WO2009142087A1 - 自動分析装置 - Google Patents
自動分析装置 Download PDFInfo
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- WO2009142087A1 WO2009142087A1 PCT/JP2009/057936 JP2009057936W WO2009142087A1 WO 2009142087 A1 WO2009142087 A1 WO 2009142087A1 JP 2009057936 W JP2009057936 W JP 2009057936W WO 2009142087 A1 WO2009142087 A1 WO 2009142087A1
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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
- G01N35/00613—Quality control
- G01N35/00663—Quality control of consumables
-
- 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
- G01N35/00732—Identification of carriers, materials or components in automatic analysers
-
- 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
- G01N35/00613—Quality control
- G01N35/00663—Quality control of consumables
- G01N2035/00673—Quality control of consumables of reagents
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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
- G01N35/00722—Communications; Identification
- G01N35/00732—Identification of carriers, materials or components in automatic analysers
- G01N2035/00742—Type of codes
- G01N2035/00782—Type of codes reprogrammmable code
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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
- G01N35/00712—Automatic status testing, e.g. at start-up or periodic
Definitions
- the present invention relates to an automatic analyzer for analyzing a component of a sample derived from a living body, and more particularly to an automatic analyzer having characteristics relating to retention of reagent information.
- IDs for identifying reagents used for analysis are attached to reagent containers, and the IDs are read to determine which measurement items are used for individual reagents. Identifying has been done.
- an identification ID label using a barcode is known (for example, see Patent Document 1).
- the barcode has the advantage that the label is easy to produce and inexpensive, but there are problems such as unreadable or misreading due to factors such as dirt on the label and moisture adhering to the surface.
- information on calibration results and information on measurement results of quality control samples are generally stored in a storage device of the main body of the automatic analyzer.
- a storage device a hard disk drive (HDD) or the like is used.
- HDD hard disk drive
- the HDD is accessed every 1.8 seconds to read / write data. Therefore, the access frequency to the HDD is high and the life of the HDD is shortened. For example, if the information on the calibration result or the measurement result of the quality control sample stored inside is lost due to a trouble in the HDD, it is necessary to execute calibration again or measure the quality control sample. There is.
- the number of reagents used is, for example, 70 types.
- the number of reagents is, for example, 70 types.
- An object of the present invention is to provide an automatic analyzer that can be reused in a short time even when a storage device is in trouble.
- the present invention provides a quality control information including a measurement result of a quality control sample by a reagent, a measurement date and time, and measured apparatus information, a calibration result by the reagent, and measurement of the calibration.
- An automatic analyzer having an analyzer processing unit for storing and storing at least one of date and time and calibration information including measured device information, and a reagent provided in a reagent container stored in a reagent storage unit storing a reagent
- a reagent management unit that reads information from the container ID tag and writes information to the reagent container ID tag is provided, and the analysis device processing unit performs the accuracy management information or The calibration information is written.
- Such a configuration makes it possible to reuse the storage device in a short time even when there is a problem with the storage device.
- the reagent management unit is provided with display means for reading the accuracy management information written in the reagent container ID tag and displaying the read accuracy management information. It is.
- the reagent management unit reads the accuracy management information written in the reagent container ID tag, and the analyzer processing unit performs calibration based on the read accuracy management information. This is to determine whether or not the implementation is necessary.
- the reagent management section includes a display means for reading the calibration information written in the reagent container ID tag and displaying the read calibration information. It is.
- the reagent management unit reads the calibration information written in the reagent container ID tag, and the analyzer processing unit detects that the read calibration information is automatically analyzed.
- the calibration result is used for the concentration calculation of the sample measurement.
- a display means for displaying the necessity of performing the calibration determined by the analyzer processing unit is provided.
- the reagent management unit reads the calibration information written in the reagent container ID tag, and the analyzer processing unit reads the calibration information from a predetermined period. If the result is a previously measured result, calibration means for automatically measuring the calibration is provided.
- the storage device can be reused in a short time even when trouble occurs.
- FIG. 1 is a system configuration diagram showing an overall configuration of an automatic analyzer according to an embodiment of the present invention. It is a front view which shows the structure of the reagent container used for the automatic analyzer by one Embodiment of this invention. It is a block diagram which shows the structure of the reading / writing of the information to the reagent container tag by the automatic analyzer by one Embodiment of this invention. It is a flowchart which shows the analysis method using the reagent container information in the automatic analyzer by one Embodiment of this invention.
- FIG. 1 is a system configuration diagram showing the overall configuration of an automatic analyzer according to an embodiment of the present invention.
- a sample container 2 containing a sample is installed on the transport rack 3.
- the transport rack 3 is transported to the position of the transport rack 3A in the vicinity of the sample dispensing mechanisms 4A and 4B.
- a plurality of reaction vessels 6 are installed on the reaction disk 5.
- the sample dispensing mechanisms 4A and 4B according to instructions from the operation unit 1, suck the measurement sample from the sample container 2 of the transport rack 3A and dispense it into the plurality of reaction containers 6, respectively.
- the reaction disk 5 can be rotated in the circumferential direction. The reason why the two sample dispensing mechanisms 4A and 4B are provided is to improve the processing capacity per unit time.
- two reagent storage units 7A and 7B are provided.
- the inside of the reagent storage units 7A and 7B is a cold storage, and holds a plurality of reagent containers 8 in a low temperature state. Different reagents are held in the reagent containers 8.
- a lid is provided on the upper part of the reagent storage units 7A, 7B, and openings 13A, 13B, 13C, 13D for aspirating the reagent are provided in part of the lids.
- Two reagent dispensing mechanisms 9A and 9B are provided in the vicinity of the reagent storage unit 7A.
- two reagent dispensing mechanisms 9C and 9D are provided in the vicinity of the reagent storage unit 7B.
- a reagent information management unit 32A is provided above the reagent storage unit 7A.
- a reagent information management unit 32B is provided above the reagent storage unit 7B.
- the reagent container 8 is attached with a reagent container tag capable of reading and writing information using radio waves or electromagnetic waves.
- the reagent container tag is, for example, an RFID.
- the reagent information management units 32A and 32B read information about the reagent from the reagent container tag, and write information to the reagent container tag.
- the reaction container 6 into which the measurement sample has been dispensed by the sample dispensing mechanisms 4A and 4B can be moved to the reagent dispensing position by the reagent dispensing mechanisms 9A, 9B, 9C, and 9D as the reaction disk 5 rotates.
- the reagent storage units 7A and 7B can be rotated, while the lids of the reagent storage units 7A and 7B do not rotate.
- a predetermined reagent can be positioned at a position below the openings 13A, 13B, 13C, and 13D.
- the reagent dispensing mechanism 9A sucks a predetermined reagent through the opening 13A and dispenses the reagent into the reaction container 6 into which the measurement sample has been dispensed.
- the reagent dispensing mechanism 9B sucks a predetermined reagent through the opening 13B and dispenses the reagent into the reaction container 6 into which the measurement sample has been dispensed.
- the reagent dispensing mechanism 9C sucks a predetermined reagent through the opening 13C and dispenses the reagent into the reaction container 6 into which the measurement sample has been dispensed.
- the reagent dispensing mechanism 9D sucks a predetermined reagent through the opening 13D and dispenses the reagent into the reaction container 6 into which the measurement sample has been dispensed.
- the reaction vessel 6 into which the sample and the reagent are dispensed is moved to the positions of the stirring mechanisms 10A and 10B and stirred.
- the stirring mechanisms 10A and 10B stirred.
- one, two, or three or more reagents are used for the analysis, so that the necessary reagents are sequentially sucked into the reaction container 6 using the reagent dispensing mechanisms 9A,. Poured and stirred.
- the reaction vessel 6 When the predetermined reaction time has elapsed after the stirring of the sample and the reagent is completed, the reaction vessel 6 is moved to the position of the photometer 11.
- the photometer 11 includes a light source lamp, a spectral diffraction grating, and a photodetector. Using the photometer 11, the color of the chemical reaction of the sample is measured and analyzed.
- reaction vessel 6 is washed by the washing mechanism 12 in order to analyze the next sample.
- the transport rack 3 on which the sample container 2 is installed is unloaded from the analysis unit.
- the reagent container 6 moves to the position of the reagent information management unit 32A, 32B and reads individual information for each reagent container from the reagent container tag or writes individual information to the reagent container tag. To do.
- FIG. 2 is a front view showing the configuration of the reagent container used in the automatic analyzer according to the embodiment of the present invention.
- a label 18 in which a reagent container tag for reading or writing using radio waves or electromagnetic waves is attached to a label for visually confirming reagent information contained in the reagent container is attached to the reagent container 8 installed in the reagent storage unit 7. It is. On the reagent container label 18, information such as the reagent manufacturer name 20, the item name 21, the expiration date 22, etc., which has not changed since the manufacture of the reagent, can be visually recognized, and the same information is written in the reagent container tag 19. Yes.
- the reagent container tag 19 is written with the results of calibration described below and the measurement results of the quality control sample.
- the analyzer measures one or more samples (calibrators) with a known concentration using a reagent, creates a calibration curve from the data representing the relationship between concentration and absorbance, and provides data for calibrating the measured values. get. This is called calibration.
- the analysis result of a general sample is output using the relationship between the concentration and absorbance obtained by calibration.
- the calibration is performed in order to correct a difference between analyzers and a difference between reagent lots with respect to measurement data of a general specimen.
- the reagent container tag 19 is written with the result of calibration, the calibration execution time, the ID of the analyzer that performed the calibration, and the like. The same information is stored in a storage unit such as an HDD in the analyzer processing unit 33 shown in FIG.
- the stability of the measured value is measured by periodically measuring a quality control sample (control) manufactured at a stable concentration in the reference range. Confirm.
- a quality control sample control
- the measurement result of the quality control sample, the execution time of the quality control, the ID of the analyzer that performed the quality control, and the like are written.
- the same information is stored in a storage unit such as an HDD in the analyzer processing unit 33.
- calibrate before starting the analysis measure the quality control sample after calibration, and confirm that the device and reagents are in a state that can be analyzed normally, then start analyzing the general sample . If the range of the accuracy control value is deviated at this time, after performing measures such as replacing the reagent or adjusting the apparatus, calibration and measurement of the accuracy control sample are performed again. Thereafter, the quality control sample is periodically measured, and the analysis of the general sample is continued while checking the state of the reagent and the apparatus. If the measurement result of the quality control sample measured periodically deviates from the range of the quality control value, calibration is performed again, and then the quality control sample is measured to check the state.
- FIG. 3 is a block diagram showing a configuration for reading and writing information to the reagent container tag by the automatic analyzer according to the embodiment of the present invention.
- the reagent container 8 is moved to the position of the reagent information management unit 32 where the information of the reagent container tag is written before, during or after the analysis of the quality control sample by the analyzer 31. Then, by the reagent information management unit 32 installed in the reagent storage unit 7, together with the analysis result of the quality control sample, the ID such as the serial number of the apparatus and the measurement date and time are used as the reagent container of the reagent container 8 used for the quality control. Write to the tag. The same information is stored in a storage unit such as an HDD in the analyzer processing unit 33.
- the accuracy management information read out by the reagent management unit 32 is displayed on the display device 34 of the analyzer, so that the user can see the accuracy management information of the necessary reagent, and can print or save data. And so on.
- the reagent container 8 is moved to the position of the reagent information management unit 32 where the information of the reagent container tag is written before, during or after the analysis of the calibrator by the analyzer 31. Then, the reagent information management unit 32 installed in the reagent storage unit 7 sets the ID such as the serial number of the apparatus and the measurement date and time together with the analysis result of the calibrator, and the reagent container 8 of the reagent used for calibration by the reagent management unit 32. Write on the reagent container tag. The same information is stored in a storage unit such as an HDD in the analyzer processing unit 33.
- the calibration information read out by the reagent management unit 32 is displayed on the display device 34 of the analyzer, so that the user can view the calibration information of the necessary reagent, and can print or save data. And so on.
- quality control information and calibration information are only stored in a storage unit such as an HDD in the analyzer processing unit, but in the present embodiment, such information is written in a reagent container tag of the reagent container. I am doing so.
- the calibration can be executed again, Since it is not necessary to perform measurement and the information written in the reagent container tag can be used, re-calibration or the like is unnecessary, and the automatic analyzer can be reused in a short time.
- FIG. 4 is a flowchart showing an analysis method using reagent container information in the automatic analyzer according to the embodiment of the present invention.
- step S10 the analyzer processing unit 33 uses the reagent management unit 32 to read calibration information from the reagent container tag of the reagent container.
- step S20 the analyzer processing unit 33 determines whether or not the device ID is different in the read calibration information. If they are different, in step S90, the analyzer processing unit 33 automatically displays on the display unit 34 so that the calibration is performed using the reagent, thereby assisting the determination by the user and simplifying the usage method. . Further, when the calibrator is installed in the analyzer, the operation method can be simplified by automatically analyzing the calibrator without a user instruction.
- step S30 the analyzer processing unit 33 determines whether or not the measurement date and time has passed a predetermined period. When the predetermined period has passed, in step S90, the analyzer processing unit 33 automatically displays on the display unit 34 so as to perform calibration using the reagent.
- step S40 the analyzer processing unit 33 determines whether or not the calibration curve is abnormal. If it is determined that there is an abnormality, in step S90, the analyzer processing unit 33 automatically displays on the display unit 34 so as to perform calibration using the reagent.
- step S50 the analyzer processing unit 33 determines whether the device IDs are the same based on the read quality control information. If they are the same, in step S60, the analyzer processing unit 33 determines whether or not the measurement date and time of the quality control sample is within a predetermined period. If it is within the predetermined period, in step S70, the analyzer processing unit 33 determines whether or not the measurement result is within the range of the quality control value. If it is out of the range, in step S90, the analyzer processing unit 33 automatically displays on the display unit 34 so as to perform calibration using the reagent.
- step S80 the analyzer processing unit 33 uses the calibration curve for the concentration calculation for general sample measurement, so that the general sample measurement can be performed without performing calibration again. The amount of calibrator used can be reduced.
- the measurement result history of the quality control sample is recorded in the reagent container tag for each device measured, and the measurement result history information of the quality control sample read from the reagent container tag by the analyzer is displayed or printed on the display device 34.
- the user can obtain information on the state of the reagent.
- a measurement item to be analyzed using a plurality of reagents When a plurality of reagents are divided into a plurality of reagent containers and used as a pair, a reagent container of one of the plurality of reagent containers By writing either or both of the quality control information and calibration analyzed using the reagent into the reagent container tag of the reagent container paired with a plurality of reagent containers, at least one of the reagent containers or the paired reagent containers By reading the information of one reagent container tag, a paired reagent container can be recognized and analyzed using the paired reagent.
- the analysis operation can be simplified by using a reagent container including an ID tag into which reagent information generated after the reagent is manufactured can be written.
- the reagent manufacturer manufactures the reagent
- information such as the calibrator lot and reference curve corresponding to the reagent is written in advance in the reagent tag of the reagent container, so that the calibration result performed by the analyzer and the tag in advance
- the user can obtain information on the calibration result and the state of the reagent at that time.
- a reagent manufacturer manufactures a reagent, it writes accuracy management information such as the type of control, lot, and target value measured with that reagent in advance in the reagent tag of the reagent container.
- accuracy management information such as the type of control, lot, and target value measured with that reagent in advance in the reagent tag of the reagent container.
- the reader and the display device that read information written in the reagent tag of the reagent container may be a computer device other than the analyzer. This makes it possible to quickly investigate the cause of an abnormality by reading the reagent tag information with a computer device other than the apparatus regardless of the customer usage status of the analyzer.
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Abstract
Description
ョン等が不要となり、自動分析装置を短時間で再使用できるようになる。
2…試料容器
3…搬送ラック
4…試料分注機構
5…反応ディスク
6…反応容器
7…試薬収納部
8…試薬容器
9…試薬分注機構
10…攪拌機構
11…光度計
12…洗浄機構
13…保冷庫の開口部
18…試薬容器のラベル
19…試薬容器タグ
20…試薬のメーカ名
21…試薬の項目名
22…試薬の有効期限
31…分析装置
32…試薬管理部
33…分析装置処理部
34…分析装置表示装置
Claims (8)
- 試薬による精度管理試料の測定結果と測定日時および測定した装置情報を含む精度管理情報と、試薬でのキャリブレーション結果とそのキャリブレーションの測定日時および測定した装置情報を含むキャリブレーション情報との少なくとも一方を記憶格納する分析装置処理部を有する自動分析装置であって、
試薬を収納する試薬収納部に収納された試薬容器に備え付けられた試薬容器IDタグから情報を読み出し、該試薬容器IDタグに情報を書き込む試薬管理部を備え、
前記分析装置処理部は、前記試薬管理部により、前記試薬容器IDタグに対して、前記精度管理情報若しくは前記キャリブレーション情報を書き込むことを特徴とする自動分析装置。 - 請求項1記載の自動分析装置において、
前記試薬管理部により、前記試薬容器IDタグに書き込まれた精度管理情報を読み取るとともに、
読み取った精度管理情報を表示する表示手段を備えることを特徴とする自動分析装置。 - 請求項1記載の自動分析装置において、
前記試薬管理部により、前記試薬容器IDタグに書き込まれた精度管理情報を読み取るとともに、
前記分析装置処理部は、読み取った精度管理情報を元にキャリブレーション実施の要否を判断することを特徴とする自動分析装置。 - 請求項3記載の自動分析装置において、
前記分析装置処理部により判断したキャリブレーション実施要否を表示する表示手段を備えることを特徴とする自動分析装置。 - 請求項1記載の自動分析装置において、
前記試薬管理部により、前記試薬容器IDタグに書き込まれたキャリブレーション情報を読み取るとともに、
読み取ったキャリブレーション情報を表示する表示手段を備えることを特徴とする自動分析装置。 - 請求項1記載の自動分析装置において、
前記試薬管理部により、前記試薬容器IDタグに書き込まれたキャリブレーション情報を読み取るとともに、
前記分析装置処理部は、読み取ったキャリブレーション情報が該自動分析で測定されたキャリブレーション結果である場合に、そのキャリブレーション結果を検体測定の濃度演算に使用することを特徴とする自動分析装置。 - 請求項5記載の自動分析装置において、
前記分析装置処理部により判断したキャリブレーション実施要否を表示する表示手段を備えることを特徴とする自動分析装置。 - 請求項5記載の自動分析装置において、
前記試薬管理部により、前記試薬容器IDタグに書き込まれたキャリブレーション情報を読み取るとともに、
前記分析装置処理部は、読み取ったキャリブレーション情報が一定期間よりも以前に測定された結果である場合に、キャリブレーションを自動的に測定するためのキャリブレーション手段を備えることを特徴とする自動分析装置。
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US12/993,147 US9075030B2 (en) | 2008-05-22 | 2009-04-21 | Automatic analyzer |
CN200980118245.1A CN102037363B (zh) | 2008-05-22 | 2009-04-21 | 自动分析装置 |
EP09750449.2A EP2282211B1 (en) | 2008-05-22 | 2009-04-21 | Automatic analyzer |
JP2010512979A JP5277245B2 (ja) | 2008-05-22 | 2009-04-21 | 自動分析装置 |
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EP (1) | EP2282211B1 (ja) |
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Also Published As
Publication number | Publication date |
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JPWO2009142087A1 (ja) | 2011-09-29 |
EP2282211A1 (en) | 2011-02-09 |
US20110090066A1 (en) | 2011-04-21 |
CN102037363B (zh) | 2014-05-07 |
JP5277245B2 (ja) | 2013-08-28 |
EP2282211B1 (en) | 2020-07-29 |
CN102037363A (zh) | 2011-04-27 |
EP2282211A4 (en) | 2015-10-28 |
US9075030B2 (en) | 2015-07-07 |
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