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WO2020096292A1 - Cartouche d'appareil d'analyse pour diagnostic in vitro - Google Patents

Cartouche d'appareil d'analyse pour diagnostic in vitro Download PDF

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Publication number
WO2020096292A1
WO2020096292A1 PCT/KR2019/014786 KR2019014786W WO2020096292A1 WO 2020096292 A1 WO2020096292 A1 WO 2020096292A1 KR 2019014786 W KR2019014786 W KR 2019014786W WO 2020096292 A1 WO2020096292 A1 WO 2020096292A1
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WO
WIPO (PCT)
Prior art keywords
membrane
capillary
reagent
cartridge
stored
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/KR2019/014786
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English (en)
Korean (ko)
Inventor
이중진
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MEDISENSOR Inc
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MEDISENSOR Inc
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Filing date
Publication date
Application filed by MEDISENSOR Inc filed Critical MEDISENSOR Inc
Publication of WO2020096292A1 publication Critical patent/WO2020096292A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/026—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations having blocks or racks of reaction cells or cuvettes
    • 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
    • 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
    • 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
    • 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
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • 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
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/028—Modular arrangements
    • 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
    • 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
    • B01L2300/046—Function or devices integrated in the closure
    • B01L2300/047—Additional chamber, reservoir
    • 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
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0672—Integrated piercing tool
    • 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
    • B01L2300/16—Surface properties and coatings
    • B01L2300/168—Specific optical properties, e.g. reflective coatings
    • 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
    • G01N2035/00178—Special arrangements of analysers
    • G01N2035/00326—Analysers with modular structure

Definitions

  • An embodiment relates to a cartridge used in an in vitro diagnostic analysis device.
  • In vitro diagnostics refers to the measurement and analysis of specific components in samples of body fluids, such as blood, sweat, and urine, to determine if there are any abnormal signs or infections. Such in vitro diagnostics are widely used to confirm the safety of blood used for pregnancy diagnosis or transfusion as well as professional disease identification.
  • in vitro diagnostic analysis devices include glycated hemoglobin (HbA1c), albumin (u-Albumin, ACR), creatinine, C-reactive protein (CRP), and di-dimer )
  • HbA1c glycated hemoglobin
  • albumin u-Albumin, ACR
  • creatinine C-reactive protein
  • CRP C-reactive protein
  • di-dimer di-dimer
  • analysis results may vary due to user's carelessness, working environment, and user-to-user variation, which has been used as a weakness in an in vitro diagnostic analysis device that requires accuracy.
  • the embodiment relates to a cartridge of an in-vitro diagnostic analysis device capable of improving the convenience and accuracy of inspection and analysis while minimizing user handling.
  • An embodiment of the cartridge of the in vitro diagnostic analysis device includes: a plurality of capillary parts; A first body including a plurality of reagent storage units for storing different reagents and a membrane housing on which a membrane capable of selectively permeating is mounted; A first sealing paper disposed above the reagent storage unit; The membrane housing is mounted and includes a measuring unit where a sample injection port is formed, a mounting unit in which a plurality of the reagent storage units are mounted, and a plurality of first seating holes formed in the mounting unit and seated in the plurality of capillary units.
  • a second body And a third body mounted on the mounting portion and formed to correspond to the first seating hole and having a plurality of second seating holes seated by the plurality of capillary parts, wherein the second body is the capillary.
  • a first analysis window is formed on the mounting portion to analyze the capillary portion from the outside when the lip is seated on the first seating hole, and a second analysis window is formed on the third body at a position corresponding to the first analysis window. It can be.
  • the capillary portion includes a cork through which a through hole through which an object is injected is formed; A seating portion for seating the coke; A second storage portion formed of a transparent material, protruding from the seating portion, and forming a storage space; And a capillary tube protruding from the second storage portion, wherein at least a portion of the second storage portion is a first width measured from the outer wall of one end to the outer wall of the other end and the other end of the inner wall of one end.
  • the second width measured up to the inner wall of the second storage unit may be formed into a uniform hollow square column along the length direction of the second storage unit.
  • the first sealing paper is perforated by the capillary tube, so that the specimen stored in the second storage unit may be mixed with the reagent stored in the reagent storage unit.
  • the membrane is formed in a square shape when viewed in the longitudinal direction of the capillary tube, and the sample injection port is formed through the portion to be measured at a position facing the one surface of the membrane, and the center of the capillary tube is A small diameter portion formed to coincide with the center of the membrane when viewed in the longitudinal direction; A large diameter portion formed at a position spaced apart from the membrane and the small diameter portion, the center of which coincides with the center of the small diameter portion, and has a larger diameter than the small diameter portion; And an inclined surface connecting the small diameter portion and the large diameter portion.
  • Another embodiment of the cartridge of the in vitro diagnostic analysis device may be one that is seated in at least one of the plurality of second seating holes and further includes a chamber in which reagents are stored.
  • the chamber may be formed through the chamber and a storage space for storing reagents may be formed, and a second sealing paper closed at the bottom of the storage space and perforated by the capillary tube may be provided below.
  • the chamber may be provided with a third sealing paper that is closed at the upper end of the storage space and is perforated by the capillary tube and the second storage unit.
  • the components of the reagents stored in the reagent storage portion of the plurality of the reagent storage portion corresponding to the chamber and the reagents stored in the chamber may be different.
  • a first analysis window is formed on the second body and a second analysis window is formed on the third body, and thus, the optical analysis device is seated on the second body from the outside through the first analysis window and the second analysis window. It is possible to easily analyze the components of the substance stored in the second storage portion of the capillary portion. Due to this structure, it is possible to carry out an in vitro diagnosis in a state seated on the cartridge without separating the capillary portion separately.
  • the reagents can be stored using a separate chamber, they cannot be mixed and stored, but reagents of different components that need to be sequentially mixed with an object during the in vitro analysis can be easily stored and used.
  • the second storage portion since at least a portion of the second storage portion has a rectangular column shape having a constant first width and a second width, refraction of the transmitted light is significantly suppressed, and thus total reflection can also be suppressed. Because total reflection is suppressed, analysis of the subject by the optical analysis device can be remarkably accurate.
  • the distribution of the binding material on the membrane can be made uniform, thereby significantly improving the accuracy of the analysis results.
  • the sample inlet coincides with the center of the membrane and is formed radially based on the center of the membrane, so the mixture material administered to the membrane through the sample inlet and the binding material contained therein is based on the center of the membrane. It has the shape of a concentric circle having a diameter equal to the width, and thus can be uniformly distributed along the transverse and longitudinal directions of the membrane.
  • FIG. 1 is a perspective view showing a cartridge of an in vitro diagnostic analysis device according to an embodiment.
  • Figure 2 is an exploded view showing a cartridge of the in vitro diagnostic analysis device of an embodiment.
  • FIG 3 is an exploded view showing a capillary portion of an embodiment.
  • FIG. 4 is a cross-sectional view of FIG. 3 viewed in the direction AA.
  • FIG. 6 is a photograph for specifically explaining the capillary portion of one embodiment.
  • (b) is a picture taken in a state in which the liquid is stored in the second reservoir shown in (a).
  • FIG. 7 is a plan view showing a first body in one embodiment.
  • FIG. 8 is a plan view showing a state in which the second body of one embodiment is coupled to the first body shown in FIG. 7.
  • FIG. 9 is a view showing part B of FIG. 8. For clarity, the second body is transparent.
  • FIG. 10 is a cross-sectional view of FIG. 9 viewed in the CC direction.
  • 11 is a photograph for comparison with the membrane of one embodiment.
  • FIG. 12 is a photograph showing a pattern in which a reagent is spread on a membrane by administering a reagent to the membrane of one embodiment.
  • FIG. 13 is a cross-sectional view of the cartridge of the in vitro diagnostic analysis device showing a state immediately before the capillary portion of one embodiment is mounted on the first body and the second body.
  • FIG 14 is a cross-sectional view of the cartridge of the in vitro diagnostic analysis device showing a state after the capillary portion of one embodiment is mounted on the first body and the second body.
  • the top (top) or bottom (bottom) (on or under) when described as being formed on the “top (top)” or “bottom (bottom) (on or under)” of each element, the top (top) or bottom (bottom) (on or under) ) Includes both two elements directly contacting each other or one or more other elements formed indirectly between the two elements.
  • the top (top) or bottom (bottom) (on or under) when expressed as “up (up)” or “down (down)” (on or under), it may include the meaning of the downward direction as well as the upward direction based on one element.
  • FIG. 1 is a perspective view showing another cartridge as an in vitro diagnostic assay of an embodiment.
  • 2 is an exploded view showing another cartridge as an in vitro diagnostic assay of an embodiment.
  • the in vitro diagnostic assay include cartridges of other glycosylated hemoglobin (HbA1c), albumin (u-Albumin, ACR), creatinine, C-reactive protein (CRP), and di-dimer (D) -Dimer) can be applied to an in vitro diagnostic analytical device that analyzes at least one of the analytes, or an equivalent level device.
  • the "subject” is taken from the human body for examination, and may be blood in an embodiment.
  • Analysis object is as described above as being detected in the subject.
  • the "reagent” is a substance that detects an analyte from a test object, and may be divided into a reactant reacting with the analyte and a washing solution that is diluted and dissolved to wash other than the analyte reacted with the reactant.
  • the "binding material” is a combination of the analyte and the reactant.
  • a “mixture” is a physical mixture of a test subject and a reactant.
  • the reactant may be, for example, XC-DAPOL-CPBA that reacts with glycated hemoglobin and boronic acid affinity among blood components.
  • the reactants are not limited to this, and various materials may be used as necessary. Accordingly, different reactants may be stored in the plurality of reagent storage units 210 and the chamber 600.
  • the cartridge of the embodiment may include a capillary portion 100, a first body 200, a first sealing paper 300, a second body 400, a third body 500 and a chamber 600.
  • a plurality of capillary parts 100 may be provided, and blood, which is a test object, may be injected into each of them.
  • the capillary unit 100 is, for example, a first cell 100-1, a second cell 100-2, and a third cell 100 having the same or very similar structure. -3) can be provided in total.
  • two or four capillary parts 100 may be provided.
  • reagents may be introduced into the capillary portion 100 through the capillary tube 140, and reagents and test objects may be mixed in the capillary portion 100.
  • the capillary unit 100 will be described in more detail below with reference to FIG. 3.
  • the first body 200 may include a plurality of reagent storage units 210 for storing different reagents and a membrane housing 220 on which a membrane 221 capable of selectively permeating is mounted. 2, the reagent storage unit 210 and the membrane housing may be integrally formed.
  • the reagent storage unit 210 may be provided in the same number as the number of the capillary unit 100, for example, the first part 210-1, the second part 210-2, and the third part ( 210-3). Of course, the reagent storage unit 210 may be provided in two or more than four.
  • the plurality of reagent storage units 210 may be formed by recessing the upper portion of the first body 200 so that the reagent can be stored, and may be disposed to be spaced apart from each other along the length direction of the first body 200.
  • the plurality of reagent storage units 210 may store at least one reactant and at least one washing solution in different cells, respectively.
  • the reactants can be in a liquid or solid state.
  • the reagent storage unit 210 may store a dissolving agent for dissolving the solid.
  • the membrane housing 220 is disposed at a position spaced apart from the reagent storage unit 210 in the longitudinal direction of the first body 200, and the membrane 221 may be mounted.
  • the membrane 221 is disposed on the membrane housing 220, and the sample injection port 411 is disposed at a position opposite to the membrane 221, so that the membrane (through the sample injection port 411) 221) may be administered a mixture of a washing solution, a test object and a reactant.
  • the membrane 221 has a structure capable of selectively permeating a substance, and can filter a binding substance formed by the combination of the analyte and the reactant.
  • the membrane 221 filters the binding material to which the analyte and the reactant are combined, and transmits a permeation layer having a pore size that transmits only the remaining components and the permeation rate of the remaining components. It may be configured to include an absorbing layer to raise.
  • the first sealing paper 300 is disposed above the reagent storage unit 210 so that the reagent stored in the reagent storage unit 210 does not leak to the outside, and may be in the form of a foil.
  • the first sealing paper 300 may be attached on the reagent storage unit 210 while the reagent is injected into the reagent storage unit 210 to prevent leakage of the reagent.
  • the test object stored in the second storage unit 130 may be mixed with reagents stored in the reagent storage unit 210. .
  • the capillary portion 100 descends in the direction of the reagent storage unit 210 by the operation of the analysis device, and the first sealing paper by the capillary tube 140
  • the reagent 300 is perforated and stored in the reagent storage unit 210 is introduced into the capillary unit 100 through the capillary tube 140, so that the test object and the reagent can be mixed with each other.
  • the second body 400, the first body 200 may be mounted, the capillary portion 100 may be seated, and also the third body 500 may be mounted, the measurement unit 410 , It may include a mounting unit 420 and the first analysis window (430).
  • the membrane to be measured 410 the membrane housing 220 is mounted and a sample injection port 411 may be formed. As described above, while the membrane housing 220 is mounted on the measurement unit 410, the membrane 221 may be disposed at a position facing the sample injection port 411.
  • a plurality of the reagent storage unit 210 is mounted on the lower portion of the mounting portion 420, and the capillary portion 100 may be mounted on the upper portion. Accordingly, a plurality of first seating holes 421 on which the plurality of capillary parts 100 are seated may be formed on the mounting part 420. Of course, the number of first seating holes 421 may be formed to correspond to the number of reagent storage units 210 and the number of capillary units 100.
  • the second body 400 has a first analysis window (not shown) on the mounting portion 420 to analyze the capillary portion 100 from the outside when the capillary portion 100 is seated in the first seating hole 421.
  • 430 may be formed.
  • the first analysis window 430 may be formed in the mounting portion 420 to communicate with the first seating hole 421. Therefore, when the capillary portion 100 is seated in the first seating hole 421, the capillary portion 100 may be inspected from the outside through the first analysis window 430.
  • the second storage portion 130 of the capillary portion 100 can be viewed from the outside through the first analysis window 430. Accordingly, a material stored in the second storage unit 130, that is, a test object, a reagent, or a binding material of the test object and the reagent may be analyzed from the outside through the first analysis window 430.
  • the cartridge is used in combination with an in vitro diagnostic analysis device, and the analysis device is equipped with an optical analysis device (not shown) to analyze the material stored in the second storage unit 130.
  • the optical analysis device for example, irradiates light of a specific color and a specific wavelength with a light source such as an LED, detects and calculates the amount of reflected light with a detector, or photographs the reflected light or the second storage unit 130 with a camera module By analyzing the creatinine value, etc. can be analyzed. Likewise, the glycated hemoglobin value and the like can be analyzed in the membrane 221 using an optical analysis device.
  • the analysis through the second storage unit 130 and the analysis through the membrane 221 may be performed by moving the same optical analysis device provided in the analysis device or by using each optical analysis device provided separately. Can be.
  • the first analysis window 430 may be provided in the required number of positions required for all or part of one or both sides of the portion corresponding to the portion where the first seating hole 421 is formed in the mounting portion 420.
  • the first analysis window 430 was formed on both sides of the site where both sides of the third cell 100-3 are seated.
  • the chamber 600 is seated and covers the first analysis window 430 at a portion where the third cell 100-3 is seated, the first analysis window 430 formed on one side is not visible.
  • the position and number of the first analysis window 430 are not limited thereto, and various numbers may be provided at various positions so that the plurality of capillary parts 100 can be viewed from the outside.
  • the first analysis window 430 may be formed on the first body 200 in various shapes.
  • the first analysis window 430 may be formed as a “+” shape slit to facilitate irradiation of light for analysis, and referring to FIG. 13 as another embodiment , It may be provided in a rectangular shape having a relatively large area in order to facilitate photography.
  • the third body 500 is mounted on the mounting portion 420, is formed to correspond to the first seating hole 421 and a plurality of second seating holes 510 seated by the plurality of capillary parts 100 It can be formed.
  • the first seating hole 421 is formed in the same number as the second seating hole 510 in a position corresponding to the second seating hole 510, and thus the capillary portion 100 and the first seating hole 421 It can be stably inserted into the second seating hole 510.
  • the third body 500 may be formed with a second analysis window 520 at a position corresponding to the first analysis window 430.
  • the optical analysis device may analyze the material stored in the second storage unit 130 through the second analysis window 520.
  • the second analysis window 520 is the third body 500 so that the second analysis window 520 corresponds to the first analysis window 430 when the third body 500 is mounted on the mounting unit 420. It is formed on, it is appropriate to have the same number and the same shape as the first body 200.
  • the first analysis window 430 is formed on the second body 400 and the second analysis window 520 is formed on the third body 500, and accordingly, the optical analysis device may include the first analysis window ( 430) and the second analysis window 520, it is possible to easily analyze the components of the material stored in the second storage unit 130 of the capillary unit 100 seated on the second body 400 from the outside. Due to this structure, it is possible to carry out an in vitro diagnosis in a state seated on the cartridge without separating the capillary portion separately.
  • the chamber 600 is seated in at least one of the plurality of second seating holes 510, and reagents may be stored.
  • the chamber 600 may be provided to be detachable from the second seating hole 510.
  • the components of the reagents stored in the reagent storage unit 210 in a position corresponding to the chamber 600 among the plurality of reagent storage units 210 and the reagents stored in the chamber 600 may be different. .
  • reagents stored in the chamber 600 may be different from reagents stored in the third part 210-3 disposed immediately below the chamber 600.
  • the reagent stored in the chamber 600 may be a reactant.
  • the chamber 600 may be used to sequentially mix a test object and a plurality of reactants of different components.
  • the first reactant and the second reactant may be used, that is, the first reactant and the second reactant.
  • the first reactant and the second reactant are stored in a mixed state, the chemical properties are different. Therefore, the first reactant and the second reactant cannot be mixed and stored in the reagent storage unit 210.
  • each is stored in a cartridge in a separate state, the test substance and the first reactant are mixed with each other to generate a first mixture, and then the first mixture and the second reactant are mixed to detect creatinine. have.
  • the first reactant is stored in the chamber 600, and the second reactant is stored in the third part 210-3 disposed at a position corresponding to the chamber 600 in the vertical direction.
  • creatinine detection can proceed.
  • the chamber 600 is formed through the chamber 600 therein, a storage space 610 for storing reagents is formed, and a second sealing paper 620 and a third sealing paper 630 may be provided. .
  • the second sealing paper 620 and the third sealing paper 630 may be formed of foils, and may be attached to the lower and upper portions of the chamber 600, respectively.
  • the second sealing paper 620 is provided at the lower portion of the chamber 600 to close the lower end of the storage space 610 and may be perforated by the capillary tube 140.
  • the third sealing paper 630 is provided on the upper portion of the chamber 600 to close the upper end of the storage space 610, to be perforated by the capillary tube 140 and the second storage unit 130 Can be.
  • Reactive materials may be mixed with each other to form a first mixed material.
  • the capillary tube 140 is stored in the second storage 130 through the capillary tube 140.
  • the first mixed material and the second reactant stored in the third part 210-3 may be mixed with each other to generate a second mixed material.
  • the reagents can be stored using a separate chamber 600, it is not possible to mix and store them, but reagents of different components that need to be mixed and used sequentially with an in vitro assay can be easily stored and used.
  • FIG. 3 is an exploded view showing the capillary portion 100 of one embodiment.
  • 4 is a cross-sectional view of FIG. 3 viewed in the direction AA.
  • the capillary unit 100 is mounted on the analysis device to proceed with analysis of the subject.
  • the analysis device is provided with a gripping portion, and the gripping portion grips the capillary portion 100 to move the capillary portion 100 in the vertical direction, the front-rear direction, and the left-right direction and may rotate.
  • the analysis device is provided with a pressure device connected to the through hole 111 of the cork 110, the pressure device pressurizes or depressurizes the inside of the capillary part 100 to suck the liquid inside the capillary part 100 Alternatively, liquid may be discharged from the inside of the capillary portion 100.
  • the test object stored in the capillary unit 100 and the reagents stored in the reagent storage unit 210 or the chamber 600 may be mixed with each other.
  • the washing solution of the reagent storage unit 210 may be sucked and administered to the membrane 221 through pressure reduction or pressure.
  • the capillary portion 100 may include a cork 110, a seating portion 120, a second storage portion 130, and a capillary tube 140.
  • the coke 110 may be provided to be detached from the seating part 120, and the seating part 120, the second storage part 130, and the capillary tube 140 may be integrally formed.
  • the cork 110 may be formed with a through hole 111 through which an object is injected, and as described above, may be connected to a pressure device of the analysis device through the through hole 111.
  • the seating portion 120 is a portion where the cork 110 is seated. Therefore, the seating portion 120 may be formed with a depression corresponding to the outer shape of the cork 110.
  • the second storage unit 130 may be formed of a transparent material, protrude from the seating unit 120, and a storage space 610 may be formed.
  • a test object, a reagent, and a liquid in which the test object and the reagent are mixed may be stored according to the progress of the analysis.
  • the optical analysis device may analyze the liquid stored in the second storage unit 130.
  • the capillary tube 140 protrudes from the second storage unit 130, and moves up and down to pierce the first sealing paper 300, the second sealing paper 620, or the third sealing paper 630 for the second storage.
  • the test object stored in the unit 130 and the reagent stored in the reagent storage unit 210 or the chamber 600 may be mixed with each other.
  • At least a portion of the second storage part 130 is measured from a first width (w1) from one end of the outer wall to the outer wall of the other end, and a measurement from the inner wall of one end to the inner wall of the other end.
  • One second width w2 may be formed as a hollow square column each having a constant length along the longitudinal direction of the second storage unit 130.
  • the total reflection phenomenon may be significantly reduced on the outer surface of the second storage unit 130 that the optical analysis device observes and analyzes, that is, the observation surface and the inner surface corresponding to the observation surface.
  • the second storage unit 130 since at least a portion of the second storage unit 130 has a square column shape in which the first width w1 and the second width w2 are constant, refraction of transmitted light is significantly suppressed, and thus total reflection is also Can be significantly suppressed. Because total reflection is suppressed, analysis of the subject by the optical analysis device can be remarkably accurate.
  • FIG. 5 is a picture for comparison with the capillary portion 100 of one embodiment.
  • 6 is a photograph for specifically explaining the capillary unit 100 of one embodiment. 5 and 6, (b) is a photograph taken in a state in which the liquid is stored in the second storage unit 130 shown in (a).
  • the second storage unit 130 ′ is provided in a hollow cone shape.
  • FIG. 5 (b) it can be seen that an extreme total reflection phenomenon occurs on the observation surface LP 'of the second storage unit 130' that the optical analysis device observes and analyzes.
  • the second storage unit 130 is provided such that the first width w1 and the second width w2 have a constant square column shape. Referring to FIG. 6 (b), it can be seen that the total reflection phenomenon is significantly reduced on the observation surface LP of the second storage unit 130 that the optical analysis device observes and analyzes, compared to the comparative example of FIG. 5. have.
  • FIG. 7 is a plan view showing the first body 200 according to an embodiment.
  • 8 is a plan view showing a state in which the second body 400 of one embodiment is coupled to the first body 200 shown in FIG. 7.
  • FIG. 9 is a view showing part B of FIG. 8. For clarity, the second body 400 is shown transparently.
  • 10 is a cross-sectional view of FIG. 9 viewed in the CC direction.
  • the membrane 221 may be formed in a square shape when viewed in the longitudinal direction of the capillary tube 140. As described above, the membrane 221 may be analyzed by an optical analysis device.
  • the binding material to which the analyte and the reactant are combined remains in a smeared state, and the optical analysis device can analyze the binding material. Therefore, in order to increase the accuracy of the analysis result by the optical analysis device, it is necessary to make the distribution of the binding material on the membrane 221 as uniform as possible. If the distribution is non-uniform, optical distortion may occur, which may degrade the accuracy of the analysis results.
  • the membrane 221 may be formed in a square shape. If the membrane 221 is formed in a rectangular shape, the lateral spreading speed and the vertical spreading speed of the membrane 221 are different from each other, and accordingly, the distribution of the binding material on the membrane 221 has a horizontal and vertical direction. As a result, the distribution of the binding material in the entire membrane 221 may become non-uniform.
  • the distribution of the binding material on the membrane 221 can be uniform, thereby significantly improving the accuracy of the analysis result.
  • the sample injection hole 411 may include a small-diameter portion 4111, a large-diameter portion 4112, and an inclined surface 4113.
  • the small-diameter portion 4111 is formed to penetrate the measured portion 410 at a position facing the one surface of the membrane 221, the center of which is seen in the longitudinal direction of the capillary tube 140, the membrane ( It may be formed to coincide with the center of 221).
  • the mixture material may be administered to the membrane 221 through the small diameter portion 4111. Therefore, by being provided so that the center of the small diameter portion 4111 and the center of the membrane 221 coincide, the mixture quality administered through the small diameter portion 4111 uniformly spreads in the horizontal and vertical directions of the square membrane 221. Accordingly, the binding material contained in the mixture may be uniformly distributed throughout the membrane 221.
  • the large-diameter portion 4112 is formed at a position spaced apart from the membrane 221 and the small-diameter portion 4111, the center of which coincides with the center of the small-diameter portion 4111, and has a larger diameter than the small-diameter portion 4111. It can be provided largely.
  • the inclined surface 4113 may be formed to connect the small-diameter portion 4111 and the large-diameter portion 4112, and to have a slope. Since the centers of the small-diameter portion 4111 and the large-diameter portion 4112 coincide, the inclined surface 4113 connecting them may be formed in a ring shape having a constant width in the radial direction.
  • the sample inlet 411 coincides with the center of the membrane 221 and is formed radially based on the center of the membrane 221, so that the membrane 221 is passed through the sample inlet 411.
  • the mixture material to be administered and the binding material contained therein have a concentric shape having a diameter equal to the width of the small-diameter portion 4111 based on the center of the membrane 221, and thus the transverse and longitudinal directions of the membrane 221. Therefore, it can be uniformly distributed.
  • 11 is a photograph for comparison with the membrane 221 of one embodiment.
  • 12 is a photograph showing a pattern that appears by spreading the reagent on the membrane 221 by administering a reagent to the membrane 221 of one embodiment. 11 and 12, the same reagent was used, and a total of three experiments were conducted with a total of three membranes.
  • the experiment was conducted using a membrane of a rectangular structure.
  • the experiment was performed using a membrane 221 having a square structure.
  • the uniformity of the pattern in the transverse and longitudinal directions of the membrane is remarkably high compared to the membrane having a rectangular structure, so that the pattern generated by the reagent is entirely on the membrane. It has a shape close to a concentric circle.
  • the uniformity of distribution in the transverse and longitudinal directions of the reagent on the membrane 221 is significantly improved when the reagent is administered to the membrane 221 Clearly. This is also the case when the mixture material containing the binding material is administered to the membrane 221.
  • FIG. 13 is a cross-sectional view of the cartridge of the in vitro diagnostic analysis device showing a state immediately before the capillary portion 100 of one embodiment is mounted on the first body 200 and the second body 400.
  • 14 is a cross-sectional view of the cartridge of the in vitro diagnostic analysis device showing a state after the capillary portion 100 of one embodiment is mounted on the first body 200 and the second body 400.
  • the analysis process of the specimen using the cartridge of the embodiment is as follows.
  • the cartridge of the embodiment is mounted on the analysis device.
  • the subsequent analysis process can be performed by the analysis device.
  • Analysis of the test specimen using the cartridge analysis apparatus of the embodiment may be variously combined by the movement of the reagents stored in the reagent storage unit 210 and the chamber 600, and the plurality of capillary units 100, but in the embodiment, the test specimen
  • the process of analyzing albumin and creatinine from water will be described as an example.
  • a first reactant that detects creatinine in the chamber 600, a creatinine detected in the third part 210-3, but a second reactant having a different component from the first reactant is stored and the first part ( 210-1) may store a washing solution, and a second reactant for detecting albumin may be stored in the second part 210-2.
  • the test object may be injected into the second cell 100-2 and the third cell 100-3, and the test object may be human blood.
  • the third body 500 moves to the lower part by operating the analysis device, and accordingly, the third sealing paper 630 above the chamber 600 is the third cell 100-3. It is perforated by the capillary tube 140. Accordingly, the test object stored in the third cell 100-3 encounters the first reactant stored in the chamber 600, and when the inside of the third cell 100-3 is pressed by the pressure device, the third cell 100 -3) the test object stored is discharged and mixed with the first reactant stored in the chamber 600. At this time, the first reactant is a reactant used for the detection of creatinine.
  • the first mixed material in which the test object in the chamber 600 is mixed with the first reactant is inside the third cell 100-3, that is, the 2 It is sucked into the storage unit 130.
  • This pressurization and depressurization can be repeated several times to ensure sufficient mixing of the test subject and the first reactant.
  • the third body 500 moves further downward, and accordingly, the second sealing paper 620 under the chamber 600 is attached to the capillary tube 140 of the third cell 100-3. Perforated by.
  • each of the first sealing papers 300 above the first parts 210-1 to the third parts 210-3 is also perforated by the capillary tube 140, and the second body 400 and The third body 500 is fully coupled to a state shown in FIG. 14.
  • the first sealing paper 300 and the second sealing paper 620 are perforated, and the second reactant stored in the third part 210-3 is stored in the second storage 130 of the third cell 100-3.
  • the first mixed material is met, and the second reactant and the first mixed material are sufficiently mixed through the above-described pressurization and decompression process. At this time, the second reactant detects creatinine, and is different from the first reactant.
  • the second mixed material in which the test object, the first reactant, and the second reactant are sufficiently mixed is stored in the second storage unit 130, and the creatinine value is analyzed from the test object using an optical analysis device. can do. Meanwhile, if necessary, the third cell 100-3 may be moved to the first part 210-1 using the gripping portion of the analysis device to inject the washing solution into the third cell 100-3.
  • the first sealing paper 300 is perforated so that the test object inside the second cell 100-2 and the third reactant inside the second part 210-2 meet each other, and the tactic Through one pressurization and depressurization process, the test object and the third reactant are sufficiently mixed with each other to form a third mixture.
  • the inside of the second cell 100-2 is pressed to inject the third mixed material inside the second cell 100-2 into the reagent injection port.
  • the second mixed material to be injected is preferably 10 to 30 ⁇ l.
  • the third mixed material is administered to the membrane 221, and a binding material in which albumin and a third reactant are combined remains in the membrane 221, and the remaining components that have not yet escaped may also remain.
  • the first sealing paper 300 is perforated so that the first cell 100-1 can inhale the washing liquid inside the first part 210-1. Accordingly, the first cell 100-1 is depressurized to suck the cleaning solution of the first part 210-1, and the first cell 100-1 is moved to the sample injection port 411 by the gripping device. The washing solution may be injected into the sample injection port 411 by pressing (100-1) again.
  • the washing solution to be injected is 10 to 30 ⁇ l.
  • albumin values from the subject can be analyzed.
  • the analysis device can be used whenever necessary.
  • the washing solution may be supplied to the second cell 100-2, the third cell 100-3, or the sample injection port 411.

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biochemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Clinical Laboratory Science (AREA)
  • Hematology (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne un mode de réalisation d'une cartouche d'un appareil d'analyse pour diagnostic in vitro qui comprend : une pluralité d'unités capillaires ; un premier corps comprenant une pluralité d'unités de stockage de réactif pour stocker différents réactifs et un boîtier de membrane comprenant une membrane à travers laquelle une perméation sélective est possible ; un premier papier de scellage disposé sur le côté supérieur de chaque unité de stockage de réactif ; un deuxième corps comprenant une unité à mesurer dans laquelle le boîtier de membrane est chargé, et ayant une entrée d'échantillon, une unité de chargement dans laquelle la pluralité d'unités de stockage de réactif sont chargées, et une pluralité de premiers trous de réception qui sont formés dans l'unité de chargement et dans lesquels la pluralité d'unités capillaires sont reçues ; et un troisième corps chargé dans l'unité de chargement et ayant une pluralité de seconds trous de réception qui sont formés pour correspondre aux premiers trous de réception et dans lesquels la pluralité d'unités capillaires sont reçues, le deuxième corps ayant, dans l'unité de chargement, une première fenêtre d'analyse à travers laquelle les unités capillaires sont analysées depuis l'extérieur lorsque les unités capillaires sont reçues dans les premiers trous de réception, et le troisième corps possède une seconde fenêtre d'analyse à une position correspondant à la première fenêtre d'analyse.
PCT/KR2019/014786 2018-11-07 2019-11-04 Cartouche d'appareil d'analyse pour diagnostic in vitro Ceased WO2020096292A1 (fr)

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KR10-2018-0135616 2018-11-07
KR1020180135616A KR20200052559A (ko) 2018-11-07 2018-11-07 체외진단용 분석장치의 카트리지

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Cited By (1)

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Publication number Priority date Publication date Assignee Title
WO2023043673A1 (fr) * 2021-09-14 2023-03-23 Illumina, Inc. Ensembles puits et procédés associés

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102480198B1 (ko) * 2022-02-21 2022-12-23 주식회사 레오바이오 당화혈색소 측정 키트

Citations (5)

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Publication number Priority date Publication date Assignee Title
KR100710122B1 (ko) * 2001-05-09 2007-04-20 엑시스-시일드 에이에스에이 분석 시스템
KR20100136744A (ko) * 2009-06-19 2010-12-29 주식회사 인포피아 당화혈색소 측정용 카세트
KR20160051253A (ko) * 2014-11-03 2016-05-11 (주)베스티드 체외진단용 분석장치의 카트리지
WO2018062587A1 (fr) * 2016-09-29 2018-04-05 주식회사 녹십자엠에스 Cassette séparable permettant de mesurer l'hémoglobine glyquée
US10117615B1 (en) * 2017-08-01 2018-11-06 Nova Biomedical Corporation Analyzer cartridge with capillary wiper

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100710122B1 (ko) * 2001-05-09 2007-04-20 엑시스-시일드 에이에스에이 분석 시스템
KR20100136744A (ko) * 2009-06-19 2010-12-29 주식회사 인포피아 당화혈색소 측정용 카세트
KR20160051253A (ko) * 2014-11-03 2016-05-11 (주)베스티드 체외진단용 분석장치의 카트리지
WO2018062587A1 (fr) * 2016-09-29 2018-04-05 주식회사 녹십자엠에스 Cassette séparable permettant de mesurer l'hémoglobine glyquée
US10117615B1 (en) * 2017-08-01 2018-11-06 Nova Biomedical Corporation Analyzer cartridge with capillary wiper

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023043673A1 (fr) * 2021-09-14 2023-03-23 Illumina, Inc. Ensembles puits et procédés associés

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