Automatic analysis device

Abstract

To provide an automatic analyzer having a mechanism for preventing a liquid in a reagent container after opening placed on the automatic analyzer from evaporating or changing in quality.SOLUTION: An automatic analyzer includes: a holding unit for mounting and holding a reagent container; a lid unit abutting against the holding unit from an upper section and capable of sealing the reagent container without coming into contact with the reagent container; a conveying unit capable of conveying the holding unit to a lower section of the lid unit; and lifting / lowering means for lifting and lowering the lid unit.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to an automatic analyzer for analyzing trace substances contained in samples such as blood, serum, plasma, and urine. [Background technology]

[0002] Analytical methods used in the fields of immunoassays and biochemical tests include adding a substrate reagent solution to a complex of the analyte in a sample and an enzyme-labeled reagent to produce an optically detectable product, and detecting an optical signal that corresponds to the concentration of the analyte.

[0003] As the container for the reagent, a sealing material is attached to a non-light-transmitting reagent container (see, for example, Patent Document 1) in order to improve the storage stability of the reagent liquid, and the tip of the dispensing nozzle pierces and opens the airtight seal of the reagent container (see, for example, Patent Document 2). When the reagent liquid remaining in the reagent container is to be reused, the reagent liquid is stored on-board in the device, but if the on-board time is long, air will flow in and out after the reagent container is opened, causing a decrease in the pH of the reagent liquid due to carbon dioxide, and a decrease due to evaporation of the reagent liquid, causing deterioration of the reagent performance, which may cause erroneous determination of the measurement. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2017-161349 A [Patent Document 2] JP 2018-004270 A Summary of the Invention [Problem to be solved by the invention]

[0005] An object of the present invention is to provide an automatic analyzer having a mechanism for preventing evaporation or deterioration of liquid in a reagent container after it has been opened and placed on the automatic analyzer. [Means for solving the problem]

[0006] a holder for mounting and holding a reagent container; a lid portion that abuts against the holder from above and is capable of sealingly sealing the reagent container without contacting the reagent container; a conveying unit capable of conveying the holding unit to a lower portion of the lid member; A lifting means for lifting and lowering the lid member; The present invention provides an automatic analyzer equipped with the above. Effect of the Invention

[0007] By sealing the reagent container with the reagent liquid remaining during analysis, during standby, after analysis, or after the analysis is stopped, it is possible to prevent the reagent from absorbing carbon dioxide and causing a decrease in pH, and to prevent the reagent liquid from decreasing due to evaporation. Therefore, when measuring again after the on-board time has elapsed, it is possible to suppress erroneous judgment of the analysis, and it is possible to use the reagent container until it is used up within the on-board time without replacing it for each measurement. In addition, by sealing the reagent container without contacting the lid of the lid device with the opening of the reagent container, it is possible to prevent contamination by other reagents. [Brief description of the drawings]

[0008] [Figure 1] 1 is a cross-sectional view showing one embodiment of a lid device and a holder on which a reagent container is placed. FIG. [Diagram 2] FIG. 2 is a perspective view of one embodiment of a substrate reagent container and a lid arrangement. [Diagram 3] FIG. 1 is a diagram showing an embodiment of an automatic analyzer of the present invention. [Figure 4] FIG. 2 is a diagram showing one aspect of a conveying section. [Diagram 5] 10 is a side view showing one embodiment of the positional relationship between a holder on which a reagent container is placed and a lid device. FIG. [Figure 6] 1 is a front view showing one embodiment of the positional relationship between a holder on which a reagent container is placed and a lid device. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] The present invention relates to an automatic analyzer that analyzes trace substances contained in samples such as blood, serum, plasma, and urine, and includes at least a reagent table on which at least specimen containers and reaction reagent containers are placed, a transport section on which at least substrate reagent containers are placed, a transport section for transporting various containers, a measurement section for performing enzyme immunoassays, a holding section for holding the reaction reagent containers or the substrate reagent containers, a drive section for moving the holding section horizontally, a lid section capable of sealing the opening of the substrate reagent container, and a lifting section for raising and lowering the lid section.

[0010] The automated analyzer of the present invention moves the holder so that the substrate reagent container placed on the holder is below the lid during measurement, while waiting for measurement, after measurement is stopped or after measurement is completed, and then lowers the lid to seal the substrate reagent container. When the next measurement is started or when measurement is resumed, the lid rises and the holder moves while holding the substrate reagent container.

[0011] In the present invention, the holding section is preferably provided with a plurality of holding positions for placing reaction reagent containers or substrate reagent containers, and the holding positions are preferably shaped so that they can be positioned by contacting the sides or bottoms of these reagent containers. The holding section may also have a function of pre-warming the substrate reagent before dispensing it into the reaction container. Furthermore, the holding section may have a function of adjusting the temperature of the substrate reagent container placed on the holding section and sealed with the lid device during standby, during measurement, or after the measurement has been stopped. Note that the storage period (on-board time) of the substrate reagent container held in the holding section is preferably within 10 hours, taking into consideration deterioration and evaporation of the substrate reagent liquid.

[0012] In consideration of deterioration and evaporation of the substrate reagent liquid, it is preferable to seal the substrate reagent container placed on the holder with the lid when the opened substrate reagent container is left for 5 seconds or more. The container to be sealed with the lid is not limited to the substrate reagent container, and any container having a shape that can be placed on the holder can be used. In order to prevent contamination of the substrate reagent liquid that has evaporated due to heating, it is preferable that the lid of the lid device does not come into contact with the substrate reagent container, but rather the edge of the lid comes into contact with the top surface of the holder to seal the opened substrate reagent container placed on the holder (see FIG. 1).

[0013] In the present invention, in order to improve the sealing of the lid, a buffer material such as porous silicon or rubber may be attached to the top of the holder. Considering the sealing, the buffer material is preferably 2 to 5 mm thick. The shape of the buffer material is not important as long as it fits the edge of the opening, but considering the cost and sealing of the automatic analyzer, a flat surface is preferable. In addition, it is preferable to install the buffer material on the top surface of the holder, except for the substrate reagent container placement area, so that the buffer material contacts the entire edge of the lid.

[0014] The transport section of the present invention is provided with a holder, a waste outlet, and a pipette tip rack (see FIG. 2), but is not limited to being integrated, and the holder, waste outlet, and pipette tip rack may each be independent.

[0015] In the present invention, it is preferable that the dispensing unit that opens the airtight seal of the substrate reagent container is equipped with a pipette tip for aspirating reagent attached to the dispensing nozzle and pierces the airtight seal, thereby minimizing the size of the hole at the opening of the substrate reagent container. EXAMPLES

[0016] Hereinafter, an embodiment of the present invention will be described in detail with reference to the accompanying drawings, but the embodiment of the present invention is not limited thereto.

[0017] Each unit of the automated chemiluminescent enzyme immunoassay device (automatic analyzer) 300 performs an analysis process according to a program in response to sample information and measurement items input to a control unit (not shown).

[0018] A sample rack 17 in which sample containers 16 are placed, and a measurement container tray 18 in which reaction reagent containers 19 containing reaction reagents are placed are arranged on the reagent table 15. The reaction reagent container has two reagent storage sections, one of which contains a solid-phase reagent in which an antibody that binds to the analyte is fixed using magnetic microparticles as carriers, together with the salt components of the buffer solution and additives, in a freeze-dried state, and the other contains a labeled reagent in which an antibody that binds to the analyte is enzyme-labeled, together with the salt components of the buffer solution and additives, in a freeze-dried state, and both reagent storage sections are sealed with a moisture-proof hermetic seal.

[0019] The transport section 20 is equipped with a substrate reagent container 21 containing a substrate reagent to be subjected to an enzyme reaction, an inspection sample container 22 containing an inspection sample for inspecting the device, and a pretreatment reagent container 23 containing a pretreatment reagent for the specimen. The substrate reagent container has two reagent containers, one containing a liquid chemiluminescence substrate reagent and the other containing a liquid enhancer reagent, and is sealed with a hermetic seal that can prevent evaporation of the reagent, including an aluminum foil layer and a resin film layer such as polyethylene. The inspection container is used to inspect contamination of the common reagent, and is sealed with a hermetic seal.

[0020] Furthermore, the transport section 20 is provided with a pipette tip rack 25 on which pipette tips 26 are placed, a holding section 200 for pre-warming the substrate reagent before dispensing it into the reaction reagent container, and a disposal port 27 for disposing of used pipette tips 26 and used reaction reagent containers.

[0021] The reagent table 15, the transport unit 20 and the dispensing and mixing unit 24 can each be moved to a position where the code reader 31 etc. can appropriately perform their functions during the measurement process.

[0022] When the control unit issues a command to start operating the automatic analyzer, the code reader 31 scans the reagents on the reagent table 15 and the transport unit 20, reads the identification information of the reagents placed at each location, and stores it in the control unit.

[0023] When an instruction to start measurement is given, the code reader 31 moves above the reaction reagent container 19 for the target measurement item by moving the dispensing unit drive unit 32 and the reagent table 15, reads the code printed on the sealing seal of the reaction reagent container, and confirms that it is a reaction reagent container containing a reaction reagent for the target measurement item. Once confirmed, the transport unit 30 transports the reaction reagent container to the dispensing and mixing unit 24, and the seal breaker 14 pierces the sealant of the two reagent storage units of the reaction reagent container to open it.

[0024] The dispensing unit 33 is fitted with a pipette tip 26, and the dispensing water supply unit 28 aspirates the required amount of dispensing water, which is then discharged by the dispensing and mixing unit 24 into the labeled reagent in the opened reaction reagent container. The dispensing unit 33 again aspirates the required amount of dispensing water with the same pipette tip, then moves to above the specimen container 16 to be measured, aspirates the required amount of specimen, and then discharges it by the dispensing and mixing unit 24 into the solid-phase reagent in the opened reaction reagent container. The dispensing and mixing unit 24 stirs the reaction reagent container to dissolve the solid-phase reagent. The dispensing and mixing unit 24 is heated to the reaction condition temperature, and the solid-phase reagent dissolved in the dispensing water containing the specimen starts an antibody-antigen reaction if the specimen contains a substance to be measured. The dispensing unit 33 moves to above the waste port 27 and discards the attached pipette tip.

[0025] If the substrate reagent container to be used is unopened, the lid device 100 does not operate, but if the substrate reagent container has been opened, the drive motor 40 operates from dispensing the sample into the reaction reagent container until the pipette tip is discarded, and the belt pulley 41 arranged on the shaft of the drive motor rotates, causing the belt 42 to rotate. When the belt rotates, the holder on which the substrate reagent container is placed moves in tandem in the horizontal direction until it reaches under the lid 11 (see FIG. 4). After the movement, the lid device motor 12 associated with the lid device 100 operates, and the lifting unit 13 arranged on the shaft of the lid device motor 12 rotates to lower the lid 11, and the edge of the lid comes into contact with the cushioning material 29 on the top surface of the holder, creating a sealed state (see FIGS. 5 and 6). Before the reaction reagent container is placed on the transport turntable 36, the lifting unit 13 attached to the shaft of the lid device motor 12 rotates to raise the lid unit 11, opening the substrate reagent container, and then the drive motor 40 is operated to rotate the belt pulley 41 attached to the shaft of the drive motor, causing the belt 42 to rotate. As the belt rotates, the holder on which the substrate reagent container is placed moves horizontally in tandem to its original position.

[0026] The transport section 30 holds the reaction reagent container in which the antibody-antigen reaction has begun, and places it through the container entrance 38 onto a container holding position 39 on a transport turntable 36 in the reaction section 35 which has been heated to the reaction temperature of the measurement unit 400 .

[0027] If the substrate reagent container to be used is unopened, the lid device 100 does not operate, but if the substrate reagent container has been opened, the drive motor 40 operates from dispensing the sample into the reaction reagent container to discarding the pipette tip, and the belt pulley 41 arranged on the shaft of the drive motor rotates, causing the belt 42 to rotate. When the belt rotates, the holder on which the substrate reagent container is placed moves in a horizontal direction in conjunction with the belt, and moves to under the lid part 11. After the movement, the lid device motor 12 associated with the lid device 100 operates, and the lifting part 13 arranged on the shaft of the lid device motor 12 rotates to lower the lid part 11, so that the edge of the lid part and the cushioning material on the upper surface of the holder come into contact with each other and are sealed. Before the reaction reagent container placed on the turntable 36 is transferred to the dispensing and mixing part 24, the lid device motor 12 operates, and the lifting part 13 arranged on the shaft of the lid device motor 12 rotates to raise the lid part 11, and the substrate reagent container is in an open state. Next, the drive motor 40 is operated, and the belt pulley 41 arranged on the shaft of the drive motor rotates, which causes the belt 42 to rotate. As the belt rotates, the holder on which the substrate reagent container is placed moves in a horizontal direction in tandem with the belt, and returns to its original position.

[0028] The reaction reagent container placed on the transport turntable 36 is incubated on the transport turntable for the time required for the reaction, and then the components that do not bind to the solid phase are sucked out together with the reaction liquid by the washing nozzle. After the B / F washing unit 37 repeatedly discharges the washing liquid, collects the solid phase, and sucks it out, the reaction reagent container is transported to the container inlet / outlet 38 by the transport turntable 36 and is temporarily returned to the dispensing and mixing unit 24 by the transfer unit 30.

[0029] If the substrate reagent container to be used is unopened, the lid device 100 does not operate, but if the substrate reagent container has been opened, the drive motor 40 operates from dispensing the sample into the reaction reagent container to discarding the pipette tip, and the belt pulley 41 arranged on the shaft of the drive motor rotates, causing the belt 42 to rotate. When the belt rotates, the holder on which the substrate reagent container is placed moves in a horizontal direction in conjunction with the belt, and moves to below the lid part 11. After the movement, the lid device motor 12 accompanying the lid device 100 operates, and the lifting part 13 arranged on the shaft of the lid device motor 12 rotates to lower the lid part 11, so that the edge of the lid part and the cushioning material on the upper surface of the holder come into contact with each other and are sealed. Before transporting the substrate reagent container to the holder 200, the lid device motor 12 operates, and the lifting part 13 arranged on the shaft of the lid device motor 12 rotates to raise the lid part 11, and the substrate reagent container is in an open state. Next, the drive motor 40 is operated, and the belt pulley 41 arranged on the shaft of the drive motor rotates, which causes the belt 42 to rotate. As the belt rotates, the holder on which the substrate reagent container is placed moves in a horizontal direction in tandem with the belt, and returns to its original position.

[0030] The transfer section 30 holds the unopened substrate reagent container 21 placed on the transport section, moves it to the holder 200, and heats the substrate reagent container.

[0031] The dispensing unit 33 is fitted with a pipette tip 26 and aspirates the required amount of labeled reagent contained in a reaction reagent container placed in the dispensing and mixing unit 24 and dispenses it into the solid-phase reagent. The mixing unit 29 mixes the reaction solution, initiating an antibody-antigen reaction between the measured substance that has bound to the antibody in the solid-phase reagent and the labeled reagent. The dispensing unit 33 then moves above the waste port 27 and discards the pipette tip attached to the dispensing nozzle 34.

[0032] The transport section 30 holds the reaction reagent container in which the reaction has started, transports it again to the measurement unit 400, and places it through the container entrance 38 at a container holding position 39 on the transport turntable 36 of the reaction section which has been heated to the reaction temperature.

[0033] The reaction reagent container placed on the transport turntable 36 is incubated on the transport turntable for the time required for the reaction, and then the components that did not form a bond consisting of the solid-phase reagent, the substance to be measured, and the labeled reagent are sucked out together with the reaction liquid by the washing nozzle. After the B / F washing unit 37 repeatedly discharges the washing liquid, collects the solid phase, and sucks out the solid phase, the reaction reagent container is transported to the container inlet / outlet 38 by the transport turntable 36 and is returned to the dispensing and mixing unit 24 by the transfer unit 300.

[0034] When the substrate reagent container to be used is unopened, the dispensing unit 33 attaches the pipette tip 26 and opens the airtight seals of the substrate reagent containers by piercing first the chemiluminescent substrate reagent, followed by the enhancer reagent, with the tip of the pipette tip, and then the dispensing unit 33 moves to above the waste port 27 and discards the attached pipette tip.

[0035] The dispensing unit 33 is fitted with a pipette tip 26, and aspirates the required amounts of enhancer reagent and chemiluminescent substrate reagent, in that order, from an opened substrate reagent container placed in the holding unit 200, and dispenses the entire amount into the storage section containing the solid phase of the reaction reagent container. The dispensing and mixing unit 24 then mixes the reaction reagent container, initiating the enzymatic reaction of the labeled reagent. The dispensing unit 33 then moves above the waste port 27 and discards the attached pipette tip.

[0036] The transport section 30 holds the reaction reagent container in which the enzyme reaction has begun, transports it again to the measurement unit 400, and places the reaction reagent container through the container entrance / exit 38 onto the container holding position 39 on the transport turntable 36 of the reaction section, which has been heated to the reaction temperature.

[0037] The reaction reagent containers placed on the transport turntable 36 are incubated on the table for the required time, then moved to the measurement unit, where the luminescence value is measured and stored in the memory unit. From the measured luminescence value, the concentration of the substance to be measured is calculated in the analysis unit and displayed on the display unit.

[0038] After the analysis by the analysis section has been completed, the reaction reagent container is transported to the container entrance 38 by the transport turntable 36 , and the reaction reagent container is discarded to the disposal port 27 by the transfer section 30 .

[0039] Before the reaction reagent container is disposed of in the disposal port 27, the drive motor 40 is operated, and the belt pulley 41 arranged on the shaft of the drive motor rotates, causing the belt 42 to rotate as well. When the belt rotates, the holder on which the substrate reagent container is placed moves in tandem in the horizontal direction until it reaches under the lid 11. After the movement, the lid device motor 12 associated with the lid device 100 is operated, and the lid 11 is lowered by a guide arranged on the shaft of the lid device motor 12, causing the edge of the lid to come into contact with the cushioning material 29 on the upper surface of the holder, creating a sealed state.

[0040] While the reaction reagent container is being discarded, another reaction reagent container placed on the reagent table is transferred to the dispensing and mixing section by the transfer section 30, the reaction reagent container is transferred to the dispensing and mixing section 24, and the substrate reagent container is kept sealed until a seal breaker provided in the dispensing section 33 pierces the sealant in the two reagent storage sections of the reaction reagent container to open it.

[0041] After the reaction reagent container is opened, the lid device motor 12 is operated, and the lifting unit 13 arranged on the shaft of the lid device motor 12 rotates to raise the lid unit 11 and open the substrate reagent container. Next, the drive motor 40 is operated, and the belt pulley 41 arranged on the shaft of the drive motor rotates, causing the belt 42 to rotate. As the belt rotates, the holder on which the substrate reagent container is placed moves horizontally in tandem with the belt, and returns to its original position.

[0042] Incidentally, a substrate reagent container that has been opened before the start of measurement and is in use is placed on holder 200 and is kept sealed by lid 11 until the start of measurement.

[0043] After the measurement starts, the substrate reagent container is opened by the lifting of the lid 11, and then the drive motor 40 is operated, and the belt pulley 41 arranged on the shaft of the drive motor rotates, causing the belt 42 to rotate. As the belt rotates, the holder on which the substrate reagent container is placed moves horizontally in tandem to its original position. [Explanation of symbols]

[0044] 100: Lid device 200: Holding part 300: Automatic analyzer 400: Measurement unit 11: Lid 12: Lid device motor 13: Lifting section 14: Seal Breaker 15: Reagent table 16: Sample container 17: Sample rack 18: Measurement container tray 19: Reagent container 20: Transport section 21: Substrate reagent container 22: Sample container for inspection 23: Pretreatment reagent container 24: Dispensing and mixing section 25: Pipette tip rack 26: Pipette tip 27: Waste outlet 28: Water supply unit 29: Cushioning material 30:Transfer section 31: Code Reader 32: Drive unit for dispensing unit 33: Dispensing section 34: Dispensing nozzle 35: Reaction section 36: Transport turntable 37: B / F cleaning unit 38: Container entrance / exit 39: Container holding position 40: Drive motor 41: Belt pulley 42: Belt

Claims

1. a holder for mounting and holding a reagent container; a lid portion that abuts against the holder from above and is capable of sealingly sealing the reagent container without contacting the reagent container; a conveying unit capable of conveying the holding unit to a lower portion of the lid unit; A lifting unit that lifts and lowers the lid unit; An automatic analyzer equipped with

2. 2. The automatic analyzer according to claim 1, further comprising a holder for controlling the temperature of the reagent container.

3. 3. The automatic analyzer according to claim 1, further comprising a buffer material in the holding section.

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