WO2011105464A1 - 自動分析装置 - Google Patents
自動分析装置 Download PDFInfo
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- WO2011105464A1 WO2011105464A1 PCT/JP2011/054067 JP2011054067W WO2011105464A1 WO 2011105464 A1 WO2011105464 A1 WO 2011105464A1 JP 2011054067 W JP2011054067 W JP 2011054067W WO 2011105464 A1 WO2011105464 A1 WO 2011105464A1
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/47—Scattering, i.e. diffuse reflection
- G01N21/49—Scattering, i.e. diffuse reflection within a body or fluid
- G01N21/51—Scattering, i.e. diffuse reflection within a body or fluid inside a container, e.g. in an ampoule
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/47—Scattering, i.e. diffuse reflection
- G01N21/49—Scattering, i.e. diffuse reflection within a body or fluid
- G01N21/53—Scattering, i.e. diffuse reflection within a body or fluid within a flowing fluid, e.g. smoke
- G01N21/532—Scattering, i.e. diffuse reflection within a body or fluid within a flowing fluid, e.g. smoke with measurement of scattering and transmission
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
- G01N21/82—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a precipitate or turbidity
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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
- G01N35/02—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
- G01N35/025—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 having a carousel or turntable for reaction cells or cuvettes
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/47—Scattering, i.e. diffuse reflection
- G01N2021/4704—Angular selective
- G01N2021/4711—Multiangle measurement
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
- G01N21/82—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a precipitate or turbidity
- G01N2021/825—Agglutination
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/11—Automated chemical analysis
- Y10T436/113332—Automated chemical analysis with conveyance of sample along a test line in a container or rack
Definitions
- the present invention relates to an automatic analyzer that analyzes the amount of a component contained in a sample, for example, an automatic analyzer that analyzes the amount of a component contained in blood or urine.
- an automatic analyzer that analyzes the amount of components contained in a sample
- light from a light source is irradiated to the sample or a reaction mixture in which the sample and the reagent are mixed, and the resulting transmitted light of a single or multiple wavelengths is measured.
- An apparatus for calculating the absorbance and calculating the component amount from the relationship between the absorbance and the concentration in accordance with Lambert-Beer's law is widely used (for example, Patent Document 1).
- Patent Document 1 a large number of cells holding the reaction solution are arranged on the circumference of a cell disk that is repeatedly rotated and stopped, and the cell light is fixed by a transmitted light measuring unit disposed at a predetermined position during the rotation of the cell disk.
- the data series (reaction process data) of the light quantity change at a certain time is measured as the change over time in the received light amount for about 10 minutes at the time interval of.
- the automatic analyzer roughly measures the reaction of the reaction solution, and measures two kinds of reactions: a color reaction between the substrate and the enzyme and an agglutination reaction between the antigen and the antibody.
- the former is biochemical analysis
- test items include LDH (lactate dehydrogenase), ALP (alkaline phosphatase), and AST (aspartate oxoglutarate aminoton rafenase).
- the latter is an immunoassay
- test items include CRP (C-reactive protein), IgG (immunoglobulin), RF (rheumatoid factor) and the like.
- CRP C-reactive protein
- IgG immunoglobulin
- RF rheumatoid factor
- Patent Document 2 a system that separates transmitted light and scattered light using a diaphragm and measures absorbance and scattered light simultaneously, or measurement of reflected scattered light in a large aggregate formed as a result of agglutination.
- Patent Document 3 Configuration to improve accuracy on the high concentration side
- Patent Document 4 integrating spheres installed before and after the reaction vessel, measure the average amount of each of the forward scattered light and the back scattered light, and correct the turbidity change due to the cell position shift
- Patent Document 5 a method of arranging a fluorescence / scattered light measurement / detection system on the same plane as the cell rotation direction, and facilitating downsizing and adjustment of the apparatus
- Patent Document 6 A turbidity measuring method for calculating turbidity from the ratio of scattered light intensity and transmitted light intensity is disclosed.
- Patent Document 2 In the photometer using scattered light, there has been no attempt to increase sensitivity by data processing of reaction process data.
- Patent Document 2 enables simultaneous measurement of scattered light and transmitted light, it does not disclose a data processing method.
- Patent Document 3 acquires scattered light, it is for improving accuracy on the high density side, and is not effective for increasing sensitivity at low density.
- scattered light is averaged by an integrating sphere, which does not lead to higher sensitivity. Furthermore, it is a system that measures during cell outage.
- Patent Document 5 is a turbidity measuring method for calculating turbidity from the ratio of the intensity of scattered light and the intensity of transmitted light, but a specific processing method is not disclosed.
- the effective data processing method differs depending on the main cause of noise.
- random noise is the main cause
- averaging processing of the light intensity measured by multiple receivers is effective, and when air bubbles and dust are the main cause, A process for obtaining a ratio or difference between the light amounts measured by a plurality of light receivers is effective.
- the wavelength of the latex agglomerate is almost the same level as that of the latex agglomerate, so that it becomes a Mie scattering region, and the amount of scattered light is large in the forward direction, which is advantageous for securing the light amount.
- the latter is often caused by the latter bubbles or dust.
- the influence of bubbles and dust is removed by taking the light quantity ratio or difference of many wavelengths, but in the case of scattered light measurement, taking the light quantity ratio or difference between many angles. Is considered advantageous.
- a plurality of light receivers are arranged so as to receive scattered light of 35 ° or less from the optical axis, and the ratio or difference of the reaction process data between the plurality of light receivers is acquired as new reaction process data, Since there is little difference between the light quantity and the light quantity change, there is a problem that the signal is lowered and the sensitivity is not improved. Therefore, there is a demand for a data processing method that improves the sensitivity by taking the ratio or difference of the light amounts without reducing the signal.
- the reaction process data received by one receiver is used as the reaction process data received by the other receiver.
- the noise is corrected by correcting with the estimated noise estimated from the above.
- the reaction process data of the sub angle light receiver The noise is reduced by subtracting the estimated noise estimated from 1 from the reaction process data of the main angle receiver.
- both the main angle receiver and the sub-angle receiver are arranged at a position where scattered light having a scattering angle larger than 0 ° and 35 ° or less is received.
- reaction process data A (t, y at ) of the main angle receiver is approximated by a fitting function f a (t), and the reaction process data B (t, y bt ) of the sub-angle receiver is fitted to the fitting function. Approximate with f b (t).
- ⁇ f a ⁇ (t) / f b ⁇ (t)
- the residual r b (t) is defined below as the difference between the data value y bt and the fitting function f b (t) of the sub-angle receiver at the reaction time t.
- r b (t) y bt -f b (t)
- the estimated noise n (t) at the reaction time t is defined below using the sensitivity ratio ⁇ and the residual r b (t).
- Noise corrected reaction process data C (t, y ct ) is obtained by using a data value y ct obtained by subtracting the estimated noise n (t) from the reaction process data value y at of the main angle receiver.
- y ct y at -n (t)
- the amount of components in the sample is quantified using the noise correction reaction process data.
- the fitting functions f a (t) and f b (t) can be linear functions, but other functions may be used.
- the transmitted light and scattered light change in the direction of the light intensity in the opposite direction (the amount of transmitted light decreases as the amount of scattered light increases), so the position of the sub-angle receiver is on the optical axis of the irradiated light
- a data processing method when arranged in the 0 ° direction is shown.
- the signal is increased by taking the difference between the reaction process data of the scattered light receiver and the reaction process data of the transmitted light receiver.
- transmitted light correction reaction process data E (t, y et ) is obtained.
- the amount of components in the sample is quantified using this transmitted light correction reaction process data. This can increase the signal, which is advantageous for high sensitivity.
- the light receiver for receiving the scattered light is practically arranged at a position for receiving the scattered light having a scattering angle larger than 0 ° and 35 ° or less.
- FIG. 1 Schematic which shows the example of whole structure of the automatic analyzer by this invention. Schematic of the scattered light measurement part by this invention.
- FIG. The figure which shows the reaction process data after the data processing in Embodiment 2.
- FIG. 1 is a schematic diagram showing an example of the overall configuration of an automatic analyzer according to the present invention.
- This automatic analyzer is equipped with a scattered light measurement unit for higher sensitivity.
- the automatic analyzer mainly has three types of disks, sample disk 3, reagent disk 6 and cell disk 9, and a dispensing mechanism for moving samples and reagents between these disks, a control unit for controlling these, a measuring unit, and a measuring unit.
- An analysis unit that processes the processed data, a control data, a measurement data, a data storage unit that stores the analysis data, an input unit that inputs and outputs data from the data storage unit, and an output unit.
- a plurality of sample cups 2 containing samples 1 are arranged on the circumference of the sample disk 3.
- a plurality of reagent bottles 5 containing the reagents 4 are arranged on the reagent disk 6.
- a plurality of cells 8 are prepared on the circumference in which the sample 1 and the reagent 4 are mixed to form a reaction solution 7.
- the sample dispensing mechanism 10 moves the sample 1 from the sample cup 2 to the cell 8 by a certain amount.
- the reagent dispensing mechanism 11 moves the reagent 4 from the reagent bottle 5 to the cell 8 by a certain amount.
- the stirring unit 12 stirs and mixes the sample 1 and the reagent 4 in the cell 8.
- the cleaning unit 14 discharges the reaction solution 7 from the cell 8 after the analysis and cleans it.
- the next sample 1 is again dispensed from the sample dispensing mechanism 10 into the washed cell 8, and a new reagent 4 is dispensed from the reagent dispensing mechanism 11 and used for another reaction.
- the cell 8 is immersed in a constant temperature fluid 17 in a constant temperature bath whose temperature and flow rate are controlled, and the cell 8 and the reaction liquid 7 therein are moved in a state where the temperature is kept constant. Water is used as the constant temperature fluid 17, and the temperature and flow rate of the constant temperature fluid are controlled by the constant temperature fluid control unit.
- the temperature is adjusted to 37 ⁇ 0.1 ° C., which is the reaction temperature.
- a transmitted light measuring unit 13 and a scattered light measuring unit 31 are provided on a part of the circumference of the cell disk. The transmitted light measurement unit 13 and the scattered light measurement unit 31 irradiate the reaction solution in the cell with light from the light source, and measure the light after interacting with the reaction solution.
- the transmitted light measurement unit 13 irradiates a moving cell with light from a halogen lamp light source, and after the transmitted light is dispersed by a diffraction grating, the light is received by a photodiode array in which photodiodes are arranged on the array.
- FIG. Irradiated light 36 from the LED light source 35 is applied to the moving cell 8, and transmitted light 37 is received by the transmitted light receiver 32.
- the main scattered light 34a and the sub scattered light 34b were measured by the scattered light receivers 33a and 33b, respectively.
- the main scattered light 34a and the sub-scattered light 34b are separated from the optical axis of the transmitted light 37 by the scattered light receiving angles ⁇ 1 and ⁇ 2, respectively.
- ⁇ 1 and ⁇ 2 are 20 ° and 30 °, respectively.
- the LED light source 35 Epitex L660-02V having an irradiation light wavelength of 660 nm was used.
- the scattered light receivers are disposed at the 20 ° and 30 ° positions, but an optical system such as a fiber or a lens may be disposed at the same position, and the light may be guided to the scattered light receivers disposed at different positions.
- an LED is used as the light source 35, a laser, a xenon lamp, or a halogen lamp may be used.
- sample 1 in the sample cup 2 is dispensed into the cell 8 by the sample dispensing mechanism 10.
- a predetermined amount of the reagent 4 in the reagent bottle 5 is dispensed into the cell 8 by the reagent dispensing mechanism 11.
- the sample disk 3, the reagent disk 6, and the cell disk 9 are rotationally driven by the respective drive units under the control of the control unit, and the sample cup 2, the reagent bottle 5, and the cell 8 are driven by the timing of the dispensing mechanism. Move to match.
- FIG. 1 is a simplified diagram showing one reagent disk and one reagent dispensing mechanism, but typically there are two reagent disks, a reagent dispensing mechanism, and a stirring unit. Transmitted light and scattered light from the reaction solution 7 are measured each time the cell disk 9 rotates and passes through the measurement positions of the transmitted light measurement unit 13 and the scattered light measurement unit 31, and data is sequentially stored through the measurement unit. Is accumulated as reaction process data. After photometry for about 10 minutes, the inside of the cell 8 is washed by the washing mechanism 14 and the next analysis is performed.
- reaction process data of the reaction solution 7 having a constant time interval is stored in the data storage unit.
- the analysis unit analyzes the component amount based on the calibration curve data for each inspection item. Data necessary for control and analysis of each unit is input from the input unit to the data storage unit. The calibration curve data is held in the data storage unit. Various data, results, and alarms are output by an output unit.
- a CRP reagent Naopia CRP, manufactured by Sekisui Medical
- a CRP calibrator manufactured by Sekisui Medical
- the scattered light measuring unit 31 measured the light amount of the reaction solution every 5 seconds for 5 minutes. The amount of components was calibrated from the measured reaction process data.
- FIG. 3A and 3B show reaction process data in the latex agglutination reaction measured by the two light receivers 33a and 33b of this embodiment.
- FIG. 3A is a diagram showing reaction process data A (t, y at ) and its fitting function f a (t) by the main angle light receiver 33a arranged at a scattering angle of 20 °, and FIG. 3B is arranged at a scattering angle of 30 °.
- secondary angle light receiver 33b according to the reaction process data B (t, y bt) is a diagram illustrating a and its fitting function f b (t).
- FIG. 3B also shows the reaction process data B (t, y bt ) at the reaction time t and the residual r b (t) which is the difference between the fitting function f b (t).
- FIG. 3C shows noise correction reaction process data C (t, y ct ) after data processing.
- the vertical axis of the reaction process data is the change in light quantity (%), which is the ratio of the light quantity difference between a certain time and the light quantity after 45 seconds, assuming that the light quantity 45 seconds after introduction of the latex reagent is 100%.
- the axis is the elapsed time from the introduction of the latex reagent.
- the data obtained by subtracting the estimated noise n (t) estimated from the reaction process data B (t, y bt ) of the sub-angle photoreceiver is shown in FIG.
- the first light receiver is disposed at a position for receiving scattered light with a scattering angle of 20 °
- the second light receiver is disposed at a transmitted light receiving position (scattering angle 0 °)
- the transmitted light is received.
- the installation position of the first light receiver is not limited to the position for receiving scattered light having a scattering angle of 20 °, and generally the scattering angle is larger than 0 ° and 35 ° depending on the analysis component and the type of reaction. What is necessary is just to arrange
- FIG. 4A shows reaction process data A (t, y at ) of the first light receiver and reaction process data D (t, y dt ) of the second light receiver.
- FIG. 4B shows transmitted light corrected reaction process data E (t, y et ) after data processing that takes the difference between reaction process data A (t, y at ) and reaction process data D (t, y dt ).
- the data value y et of the transmitted light correction reaction process data E (t 1, y et ) is calculated from y at and y dt as follows.
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Abstract
Description
反応時間tにおける副角度受光器の、データ値ybtとフィッティング関数fb(t)との差として残差rb(t)を以下で定義する。
感度比αと残差rb(t)を用いて反応時間tにおける推定ノイズn(t)を以下で定義する。
主角度受光器の反応過程データ値yatから推定ノイズn(t)を引いたデータ値yctを用いノイズ補正反応過程データC(t , yct)を得る。
このノイズ補正反応過程データを用いてサンプル中の成分量を定量する。上記フィッティング関数fa(t)及びfb(t)は一次関数とすることができるが、それ以外の関数を用いてもよい。
yet=yat-ydt
として、透過光補正反応過程データE(t , yet)を得る。この透過光補正反応過程データを用いてサンプル中の成分量を定量する。これによりシグナルを増大させることができ、高感度化に有利である。この場合にも、散乱光を受光する受光器は、実用的には、散乱角度が0゜より大きく、35゜以下の散乱光を受光する位置に配置する。
主角度受光器を散乱角度20°に、副角度受光器を30°に配置した場合を例に説明する。
これにより図3Aに示した主角度受光器の反応過程データでは1分間のデータ値間の標準偏差が0.1%であったが、図3Cに示したデータ処理後の反応過程データにおいては1分間のデータ値間の標準偏差は0.07%と7割程度に低減され、高感度化を図ることができた。
本実施形態では、第1の受光器を散乱角度20°の散乱光を受光する位置に配置し、第2の受光器を透過光受光位置(散乱角度0°)に配置し、透過光を受光する場合のこれら2つの受光器の反応過程データを用いてシグナルを増大させる方法を説明する。他の装置構成は実施形態1と同等である。また、第1の受光器の設置位置は、散乱角度20゜の散乱光を受光する位置には限られず、分析成分や反応のタイプに応じて、一般に、散乱角度が0゜より大きく、35゜以下の散乱光を受光する位置に配置すればよい。
反応過程データA(t , yat)のフィッティング関数fa(t)の傾きが0.4%/分であったのに対し、データ処理後の透過光補正反応過程データE(t , yet)のフィッティング関数fe(t)傾きは0.6%/分と上昇した。これにより光量変化が大きくとれるため、精度が向上する。また本実施形態は、光量が多く得られる透過光の反応過程データをベースとして用いるため、ノイズを抑えたまま、高感度化を図ることができる。
2 サンプルカップ
3 サンプルディスク
4 試薬
5 試薬ボトル
6 試薬ディスク
7 反応液
8 セル
9 セルディスク
10 サンプル分注機構
11 試薬分注機構
12 攪拌部
13 透過光測定部
14 洗浄部
17 恒温流体
31 散乱光測定部
32 透過光受光器
33a,33b 散乱光受光器
34a,34b 散乱光
35 光源
36 照射光
37 透過光
Claims (4)
- サンプルと試薬とが混合した反応液を収めたセルを円周上に保持し、回転と停止を繰り返すセルディスクと、
前記セルディスクの回転中に光源からの照射光を前記セルに照射し、前記セル中の反応液と相互作用した後の光を測定する光測定部とを有し、
前記光測定部は、前記照射光の光軸に近い側の散乱光を受光する第1の受光器と、前記光軸から遠い側の散乱光を受光する第2の受光器とを有し、各受光器による受光量の経時変化をそれぞれ反応過程データとして測定し、
前記第2の受光器の反応過程データと当該反応過程データをフィッティングするフィッティング関数との差に、前記第1の受光器と前記第2の受光器の感度比を乗ずることにより推定したノイズを、前記第1の受光器の反応過程データから差引いたデータを用いて、前記反応液中の成分量を定量す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、前記主角度受光器と前記副角度受光器は共に散乱角度が0°より大きく、35°以下の散乱光を受光する位置に配置されてい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、前記フィッティング関数は一次関数であることを特徴とする自動分析装置。
- サンプルと試薬とが混合した反応液を収めたセルを円周上に保持し、回転と停止を繰り返すセルディスクと、
前記セルディスクの回転中に光源からの照射光を前記セルに照射し、前記セル中の反応液と相互作用した後の光を測定する光測定部とを有し、
前記光測定部は、前記照射光の光軸から35゜以下の角度で散乱された散乱光を受光する第1の受光器と、前記照射光の光軸上に配置された第2の受光器とを有し、各受光器による受光量の経時変化をそれぞれ反応過程データとして測定し、
前記第1の受光器の反応過程データから、前記第2の受光器の反応過程データを差引いたデータを用いて、前記反応液中の成分量を定量することを特徴とする自動分析装置。
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US13/577,963 US8858882B2 (en) | 2010-02-25 | 2011-02-24 | Automatic analysis device |
CN201180009103.9A CN102753957B (zh) | 2010-02-25 | 2011-02-24 | 自动分析装置 |
EP11747424.7A EP2541233B1 (en) | 2010-02-25 | 2011-02-24 | Automatic analysis device |
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EP (1) | EP2541233B1 (ja) |
JP (1) | JP5379044B2 (ja) |
CN (1) | CN102753957B (ja) |
WO (1) | WO2011105464A1 (ja) |
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WO2022270037A1 (ja) * | 2021-06-25 | 2022-12-29 | 古野電気株式会社 | 測光装置および分析装置 |
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US8858882B2 (en) | 2014-10-14 |
EP2541233B1 (en) | 2017-11-01 |
US20120315190A1 (en) | 2012-12-13 |
CN102753957B (zh) | 2015-05-13 |
EP2541233A1 (en) | 2013-01-02 |
JP5379044B2 (ja) | 2013-12-25 |
EP2541233A4 (en) | 2014-05-21 |
JP2011174842A (ja) | 2011-09-08 |
CN102753957A (zh) | 2012-10-24 |
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