WO2004074827A1 - バイオセンサ用測定装置及びこれを用いた測定方法 - Google Patents
バイオセンサ用測定装置及びこれを用いた測定方法 Download PDFInfo
- Publication number
- WO2004074827A1 WO2004074827A1 PCT/JP2004/001848 JP2004001848W WO2004074827A1 WO 2004074827 A1 WO2004074827 A1 WO 2004074827A1 JP 2004001848 W JP2004001848 W JP 2004001848W WO 2004074827 A1 WO2004074827 A1 WO 2004074827A1
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- WIPO (PCT)
- Prior art keywords
- sample
- measuring
- biosensor
- light
- electrode system
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Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/28—Electrolytic cell components
- G01N27/30—Electrodes, e.g. test electrodes; Half-cells
- G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
- G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
- G01N27/3274—Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration
Definitions
- the present invention relates to a measuring device for a biosensor, which can easily and accurately measure the concentration of a specific substance contained in a sample in a short time, and a measuring method using the same.
- This biosensor is obtained by forming an electrode system on an insulating substrate and forming an enzyme reaction layer on the electrode system with a mixture of a hydrophilic polymer, an oxidoreductase and an electron acceptor. Then, a change in the substance concentration due to the reaction between the oxidoreductase, the electron acceptor, and the sample is electrochemically detected by the electrode system, and a specific component in the sample is measured.
- this biosensor is used as a glucose sensor.
- the enzyme reaction layer is dissolved by the sample.
- Glucose is oxidized by glucose oxidase (GO x), which is an oxidoreductase in the enzyme reaction layer, and at this time, the electron acceptor in the enzyme reaction layer is reduced.
- GO x glucose oxidase
- a suitable constant voltage is applied between the measurement electrode and the counter electrode. The reduced form of the electron acceptor is oxidized.
- the measurement result was sometimes affected by the presence of a substance in the sample that affected the physical properties of the sample.
- the sample is blood
- the hematocrit value varies by about 20 to 30% depending on the sample, and even when the same amount of sample is used, the volume ratio of the solid component, blood cells, to the liquid component is Are different. Therefore, when the hematocrit value increases, the viscosity of blood increases, and the degree of adsorption of blood cell components to electrodes and enzymes increases. was there.
- JP-A-5-3400915 discloses a main electrode system and a sub-electrode on an insulating substrate.
- a biosensor in which a reaction system containing an enzyme is formed on the main electrode system is disclosed.
- the physical properties of the sample can be determined based on the time difference between the detection of the change in the electric characteristics in the main electrode system and the change in the electric characteristics in the sub-electrode system.
- the measurement operation of the biosensor will be described by taking as an example a case where the sensor is used as a Darcos sensor.
- blood whole blood
- the blood first reaches the sub-electrode system, and the impedance between the measurement electrode and the counter electrode of the sub-electrode system decreases.
- the blood reaches the main electrode system, and when the reaction layer of the main electrode system dissolves, the impedance between the measurement electrode and the counter electrode of the main electrode system decreases.
- the reaction layer dissolves in the blood, glucose in the blood is oxidized by GOX, and at the same time, the electron acceptors coexisting in the reaction layer are reduced.
- an appropriate constant voltage is applied between the measurement electrode and the counter electrode, and the reduced form of the electron acceptor is oxidized.
- the glucose concentration in the sample can be quantified.
- this biosensor by providing a sub-electrode system separately from the main electrode system, it is possible to predict the viscosity of the sample from the time difference of impedance change between the sub-electrode system and the main electrode system and correct the current value. is there.
- Japanese Patent Application Laid-Open No. 9-157720 discloses a biosensor for optically measuring both a specific component in blood and a hematocrit value. Separate sites for the measurement require the capillary chamber and the reagent section, and these sections must be sufficiently filled with the sample. There is a problem that it is difficult to reduce the amount.
- the present invention provides a biosensor measuring device capable of performing accurate measurement without being affected by the substance even when there is a substance that affects the physical properties of the sample. And a measurement method using the same.
- the present invention provides a rapid and physical property of a sample by separately providing a means for determining the physical property of the sample and a means for detecting a sensor response.
- a measuring device for a pyrosensor capable of performing accurate measurement without being affected by the measurement, and a measuring method using the same.
- the present invention provides a support unit for detachably supporting a biosensor provided with an electrode system including a measurement electrode and a counter electrode and a sample supply path having a position capable of irradiating light from the outside; a support unit electrically connected to the electrode system.
- a light source provided at a position to obtain the light; a light receiving unit for receiving light from the site; an optical signal measuring circuit for measuring an optical change in the site via the light receiving unit; a change in the electric signal and the optical change.
- the present invention relates to a measuring device for a biosensor for measuring a volume ratio between a solid and a liquid contained in a sample by irradiating the sample supply path with light.
- the sample is blood and the volume ratio is a hematocrit value.
- a method for measuring a specific component including a step of measuring a volume ratio between a solid and a liquid in the sample from the measurement result of the step (f) and correcting the measurement result of the step (i).
- the method for measuring the specific component preferably further includes a step of (k) detecting the presence of the sample in the sample supply path from the measurement result of the step (f).
- FIG. 1 is a top view of a biosensor according to an embodiment of the present invention.
- FIG. 2 is a cross-sectional view of the Pyo sensor according to the embodiment of the present invention.
- Figure 3 is a schematic oblique view of Paiosensa measurement apparatus according to the embodiment of the present invention ⁇
- Figure 4 is a perspective view showing a state supporting the biosensor to the measuring device for a biosensor shown in FIG. 2 beta
- FIG. 5 is a block diagram showing a configuration of a biosensor measurement device according to the embodiment of the present invention.
- Figure 6 shows another embodiment of a cross-sectional view of a biosensor according to Embodiment £ BEST MODE FOR CARRYING OUT THE INVENTION the present invention
- the present invention provides a support unit that detachably supports an electrode system including a measurement electrode and a counter electrode and a biosensor including a sample supply path having a portion that can be irradiated with light from the outside.
- the measuring device for a biosensor is characterized by using a combination of an optical system and an electrode system. Specifically, the measurement itself is performed by an electrode system and the hematocrit value in blood is measured. The effect is corrected optically. As a result, the electrode type measurement site and the optical type measurement site can be close to each other, and if reflected light is used, the same site can be used for the electrode type measurement site and the optical type measurement site. It can also be used as a bird. This is effective because it leads to a compact biosensor to be used.
- a biosensor that can be used in the present invention includes a sample supply port on an insulating substrate, a sample supply path communicating with the sample supply port, an electrode system including a measurement electrode and a counter electrode provided in the sample supply path, And a reagent section containing an enzyme. At least a part of the electrode system and at least a part of the reagent section are respectively exposed in a sample supply path, and the sample supply path is further provided in at least a part of the sample supply path. It has a part (light irradiation part) that can irradiate the sample inside.
- the reagent section is preferably provided near the electrode system. Further, the reagent section may be provided in a state of being mixed with a conductive material constituting a measurement electrode or a counter electrode.
- the electrode system provided in the sample supply path is located closer to the sample supply port than the light irradiation part. If the electrode system is arranged so as to be located closer to the sample supply port than the light irradiation site, the presence or absence of the sample can be determined by optical change, and it is detected that the sample has been sufficiently supplied. do it From this, it becomes possible to measure a specific component in the sample.
- the sample supply path can be designed to be short, and the amount of the sample required for measurement can be reduced.
- the direction facing the sample supply path in a direction perpendicular to the surface of the insulating substrate is referred to as “upward”.
- at least a part of the members forming the biosensor may be formed of a light transmitting material.
- the volume ratio between the solid and the liquid contained in the sample can be measured by irradiating the sample supply path with light using the biosensor measuring device according to the present invention.
- the volume ratio is a hematocrit value.
- the present invention also relates to a method for measuring a specific component using the biosensor measuring device according to the present invention.
- the method for measuring the specific component further includes the step of (k) detecting the presence of the sample in the sample supply path from the measurement result of the step (f).
- the method for measuring a specific component according to the present invention may include only the step (k) instead of the step (j).
- the method for measuring the specific component according to the present invention is as follows.
- step (h) a step of measuring a current flowing through the electrode system via the connection terminal, (i) a step of calculating a measurement result of the step (h), and
- FIG. 1 is a top view showing an overview of a biosensor 1 that can be used in the present invention.
- the center line is indicated by a chain line.
- FIG. 2 is a diagram showing a cross section of the biosensor taken along a dashed line in FIG. Figure 1 A method for producing a biosensor according to the present invention will be described with reference to FIG.
- a silver paste is printed on the insulating substrate 2 made of resin (polyethylene terephthalate (PET)) by screen printing to form the leads 3 ( then, a paste containing a resin binder and conductive carbon is printed).
- PET polyethylene terephthalate
- a paste containing a resin binder and conductive carbon is printed.
- the measuring electrode 4 and then print the insulating paste (resist) to form the insulating layer 5.
- the paste containing the resin binder and conductive carbon again to form the counter electrode 6.
- the insulating layer 5 defines the area of the measuring electrode 4.
- a reagent portion 13 containing an enzyme and an electron acceptor is formed on an electrode system including the measurement electrode 4 and the counter electrode 6. Further, the insulating substrate 2, the resin spacer 7, and the cover 8 having the air holes 9 are sequentially bonded to complete the biosensor 1.
- a transparent resin for example, polyethylene terephthalate (PET) is used for the cover 18.
- PET polyethylene terephthalate
- the sample is introduced into the sample supply path 11 formed by the spacer 7 and the cover 18 by capillary action only by bringing the sample into contact with the sample supply port 10 and reaches the reagent section 13.
- FIG. 3 is a perspective view showing an overview of a measuring device for a biosensor according to an embodiment of the present invention.
- a support unit 15 is provided in the biosensor measuring device 101, and the biosensor 1 is mounted and supported by inserting the biosensor 1 therein.
- Fig. 4 shows how the biosensor 1 was attached.
- the measuring unit 101 is provided with a display unit 14. Next, using a lancet, insert the tip of the finger into the tip of the finger and confirm that blood seeps out of the finger.Then, the blood is brought into contact with the sample supply port 10 of the biosensor 1, and the Introduce.
- the measuring device 101 has a plurality of connection terminals electrically connected to the electrode system, a voltage is applied to the electrode system via the connection terminals, and the connection terminals are connected to the electrode system.
- An electric signal measuring circuit for measuring a change in an electric signal of the electrode system through the light source, a light source, a light receiving unit, an optical signal measuring circuit for measuring an optical change through the light receiving unit, and a change in the electric signal.
- An arithmetic unit for calculating the optical change is provided.
- FIG. 5 is a diagram showing a configuration of the measuring apparatus 101 including the biosensor 1 according to the present invention. The method for measuring a specific component according to the present invention will be described with reference to FIG.
- the biosensor 1 is inserted into the support portion 15 of the measuring device 101 and fixed (step (a)).
- the connection terminal 16 is provided inside the support portion 15 at a position where it contacts the lead 3 of the biosensor 1.
- the connection terminal 16 and the lead 3 are connected by mounting the biosensor 1 (step (b)).
- step (c) a sample is supplied from the sample supply port (10 in FIG. 2) of the biosensor 1 (step (c)). Further, light source 17 is turned on.
- the light irradiation part 1 2 is provided in a transparent force par 8 covering the sample supply path 11. It is located at the far end of the counter electrode 5 from the sample supply port 10 and before the air hole 9. are doing.
- step (e) the light emitted from the light source 17 to the light irradiation part 12 is received by the light receiving part 18 and measurement of the optical change is started (step (e)).
- This measurement is performed by the optical signal measurement circuit 19, and based on the obtained measurement value, the operation unit 21 calculates the volume ratio between the solid and the liquid of the sample (step (f)).
- the sample is introduced into the sample supply path 11 from the sample supply port 10, and when the sample reaches the light irradiation part 12, the light By detecting the change, it is possible to determine in the calculation unit 21 that a sufficient amount of the sample has been supplied for the measurement in the biosensor 1 (step (j)).
- the redox state of the electron acceptor changes due to the reaction between the enzyme contained in the reagent section 13 and the substrate as a specific substance in the sample.
- a current value obtained by an electrochemical redox reaction of the electron acceptor caused by applying a voltage between the electrodes from the electric signal measuring circuit 20 is calculated as The measurement is performed in the electric signal measurement circuit 20 (step (li)).
- the volume ratio between the solid and the liquid contained in the sample is determined by measuring the intensity of the scattered light or the intensity of the reflected light at the light receiving section 18 and the current value is corrected. The determination and the current value correction are performed in the calculation unit 21.
- the numerical value obtained in the step (h) is converted into numerical information of the sample in the calculation unit 21 (step (i)), and displayed using the display unit 14.
- Numerical values displayed on the display unit 14 are a blood glucose level, a plasma level (amount of liquid in a sample), and a hematocrit level.
- the electrode system is set so that the sample supply port 10
- a light irradiation site may be provided above the electrode system as shown in FIG. By doing so, the sample supply path can be shortened.
- the same components as those indicated by the reference numerals in FIG. 2 are also denoted by the same reference numerals in FIG. Example 1
- the concentration of dalcos in blood as a sample was measured.
- the reagent part 13 of the biosensor 1 was prepared as follows. First, an aqueous solution containing an enzyme, glucose dehydrogenase, and an electron acceptor, ferricyanidation sphere, was dropped and dried to form an enzyme layer. Further, in order to facilitate aspiration of the sample, a solution containing lecithin was dropped on the enzyme layer, and the enzyme layer was subjected to hydrophilic treatment by drying.
- Hematocrit is the volume ratio of solid to liquid in blood, but most of the solid components are red blood cells.
- Hemoglobin present in red blood cells includes oxyhemoglobin not bound to oxygen (absorption maximum: 5.55 nm) and oxyhemoglobin bound to oxygen (absorption pole). Large: 577, 540 nm). Although each has an absorption maximum in the visible region, the absorption maximum wavelength differs depending on the bonding state with oxygen. The isosbestic point of the absorption spectrum of deoxyhemoglobin and oxyhemoglobin (520, 5 It is desirable to measure the hemoglobin concentration in blood using wavelengths around 50, 570, and 585 nm.
- the amount of hemoglobin can be accurately measured without depending on the state of binding to oxygen.
- 550 nm which has the largest absorbance among the isosbestic points, was selected, but the invention is not limited to this.
- the correlation between the reflected light intensity and the hematocrit value depends on the material and configuration of the biosensor used.
- the transparent PET is used as the cover 8 so that the irradiation part sample supply path 11 is provided with a portion capable of irradiating the sample with light, but the members constituting the sample supply path 11
- a light transmissive material may be used for a part or all of the light transmitting material.
- resin-glass such as polyethylene terephthalate is suitable.
- a portion that can irradiate the sample with light can be provided by providing a notch.
- the light receiving section 18 is installed at a position where scattered light and reflected light can be detected, it may be installed at a position where transmitted light can be detected.
- a specific wavelength may be applied by providing a means for splitting light on the optical path L of the light source.
- the characteristics of the sample that can be determined by the biosensor and the biosensor measuring device include the color, viscosity, and amount of suspended solids (including insolubles) of the sample. By determining this characteristic, the specific component in the sample can be measured. For example, if a difference in the color of a sample can be detected, it is possible to distinguish between a standard solution used for evaluating the operation of a blood glucose meter and blood. Industrial potential
- a measuring device for a biosensor that can easily and accurately measure a specific component in a sample without being affected by the physical properties of the sample, and a measurement of the specific component A method can be provided.
Abstract
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Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
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US10/516,751 US20050176133A1 (en) | 2003-02-21 | 2004-02-18 | Measuring instrument for biosensor and measuring method using same |
JP2005502749A JPWO2004074827A1 (ja) | 2003-02-21 | 2004-02-18 | バイオセンサ用測定装置及びこれを用いた測定方法 |
EP04712205A EP1596189A1 (en) | 2003-02-21 | 2004-02-18 | Measuring instrument for biosensor and measuring method using same |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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JP2003044529 | 2003-02-21 | ||
JP2003-044529 | 2003-02-21 |
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WO2004074827A1 true WO2004074827A1 (ja) | 2004-09-02 |
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PCT/JP2004/001848 WO2004074827A1 (ja) | 2003-02-21 | 2004-02-18 | バイオセンサ用測定装置及びこれを用いた測定方法 |
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US (1) | US20050176133A1 (ja) |
EP (1) | EP1596189A1 (ja) |
JP (1) | JPWO2004074827A1 (ja) |
CN (1) | CN1697970A (ja) |
WO (1) | WO2004074827A1 (ja) |
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JP2015503741A (ja) * | 2011-12-29 | 2015-02-02 | ライフスキャン・スコットランド・リミテッド | 分析物を含有する試料の感知された物理的特性に基づく電気化学的試験片における分析物の正確な測定 |
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EP3578959A3 (en) * | 2013-01-07 | 2020-02-26 | Ixensor Co., Ltd. | Method for reading test strips |
CN105816184B (zh) * | 2015-01-06 | 2018-11-27 | 陈建诚 | 血糖量测方法及其装置 |
CN111982987B (zh) * | 2020-08-27 | 2023-04-07 | 江苏鱼跃医疗设备股份有限公司 | 一种葡萄糖传感器及量测校正方法 |
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- 2004-02-18 JP JP2005502749A patent/JPWO2004074827A1/ja active Pending
- 2004-02-18 WO PCT/JP2004/001848 patent/WO2004074827A1/ja not_active Application Discontinuation
- 2004-02-18 US US10/516,751 patent/US20050176133A1/en not_active Abandoned
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Cited By (10)
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JP2009115519A (ja) * | 2007-11-02 | 2009-05-28 | Sumitomo Electric Ind Ltd | バイオセンサ測定器 |
JP2011137816A (ja) * | 2009-12-30 | 2011-07-14 | Lifescan Inc | 初期充填速度に基づく全血ヘマトクリット値を測定するためのシステム、デバイス、及び方法 |
JP2015503741A (ja) * | 2011-12-29 | 2015-02-02 | ライフスキャン・スコットランド・リミテッド | 分析物を含有する試料の感知された物理的特性に基づく電気化学的試験片における分析物の正確な測定 |
US9903830B2 (en) | 2011-12-29 | 2018-02-27 | Lifescan Scotland Limited | Accurate analyte measurements for electrochemical test strip based on sensed physical characteristic(s) of the sample containing the analyte |
US11162916B2 (en) | 2011-12-29 | 2021-11-02 | Lifescan Ip Holdings, Llc | Accurate analyte measurements for electrochemical test strip based on sensed physical characteristic(s) of the sample containing the analyte |
KR20190112099A (ko) * | 2017-02-06 | 2019-10-02 | 이에프에이-엔지니어링 포 올 엘티디. | 휴대용 디지털 진단 장치 |
JP2020507071A (ja) * | 2017-02-06 | 2020-03-05 | イーエフエー—エンジニアリング フォー オール エルティーディー. | 携帯用のデジタル診断デバイス |
JP7004333B2 (ja) | 2017-02-06 | 2022-01-21 | イーエフエー―エンジニアリング フォー オール エルティーディー. | 携帯用のデジタル診断デバイス |
KR102537664B1 (ko) | 2017-02-06 | 2023-05-30 | 이에프에이-엔지니어링 포 올 엘티디. | 휴대용 디지털 진단 장치 |
US11865537B2 (en) | 2017-02-06 | 2024-01-09 | E.F.A. Engineering For All Ltd. | Portable digital diagnostic device |
Also Published As
Publication number | Publication date |
---|---|
CN1697970A (zh) | 2005-11-16 |
EP1596189A1 (en) | 2005-11-16 |
JPWO2004074827A1 (ja) | 2006-06-01 |
US20050176133A1 (en) | 2005-08-11 |
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