WO2021149465A1 - Dispositif de traitement et système de mesure - Google Patents

Dispositif de traitement et système de mesure Download PDF

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Publication number
WO2021149465A1
WO2021149465A1 PCT/JP2020/049204 JP2020049204W WO2021149465A1 WO 2021149465 A1 WO2021149465 A1 WO 2021149465A1 JP 2020049204 W JP2020049204 W JP 2020049204W WO 2021149465 A1 WO2021149465 A1 WO 2021149465A1
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WIPO (PCT)
Prior art keywords
heat medium
temperature
processing apparatus
storage tank
sample solution
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PCT/JP2020/049204
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English (en)
Japanese (ja)
Inventor
貴亮 森
崇裕 宮戸
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富士フイルム株式会社
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Priority to JP2021573038A priority Critical patent/JP7394885B2/ja
Publication of WO2021149465A1 publication Critical patent/WO2021149465A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01L—MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
    • G01L7/00—Measuring the steady or quasi-steady pressure of a fluid or a fluent solid material by mechanical or fluid pressure-sensitive 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
    • G01N33/579—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving limulus lysate
    • 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

Definitions

  • This disclosure relates to processing equipment and measurement systems.
  • a measurement using a lysate reagent containing a horseshoe crab blood cell extract is known.
  • the amount of endotoxin and the amount of ⁇ -glucan in the sample solution can be measured.
  • Endotoxin is a lipopolysaccharide that constitutes the cell wall of Gram-negative bacteria, and is a typical pyrogen that causes a biological reaction such as fever when it enters the blood even in a trace amount.
  • Specimens include biological samples such as blood, as well as pharmaceuticals (for example, injections) that are directly introduced into the living body.
  • Japanese Unexamined Patent Publication No. 2017-129249 describes a measuring device for measuring the amount of endotoxin in a sample solution using a LAL (Limulus Amebocyte Lysate) reagent as a lysate reagent. Further, Japanese Patent Application Laid-Open No. 08-029432 describes a processing apparatus for pretreating a sample solution.
  • LAL Limulus Amebocyte Lysate
  • the processing apparatus described in Japanese Patent Application Laid-Open No. 08-029432 includes a transport mechanism for transporting a sample container from a heating unit to a cooling unit by a handling robot.
  • a transport mechanism for transporting a sample container from a heating unit to a cooling unit by a handling robot.
  • the sample container inserted into the container insertion hole of the heating unit is grasped by the handling robot, and the arm of the robot is moved upward to pull out the sample container from the container insertion hole.
  • the handling robot conveys the sample container to the upper part of the cooling unit, and the arm of the robot is moved downward to insert the sample container into the container insertion hole of the cooling unit.
  • the technique of the present disclosure can suppress a transport defect when transporting the sample container from the heating section to the cooling section, and can suppress a long processing time due to the transport of the sample container. It is an object of the present invention to provide a possible processing device and a measurement system including the processing device.
  • the processing apparatus accommodates a sample container and can store a fluid heat medium for changing the temperature of the sample solution in the sample container around the sample container.
  • the accommodation tank is provided with a supply port for supplying a heat medium and a discharge port for discharging the heat medium, and the heat medium exchange mechanism is connected to the supply port and the discharge port.
  • the first heat medium or the second heat medium in the accommodating tank may be circulated through the pipes provided.
  • the processing apparatus of the above aspect it is connected to the first supply path connected to the first heat medium supply unit that supplies the first heat medium and the second heat medium supply unit that supplies the second heat medium.
  • a valve for switching between a second supply path, a first state for communicating the first supply path and the supply port, and a second state for communicating the second supply path and the supply port may be provided.
  • the heat medium supplied from the heat medium supply unit is supplied to the supply port, and the heat medium is placed on the supply path at the first temperature before being supplied to the supply port.
  • a first temperature adjusting unit that converts to a first heat medium by heating above, and a second heat medium that is arranged on a supply path and cools the heat medium to a second temperature or lower before being supplied to a supply port.
  • a second temperature adjusting unit for converting to may be provided.
  • the heat medium may be a liquid.
  • the heat medium exchange mechanism is controlled to control the second heat to the storage tank.
  • a control unit for supplying a medium may be provided.
  • the processing apparatus of the above aspect includes a heater that heats the heat medium to be the first heat medium, and the temperature of the heater may be 30 ° C. or higher and 80 ° C. or lower.
  • the temperature of the heater may be 60 ° C. or higher and 80 ° C. or lower.
  • the processing apparatus of the above aspect includes a cooling element for cooling in order to use the heat medium as the second heat medium, and the temperature of the cooling element may be 0 ° C. or higher and 10 ° C. or lower.
  • the storage tank may be configured to store a plurality of sample containers.
  • the sample solution is the measurement target of the measurement using the reagent containing the horseshoe crab blood cell extract, and the process of changing the temperature of the sample solution by the heat medium exchange mechanism executes the above measurement. It may be a pretreatment performed before the processing is performed.
  • the measurement system includes the above-mentioned processing device and a measuring device for measuring a sample solution.
  • an apparatus and a measurement system including the processing apparatus can be provided.
  • FIG. 1 is a diagram showing an outline of a measurement system 1 provided with a processing device 10 according to the first embodiment of the present disclosure.
  • the measuring system 1 includes a processing device 10 and a measuring device 60.
  • the processing apparatus 10 performs pretreatment performed before performing endotoxin measurement on the sample solution C produced by adding the buffer solution B to the sample A such as a biological sample and diluting it.
  • the measuring device 60 executes endotoxin measurement with the sample solution C after pretreatment as a measurement target.
  • endotoxin is a typical pyrogen that causes a biological reaction such as fever by entering the blood even in a small amount, and sample A is directly introduced into the living body in addition to a biological sample such as blood. Pharmaceuticals (eg, injections, etc.).
  • the amount of endotoxin in the sample solution C is measured, and the endotoxin in the sample A is quantified.
  • the endotoxin measurement is a measurement using a reagent such as lysate reagent D containing horseshoe crab blood cell extract.
  • Endotoxin measurement is a measurement utilizing the fact that endotoxin causes aggregation and coagulation of horseshoe crab blood cell extract.
  • lysate reagent D containing horseshoe crab blood cell extract is added to sample solution C.
  • the sample solution E is produced by stirring the sample solution C to which the lysate reagent D is added.
  • the amount of endotoxin in the sample solution E is measured based on the change in the characteristics of the sample solution E.
  • a lysate reagent prepared from a blood cell extract of Atlantic horseshoe crab is called a LAL (Limulus Amebocyte Lysate) reagent.
  • the measuring device 60 in the measuring system 1 of the present embodiment uses the LAL reagent as the lysate reagent D, and the ratio using the change in turbidity of the sample solution E in the process of gelation of the lysate reagent D by the reaction with endotoxin as an index. Endotoxin is measured by the turbidity method.
  • endotoxin measurement is performed by the turbidimetry method, pretreatment for heating and cooling the sample solution C is required prior to the measurement. As shown in FIG. 1, pretreatment is performed on the sample solution C, and endotoxin measurement is performed on the sample solution E containing the sample solution C and the lysate reagent D after the pretreatment.
  • a sample solution C produced by adding a buffer solution B to a sample A and diluting the sample solution C is about.
  • Heat treatment is performed to inactivate the interfering factors in endotoxin measurement by heating at a temperature of 70 ° C. for about 10 minutes.
  • the sample solution C at about 70 ° C. is cooled to a temperature of about 5 ° C. to perform a cooling treatment for stopping the inactivation treatment.
  • the time of the cooling process from the start of cooling to the end of cooling is, for example, about 3 minutes.
  • the cooling treatment if it takes time to cool the sample solution C at about 70 ° C to a temperature of about 5 ° C., the time for the inactivation treatment for the sample solution C varies, and the accuracy of endotoxin measurement decreases. Therefore, in the pretreatment, it is necessary to rapidly cool the sample solution C, specifically, to cool the sample solution C at about 70 ° C to a temperature of about 5 ° C. in a short time.
  • the processing device 10 in the measurement system 1 of the present embodiment is a device that performs the above pretreatment on the sample solution C diluted by adding the buffer solution B to the sample A.
  • FIG. 3 is a schematic view showing the configuration of the processing device 10.
  • the processing device 10 includes a storage tank 20, a heat medium exchange mechanism, and a control unit 11.
  • the storage tank 20 can house the sample container 5 and store the fluid heat medium 15 for changing the temperature of the sample solution C in the sample container 5.
  • the heat medium exchange mechanism exchanges the heat medium in the accommodating tank 20.
  • the control unit 11 controls the heat medium exchange mechanism.
  • the sample container 5 loaded in the processing device 10 has, for example, a cylindrical appearance, and includes a main body 5a and a lid 5b.
  • FIG. 4 is a perspective view of the storage tank 20.
  • FIG. 5 is an exploded perspective view of the storage tank 20.
  • FIG. 6 is a cross-sectional view of the storage tank 20 (VI-VI line cross-sectional view in FIG. 4).
  • the sample container 5 is not a cross-sectional view but a side view.
  • a plurality of container insertion holes 20b for inserting the sample container 5 are formed on the upper surface 20a of the storage tank 20.
  • a supply port 20d for supplying the heat medium 15 into the storage tank 20 is provided on one side surface 20c in the longitudinal direction.
  • a discharge port 20f for discharging the heat medium 15 from the inside of the storage tank 20 is provided on the other side surface 20e in the longitudinal direction.
  • the storage tank 20 includes a water tank type container body 21 having an open upper surface, a holding member 22 for holding the sample container 5, a lid 23 for sealing the opening of the container body 21, and piping attachment on the side of the supply port 20d.
  • a metal fitting 24 and a pipe mounting metal fitting 25 on the side of the discharge port 20f are provided.
  • a supply port 20d is formed on one side surface 21c in the longitudinal direction, and a discharge port 20f is formed on the other side surface 21e.
  • the container body 21 is made of polyphthalamide.
  • the container body 21 is preferably made of a resin material having high heat resistance and heat insulating properties, high chemical resistance to a heat medium, and a small heat capacity, such as polyphthalamide (PPA) or polyphenylene ether (PPE).
  • the holding member 22 has a shape in which a flat plate-shaped pedestal portion 22a and a plurality of tubular container insertion portions 22b provided on the pedestal portion 22a are integrally formed.
  • the holding member 22 is housed inside the container body 21.
  • the holding member 22 is made of aluminum.
  • the holding member 22 is preferably made of a metal material such as aluminum, which has excellent thermal conductivity, is resistant to rust, is inexpensive, and has high workability.
  • the lid 23 is formed with insertion ports 23a for a plurality of container insertion holes 20b.
  • the insertion port 23a of the lid 23 and the inside of the container insertion portion 22b of the holding member 22 communicate with each other to form the container insertion hole 20b.
  • the lid 23 is made of polyphthalamide, like the container body 21.
  • the lid 23 is preferably made of a resin material such as polyphthalamide (PPA) or polyphenylene ether (PPE), which has high heat resistance and heat insulating properties, high chemical resistance to a heat medium, and a small heat capacity. ..
  • the inner diameter of the container insertion hole 20b is formed to be slightly larger than the outer diameter of the sample container 5, but is substantially the same diameter. Therefore, when the sample container 5 is inserted into the container insertion hole 20b, the sample container 5 is held in the container insertion hole 20b without tilting.
  • 10 container insertion holes 20b are arranged side by side in a row.
  • the processing device 10 can be loaded with up to 10 sample containers 5 and can be pretreated at the same time.
  • the pipe mounting metal fitting 24 includes a metal fitting body 24a and a bolt 24b in which a pipe mounting portion and a bolt joint portion are formed.
  • the pipe mounting bracket 24 is formed by inserting the bolt coupling portion of the metal fitting body 24a into the supply port 20d from the outside of the container body 21 and connecting the bolt 24b to the metal fitting body 24a from the inside of the container body 21. It is attached to the container body 21.
  • the pipe mounting bracket 24 has a through hole, and when the pipe mounting bracket 24 is attached to the container body 21, the through hole of the pipe mounting bracket 24 functions as a supply port 20d (also in FIG. 6). reference).
  • the pipe mounting metal fitting 25 also includes a metal fitting body 25a and a bolt 25b in which a pipe mounting portion and a bolt joint portion are formed.
  • the pipe mounting bracket 25 is formed by inserting the bolt coupling portion of the metal fitting body 25a into the discharge port 20f from the outside of the container body 21 and connecting the bolt 25b to the metal fitting body 25a from the inside of the container body 21. It is attached to the container body 21.
  • the pipe mounting bracket 25 has a through hole, and when the pipe mounting bracket 25 is attached to the container body 21, the through hole of the pipe mounting bracket 25 functions as a discharge port 20f (also in FIG. 6). reference).
  • the heat medium exchange mechanism includes a first heat medium supply section 30, a first supply path 40, a first discharge path 44, a second heat medium supply section 31, a second supply path 41, and a second discharge path. It has 45.
  • the storage tank 20, the first heat medium supply unit 30, the first supply path 40, and the first discharge path 44 form a circulation path for the first heat medium 15a.
  • the first heat medium supply unit 30 supplies the first heat medium 15a to the accommodating tank 20 through the first supply path 40.
  • the first heat medium 15a heats the sample solution C stored in the sample container 5 in the storage tank 20 to the first temperature.
  • the first heat medium 15a supplied to the storage tank 20 is discharged from the storage tank 20 through the first discharge passage 44, and is collected in the first heat medium supply unit 30 through the first discharge passage 44.
  • the storage tank 20, the second heat medium supply unit 31, the second supply path 41, and the second discharge path 45 form a circulation path for the second heat medium 15b.
  • the second heat medium supply unit 31 supplies the second heat medium 15b to the accommodating tank 20 through the second supply path 41.
  • the second heat medium 15b cools the sample solution C stored in the sample container 5 in the storage tank 20 from the state heated to the first temperature to the second temperature.
  • the second heat medium 15b supplied to the storage tank 20 is discharged from the storage tank 20 through the second discharge passage 45, and is collected in the second heat medium supply unit 31 through the second discharge passage 45.
  • the first supply path 40 and the second supply path 41 are connected to the supply port 20d of the storage tank 20 via the valve 32 and the common supply path 42.
  • the valve 32 switches between a first state in which the first supply path 40 and the supply port 20d communicate with each other and a second state in which the second supply path 41 and the supply port 20d communicate with each other. In the first state, the first heat medium 15a is supplied to the storage tank 20, and in the second state, the second heat medium 15b is supplied to the storage tank 20.
  • the first discharge passage 44 and the second discharge passage 45 are connected to the discharge port 20f of the storage tank 20 via the valve 33 and the common discharge passage 43.
  • the valve 33 switches between a first state in which the first discharge path 44 and the discharge port 20f communicate with each other and a second state in which the second discharge path 45 and the discharge port 20f communicate with each other.
  • the first heat medium supply unit 30 includes a storage unit 30a for storing the heat medium 15a, a heater 30b for heating the heat medium 15 stored in the storage unit 30a as the first heat medium 15a, and a pump 30d.
  • a pipe 30c for connecting the discharge port of the storage unit 30a and the supply port of the pump 30d is provided.
  • the temperature of the heater 30b can be set to 30 ° C. or higher and 80 ° C. or lower.
  • the temperature of the heater 30b is more preferably 60 ° C. or higher and 80 ° C. or lower.
  • the temperature of the heater 30b is set to 70 ° C. (an example of the first temperature) based on the control from the control unit 11.
  • the first supply path 40 is composed of a pipe connecting the discharge port of the pump 30d and the connection port 32a of the valve 32.
  • the first discharge passage 44 is composed of a pipe connecting the connection port 33a of the valve 33 and the supply port of the first heat medium supply unit 30.
  • the second heat medium supply unit 31 includes a storage unit 31a for storing the heat medium 15, a cooling element 31b for cooling the heat medium 15 stored in the storage unit 31a to be the second heat medium 15b, and a pump 31d. And a pipe 31c for connecting the discharge port of the storage unit 31a and the supply port of the pump 31d.
  • the temperature of the cooling element 31b can be set to 0 ° C. or higher and 10 ° C. or lower.
  • the temperature of the cooling element 31b is set to 5 ° C. (an example of the second temperature) based on the control from the control unit 11.
  • a Perche element is used as the cooling element 31b.
  • the second supply path 41 is composed of a pipe connecting the discharge port of the pump 31d and the connection port 32b of the valve 32.
  • the second discharge passage 45 is composed of a pipe connecting the connection port 33b of the valve 33 and the supply port of the second heat medium supply unit 31.
  • the valve 32 is a three-way valve, and is a common supply path connecting the connection port 32a to which the first supply path 40 is connected, the connection port 32b to which the second supply path 41 is connected, and the valve 32 and the supply port 20d.
  • a connection port 32c to which the 42 is connected is provided.
  • the valve 32 can switch between a first state in which the first supply path 40 and the supply port 20d communicate with each other and a second state in which the second supply path 41 and the supply port 20d communicate with each other based on the control from the control unit 11. It is configured in. In the first state, the connection port 32a and the connection port 32c communicate with each other internally. In the second state, the connection port 32b and the connection port 32c communicate with each other internally.
  • the common supply path 42 is composed of a pipe connecting the connection port 32c and the supply port 20d.
  • the valve 33 is a three-way valve, and is a common discharge path that connects the connection port 33a to which the first discharge path 44 is connected, the connection port 33b to which the second discharge path 45 is connected, and the valve 33 and the discharge port 20f.
  • a connection port 33c to which the 43 is connected is provided.
  • the valve 33 can switch between a first state in which the first discharge path 44 and the discharge port 20f communicate with each other and a second state in which the second discharge path 45 and the discharge port 20f communicate with each other based on the control from the control unit 11. It is configured in. In the first state, the connection port 33a and the connection port 33c communicate with each other internally. In the second state, the connection port 33b and the connection port 33c communicate with each other internally.
  • the common discharge path 43 is composed of a pipe connecting the discharge port 20f and the connection port 33c.
  • the control unit 11 includes a CPU (Central Processing Unit) 11a, a memory 11b, and a storage 11c in which a control program is stored.
  • the memory 11b is a work memory used by the CPU 11a when executing a control program, and for example, a volatile memory is used.
  • the storage 11c is a non-volatile memory for storing various data, and a flash memory or the like is used.
  • the control unit 11 functions as a control unit that controls each unit of the heater 30b, the pump 30d, the cooling element 31b, the pump 31d, the valve 32, and the valve 33 by executing the control program.
  • FIG. 7 is a schematic view showing the configuration of the measuring device 60.
  • the measuring device 60 includes an LED (Light Emitting Diode) 61 that irradiates the sample container 5 with measurement light, and a PD (Photodiode) arranged at a position facing the LED 61 across the sample container 5. ) 62 and a measurement control unit 63.
  • the measurement control unit 63 measures the amount of endotoxin in the sample solution E based on the detection result of PD62. Further, the measurement control unit 63 controls the LED 61 and the PD 62.
  • the sample container 5 contains a sample solution E in which the pretreated sample solution C and the lysate reagent D are mixed.
  • the measurement control unit 63 includes a CPU (Central Processing Unit) 63a, a memory 63b, and a storage 63c in which a measurement control program is stored.
  • the memory 63b is a work memory used by the CPU 63a when executing a measurement control program, and for example, a volatile memory is used.
  • the storage 63c is a non-volatile memory for storing various data, and a flash memory or the like is used.
  • the measurement control unit 63 functions as a control unit that controls each unit of the LED 61 and the PD 62 by executing the measurement control program. Further, the measurement control unit 63 functions as a measurement unit that measures the amount of endotoxin in the sample solution E based on the detection result of PD62 by executing the measurement control program.
  • the turbidimetry method is a method using the change in turbidity in the process of gelation of lysate reagent D by the action of endotoxin as an index.
  • the turbidity of the sample solution E changes depending on the amount of endotoxin in the sample solution E and the elapsed time from the addition of the lysate reagent D to the sample solution C after the pretreatment.
  • the turbidity of the sample solution E changes, the amount of measurement light transmitted through the sample solution E changes.
  • the state and transition of the turbidity of the sample solution E are measured by measuring the change over time in the amount of transmitted light with the PD62. can do.
  • the measurement control unit 63 calculates the amount of endotoxin in the sample solution E based on the state and transition of the turbidity of the sample solution E.
  • FIG. 8 is a flowchart for explaining the flow of preprocessing in the processing apparatus 10.
  • sample solution C is produced by adding buffer solution B to sample A and diluting it.
  • the sample container 5 containing the generated sample solution C is inserted into the container insertion hole 20b of the storage tank 20.
  • the control unit 11 starts supplying the first heat medium 15a into the storage tank 20 and starts the circulation of the first heat medium 15a (step S1). Specifically, the control unit 11 controls the valve 32 to switch to the first state in which the first supply path 40 and the supply port 20d communicate with each other. Further, the valve 33 is controlled to switch to the first state in which the first discharge path 44 and the discharge port 20f communicate with each other.
  • the control unit 11 drives the pump 30d, and as shown by an arrow in FIG. 9, the first heat medium 15a in the first heat medium supply unit 30 is connected to the first supply path 40 and the first discharge path. Control is performed to circulate in the storage tank 20 through 44.
  • control unit 11 determines whether or not 10 minutes have passed since the circulation of the first heat medium 15a into the storage tank 20 was started (step S2). If it is determined in step S2 that 10 minutes have not passed (determination result No.), the control unit 11 continues to circulate the first heat medium 15a into the storage tank 20.
  • step S3 the control unit 11 controls the valve 32 to switch to the second state in which the second supply path 41 and the supply port 20d communicate with each other. Further, the valve 33 is controlled to switch to the second state in which the second discharge path 45 and the discharge port 20f communicate with each other.
  • the control unit 11 drives the pump 31d, and as shown by an arrow in FIG. 10, connects the second heat medium 15b in the second heat medium supply unit 31 to the second supply path 41 and the second discharge path. Control is performed to circulate in the storage tank 20 through 45.
  • control unit 11 determines whether or not 3 minutes have passed since the circulation of the second heat medium 15b into the storage tank 20 was started (step S4). When it is determined in step S4 that 3 minutes have not passed (determination result No.), the control unit 11 continues the circulation of the second heat medium 15b into the storage tank 20.
  • step S4 when it is determined that 3 minutes have passed (determination result Yes), the control unit 11 controls to stop the circulation of the second heat medium 15a into the accommodation tank 20 and ends the process.
  • the processing apparatus 10 of the present embodiment contains the sample container 5 and provides the sample container 5 with a fluid heat medium 15 for changing the temperature of the sample solution C in the sample container 5.
  • a heat medium exchange mechanism for exchanging a first heat medium 15a and a second heat medium 15b for cooling the sample solution C to a second temperature lower than the first temperature is provided.
  • both heating and cooling can be performed without moving the plurality of sample containers 5. Therefore, the processing time can be shortened as compared with the case where the sample containers are transported one by one by the handling robot as in the conventional processing apparatus.
  • the storage tank 20 is provided with a supply port 20d for supplying the heat medium 15 and a discharge port 20f for discharging the heat medium 15, and the heat medium exchange mechanism is provided.
  • the first heat medium 15a or the second heat medium 15b in the storage tank 20 is circulated through the pipes connected to the supply port 20d and the discharge port 20f.
  • the first heat medium 15a or the second heat medium 15b discharged from the storage tank 20 can be easily returned to the set temperature and supplied to the storage tank 20. It is easy to maintain the first heat medium 15a or the second heat medium 15b at a set temperature. Therefore, it is easier to heat or cool the heat medium 15a or the second heat medium 15b more quickly than in the case where the first heat medium 15a or the second heat medium 15b is not circulated.
  • the processing apparatus 10 of the present embodiment has a first supply path connected to a first heat medium supply unit 30 that supplies the first heat medium 15a, and a second heat medium supply unit that supplies the second heat medium 15b.
  • a second supply path connected to 31 and a valve 32 for switching between a first state for communicating the first supply path and the supply port 20d and a second state for communicating the second supply path and the supply port 20d are provided. ..
  • valve 32 By providing the valve 32 in this way, it is possible to distinguish between the supply paths of the first heat medium 15a and the second heat medium 16b having different temperatures.
  • the first heat medium supply unit 30 and the second heat medium supply unit 31 can be provided separately. Therefore, the first heat medium 15a and the second heat medium 15b are prepared separately, and one of them is selectively supplied into the storage tank 20, so that the first heat medium 15a or the second heat medium 15a or the second heat medium having a stable temperature can be selectively supplied.
  • the heat medium 15b can be supplied.
  • the heat medium 15 is harder to heat and cool when the specific heat is larger.
  • the heat medium 15 is more likely to heat the sample solution C using a heat medium 15 having a large specific heat (that is, difficult to cool) than to use a heat medium 15 having a relatively small specific heat (that is, easy to cool). Since the heat medium 15 is maintained in a heated state, the sample solution C can be heated quickly.
  • the heat medium 15 having a large specific heat that is, difficult to warm
  • the heat medium 15 is compared with the case where the heat medium 15 having a relatively small specific heat (that is, easy to warm) is used. Since the cooled state is maintained, the sample solution C can be cooled quickly.
  • pure water is used as the heat medium 15. Since pure water has few impurities and is hard to corrode, in addition to the above effects, it also contributes to the prevention of clogging of the piping of the heat medium exchange mechanism.
  • control for supplying the second heat medium 15b to the storage tank 20 by controlling the heat medium exchange mechanism after a preset set time has elapsed since the first heat medium 15a was supplied to the storage tank 20.
  • a heater 30b for heating the heat medium 15 as the first heat medium 15a is provided, and by setting the temperature of the heater 30b to 30 ° C. or higher and 80 ° C. or lower, pretreatment for endotoxin measurement by the turbidimetry method is performed. It is possible to carry out a heat treatment suitable for. By setting the temperature of the heater 30b to 60 ° C. or higher and 80 ° C. or lower, the heat treatment can be performed more efficiently.
  • a cooling element 31b for cooling the heat medium 15 as the second heat medium 15b is provided, and by setting the temperature of the cooling element 31b to 0 ° C. or higher and 10 ° C. or lower, endotoxin measurement by the turbidimetric method can be performed.
  • a cooling process suitable for the pretreatment can be performed.
  • the measurement system 1 can change the processing device 10 to the processing device 10B according to the second embodiment. Since the configurations other than the processing device 10B are the same as those in the first embodiment, the description other than the processing device 10B will be omitted.
  • FIG. 11 is a schematic view showing the configuration of the processing apparatus 10B according to the second embodiment.
  • the processing apparatus 10B accommodates the sample container 5 and can store the fluid heat medium 15 for changing the temperature of the sample solution C in the sample container 5.
  • the tank 20 includes a heat medium exchange mechanism for exchanging the heat medium in the accommodating tank 20, and a control unit 12 for controlling the heat medium exchange mechanism.
  • the storage tank 20 is the same as the processing device 10 according to the first embodiment, the description thereof will be omitted.
  • the heat medium exchange mechanism is arranged and supplied on the heat medium supply unit 34, the supply path 46 for supplying the heat medium 15 supplied from the heat medium supply unit 34 to the supply port 20d of the storage tank 20, and the supply path 46.
  • a first temperature adjusting unit 35 that converts the heat medium 15 into a first heat medium 15a by heating the heat medium 15 to a first temperature or higher before being supplied to the port 20d, and a first temperature adjusting unit 35 that is arranged on the supply path 46 and supplied to the supply port 20d.
  • a second temperature adjusting unit 36 that converts the heat medium 15 into a second heat medium 15b by cooling the heat medium 15 to a second temperature or lower, and a heat medium 15 discharged from the storage tank 20 are sent to the heat medium supply unit 34. It is provided with a discharge path 47 for returning.
  • the heat medium supply unit 34 includes a storage unit 34a for storing the heat medium 15, a pump 34c, and a pipe 34b for connecting the discharge port of the storage unit 34a and the supply port of the pump 34c.
  • the supply path 46 is composed of a pipe connecting the discharge port of the pump 34c and the supply port 20d of the storage tank 20.
  • the first temperature adjusting unit 35 is provided with a heater.
  • a pretreatment for the sample solution C when endotoxin measurement is performed by the turbidimetry method it is preferable to heat at 60 ° C. or higher and 80 ° C. or lower.
  • the temperature of the first heat medium 15a is 70 ° C.
  • the temperature of the heater is set so that the temperature of the heat medium 15 passing through the mounting position of the first temperature adjusting unit 35 of the supply path 46 is 70 ° C.
  • the second temperature adjusting unit 36 includes a Perche element which is a cooling element.
  • a Perche element which is a cooling element.
  • the temperature of the second heat medium 15b is set to 5 ° C.
  • the temperature of the cooling element is set so that the temperature of the heat medium 15 passing through the mounting position of the second temperature adjusting unit 36 of the supply path 46 is 5 ° C.
  • the discharge path 47 is composed of a pipe connecting the discharge port 20f of the storage tank 20 and the supply port of the storage unit 34a.
  • FIG. 12 is a cross-sectional view showing the peripheral structures of the first temperature adjusting unit 35 and the second temperature adjusting unit 36.
  • the first temperature adjusting unit 35 is attached so as to be in close contact with the supply path 46, and the heat medium 15 passing through the attachment position of the first temperature adjusting unit 35 in the supply path 46 is instantaneously passed. Is converted into the first heat medium 15a.
  • the cross-sectional shape of the supply path 46 is, for example, a flat shape having a thin thickness in the direction parallel to the paper surface and a long depth in the direction orthogonal to the paper surface with respect to the thickness.
  • the first temperature adjusting unit 35 extends in the depth direction of the supply path 46 so that the contact area with the supply path 46 becomes large. Therefore, since the amount of the heat medium 15 per unit time passing through the mounting position of the first temperature adjusting unit 35 is small, the heat medium 15 can be heated instantaneously.
  • the second temperature adjusting unit 36 also instantly converts the heat medium 15 passing through the mounting position of the second temperature adjusting unit 36 in the supply path 46 into the second heat medium 15b, similarly to the first temperature adjusting unit 35. ..
  • the second temperature adjusting unit 36 is also attached so as to be in close contact with the supply path 46, and is oriented in the depth direction of the supply path 46 so that the contact area with the supply path 46 becomes large. It is extending. As a result, since the amount of the heat medium 15 per unit time passing through the mounting position of the second temperature adjusting unit 36 is small, the heat medium 15 can be cooled instantly.
  • control unit 12 includes a CPU (Central Processing Unit) 12a, a memory 12b, and a storage 12c in which a control program is stored.
  • the control unit 12 functions as a control unit that controls each unit of the pump 34c, the first temperature adjustment unit 35, and the second temperature adjustment unit 36 by executing the control program.
  • FIG. 8 (common to the first embodiment) is a flowchart for explaining the flow of preprocessing in the processing apparatus 10B.
  • the control unit 12 sets the first heat medium. 15a is circulated in the storage tank 20 (step S1). Specifically, the control unit 12 drives the pump 34c and the first temperature adjusting unit 35 to convert the heat medium 15 passing through the supply path 46 into the first heat medium 15a, which is indicated by an arrow in FIG. As described above, the control is performed so that the first heat medium 15a is circulated in the storage tank 20.
  • control unit 12 determines whether 10 minutes have passed since the circulation of the first heat medium 15a into the storage tank 20 was started (step S2). If it is determined in step S2 that 10 minutes have not passed (determination result No.), the control unit 12 continues to circulate the first heat medium 15a into the storage tank 20.
  • step S2 When it is determined in step S2 that 10 minutes have passed (determination result Yes), the control unit 12 stops the circulation of the first heat medium 15a into the storage tank 20 and puts the second heat medium 15b in the storage tank. Circulate within 20 (step S3). Specifically, the control unit 12 stops driving the first temperature adjusting unit 35 and drives the second temperature adjusting unit 36 while driving the pump 34c to drive the heat medium 15 passing through the supply path 46. It is converted into a second heat medium 15b, and as shown by an arrow in FIG. 11, the second heat medium 15b is controlled to be circulated in the storage tank 20.
  • control unit 12 determines whether 3 minutes have passed since the circulation of the second heat medium 15b into the storage tank 20 was started (step S4). If it is determined in step S4 that 3 minutes have not passed (determination result No.), the control unit 12 continues to circulate the second heat medium 15b into the storage tank 20.
  • step S4 when it is determined that 3 minutes have passed (determination result Yes), the control unit 12 controls to stop the circulation of the second heat medium 15a into the storage tank 20 and ends the process.
  • the processing device 10B of the present embodiment can solve the problem of poor transport of the sample container and can shorten the processing time.
  • the processing apparatus 10B of the present embodiment is arranged on the supply path 46 and the supply path 46 for supplying the heat medium 15 supplied from the heat medium supply unit 34 to the supply port 20d.
  • a first temperature adjusting unit 35 that converts the heat medium 15 into a first heat medium 15a by heating the heat medium 15 to a first temperature or higher before being supplied to the supply port 20d, and a first temperature adjusting unit 35 arranged on the supply path 46 and connected to the supply port 20d.
  • a second temperature adjusting unit 36 that converts the heat medium 15 into a second heat medium 15b by cooling the heat medium 15 to a second temperature or lower before being supplied is provided.
  • the lysate reagent used for endotoxin measurement is not limited to the LAL reagent, and a TAL (Tachypleus Amebocyte Lysate) reagent prepared from a blood cell extract of a horseshoe crab (Tachypleus tridentatus), which is a different species from the American horseshoe crab, may be used.
  • TAL Techypleus Amebocyte Lysate
  • the endotoxin test method is not limited to the turbidimetry method described in the above embodiment, but is a gelation method using the gel formation of a lysate reagent by the action of endotoxin as an index, or a color development by hydrolysis of a synthetic substrate as an index. You may use the colorimetric method.
  • the measurement using the reagent containing the horseshoe crab blood cell extract is not limited to endotoxin, but may be ⁇ -glucan.
  • a processing apparatus that performs pretreatment for measurement using a reagent containing horseshoe crab blood cell extract has been described as an example, but it is applied to a processing apparatus that performs pretreatment for measurement using other reagents. You may.
  • the pretreatment for the sample solution is not limited to the treatment for heating for 10 minutes and then cooling for 3 minutes as described in the above embodiment, and may be appropriately changed according to the measurement performed on the sample solution.
  • the temperature adjustment process for the sample solution performed by the processing device is not limited to the pretreatment performed prior to the measurement, and may be used for any purpose.
  • the heat medium is not limited to pure water, and antifreeze may be used.
  • an antifreeze solution is used as the heat medium, the heat medium can be circulated in the heat medium exchange mechanism without freezing even at a temperature close to 0 ° C., so that the sample solution can be cooled more quickly.
  • the heat medium is not limited to a liquid, and any fluid may be used.
  • the hardware structure of the processing unit (Processing Unit) that executes various processes such as the control units 11 and 12 and the measurement control unit 63 includes various processors (Processors) shown below. ) Can be used.
  • processors in addition to the CPU (Central Processing Unit), which is a general-purpose processor that executes software and functions as various processing units, the circuit configuration can be changed after the manufacture of FPGA (Field Programmable Gate Array), etc.
  • FPGA Field Programmable Gate Array
  • a dedicated electric circuit that is a processor having a circuit configuration specially designed to execute a specific process such as a programmable logic device (PLD) and / or an ASIC (Application Specific Integrated Circuit). Etc. are included.
  • One processor may be composed of one of these various processors, or a combination of two or more processors of the same type or different types (for example, a combination of a plurality of FPGAs and / or a CPU and a CPU). It may be configured in combination with FPGA).
  • the various processing units are configured by using one or more of the above-mentioned various processors as a hardware structure.
  • an electric circuit in which circuit elements such as semiconductor elements are combined can be used.

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Abstract

Ce dispositif de traitement est pourvu de : un réservoir de logement qui loge en son sein un récipient d'échantillon et qui peut stocker, autour du récipient d'échantillon, un milieu de chaleur à l'état fluide pour modifier la température d'une solution d'échantillon dans le récipient d'échantillon ; et un mécanisme de remplacement de milieu de chaleur qui est destiné à remplacer un milieu de chaleur dans le réservoir de logement et qui est destiné à échanger un premier milieu de chaleur pour chauffer la solution d'échantillon dans le récipient d'échantillon à une première température avec un second milieu de chaleur pour refroidir la solution d'échantillon à une seconde température inférieure à la première température.
PCT/JP2020/049204 2020-01-22 2020-12-28 Dispositif de traitement et système de mesure WO2021149465A1 (fr)

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JPS62192659A (ja) * 1986-02-20 1987-08-24 Nitsuteku:Kk 自動分析装置
JPH03297377A (ja) * 1990-04-12 1991-12-27 Seiko Instr Inc 自動反応装置
JP2007078665A (ja) * 2005-09-16 2007-03-29 Japan Science & Technology Agency 血液エンドトキシン測定方法
JP2007510911A (ja) * 2003-11-07 2007-04-26 キャンブレックス・バイオ・サイエンス・ウォーカーズヴィル・インコーポレーテッド 内毒素レベルを測定するオンライン装置および方法
WO2013080939A1 (fr) * 2011-11-28 2013-06-06 財団法人神奈川科学技術アカデミー Dispositif d'amplification génique à grande vitesse à reflux liquide
JP2017026522A (ja) * 2015-07-24 2017-02-02 株式会社日立ハイテクノロジーズ 自動分析装置、遺伝子検査装置及び温度制御方法
JP2017129429A (ja) * 2016-01-19 2017-07-27 稲田　捷也 多白血球血漿の調整方法

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE112016003921T5 (de) * 2015-08-28 2018-05-17 Amano Enzyme Inc. Endotoxin-reduziertes Thermolysin

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS62192659A (ja) * 1986-02-20 1987-08-24 Nitsuteku:Kk 自動分析装置
JPH03297377A (ja) * 1990-04-12 1991-12-27 Seiko Instr Inc 自動反応装置
JP2007510911A (ja) * 2003-11-07 2007-04-26 キャンブレックス・バイオ・サイエンス・ウォーカーズヴィル・インコーポレーテッド 内毒素レベルを測定するオンライン装置および方法
JP2007078665A (ja) * 2005-09-16 2007-03-29 Japan Science & Technology Agency 血液エンドトキシン測定方法
WO2013080939A1 (fr) * 2011-11-28 2013-06-06 財団法人神奈川科学技術アカデミー Dispositif d'amplification génique à grande vitesse à reflux liquide
JP2017026522A (ja) * 2015-07-24 2017-02-02 株式会社日立ハイテクノロジーズ 自動分析装置、遺伝子検査装置及び温度制御方法
JP2017129429A (ja) * 2016-01-19 2017-07-27 稲田　捷也 多白血球血漿の調整方法

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