[go: up one dir, main page]

WO2023127182A1 - Dispositif et procédé d'analyse automatique - Google Patents

Dispositif et procédé d'analyse automatique Download PDF

Info

Publication number
WO2023127182A1
WO2023127182A1 PCT/JP2022/026174 JP2022026174W WO2023127182A1 WO 2023127182 A1 WO2023127182 A1 WO 2023127182A1 JP 2022026174 W JP2022026174 W JP 2022026174W WO 2023127182 A1 WO2023127182 A1 WO 2023127182A1
Authority
WO
WIPO (PCT)
Prior art keywords
reagent
reaction
sample
measurement sequence
chip
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/JP2022/026174
Other languages
English (en)
Japanese (ja)
Inventor
純一 近藤
恭一 岩橋
智英 浅井
弘至 高橋
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sekisui Medical Co Ltd
Original Assignee
Sekisui Medical Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Sekisui Medical Co Ltd filed Critical Sekisui Medical Co Ltd
Publication of WO2023127182A1 publication Critical patent/WO2023127182A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Images

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • 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
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices

Definitions

  • the present invention relates to an automatic analyzer and an automatic analysis method that can obtain measurement information on various analysis items (test items) by treating and measuring samples (specimens) such as blood and urine with various reagents. .
  • Blood coagulation analyzers treat biological samples such as blood and urine with various reagents and measure various test items (measurement items).
  • ELIA electrochemiluminescence immunoassay
  • Various forms of automated analyzers capable of obtaining measurement information regarding are known. For example, a specimen as a biological sample is dispensed from a specimen container into a reaction container, and the dispensed specimen is mixed with reagents corresponding to test items to perform various measurements and analyses.
  • reaction containers such as a mechanism for dispensing specimens and reagents, a reaction container (cuvette) for reacting specimens and reagents, and a mechanism for stirring specimens and reagents, are shared in the measurement of a plurality of test items.
  • a mechanism for dispensing specimens and reagents such as a mechanism for dispensing specimens and reagents, a reaction container (cuvette) for reacting specimens and reagents, and a mechanism for stirring specimens and reagents
  • cuvette for reacting specimens and reagents
  • stirring specimens and reagents are shared in the measurement of a plurality of test items.
  • measurement results may be erroneous due to contamination occurring between the respective reaction solutions and reagents.
  • the reagent component of analysis item A contains a substance that participates in the reaction of analysis item B (reaction inhibition, promotion, etc.)
  • reaction inhibition, promotion, etc. when analysis item A and analysis item B are continuously measured, If the reagent for analysis item A contaminates the reagent for analysis item B, the reaction for analysis item A proceeds simultaneously with the reaction for analysis item B, which may cause an error in the measurement result. Therefore, in such multi-item analyzers, in order to avoid such contamination, instruments such as nozzle tips for aspirating specimens and reagents and reaction vessels (cuvettes) into which specimens are dispensed are usually , are exchanged each time a measurement (or reaction) is performed (see, for example, Patent Document 1).
  • ⁇ -D glucan is a component that exists as normal bacteria, in order to accurately measure its abundance in the blood, consumables such as nozzle tips and reaction vessels must contain ⁇ -D glucan. It is required to be uncontaminated, ie ⁇ -D glucan free. At present, many problems still remain and it is not easy to perform multiple analyzes including ⁇ -D glucan in the same apparatus while preventing such contamination.
  • the present invention has been made with a focus on the above-mentioned problems, and it is possible to select whether or not to attach a chip as needed, and to separate ⁇ -D glucan from other test objects while preventing contamination.
  • An object of the present invention is to provide an automatic analyzer and an automatic analysis method that enable batch measurement.
  • the present invention comprises a reaction section that holds a reaction container into which a specimen is dispensed, and a reagent supply section that supplies a reagent.
  • a test item selection unit for alternatively selecting the specific test item and the normal test item; a nozzle moving mechanism for moving a suction nozzle for suctioning a specimen and a reagent within the device;
  • a sample chip supply unit for supplying a disposable sample chip attached to the tip of a sample aspiration nozzle, the sample chip supply unit supplying a first sample chip used when a normal test item is selected by the test item selection unit.
  • a first sample chip supply unit and a second sample chip supply unit that supplies a ⁇ -D glucan-free second sample chip used when a specific test item is selected by the test item selection unit.
  • a reagent chip supply unit for supplying a ⁇ -D glucan-free disposable reagent chip attached to the tip of a reagent suction nozzle when a specific test item is selected by the test item selection unit.
  • a controller for controlling the operation of each part of the device and the nozzle moving mechanism, the controller using the reagent suction nozzle to dispense and agitate the plurality of types of reagents into the reaction vessel in several batches.
  • a first measurement sequence, and a second measurement sequence in which the number of steps is reduced compared to the first sequence by omitting B/F separation a predetermined number of times after reagent dispensing, and the control mode includes: Executed when the normal test item is selected by the test item selection unit, and controls the first measurement sequence or the second measurement sequence without attaching the reagent chip to the tip of the reagent suction nozzle. and a first control mode that is executed when the specific test item is selected by the test item selection unit, and controls the second measurement sequence with attachment of the reagent chip to the tip of the reagent suction nozzle. and a second control mode for
  • measurement information regarding specific test items for measuring ⁇ -D glucan and normal test items for measuring other test objects can be obtained with a single device.
  • All inspection items, including D-glucan measurement can be completed with a single device, there is no need to use a dedicated machine to measure ⁇ -D-glucan as in the past (need to use different devices) do not have). Therefore, continuous inspection becomes possible, and the overall inspection time until the measurement of all inspection items is completed can be shortened. Measurement accuracy can also be improved by minimizing the impact of time loss on measurement accuracy.
  • the control mode can be selected according to the inspection item (it is possible to select whether or not the reagent chip is attached and the measurement sequence can be selected), a measurement sequence suitable for the inspection object can be realized. That is, by adopting a second measurement sequence with a small number of steps in a specific test item for measuring ⁇ -D glucan and using a ⁇ -D glucan-free disposable reagent chip, the opportunity to be exposed to the risk of contamination is reduced as much as possible. can be less. Therefore, it is possible to reduce the contamination risk and improve the measurement accuracy.
  • the first measurement sequence includes: a first step of inducing a first reaction by dispensing and stirring a sample diluent and a sample as a first reagent into a reaction container; Antibody-bound magnetic beads are added as a second reagent to the reaction solution obtained in step 1 to cause a second reaction, and the magnetic beads after the reaction are captured with a magnet to draw out the liquid in the reaction vessel, followed by a washing solution.
  • a second step of performing a first B/F separation in which the magnetic beads are washed with to remove non-specific binding substances other than the antigen-antibody reaction, and a ruthenium complex as a third reagent in the liquid after the second step
  • a third reaction is caused by adding a labeled antibody, the magnetic beads after the reaction are captured with a magnet, the liquid in the reaction vessel is extracted, and the magnetic beads are washed with a washing solution to remove non-specific binding substances other than the antigen-antibody reaction.
  • a third step of removing a second B/F separation wherein said second measurement sequence preferably consists of said first measurement sequence omitting said first B/F separation.
  • the second sample chip supply unit and the reagent chip supply unit perform a first measurement sequence or a second measurement sequence executed when the inspection item selection unit selects a normal inspection item. It is preferably positioned so as not to interfere with the movement path of the nozzle movement mechanism in the measurement sequence.
  • ⁇ -D glucan is measured by providing the second sample chip supply unit and the reagent chip supply unit that supply ⁇ -D glucan-free chips at positions that do not interfere with the nozzle movement path during normal test item measurement. This avoids the risk of contamination between a measurement sequence for measuring an object to be inspected and a measurement sequence for measuring another object to be inspected. For example, specifically, it is possible to avoid the risk of contamination such as dripping or contamination of foreign matter that may occur during normal test item measurement without providing a complicated device mechanism. This leads to improved measurement accuracy.
  • a contamination check section for checking the ⁇ -D glucan-free state in the device is further provided.
  • the contamination check unit may be individually provided in each part of the apparatus. etc. are contaminated with ⁇ -D glucan.
  • a reaction container supply unit for supplying reaction containers is further provided.
  • FIG. 1 is a schematic overall external view of an automatic analyzer according to an embodiment of the present invention
  • FIG. 2 is a schematic plan view showing the internal configuration of the automatic analyzer of FIG. 1
  • FIG. 2 is a block diagram showing the main components of the autoanalyzer of FIG. 1
  • FIG. 2 is a flowchart showing an example of processing steps of the automatic analyzer of FIG. 1
  • FIG. A first measurement sequence that performs B/F separation in which multiple types of reagents are divided into several batches by a reagent aspirating nozzle and stirred into reaction containers, and labeled antibodies that do not form immune complexes are washed and discarded. It is a figure which shows an example typically.
  • FIG. 1 is a schematic overall external view of the automatic analyzer of this embodiment
  • FIG. 2 is a schematic plan view showing the internal configuration of the automatic analyzer of FIG. 1
  • FIG. 2 is a block diagram showing the components of the system
  • the automatic analyzer 1 of the present embodiment includes a reaction section 40 (see FIGS. 2 and 3) that holds reaction containers (cuvettes) C into which samples are dispensed. and a reagent supply unit 30 (see FIG. 2) that supplies a reagent. It is possible to obtain measurement information regarding specific test items for measuring ⁇ -D glucan and normal test items for measuring other test objects. Therefore, the automatic analyzer 1 has an inspection item selection unit 120 for alternatively selecting the specific inspection item and the normal inspection item (see FIG. 3).
  • the automatic analyzer 1 of the present embodiment includes a nozzle moving mechanism 130 (see FIG. 3) that moves a suction nozzle (not shown) for sucking a sample and a reagent within the device 1, and each part of the device (reaction part 40 (to be described later) and a control unit 110 for controlling the operation of the nozzle moving mechanism 130 .
  • the automatic analyzer 1 of this embodiment has a contamination check section 114 that checks the ⁇ -D glucan-free state in the device 1 .
  • the contamination check unit 114 may be provided in at least one of the processing units 10, 20, 30, 40, and 50 of the apparatus 1 or individually, and for example, the detection value detected by the component detection sensor and the like By comparing with a predetermined reference value, it is checked whether or not each processing section, instrument, etc. in the device 1 is contaminated with ⁇ -D glucan.
  • the control unit 110 constantly monitors the state of contamination by ⁇ -D glucan by constantly receiving the detection signal from the contamination check unit 114, and when the state of contamination is detected, notifies the operator to that effect. generate a signal or take some other action (for example, stop the device 1).
  • the automatic analyzer 1 of the present embodiment has a rack R loaded with a predetermined number of disposable instruments used in the automatic analyzer 1, and a predetermined instrument take-out device described later.
  • a reaction unit 40 for reacting a sample and a reagent; and a B/F separation/measurement unit 50 for processing and measuring the reacted sample.
  • 30, 40 and 50 are arranged in a housing 100 (see FIG. 1).
  • the rack R transported by the transport unit 10 includes a sample chip supply unit for supplying disposable sample chips T attached to the tip of a sample aspirating nozzle (not shown) moved by the nozzle moving mechanism 130, and a reaction container C. and a reaction vessel supply for supplying the
  • the rack R is a first sample chip supply section 300A that supplies the first sample chips T1 used when a normal test item is selected by the test item selection section 120 (FIG. 3). and a first reaction container supply unit 200A for supplying the first reaction container C1 used when the test item selection unit 120 selects a normal test item.
  • the first sample chips T1 are two-dimensionally arranged and held in the first sample chip supply unit 300A
  • the first reaction containers C1 are two-dimensionally arranged in the first reaction container supply unit 200A. are arranged and held.
  • the automatic analyzer 1 includes the above-described control unit 110 (FIG. 3) for controlling the operations of these processing units 10, 20, 30, 40, and 50, and a transfer mechanism (not shown) that moves in the XY directions.
  • the transfer mechanism includes a nozzle movement mechanism 130, and uses a holding part such as a grip arm to transfer various instruments (specimen chips, reaction containers, etc.), and moves in the XY direction to perform aspiration of specimens and reagents by the nozzles. can move.
  • the transfer mechanism can not only move in the XY directions within the housing 100 along, for example, extended rails, but can also move (lift) in the vertical direction (Z direction) at a predetermined position.
  • the transport unit 10 vertically stacks the plurality of racks R loaded with the first sample chips T1 and the first reaction containers C1, and lifts the racks R by an elevating mechanism.
  • the sample is transported toward the rack standby position (supply side position) I facing the upper sample processing space (hereinafter simply referred to as processing space) S in the housing 100 .
  • the rack R is moved to the take-out position (recovery side position) II where the sample chips T1 and the reaction containers C1 are taken out for analysis and measurement processing, and the sample chips T1 and the reaction containers C1 are all taken out and the rack R is empty. are sequentially lowered by an elevating mechanism to be collected.
  • the operator pulls out the conveying unit 10 to the outside of the apparatus 1 along the Y direction (the pulled out conveying unit is denoted by reference numeral 10' in FIG. 2). ), an empty rack R can be recovered from the transport section 10, and the transport section 10 can be replenished with unused racks R loaded with sample chips T and reaction containers C, respectively.
  • the automatic analyzer 1 has a ⁇ -D glucan-free ⁇ -D glucan-free sample used when a specific test item is selected by the test item selection unit 120, adjacent to the take-out position (recovery side position) II.
  • a second sample chip supply unit 300B (left half) that supplies a second sample chip T2, and a ⁇ -D glucan-free second sample chip used when a specific test item is selected by the test item selection unit 120.
  • a second reaction container supply section 200B (right half) for supplying the reaction container C2.
  • This temporary storage site becomes a tip/reaction container standby position III where the first sample chip T1 and the first reaction container C1 in the rack R located at the take-out position II are transferred by the transfer mechanism and temporarily placed.
  • the reaction container C1 may be transferred and set directly from the rack R to the reaction section 40 by the holding section of the instrument transfer section without going through the tip/reaction container standby position III.
  • the sample supply unit 20 is placed on a sample table 23 that is movable along the X direction in FIG.
  • the sample rack supply unit 20 has a configuration in which a plurality of box-shaped sample racks 22 are arranged along the moving direction of the sample table 23, for example.
  • Each sample rack 22 is loaded with a plurality of sample containers 21, and each of these sample containers 21 contains a sample to be analyzed or measured.
  • the sample supply unit 20 arranged on the right side in FIG. 2 moves to the left side in FIG. 22 is transferred to the specimen aspirating position IV between the reaction section 40 and the tip/reaction container standby position III and waits at this position.
  • a sample transporting unit for transporting the sample constituting the transport mechanism A first uniaxial transfer line (first sample transfer line) L1 is formed along this straight line along which the sample moves only in one axial direction (X-axis direction). Specifically, when a normal test item is selected by the test item selection unit 120, a holding unit that holds a sample suction nozzle (not shown) is moved along the first uniaxial transfer line L1 by the sample transfer unit. It is moved only in the X-axis direction.
  • This sample aspirating nozzle is moved in the + direction of the X axis (rightward in FIG. 2) by the sample transfer section, and the tip thereof reaches the first sample chip T1 temporarily placed at the tip/reaction container standby position III.
  • the specimen aspirating nozzle After being connected (when connecting, the specimen aspirating nozzle is moved up and down in the Z-axis direction by the specimen transfer section), while holding the first specimen chip T1 at the tip, it is further moved in the - direction of the X-axis (to the left in FIG. 2). ) to aspirate the sample through the first sample chip T1 from the sample container 21 waiting at the sample aspirating position IV, and then move toward the reaction section 40 in the - direction of the X axis.
  • the specimen aspirating nozzle dispenses (discharges) the specimen aspirated through the first specimen chip T1 into the first reaction container C1 on the reaction section 40 .
  • the specimen aspirating nozzle is moved by the specimen transfer section toward the tip disposal section 121 (provided between the reaction section 40 and the specimen aspiration position IV) on the first uniaxial transfer line L1. , and the used first sample chip T1 is detached from the sample aspirating nozzle and discarded by the tip disposal unit 121 thereof.
  • a second uniaxial transfer line (second sample transfer line) L2 along which a sample transfer section for transferring a sample, which constitutes the transfer mechanism, moves only in one axial direction (X-axis direction) along this straight line is the first uniaxial transfer line. It is formed without interfering with the transfer line L1. Specifically, when a specific test item is selected by the test item selection unit 120, a holding unit that holds a sample suction nozzle (not shown) is moved along the second uniaxial transfer line L2 by the sample transfer unit.
  • This specimen aspirating nozzle is moved in the + direction of the X axis (rightward in FIG. 2) by the specimen transporting section, and the tip thereof is held by the second specimen chip supplying section 300B.
  • the sample aspirating nozzle After being connected to the second sample chip T2 (during connection, the sample aspirating nozzle is moved up and down in the Z-axis direction by the sample transfer unit), while holding the second sample chip T2 at the tip, it is further moved in the - direction of the X-axis.
  • the sample is aspirated from the sample container 21 that is moved (to the left in FIG. 2) and stands by at the sample aspirating position IV through the second sample chip T2. be.
  • the ⁇ -D glucan-free second reaction vessel C2 held in the second reaction vessel supply section 200B is transferred to the reaction section 40 by the instrument transfer section constituting the transfer mechanism. It has already been set and awaited using the unit. Therefore, the specimen aspirating nozzle dispenses (discharges) the specimen aspirated through the second specimen chip T2 into the second reaction container C2 on the reaction section 40 . After that, the specimen aspirating nozzle is moved by the specimen transfer section toward the tip disposal section 122 (provided between the reaction section 40 and the specimen aspiration position IV) on the second uniaxial transfer line L2. , and the used second sample chip T2 is detached from the sample aspirating nozzle and discarded by the tip disposal unit 122 thereof.
  • the reaction section 40 includes a rotary table 42 that is driven to rotate, and a plurality of reaction vessel support sections 43 are provided on the outer periphery of the rotary table 42 at predetermined intervals over the entire circumference.
  • the reaction vessels C (C1, C2) are transferred and set on these reaction vessel support parts 43 by using the holding parts transferred by the instrument transfer part constituting the transfer mechanism as described above. Then, the sample is discharged from the sample suction nozzle into the reaction container C (C1, C2) rotated to the sample receiving position (dispensing position) by the rotary table 42, as described above.
  • the reagent supply unit 30 holds a plurality of reagent storage units 32 that store reagents corresponding to various types of analysis items in a unit form, for example, by a rotary table 34. 32 are rotated by the rotary table 34 to the corresponding reagent suction positions V (FIG. 2) positioned on a third uniaxial transfer line L3 (described later) that does not interfere with the first and second uniaxial transfer lines L1 and L2. (inside only one reagent aspiration position is labeled V).
  • the reagent supply unit 30 of the present embodiment is integrated so that a plurality of (three in the figure) reagent storage units 32 each form an elongated reagent container and are arranged along the radial direction of the turntable 34 .
  • a plurality of reagent storage units U configured by storing and holding formed container units in container holders are provided.
  • a predetermined number of reagent storage units U are radially arranged along the circumferential direction of the rotary table 34 .
  • the reagent supply unit 30 also includes a cooling device 36 for cooling the inside of the reagent storage, and a reagent container lid opening/closing unit for opening and closing container lids that close the openings of the reagent storage units 32 that constitute the reagent storage unit U. and a mechanism 160 .
  • a reagent chip supply unit 70 is provided on the outside of the reagent supply unit 30, that is, on the side opposite to the reaction unit 40 with respect to the reagent supply unit 30.
  • the reagent chip supply unit 70 is a ⁇ -D glucan-free sample attached to the tip of a reagent suction nozzle (not shown) that is moved by the nozzle moving mechanism 130 when a specific test item is selected by the test item selection unit 120. It has a rack 74 loaded with disposable reagent tips 72 .
  • the reagent chip supply unit 70 moves the reagent chip 72 on the rack 74 along the Y direction under position control using a position sensor, thereby moving the reagent chip 72 on the rack 74 to a third uniaxial transfer line described later.
  • a third uniaxial transfer line L3 which will be described later, is positioned so that the reagent suction nozzle is a nozzle cleaning liquid ( A plurality (three in this embodiment) of nozzle washing units 29 for washing with CC liquid) and a plurality (three in this embodiment) of tip discarding units 25 for discarding reagent chips 72 are provided. .
  • a third uniaxial transfer line (reagent transfer line) L3 is formed in which the reagent transfer section for the reagent moves only in one axial direction (X-axis direction) along this straight line.
  • three third uniaxial transfer lines L3 are also provided (of course, the number of third uniaxial transfer lines L3 is It is not limited to 3. It may be 4 or more, or 2 or less).
  • a holding unit that holds a reagent suction nozzle (not shown) is attached to the reagent transfer unit in each of the third uniaxial transfer lines L3. is moved only in the X-axis direction along the third uniaxial transfer line L3.
  • the reagent aspirating nozzle directly aspirates the reagent corresponding to the inspection item from the reagent storage portion 32 positioned at the reagent aspirating position V on the rotary table 34 in the reagent supplying portion 30 through the nozzle aspirating portion at the tip thereof, After that, it is moved in the + direction of the X-axis toward the reaction section 40 .
  • the first reaction container C1 which has already received the sample at the aforementioned sample receiving position, is rotated to the reagent receiving position by the rotary table 42. is dispensed (discharged) into this first reaction vessel C1. After that, the reagent aspirating nozzle is moved in the - direction of the X axis and washed in the nozzle washing section 29 .
  • the aspiration nozzle is operated after the reagent chip 72 is connected to the tip of the reagent chip supply unit 70 (at the time of connection, the reagent aspiration nozzle is moved in the Z-axis direction by the reagent transfer unit).
  • the reagent suction nozzle is further moved in the + direction of the X-axis toward the reaction section 40, and the reagent is applied to the ⁇ -D glucan-free second reaction container C2 positioned at the reagent receiving position as described above. is dispensed (dispensed).
  • the reagent aspirating nozzle is moved in the - direction of the X-axis toward the corresponding tip disposal section 25 of the tip disposal section 25 by the reagent transfer section, and the used reagent tip 72 is removed in the tip disposal section 25. It is detached from the reagent suction nozzle and discarded.
  • the mixed liquid of the sample and the reagent dispensed into the reaction containers C (C1, C2) as described above is reacted on the turntable 42 at a predetermined temperature for a predetermined time, and then the reaction product is is formed, the reaction container C (C1, C2) is rotated to the reaction container take-out position VI by the rotation of the turntable 42 .
  • the reaction container C (C1, C2) positioned at the reaction container take-out position VI is gripped by a holding part (grasping arm, etc.) transferred by the corresponding transfer part constituting the transfer mechanism, and B/F separation/measurement is performed. Introduced into unit 50 .
  • the B/F separation/measurement unit 50 performs predetermined processing on the introduced reaction product and performs electrical and optical measurements. Specifically, in analytical measurements using electrochemiluminescence immunoassay (ECLIA), B/F separation is performed to wash and discard labeled antibodies that do not form immune complexes. , B/F separation is provided.
  • a photometric part (chemiluminescence introduction/photometric part) 120 is also provided for sucking the processed material treated by them and measuring it based on electrochemiluminescence.
  • the used reaction vessel C for which the measurement has been completed is moved to a predetermined position by the rotation of the rotary table 52, and is gripped by the holding section transferred by the corresponding transfer section constituting the transfer mechanism and disposed of as a predetermined disposal. discarded by the department.
  • the measurement sequence includes a first measurement sequence in which B/F separation after reagent dispensing is performed a specified number of times, and a B/F separation after reagent dispensing that is omitted a predetermined number of times, resulting in a larger number of steps than the first sequence. and a second measurement sequence in which is reduced.
  • a sample diluent (R1) as a first reagent and a sample are dispensed into a first reaction container C1 and stirred.
  • a first step S1 for causing the first reaction, and antibody-bound magnetic beads (R2) are added as a second reagent to the reaction solution obtained in the first step S1 to cause a second reaction, and after the reaction
  • the magnetic beads are captured by the magnet 90, the liquid in the first reaction vessel C1 is extracted, and the magnetic beads are washed with a magnetic bead washing liquid (BF liquid) to remove non-specific binding substances other than the antigen-antibody reaction.
  • BF liquid magnetic bead washing liquid
  • a second step S2 of performing B/F separation, and adding a ruthenium complex-labeled antibody (R3) as a third reagent to the liquid after the second step S2 causes a third reaction, and magnetic beads after the reaction is captured by a magnet 90, the liquid in the first reaction vessel C1 is extracted, and the magnetic beads are washed with a washing liquid to remove non-specific binding substances other than the antigen-antibody reaction. and the steps of These first to third steps are performed in the B/F separation section (reaction system) of the reaction section 40 and the B/F separation/measurement section 50 .
  • a voltage is applied to the electrodes 95 in the presence of a buffer solution containing tripropylamine (TPA), which is a light-emitting electrolyte (EB solution), and the resulting electrochemiluminescence signal is read by a photodetector (photoelectron A step S4 of processing the resulting signal by recording it with a multiplier 96 is performed.
  • This step S4 is executed by the photometry section 120 (photometry system) of the B/F separation/measurement section 50 . Note that in the first measurement sequence including these steps S1 to S4, the first sample chip T1 is used during sample dispensing, but the ⁇ -D glucan-free reagent chip 72 is used during reagent dispensing. is not used.
  • the second measurement sequence is obtained by omitting the first B/F separation (B/F separation after the second reaction in the second step S2) from the above-described first measurement sequence.
  • the first sample chip T1 is used when the sample is dispensed, and the reagent
  • the ⁇ -D glucan-free reagent chip 72 is not used at the time of dispensing
  • a ⁇ -D glucan-free chip is used instead of the first reaction container C1.
  • a second reaction container C2 is used, a ⁇ -D glucan-free second sample chip T2 is used during sample dispensing, and a ⁇ -D glucan-free reagent is used during reagent dispensing Chip 72 is used.
  • the above-described control mode of the control unit 110 for controlling such a measurement sequence is executed when a normal test item is selected by the test item selection unit 120.
  • the inspection item selection unit 120 alternatively selects the specific inspection item and the normal inspection item (inspection item selection step S10), and the selection is the specific inspection item. (YES in step S11), the control unit 110 executes the control steps of the second control mode.
  • sample aspirating nozzle for aspirating the sample is moved along the second uniaxial transfer line L2 by the nozzle moving mechanism 130 (nozzle moving step), and held by the second sample chip supply section 300B as described above.
  • a ⁇ -D glucan-free second sample chip T2 is attached to the tip of the sample aspiration nozzle (sample chip attachment step S12).
  • sample chip attachment step S12 the sample is aspirated by the sample aspiration nozzle from the sample container 21 waiting at the sample aspiration position IV through the second sample chip T2, and the sample is transferred to the ⁇ -D glucan-free second sample on the reaction section 40. is dispensed (discharged) into the reaction container C2 (step S13).
  • the reagent aspirating nozzle for aspirating the reagent is moved along the third uniaxial transfer line L3 by the nozzle moving mechanism 130 (nozzle moving step).
  • ⁇ -D glucan-free reagent chip 72 is attached to (reagent chip attaching step S14).
  • the reagent is aspirated by the reagent aspirating nozzle through the reagent chip 72 in the reagent supply unit 30, and the reagent is dispensed into the second reaction container C2 at the reagent receiving position to which the sample has already been dispensed. (ejection) (step S15).
  • the B/F separation is performed by dividing the plurality of types of reagents into several batches and distributing them into the second reaction container C2, stirring them, and washing and discarding the labeled antibodies that do not form immunocomplexes.
  • the second control mode ends by completing the second measurement sequence (step S16).
  • control Unit 110 executes the control steps of the first control mode. That is, the sample aspirating nozzle for aspirating the sample is moved along the first uniaxial transfer line L1 by the nozzle moving mechanism 130 (nozzle moving step), and is temporarily placed at the chip/reaction container standby position III as described above. The first sample chip T1 that has been held is attached to the tip of the sample aspiration nozzle (sample chip attaching step S17).
  • the sample is aspirated from the sample container 21 waiting at the sample aspirating position IV by the sample aspirating nozzle through the first sample chip T1, and the sample is transferred into the first reaction container C1 on the reaction section 40. It is dispensed (discharged) (step S18).
  • the reagent aspirating nozzle for aspirating the reagent is moved along the third uniaxial transfer line L3 by the nozzle moving mechanism 130 (nozzle moving step), and the ⁇ -D glucan-free reagent chip 72 is removed as described above.
  • the reagent is aspirated by the reagent aspirating nozzle in the reagent supply unit 30 without attachment, and the reagent is dispensed (discharged) into the first reaction container C1 at the reagent receiving position where the sample has already been dispensed (step S19). Then, in this way, a plurality of types of reagents are divided into several times, and the B/F separation is performed by dispensing and stirring into the first reaction container C1, and washing and discarding the labeled antibody that does not form an immune complex.
  • the first control mode ends by completing the first measurement sequence or the second measurement sequence (step S20).
  • each of the uniaxial transfer lines L1, L2, and L3 is separated from each other in the first control mode and the second control mode in order to eliminate the movement paths in which the ⁇ -D glucan may be mutually contaminated.
  • the second sample chip supply unit 300B and the reagent chip supply unit 70 are executed when the normal test item is selected by the test item selection unit 120. Since it is located at a position that does not interfere with the movement path of the nozzle moving mechanism 130 in the first measurement sequence or the second measurement sequence, the measurement sequence for measuring ⁇ -D glucan and the measurement sequence for measuring other test objects avoid the risk of contamination between
  • the order of measurement of ⁇ -D glucan (measurement of specific test items) and other measurements (measurement of normal test items) is changed. may be specified. In this case, for example, it is possible to perform contamination risk control according to inspection items, and obtain the effect of obtaining highly accurate measurement results.
  • measurement information on specific test items for measuring ⁇ -D glucan and normal test items for measuring other test objects can be collected by one device.
  • all inspection items, including ⁇ -D glucan measurement can be completed with one device. (There is no need to use different devices), so continuous inspection is possible and the overall inspection time until measurement of all inspection items is completed can be shortened. can be reduced. Furthermore, the influence of time loss on measurement accuracy can be minimized to improve measurement accuracy.
  • the test time is shortened by the continuous test, it is not affected by deterioration (change in property) of the specimen over time, so that more accurate measurement values can be obtained.
  • control mode can be selected according to the inspection item (it is possible to select whether or not the reagent chip is attached and the measurement sequence can be selected)
  • a measurement sequence suitable for the inspection object can be realized. That is, by adopting a second measurement sequence with a small number of steps in a specific test item for measuring ⁇ -D glucan and using a ⁇ -D glucan-free disposable reagent chip, the opportunity to be exposed to the risk of contamination is reduced as much as possible. can be less. Therefore, it is possible to reduce the contamination risk and improve the measurement accuracy.

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pathology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Hydrology & Water Resources (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

L'invention concerne un dispositif d'analyse automatique et un procédé d'analyse automatique qui permettent de choisir si le montage d'une puce est nécessaire, et de mesurer en une fois le β-D glucane et une autre cible de test tout en prévenant une contamination. Ce dispositif d'analyse automatique comporte des modes de commande pour commander des séquences de mesure dans lesquelles une pluralité de réactifs sont distribués dans un récipient de réaction en plusieurs additions au moyen d'une buse d'aspiration de réactif et agités, et une séparation B/F est réalisée pour nettoyer et éliminer un anticorps marqueur n'ayant pas formé un complexe immun. Les séquences de mesure comprennent une première séquence de mesure dans laquelle la séparation B/F est réalisée un nombre spécifié de fois après la distribution des réactifs, et une seconde séquence de mesure dans laquelle on réduit le nombre d'étapes en omettant un nombre prescrit de fois de réaliser la séparation B/F. Les modes de commande comprennent un premier mode de commande, qui est exécuté pendant le test d'un article normal et commande la première séquence de mesure ou la seconde séquence de mesure sans fixer une puce de réactif à l'extrémité de la buse, et un second mode de commande qui est exécuté pendant le test d'un article spécial, fixe une puce de réactif à l'extrémité de la buse et commande la seconde séquence de mesure.
PCT/JP2022/026174 2021-12-28 2022-06-30 Dispositif et procédé d'analyse automatique Ceased WO2023127182A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2021214146A JP7114794B1 (ja) 2021-12-28 2021-12-28 自動分析装置及び自動分析方法
JP2021-214146 2021-12-28

Publications (1)

Publication Number Publication Date
WO2023127182A1 true WO2023127182A1 (fr) 2023-07-06

Family

ID=82748824

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2022/026174 Ceased WO2023127182A1 (fr) 2021-12-28 2022-06-30 Dispositif et procédé d'analyse automatique

Country Status (2)

Country Link
JP (1) JP7114794B1 (fr)
WO (1) WO2023127182A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH10123136A (ja) * 1996-10-24 1998-05-15 Nippon Tectron Co Ltd 自動免疫分析装置
JP2001264344A (ja) * 1998-07-27 2001-09-26 Hitachi Ltd 分析装置
JP2003083988A (ja) * 2001-09-13 2003-03-19 Olympus Optical Co Ltd 自動分析装置

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH10123136A (ja) * 1996-10-24 1998-05-15 Nippon Tectron Co Ltd 自動免疫分析装置
JP2001264344A (ja) * 1998-07-27 2001-09-26 Hitachi Ltd 分析装置
JP2003083988A (ja) * 2001-09-13 2003-03-19 Olympus Optical Co Ltd 自動分析装置

Also Published As

Publication number Publication date
JP7114794B1 (ja) 2022-08-08
JP2023097818A (ja) 2023-07-10

Similar Documents

Publication Publication Date Title
US6579717B1 (en) Specific solution handling method for calibration and quality control by automatic analytical apparatus
US9594089B2 (en) Analyzing apparatus, solid-liquid separation device and solid-liquid separation method
US7341691B2 (en) Automatic analyzing apparatus
EP1087231B1 (fr) Appareil automatique d'analyse
JP2950698B2 (ja) 洗浄機能付き自動分析装置
JP5300447B2 (ja) 自動分析装置および自動分析装置における検体分注方法
EP2878956B1 (fr) Analyseur automatisé
WO2010117044A1 (fr) Auto-analyseur et appareil distributeur
EP3974837B1 (fr) Dispositif d'analyse automatique
WO2007139212A1 (fr) Analyseur automatique
JP2022140602A (ja) ラックの搬送方法、検体測定システム
JP2011163909A (ja) 自動分析装置および分注手段の洗浄方法
US20200256868A1 (en) Immunoassay apparatus
WO2020217636A1 (fr) Dispositif d'analyse automatique
WO2019176296A1 (fr) Dispositif d'analyse automatique
JP3391734B2 (ja) 生体サンプルの取扱い方法及び分析装置
US8900876B2 (en) Abnormality-identifying method and analyzer
CN102103146A (zh) 用于分析液体样品的系统和过程
JP7114794B1 (ja) 自動分析装置及び自動分析方法
JP7054616B2 (ja) 自動分析装置
WO2023190216A1 (fr) Analyseur automatisé
JP3109443U (ja) 自動分析装置
JP7529663B2 (ja) 自動分析装置
JP2023056431A (ja) 自動分析装置
JP7506071B2 (ja) 自動分析装置

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22915417

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 22915417

Country of ref document: EP

Kind code of ref document: A1