WO2022154254A1 - Appareil de diagnostic moléculaire utilisant une cartouche de type rotatif - Google Patents

Appareil de diagnostic moléculaire utilisant une cartouche de type rotatif Download PDF

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Publication number
WO2022154254A1
WO2022154254A1 PCT/KR2021/017799 KR2021017799W WO2022154254A1 WO 2022154254 A1 WO2022154254 A1 WO 2022154254A1 KR 2021017799 W KR2021017799 W KR 2021017799W WO 2022154254 A1 WO2022154254 A1 WO 2022154254A1
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WIPO (PCT)
Prior art keywords
chamber
cartridge
reaction
reagent
nucleic acid
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PCT/KR2021/017799
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English (en)
Korean (ko)
Inventor
김근영
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(주)오상헬스케어
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Publication of WO2022154254A1 publication Critical patent/WO2022154254A1/fr

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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5085—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above for multiple samples, e.g. microtitration plates
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L7/00—Heating or cooling apparatus; Heat insulating devices
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L7/00—Heating or cooling apparatus; Heat insulating devices
    • B01L7/52—Heating or cooling apparatus; Heat insulating devices with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples
    • 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]
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/025—Align devices or objects to ensure defined positions relative to each other
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/04—Exchange or ejection of cartridges, containers or reservoirs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0647—Handling flowable solids, e.g. microscopic beads, cells, particles
    • B01L2200/0663—Stretching or orienting elongated molecules or particles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/10—Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0803—Disc shape

Definitions

  • the present invention uses a rotary cartridge that can improve convenience while realizing high sensitivity and specificity of molecular diagnostics by enabling quantitative and accurate nucleic acid extraction, amplification, and diagnosis simply by inserting a sample into a cartridge and driving the device. It is about molecular diagnostic devices.
  • Molecular diagnosis is a diagnostic technique that detects changes in various molecular levels occurring in cells.
  • nucleic acids are extracted from a sample and nucleic acids are analyzed by polymerase chain reaction (PCR). It is amplified to diagnose infectious diseases and the like.
  • PCR polymerase chain reaction
  • Patent No. 10-1667548 registered on October 13, 2016 "Rotational PCR chip, rotational RNA pretreatment chip and RNA pretreatment method using the same, rotational RT-PCR chip comprising them, and rotational RT-PCR method using the same"
  • the collected sample is subjected to a nucleic acid extraction process using various extraction reagents and equipment, the nucleic acid obtained through this process is mixed with an amplification reagent, and the result is installed in an expensive large real-time PCR equipment. Therefore, there are problems in that it is inconvenient to go through several procedures in the molecular diagnosis process, and it requires expensive and large-scale equipment, which is economical and has environmental restrictions on detection.
  • the present invention has been devised to solve the above problems,
  • the present invention uses a rotary cartridge that can improve convenience while realizing high sensitivity and specificity of molecular diagnostics by enabling quantitative and accurate nucleic acid extraction, amplification, and diagnosis simply by inserting a sample into a cartridge and driving the device.
  • An object of the present invention is to provide a molecular diagnostic device.
  • the present invention is implemented by an embodiment having the following configuration in order to achieve the above object.
  • the molecular diagnosis apparatus is characterized in that it includes a rotating cartridge that stores a reagent for extracting a nucleic acid and performs a reaction in which the nucleic acid is extracted from a sample.
  • the rotary cartridge rotates up and down, and the rotary cartridge includes an upper cartridge; a lower cartridge rotatably coupled to the upper cartridge and storing reagents for extracting nucleic acids; and a capture unit located in the lower cartridge to capture the nucleic acid dissolved from the sample, and using the vertical inversion of the rotary cartridge through left and right rotation of the lower cartridge and vertical rotation of the rotary cartridge, the capture unit It is characterized by supplying a reagent for extracting the nucleic acid to the.
  • the upper cartridge includes a temporary chamber in which the fluid is temporarily stored by being depressed from the lower surface to the upper side, and the lower cartridge is depressed from the upper surface to the lower side.
  • each of the plurality of reagent chambers stores different reagents, and when the rotation angle of the lower cartridge is changed, the reagent communicates with the temporary chamber.
  • the chamber is different, and it is characterized in that different reagents can be supplied to the capture unit.
  • the lower cartridge in the molecular diagnostic apparatus according to the present invention, is recessed from the top to the bottom, stores the PCR reagent, receives the nucleic acid eluted from the capture unit, and receives a polymerase It further includes a PC chamber in which a chain reaction occurs, the lower cartridge is rotated at a predetermined angle to communicate the extraction chamber and the temporary chamber, and the rotational cartridge is rotated up and down to invert the rotary cartridge up and down to elution of the extraction chamber After moving the fluid containing the nucleic acid to the temporary chamber, the lower cartridge is rotated at a predetermined angle to communicate the PC chamber and the temporary chamber, and the rotational cartridge is rotated up and down to invert the rotary cartridge up and down to create a temporary chamber. The fluid containing the eluted nucleic acid is moved to the PCR chamber, and the fluid containing the eluted nucleic acid of the extraction chamber is supplied to the PCR chamber.
  • the molecular diagnosis apparatus further includes a temperature module for supplying heat so that a polymerase chain reaction occurs in the PCR chamber, and rotates the lower cartridge left and right to make the
  • a temperature module for supplying heat so that a polymerase chain reaction occurs in the PCR chamber, and rotates the lower cartridge left and right to make the
  • the PC chamber sequentially has a temperature for each process required for amplification of a nucleic acid by a polymerase chain reaction.
  • the lower cartridge further includes a waste liquid chamber storing waste fluid in the extraction chamber, and the extraction chamber and the waste liquid chamber are connected by a communication path.
  • a valve is installed in the communication path, and by controlling the operation of the valve to open the communication path, the waste fluid in the extraction chamber is stored in the waste liquid chamber, and the reagent chamber is a dissolution chamber in which a dissolution buffer for dissolving the sample is stored.
  • a washing chamber storing a washing buffer for washing the capture unit
  • an elution chamber storing an elution buffer for eluting the nucleic acid captured by the capturing unit.
  • the rotary cartridge in the molecular diagnosis apparatus according to the present invention, includes a reagent receiving unit for storing reagents used for extracting nucleic acids; a solution supply control unit located below the reagent receiving unit and rotatably coupled to the reagent receiving unit to supply different types of reagents to the reaction chamber according to the rotation angle; It is located below the solution supply control unit, characterized in that it comprises a reaction chamber unit in which a reaction in which the nucleic acid is extracted from the sample by receiving the reagent.
  • the rotatable cartridge is located below the reaction chamber, and further includes a reaction fluid receiving portion rotatably coupled to the reaction chamber in the left and right directions.
  • the reaction fluid accommodating unit includes a waste liquid chamber accommodating the waste fluid discharged from the reaction chamber unit, a PC accommodating a PC reagent, and a PC receiving a fluid containing a nucleic acid from the reaction chamber unit to cause a polymerase chain reaction and an R chamber, wherein only one of the waste liquid chamber and the PCR chamber communicates with the reaction chamber part according to the rotation angle of the reaction fluid accommodating part.
  • the rotary cartridge is inserted into the stacked reagent accommodating part, solution supply control part, and reaction chamber part in turn, and has magnetic properties to produce magnetic beads. It further includes a pulling rod, wherein the reaction chamber reacts with a sample, a magnetic bead binding to a nucleic acid, and a reagent for extracting the nucleic acid.
  • the molecular diagnostic apparatus further includes a controller for controlling left and right rotation of the solution supply control unit and the reaction fluid receiving unit, and the reagent receiving unit is a dissolution buffer for dissolving the sample is stored, and includes a dissolution chamber into which a sample and magnetic beads are introduced, a washing chamber in which a washing buffer is stored, and an elution chamber in which an elution buffer for eluting nucleic acids is stored, wherein the reaction chamber includes a sample, magnetic beads, and nucleic acids from the sample. It is characterized in that it comprises a reaction chamber in which the reagent used to extract the reaction is introduced.
  • the controller rotates the solution supply control unit so that the dissolution chamber and the reaction chamber communicate with each other, so that the sample, magnetic beads and dissolution buffer are included.
  • a fluid is supplied to the reaction chamber so that the eluted nucleic acid binds to the magnetic beads, and the magnetic beads to which the nucleic acid is bound gather on the wall of the reaction chamber adjacent to the rod part by magnetic force, so that the nucleic acid is eluted, and the nucleic acid is eluted
  • the controller rotates the reaction fluid receiving part to communicate the reaction chamber and the waste liquid chamber so that the waste fluid including the reaction sample and the dissolution buffer in the reaction chamber flows into the waste liquid chamber.
  • the rotary cartridge rotates up and down, the rotary cartridge stores reagents for extracting nucleic acids, and a reaction unit including a plurality of accommodating chambers in which a reaction occurs; and a flow path forming part that is rotatably coupled to the reaction part and communicates with specific accommodation chambers as it rotates, and by using the vertical rotation of the flow path forming part and the vertical rotation of the rotary cartridge, the fluid is transferred from the one accommodation chamber. It is characterized in that it can be moved to another receiving chamber.
  • the molecular diagnostic apparatus further includes a controller for controlling left and right rotation of the rotary cartridge and the flow path forming unit, wherein the controller is a rotary type One accommodating chamber having the fluid that has been reacted by rotating the cartridge is located on the upper side, and the other accommodating chamber to be supplied with the fluid is located at the lower side, and then the flow path forming part is rotated to separate the one accommodating chamber and the other accommodating chamber It is characterized in that the fluid in one accommodating chamber flows into the other accommodating chamber by gravity by communicating.
  • the reaction part is recessed from the front side to the rear side, and an insertion groove into which the protruding insertion part of the flow path forming part is inserted, and the receiving chamber and the receiving chamber are spaced apart.
  • the flow path forming part is formed to protrude from the rear side and inserted into the insertion groove, and the protruding insertion part is formed to communicate with the receiving chambers or between the receiving chamber and the fish chamber as the flow path forming part rotates. It is characterized in that it includes an opening and closing part.
  • the present invention can obtain the following effects by the configuration, combination, and use relationship described below with the present embodiment.
  • the present invention has the effect of improving convenience while realizing high sensitivity and specificity of molecular diagnosis by enabling quantitative and accurate nucleic acid extraction, amplification, and diagnosis simply by inserting a sample into a cartridge and driving the device.
  • FIG. 1 is a perspective view of a molecular diagnostic apparatus according to the present invention.
  • FIG. 2 is a schematic plan view of the molecular diagnostic apparatus according to an embodiment of the present invention, viewed from above with a cover removed;
  • Fig. 3 is a schematic front view of the molecular diagnostic apparatus of Fig. 2 when the housing is cut along the line A-A and viewed from the front;
  • FIG. 4 is a perspective view of a cartridge constituting a molecular diagnostic apparatus according to an embodiment of the present invention.
  • Figure 5 is an exploded perspective view of the cartridge of Figure 4.
  • FIG. 6 is a block diagram of a controller used in a molecular diagnosis apparatus according to an embodiment of the present invention.
  • FIG. 7 is a reference diagram for explaining an operation process of the molecular diagnostic apparatus according to an embodiment of the present invention.
  • FIG. 8 is a schematic plan view of a molecular diagnostic apparatus according to another exemplary embodiment of the present invention with a cover removed, as viewed from above;
  • Fig. 9 is a schematic front view of the molecular diagnostic apparatus of Fig. 8 when the housing is cut along the line B-B and viewed from the front;
  • FIG. 10 is an exploded perspective view of a cartridge constituting a molecular diagnostic apparatus according to another embodiment of the present invention, viewed from above;
  • FIG. 11 is an exploded perspective view of a cartridge constituting a molecular diagnostic apparatus according to another embodiment of the present invention, viewed from the bottom;
  • FIG. 12 is a schematic plan view of a molecular diagnostic apparatus according to another embodiment of the present invention with a cover removed, viewed from above;
  • FIG. 13 is an exploded perspective view of a cartridge constituting a molecular diagnostic apparatus according to another embodiment of the present invention.
  • FIG. 14 is a cross-sectional view of a cartridge constituting a molecular diagnostic apparatus according to another embodiment of the present invention.
  • 15 is a reference diagram for explaining an operation process of a molecular diagnostic apparatus according to another embodiment of the present invention.
  • the molecular diagnostic apparatus includes a housing 11 forming an outer shape, and upper and lower portions inside the housing 11 .
  • a cartridge 12 for extracting and amplifying a nucleic acid is rotatably coupled to invert up and down, a vertical rotation driving unit 13 for rotating the cartridge 12 up and down, and a lower cartridge 122 of the cartridge 12
  • a left and right rotation drive unit 14 for rotating left and right, and a temperature module 15 positioned at a predetermined interval on one side of the cartridge 12 to supply heat so that a polymerase chain reaction occurs in the cartridge 12;
  • a detection unit 16 that is spaced apart from one side of the cartridge 12 at regular intervals and irradiates and measures light to the cartridge 12 after performing a polymerase chain reaction to detect the presence of a specific nucleic acid; and the housing; It includes a display 17 formed on one side of (11) to display analysis results, and a controller 18 to control
  • vertical rotation means rotation about an axis parallel to the horizontal plane
  • left and right rotation means rotation about an axis parallel to the vertical plane
  • the sample is suspected of containing the nucleic acid to be analyzed. It means a substance, and may also be referred to as a sample or a sample.
  • the housing 11 forms the outer shape of the molecular diagnostic device and is configured to accommodate the components constituting the molecular diagnostic device. part 112 and the like.
  • a display 17 for displaying an analysis result is positioned on the front surface of the body 111 .
  • the cartridge 12 is detachable and rotatably coupled to the inside of the housing 11 to extract and amplify nucleic acids.
  • an upper cartridge 121 including a sample inlet 121b through which the sample is introduced and a closure 121c that closes the sample inlet 121b by penetrating the upper and lower portions;
  • a lower cartridge 122 that is rotatably coupled to the upper cartridge 121 and includes a chamber recessed from the upper surface to the lower side; It is located in one chamber of the lower cartridge 122 and includes a capture unit 123 and the like for capturing the nucleic acid dissolved from the specimen.
  • the lower cartridge 122 is rotatably coupled to the upper cartridge 121 and is configured to include a chamber recessed from the upper surface to the lower side, and the chamber may be formed in a certain number and in a certain shape, preferably A plurality may be formed at regular intervals in a radial manner.
  • the chamber includes an extraction chamber 122a in which a capture unit 123 is located and a sample and a reagent used for extracting nucleic acid from the sample are introduced, and a plurality of reagent chambers in which a reagent used for extracting a nucleic acid from the sample is stored.
  • the waste liquid chamber 122d includes a cover 1224 covering the upper surface, and although not shown, the extraction chamber 122a and the waste liquid chamfer 122d are communicated by a communication path, and a valve is installed in the communication path, The controller 17 controls the operation of the valve to open the communication path so that the waste fluid in the extraction chamber 122d is stored in the waste liquid chamber 122d.
  • the lower cartridge 122 may be integrally molded and formed, or may be formed by combining components in which each channel is formed, and the portion of the lower cartridge 122 surrounding the PCR chamber 122c is not deformed by heat. It is preferably made of a transparent material. In addition, although not shown, a configuration for watertightness may be additionally positioned between the upper cartridge 121 and the lower cartridge 122, for example, a watertight member such as an O-ring enclosing the chamber by coupling to the lower cartridge may be used. .
  • the reagent chamber 122b includes a dissolution chamber 1221 in which a dissolution buffer for dissolving a sample is stored, a washing chamber 1222 in which a washing buffer for cleaning the capture unit 123 is stored, and the capture unit 123. and an elution chamber 1223 in which an elution buffer for eluting the captured nucleic acid is stored.
  • a dissolution chamber 1221 in which the dissolution buffer is stored may be separately present, and the dissolution buffer may be mixed and supplied with the sample without a separate dissolution chamber, and the dissolution buffer is transferred to the extraction chamber 122a ) can also be stored.
  • one cleaning chamber 1222 is illustrated in FIG.
  • a plurality of cleaning chambers may be formed to sequentially supply a cleaning liquid to the extraction chamber 122a.
  • the lysis buffer (Lysis buffer) is used to dissolve the sample, and various known lysis buffers may be used, for example, a chaotropic agent such as guanidine salt, a chelating agent such as ethylenediamine tetraacetate acid, trihydroxymethyl and buffer salts such as aminomethane.
  • the washing buffer is used to clean the capture unit 123 in which the nucleic acid is captured, and various known washing buffers may be used, and may include, for example, ethanol, isopropanol, and the like.
  • the elution buffer is used to elute the nucleic acid captured by the capture unit 123, and various known elution buffers may be used, for example, water or a TE (Tris-EDTA) buffer, etc. may be used,
  • the PCR reagent is mixed with a nucleic acid to cause a polymerase chain reaction according to temperature control, and various known PCR reagents may be used, for example, it may include Primer, DNA polymerase, dNTP, etc. have.
  • the capture unit 123 is fixed in the extraction chamber 122a of the lower cartridge 122 to capture the nucleic acid dissolved from the sample, and various known means for capturing the nucleic acid may be used, for example, negatively charged.
  • a silica membrane having a positive charge, a porous material made of glass fibers, etc. may be used to trap nucleic acids having
  • the vertical rotation driving unit 13 is configured to couple the cartridge 12 to the inside of the housing 11 so as to be vertically rotatable integrally, and the cartridge 12 to be vertically rotatable inside the housing 11 .
  • the vertical rotation drive unit 13 is a drive motor 131 coupled to one inner surface of the body portion 111, the drive motor (131)
  • a first connecting portion 132 that rotates by being coupled to the shaft, a rotating body 133 that rotates in combination with the first connecting portion 132 and accommodates the cartridge 12 therein, and one end of the rotating body 133
  • the other end includes a second connecting portion 134 that rotates by being coupled to the other inner surface of the body portion (111).
  • the rotating body 133 accommodates the cartridge 12 therein and rotates by the driving force of the driving motor 131, has a predetermined shape, but preferably has the shape of a rectangular parallelepiped barrel with an open upper surface, It includes a ring-shaped coupling portion 133a surrounding the upper cartridge 121 of the cartridge 12, and a connection support portion 133b connecting the outer surface of the coupling portion 133a and the inner surface of the rotating body 133. .
  • the left and right rotation driving unit 14 is configured to rotate only the lower cartridge 122 of the cartridge 12 left and right, and various conventional means that can rotate the lower cartridge 122 left and right may be used, for example, rotation It is coupled to the lower inner surface of the body 133 and the shaft is inserted into the lower surface of the lower cartridge 122 (not shown, but a groove into which the shaft is fitted may be formed on the lower surface of the lower cartridge) to rotate the lower cartridge 122 left and right A driving motor that can make it happen may be used.
  • the shaft of the left and right rotational driving part is inserted into a groove (not shown) formed on the lower surface of the lower cartridge 122, and the coupling part 133a is inserted into the upper cartridge. Tightly surrounding 121, the cartridge 12 is fixed inside the housing 11, and then, when the left and right rotation driving unit 14 is operated, only the lower cartridge 122 is rotated and shown in (b) of FIG. As shown, one chamber of the temporary chamber 121a and the lower cartridge 122 communicates with each other, and when the vertical rotation driving unit 14 is operated, the rotating body 133 rotates and the cartridge 12 also rotates, at this time As shown in (c) of Figure 7, the cartridge 12 is turned upside down.
  • the temperature module 15 is located at the lower side of the cartridge 2 at a predetermined interval to supply heat so that a polymerase chain reaction occurs in the cartridge 12, and the PC chamber 122c is specified.
  • Various conventional means capable of heating to a temperature may be used, and for example, a light source such as a light emitting diode (LED) or a laser diode (LD) that emits heat may be used.
  • LED light emitting diode
  • LD laser diode
  • the PC chamber 122c In order for the nucleic acid to be amplified by the polymerase chain reaction in the PC chamber 122c, the PC chamber 122c is subjected to denaturation (90 ⁇ 96 °C), annealing (50 ⁇ 65 °C), elongation (68 ⁇ 74 °C) To bring the temperature required for the process, the PC chamber 122c is heated or cooled by flickering the light source in the temperature module 15, or the lower cartridge 122 is rotated left and right to change the distance from the light source. By positioning it, the PC chamber 122c can have a temperature sequentially in each process necessary for amplification of a nucleic acid by a polymerase chain reaction.
  • the detection unit 16 is located on one side of the cartridge 12 spaced apart at regular intervals to irradiate and measure light to the cartridge 12 after performing a polymerase chain reaction to detect the presence of a specific nucleic acid. . Since the detection unit 16 analyzes the captured image to determine the presence of a nucleic acid is a known technique, a detailed description thereof will be omitted.
  • the controller 18 is configured to control the operation of the molecular diagnostic device, and a sample and a lysis buffer are introduced and reacted in the extraction chamber 122a so that the nucleic acid is eluted and the eluted nucleic acid is captured by the capture unit 123 .
  • the temperature module 15 is operated, and the PC chamber 122c is required for the polymerase chain reaction.
  • a temperature control unit 185 that controls the blinking of the light source in the temperature module 15 or controls the left and right rotation driving unit 14 so as to have a temperature, and the detection unit 16 after the nucleic acid amplification process is performed After irradiating light to the PC chamber 122c and photographing, the detection control unit 186 that analyzes the photographed image to determine the presence of a specific nucleic acid and displays the result on the display 17, and the analysis and a storage unit 187 for storing information necessary for the operation of the diagnostic apparatus and information generated by the apparatus, and a control unit 188 for controlling the overall operation of the controller.
  • the sample inlet 121b and the extraction chamber 122a are in communication with each other, the sample is supplied through the sample inlet 121b and the closed part 121c.
  • the dissolution control unit 181 operates the left and right rotation driving unit 14 to rotate the lower cartridge 122 and only the dissolution chamber 1221 is a temporary chamber.
  • the dissolution control unit 181 operates the vertical rotation driving unit 13 to rotate the cartridge 12 so that the cartridge 12 is inverted so that the dissolution chamber 1221 is located on the upper side and the lower side
  • the temporary chamber 121a is located so that the dissolution buffer of the dissolution chamber 1221 is stored in the temporary chamber 121a, and then the dissolution control unit 181 operates the left and right rotation driving unit 14 to operate the lower cartridge 122.
  • the dissolution control unit 181 operates the vertical rotation driving unit 13 to rotate the cartridge 12, and the cartridge 12 is inverted.
  • the temporary chamber 121a is located on the upper side and the extraction chamber 122a is located on the lower side, so that the lysis buffer of the temporary chamber 121a flows into the extraction chamber 122a, the lysis buffer reacts with the sample and the eluted nucleic acid is It is captured by the catcher 123 . Thereafter, when the dissolution control unit 181 operates the valve to open the communication path, the waste fluid including the sample after the reaction in the extraction chamber 122a and the dissolution buffer passes through the communication path and moves to the waste liquid chamber 122d. .
  • the washing control unit 182 operates the left and right rotation driving unit 14 to rotate the lower cartridge 122 so that only the washing chamber 1222 communicates with the temporary chamber 121a, and then the washing control unit 182 is By operating the vertical rotation driving unit 13, the cartridge 12 is rotated so that the cartridge 12 is inverted so that the cleaning chamber 1222 is located on the upper side and the temporary chamber (121a) is located on the lower side, so that the cleaning chamber 1222 is cleaned.
  • the buffer is stored in the temporary chamber 121a, and then the washing control unit 182 operates the left and right rotation driving unit 14 to rotate the lower cartridge 122, so that only the extraction chamber 122a and the temporary chamber 121a and After being communicated, the washing control unit 182 operates the vertical rotation driving unit 13 to rotate the cartridge 12 so that the cartridge 12 is inverted so that the temporary chamber 121a is located on the upper side and the extraction chamber is located on the lower side ( 122a) is located, so that the cleaning buffer of the temporary chamber 121a flows into the extraction chamber 122a, impurities are separated from the trapping part 123. Thereafter, when the washing control unit 182 operates the valve to open the communication path, the waste fluid including impurities and the washing buffer in the extraction chamber 122a passes through the communication path and moves to the waste liquid chamber 122d.
  • the dissolution control unit 183 operates the left and right rotation driving unit 14 to rotate the lower cartridge 122 so that only the dissolution chamber 1223 communicates with the temporary chamber 121a, and then the dissolution control unit 183 is By operating the vertical rotation driving unit 13, the cartridge 12 is rotated so that the cartridge 12 is inverted, so that the dissolution chamber 1223 is located on the upper side and the temporary chamber (121a) is located on the lower side, so that the dissolution chamber 1223 is eluted.
  • the buffer is stored in the temporary chamber 121a, and then the dissolution control unit 182 operates the left and right rotation driving unit 14 to rotate the lower cartridge 122, so that only the extraction chamber 122a and the temporary chamber 121a and After communication, the dissolution control unit 183 operates the vertical rotation driving unit 13 to rotate the cartridge 12 so that the cartridge 12 is inverted so that the temporary chamber 121a is located on the upper side and the extraction chamber is located on the lower side ( 122a) is positioned so that the elution buffer of the temporary chamber 121a flows into the extraction chamber 122a, and the nucleic acid is eluted from the capture unit 123.
  • the nucleic acid supply control unit 184 operates the left and right rotation driving unit 14 to rotate the lower cartridge 122 so that only the extraction chamber 122a communicates with the temporary chamber 121a, and then the nucleic acid supply control unit 184 ) operates the vertical rotation driving unit 13 to rotate the cartridge 12 so that the cartridge 12 is inverted so that the extraction chamber 122a is located on the upper side and the temporary chamber 121a is located on the lower side, so that the extraction chamber (122a)
  • the fluid containing the nucleic acid of Only communicates with the temporary chamber 121a
  • the nucleic acid supply control unit 184 operates the vertical rotation driving unit 13 to rotate the cartridge 12 so that the cartridge 12 is inverted and the temporary chamber 121a on the upper side.
  • the PCR chamber 122c is positioned at the lower side, so that the fluid in which the nucleic acid and the PCR reagent are mixed is positioned in the PCR chamber 122c.
  • the temperature control unit 185 operates the temperature module 15 and flickers the light source in the temperature module 15 to heat or cool the PCR chamber 122c, or operate the left and right rotation drive unit 14 . to adjust the distance between the PC chamber 122c and the temperature module 15 so that the PC chamber 122c can have a temperature required for each step of the polymerase chain reaction to amplify the nucleic acids, and then
  • the detection control unit 186 controls the detection unit 16 to irradiate the PC chamber 122c with light and photograph it, analyze the photographed image to determine the presence of a specific nucleic acid, and display the result on the display 17 .
  • the present invention selects the chamber of the lower cartridge 122 communicating with the temporary chamber 121a through the left and right rotation of the lower cartridge 12, and uses the vertical rotation of the cartridge 12 to move the cartridge 12 By inverting, the fluid located in the specific chamber of the lower cartridge 12 can be located in the temporary chamber 121a, and the specific fluid located in the temporary chamber 121a is placed in the specific chamber of the lower cartridge 12 in an appropriate amount.
  • the molecular diagnostic apparatus includes a housing 21 forming an outer shape and a position inside the housing 21 .
  • a cartridge 22 for extracting and amplifying nucleic acids includes a first rotation driving unit 23 for rotating the solution supply control unit 222 of the cartridge 22 left and right, and a reaction fluid receiving unit of the cartridge 22 ( 224), a second rotation driving unit 24 for rotating left and right, and a temperature module positioned at a predetermined interval on one side of the cartridge 22 to supply heat so that a polymerase chain reaction occurs in the cartridge 22 ( 25) and a detection unit 26 that is spaced apart from one side of the cartridge 22 at a predetermined interval and detects the presence or absence of a specific nucleic acid by irradiating and measuring light to the cartridge 22 after performing a polymerase chain reaction.
  • the housing 21 forms the outer shape of the molecular diagnostic device and is configured to accommodate the components constituting the molecular diagnostic device.
  • the part 212, the first coupling part 213a of the ring hair surrounding the reagent receiving part 221 of the cartridge 22, the outer surface of the first coupling part 213a, and the inner surface of the body part 211 A first support frame 213 including a first connecting support portion 213b for connecting, and a ring positioned below the first support frame 213 and enclosing the reaction chamber portion 223 of the cartridge 22 .
  • the cartridge 22 is detachably coupled to the interior 21 of the housing to extract and amplify nucleic acids, and includes a reagent receiving unit 221, a solution supply control unit 222, a reaction chamber unit 223, and a reaction fluid accommodating part 224 , a rod part 225 , and the like.
  • the reagent accommodating part 221 is fixed by the first support frame 213 and has a configuration in which reagents used for extracting nucleic acids are stored. 221a) and a plurality of accommodation chambers 221b formed outside the hollow 221a to store reagents used for extracting nucleic acids from a specimen.
  • the accommodating chamber 221b is configured to store reagents used for extracting nucleic acids from a specimen, and may be formed in a predetermined number and in a predetermined shape. It has a form blocked by the solution supply control unit 222, and may be formed in plurality at regular intervals in a radial direction on the outside of the hollow 221a.
  • the receiving chamber 221b includes a dissolution chamber 2211 in which a dissolution buffer for dissolving a sample is stored, a first washing chamber 2212 in which a washing buffer is stored, a second washing chamber 2213 in which a washing buffer is stored, and nucleic acids. and an elution chamber 2214 in which an elution buffer for elution is stored.
  • the sample and the magnetic beads are introduced into the dissolution chamber 2211, the sample is dissolved by the dissolution buffer, and the discharged nucleic acid is combined with the magnetic beads.
  • magnétique beads various known magnetic beads that bind to nucleic acids and bind to magnets may be used, for example, a core made of a metal and a silica coating layer formed on the outside of the core to trap nucleic acids having negative charges.
  • a core made of a metal and a silica coating layer formed on the outside of the core to trap nucleic acids having negative charges may include
  • the solution supply control unit 222 is located at the lower side of the reagent receiving unit 221 , and is rotatably coupled to the reagent receiving unit 221 , and according to the rotation angle, the reaction chamber unit 223 is rotated. Different types of reagents are supplied to the reaction chamber 223b.
  • the solution supply control unit 222 includes a hollow 222a that is vertically penetrating and into which the rod 225 is inserted, and a plurality of communication holes 222b that are vertically penetrated on the outside of the hollow 222a. .
  • the communication hole 222b is configured to communicate the accommodation chamber 221b and the reaction chamber 223b, and may be formed in a predetermined number and a predetermined shape, for example, vertically penetrating through the solution supply control unit 222, , a plurality of radially spaced apart from the outside of the hollow (222a) may be formed.
  • the communication hole 222b communicates with the reaction chamber 223b, and communicates with the dissolution chamber 2211 when the solution supply control unit 222 rotates at a predetermined angle to thereby communicate with the dissolution chamber 2211 and the reaction chamber 223b.
  • the second communication hole communicates with the first cleaning chamber 2212 to communicate the first cleaning chamber 2212 and the reaction chamber 223b to supply the cleaning buffer to the reaction chamber 223b.
  • the dissolution chamber 2211, the first cleaning chamber 2212, the second cleaning chamber 2213, and the dissolution chamber 2214, the distance between each other is a first communication hole 2221, a second communication hole 2222, the third Since the communication hole 2223 and the fourth communication hole 2224 have a gap and a difference between each other, when the solution supply control unit 222 is rotated to communicate the dissolution chamber 2211 and the first communication hole 2221, the first The first cleaning chamber 2212 , the second cleaning chamber 2213 , and the dissolution chamber 2214 are blocked by the solution supply control unit 222 , and rotate the solution supply control unit 222 to rotate the first cleaning chamber 2212 .
  • the dissolution chamber 2211, the second cleaning chamber 2213 and the dissolution chamber 2214 are blocked by the solution supply control unit 222, and the solution supply control
  • the solution supply control unit 222 When the second cleaning chamber 2213 and the third communication hole 2223 are communicated with each other by rotating the part 222, the dissolution chamber 2211, the first cleaning chamber 2212, and the dissolution chamber 2214 provide the solution supply.
  • the dissolution chamber 2211 and the first cleaning chamber 2212 are blocked by the control unit 222, and the dissolution chamber 2214 and the fourth communication hole 2224 are communicated by rotating the solution supply control unit 222.
  • the second cleaning chamber 2213 are blocked by the solution supply control unit 222 .
  • any one of the plurality of communication holes communicates with any one of the receiving chambers among the plurality of receiving chambers, that is, the rotation angle of the solution supply control unit is different.
  • the receiving chamber communicating with the reaction chamber is changed, so that different kinds of reagents are introduced into the reaction chamber.
  • the reaction chamber unit 223 is located below the solution supply control unit 222, is fixed by the second support frame 214, and contains samples, beads, and reagents used for extracting nucleic acids from the samples.
  • a hollow 223a formed through vertical penetration and into which the rod part 225 is inserted, and a reagent formed outside the hollow 223a and used for extracting nucleic acids from a sample, beads, and sample are introduced It includes a reaction chamber 223b that is used as a reaction chamber, and a discharge hole 223c that is formed vertically through the lower surface of the reaction chamber 223b to discharge the fluid of the reaction chamber 223b.
  • the reaction chamber 223b is configured to receive a sample, beads, and reagents used for extracting nucleic acids from the sample, and may be formed in a certain number and in a certain shape, for example, it is formed by being recessed in the reaction chamber part 223 and , a plurality of the hollow 223a may be radially spaced apart from each other, and it is preferable that the plurality of reaction chambers communicate with each other.
  • the reaction chamber 223b communicates with the first communication hole 2221 and communicates with the first reaction chamber 2231 and the second communication hole 2222 through which the solution containing the sample, magnetic beads, and dissolution buffer is introduced.
  • the second reaction chamber 2232 into which the cleaning buffer flows, the third reaction chamber 2233 communicated with the third communication hole 2223 and the cleaning buffer flows in, and the fourth communication hole 2224 communicated with the elution buffer includes a fourth reaction chamber 2234 into which is introduced.
  • the discharge hole 223c is formed vertically through the lower surface of the reaction chamber 223b to discharge the fluid of the reaction chamber 223b, and the reaction fluid receiving part according to one rotation of the reaction fluid receiving part 224
  • a first discharge hole 2235 communicating with the waste liquid chamber (not shown) of 224, and a PC chamber (not shown) of the reaction fluid accommodating part 224 according to another rotation of the reaction fluid accommodating part 224 ) and a second discharge hole 2236 in communication.
  • the reaction fluid accommodating part 224 is located below the reaction chamber part 223 and is rotatably coupled to the reaction chamber part 223 to be left and right, depending on the rotation angle, from the reaction chamber part 223 . It is a configuration that receives other fluids.
  • the reaction fluid accommodating part 224 is formed to be depressed from the upper surface to the lower side, the depression groove 224a into which the rod part 225 is inserted, and the reaction chamber part 223 formed outside the depression groove 224a.
  • a waste liquid chamber for accommodating the waste fluid discharged in The first inlet hole 224b, which is formed vertically through the upper surface of the waste liquid chamber (not shown) and into which the waste fluid flows from the reaction chamber part 223, and the upper and lower penetrations are formed on the upper surface of the PCR chamber (not shown) to react and a second inlet hole 224c through which a fluid containing a nucleic acid is introduced from the chamber unit 223 .
  • the reaction fluid of the reaction fluid unit 224 may be selectively supplied to a waste liquid chamber (not shown) or a PCR chamber (not shown).
  • a watertight member for improving the watertight function is positioned between each of the reagent accommodating part 221 , the solution supply adjusting part 222 , the reaction chamber part 223 and the reaction fluid accommodating part 224 .
  • the rod part 225 is configured to be inserted into the reagent accommodating part 221, the solution supply control part 222, the reaction chamber part 223 and the reaction fluid accommodating part 224, which are sequentially stacked, and has a magnetic property. will attract the bead.
  • the first rotation driving unit 23 is configured to rotate the solution supply control unit 222 of the cartridge 22 left and right at a predetermined angle, and the housing can rotate the solution supply control unit 222 left and right at a predetermined angle.
  • Various conventional means that can be coupled to the inside of 11 can be used, for example, a cylinder 231 coupled to one inner surface of the body 211, and the solution supply control section 222 on the outside. It is formed and may include a connection part 232 hinged with the piston end of the cylinder 231, and the like.
  • the second rotation driving unit 24 is configured to rotate the reaction fluid receiving unit 224 of the cartridge 22 left and right at a predetermined angle, and the reaction fluid receiving unit 224 can be rotated left and right at a predetermined angle.
  • Various means of can be used, for example, coupled to the lower inner surface of the body portion 211 and the shaft is fitted to the lower surface of the reaction fluid accommodating part 224 (not shown, a groove into which the shaft is fitted on the lower surface of the reaction fluid accommodating part) may be formed), a driving motor capable of rotating the reaction fluid accommodating part 224 left and right may be used.
  • the controller When the cartridge 22 assembled with the part 225 is inserted and positioned inside the housing 21, supplying a sample and magnetic beads to the dissolution chamber 2211 and operating the molecular diagnostic device, the controller When the first rotation driving unit 23 is controlled to rotate the solution supply control unit 222 so that only the dissolution chamber 2211 and the first communication hole 2221 communicate with each other, the sample of the dissolution chamber 2211, The fluid containing the magnetic beads and the dissolution buffer flows into the first reaction chamber 2231, reacts, and the eluted nucleic acid binds to the magnetic beads, and the magnetic beads to which the nucleic acid is bound enter the rod unit 2225 by magnetic force.
  • the controller controls the second rotation driving unit 24 to rotate the reaction fluid receiving unit 224 so that only the first discharge hole 2235 and the first inlet hole 224b communicate with each other, the reaction chamber ( 223b), the waste fluid including the sample after the reaction and the dissolution buffer passes through the first outlet hole 2235 and the first inlet hole 224b in sequence to be introduced into the waste liquid chamber.
  • the controller controls the second rotation driving unit 24 to rotate the reaction fluid receiving unit 224 so that the first discharge hole 2235 is closed.
  • the controller rotates the solution supply control unit 222 by controlling the first rotation driving unit 23 so that only the first cleaning chamber 2212 and the second communication hole 2222 communicate with each other.
  • the cleaning buffer of the first cleaning chamber 2212 flows into the second reaction chamber 2232 to clean the magnetic beads collected on the wall surface of the reaction chamber 223b.
  • the controller controls the second rotation driving unit 24 to rotate the reaction fluid receiving unit 224 so that only the first discharge hole 2235 and the first inlet hole 224b communicate
  • the reaction chamber ( The waste fluid including impurities and the cleaning buffer in 223b) sequentially passes through the first discharge hole 2235 and the first inlet hole 224b to be introduced into the waste liquid chamber.
  • the controller controls the second rotation driving unit 24 to rotate the reaction fluid receiving unit 224 so that the first discharge hole 2235 is closed.
  • the controller controls the first rotation driving unit 23 to rotate the solution supply control unit 222 so that only the second cleaning chamber 2213 and the third communication hole 2223 communicate with each other.
  • the cleaning buffer of the second cleaning chamber 2213 is introduced into the third reaction chamber 2233 so that the magnetic beads collected on the wall surface of the reaction chamber 223b are cleaned once more.
  • the controller controls the second rotation driving unit 24 to rotate the reaction fluid receiving unit 224 so that only the first discharge hole 2235 and the first inlet hole 224b communicate with each other, the reaction chamber ( The waste fluid including impurities and the cleaning buffer in 223b) sequentially passes through the first discharge hole 2235 and the first inlet hole 224b to be introduced into the waste liquid chamber.
  • the controller controls the second rotation driving unit 24 to rotate the reaction fluid receiving unit 224 so that the first discharge hole 2235 is closed.
  • the controller controls the first rotational driving unit 23 to rotate the solution supply control unit 222 so that only the dissolution chamber 2214 and the fourth communication hole 2224 communicate with each other, the dissolution chamber ( The elution buffer of 2214) flows into the fourth reaction chamber 2234, and the nucleic acids are eluted from the magnetic beads collected on the wall of the reaction chamber 223b.
  • the controller controls the second rotation driving unit 24 to rotate the reaction fluid receiving unit 224 so that only the second discharge hole 2236 and the second inlet hole 224c communicate with each other, the reaction chamber ( 223b), the fluid containing the nucleic acid passes through the second outlet hole 2236 and the second inlet hole 224c in sequence to be introduced into the PCR chamber.
  • the controller operates the temperature module 25 and flickers the light source in the temperature module 25 to heat or cool the PCR chamber (not shown), or operate the second rotation driving unit 24 to operate the PC
  • the controller controls the detection unit 26 to irradiate light to a PCR chamber (not shown) and photograph it, analyze the photographed image to determine the presence of a specific nucleic acid, and display the result on the display 27 .
  • the molecular diagnostic apparatus has an external shape, includes a body 311 with an open upper surface, and a detachable device.
  • a housing 31 including a cover portion 312 covering the upper surface of the body portion 311, and a cartridge 32 rotatably coupled to the inside of the housing 31 to extract and amplify nucleic acids;
  • a first rotation driving part 33 for rotating the cartridge 32 up and down, a second rotation driving part 34 for vertically rotating the flow path forming part 322 of the cartridge 32, and one side of the cartridge 32
  • a temperature module 35 that is spaced apart from each other at a predetermined interval to supply heat so that a polymerase chain reaction occurs in the cartridge 32, and a polymerase chain reaction spaced apart from one side of the cartridge 32 at a predetermined interval
  • a detection unit 36 for detecting the presence or absence of a specific nucleic acid by irradiating and measuring light to the cartridge 32 after performing a display 37 formed on one side of the housing 31 to display the analysis result; and a controller (not shown) for controlling the overall operation of the molecular diagnostic device.
  • the cartridge 32 is detachable and rotatably coupled to the inside of the housing 31 to extract and amplify nucleic acids, and includes a reaction unit 321 , a flow path forming unit 322 , and the like.
  • the reaction unit 321 is fixed in the rotating body 333, stores reagents for extracting nucleic acids, extracts nucleic acids from a sample, and a reaction in which the extracted nucleic acids are amplified, and is inserted from the front side to the rear side It is formed and is formed on the outside of the insertion groove 321a into which the protruding insertion part 322a of the flow path forming part 322 is inserted, and the insertion groove 321a to store reagents for extracting nucleic acids from the specimen.
  • the receiving chamber 321b is formed on the outside of the insertion groove 321a to store reagents for extracting nucleic acids from a specimen, and a reaction for extracting nucleic acids from a specimen occurs.
  • the front side is recessed from the front side to the rear side so that the front side is blocked by the flow path forming part 322, and a plurality of them may be formed on the outside of the insertion groove 321a in a radial direction at regular intervals. .
  • the receiving chamber 321b includes a dissolution chamber 3211 in which a dissolution buffer for dissolving a sample is stored, a first washing chamber 3212 in which a washing buffer is stored, a second washing chamber 3213 in which a washing buffer is stored, and a nucleic acid. and an elution chamber 3214 in which an elution buffer for elution is stored.
  • the sample and magnetic beads are introduced into the dissolution chamber 3211 .
  • the PC chamber (321c) is spaced apart from the accommodation chamber (321b) at a predetermined interval, receives the PCR reagent, receives the nucleic acid from the accommodation chamber (321b), and a polymerase chain reaction occurs. and may be formed in a certain shape, for example, it is recessed from the front side to the rear side so that the front side is blocked by the flow path forming part 322, and the receiving chamber 321b is on the outside of the insertion groove 321a. and one may be formed with a predetermined interval therebetween.
  • the communication part 321d is configured to communicate the receiving chamber 321b or the PCR chamber 321c with the insertion groove 321a, and the dissolution chamber 3211 and the insertion groove 321a are communicated to communicate with the dissolution chamber 3211 ) a first discharge path 321da for discharging the fluid, and a first inflow path through which the first washing chamber 3212 and the insertion groove 321a communicate with each other so that the fluid flows into the first washing chamber 3212 ( 321db) and the first inflow path 321db, which are spaced apart from each other by a predetermined interval, and communicate with the first cleaning chamber 3212 and the insertion groove 321a to discharge the fluid in the first cleaning chamber 3212; a second inflow path 321dd that communicates the furnace 321dc with the second cleaning chamber 3213 and the insertion groove 321a so that the fluid flows into the second cleaning chamber 3212, and the second inflow path ( 321dd) and a third discharge path (321de) for discharging the fluid in
  • the flow path forming part 322 is rotatably coupled to the reaction part 321 up and down, and a protruding insertion part 322a which is formed protruding from the rear side and is inserted into the insertion groove 321a, and the protruding insertion part ( 322a) is formed to have both sides open, and as the flow path forming part 222 rotates, a flow path opening and closing part communicates between the accommodating chambers 321b or between the accommodating chamber 321b and the fish chamber 321c. (322b) and the like. As the flow path forming part 322 rotates at a certain angle, the flow path opening and closing part 322b communicates between the accommodating chambers 321b or between the accommodating chamber 321b and the fish chamber 321c.
  • a watertight member for improving the watertight function may be positioned between the reaction unit 321 and the flow path forming unit 322 .
  • the first rotation driving unit 33 is configured to rotate the cartridge 32 up and down integrally, and the cartridge 32 can be integrally rotated up and down in a variety of conventional ways that can be coupled to the inside of the housing 31 .
  • the first rotational driving unit 33 includes a driving motor 331 coupled to one inner surface of the body 311 and a first rotating driving motor 331 coupled to a shaft of the driving motor 331 .
  • One connecting portion 332, the first connecting portion 332 and rotating, and rotating body 333 for accommodating the cartridge 32 therein, one end is coupled to the rotating body 333 and the other end is the body portion It includes a second connection part 334 that rotates by being coupled to the other inner surface of the 311 .
  • the rotating body 333 accommodates the cartridge 32 therein and rotates by the driving force of the driving motor 331, has a predetermined shape, but preferably has a rectangular parallelepiped shape with an open upper surface, It includes a ring-shaped coupling part 333a surrounding the reaction part 321 of the cartridge 32, and a connection support part 333b connecting the outer surface of the coupling part 333a and the inner surface of the rotating body 333. .
  • the second rotation driving unit 34 is configured to rotate only the flow path forming unit 322 of the cartridge 32 up and down, and various conventional means for rotating the flow path forming unit 322 up and down may be used.
  • it is coupled to the inner side surface of the rotating body 333 and the shaft is fitted on the front side of the flow path forming part 322 (not shown, but a groove into which the shaft is fitted may be formed on the front side of the flow path forming part) to form the flow path
  • a driving motor capable of rotating the unit 322 up and down may be used.
  • the molecular diagnosis apparatus may further include a magnetic force module that provides a magnetic force to fix the magnetic beads in the accommodation chamber 321b.
  • electromagnets are located outside each of the accommodating chambers, and by the controller operates the one electromagnet, the magnetic bead can be fixed by pulling the magnetic bead of a specific accommodating chamber, and the magnetic bead is released by releasing the action of the one electromagnet. can move freely.
  • a waste liquid chamber in which waste fluid is stored may be formed in the reaction unit, the receiving chamber and the waste liquid chamfer are communicated by a communication path, and a valve is installed in the communication path, so that the controller operates the valve By controlling the operation of the control unit to open the communication path, the waste fluid in the accommodation chamber can be stored in the waste liquid chamber.
  • the dissolution buffer 3211 removes the sample from the sample.
  • the controller operates the magnetic force module to generate a magnetic force outside the dissolution chamber 3211, the magnetic bead to which the nucleic acid is bound is magnetically generated in the dissolution chamber 3211. will be fixed to the wall.
  • the controller operates the valve to open the communication path, the waste fluid including the reaction sample and the dissolution buffer in the dissolution chamber 3211 flows into the waste liquid chamber.
  • the controller rotates the flow path forming unit 322 by controlling the second rotation driving unit 34 to rotate the first discharge path 321da and the flow path opening and closing unit 322b as shown in (a) of FIG. 15 . ) and the first inflow path 321db are communicated, and when the operation of the magnetic force module is stopped, the magnetic beads bound to the nucleic acid are introduced into the first washing chamber 3212 by gravity to be cleaned. Then, when the controller operates the magnetic force module to generate a magnetic force outside the first cleaning chamber 3212, the magnetic beads to which the nucleic acid is bound are fixed to the wall surface of the first cleaning chamber 3212 by magnetic force.
  • the controller controls the second rotation driving unit 34 to rotate the flow path forming unit 322 to close the first inflow path 321db and the second discharge path 321dc.
  • the controller controls the first rotation driving unit 33 to rotate the cartridge 32 so that the first cleaning chamber 3212 is located on the upper side and the second cleaning chamber 3213 is located on the lower side, and , by controlling the second rotation driving unit 34 to rotate the flow path forming unit 322, as shown in FIG. 15 (b), the second discharge path 321dc, the flow path opening and closing unit 322b and the
  • the inflow path 321dd is communicated and the operation of the magnetic force module is stopped, the magnetic beads bound to the nucleic acid are introduced into the second cleaning chamber 3213 by gravity to be cleaned.
  • the controller operates the magnetic force module to generate a magnetic force outside the second cleaning chamber 3213, the magnetic beads to which the nucleic acid is bound are fixed to the wall surface of the second cleaning chamber 3213 by magnetic force. Then, when the controller operates the valve to open the communication path, the waste fluid including impurities and the cleaning buffer in the second cleaning chamber 3213 flows into the waste liquid chamber. Thereafter, the controller controls the second rotation driving unit 34 to rotate the flow path forming unit 322 so that the second inflow path 321dd and the third discharge path 321de are closed.
  • the controller controls the first rotational driving unit 33 to rotate the cartridge 32, so that the second cleaning chamber 3213 is located on the upper side and the dissolution chamber 3214 is located on the lower side, As shown in FIG. 15 (c) by controlling the second rotation driving unit 34 to rotate the flow path forming unit 322, the third discharge path 321de, the flow path opening and closing unit 322b, and the third inlet
  • the furnace 321df is communicated and the operation of the magnetic force module is stopped
  • the magnetic beads bound to the nucleic acids are introduced into the elution chamber 3214 by gravity to elute the nucleic acids from the magnetic beads.
  • the controller controls the second rotation driving unit 34 to rotate the flow path forming unit 322 to close the third inflow path 321df and the fourth discharge path 321dg.
  • the controller controls the first rotation driving unit 33 to rotate the cartridge 32 so that the dissolution chamber 3214 is located on the upper side and the PCR chamber 321c is located on the lower side, and the second By controlling the two-rotation driving unit 34 to rotate the flow path forming unit 322, as shown in FIG. 321dh), the fluid containing the nucleic acid flows into the PCR chamber 321c by gravity. Thereafter, the controller controls the second rotation driving unit 34 to rotate the flow path forming unit 322 so that the fourth inflow path 321dh is closed.
  • the controller operates the temperature module 35 and flickers the light source in the inner ear of the temperature module 35 to heat or cool the PC chamber 321c, or operate the first rotation driving unit 33 to operate the PC chamber
  • the controller controls the detection unit 36. is controlled to irradiate light to the PC chamber 321c to be photographed, analyze the photographed image to determine the presence of a specific nucleic acid, and display the result on the display 37 .
  • housing 12 cartridge 13: vertical rotation drive part
  • cover portion 121 upper cartridge 122: lower cartridge
  • control unit 121a temporary chamber
  • 121b sample inlet unit
  • PCR chamber 122d waste liquid chamber 133a: coupling part
  • connection support 1221 dissolution chamber 1222 cleaning chamber
  • housing 22 cartridge 23: first rotational driving unit
  • first support frame 214 second support frame 221: reagent receiving part
  • reaction chamber unit 224 reaction fluid receiving unit
  • rod part 231 cylinder 232: hinge connection part
  • first coupling part 213b first connection support part 214a: second coupling part
  • reaction chamber 223c discharge hole 224a: depression groove
  • first inlet hole 224c second inlet hole 2211: dissolution chamber
  • first cleaning chamber 2213 second cleaning chamber 2214: dissolution chamber
  • first through hole 2222 second through hole 2223: third through hole
  • housing 32 cartridge 33: first rotational driving unit
  • reaction unit 322 flow path forming unit 331: drive motor
  • first connection part 333 rotating body 334: second connection part
  • 321a insertion groove 321b: receiving chamber 321c: PCR chamber
  • 321d communication part 333a: coupling part 333b: connection support part
  • protruding insertion part 322b flow path opening and closing part 3211: melting chamber
  • 321da first outlet 321db: first inlet 321dc: second outlet

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Abstract

La présente invention concerne un appareil de diagnostic moléculaire utilisant une cartouche de type rotatif, l'appareil permettant une extraction, une amplification et un diagnostic quantitatifs et précis des acides nucléiques, uniquement à partir de l'activation de l'appareil après avoir placé un échantillon dans la cartouche, permettant ainsi un diagnostic moléculaire plus commode tout en étant hautement sensible et spécifique.
PCT/KR2021/017799 2021-01-12 2021-11-29 Appareil de diagnostic moléculaire utilisant une cartouche de type rotatif WO2022154254A1 (fr)

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KR10-2021-0004268 2021-01-12
KR1020210004268A KR20220102059A (ko) 2021-01-12 2021-01-12 회전형 카트리지를 이용하는 분자 진단 장치

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WO2022154254A1 true WO2022154254A1 (fr) 2022-07-21

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EP4246692A1 (fr) 2021-08-17 2023-09-20 LG Energy Solution, Ltd. Bloc-batterie et dispositif le comprenant

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KR20140076327A (ko) * 2012-12-12 2014-06-20 한국과학기술원 회전 ｐｃｒ 공정용 시료 처리 칩, 이를 구비하는 회전 ｐｃｒ 장치 및 이를 이용한 회전 ｐｃｒ 방법
US20190046972A1 (en) * 2016-02-23 2019-02-14 Bigtec Private Limited A cartridge for purifying a sample and analysis
KR101989920B1 (ko) * 2017-12-28 2019-06-17 에스디 바이오센서 주식회사 핵산 추출용 카트리지
KR20200064466A (ko) * 2018-11-29 2020-06-08 경희대학교 산학협력단 회전식 유전자 진단용 통합 마이크로 디바이스

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Publication number Priority date Publication date Assignee Title
KR20120016934A (ko) * 2010-08-17 2012-02-27 한국과학기술원 회전 ｐｃｒ 장치, 이를 위한 ｐｃｒ 칩 및 이를 이용한 회전 ｐｃｒ 방법
KR20140076327A (ko) * 2012-12-12 2014-06-20 한국과학기술원 회전 ｐｃｒ 공정용 시료 처리 칩, 이를 구비하는 회전 ｐｃｒ 장치 및 이를 이용한 회전 ｐｃｒ 방법
US20190046972A1 (en) * 2016-02-23 2019-02-14 Bigtec Private Limited A cartridge for purifying a sample and analysis
KR101989920B1 (ko) * 2017-12-28 2019-06-17 에스디 바이오센서 주식회사 핵산 추출용 카트리지
KR20200064466A (ko) * 2018-11-29 2020-06-08 경희대학교 산학협력단 회전식 유전자 진단용 통합 마이크로 디바이스

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