所述第一沉孔内，且所述磁棒件用于吸附磁珠。
可选地，所述磁棒套包括震动件，所述震动件位于所述磁棒套内，且远离所述第一沉孔设置，所述震动件电连接于所述驱动机构。
可选地，多个所述储液空间包括并列设置的第一储液腔、第二储液腔、第三储液腔、第四储液腔和第五储液腔，所述磁棒组件可分别朝向所述第一储液腔、所述第二储液腔、所述第三储液腔、所述第四储液腔和所述第五储液腔内往复运动；
所述第一储液腔用于放置裂解液，所述第二储液腔用于放置磁珠保存液，所述第三储液腔用于放置第一清洗液，所述第四储液腔用于放置第二清洗液，所述第五储液腔用于放置纯水。
可选地，所述核酸纯化试剂盒包括加热组件，所述加热组件位于所述第一储液腔的底部，用于为所述第一储液腔加热。
可选地，多个所述储液空间开口处两侧设置有齿条；
所述传动组件包括齿轮，所述齿轮啮合于所述齿条，以使所述齿条带动所述储液组件往复运动。
可选地，所述传动组件包括齿轮轴，所述齿轮轴两端连接于核酸检测仪器，所述齿轮穿设在所述齿轮轴上，所述齿轮轴带动所述齿轮转动；
所述齿轮轴上设置有开膜部，所述开膜部在所述储液组件运动过程中打开所述封口膜。
本申请还提出一种核酸检测装置，包括：
如上所述的核酸纯化试剂盒，所述壳体组件上设置有第二通孔；
PCR反应组件，包括反应腔和针管，所述反应腔用于放置冻干球和固体石蜡，所述针管一端连通于所述反应腔，所述针管另一端穿过所述第二通孔连通于所述第五储液腔；
检测探针，位于所述PCR反应组件的一侧，所述检测探针用于发出检测荧光；
所述第五储液腔内的反应液进入所述反应腔进行PCR反应，并使用所述检测探针发出检测荧光进行检测。
本申请的有益效果是：区别于现有技术，本申请通过设置壳体组件，为储液组件、传动组件和磁棒组件提供了容置空间，使得核酸纯化过程在壳体组件内完成，壳体组件使得核酸纯化检测环境全封闭，在完全封闭的状态实现样本核酸的裂解、核酸结合、清洗、洗脱以及PCR检测，保证了核酸提取及扩张过程的密闭性，减少外界气溶胶对检测结果的干扰，以及防止样本对检测人员的传染危害，实现了样本进结果出的全自动化检测过程；其次，本申请通过在储液组件内设置多个储液空间，使得多个储液空间用于纯化核酸，在储液空间内完成核酸的裂解、核酸的结合、核酸的清洗以及核酸的洗脱等过程，无需人工手动转移降低了操作繁琐度，增大了检测结果的稳定性，便于实现大量检测；另外，本申请通过将传动组件固定在储液组件的上方，传动组件可带动储液组件往复运动，传动组件能将储液组件的任一位置运动至磁棒组件的下方，当需要对对应的储液空间内的核酸完成一个步骤时，可使用磁棒组件将核酸在多个储液空间之间转移；此外，本申请通过设置磁棒组件用于吸附磁珠，磁珠吸附核酸，实现核酸在多个储液空间之间转移，即当传动组件带动相应的储液空间运动至磁棒组件下方时，磁棒组件可吸附磁珠进出储液空间，以对核酸实施纯化的各种步骤，使得能够自动进行核酸提取检测，操作简单方便、检测结果稳定、降低了大量检测的实现难度。
应当理解的是，以上的一般描述和后文的细节描述仅是示例性和解释性的，而非限制本申请。
附图说明
为了更清楚地说明本申请实施例中的技术方案，下面将对实施例描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1是本申请壳体组件的结构示意图；
图2是本申请核酸纯化试剂盒的结构示意图；
图3是本申请储液组件和磁棒组件的结构示意图；
图4是本申请封口膜和卷动机构的结构示意图。
其中，图中各附图标记：10、壳体组件；11、容置空间；13、第一壳体；14、第二壳体；15、卡扣结构；20、储液组件；21、储液空间；22、封口膜；23、齿条；24、第一储液腔；25、第二储液腔；26、第三储液腔；27、第四储液腔；28、第五储液腔；30、传动组件；31、齿轮；32、齿轮轴；34、尖刺；35、卷动机构；40、磁棒组件；42、磁棒套；43、第一凸台；44、第一沉孔；50、PCR反应组件；52、针管。
具体实施方式
为使本领域的技术人员更好地理解本申请的技术方案，下面结合附图和具体实施方式对本申请所提供的核酸纯化试剂盒及检测装置做进一步详细描述。可以理解的是，所描述的实施例仅仅是本申请一部分实施例，而不是全部实施例。基于本申请中的实施例，本领域普通技术人员在没有做出创造性的劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
本申请中的术语“第一”、“第二”等是用于区别不同对象，而不是用于描述特定顺序。此外，术语“包括”和“具有”以及它们任何变形，意图在于覆盖不排他的包含。例如包含了一系列步骤或单元的过程、方法、系统、产品或设备没有限定于已列出的步骤或单元，而是可选地还包括没有列出的步骤或单元，或可选地还包括对于这些过程、方法、产品或设备固有的其他步骤或单元。
本申请提供一种核酸纯化试剂盒及检测装置，以解决现有技术中手动转移进行核酸提取检测，带来的操作繁琐、检测结果不稳定、大量检测实现难度大的问题。
请参阅图1至图4，图1是本申请壳体组件的结构示意图；图2是本申请核酸纯化试剂盒的结构示意图；图3是本申请储液组件和磁棒组件的结构示意图；图4是本申请封口膜和卷动机构的结构示意图。
在一实施例中，如图1至图4所示，本申请提出一种核酸纯化试剂盒，可用于核酸检测仪器，核酸纯化试剂盒包括壳体组件10、储液组件20、传动组件30和磁棒组件40。其中，壳体组件10可具有容置空间11，储液组件20可位于容置空间11内，储液组件20可沿预设方向排列的具有多个储液空间21，多个储液空间21可用于纯化核酸，预设方向可以设置为一排、一列或者其它形状排列，传动组件30可固定设置在储液组件20的上方，传动组件30可用于带动储液组件20沿所述预设方向进行往复运动，磁棒组件40可位于储液组件20的上方，且可位于传动组件30的一侧，磁棒组件40可用于吸附磁珠，磁珠可用于在多个储液空间21之间转移核酸，当传动组件30带动相应的储液空间21运动至 磁棒组件40下方时，磁棒组件40吸附或者下方磁珠进出不同的储液空间21。
在本申请的实施例中，本申请采用传统的磁棒法提取样本核酸的原理，将纯化核酸的各个工序的反应液分别放置于多个储液空间21内，通过磁珠吸附核酸，磁棒组件40吸附带有核酸的磁珠，完成核酸在多个储液空间21之间的转移，以使核酸在全封闭的储液空间21内完成核酸的裂解、核酸的结合、核酸的清洗以及核酸的洗脱等过程，对复杂样本从核酸提取及纯化到PCR检测的全集成，节省了检测的前处理时间，且无需人工手动转移降低了操作繁琐度，增大了检测结果的稳定性，便于实现大量检测；其次，本申请通过将传动组件30固定在储液组件20的上方，传动组件30可带动储液组件20往复运动，传动组件30能将储液组件20的任一位置运动至磁棒组件40的下方，当需要对对应的储液空间21内的核酸完成一个步骤时，可使用磁棒组件40将核酸在多个储液空间21之间转移；另外，本申请通过设置磁棒组件40用于吸附磁珠，磁珠吸附核酸，实现核酸在多个储液空间21之间转移，即当传动组件30带动相应的储液空间21运动至磁棒组件40下方时，磁棒组件40可吸附磁珠进出储液空间21，以对核酸实施纯化的各种步骤，使得能够自动进行核酸提取检测，操作简单方便、检测结果稳定、降低了大量检测的实现难度。
在一些实施例中，如图2至图3所示，多个储液空间21开口处两侧可设置有齿条23，传动组件30可包括齿轮31，齿轮31可啮合于齿条23，齿轮31滚动，进而驱动齿条23前后行进，以使齿条23带动储液组件20往复运动。
可选地，传动组件30可包括齿轮轴32，齿轮轴32两端可连接于核酸检测仪器，齿轮31可穿设在齿轮轴32上，齿轮轴32可带动齿轮31转动，核酸检测仪器将动力传递给齿轮轴32，齿轮31跟随齿轮轴32转动，以使齿轮31带动齿条23往复运动。
其中，通过齿轮31齿条23的啮合传动的设计，通过传动轴的转动带动试剂储存的储液组件20进行水平移动，实现磁棒组件40正下方多个储液空间21内不同溶液的切换。
在一些实施例中，如图4所示，储液组件20可包括封口膜22，封口膜22可用于封闭多个储液空间21，减少多个储液空间21内的反应液、核酸与外界空气的接触。
可选地，封口膜22可设置为铝膜，并采用热封将铝膜封口置在储液空间21开口处。
在一些实施例中，齿轮轴32上可设置有开膜部，开膜部可在储液组件20运动过程中打开封口膜22，便于磁棒组件40进出储液空间21。
可选地，如图2所示，齿轮轴32上可以设置有尖刺34，尖刺34一体连接在齿轮轴32上，尖刺34可跟随齿轮轴32转动，尖刺34在转动过程中用于刺破封口膜22，方便正上方的磁棒套42在磁棒件的带动下进入储液空间21内进行磁珠的转移。
其中，尖刺34可设置为多个，多个尖刺34分别分布在齿轮轴32的四周，以使齿轮轴32转动过程中，一直有尖刺34刺破封口膜22，减少磁棒组件40进出储液空间21的阻力。
可选地，如图4所示，传动组件30还可以包括卷动机构35，卷动机构35可位于两个齿轮31之间，并连接于齿轮轴32，手动撕开一些第一储液腔24处的封口膜22，将封口膜22的起始端卷在齿轮轴32上，在齿轮轴32转动过程中，卷动机构35跟随卷起封口膜22，以使打开多个储液空间21。在齿轮轴32转动过程中，当某个储液空间21不需要使用时，卷动机构35可松开对应的封口膜22，临时覆盖储液空间21，减少储液空间21内的反应液与空气接触，还保留了封口膜22的完整性。
在一些实施例中，壳体组件10上可设置有第一通孔，磁棒组件40可包括驱动机构和磁棒套42，磁棒套42可电连接于驱动机构，磁棒套42一端可设置有第一凸台43，磁棒套42另一端可穿过第一通孔朝向容置空间11延伸，且第一凸台43可卡嵌于第一通孔外，以使磁棒套42不会完全掉落进入容置空间11内，磁棒套42具有可伸缩功能，驱动机构可电动控制驱动磁棒套42伸缩进出储液空间21内。
可选地，磁棒套42可以设置为硅胶材质，硅胶材质不会干扰磁棒件的磁性。
在一些实施例中，磁棒套42可以包括第一沉孔44，第一沉孔44可设置在朝向第一凸台43的一端，即第一沉孔44位于磁棒套42的上半部分，磁棒组件40可以包括磁棒件，驱动机构可电连接于磁棒件，磁棒件可以套设在第一沉孔44内，且磁棒件可用于吸附磁珠。
可以理解的，驱动机构电动控制磁棒套42和磁棒件运动，驱动机构可电动驱动磁棒件进出第一沉孔44内，当磁棒件位于第一沉孔44内时，磁棒套42的上半部分具有磁性，可以吸附磁珠；当磁棒件离开第一沉孔44内时，磁棒套42的上半部分不具有磁性，不可以吸附磁珠。
可选地，磁棒件可以设置为电磁件，也可在磁棒件内设置磁芯，使得磁棒件进入第一沉孔44内时，具有吸附功能即可。
在一些实施例中，磁棒套42可包括震动件，震动件可位于磁棒套42内，且震动件可远离第一沉孔44设置，即位于磁棒套42的底部，震动件可电连接于驱动机构，当磁棒套42进入储液空间21内时，其启动驱动机构的开关，使得磁棒套42震动，使得储液空间21内的核酸纯化反应更充分。
可选地，震动件可以设置为超声元器件，还可以设置为振动周期与声波频率数量级相 当的震动器件，能够满足需要即可，此处不再一一赘述。
在一些实施例中，核酸纯化试剂盒还可以包括加热组件，加热组件可设置在第一储液腔24的底部，当进行核酸裂解时，加热组件用于为第一储液腔24内的核酸裂解过程加热。
在一些实施例中，如图3所示，多个储液空间21可包括并列设置的第一储液腔24、第二储液腔25、第三储液腔26、第四储液腔27和第五储液腔28，磁棒组件40可分别朝向第一储液腔24、第二储液腔25、第三储液腔26、第四储液腔27和第五储液腔28内往复运动。其中，第一储液腔24可位于远离第二通孔的位置，以使第五储液腔28位于第二通孔处，便于针管52刺入橡胶材质的第五储液腔28。第一储液腔24可用于放置裂解液，第二储液腔25可用于放置磁珠保存液，第三储液腔26可用于放置第一清洗液，第四储液腔27可用于放置第二清洗液，第五储液腔28可用于放置纯水或者其他洗脱液。
可选地，本申请的核酸纯化试剂盒可以使用的检测样本包括且不限于痰液、组织、血液、粪便，本申请的核酸纯化试剂盒可针对不同种类的样本配置不同的反应液，设置不同的处理方式，如化学裂解液异硫氰酸胍、生物酶裂解液蛋白酶K、以及加热和机械剪切等。
样本裂解的工作过程：手动撕开第一储液腔24上方的一点封口膜22，将样本加入到第一储液腔24后，盖上第二壳体14，在第一储液腔24内裂解液的作用下，实现样本的裂解，在裂解的过程中可以使用加热组件对第一储液腔24外部进行加热至70摄氏度，更好的促进样本的裂解。
核酸结合的工作过程：待样本在第一储液腔24内的裂解过程中，可同时通过外部配套的核酸检测仪器提供动力，使得齿轮轴32驱动存有磁珠保存液的第二储液腔25，移动到磁棒套42的正下方，核酸检测仪器的驱动机构对磁棒件施加推动力，将磁棒件对准磁棒套42向下运动至第二储液腔25的底部，在磁棒件磁场的作用下，磁珠被全部吸附在磁棒套42的顶部。
待完成磁珠的磁吸后，磁棒件和磁棒套42一起缓慢向上运动至磁棒套42恢复初始位置后停止运动，接下来核酸检测仪器驱动齿轮轴32转动，使第一储液腔24位移至磁棒套42的正下方，磁棒件和磁棒套42一起开始缓慢向下运动至第一储液腔24的底部，驱动机构驱动磁棒件恢复初始位置，但磁棒套42还保留原位置不动，由于磁棒套42内无磁棒件，磁棒套42失去磁场，磁珠在磁棒套42的振荡作用下均匀分散在第一储液腔24的裂解液中，此时，驱动机构启动震动件，使得震动件震动第一储液腔24内的裂解液，震动件持续保持振荡状态，促进磁珠和裂解液中的个个核酸结合。
核酸清洗的工作过程：磁珠在第一储液腔24内完成吸附核酸后，关闭震动件，磁棒 件向下运动至磁棒套42内，在磁棒件的磁场作用下，将裂解液中的磁珠吸附到磁棒套42的顶部位置，磁棒件、磁棒套42一起向上运动至磁棒组件40的初始状态位置。
接下来核酸检测仪器驱动齿轮轴32转动，将放置第一清洗液的第三储液腔26移动到磁棒组件40的正下方位置，磁棒件及磁棒套42一起向下运动至第一清洗液中，磁棒离开磁棒套42，开启震动件，磁棒套42顶部的磁珠在磁棒套42的振荡作用下完全分散到第一清洗液中，完成清洗后，关闭震动件，磁棒件向下运动到磁棒套42内，将第一清洗液中的磁珠吸附到硅胶套的顶部，完成磁珠的吸附后，磁棒件和磁棒套42一起上升到初始位置停留。
核酸检测仪器继续驱动齿轮轴32转动，将放置第二清洗液的第四储液腔27移动到磁棒组件40的正下方位置，磁棒及磁棒套42一下向下运动到第二清洗液中，磁棒件离开磁棒套42，磁棒套42顶部的磁珠失去磁吸力，启动震动件，磁珠在磁棒套42的振荡作用下完全分散到第二清洗液中，完成二级清洗后，关闭震动件，磁棒件向下运动到磁棒套42内，将第二清洗液中的磁珠吸附到磁棒套42的顶部，完成磁珠的吸附后，磁棒件和磁棒套42一起上升到初始位置停留，可悬空保持停留1-5min，以使磁珠上附着的有机溶液挥发干净。
核酸洗脱的工作过程：待磁珠干燥完成后，核酸检测仪器驱动齿轮轴32，使放置有洗脱液的第五储液腔28处于弹性磁棒套42的正下方位置，磁棒和磁棒套42往下运动到洗脱液中，启动震动件，振动磁棒套42使磁珠充分分散到洗脱液中，等待1-5min后，关闭震动件，磁棒件往下运动，完成吸磁后，磁棒件和磁棒套42往上运动离开洗脱液，完成核酸的提取。
本申请的核酸纯化试剂盒适合于多种临床样本，如尿液、血液、鼻咽拭子、痰液、组织、粪便等样本，能兼容多种形式的样本，还可以根据具体的样本调整试剂配方及增减处理步骤，或者预置不同的储液空间21的位置，储液空间21的数量及形状均可以根据具体的需求进行变更调整。
核酸纯化试剂盒集成了核酸提取和检测试剂，样本添加后，即可实现全封闭自动化处理，不与外部空气连通，能极大地避免外部环境对检测结果的影响，也能保护检测人员的健康，实现了“样本进结果出”的自动化装置；
可选地，第五储液腔28远离第一储液腔24的侧壁上可设置有第三通孔，第三通孔可使用橡胶塞封闭，以使第五储液腔28处于封闭状态，橡胶塞可便于PCR反应时针管52刺破橡胶塞进而进入第五储液腔28内，取出核酸提纯液。
可选地，壳体组件10可包括第一壳体13和第二壳体14，第一壳体13设置在底部，第一壳体13具有第一平台，齿条23放置在第一平台上，以使储液组件20以第一平台为支撑力悬挂，便于取放储液组件20。第二壳体14设置在顶部，配合于第一壳体13，第一壳体13和第二壳体14之间设置有卡扣结构15，使得第一壳体13和第二壳体14之间封闭更严实，隔绝外界，为核酸提取过程实现全密封的环境。
其中，核酸纯化试剂盒的外部尺寸可以分别设置为长120mm、高65mm、宽24mm，以使核酸纯化试剂盒更小巧便携。
可选地，本申请的核酸纯化试剂盒可采用注塑成型的加工方式，可以实现批量化生产，具有产量高，成本低等优势。
本申请还提出一种核酸检测装置，包括如上实施例任一项的核酸纯化试剂盒、PCR反应组件50(Polymerase Chain Reaction，指聚合酶链式反应)和检测探针。其中，壳体组件10上可设置有第二通孔，PCR反应组件50可包括反应腔和针管52，反应腔可用于放置冻干球和固体石蜡，针管52一端可连通于反应腔，针管52另一端可穿过第二通孔连通于第五储液腔28，检测探针可设置在PCR反应组件50的一侧，检测探针用于发出检测荧光，在外部推力的作用下，针管52可以刺穿磁棒组件40的第五储液腔28，第五储液腔28内的反应液进入反应腔和冻干球混合后进行PCR反应，并使用检测探针发出检测荧光进行检测。
在一些实施例中，核酸检测装置还可以包括PCR反应加热部，PCR反应加热部设置在PCR反应组件50的一侧，并用于为PCR反应组件50加热，以使满足PCR反应的条件。
PCR反应组件50的工作过程：
首先，配制PCR反应液的过程，PCR反应组件50内置有PCR反应所需试剂的冻干球，在配套的核酸检测仪器的辅助下，PCR反应组件50的针管52通过第五储液腔28内壁上的橡胶塞刺入核酸提纯液中，在外部的压力作用下，核酸纯化液顺着进样针进入到PCR的反应腔内将冻干球复融。
再次，PCR反应及检测的过程，在配套核酸检测仪器的辅助下，当温度上升后，PCR反应腔内的固体石蜡会溶解并上浮到反应腔室的液体上层，可以起到防止液体蒸发的作用，并使用PCR反应加热部进行加热，在PCR反应的过程中，根据反应进行检测探针荧光检测。
可选地，本申请的冻干球还可以根据需要进行变更，不仅可以应用于核酸检测装置，还可以应用于核酸检测仪器，还可以应用于RPA(Robotic Process Automation，即机器人 流程自动化)及其他PCR方法所用到的试剂体系和探针体系，均属于本申请的保护范围。
本申请的冻干球的形式实现PCR试剂的存放，解决了常规PCR试剂需要冷冻保存的问题，且本申请采用针管52穿刺取样的方式实现PCR反应液的转移及配制，解决了核酸提纯液的液体保存与配制PCR反应液之间存在的液体转移难题。
综上所述，本申请通过设置壳体组件10具有容置空间11，设置储液组件20位于容置空间11内，使得储液组件20具有多个储液空间21，设置多个储液空间21用于纯化核酸，将传动组件30固定设置在储液组件20的上方，使得传动组件30用于带动储液组件20往复运动，设置磁棒组件40位于储液组件20的上方，且位于传动组件30的一侧，使得磁棒组件40用于吸附磁珠，磁珠用于在多个储液空间21之间转移核酸，将核酸放置在相应的储液空间21内，当传动组件30带动相应的储液空间21运动至磁棒组件40下方时，磁棒组件40可吸附磁珠进出储液空间21，以对核酸实施各种纯化的步骤，使得能够自动进行核酸提取检测，操作简单方便、检测结果稳定、降低了大量检测的实现难度。其次，通过设置储液组件20包括封口膜22，封口膜22用于封闭多个储液空间21，减少多个储液空间21内的反应液、核酸与外界空气的接触，增加核酸检测的稳定性。此外，通过在核酸纯化试剂盒一侧设置PCR反应组件50和检测探针，解决了常规PCR试剂需要冷冻保存的问题，且针管52穿刺取样的方式实现PCR反应液的转移及配制，解决了核酸提纯液的液体保存与配制PCR反应液之间存在的液体转移难题。
需要说明的是，本申请实施例中介绍的多种可选的实施方式，彼此可以相互结合实现，也可以单独实现，对此本申请实施例不作限定。
在本申请的描述中，需要理解的是，术语“上”、“下”、“左”、“右”等指示方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以及特定的方位构造和操作。因此，不能理解为对本申请的限制。此外，“第一”、“第二”仅由于描述目的，且不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。因此，限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者多个该特征。本申请的描述中，除非另有说明，“多个”的含义是两个或两个以上。
在本申请的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”等应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接连接，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术 语在本申请中的具体含义。
上述实施例是参考附图来描述的，其他不同的形式和实施例也是可行而不偏离本申请的原理，因此本申请不应被建构成为在此所提出实施例的限制。更确切地说，这些实施例被提供以使得本申请会是完善又完整，且会将本申请范围传达给本领域技术人员。在附图中，组件尺寸及相对尺寸也许基于清晰起见而被夸大。在此所使用的术语只是基于描述特定实施例目的，并无意成为限制。术语“包含”及/或“包括”在使用于本说明书时，表示所述特征、整数、构件及/或组件的存在，但不排除一或更多其他特征整数、构件、组件及/或其族群的存在或增加。除非另有所示，陈述时，数值范围包含该范围的上下限及其间的任何子范围。
以上所述仅为本申请的部分实施例，并非因此限制本申请的保护范围，凡是利用本申请说明书及附图内容所作的等效装置或等效流程变换，或直接或间接运用在其他相关的技术领域，均同理包括在本申请的专利保护范围内。

Claims (10)

  1. 一种核酸纯化试剂盒，其特征在于，包括：
    壳体组件，具有容置空间；
    储液组件，位于所述容置空间内，所述储液组件具有沿预设方向排列的多个储液空间，多个所述储液空间用于纯化核酸；
    传动组件，固定设置在所述储液组件的上方，所述传动组件用于带动所述储液组件沿所述预设方向进行往复运动；
    磁棒组件，位于所述储液组件的上方，所述磁棒组件用于吸附磁珠；
    所述传动组件驱动所述储液组件移动，使不同的所述储液空间运动至所述磁棒组件下方，所述磁棒组件吸附或者下方所述磁珠至不同的所述储液空间。
  2. 根据权利要求1所述的核酸纯化试剂盒，其特征在于，所述壳体组件上设置有第一通孔；
    所述磁棒组件包括驱动机构和磁棒套，所述磁棒套电连接于所述驱动机构，所述磁棒套一端设置有第一凸台，所述磁棒套另一端穿过所述第一通孔朝向所述容置空间延伸，且所述第一凸台卡嵌于所述第一通孔外。
  3. 根据权利要求2所述的核酸纯化试剂盒，其特征在于，所述磁棒套包括第一沉孔，所述第一沉孔位于朝向所述第一凸台的一端；
    所述磁棒组件包括磁棒件，所述驱动机构电连接于所述磁棒件，所述磁棒件套设在所述第一沉孔内，且所述磁棒件用于吸附磁珠。
  4. 根据权利要求3所述的核酸纯化试剂盒，其特征在于，所述磁棒套包括震动件，所述震动件位于所述磁棒套内，且远离所述第一沉孔设置，所述震动件电连接于所述驱动机构。
  5. 根据权利要求1所述的核酸纯化试剂盒，其特征在于，多个所述储液空间包括并列设置的第一储液腔、第二储液腔、第三储液腔、第四储液腔和第五储液腔，所述磁棒组件可分别朝向所述第一储液腔、所述第二储液腔、所述第三储液腔、所述第四储液腔和所述第五储液腔内往复运动；
    所述第一储液腔用于放置裂解液，所述第二储液腔用于放置磁珠保存液，所述第三储液腔用于放置第一清洗液，所述第四储液腔用于放置第二清洗液，所述第五储液腔用于放置纯水。
  6. 根据权利要求5所述的核酸纯化试剂盒，其特征在于，所述核酸纯化试剂盒包括加热组件，所述加热组件位于所述第一储液腔的底部，用于为所述第一储液腔加热。
  7. 根据权利要求1所述的核酸纯化试剂盒，其特征在于，所述储液组件包括封口膜，所述封口膜用于封闭多个所述储液空间。
  8. 根据权利要求7所述的核酸纯化试剂盒，其特征在于，多个所述储液空间开口处两侧设置有齿条；
    所述传动组件包括齿轮，所述齿轮啮合于所述齿条，以使所述齿条带动所述储液组件往复运动。
  9. 根据权利要求8所述的核酸纯化试剂盒，其特征在于，所述传动组件包括齿轮轴，所述齿轮轴两端连接于核酸检测仪器，所述齿轮穿设在所述齿轮轴上，所述齿轮轴带动所述齿轮转动；
    所述齿轮轴上设置有开膜部，所述开膜部在所述储液组件运动过程中打开所述封口膜。
  10. 一种核酸检测装置，其特征在于，包括：
    如权利要求1-9任一项所述的核酸纯化试剂盒，所述壳体组件上设置有第二通孔；
    PCR反应组件，包括反应腔和针管，所述反应腔用于放置冻干球和固体石蜡，所述针管一端连通于所述反应腔，所述针管另一端穿过所述第二通孔连通于第五储液腔；
    检测探针，位于所述PCR反应组件的一侧，所述检测探针用于发出检测荧光；
    所述第五储液腔内的反应液进入所述反应腔进行PCR反应，并使用所述检测探针发出检测荧光进行检测。
PCT/CN2023/102714 2023-06-14 2023-06-27 一种核酸纯化试剂盒及检测装置 Ceased WO2024254900A1 (zh)

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CN209508217U (zh) * 2018-12-17 2019-10-18 深圳先进技术研究院 一种数字pcr荧光检测装置
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CN219032123U (zh) * 2022-11-10 2023-05-16 深圳先进技术研究院 一种核酸提纯及检测反应液配制装置

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CN209508217U (zh) * 2018-12-17 2019-10-18 深圳先进技术研究院 一种数字pcr荧光检测装置
CN112226361A (zh) * 2020-10-15 2021-01-15 东南大学 一种基于磁珠转移和阀控移液的核酸检测卡盒及检测方法
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