WO2022124672A1 - Cartouche de diagnostic moléculaire et dispositif de diagnostic moléculaire l'utilisant - Google Patents

Cartouche de diagnostic moléculaire et dispositif de diagnostic moléculaire l'utilisant Download PDF

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Publication number
WO2022124672A1
WO2022124672A1 PCT/KR2021/017798 KR2021017798W WO2022124672A1 WO 2022124672 A1 WO2022124672 A1 WO 2022124672A1 KR 2021017798 W KR2021017798 W KR 2021017798W WO 2022124672 A1 WO2022124672 A1 WO 2022124672A1
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Prior art keywords
unit
groove
elevating
cartridge
molecular diagnostic
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PCT/KR2021/017798
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English (en)
Korean (ko)
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김주형
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(주)오상헬스케어
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Publication of WO2022124672A1 publication Critical patent/WO2022124672A1/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
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • 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
    • 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
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/041—Connecting closures to device or container
    • B01L2300/044—Connecting closures to device or container pierceable, e.g. films, membranes
    • 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 invention relates to a molecular diagnostic cartridge and a molecular diagnostic device using the same, and more particularly, nucleic acid extraction and amplification are possible only by inserting a sample into the cartridge and driving the device.
  • the reagent supply unit communicating with the inlet groove is different, so that different types of reagents are introduced into the body, so that various reagents for extracting nucleic acids can be accurately supplied at the right time, and the waste fluid is removed through the rotation of the body and the elevation of the elevation part and a molecular diagnostic cartridge capable of simply supplying nucleic acids to a PCR unit, thereby realizing high sensitivity and specificity of molecular diagnostics, and improving convenience, and a molecular diagnostic apparatus using the same.
  • Molecular diagnosis is a diagnostic technique that detects changes at various molecular levels that occur in cells.
  • nucleic acids are extracted from a specimen and nucleic acids are analyzed by polymerase chain reaction (PCR). It is amplified to diagnose infectious diseases and the like.
  • Patent No. 10-1667548 registered on October 13, 2016
  • the collected sample is subjected to a nucleic acid extraction process using various extraction reagents and equipment, and the obtained nucleic acid is mixed with an amplification reagent and then mounted on 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 provides a molecular diagnostic cartridge and a molecular diagnostic device using the same, which enables extraction and amplification of nucleic acids simply by inserting a sample into a cartridge and driving the device, thus realizing high sensitivity and specificity of molecular diagnostics and improving convenience Its purpose is to provide
  • An object of the present invention is to provide a molecular diagnostic cartridge that can be supplied and a molecular diagnostic apparatus using the same.
  • the present invention provides a molecular diagnostic cartridge capable of improving the efficiency of the nucleic acid extraction and amplification process by removing waste fluid and supplying nucleic acids to the PCR part through rotation of the body and the elevation of the elevation part, and molecular diagnostics using the same
  • the purpose is to provide a device.
  • the present invention is implemented by an embodiment having the following configuration in order to achieve the above object.
  • the molecular diagnostic cartridge located inside the molecular diagnostic apparatus according to the present invention for extracting and amplifying nucleic acids from a sample is rotatable, and the sample and reagents used to extract nucleic acids from the sample are rotatable.
  • the molecular diagnosis cartridge according to the present invention is fixed to the inside of the molecular diagnosis apparatus, and further includes a plurality of reagent supply units located along the outer circumferential surface of the body at regular intervals from each other, Each of the plurality of reagent supply units supplies a different reagent, and the body includes an inlet groove formed through the outer surface, and when the rotation angle of the body is changed, the reagent supply unit communicating with the inlet groove is different do.
  • a plurality of inflow grooves are formed at regular intervals along the outer surface of the body, and the plurality of inflow grooves have different vertical positions, respectively, and the When the body rotates at a specific angle, any one of the plurality of inlet grooves communicates with any one of the reagent supply units among the plurality of reagent supply units.
  • the molecular diagnostic cartridge according to the present invention is characterized in that it further comprises a capture unit binding to the upper side of the elevating unit to capture the nucleic acid dissolved from the specimen.
  • the molecular diagnostic cartridge according to the present invention is located on the outside of the body, accommodates the PCR reagent, and receives the nucleic acid eluted from the capture unit, thereby causing the polymerase chain reaction to occur. It further comprises a part, characterized in that the nucleic acid is supplied to the PCR part by pushing the fluid containing the nucleic acid upward as the elevating part rises.
  • the PCR part in the molecular diagnostic cartridge according to the present invention, includes an open receiving part, a seat part covering the lower surface of the receiving part, and a PCR reagent located inside the receiving part. and an adhesive part formed on the outside of the lower surface of the seat part to couple the PCR part and the body, wherein the catch part includes a protrusion formed protruding from the upper surface, and the elevating part rises so that the protrusion fills the hollow of the body. It is characterized in that the fluid containing the nucleic acid is supplied to the receiving part by tearing the sheet part through it.
  • the molecular diagnosis apparatus includes a housing forming an external shape, a molecular diagnosis cartridge positioned inside the housing, a rotational driving unit for rotating the body, and the elevating and lowering unit. It characterized in that it comprises a controller for controlling the operation of the lifting and lowering drive unit for lowering, and the rotary driving unit and the lifting and lowering drive unit.
  • the cartridge in the molecular diagnosis apparatus according to the present invention, is fixed to the inside of the housing, and is located outside the body at a predetermined distance from the reagent supply unit to remove the waste fluid in the body. It further includes a discharge unit for discharging, the body is located above the inlet groove and is formed through the outer surface of the body, and further includes a discharge groove communicating with the end of the discharge unit when the body rotates at a specific angle wherein the reagent supply unit includes a first supply unit for supplying a sample and a lysis buffer for dissolving the sample, a second supply unit for supplying a washing buffer for cleaning the capture unit, and an elution buffer for eluting the nucleic acid captured in the capture unit. and a third supply unit for supplying, wherein the inlet groove includes a first groove through which the sample and dissolution buffer are introduced, a second groove through which the cleaning buffer flows, and a third groove through which the dissolution buffer is introduced. .
  • the controller controls the rotation driving unit to rotate the body so that the first groove and the first supply unit are in communication with the sample and the dissolution buffer. After flowing into the body and reacting so that the nucleic acid is captured by the capture unit, the rotating drive unit is controlled to rotate the body so that the discharge groove and the discharge unit are communicated, and the elevating unit is controlled to raise the elevating unit.
  • a dissolution control unit for discharging the waste fluid containing the sample and dissolution buffer after the reaction in the body, and after the waste fluid containing the sample and dissolution buffer after the reaction in the body is discharged
  • the first supply unit, the second supply unit, the third supply unit, and the discharge unit are all in communication with the body by controlling the rotation driving unit to rotate the body. It is characterized in that it includes a dissolution control unit for controlling the elevating and descending driving unit to raise the elevating unit so that the fluid containing the nucleic acid is supplied to the PCR unit.
  • the molecular diagnosis apparatus includes a temperature module located inside the housing and heating the PCR part to amplify nucleic acids by a polymerase chain reaction, and a light to the PCR part. It is characterized in that it further comprises a detection unit for detecting the presence or absence of a specific nucleic acid by irradiating and photographing.
  • the present invention can obtain the following effects by the configuration, combination, and use relationship described below with the present embodiment.
  • nucleic acid extraction and amplification are possible only by inserting a sample into a cartridge and driving the device, thereby improving convenience while realizing high sensitivity and specificity of molecular diagnosis.
  • the reagent supply unit communicating with the inlet groove formed in the body is changed, so that different types of reagents are introduced into the body, so that various reagents for extracting nucleic acids are accurately and timely It has the effect of supplying it.
  • the present invention has the effect of improving the efficiency of the nucleic acid extraction and amplification process by removing the waste fluid and supplying the nucleic acid to the PCR part through the rotation of the body and the elevation of the elevation part.
  • FIG. 1 is a perspective view of a cartridge according to an embodiment of the present invention viewed from the front.
  • Figure 2 is a perspective view seen from the rear of the cartridge according to an embodiment of the present invention.
  • FIG 3 is a plan view of a cartridge according to an embodiment of the present invention.
  • Figure 4 is a bottom view of the cartridge according to an embodiment of the present invention.
  • FIG. 5 is a cross-sectional view of a cartridge according to an embodiment of the present invention.
  • 6 to 10 are reference views for explaining a process of extracting and amplifying nucleic acids using a cartridge according to an embodiment of the present invention.
  • FIG. 11 is a perspective view of a molecular diagnostic apparatus according to another embodiment of the present invention.
  • FIG. 12 is a reference diagram for explaining an example of a structure in which the cartridge is coupled to the inside of the housing of the molecular diagnostic apparatus according to an embodiment of the present invention.
  • FIG. 13 is a reference diagram for explaining a process in which the cartridge according to an embodiment of the present invention operates within the housing of the molecular diagnostic apparatus.
  • FIG. 14 is a block diagram of a controller of a molecular diagnostic apparatus according to another embodiment of the present invention.
  • the molecular diagnosis cartridge 1 is rotatable, and a body 11 into which a reagent used for extracting nucleic acids from a specimen is introduced; an elevating unit 12 for moving the fluid by elevating within the body 11; a capture unit 13 that binds to the upper side of the elevating unit 12 and captures the nucleic acid dissolved in the specimen; a PCR unit 14 located on the outside of the body 11, receiving PCR reagents, and receiving nucleic acids eluted from the capture unit 13 to perform a polymerase chain reaction; a plurality of reagent supply units 15 fixed to the inside of the molecular diagnosis apparatus and positioned at regular intervals along the outer circumferential surface of the body 11; and a discharging unit 16 positioned outside the body 11 at a predetermined distance from the reagent supply unit 15 to discharge the waste
  • the body 11 of the cartridge 1 is configured to be connected to the molecular diagnostic apparatus by various well-known methods. is rotatably coupled to the inside of the housing 2 of the As an example, as shown in FIG.
  • the ring-shaped guide part 231 and the guide part 231 The cartridge 1 can be positioned inside the housing by using a support frame 23 including a connection support 232 connecting the outer surface and the inner surface of the housing 2 , and specifically, the body 11 is a guide It is inserted into the inside of the part 231 to guide the rotation, and an indentation groove 231a is formed on the inner surface of the guide part 231 in the longitudinal direction so that a plurality of reagent supply parts 15 and the discharge part 16 are each It is fitted and positioned adjacent to each other at a predetermined distance along the outer circumferential surface of the body 11 .
  • the body 11 is rotatable, and is configured to receive a sample and a reagent used for extracting nucleic acids from the sample.
  • the body 11 is rotatably coupled to the inside of the housing 2 of the molecular diagnostic device and the On the outer surface of the body 11 , a plurality of reagent supply units 15 and the discharge unit 16 are located adjacent to each other at regular intervals along the outer circumferential surface of the body 11 .
  • the body 11 has a predetermined shape, but preferably has a cylindrical shape with an open lower surface, a hollow 11a formed through the upper and lower sides from the upper surface, and a plurality of inlet grooves 111 penetrating through the outer surface of the body 11 . ) and a discharge groove 112 positioned above the inlet groove 111 and formed through the outer surface of the body 11 .
  • a plurality of the inflow grooves 111 are formed at regular intervals along the outer surface of the body 11, and the plurality of inflow grooves 111 each have different vertical positions, and a first groove ( 111a), a second groove 111b located above the first groove 111a and into which the cleaning buffer flows, and a third groove located above the second groove 111b and into which the dissolution buffer flows ( 111c).
  • the sample refers to a substance suspected of containing a nucleic acid to be analyzed, and may also be referred to as a sample or a sample.
  • 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 wash the capture unit 13 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 13, and various known elution buffers may be used, for example, water or a TE (Tris-EDTA) buffer may be used.
  • the elevating unit 12 is configured to move the fluid by elevating within the body 11, and has a predetermined shape, but preferably has a cylindrical shape. 13) is located.
  • the capture unit 13 is configured to bind to the upper side of the elevating unit 12 to capture dissolved nucleic acids from a specimen, and any known means for capturing nucleic acids may be used, for example, to capture nucleic acids having a negative charge.
  • the catch portion 13 may include a protrusion 131 protruding from the upper surface, and the protrusion 131 preferably has a shape in which the width becomes narrower toward the upper side.
  • the PCR part 14 is located on the outside of the body 11, accommodates a PCR reagent, receives the nucleic acid eluted from the capture part 13, and a polymerase chain reaction occurs.
  • the receiving part 141, the seat part 142 covering the lower surface of the receiving part 141, the PCR reagent 143 positioned inside the receiving part 141, and the lower surface of the seat part 142 It is formed on the outside and includes an adhesive part 144 for bonding the PCR part 14 and the body 11 to each other.
  • the accommodating part 141 may be made of various materials, for example, may be made of a transparent material that is not deformed by heat, and the sheet part 142 may be made of various materials, for example, a synthetic material that is easily torn by a sharp object.
  • PCR reagent 143 is configured to be mixed with a nucleic acid to perform a polymerase chain reaction according to temperature control, and various known PCR reagents may be used, for example, Primer, DNA polymerase, dNTP. and the like.
  • the elevating part 12 rises so that the protrusion 131 passes through the hollow 11a of the body 11 and tears the seat part 142 so that the fluid containing the nucleic acid is supplied to the receiving part 141, and then
  • a polymerase chain reaction is performed to amplify the nucleic acid
  • the PCR part 14 is an adhesive part ( 144) to the upper surface of the body 11, so after the polymerase chain reaction is completed and the analysis is completed, it can be easily removed by pulling the PCR part 14, etc., and the unused PC
  • the egg 14 can be easily combined by adhering to the upper surface of the body 11 . That is, the PCR part 14 is detachably coupled to the upper surface of the body 11 .
  • the reagent supply unit 15 is fixed to the inside of the diagnostic device, and a plurality of reagent supply units 15 are positioned along the outer circumferential surface of the body 11 at regular intervals from each other, and each of the plurality of reagent supply units 15 supplies a different reagent. do.
  • the reagent supply unit 15 includes a first supply unit 151 for supplying a specimen and a lysis buffer for dissolving the specimen, a second supply unit 152 for supplying a cleaning buffer for cleaning the capture unit 13, and the and a third supply unit 153 for supplying an elution buffer for eluting the captured nucleic acid to the capture unit 13 .
  • the first supply unit 151 is formed through the lower side of the outer surface and includes a first supply groove 151a for discharging the sample and the dissolution buffer introduced from the upper end, and the second supply unit 152 is formed on the lower side of the outer surface.
  • the third supply groove 153a includes a supply groove (153a).
  • the first groove 111a and the first supply groove 151a are formed at the same height from the lower surface of the body, and the second groove 111b and the second supply groove 152a are formed at the same height from the lower surface of the body.
  • the third groove 111c and the third supply groove 153a are formed at the same height from the lower surface of the body, and the third groove 111c and the third supply groove 153a are the second groove 111b.
  • the second groove 111b and the second supply groove 152a are located above the first groove 111a and the first supply groove 151a, , the first groove 111a, the second groove 111b, and the third groove 111c are spaced apart from each other by the first supply groove 151a, the second supply groove 152a and the third supply groove 153a.
  • the second supply groove 152a and the third supply groove 153a are connected to the body (11), and then rotate the body 11 to communicate the second groove (111b) and the second supply groove (152a), the first supply groove (151a) and the third supply groove (153a) is blocked by the body 11, and then rotates the body 11 to communicate the third groove 111a and the third supply groove 153a, the first supply groove 151a and the second supply groove ( 152a is blocked by the body 11 .
  • any one of the plurality of inflow grooves communicates with any one of the plurality of reagent supply units, that is, when the body rotates at a different angle, the The reagent supply unit communicating with the inlet groove is different, so that different types of reagents are introduced into the body.
  • the reagent supply unit 15 may further include a valve for opening and closing the inside, and a watertight member such as an O-ring that is coupled to the body and surrounds the outside of the first, second, and third supply grooves.
  • the discharge unit 16 is fixed to the inside of the housing 2 and is located outside the body 11 at a predetermined distance from the reagent supply unit 15 to discharge the waste fluid in the body 11 . to be.
  • the discharge unit 16 includes a discharge unit groove 161 that is formed through the upper side of the outer surface and into which the waste fluid discharged from the body 11 flows.
  • the discharge groove 112 and the discharge groove 161 are formed at the same height from the lower surface of the body 11, and the discharge groove 112 and the discharge groove 161 are the third groove 111c and the third supply groove. It is located above the groove 153a, and when the body 11 is rotated to communicate the discharge groove 112 and the discharge groove 161, the first supply groove 151a, the second supply groove 152a and the third The supply groove 153a is blocked by the body 11, and when the body 11 rotates at a specific angle, the discharge groove 112 and the discharge groove 161 communicate with each other to discharge the waste fluid to the outside.
  • the discharge unit 15 may further include a valve for opening and closing the inside, and a watertight member such as an O-ring coupled to the body to surround the outside of the discharge unit groove.
  • the lower end of the discharge unit 16 may have an open or closed shape. When the lower end has an open shape, the waste fluid is discharged to the outside of the discharge unit 16 and has a closed lower end. In this case the waste fluid is located in the outlet 16 .
  • the molecular diagnostic apparatus includes a cartridge 1, a housing 2, a rotary drive unit 3, an elevating drive unit 4, It includes a temperature module (not shown), a detection module (not shown), a display 5 , a controller 6 , and the like. Since the cartridge 1 described above is used as the cartridge 1, a detailed description thereof will be omitted.
  • the housing 2 forms the outer shape of the molecular diagnostic device and is configured to accommodate the components constituting the molecular diagnostic device. It includes a portion 22 and a support frame 23 formed inside the body portion 21 to couple the cartridge 1 to the inside of the body portion 21 .
  • the display 5 for displaying the analysis result is located on the front side of the body part 21 . Since the support frame 23 has been described above, a detailed description thereof will be omitted.
  • the rotary driving unit 3 is configured to rotate the body 11 , and various conventional means for rotating the body 11 may be used, for example, coupled to the inner lower surface of the body 21 . and a rotating plate 32 that rotates by being coupled to the shaft of the driving motor 31, and a rotating connection part 33 connecting the rotating plate 32 and the lower outer surface of the body 11.
  • the rotating plate 31 rotates and the body 11 rotates.
  • the elevating driving unit 4 is configured to elevate the elevating unit 12, and various conventional means capable of elevating the elevating unit 12 without interference with the rotation of the body 11 may be used.
  • various conventional means capable of elevating the elevating unit 12 without interference with the rotation of the body 11 may be used.
  • a linear motor, hydraulic cylinder, etc. capable of elevating and lowering the elevating unit 12 by pushing and pulling the lower surface of the elevating unit 12 by being coupled to the upper surface of the rotating plate 31 may be used.
  • the temperature module (not shown) is located on the upper side of the PCR unit 14 and is controlled by the controller 6 so that nucleic acids are amplified by the polymerase chain reaction in the PCR unit 14, the PCR unit ( 14) is a configuration that supplies heat to have the temperature required for the transformation (90 ⁇ 96 °C), annealing (50 ⁇ 65 °C), elongation (68 ⁇ 74 °C) process.
  • the temperature module various conventional means for heating the PCR unit to a specific temperature may be used, for example, a heating plate may be used.
  • the detection unit (not shown) is positioned to be spaced apart from the temperature module by a predetermined interval, and is configured to detect the presence of a specific nucleic acid by irradiating and photographing light to the PCR unit 14 after performing PCR.
  • a method of determining the presence or absence of a nucleic acid by analyzing the captured image by the detector is a known technique, and thus a detailed description thereof will be omitted.
  • the controller 6 is configured to control the operation of the molecular diagnostic device, and the sample and the lysis buffer are introduced into the body 11 and reacted to elute the nucleic acid and rotate so that the eluted nucleic acid is captured by the capture unit 13 .
  • the dissolution control unit 61 for controlling the driving unit 3 and the elevating unit 4, and the rotating driving unit 3 and the elevating unit so that the cleaning solution flows into the body 11 to remove impurities from the trapping unit 13
  • the washing control unit 61 that controls (4) the elution buffer flows into the body 11 so that the nucleic acid is eluted from the capture unit 13, the fluid containing the nucleic acid is supplied to the PCR unit 14
  • the dissolution control unit 63 for controlling the rotational driving unit 3 and the elevating unit 4 so as to be possible, and after the nucleic acid is supplied to the PCR unit 14, a polymerase chain reaction is performed in the PCR unit 14 to amplify the nucleic acid
  • the temperature control unit 64 for controlling the temperature module so as to be able to, and after the nucleic acid amplification process is performed, the detection unit is controlled to irradiate light to the PCR unit 14 and photograph it, and then analyze the photographed image to determine the specific value.
  • a detection control unit 65 for determining the presence or absence of a nucleic acid and displaying the result on the display 5, a storage unit 66 for storing information necessary for the operation of the analysis and diagnosis apparatus and information generated by the apparatus; , a control unit 67 for controlling the overall operation of the controller 6, and the like.
  • the first supply groove 151a, the second supply groove 152a, and the third supply groove 153a are blocked by the body 11, and the elevating part ( 12) is at the lower side, the sample and dissolution buffer are put through the upper end of the first supply unit 151 , and the cleaning solution is put through the upper end of the second supply unit 152 , and the third supply unit 153 .
  • the dissolution control unit 61 controls the rotation driving unit 3 to rotate the body 11, and as shown in FIG.
  • the dissolution control unit 61 controls the rotation driving unit 3 to rotate the body 11 so that the discharge groove 112 and the discharge unit groove 161 are in communication with each other and , when the elevating unit 12 is raised by controlling the elevating driving unit 4, the waste fluid including the sample after the reaction in the body 11 and the dissolution buffer is discharged through the discharge groove 112 and the discharge unit groove 161. It passes through in turn and is discharged to the outside of the body 11 .
  • the washing control unit 62 controls the elevating driving unit 4 to lower the elevating unit 12, and controlling the rotating driving unit 3 to rotate the body 1, as shown in FIG.
  • the washing control unit 62 controls the rotation driving unit 3 to rotate the body 11 so that the discharge groove 112 and the discharge unit groove 161 communicate with each other, and the elevating driving unit 4
  • the elevating part 12 is raised by controlling the will become
  • the dissolution control unit 63 controls the elevating driving unit 4 to lower the elevating unit 12, and controlling the rotation driving unit 3 to rotate the body 1, as shown in FIG.
  • the elution buffer in the third supply part (153) passes through the third supply groove (153a) and the third groove (111c) sequentially.
  • the nucleic acid is introduced into the body 11 and the nucleic acid is eluted from the capture unit 13 .
  • the dissolution control unit 63 controls the rotation driving unit 3 to rotate the body 11 to a first supply groove 151a and a second supply groove 152a.
  • the dissolution control unit 63 controls the elevating driving unit 4 to control the elevating unit 12 ) so that the protrusion 131 passes through the hollow 11a of the body 11 and tears the sheet portion 142 so that the fluid containing the nucleic acid is supplied to the receiving portion 141 .
  • the temperature control unit 64 controls the temperature module so that a polymerase chain reaction is performed in the PCR unit 14 to amplify the nucleic acid
  • the detection control unit 65 controls the detection unit to control the PCR unit ( 14) is irradiated with light to be photographed, the photographed image is analyzed to determine the presence of a specific nucleic acid, and the result is displayed on the display 5 .
  • PCR unit 15 reagent supply unit 16: discharge unit
  • dissolution control unit 62 washing control unit 63: dissolution control unit
  • control unit 11a hollow 111: inlet groove
  • first supply unit 152 second supply unit 153: third supply unit
  • discharge part groove 231 guide part 232: connection support part
  • first groove 111b second groove 111c: third groove
  • first supply groove 152a second supply groove 153a: third supply groove

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  • Apparatus Associated With Microorganisms And Enzymes (AREA)

Abstract

La présente invention concerne une cartouche de diagnostic moléculaire et un dispositif de diagnostic moléculaire l'utilisant et, plus spécifiquement, une cartouche de diagnostic moléculaire et un dispositif de diagnostic moléculaire l'utilisant, la cartouche permettant l'extraction et l'amplification d'acide nucléique par simple ajout d'un échantillon dans la cartouche et l'entraînement du dispositif, et permettant, lorsqu'un corps tourne à un angle spécifique, à la partie d'alimentation en réactif, qui communique avec une rainure d'entrée formée sur le corps, de se transformer de sorte que différents types de réactifs soient introduits dans le corps, et ainsi divers réactifs pour extraire les acides nucléiques sont fournis avec précision au moment approprié, et permettant d'éliminer des fluides résiduaires et de fournir facilement des acides nucléiques à une partie de PCR par l'intermédiaire de la rotation du corps et de l'élévation/de l'abaissement d'une partie d'élévation/d'abaissement, et par conséquent la commodité peut être améliorée tout en mettant en œuvre une sensibilité et une spécificité élevées dans le diagnostic moléculaire.
PCT/KR2021/017798 2020-12-09 2021-11-29 Cartouche de diagnostic moléculaire et dispositif de diagnostic moléculaire l'utilisant WO2022124672A1 (fr)

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KR1020200171668A KR20220081789A (ko) 2020-12-09 2020-12-09 분자 진단 카트리지 및 이를 이용하는 분자 진단 장치

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CN117535121B (zh) * 2024-01-09 2024-03-19 四川博浩达生物科技有限公司 一种工业酶样品提取设备

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