WO2021131296A1 - 自動分析装置及び自動分析装置用の制御プログラム - Google Patents

自動分析装置及び自動分析装置用の制御プログラム Download PDF

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Publication number
WO2021131296A1
WO2021131296A1 PCT/JP2020/040176 JP2020040176W WO2021131296A1 WO 2021131296 A1 WO2021131296 A1 WO 2021131296A1 JP 2020040176 W JP2020040176 W JP 2020040176W WO 2021131296 A1 WO2021131296 A1 WO 2021131296A1
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WIPO (PCT)
Prior art keywords
sample
reaction vessel
measurement
detection unit
dispensing
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/JP2020/040176
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English (en)
French (fr)
Japanese (ja)
Inventor
雄一郎 大田
健太 今井
俊輔 佐々木
秀和 手塚
博也 梅木
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Hitachi High Tech Corp
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Hitachi High Tech Corp
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 Hitachi High Tech Corp filed Critical Hitachi High Tech Corp
Priority to US17/781,851 priority Critical patent/US12584933B2/en
Priority to JP2021566861A priority patent/JP7304969B2/ja
Priority to CN202080084786.3A priority patent/CN114829945B/zh
Priority to EP20904288.6A priority patent/EP4083635B1/en
Publication of WO2021131296A1 publication Critical patent/WO2021131296A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00594—Quality control, including calibration or testing of components of the analyser
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/0092—Scheduling
    • 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
    • G01N35/1009—Characterised by arrangements for controlling the aspiration or dispense of liquids
    • G01N35/1011—Control of the position or alignment of the transfer device
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N2035/00891—Displaying information to the operator
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/0092—Scheduling
    • G01N2035/0094—Scheduling optimisation; experiment design
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/0092—Scheduling
    • G01N2035/0096—Scheduling post analysis management of samples, e.g. marking, removing, storing
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G01N2035/0439—Rotary sample carriers, i.e. carousels
    • G01N2035/0441—Rotary sample carriers, i.e. carousels for samples
    • 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
    • G01N35/1009—Characterised by arrangements for controlling the aspiration or dispense of liquids
    • G01N35/1011—Control of the position or alignment of the transfer device
    • G01N2035/1013—Confirming presence of tip
    • 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
    • G01N35/1081—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices characterised by the means for relatively moving the transfer device and the containers in an horizontal plane
    • G01N35/1083—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices characterised by the means for relatively moving the transfer device and the containers in an horizontal plane with one horizontal degree of freedom
    • G01N2035/1086—Cylindrical, e.g. variable angle

Definitions

  • the present invention relates to an automatic analyzer and its control program.
  • An automatic analyzer usually has a sample dispensing mechanism for dispensing a sample and a detection unit for inspecting the dispensed sample by reacting it with a reagent in a reaction vessel. Further, a plurality of detection units are provided in one device, and the inspection is executed in the corresponding detection units according to the inspection items (see, for example, Patent Document 1). The analysis time can be shortened by operating a plurality of detectors in parallel.
  • a measurement item may be specified for each supplied sample, and one of a plurality of detection units may be specified for each measurement item.
  • the automatic analyzer assigns a designated detector and executes the inspection sequentially.
  • the same detection unit may be specified consecutively in a plurality of consecutive measurement items. In this case, only one of the plurality of detection units is continuously used, and the other is not used continuously, resulting in a state in which the plurality of detection units cannot be operated in parallel. As a result, the total analysis time may increase.
  • An object of the present invention is to provide an automatic analyzer and a control program capable of shortening the total analysis time.
  • the automatic analyzer includes a sample rack for accommodating a sample, a sample dispensing mechanism for sucking the sample from the sample rack and dispensing the sample into the reaction vessel, and the reaction vessel. It includes a plurality of detection units for detecting the reaction solution, the sample dispensing mechanism, and a control unit for controlling the detection unit.
  • the control unit is configured to confirm a measurement item designated for the sample and to confirm one of the plurality of detection units specified in the measurement item, and the plurality of detection units.
  • the total analysis time can be shortened by rearranging the sample dispensing and measuring in order with the alternate detection units as much as possible. ..
  • the flowchart explaining the operation of the immunoassay apparatus 101 of the 3rd Embodiment The flowchart explaining the operation of the immunoassay apparatus 101 of the 3rd Embodiment.
  • FIG. 1 is a schematic configuration diagram of an automatic analyzer according to the first embodiment.
  • a case where it is applied to an immunoassay device as an automatic analyzer will be described as an example.
  • the immunoassay device 101 includes a control unit 102, a sample rack 103, a rack transfer line 104, a sample dispensing mechanism 105, an incubator (container installation unit) 106, a reaction vessel transfer mechanism 107, and a reaction vessel holding unit. It includes 108, a reaction vessel stirring mechanism 109, and a waste hole 110.
  • the immunoassay device 101 includes a reagent disk 111, a reagent dispensing mechanism 112, a B / F separation and transport mechanism 113, a B / F separation mechanism 114, a reaction liquid suction mechanism 115 for B / F separation, and a buffer discharge.
  • a mechanism 116 It is provided with a mechanism 116, a stirring mechanism 117 after B / F separation, a reaction liquid suction mechanism 118 for detection, and a plurality of detection units 119 (here, two (first detection unit 119A, second detection unit 119B)).
  • the control unit 102 controls the entire immunoassay device 101 including the sample dispensing mechanism 105. The details of the control will be clarified by the explanation described later.
  • the sample rack 103 installs a sample container 120 for holding a sample.
  • One sample rack 103 may be configured to hold a plurality of sample containers 120.
  • the rack transport line 104 moves the sample container 120 erected on the sample rack 103 to the sample dispensing position near the sample dispensing mechanism 105.
  • the control unit 102 stores an operation unit 133 that receives various operations from the operator, a display unit 134 that displays an interface screen, measurement results, etc., and various data and control programs (programs that control sample dispensing, analysis, etc.). It has a storage unit 135.
  • the sample dispensing mechanism 105 is provided with a nozzle capable of rotating and moving in the vertical direction, sucks the sample held in the sample container 120, and then discharges the sucked sample into the reaction container 121 on the incubator 106.
  • the incubator 106 is configured to be able to hold a plurality of reaction vessels 121 in a heated state, and has a reaction disk that accelerates the reaction of the reaction solution contained in the reaction vessel 121.
  • the reaction disk is configured to be rotatable around a rotation axis.
  • reaction vessel 121 As the reaction disk rotates, the reaction vessel 121 is moved to the reaction vessel installation position L1, the reagent discharge position L2, the sample discharge position L3, the reaction liquid suction position L4 for detection, the reaction vessel disposal position L5, and the B / F separation and transport position L6. Can be moved to.
  • the reaction vessel transport mechanism 107 is a three-axis transport mechanism that can move in three directions of the X-axis, the Y-axis, and the Z-axis, and grips the sample dispensing tip 128 and the reaction vessel 121 to transport the sample to a predetermined position.
  • the reaction vessel holding unit 108 is a holding unit that holds a large number of unused reaction vessels 121 and sample dispensing chips 128.
  • the reaction vessel stirring mechanism 109 is a stirring mechanism that mixes the sample and the reagent in the reaction vessel 121 by applying a rotary motion to the reaction vessel 121.
  • the disposal hole 110 is a hole connected to a disposal container (not shown) for discarding the used reaction vessel 121 and the sample dispensing chip 128.
  • the reaction vessel transport mechanism 107 moves between the reaction vessel holding portion 108, the reaction vessel stirring mechanism 109, the disposal hole 110, the mounting position L7 of the sample dispensing chip 128, and the incubator 106, and moves between the sample dispensing chip 128 and the reaction vessel 121. Is carried.
  • the reagent disk 111 is provided with a plurality of reagent containers 136 holding reagents.
  • the inside of the reagent disk 111 is maintained at a predetermined temperature, and a cover 130 is provided on the upper part of the reagent disk 111.
  • a cover opening 131 is provided in a part of the cover 130.
  • the reagent dispensing mechanism 112 includes a nozzle configured to be rotatable and vertically movable, sucks the reagent held in the reagent container 136 in the reagent disk 111, and sucks the sucked reagent into the reaction container 121 on the incubator 106. It is configured so that it can be discharged to.
  • the B / F separation / transfer mechanism 113 moves the reaction vessel 121, which has passed a predetermined time on the incubator 106, from the B / F separation / transfer position L6 to the B / F separation / transfer mechanism 114.
  • the B / F separation mechanism 114 magnetically attracts magnetic particles containing a substance immunobonded to a measurement object existing in the reaction solution contained in the reaction vessel 121 to the inner wall of the reaction vessel 121. This is a mechanism for separating the reaction liquid containing no magnetic particles and the magnetic particles.
  • the reaction liquid suction mechanism 115 for B / F separation is configured to be movable in the X-axis and Z-axis directions.
  • the reaction liquid suction mechanism 115 for B / F separation moves and descends above the reaction vessel 121 after a predetermined time has passed on the B / F separation mechanism 114, and sucks the reaction liquid containing no magnetic particles in the reaction vessel 121. To do.
  • the buffer solution discharge mechanism 116 is configured to be movable in the X-axis and Z-axis directions, and moves above the reaction vessel 121 in which the reaction solution containing no magnetic particles is sucked on the B / F separation mechanism 114. -Descent and discharge the buffer solution into the reaction vessel 121.
  • the stirring mechanism 117 after B / F separation applies a rotary motion to the reaction vessel 121 to mix the magnetic particles in the reaction vessel 121 with the buffer solution.
  • the mixed reaction vessel 121 is transported to the B / F separation / transfer position L6 of the incubator 106 by the B / F separation / transfer mechanism 113.
  • the reaction liquid suction mechanism 118 for detection is configured to be rotatable and vertically movable, and is configured to be able to suck the reaction liquid contained in the reaction vessel 121 on the incubator 106 and send the liquid to the detection unit 119.
  • the detection unit (analysis unit) 119 is provided with a plurality of detection units 119 (here, two detection units 119A and a second detection unit 119B) in order to shorten the measurement time.
  • the concentration of the object to be detected in the reaction solution sucked and sent from the liquid suction mechanism 118 is detected (analyzed).
  • the first detection unit 119A and the second detection unit 119B are connected to the detection reaction liquid suction mechanism 118 via the liquid feed flow path 132.
  • control unit 102 receives the measurement input signal from the operation unit 133, outputs a control signal to each mechanism in the immunoassay device 101 to perform the analysis, and controls the operation. ..
  • the reaction vessel transport mechanism 107 moves above the reaction vessel holding portion 108, descends, grips the unused reaction vessel 121, and rises. After that, the reaction vessel transport mechanism 107 moves above the reaction vessel installation position L1 of the incubator 106 and descends, and installs the unused reaction vessel 121 on the incubator 106.
  • the transport mechanism 107 moves above the reaction vessel holding portion 108, descends, grips the unused sample dispensing tip 128, and rises. After that, the transport mechanism 107 moves above the chip mounting position L7 and descends, and installs the unused sample dispensing chip 128 on the chip mounting position L7. After that, the nozzle of the sample dispensing mechanism 105 moves above the tip mounting position L7 and descends, and the sample dispensing tip 128 is mounted on the tip of the dispensing nozzle of the sample dispensing mechanism 105.
  • the nozzle of the reagent dispensing mechanism 112 rotates and moves above the opening 131 of the reagent disk cover 130 and descends, and the tip of the nozzle is brought into contact with the reagent in the predetermined reagent container 136 to bring the reagent into a predetermined amount. Aspirate the reagent.
  • the nozzle of the reagent dispensing mechanism 112 moves above the reagent discharge position L2 of the incubator 106, and discharges the reagent to the reaction vessel 121 installed in the incubator 106.
  • the nozzle of the sample dispensing mechanism 105 moves above the sample container 120 arranged in the sample rack 103 and descends after mounting the sample dispensing tip 128, and places the sample held in the sample container 120. A fixed amount of suction. After that, the nozzle of the sample dispensing mechanism 105 moves to the sample discharging position L3 of the incubator 106 and descends, and discharges the sample to the reaction vessel 121 into which the reagent has been dispensed. After discharging the sample, the nozzle of the sample dispensing mechanism 105 performs a mixing operation. After the mixing operation is completed, the nozzle of the sample dispensing mechanism 105 moves above the disposal hole 110, and the used sample dispensing tip 128 is discarded into the disposal hole 110.
  • control unit 102 rotates the incubator 106 to move the reaction vessel 121 in which the sample and the reagent are mixed to the reaction vessel installation position L1, and the transfer mechanism 107 moves the reaction vessel 121 to the reaction vessel stirring mechanism 109. Transport.
  • the reaction vessel stirring mechanism 109 applies a rotary motion to the reaction vessel 121 to agitate the sample and the reagent in the reaction vessel 121 in order to mix them. After that, the control unit 102 returns the reaction vessel 121 after stirring to the reaction vessel installation position L1 of the incubator 106 by the transfer mechanism 107.
  • the control unit 102 selectively carries out the B / F separation step described below according to the measurement item according to the analysis protocol.
  • the reaction vessel 121 after a predetermined time has passed on the incubator 106 is moved to the B / F separation and transport position L6 by the rotation of the incubator 106, and the reaction is carried out by the B / F separation and transport mechanism 113 to the B / F separation and transport mechanism 114. Transport the container 121.
  • the B / F separation mechanism 114 magnetically adsorbs magnetic particles containing a substance immunobound to the measurement target existing in the reaction solution of the reaction vessel 121 to the inner wall of the reaction vessel 121.
  • the nozzle of the reaction liquid suction mechanism 115 for B / F separation is moved and lowered above the reaction vessel 121 to suck the reaction liquid containing no magnetic particles in the reaction vessel 121.
  • the nozzle of the buffer solution discharge mechanism 116 is moved and lowered above the reaction vessel 121 to discharge the buffer solution into the reaction vessel 121. Then, the reaction vessel 121 is transported to the stirring mechanism 117 after the B / F separation by the B / F separation and transport mechanism 113.
  • the stirring mechanism 117 applies a rotary motion to the reaction vessel 121 to mix the magnetic particles in the reaction vessel 121 with the buffer solution.
  • the reaction vessel 121 in which the mixing of the magnetic particles and the buffer solution is completed is returned to the B / F separation / transfer position L6 of the incubator 106 by the transfer mechanism 113 after the B / F separation.
  • the above dispensing and reaction steps are carried out for each measurement item in a cycle of, for example, 12 seconds.
  • the detection step of detecting the object to be measured in the reaction solution by the detection unit 119 will be described in detail below.
  • the reaction vessel 121 in which the sample and the reagent are dispensed and a predetermined time has passed on the incubator 106, or the reaction vessel 121 that has undergone B / F separation is moved to the detection reaction solution suction position L4 by the rotation of the incubator 106.
  • the nozzle of the detection reaction liquid suction mechanism 118 moves and descends above the reaction vessel 121 to suck the reaction liquid in the reaction vessel 121.
  • This reaction solution is sent to the flow cell type detection unit 119 (first detection unit 119A or second detection unit 119B) via the liquid supply flow path 132, and the detection unit 119 detects the object to be measured. I do. Whether to use the first detection unit 119A or the second detection unit 119B is determined according to the designation in the measurement item. In some cases, the detection unit to be used is not specified in the measurement item, in which case the control unit 102 can appropriately select the detection unit currently on standby.
  • the control unit 102 derives a measurement result (concentration of the detection object in the sample, etc.) based on the detection value of the measurement object detected by the detection unit 119, and stores it in the storage unit 135.
  • the measurement result can also be displayed on a display unit 134 such as a display.
  • the control unit 102 moves the reaction vessel 121 in which the reaction liquid is sucked to the reaction vessel disposal position L5 by the rotation of the incubator 106, moves it from the incubator 106 to the upper part of the waste hole 110 by the transport mechanism 107, and causes the waste hole 110. Discard from.
  • the above detection steps can be carried out in the first detection unit 119A or the second detection unit 119B for each measurement item, for example, in a 24-second cycle.
  • the detection unit (119A or 119B) to be used may be specified in the measurement item.
  • the first detection unit 119A performs detection for a certain measurement item because only the first detection unit 119A has the calibration data. May be done.
  • the detection unit may be specified for each measurement item on the GUI, and even in that case, only one of the plurality of detection units may be specified.
  • the measurement items A to C are instructed in the measurement numbers 1 to 3, respectively, but the first detection unit 119A is instructed in each of the measurement items ((1)). Further, in the measurement numbers 4 to 6, the measurement items D to F are instructed, respectively, but in each of the measurement items, the second detection unit 119B is instructed ((2)).
  • the detection by the first detection unit 119A is executed three times in a row.
  • the detection by the second detection unit 119B is executed three times in a row.
  • the second detection unit 119B does not operate and is idle while the detection operation by the first detection unit 119A is being executed, and conversely, the first detection operation is being executed by the second detection unit 119B.
  • the detection unit 119A of the above is not operating and is playing.
  • the first detection unit 119A and the second detection unit 119B cannot operate in parallel, and the total analysis time becomes long.
  • the time required for dispensing is 72 seconds, parallel measurement is not possible, so the total detection time is as long as 132 seconds.
  • the sample is dispensed so that the same detection unit is not continuous.
  • the operation of changing the order of is executed. The operation of changing the order of sample dispensing will be described in more detail with reference to FIG.
  • FIG. 3 is a schematic diagram illustrating the operation of the first embodiment. As shown in FIG. 3A, consider a case where six measurement numbers are specified as in the example of FIG. In the first embodiment, when the same detection unit is specified in consecutive measurement numbers, the control unit 102 executes an operation of changing the order of sample dispensing so that the same detection unit is not continuous. To do.
  • the measurement items (measurement numbers 1 to 3) that specify the first detection unit 119A are consecutive three times.
  • the measurement items (measurement numbers 4 to 6) that specify the second detection unit 119B are also three times in succession. Therefore, the control unit 102 confirms the detection unit designated by the next measurement item of measurement number 2 after the dispensing operation related to the measurement number 1 (sample a, measurement item A) is completed.
  • the control unit 102 determines that the same detection unit (first detection unit 119A) is continuously designated, and changes the order of dispensing. In the example of FIG. 3A, it is the measurement number 4 that the second detection unit 119B, which is not the same as the first detection unit 119A designated by the measurement number 1, is designated. Therefore, after the dispensing operation of measurement number 1 is completed, the control unit 102 skips measurement numbers 2 and 3 (hereinafter, such an operation is referred to as “dispensing skip operation”) and jumps to measurement number 4. To execute the dispensing operation.
  • the control unit 102 skips the measurement numbers 5 and 6 and jumps to the measurement number 2 where the dispensing operation has not been completed yet.
  • the control unit 102 dispenses the sample by changing the order of the dispensing operations so that the measurement numbers specified in the measurement items for the same detection unit are not consecutive.
  • the dispensing operation is executed in the order of measurement numbers 1, 4, 2, 5, 3, and 6. According to such an operation, it is possible to minimize the continuous use of the same detection unit in continuous measurement items (measurement numbers).
  • the first detection unit 119A and the second detection unit 119B have more chances to operate in parallel.
  • the total analysis time can be shortened accordingly. For example, when the time required for dispensing is 72 seconds, the total analysis time can be reduced to, for example, 84 seconds by executing the parallel measurement.
  • the details of the sample dispensing operation in the first embodiment will be described with reference to the flowchart of FIG.
  • the control of the sample dispensing operation is performed by the control unit 102.
  • the sample rack 103 on which a plurality of samples are loaded is transported to the immunoassay device 101 (step S301).
  • the control unit 102 confirms the measurement items of each sample in the order of the measurement numbers (step S302).
  • the immunoassay device 101 reads a barcode attached to the sample container 120 using a barcode detector (not shown), and recognizes a measurement item of each sample and a detection unit designated by the measurement item (step).
  • the barcode and the barcode detector are merely examples of the configuration for confirming the measurement items, and the format does not matter as long as the information of the measurement items and the designated detection unit can be provided to the control unit 102. ..
  • the sample rack 103 moves along the rack transfer line 104 to the front of the sample discharge position L3 (step S303). When the movement is completed, it waits until the dispensing operation is started. A plurality of sample racks can stand by on the rack transport line 104. If the dispensing operation of the sample rack 103 related to the previous measurement number is not completed, the new sample rack 103 waits at the retracted position until the dispensing of the previous sample rack 103 is completed, and after that, the sample is sampled. Move to the discharge position.
  • the sample dispensing mechanism 105 dispenses the amount of the sample according to the measurement protocol shown in the measurement item into the reaction vessel 121 (step S304).
  • step S305A it is confirmed whether or not the dispensing has been completed for all the samples and all the measurement numbers in the sample rack 103 currently at the sample discharge position L3 (step S305A).
  • the dispensing of all the samples and all the measurement numbers is completed (Yes in step S305A)
  • the rack transfer line 104 is not in the next sample rack 103 (No in step S309A)
  • the measurement is completed or the state transitions to the standby state (step S310).
  • the "standby state” is a state in which when the sample rack is transported to the immunoassay device 101, sample dispensing can be started immediately.
  • step S305A when it is determined that the dispensing of all the samples and all the measurement numbers in the sample rack 103 currently at the sample discharge position L3 has not been completed (No in step S305A), the measurement items related to the next measurement number. However, it is confirmed whether or not the same detection unit as the measurement item related to the immediately preceding (previous) measurement is specified (step S306A). If the same detection unit is not specified (No), the operation proceeds to step S311A. On the other hand, if the same detection unit is specified (Yes), the operation proceeds to step S307A.
  • step S311A it is further determined whether or not the sample related to the next measurement item is the same sample as the sample related to the previous measurement number. In the case of the same sample (Yes in step 311A), the sample rack 103 is not moved, and the sample is dispensed from the same sample container 120 as the previous time. If the samples are not the same (No in step 311A), the sample rack 103 is moved to the position of the sample according to the measurement item, and then the same sample is dispensed.
  • step S307A in order to avoid designating the same detection unit consecutively, measurement numbers having measurement items that specify the same detection unit are skipped (dispensing skip operation), and different detection units are specified instead. It is determined whether or not the sample related to the measurement number having the measurement item to be measured exists in the sample rack 103. If the sample is present (Yes in step S307A), the operation proceeds to step S313. If the sample does not exist (No in step S307A), the process proceeds to step S308A. In step S313, the moving amount and moving direction of the sample rack 103 are confirmed based on, for example, the output of the barcode detector described above, and the sample rack is moved (step S314).
  • Step S308A When there is no corresponding sample in the sample rack 103 currently at the sample discharge position L2 (No in step 307A), it is determined whether or not the dispensing skip operation has been executed in the sample rack 103 so far.
  • the control unit 102 can store as historical data whether or not the dispensing skip operation has been performed, and the determination in step S308A is executed according to the historical data.
  • the dispensing skip operation is executed (Yes), the operation proceeds to step S313, and the same operation as described above is executed.
  • the dispensing skip operation is not executed (No)
  • the operation proceeds to step S309A, and the same operation as described above is executed.
  • the sample rack 103 normally moves in the forward direction, but when it is determined that the same detection unit is continuously specified, the sample rack 103 moves in the opposite direction unlike the normal case. , The direction of movement may be switched.
  • the above sample dispensing is repeated until all the measurement items of the sample placed in the sample rack are completed. That is, in the first embodiment, the sample rack is moved according to the measurement items in order to measure alternately in the plurality of detection units within the possible range. As a result, parallel measurement can be performed by a plurality of detection units, and the total analysis time can be shortened.
  • the present invention is not limited to this, and the same operation may be performed across a plurality of sample racks. In that case, the measurement information of the plurality of sample racks is confirmed, and the order of the dispensing operations is changed among the plurality of sample racks.
  • FIG. 5 is a schematic view illustrating a part of the configuration of the automatic analyzer (immunoassay apparatus) of the second embodiment. Since the immunoassay apparatus of the second embodiment is the same as the configuration of the first embodiment except for the portion shown in FIG. 5, redundant description will be omitted below.
  • the difference between the second embodiment and the first embodiment is that the linear sample rack 103 is used in the first embodiment, but it can be moved in a circumferential shape in the second embodiment. The point is that the sample racks 501 and 505 are used.
  • FIG. 5 is a schematic view illustrating a part of the configuration of the automatic analyzer (immunoassay apparatus) of the second embodiment. Since the immunoassay apparatus of the second embodiment is the same as the configuration of the first embodiment except for the portion shown in FIG. 5, redundant description will be omitted below.
  • the difference between the second embodiment and the first embodiment is that the linear sample rack 103 is used in the first embodiment, but it can be moved in a circumferential shape in the second
  • the sample rack 501 is a rack that is first moved to the sample dispensing position L3', and the sample rack 505 is moved to the sample dispensing position L3'after the dispensing operation of the sample rack 501 is completed. It is a rack to be used.
  • the immunoassay apparatus of the second embodiment includes a transport path in which the rack transport line 504 is configured in a circumferential shape, and the sample is provided along the circumferential transport path.
  • the racks 501 and 505 are configured to be movable.
  • the sample racks 501 and 505 are configured by connecting a plurality of container storage portions.
  • a plurality of container storage portions in one sample rack 501, 505 are connected by, for example, a hinge member or an elastic member, and the shape of one sample rack 501, 505 can be flexibly changed along the shape of the transport path. Has been done.
  • the nozzle of the sample dispensing mechanism 105A is configured to be rotatable around a rotation axis, and the tip of the nozzle is movable along the circumferential path of the rack transport line 504. Therefore, when the sample racks 501 and 505 are introduced into the rack transport line 504, the sample dispensing mechanism 105A can access any sample position of the sample racks 501 and 505.
  • the rack transport line 504 is provided with a turnout 506 capable of switching the traveling direction of the sample racks 501 and 505.
  • the turnout 506 rotates and the sample rack at the sample dispensing position L3' Move 501 backwards.
  • the turnout 506 is rotated toward the sample rack traveling direction 507, and the sample rack 501 is moved in the sample rack traveling direction 507.
  • the turnout 506 is rotated to the sample dispensing position L3', and the sample rack 505 waiting at the rack transfer line 504 is moved to the sample dispensing position L3'.
  • step S608A corresponding to step 308A in FIG. 4
  • step S613 the sample dispensing mechanism 105A moves to the confirmed sample position (step S614).
  • Other operations are substantially the same as those in the first embodiment.
  • the same effect as that of the first embodiment can be obtained by using the sample racks 501 and 505 that can be moved in a circumferential shape.
  • the order of the dispensing operations can be changed across a plurality of racks.
  • FIG. 7 is a schematic view illustrating a part of the configuration of the automatic analyzer (immunoassay apparatus) of the third embodiment. Since the immunoassay apparatus of the third embodiment is the same as the configuration of the above-described embodiment except for the portion shown in FIG. 7, duplicated description will be omitted below.
  • the dispensing skip operation of changing the dispensing order of the sample is performed according to the detection unit designated by the measurement item.
  • the same operation is performed in principle, but when the dispensing skip operation is executed, a child sample is generated and the child sample can be temporarily stored in an area (hereinafter, "" It is placed in the child sample area 701).
  • a child sample is an amount of sample required to carry out the measurement of a certain measurement item.
  • a plurality of child samples can be generated in the child sample area 701, but the number is not limited to a specific number.
  • a child sample area 701 capable of temporarily storing the child sample is provided on the circumference on which the nozzle of the sample dispensing mechanism 105B moves.
  • the reaction vessel 121 can be installed in the child sample area 701 by the reaction vessel transport mechanism 107.
  • the sample rack 103 and the rack transfer line 104 are the same as those in the first embodiment, the same sample rack and rack transfer line as in the second embodiment may be adopted.
  • FIGS. 8A and 8B show a flow of a series of sample dispensing operations.
  • the control of the sample dispensing operation is performed by the control unit 102.
  • Steps S801 to S809 in FIG. 8A are substantially the same as steps S302 to S306A, S311A, and S312 of FIG. 4 of the first embodiment. Therefore, duplicate description will be omitted.
  • the operation loops between steps S801 to S806A to S808A.
  • step S806A when it is confirmed that the detection unit specified by the measurement item related to the next measurement number is the same as the detection unit specified by the measurement item related to the immediately preceding (previous) measurement number (Yes), the above-mentioned The procedure for preparing the child sample is started.
  • step S807A it is determined whether or not the sample related to the next measurement number is the same as the sample related to the previous measurement number.
  • step S811 the sample rack is moved by one sample, and then a child sample of a sample different from the previous measurement number is created in the child sample area 701 (step S811).
  • step S810 the sample rack is moved by one sample, and then a child sample of a sample different from the previous measurement number is created in the child sample area 701 (step S811).
  • step S811 the sample rack is moved by one sample, and then a child sample of a sample different from the previous measurement number is created in the child sample area 701 (step S811).
  • the next measurement number is the same sample as the previous measurement number (Yes in step S807A)
  • a child sample of the same sample as the previous measurement number is created in the child sample area 701 (step S811).
  • the sample rack 103 is moved by one sample (step S812). It is determined whether or not the transferred sample is the final sample in the sample rack 103 currently in the sample dispensing position (step S813A).
  • step S813A If it is not the final sample (No in step S813A), the sample is dispensed from the undispensed sample container in the sample rack 103 (step S814), and then the process proceeds to step S815A. On the other hand, if it is the final sample (Yes in step S813A), the process proceeds to step S817A.
  • step S815A it is confirmed whether or not there is a child sample in the child sample area 701 that specifies a detection unit different from the detection unit specified by the previous measurement number (step S815A). If such a child sample is present in the child sample area 701 (Yes in step S815A), the corresponding child sample is dispensed from the child sample area 701 (step S816). In the child sample area 701, steps S815A and S816 are repeated until there are no such child samples.
  • the child sample area 701 if there is a child sample that specifies a detection unit different from the detection unit specified by the previous measurement number, the child sample is dispensed and measured alternately (in parallel) by the two detection units. It can be performed. However, when there is no such child sample in the child sample area 701 (No in step S815A), the detection unit designated by the measurement item with reference to the next measurement number is the sample targeted by the previous measurement number. It is confirmed whether or not the samples are the same (step S819A).
  • step S819A If it is determined that the samples are not the same (No in step S819A), the sample rack is moved by one sample in order to dispense the next sample (step S812). On the other hand, when it is determined that the samples are the same (No in step S819A), it is confirmed whether the measurement item related to the next measurement number specifies the same detection unit as the previous measurement number (step S820A). ).
  • step S820A If it is determined that a different detection unit is specified (No in step S820A), sample dispensing is continued from the same position without moving the sample rack. On the other hand, when it is determined that the same detection unit is designated (Yes in step S820A), the step of creating a child sample in the child sample area 701 is carried out in the same manner as described above (step S811).
  • Steps S811 to S816 described above are repeated until the measurement for all the measurement numbers in one sample rack is completed. After that, when it becomes the final sample in the sample rack 103 (Yes in step S813A), all the unmeasured child samples stored in the child sample area 701 are dispensed (step S818), and then in the sample rack. Dispensing of the final sample of 03 is completed (step S822). After the dispensing is completed, as described above, the same sample dispensing operation is repeated for another sample rack, the measurement is completed, or the state transitions to the standby state (steps S823 and S824).
  • the third embodiment by using a plurality of detection units alternately, it is possible for the plurality of detection units to perform measurement in parallel. At this time, by generating the child sample in the child sample area 701, the execution of this procedure becomes easy.
  • FIG. 9 is a schematic view illustrating a part of the configuration of the automatic analyzer (immunoassay apparatus) of the fourth embodiment. Since the immunoassay apparatus of the fourth embodiment is the same as the configuration of the above-described embodiment except for the portion shown in FIG. 9, duplicate description will be omitted below.
  • the differences between the fourth embodiment and the third embodiment are as follows.
  • a configuration is adopted in which the child sample is temporarily stored in the child sample area 701.
  • a configuration is adopted in which the child sample is temporarily stored in the incubator 106.
  • the immunoassay apparatus of the fourth embodiment has substantially the same structure as that of FIG. 1 except for the sample dispensing mechanism 105C.
  • the dispensing skip operation is executed when the same detection unit is continuously designated.
  • the reaction vessel transport mechanism 107 transports the reaction vessel 121 for preparing the child sample to a predetermined position of the incubator 106.
  • the number of reaction vessels 121 installed is set according to the number of times the dispensing skip operation is executed.
  • the reaction vessel transport mechanism 107 may access a predetermined position of the incubator 106, or conversely, the incubator 106 reacts by the rotation of the incubator 106. You may access the side of the container transport mechanism 107.
  • the sample dispensing mechanism 105C sucks the samples related to a plurality of measurement numbers to be generated as the child sample, which are skipped by the dispensing skip operation, from the sample rack 103 at once. can do.
  • the sample sucked in a batch is divided into a plurality of reaction vessels 108 and discharged according to a plurality of measurement numbers.
  • Samples for a plurality of measurement numbers are sequentially discharged into a plurality of reaction vessels 121 by rotation of the incubator 106, for example. For example, when three measurement items of a sample dispensing amount of 10 uL are skipped, three reaction vessels 121 are installed on the incubator 106. Subsequently, the sample dispensing mechanism 105C sucks 30 uL of the sample from, for example, the sample rack 903, and discharges 10 uL each into the three reaction vessels 121 placed on the incubator 106.
  • the operation of creating a child sample in the child sample area 701 and then dispensing the sample from the child sample area 701 to the incubator 106 is performed.
  • the child sample dispensing as in the third embodiment is unnecessary. It becomes. Therefore, according to the fourth embodiment, as in the first to second embodiments, the order of dispensing is changed according to the content of the measurement items, and the parallel measurement is executed by the plurality of detection units. be able to.
  • FIG. 10 is a schematic view illustrating a part of the configuration of the automatic analyzer (immunoassay apparatus) of the first modification.
  • the sample dispensing mechanism 105D includes a rotating shaft 1001 and a dispensing nozzle 1002.
  • the rotary shaft 1001 is rotatable about the rotary shaft O1.
  • the dispensing nozzle 1002 is configured to be rotatable around a rotating shaft O2 provided at the tip of the rotating shaft 1001.
  • the sample dispensing mechanism 105D has two rotating portions and two rotating axes, whereby the sample rack 103 and the incubator 106 It is said that any location can be accessed.
  • FIG. 11 is a schematic view illustrating a part of the configuration of the automatic analysis (immunoassay device) of the second modification.
  • one sample rack contains a plurality of sample containers and is transported by a rack transfer line.
  • the sample containers 1101, 1104 ... are individually transported along the rack transport line 1102.
  • the sample containers 1101, 1104 ... Can be moved not only in the longitudinal direction of the rack transport line 1102 but also in the lateral direction by magnetic transport or the like.
  • the samples are dispensed in the order of arrival at the sample dispensing position 1103 along the rack transport line 1102, but the same detection unit is designated as in the above-described embodiment.
  • the order can be changed as appropriate to dispense the sample.
  • the immunoassay device is connected to the sample transfer and sample transfer pretreatment unit, and the arrangement of the child samples is changed in advance according to the order of the measurement items when the child sample is prepared.
  • the control unit 102 stores the history of the skipping of the dispensing and the replacement of the measurement order, and based on this history data.
  • a function is provided to recommend changing the detector specified by the measurement item.
  • the history data of changing the measurement order can be stored in the storage unit 118. Further, the decision as to whether or not to recommend the change of the detection unit based on the historical data can be made in the computer program executed by the control unit 102.
  • the detection unit designated at the time of measurement is biased.
  • the detection unit specified in any of the measurement items it is possible to calculate how much the number of times the dispensing can be rearranged can be reduced based on the historical data.
  • a message recommending the change of the designated detection unit is displayed on the display unit 102. Based on the information, the operator can determine whether or not to change the detection unit specified in each measurement item.
  • the present invention is not limited to the above embodiment, and includes various modifications.
  • the above-described embodiment has been described in detail in order to explain the present invention in an easy-to-understand manner, and is not necessarily limited to the one including all the described configurations.
  • it is possible to replace a part of the configuration of one embodiment with the configuration of another embodiment and it is also possible to add the configuration of another embodiment to the configuration of one embodiment.
  • Buffer Liquid discharge mechanism 117 ... B / F separation and stirring mechanism, 118 ... Detection reaction liquid suction mechanism, 119, 119A, 119B ... Detection unit (analysis unit), 120 ... Sample container, 121 ... Reaction vessel, L1 ... Reaction vessel installation position, L2 ... Reagent discharge position, L3 ... Specimen discharge position, L4 ... Detection reaction liquid suction position, L5 ... Reaction vessel disposal position , L6 ... B / F separation and transport position, L7 ... Chip mounting position, 128 ... Sample dispensing chip, 130 ... Reagent disk cover, 131 ... Opening, 132 ... Liquid delivery Flow path 133 ... Operation unit, 134 ... Display unit, 135 ... Storage unit, 501, 505 ... Specimen rack, 506 ... Brancher, 507 ... Specimen rack traveling direction, 701 ⁇ ⁇ ⁇ Child sample area.

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JP2021566861A JP7304969B2 (ja) 2019-12-26 2020-10-27 自動分析装置及び自動分析装置用の制御プログラム
CN202080084786.3A CN114829945B (zh) 2019-12-26 2020-10-27 自动分析装置以及自动分析装置用的控制程序产品
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EP4083635B1 (en) 2025-09-03

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