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WO2018139733A1 - Appareil de séparation de composés et appareil d'immunoessai par chimiluminescence utilisant celui-ci - Google Patents

Appareil de séparation de composés et appareil d'immunoessai par chimiluminescence utilisant celui-ci Download PDF

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Publication number
WO2018139733A1
WO2018139733A1 PCT/KR2017/011704 KR2017011704W WO2018139733A1 WO 2018139733 A1 WO2018139733 A1 WO 2018139733A1 KR 2017011704 W KR2017011704 W KR 2017011704W WO 2018139733 A1 WO2018139733 A1 WO 2018139733A1
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Prior art keywords
unit
compound
sample container
sample
separation
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English (en)
Korean (ko)
Inventor
고재호
최기창
김점용
문현석
송호상
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/76—Chemiluminescence; Bioluminescence
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G01N33/491—Blood by separating the blood components
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/536—Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54313—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
    • G01N33/54326—Magnetic particles
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57407—Specifically defined cancers
    • G01N33/57438—Specifically defined cancers of liver, pancreas or kidney
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00732—Identification of carriers, materials or components in automatic analysers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N2035/00465—Separating and mixing arrangements
    • G01N2035/00564—Handling or washing solid phase elements, e.g. beads
    • G01N2035/00574—Means for distributing beads
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/0098—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor involving analyte bound to insoluble magnetic carrier, e.g. using magnetic separation

Definitions

  • the technology disclosed herein relates to a compound separation device and a chemiluminescent immunoassay device using the same, and in detail, a compound separation device and a compound separation device capable of separating and extracting only a specific component contained in a sample using magnetism It relates to a chemiluminescent immunoassay device that can measure the content of the specific component contained in the blood or serum of the human body through chemiluminescence.
  • the technique of separating compounds is used in the field of clinical examination to diagnose various diseases using biological samples (blood, urine, etc.).
  • biological samples blood, urine, etc.
  • various measurement methods have been developed and used. Representative methods of such measurement methods include biochemical assays using enzyme reactions and immunoassays using antigen-antibody reactions. In recent years, precise measurement of components in biological samples is required, and immunoassay methods using high specificity antigen-antibody reactions have been widely used.
  • Immunoassay methods include radioimmunoassay (RIA), which detects signals using radioisotopes, and enzyme-linked immunosorbent assays (ELISA). Or it can be divided into EIA (enzyme immunoassay), fluorescence antibody (FA) fluorescence antibody detection (fluorescence antibody technique), chemiluminescence immunoassay (CLIA: chemiluminescenceimmunoassay) using chemiluminescence, and other uses of the label Various classifications are possible depending on the method or type of substrate.
  • enzyme immunoassay is the most sensitive because it has excellent sensitivity, specificity, rapidity and reproducibility of reactions and can be used for the detection of various kinds of antigens and antibodies by the same operation when different antigens or antibodies are used. It is used. Enzyme immunoassay can be subdivided into three types, direct ELISA, indirect ELISA, and sandwich enzyme immunoassay, depending on how the antibody is used.
  • direct enzyme immunoassay when an enzyme-linked antibody binds to an antigen immobilized on a solid surface, the enzyme generates a signal by catalyzing the reaction of a substrate.
  • Indirect enzyme immunoassay firstly binds the primary antibody to the antigen, and the secondary antibody to which the enzyme is secondly linked recognizes the primary antibody. In this state, the enzyme linked to the auxiliary antibody catalyzes the reaction of the substrate to signal.
  • sandwich enzyme immunoassay the most widely used form, uses two antibodies with different epitopes for one antigen to be detected and shows high selectivity for the antigen to be detected for diagnostic purposes. It is used a lot.
  • Korean Patent No. 10-1495665 (published February 26, 2015) includes a first transfer step of moving a magnetic conjugate including a magnetic bead and a first antibody to a first well containing a sample by using a magnet; A first binding step in which the magnetic conjugate and the target antigen in the sample bind to form a magnetic conjugate-antigen complex, and a second movement to move the magnetic conjugate-antigen complex to a second well containing a marker using a magnet
  • an immunoassay method comprising a second binding step of combining the magnetic conjugate-antigen complex and the marker to form a magnetic conjugate-antigen-marker complex, and a detection step of detecting the magnetic conjugate-antigen-marker complex It is.
  • a fluorescence multiple immunoassay device including a fluorescence detection unit and a moving unit capable of moving the wells to the fluorescence detection unit.
  • Korean Patent No. 1991-0008409 discloses a container having an opening, a solid porous element in the container, a porous absorbent material in the container that is chemically inert to a chemiluminescence reaction, Means for equally distributing a chemiluminescent solution to said porous element to effect said chemiluminescence reaction adjacent said opening, and said light detecting means adjacent said opening, wherein said chemiluminescent portion is said solid porous element.
  • a chemiluminescence assay device is disclosed that permits passage of a chemiluminescent analyte and prevents its movement while allowing passage of other reaction components.
  • Republic of Korea Patent Publication No. 10-2009-0033694 (published April 06, 2009) is a step of capturing the antigen with magnetic macroparticles (hereinafter referred to as MMPs) fixed to the primary antibody specific for the antigen to be analyzed And treating silica nanoparticles (hereinafter referred to as SPs) in which the cascade reaction initiator and the secondary antibody specific for the antigen are immobilized on the collected antigen of step 1), and converting the enzyme into an active enzyme by the cascade reaction initiator.
  • MMPs magnetic macroparticles
  • SPs silica nanoparticles
  • Disclosed is a method for detecting an antigen, comprising treating a precursor enzyme and a signal-forming substrate specific for the active-type enzyme, and measuring a change in a formation signal.
  • the compound separator disclosed herein provides a compound separator capable of precise separation of a compound and a non-compound in a short time using magnetic.
  • chemiluminescent immunoassay device that can measure the amount of a specific component contained in the blood or serum of the human body in a short time by supplying only one or more sample containers containing the blood or serum of the human body using the compound separation device do.
  • a compound separation device and a chemiluminescent immunoassay device using the same are disclosed.
  • the compound separation device includes a fermentation part through which a sample container containing a compound having magnetic properties and a non-magnetic property is accommodated, an agglomeration part arranged at the side of the sample container, and agglomerating the compound, and the non-compound contained in the sample container. And a non-compound separation unit for separating, wherein the compound and the non-compound are generated through the reaction of a sample containing an antigen with a conjugate reacting with the antigen, wherein the conjugate comprises an antibody reacting with the antigen and a magnetic substance associated with the antibody.
  • the agglomeration part includes a permanent magnet for agglomerating the binder contained in the sample container and a magnetic force moving part for moving the permanent magnet close to the sample container.
  • the apparatus further includes a control unit for operating each of the agglomeration units and another agglomeration unit disposed on the other side of the sample container in which the agglomeration units are not disposed.
  • the non-compound separation unit is located at a point outside the agglomerated position of the conjugate inside the sample container, and is connected to the separation suction part and the separation suction part to move the separation suction part inside and outside the sample container. It includes a separation moving part.
  • the non-compound separation unit includes a washing solution supply unit for supplying a washing solution into the sample container.
  • the non-compound separation unit includes a washing liquid moving unit for moving the washing liquid supply unit into the sample container and spraying the washing liquid to a position where the conjugate is aggregated.
  • the non-compound separation unit includes a washing liquid guide connected to the washing liquid supply unit and having an upper surface inclined toward an inner surface of the sample container facing the agglomerating unit.
  • the chemiluminescent immunoassay device is a fermentation moving part for moving the compound separation device and the cradle, the light emitting unit for supplying a chemiluminescent material to the sample container provided by the compound separation device is disposed on the movement path and the cradle
  • a light source measuring part disposed on a moving path of a part and measuring a light emitted from the sample container supplied with the chemiluminescent material, wherein the compound separation device is disposed on a moving path of the mounting part and supplies the binder;
  • a sample supply unit in the sample container mounted on the mounting unit wherein the sample container in which the sample is accommodated is provided to the combination supply unit through the mounting moving unit, and the combination supply unit is provided in the mounting container. Supplying the binder to the sample container to provide Preparing the sample container in which the compound and the non-compound are accommodated.
  • the mounting portion includes a mounting plate body connected to the mounting movement portion and one or more sample vessel holes arranged in a circular shape in which the sample vessel is inserted into the mounting plate body, and the mounting movement portion is connected to the mounting portion to connect the mounting portion. And a driving device to rotate.
  • the binder supply unit is connected to the binder container containing the binder and the binder container connected to the binder container for injecting and injecting the binder, the binder injection nozzle connected to the binder pump and guiding the binder into the sample container and the binder injection nozzle. It is connected to and comprises a conjugate injection nozzle moving unit for moving the conjugate injection nozzle to the inside and outside the sample container.
  • the aggregation part is disposed below the cradle, and the non-compound separation unit includes an upper portion of the cradle corresponding to the aggregation part.
  • the light emitting unit may be disposed above the cradle, and the light source measuring unit may be disposed below the cradle facing the light emitting unit.
  • the antigens are CA-19-9 and Glypican-1
  • the sample comprises a fluorescent conjugate including a phosphor conjugated with an antibody reactive to CA-19-9 and another phosphor coupled with an antibody reactive with Glypican-1.
  • the conjugate comprises a magnetic substance bound to an antibody responsive to CA-19-9 and a magnetic substance bound to an antibody responsive to Glypican-1, wherein the two kinds of phosphors of the fluorescent binder have different light wavelengths.
  • the chemiluminescent material and the two kinds of phosphors react with each other to generate light having different wavelengths (hereinafter referred to as “first wavelength” and “second wavelength”), and the light source measuring unit stands between the sample containers.
  • a first optical sensor and a second optical sensor and the first optical sensor or the second optical sensor configured to photograph the light of the first wavelength and the light of the second wavelength, respectively.
  • Courageous or remote It includes moving the optical sensor such that the mobile unit for.
  • Compound separating apparatus disclosed herein can easily separate the compound and the non-compound in the sample container through the aggregation portion, there is an effect that can separate the compound and the non-compound in a short time.
  • the cohesive force of the compound and the coagulation and separation can be repeated through the coagulation portion, and the non-compound can be precisely separated in a short time.
  • the chemiluminescent immunoassay device using the compound separation device can measure the amount of a specific component contained in the blood or serum of the human body by supplying only one or more sample containers containing the blood or serum of the human body.
  • pancreatic cancer can be diagnosed early.
  • FIG. 1 is a view showing an embodiment of a compound separator disclosed herein.
  • FIG. 2 is a view showing the working relationship of the aggregation.
  • FIG 3 is a view showing another embodiment of the aggregation portion.
  • FIG. 5 is a view illustrating a separate suction unit.
  • FIG. 6 is a view showing another embodiment of the non-compound separation unit.
  • FIG. 7 is a view showing the operating relationship of the non-compound separation unit.
  • FIG. 8 is a view showing another embodiment of the non-compound separation unit.
  • FIG. 9 is a view showing an embodiment of a chemiluminescent immunoassay device disclosed herein.
  • FIG. 10 is a view showing another embodiment of the chemiluminescent immunoassay device disclosed herein.
  • FIG. 11 is a view showing a combination supply unit, a light emitting unit supply unit and a light source measuring unit disclosed in the present specification.
  • placement in another component, it may include a case in which one component is directly disposed in the other component, as well as a case in which additional components are interposed therebetween.
  • one component When one component is referred to as "connecting" to another component, it may include a case in which the one component is directly connected to the other component, as well as a case in which additional components are interposed therebetween.
  • one component When one component is referred to as "forming" in another component, it may include a case in which one component is directly formed in the other component, as well as a case in which additional components are interposed therebetween.
  • one component When one component is referred to as being "coupled" to another component, it may include a case in which the one component is directly coupled to the other component, as well as a case in which additional components are interposed therebetween.
  • 1 is a view showing an embodiment of a compound separator disclosed herein.
  • 2 is a view showing the working relationship of the aggregation.
  • 3 is a view showing another embodiment of the aggregation portion.
  • 4 is a view showing another working relationship of the aggregation part.
  • 5 is a view illustrating a separate suction unit.
  • 6 is a view showing another embodiment of the non-compound separation unit.
  • 7 is a view showing the operating relationship of the non-compound separation unit.
  • 8 is a view showing another embodiment of the non-compound separation unit.
  • 9 is a view showing an embodiment of a chemiluminescent immunoassay device disclosed herein.
  • 10 is a view showing another embodiment of the chemiluminescent immunoassay device disclosed herein.
  • 11 is a view showing a combination supply unit, a light emitting unit supply unit and a light source measuring unit disclosed in the present specification.
  • the compound separation device disclosed in the present specification is a mounting portion 100 And agglomerating unit 200 and non-compound separation unit 300 to separate the specific components present in the sample.
  • the compound separation device optionally includes a control unit 250 to efficiently separate specific components present in the sample.
  • the non-compound separation unit 300 may include a separation suction unit 310 and a separation moving unit 320 to remove the non-compound (4).
  • the non-compound separation unit 300 may selectively separate the non-compound (4) by optionally including a washing solution supply unit 330, the washing liquid moving unit 340 and the washing liquid guide 350.
  • the amount can be measured through the light emission of a specific component contained in the blood or serum sample.
  • the mounting moving unit 400 includes a driving device 410 to automatically move the sample.
  • the binder supplying part 500 includes a binder container 510 and a binder pump 520, a binder injection nozzle 530, and a binder injection nozzle moving part 540, and a binder 2 reacting with a specific component of a sample. Feed the sample.
  • the light source measuring unit 700 includes a first optical measuring sensor 710, a second optical measuring sensor 720, and an optical measuring sensor moving unit 730 to analyze heterogeneous components.
  • Mounting unit 100 is such that the sample container (10) containing the compound (3) and the non-compound (4) of the antigen (1) and the conjugate (2) containing the antibody and magnetism that reacts to the antigen (1) It is composed.
  • the sample stored in the sample container 10 is blood or serum of the human body, and the binder (2) reacting to specific components (biomarkers such as CA 19-9 and Glypican-1) present in the sample. Is mixed. That is, in the sample container 10, the compound (3) and the non-compound (4) in which the said specific component and the binder (2) reacted exist.
  • the conjugate 2 includes antibodies and magnetic bodies that respond to specific components contained in blood or serum.
  • the binder 2 may contain a phosphor.
  • the mounting portion 100 may include a mounting plate body 110 disposed at a position away from the ground. And it may include a sample vessel hole 120 penetrating through the mounting plate body (110). The mounting portion 100 is inserted into the sample container 10, so that the sample container 10 is exposed to the lower plate body 110.
  • the sample vessel hole 120 in the embodiment may be formed as a groove, the sample vessel 10 may be inserted into the groove to be exposed to the upper plate 110. That is, the mounting portion 100 will be sufficient if the configuration that can be securely fixed to the sample container (10).
  • the mounting portion 100 may include a mounting plate body 110 disposed at a position away from the ground. And it may include a sample vessel hole 120 penetrating through the mounting plate body (110). One or more sample vessel holes 120 are arranged, and may be arranged in a circular shape on the mounting plate body 110.
  • Mounting unit 100 is inserted into the sample container 10, the sample container 10 is exposed to the lower plate body 110, it is rotated through the mounting moving unit 400 to be described below.
  • the mounting portion 100 has an effect that can provide the optimum space required for the movement of the sample container (10).
  • the sample vessel hole 120 in another embodiment may be formed as a groove, so that the sample vessel 10 is inserted into and fixed to the groove to expose the upper plate 110.
  • the aggregation unit 200 is arranged on the side of the sample container 10 is configured to aggregate the compound (3).
  • the aggregation part 200 includes a conventional permanent magnet 210.
  • the aggregation unit 200 is disposed on the side of the sample container 10 to apply magnetism into the sample container 10.
  • the agglomeration part 200 aggregates the compound 3 reacted with the binder 2 by the magnetism of the permanent magnet 210 on the inner surface of the sample container 10 in the direction in which the permanent magnet 210 is disposed. That is, certain components of blood or serum reacted with the binder 2 are aggregated, and the remaining components contained in the blood or serum are present in the sample container 10 without being aggregated.
  • Such agglomerates 200 have the effect of being able to easily remove the non-reactant 4 by primarily separating specific components contained in blood or serum through the binder 2.
  • the agglomeration part 200 may be disposed to be positioned below the sample container 10, and may be sufficient to only agglomerate the compound 3 to any specific position within the sample container 10.
  • the agglomeration part 200 includes a permanent magnet 210 and is connected to the permanent magnet 210, and the permanent magnet 210 is close to the side of the sample container 10. It may include a magnetic force moving unit 220 to move to.
  • the magnetic force moving unit 220 may be configured as a conventional piston. The magnetic force moving unit 220 is connected to the permanent magnet 210 to move forward to the side of the sample container 10, the permanent magnet 210 is moved backward to move away from the sample container (10).
  • the agglomeration part 200 When the permanent magnet 210 is separated from the sample container 10 by the magnetic force moving part 220, the agglomeration part 200 is lowered in the cohesive force of the compound (3) and mixed with the non-compound (4), and the permanent magnet 210 is As the sample container 10 approaches, the cohesive force of the combination 2 is increased. And the aggregation unit 200 can adjust the aggregation of the binder (2) by adjusting the distance with the sample container (10). The agglomeration part 200 adjusts the cohesive force to finely move the compound (3), so that the non-compound (4) existing between the non-compound (4) remaining in the compound (3) or the aggregated compound (3) is dropped. It is effective to separate specific components more precisely.
  • the magnetic force moving unit 220 may be composed of a conventional servo motor, etc., it will be sufficient if the configuration to move the permanent magnet 210 to the sample container (10).
  • the aggregation unit 200 supplies power to the electromagnet 230 and the conventional electromagnet 230 in which the aggregate 2 is aggregated inside the sample container 10. And a magnetic force moving unit 220 for moving the power supply unit 240 and the electromagnet 230 to approach the sample container 10.
  • the agglomeration portion 200 is a magnetic force generated from the electromagnet 230, the cohesive force of the assembly 2 is high, when the magnetism disappears from the electromagnet 230, the cohesive force of the binder 2 is lowered.
  • the aggregation unit 200 may finely adjust the aggregation of the assembly 2 according to the amount of power provided by the power supply unit 240.
  • the agglomeration part 200 controls the cohesion force to finely move the compound (3), so that the non-compound (4) remaining in the compound (3) or the non-compound (4) existing between the aggregated compound (3) Dropping has the effect of separating specific components more accurately.
  • the magnetic force moving unit 220 can prevent the interference of the sample container 10 that may occur when the circular holder 100 is performed.
  • the oral and electromagnets 230 rotated through the control unit 250 to be moved away from the sample container 10, the electromagnet (when the movement of the sample container 10 is stopped) 230 to be close to the sample container (10).
  • the aggregation part 200 may include a permanent magnet 210 or an electromagnet 230, and may be disposed on the left and right sides of the sample container 10. Is connected to each permanent magnet 210 or electromagnet 230, may include a magnetic force moving unit 220 for moving the permanent magnet 210 or electromagnet 230 to the side of the sample container 10. .
  • the magnetic force moving unit 220 may be composed of a conventional piston.
  • the magnetic force moving unit 220 is connected to the permanent magnet 210 or the electromagnet 230 to move forward to the side of the sample container 10, the permanent magnet 210 or electromagnet 230 is far from the sample container 10 Move backward to lose.
  • the permanent magnet 210 or the electromagnet 230 is separated from the sample container 10 by the magnetic force moving part 220, the agglomeration part 200 is lowered in the cohesive force of the compound (3) and mixed with the non-compound (4), and permanent When the magnet 210 or the electromagnet 230 is close to the sample container 10 to increase the cohesion of the combination (2).
  • the aggregation unit 200 can adjust the aggregation of the binder (2) by adjusting the distance with the sample container (10).
  • the agglomeration part 200 adjusts the cohesive force to finely move the compound (3), so that the non-compound (4) existing between the non-compound (4) remaining in the compound (3) or the aggregated compound (3) is dropped. It is effective to separate specific components more precisely.
  • the agglomeration part 200 may move the compound 3 to the left and the right inside the sample container 10 as the agglomeration part 200 is disposed on the left and right sides of the sample container 10, respectively. From this movement of compound (3), non-compounds (4) present between the compounds (3) can be separated from the aggregates of the compounds (3) to form a more pure compound (3) aggregate.
  • control unit 250 will be described in more detail below.
  • Non-compound separation unit 300 is configured to separate the non-compound (4) contained in the sample container (10).
  • the non-compound separation unit 300 is located at a point outside the aggregated position of the aggregate 2 in the sample container 10, and separated and suctioned to suck the non-compound 4. It may include a portion 310. It is connected to the separation suction unit 310, including a separation moving unit 320 for moving the separation suction unit 310 to the inside and outside the sample container 10, by sucking the non-compound (4) inside the sample container 10 Isolate.
  • the separation suction unit 310 is connected to the non-compound container 311 and the non-compound container 311 and the tube for storing the separated non-compound (4), the non-compound (4) in the sample container (10) It may include a separation pump 312 to suck. It may include a separation nozzle 313 connected to the separation pump 312 and the tube. Separation nozzle 313 may be disposed in the separation moving unit 320 to be described below, the separation nozzle 313 as shown in Figure 6 is a sample container 10 is out of the position where the compound (3) is agglomerated by the aggregation unit 200 It may be arranged to be located inside.
  • Separation moving part 320 is composed of a conventional piston, may be disposed on one side of the mounting portion (100). Separation moving part 320 is the end of the piston is connected to the separation nozzle 313 to move the separation nozzle 313 inside the sample container 10, and again to the outside of the sample container (10). In the present embodiment, the separating moving part 320 may operate so that the end of the separating nozzle 313 is close to the bottom surface of the sample container 10.
  • the separation suction unit 310 is the separation nozzle 313 is inserted into the sample container 10 by the separation moving unit 320, the non-agglomerated non-compound (4) is sucked by the separation pump 312, Inhaled non-compound (4) is moved to the non-compound container (311). That is, the non-compound 4 included in the sample container 10 may be separated through the non-compound separation unit 300.
  • the separation pump 312 and the non-compound container 311 may be disposed in the separation moving part 320, it may be configured to suck the non-compound (4) by only the tube from which the separation nozzle 313 is removed.
  • the separation moving part 320 may be configured as a normal servo motor, and the separation moving part 320 may be configured to move the separation nozzle 313 into the sample container 10.
  • the non-compound separation unit 300 may further include a washing solution supply unit 330 for supplying the washing solution 20 into the sample container 10.
  • the non-compound separation unit 300 may inhale the non-compound 4 with a suction force in a range in which the binder 2 is not disturbed by lowering the density of the mixed sample present in the sample container 10.
  • the washing solution supply unit 330 is connected to the washing vessel 331 and the washing vessel 331 and the tube in which the washing liquid 20 is stored, and supplies the washing liquid 20 to the sample container 10. It may include a washing pump (332). It may include a washing pump 332 and the washing nozzle 333 connected to the tube.
  • the cleaning nozzle 333 may be disposed in the washing liquid moving unit 340 to be described below, and may be disposed on one side of the separation nozzle 313 described above.
  • the cleaning nozzle 333 is disposed to face the sample container 10 at a position that does not interfere with the separation nozzle 313.
  • the washing solution 20 may be a conventional PBST (Phosphate Buffered Saline Tween-20).
  • the washing liquid supplying unit 330 operates the washing pump 332 to move the washing liquid 20 stored in the washing container 331 to the washing nozzle 333 so that the washing liquid 20 is supplied into the sample container 10. .
  • the washing solution 20 thus supplied lowers the overall density of the sample present in the sample container 10.
  • the lower density of the sample may be easily sucked through the separation suction unit 310 described above, and may later reduce noise during photoexpression of the compound 30.
  • due to the lower density of the sample it is possible to lower the suction force of the separate suction part 310 described above, which is correlated with the cohesive force of the flocculation part 200 described above.
  • the washing solution supply unit 330 may include a washing solution moving unit 340.
  • Washing liquid moving part 340 is composed of a conventional piston, may be disposed on one side of the mounting portion (100).
  • the washing liquid moving part 340 is connected to the washing nozzle 333 at the end of the piston to move the washing nozzle 333 into the sample container 10, and again to the outside of the sample container 10.
  • the washing liquid moving part 340 may operate so that the end of the washing nozzle 333 is close to the compound 3 that is aggregated on the inner surface of the sample container 10.
  • the washing liquid moving unit 340 may allow the aggregation of the compound 3 to be released by the washing pump 332 after the washing nozzle 333 is inserted into the sample container 10. Furthermore, by repeating the aggregation and release of the compound (3) together with the agglomeration unit 200 described above, the non-compound (4) remaining in the aggregate of the compound (3) can be separated.
  • the washing pump 332 and the washing vessel 331 may be disposed in the washing liquid moving part 340, it may be configured to supply the washing liquid 20 only the tube from which the washing nozzle 333 is removed.
  • the washing liquid moving unit 340 may be configured as a conventional servo motor, it is sufficient if the configuration to move the washing nozzle 333 into the sample container (10).
  • the cleaning nozzle 333 may be disposed in the separation moving part 320 described above.
  • the end of the washing nozzle 333 is disposed to face the inner surface of the sample container 10, it may be to the compound (3) in the aggregated direction.
  • the washing nozzle 333 can easily release the aggregates of the compound (3), as well as the non-compound 40 is separated by the separation suction unit 310 described above to the sample to which the sample is reduced in volume. It can be to be washed in the sample container (10) by. This can easily release the agglomeration of the compound (3) and can be supplied while gradually reducing the amount of the washing liquid 20 as the volume of the sample decreases, so that all the compound (3) is present in the washing liquid (20). Can be.
  • the non-compound separation unit 300 is connected to the cleaning solution supply unit 330, and has a cleaning solution guide 350 having an inclined upper surface in a direction in which the aggregation unit 200 is disposed. It may include.
  • the cleaning solution guide 350 allows the cleaning solution 20 to flow into the aggregated compound 3 regardless of the direction and position of the cleaning solution 20.
  • the cleaning solution guide 350 may include a guide part 351 inclined in one direction and a coupling part 352 coupled to the cleaning nozzle 333.
  • the guide part 351 may be formed to be inclined upward toward the coupling part 352.
  • the cleaning solution guide 350 may be formed to a size that is inserted into the sample container (10).
  • the cleaning solution guide 350 is disposed in the cleaning nozzle 333 through the coupling part 352 so that the end of the cleaning nozzle 333 is located at the top of the guide 351.
  • the washing liquid 20 flows along the guide portion 351 to the other end.
  • the cleaning liquid guide 350 may be configured of a nozzle (not shown) bent in a 'b' shape.
  • the control unit 250 is configured to selectively control the magnetic force moving unit 220 and the power supply unit 240, the separation pump 312, the washing pump 332 and the washing liquid moving unit 340 described above.
  • the controller 250 may control to sequentially operate the magnetic force moving unit 220 disposed on the left and right sides of the sample container 10, respectively. Furthermore, the movement of the mounting moving unit 400, the assembly supply unit 500, the light emitting unit supply unit 600 and the light source measuring unit 700 may be controlled.
  • the compound separation device can shorten the time required for separation as the compound (3) and the non-compound (4) in the sample container 10 is separated.
  • Mounting moving part 400 is configured to move the mounting part (100).
  • the cradle moving unit 400 automatically moves the sample container 10 to the combination supply unit 500 and the compound separation device, the light emitting unit supply unit 600, and the light source measuring unit 700 described above.
  • the mounting moving unit 400 may be configured as a conventional conveyor belt.
  • Mounting unit 100 is disposed on the conveyor belt.
  • the combination supply unit 500 to be described below and the compound separator, the light emitting unit supply unit 600 and the light source measuring unit 700 to be described below may be arranged side by side. have.
  • the mounting moving unit 400 may be configured to rotate the mounting unit 100.
  • Mounting moving unit 400 may include a drive device 410 composed of a conventional motor.
  • the mounting moving unit 400 is disposed below the mounting unit 100 to rotate the mounting unit 100.
  • the assembly supply unit 500 to be described below is disposed on one side of the mounting unit 100, and the light source measuring unit 700 and the light emitting unit are provided to the right of the assembly supply unit 500. 600 and the compound separator described above can be disposed.
  • Mounting unit 100 is arranged in a circular plate body 110 and the sample container 10 is inserted into the mounting plate body 110 is connected to the mounting moving unit 400 It may include one or more sample vessel holes 120.
  • the agglomeration part 200 of the compound separation device is disposed below the mounting part 100, and the non-compound separation part 300 is disposed above the mounting part 100 corresponding to the agglomeration part 200.
  • the driving device 410 of the mounting moving unit 400 may include a gear or a belt to rotate in contact with the side of the mounting unit 100 and may be composed of other driving devices for driving the gear or belt, Mounting moving unit 400 is sufficient if the configuration to rotate or move the mounting unit (100).
  • the binder supply unit 500 is configured to supply the binder 2 to the sample container 10 in which blood or serum is stored.
  • the binder supply unit 500 may include a binder container 510 in which the binder 2 is accommodated. It may include a combined pump 520 connected to the combined container 510 to suck and spray the combined body (2). Connected to the conjugate pump 520 may include a conjugate spray nozzle 530 for guiding the conjugate 2 into the sample container 10.
  • the binder supply unit 500 supplies the binder 2 reacting to the specific antigen 1 to the sample container 10 in which only blood or serum is stored, so that the sample stored in the sample container 10 is a specific antigen (1). ) And the binder (2) are separated into the compound (3) and non-compound (4) reacted.
  • the combined injection nozzle 530 is arranged to be connected to the light emitting nozzle moving part 640 and moved upward and downward. This can be operated in the same way as the light emitting nozzle 630, it is possible to shorten the overall process time, and to prevent the assembly injection nozzle 530 from being caught from the movement of the sample container 10 in accordance with the rotation of the mounting portion (100).
  • conjugate injection nozzle 530 it is connected to the conjugate injection nozzle 530 may be configured separately to the conjugate injection nozzle moving unit 540 for moving the conjugate injection nozzle 530 to the inside and outside the sample container (10).
  • the conjugate 2 is provided with a conjugate 2 including heterologous antibodies and magnetic and phosphors that react with CA-19-9 and Glypican-1 contained in blood or serum, respectively. Therefore, the combination supply unit 500 is also implemented in two, the two injection nozzles 530 in one sample container 10 is arranged in a position that does not interfere with each other.
  • the light emitter supply unit 600 is disposed on the movement path of the mounting unit 100 and configured to supply the chemiluminescent material 6 to the sample container 10 provided by the compound separation device.
  • the light emitting unit 600 according to the exemplary embodiment disclosed in FIGS. 10 to 11 is the same as the configuration of the assembly supply unit 500 described above, the light emitting container 610, the light emitting pump 620, the light emitting nozzle 630 and the light emitting body.
  • the nozzle mover 640 may be configured.
  • the light emitter supply unit 600 may be disposed on the right side of the light emitter supply unit 600.
  • the light emitter supply unit 600 mixes the chemiluminescent material 6 in the sample container 10 in which the blood or serum is stored and the sample container 10 passed through the compound supply unit 500 and the compound separation device described above.
  • the chemiluminescent material 6 carried out in the above embodiment employs ODI (Oxalyldiimidazole) and hydrogen peroxide (H 2 O 2) for easy description of the present invention. Accordingly, the light emitting unit 600 may also be composed of two.
  • the light source measuring unit 700 is configured to measure light emitted from the sample container 10 to which the chemiluminescent material 6 is supplied and disposed on the movement path of the mounting unit 100.
  • the light source measuring unit 700 may be configured as a first optical measuring sensor 710 capable of capturing and analyzing an image.
  • Typical photometric sensors include PMT (Photomultiplier Tube) sensor and SIPM, and a light source measuring camera can be used in place of the sensor.
  • the light source measuring unit 700 may be disposed below the mounting unit 100 facing the light emitting unit 600. As the light source measuring unit 700 is disposed below the mounting unit 100, the installation area may be minimized.
  • the conjugate 2 is composed of heterologous antibodies, magnetic, and phosphors that react with CA-19-9 and Glypican-1 contained in blood or serum, respectively, and the phosphors have different colors. It is practiced that this can be expressed.
  • the light source measuring unit 700 may further include a second optical measuring sensor 720 to measure light sources of different wavelength regions.
  • the first optical measuring sensor 710 and the second optical measuring sensor 720 may allow the sample container 10 moved by the mounting moving unit 400 to pass between the light source measuring unit 700.
  • the light source measuring unit 700 may include an optical measuring sensor moving unit 730 for moving the second optical measuring sensor 720.
  • the optical sensor moving unit 730 may be configured of a conventional piston.
  • the optical measuring sensor moving part 730 moves the second optical measuring sensor 720 disposed on the rear surface of the sample container 10 to move away from or close to the sample container 10.
  • the optical measuring sensor moving part 730 prevents the sample container 10 moving in a circular shape from interfering with the second optical measuring sensor 720.
  • the sample container 10 is stored a sample containing blood or serum of the human body.
  • the antigen (1) is CA-19-9 and Glypican-1
  • the sample comprises a phosphor bound to an antibody that responds to CA-19-9 and another phosphor bound to an antibody that responds to Glypican-1.
  • a fluorescent substance wherein the conjugate (2) includes a magnetic substance bound to an antibody responsive to CA-19-9 and a magnetic substance bound to an antibody responsive to Glypican-1, wherein the two kinds of phosphors of the fluorescent binder Have different wavelengths of light, and the chemiluminescent material 6 and the two kinds of phosphors react with each other to produce light having different wavelengths (hereinafter referred to as first wavelength and second wavelength).
  • the sample container 10 containing such a sample is inserted into the sample container hole 120 of the mounting portion (100).
  • One or more sample container holes 120 are mounted with a sample container 10 containing different people's samples.
  • the binder 2 is supplied to the sample container 10 positioned below the binder supplying unit 500. After that, the moving unit 400 is rotated so that the new sample container 10 is located at the bottom of the combination supply unit 500.
  • the sample to which the conjugate 2 was first supplied is reacted with the antigen 1 while being moved to the compound separation device by the cradle moving part 400 to generate the compound 3.
  • the sample container 10 holds a sample composed of a compound (3) and a non-compound (4) composed of other components.
  • the agglomeration unit 200 is operated to aggregate the compound 3 on the side wall of the sample container 10.
  • the non-compound separation unit 300 operates to inhale and separate the non-compound (4).
  • FIG. 6 a sample in which only the compound (3) is present in the sample container 10 can be obtained.
  • the non-compound (4) is inhaled, the non-compound may remain in the compound (3).
  • the agglomeration part 200 performs an operation in which the agglomeration part 200 approaches and moves away from the sample container 10, a process of aggregating and separating the compound 3 proceeds.
  • the non-compound (4) attached to the surface of the compound (3) may fall.
  • the aggregated compound (3) can move as shown in Figure 5 can leave the non-compound (4) that may exist between the compound (3).
  • the washing solution 20 is supplied to the sample container 10, the above operation can be proceeded more easily.
  • the sample container 10 advanced as described above is moved to the lower part of the light emitting unit 600 by the mounting moving unit 400.
  • the light emitter supply unit 600 is operated to supply the chemiluminescent material 6 to the sample container 10.
  • the chemiluminescent material 6 contacts the compound 3 and emits light to analyze the light source.

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  • Immunology (AREA)
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  • Plasma & Fusion (AREA)
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  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)

Abstract

La présente invention concerne une technologie portant sur un appareil de séparation de composés et un appareil d'immunoessai par chimiluminescence utilisant celui-ci. L'appareil de séparation de composés selon la présente invention comprend une unité de support, une unité d'agrégation et une unité de séparation de non composés pour séparer un composant spécifique présent dans un échantillon. L'appareil d'immunoessai par chimiluminescence comportant l'appareil de séparation de composés comprend une unité mobile de support, une unité d'alimentation de corps de couplage, une unité d'alimentation d'émetteur de lumière et une unité de mesure de source de lumière, et peut ainsi mesurer une quantité d'un constituant spécifique contenu dans un échantillon de sang ou de sérum, par l'intermédiaire d'une luminescence du constituant spécifique.
PCT/KR2017/011704 2017-01-25 2017-10-23 Appareil de séparation de composés et appareil d'immunoessai par chimiluminescence utilisant celui-ci Ceased WO2018139733A1 (fr)

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KR102245068B1 (ko) * 2019-10-23 2021-04-28 안양대학교 산학협력단 포터블 초미세기포 농도 측정 분석 장치
US20230311128A1 (en) * 2020-09-02 2023-10-05 Menarini Silicon Biosystems S.P.A. System, kit, method and process for handling a sample

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