WO2023037732A1 - 自動分析装置とその制御方法 - Google Patents

自動分析装置とその制御方法 Download PDF

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Publication number
WO2023037732A1
WO2023037732A1 PCT/JP2022/026252 JP2022026252W WO2023037732A1 WO 2023037732 A1 WO2023037732 A1 WO 2023037732A1 JP 2022026252 W JP2022026252 W JP 2022026252W WO 2023037732 A1 WO2023037732 A1 WO 2023037732A1
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WO
WIPO (PCT)
Prior art keywords
measurement
analysis
analysis module
sample
calibration
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/JP2022/026252
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English (en)
French (fr)
Japanese (ja)
Inventor
博文 塩畑
正志 圷
真章 近久
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.)
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 CN202280055387.3A priority Critical patent/CN117795346A/zh
Priority to US18/686,198 priority patent/US20240353435A1/en
Priority to EP22867056.8A priority patent/EP4400843A4/en
Priority to JP2023546797A priority patent/JP7673216B2/ja
Publication of WO2023037732A1 publication Critical patent/WO2023037732A1/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
    • G01N35/00693—Calibration
    • 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
    • G01N35/00594—Quality control, including calibration or testing of components of the analyser
    • G01N35/00712—Automatic status testing, e.g. at start-up or periodic
    • 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

Definitions

  • the present invention relates to an automatic analyzer that analyzes biological samples such as blood and urine.
  • Automated analyzers that automatically qualitatively or quantitatively analyze specific components contained in biological samples such as the blood and urine of subjects require the use of calibrators and quality control samples, which are samples with known concentrations, in order to maintain analytical accuracy. are analyzed on a regular basis. In addition, in order to prevent mixing of the calibrator or quality control sample with the biological sample provided by the subject, it is generally controlled so that the biological sample is not analyzed until the analysis of the calibrator or quality control sample is completed. is.
  • the analysis module is controlled so that the biological sample is not analyzed even after the analysis of the calibrator and the quality control sample is completed and the analysis module is capable of analyzing the biological sample, the analysis processing speed will be reduced. may decline.
  • Patent Document 1 in order not to reduce the analysis processing speed of an automatic analyzer, transportation of a biological sample to an analysis module in which a calibrator or quality control sample is transported is prohibited, and transportation of a biological sample to other analysis modules is prohibited. Disclosed is allowing transport.
  • an object of the present invention is to provide an automatic analyzer capable of improving the analysis processing speed.
  • the present invention provides an automatic analyzer comprising an analysis module for analyzing a sample and a controller for controlling the analysis module, wherein the controller controls a plurality of samples registered in the analysis module.
  • the analysis module is controlled to permit analysis of the biological sample.
  • the present invention also provides a control method for an automatic analyzer provided with an analysis module for analyzing a sample, wherein, among a plurality of measurement items registered in the analysis module, a measurement item for which calibration or quality control measurement has been instructed is selected. control the analysis module to prohibit the analysis of the biological sample provided by the subject, and to permit the analysis of the biological sample for measurement items for which calibration and quality control measurement are not instructed. characterized by
  • FIG. 4 is a diagram showing the flow of processing according to the first embodiment;
  • FIG. 4 is a diagram showing part of the flow of processing according to the first embodiment;
  • the automatic analyzer includes an input section 103 , an ID reader 104 , a transfer line 105 , three analysis modules 110 , a branch section 108 , a standby section 109 , a discharge section 106 and a control section 101 .
  • the number of analysis modules 110 is not limited to three, and may be one or more. Each part will be described below.
  • the input unit 103 is loaded with a sample container 102 containing a biological sample such as blood or urine provided by a subject, a calibrator that is a sample having a known concentration, and a quality control sample.
  • a biological sample such as blood or urine provided by a subject
  • a calibrator that is a sample having a known concentration
  • a quality control sample may be placed on a dish-shaped carrier and introduced into the introduction section 103 .
  • the loading of the sample container 102 into the loading unit 103 may be performed manually by the user, or may be performed automatically by an external transport system.
  • the sample container 102 loaded into the loading section 103 is transported to the ID reader 104 , the analysis module 110 , the branch section 108 , the standby section 109 and the discharge section 106 by the transport line 105 and the return line 107 .
  • the return line 107 is a transport path that transports the sample container 102 from downstream to upstream of the transport line 105 .
  • the ID reader 104 is a device that reads a sample ID, which is an identifier assigned to the sample container 102, and is, for example, a barcode reader or an RFID reader.
  • the sample ID is associated in advance with the reception number, the subject's name, which are attribute information related to the sample contained in the sample container 102, and the measurement request item, which is the requested measurement item.
  • the analysis module 110 is a device that dispenses and analyzes the sample contained in the sample container 102 based on the measurement request items. Since measurement items are diverse, several measurement items are registered for each of the plurality of analysis modules 110 and stored in the analysis module table 201 illustrated in FIG.
  • the analysis module table 201 has columns of analysis module names 202 and measurement items 203, and stores which measurement items are registered in each analysis module. In the analysis module table 201 of FIG. 2, measurement item A and measurement item D are registered in analysis module ⁇ , measurement item B is registered in analysis module ⁇ , and measurement item C is registered in analysis module ⁇ .
  • each of the analysis modules 110 calibration using a calibrator and quality control measurement using a quality control sample are periodically performed in order to maintain the analysis accuracy of the registered measurement items.
  • the contents stored in the analysis module table 201 are updated to, for example, "calibration in progress”. Further, when calibration and quality control measurement are completed, the measurement items registered in each analysis module become measurable, and the contents stored in the analysis module table 201 are updated to "measurable”.
  • a branching portion 108 is provided at a connecting portion between the transfer line 105 and the return line 107, and determines the transfer destination of the sample container 102 from the return line 107 based on the implementation status of the measurement request item associated with the sample ID of the sample container 102. It is set to either the discharge unit 106 or the discharge unit 106 . That is, if all the requested measurement items associated with the sample ID have been performed, the sample container 102 is transported to the discharge unit 106, and if there is an unimplemented measurement request item, the sample container 102 is transported to the return line 107. .
  • the waiting section 109 is provided in the middle of the return line 107 and makes the transported sample container 102 wait. Note that when a predetermined condition is satisfied, the sample container 102 waiting in the waiting section 109 is transported upstream on the transport line 105 .
  • the discharge unit 106 discharges the sample container 102 for which all measurement request items have been completed. Ejection of the sample container 102 from the ejection unit 106 may be performed manually by the user, or may be performed automatically by an external transport system.
  • the control unit 101 is a device such as a computer that controls the operation of each unit of the automatic analyzer and executes processing related to analysis.
  • a sample container 102 containing a biological sample, a calibrator, and a quality control sample is loaded into the loading unit 103 .
  • a sample ID is assigned to the sample container 102 .
  • the sample container 102 loaded into the loading section 103 is transported to the ID reader 104 by the transport line 105 .
  • the ID reader 104 reads the sample ID of the sample container 102 .
  • the read sample ID is transmitted to the control unit 101 .
  • the control unit 101 acquires measurement request items by checking the received sample ID against the sample ID table 401 illustrated in FIG.
  • the sample ID table 401 has columns of sample ID 402 , sample type 403 and measurement request item 404 . That is, the sample ID table 401 stores what type of sample the sample contained in the sample container 102 of each sample ID is and what measurement items are requested for the sample.
  • the sample container 102 with a sample ID of 1 contains a calibrator and the measurement item A is requested
  • the sample container 102 with a sample ID of 2 contains a biological sample. It stores that measurement items A to D are requested.
  • the control unit 101 determines whether the sample type is a biological sample. If the sample type is a biological sample, the process proceeds to S305. If the sample type is not a biological sample but a calibrator or quality control sample, the process proceeds to S313, and the analysis module 110 is instructed to perform calibration or quality control measurement.
  • the control unit 101 determines whether or not the measurement request items acquired in S303 include a measurement request item for which calibration or quality control measurement has been instructed. If there is a measurement request item for which calibration or quality control measurement has been instructed, the process proceeds to S306; otherwise, the process proceeds to S307. Note that the analysis module table 201, for example, is referred to determine whether or not there is a measurement request item for which calibration or quality control measurement has been instructed.
  • the control unit 101 causes the analysis module 110 to implement the measurement request items. However, the measurement request items whose execution is prohibited in S306 are not executed. In other words, the measurement request items that are not prohibited from being performed are permitted to be performed.
  • the control unit 101 determines whether or not all biological sample measurement request items have been performed. If all measurement request items have been performed, the process proceeds to S309, and if there are measurement request items that have not been performed, the process proceeds to S310.
  • the control section 101 causes the sample container 102 to be transported to the discharge section 106 by the branch section 108 and the transport line 105 .
  • the control unit 101 causes the sample container 102 to be transported to the standby unit 109 through the branching unit 108 and the return line 107 .
  • the control unit 101 determines whether or not the measurement request items whose execution is prohibited in S306 are permitted. If there is a permitted measurement request item, the process proceeds to S312, and if there is no permitted measurement request item, the process of S311 is repeated.
  • the control unit 101 transports the sample container 102 to the analysis module 110 through the return line 107 and the transport line 105 . After that, in S307, the measurement request item is executed.
  • the control unit 101 updates the status of the analysis module in response to instructions for calibration and quality control measurement. Specifically, the content stored in the analysis module table 201 is updated to, for example, "calibration in progress". Note that the contents are updated only for measurement items for which calibration or quality control measurement has been instructed. After updating, the process proceeds to S309.
  • the control unit 101 performs the processing in FIG. 5 in parallel with the processing in FIG.
  • the control unit 101 determines whether or not the instructed calibration and quality control measurement have been completed. If the instructed calibration or quality control measurement is completed, the process proceeds to S502, and if not completed, the process of S501 is repeated.
  • the control unit 101 updates the status of the analysis module upon completion of calibration and quality control measurement. Specifically, the content stored in the analysis module table 201 is updated to, for example, "measurable". Note that the contents are updated only for measurement items for which calibration and quality control measurement have been completed.
  • the processing flow described above can improve the analysis processing speed. That is, only measurement items for which calibration or quality control measurement is instructed are prohibited, and measurement items for which calibration or quality control measurement is not instructed are permitted. analyzed.
  • the sample containers 102 for which measurement request items are prohibited are collectively put on standby in the waiting section 109, so that each of the analysis modules 110 has a space for waiting the sample containers 102. It is also possible to reduce the size of the automatic analyzer without providing a .
  • measurement items whose implementation is prohibited in S306 may be permitted for measurement items having past measurement results of calibration and quality control measurement.
  • the biological sample can be quickly analyzed without waiting for the completion of calibration and quality control measurements.
  • whether or not to use past measurement results of calibration or quality control measurement may be switched by the user via the setting screen of the control unit 101 .
  • the control unit 101 may switch whether or not to use the past measurement results according to the priority of the biological sample. For example, past measurement results may be preferentially used in order to quickly obtain measurement results for biological samples that are urgent and of high priority.
  • implementation may be prohibited for measurement items that do not have the measurement results of calibration or quality control measurement.
  • implementation may be prohibited for measurement items that do not have the measurement results of calibration or quality control measurement.
  • 101 control unit
  • 102 sample container
  • 103 input unit
  • 104 ID reader
  • 105 transport line
  • 106 discharge unit
  • 107 return line
  • 108 branch unit
  • 109 standby unit
  • 110 analysis module
  • 201 Analysis module table
  • 202 Analysis module name
  • 203 Measurement item
  • 401 Sample ID table
  • 402 Sample ID
  • 403 Sample type
  • 404 Measurement request item

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  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Quality & Reliability (AREA)
  • Engineering & Computer Science (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
PCT/JP2022/026252 2021-09-08 2022-06-30 自動分析装置とその制御方法 Ceased WO2023037732A1 (ja)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CN202280055387.3A CN117795346A (zh) 2021-09-08 2022-06-30 自动分析装置及其控制方法
US18/686,198 US20240353435A1 (en) 2021-09-08 2022-06-30 Automated Analyzing Device, and Control Method for Same
EP22867056.8A EP4400843A4 (en) 2021-09-08 2022-06-30 AUTOMATED ANALYSIS DEVICE AND CONTROL METHOD THEREOF
JP2023546797A JP7673216B2 (ja) 2021-09-08 2022-06-30 自動分析装置とその制御方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2021146034 2021-09-08
JP2021-146034 2021-09-08

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WO2023037732A1 true WO2023037732A1 (ja) 2023-03-16

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US (1) US20240353435A1 (https=)
EP (1) EP4400843A4 (https=)
JP (1) JP7673216B2 (https=)
CN (1) CN117795346A (https=)
WO (1) WO2023037732A1 (https=)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006038881A (ja) * 2005-10-20 2006-02-09 Hitachi Ltd 生体サンプルの自動分析システム
JP2007240223A (ja) * 2006-03-07 2007-09-20 Hitachi High-Technologies Corp 自動分析装置
JP2020064061A (ja) * 2018-10-16 2020-04-23 エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft 分析実験室の操作方法

Family Cites Families (9)

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Publication number Priority date Publication date Assignee Title
JP2996860B2 (ja) * 1994-03-18 2000-01-11 株式会社日立製作所 自動分析装置
JP2002350970A (ja) 2001-05-23 2002-12-04 East Japan Railway Co カメラ用ハウジング
JP4456962B2 (ja) 2004-09-02 2010-04-28 株式会社キーエンス 試料表示装置、試料表示装置の操作方法、試料表示装置操作プログラムおよびコンピュータで読み取り可能な記録媒体又は記録した機器
US20080006653A1 (en) 2006-03-13 2008-01-10 Biomachines, Inc. Small volume liquid handling system
JP2008175791A (ja) 2007-01-22 2008-07-31 Juki Corp 分注装置
JP5210903B2 (ja) 2009-01-30 2013-06-12 株式会社日立ハイテクノロジーズ 試料分析装置
JP6886243B2 (ja) 2016-02-25 2021-06-16 株式会社日立ハイテク 自動分析装置
EP3588093B1 (en) * 2017-02-22 2024-12-18 Hitachi High-Tech Corporation Automated analyzer
JP6934244B2 (ja) 2017-06-19 2021-09-15 国立大学法人東京工業大学 テレスコピック型ロボットアーム

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006038881A (ja) * 2005-10-20 2006-02-09 Hitachi Ltd 生体サンプルの自動分析システム
JP2007240223A (ja) * 2006-03-07 2007-09-20 Hitachi High-Technologies Corp 自動分析装置
JP4919677B2 (ja) 2006-03-07 2012-04-18 株式会社日立ハイテクノロジーズ 自動分析システム及び当該自動分析システムの制御方法
JP2020064061A (ja) * 2018-10-16 2020-04-23 エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft 分析実験室の操作方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP4400843A4

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Publication number Publication date
EP4400843A4 (en) 2025-08-06
JPWO2023037732A1 (https=) 2023-03-16
CN117795346A (zh) 2024-03-29
EP4400843A1 (en) 2024-07-17
US20240353435A1 (en) 2024-10-24
JP7673216B2 (ja) 2025-05-08

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