WO2005108968A1 - Biocapteur, contenant pour biocapteur et appareil de mesure de biocapteur - Google Patents

Biocapteur, contenant pour biocapteur et appareil de mesure de biocapteur Download PDF

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Publication number
WO2005108968A1
WO2005108968A1 PCT/JP2005/007982 JP2005007982W WO2005108968A1 WO 2005108968 A1 WO2005108968 A1 WO 2005108968A1 JP 2005007982 W JP2005007982 W JP 2005007982W WO 2005108968 A1 WO2005108968 A1 WO 2005108968A1
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WIPO (PCT)
Prior art keywords
biosensor
temperature
container
color tone
substance
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Application number
PCT/JP2005/007982
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English (en)
Japanese (ja)
Inventor
Mariko Miyashita
Yuko Taniike
Toshihiko Yoshioka
Original Assignee
Matsushita Electric Industrial Co., Ltd.
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Application filed by Matsushita Electric Industrial Co., Ltd. filed Critical Matsushita Electric Industrial Co., Ltd.
Publication of WO2005108968A1 publication Critical patent/WO2005108968A1/fr

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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/001—Enzyme electrodes
    • C12Q1/005—Enzyme electrodes involving specific analytes or enzymes
    • C12Q1/006—Enzyme electrodes involving specific analytes or enzymes for glucose

Definitions

  • Biosensor Biosensor container, and biosensor measurement device
  • the present invention relates to a biosensor, a biosensor container, and a biosensor measuring device that can easily, quickly, and accurately measure the concentration of a specific substance contained in a sample.
  • the biosensor disclosed in Patent Literature 1 below discloses an enzyme reaction comprising a mixture of a hydrophilic polymer, an oxidoreductase, and an electron carrier on an electrode formed on an insulating substrate. A reaction layer is formed. By supplying the sample on the electrode, a reaction between the oxidoreductase, the electron carrier, and the sample occurs.
  • the biosensor is used for electrochemically detecting a change in the concentration of each substance during the reaction and measuring a specific component in the sample.
  • the measurement operation of the biosensor will be described.
  • the biosensor is a glucose sensor
  • a sample containing glucose is supplied to a glucose sensor, the enzyme reaction layer dissolves, and the sample and the substance in the enzyme reaction layer are mixed.
  • Glucose is oxidized by dalcosoxidase (hereinafter referred to as GOx), which is an oxidoreductase in the enzyme reaction layer, and at the same time, the electron carrier in the enzyme reaction layer is reduced.
  • GOx dalcosoxidase
  • the reduced form of the electron carrier is oxidized. By measuring the oxidation current value at this time, the glucose concentration in the sample is quantified.
  • the enzymatic reaction and the electrode reaction used in the biosensor are affected by the temperature of the environment in which the measurement is performed.
  • sensors such as blood glucose meters usually have a guaranteed temperature force of up to 40 ° C, and there are cases where the temperature rises to 50 ° C or more and the sensor or the user exceeds the sensor's guaranteed temperature range during transportation. It was hot.
  • Patent Document 1 JP-A-3-202764
  • Patent Document 2 JP-A-61-294356
  • the biosensor described in Patent Document 2 incorporates a thermistor to correct the influence of the environmental temperature.
  • the manufacturing process for incorporating the thermistor into the biosensor is complicated, and the manufacturing cost is high.
  • the present invention has been made in view of the above circumstances, and has as its object to provide a biosensor, a neurosensor container, and a biosensor measurement device capable of performing accurate measurement.
  • the biosensor of the present invention is a biosensor for measuring a substance to be measured contained in a sample, and includes a substrate, a protein provided on the substrate, and specifically reacting with the substance to be measured. And a temperature detection unit formed of a material including a temperature-sensitive material whose color tone changes according to the temperature.
  • the biosensor of the present invention it is possible to measure the environmental temperature of the biosensor based on the color tone change of the temperature detection unit when measuring the substance to be measured. Therefore, the influence of the environmental temperature of the biosensor at the time of measuring the substance to be measured can be corrected, so that accurate measurement can be performed.
  • the biosensor of the present invention includes a conventional thermistor. The manufacturing cost is very low.
  • the temperature-sensitive material may contain a dye whose color tone changes irreversibly, or may contain a dye whose color tone changes reversibly.
  • the measured value can be corrected based on the measured temperature, so that the reliability of the measured result can be improved.
  • thermosensitive material whose color tone changes irreversibly, a material containing at least p-dimethylaminoazobenzene or a derivative thereof and an organic acid and a metal salt of Z or an organic acid is preferable.
  • the organic acid is at least one selected from salicylic acid, citric acid, benzoic acid, and maleic acid, and the metal salt thereof is preferably a zinc salt, a sodium salt, or an aluminum salt.
  • the conductivity-imparting substance imparts the necessary chargeability to the ink for facilitating printing with an ink-jet printer, and improves the particleization and charge deflection of the ink.
  • Examples include ammonium thiocyanate, sodium thiocyanate, lithium nitrate, and potassium iodide.
  • the biosensor container of the present invention includes a substrate, and a reagent unit provided on the substrate and containing a protein specifically reacting with a substance to be measured contained in the sample, and supplied with the sample.
  • the temperature of Based on the color change of the part it is possible to measure the environmental temperature of the reagent part of the biosensor or to detect the history of the temperature experienced by the biosensor. Therefore, it is possible to correct the measured value based on the ambient temperature of the reagent part of the biosensor at the time of measurement of the substance to be measured, and to remove defective products before measurement beforehand. Measurement can be performed. Further, according to the present invention, since it is not necessary to incorporate a thermistor into a biosensor as in the related art, the manufacturing cost of the biosensor can be extremely reduced.
  • the biosensor measurement device of the present invention includes a substrate, a reagent unit provided on the substrate, which includes a protein that specifically reacts with an analyte contained in the sample, and to which the sample is supplied, A biosensor measuring device for measuring the above-mentioned substance to be measured using a biosensor having a temperature detecting portion whose color tone changes according to the color tone, wherein the color tone detecting portion for detecting the color tone of the temperature detecting portion; A measuring unit connected to the color tone detecting unit and measuring the temperature of the reagent unit based on the color tone.
  • the influence of the environmental temperature can be automatically corrected based on the change in the color tone of the temperature detection unit of the biosensor when measuring the substance to be measured. Therefore, it is possible for the measurer to automatically perform an accurate measurement without requiring special knowledge. In addition, it is also possible to determine whether the biosensor is defective.
  • a configuration may further include a housing having the color tone detection unit and the measurement unit therein, and a temperature sensor for measuring a temperature in the housing.
  • Another neurosensor measurement device of the present invention includes a substrate, and a reagent unit provided on the substrate, which includes a protein that specifically reacts with a substance to be measured contained in the sample, and to which the sample is supplied.
  • a biosensor a housing having a hollow portion, and a temperature sensor provided on the outer surface of the housing, a container for a biosensor for housing the biosensor, which is used for the measurement, A biosensor measuring device for measuring a substance, A color tone detection unit that detects a color tone of the temperature detection unit; and a measurement unit that is connected to the color tone detection unit and measures the temperature of the reagent unit based on the color tone.
  • the influence of the environmental temperature can be automatically corrected based on the color tone change of the temperature detection unit of the biosensor container when measuring the substance to be measured. . Therefore, it is possible for the measurer to automatically perform accurate measurement without requiring special knowledge. In addition, it is also possible to determine whether the biosensor is defective.
  • a configuration may further include a housing having the color tone detection unit and the measurement unit therein, and a temperature sensor for measuring a temperature in the housing.
  • the present invention it is possible to provide a biosensor, a biosensor container, and a nanosensor measuring device capable of performing accurate measurement.
  • FIG. 1 (a) is a top view of a biosensor
  • FIG. 1 (b) is a cross-sectional view taken along line XX shown in FIG. 1 (a).
  • FIG. 2 (a) is a perspective view showing a biosensor measuring device
  • FIG. 2 (b) is a diagram in which a biosensor is mounted on a biosensor measuring device, and the biosensor can be measured.
  • FIG. 2C is a diagram illustrating a state
  • FIG. 2C is a schematic diagram illustrating a configuration of a biosensor measurement device.
  • FIG. 3 is a flowchart showing an operation of the biosensor measurement device.
  • FIG. 4 is a flowchart showing an operation of the biosensor measurement device.
  • FIG. 5 (a) and FIG. 5 (b) are perspective views showing the appearance of a biosensor container.
  • FIG. 6 (a) is a perspective view showing a biosensor measuring device
  • FIG. 6 (b) is a diagram illustrating a biosensor measuring device equipped with a biosensor and a biosensor container
  • FIG. 6 (c) is a schematic diagram illustrating a configuration of a biosensor measurement device.
  • connection shall mean “electrical connection” unless otherwise specified.
  • a biosensor used for quantification of glucose will be described as an example. As will be described later, the present embodiment does not limit the present invention to a Noo sensor in which the substance to be measured is glucose.
  • FIG. 1B is a top view of the biosensor of the present embodiment, and FIG. 1B is a cross-sectional view taken along line XX shown in FIG. 1A.
  • a biosensor 100 As shown in FIGS. 1 (a) and 1 (b), a biosensor 100 according to the present embodiment has a lead wire 3 formed by screen printing on a substrate 2 formed of an insulating material, and a lead wire 3 formed by screen printing.
  • a reagent section 8 is formed.
  • the reagent section 8 is formed by dropping into an aqueous solution containing glucose oxidase as a protein that specifically reacts with glucose as a substance to be measured and potassium ferricyanide as an electron carrier, followed by drying.
  • the reagent section 8 is not particularly limited as long as it is configured to dissolve when the sample is dropped and to come into contact with the measurement electrode 4 and the counter electrode 6 while being mixed with the sample. . However, as described above, it is preferable to provide the measurement electrode 4 and the counter electrode 6 so as to cover them. Further, the reagent section 8 may be provided in a state where the conductive materials constituting the measurement electrode 4 and the counter electrode 6 are further mixed.
  • the temperature detecting section 7 is provided so as not to contact the reagent section 8 and as close to the reagent section 8 as possible.
  • the specificity of the reaction of the protein contained in the reagent section 8 with the substance to be measured depends on the place where the reaction occurs, that is, the temperature of the reagent section 8 in the present embodiment. Therefore, the closer the temperature detected by the temperature detection unit 7 is to the temperature of the reagent unit 8, the higher the effect of the temperature correction becomes.
  • the temperature detecting section 7 is formed of a material having a temperature-sensitive material as a main component.
  • the temperature-sensitive material used in the temperature detection unit 7 of the present embodiment is a material that reversibly responds to a temperature change, and in particular, a material whose color tone changes with the temperature change is preferable. As a result, the reliability of the measurement result is improved without making it impossible for the temperature detection unit to measure the temperature.
  • a metal complex salt, a cholesteric liquid crystal compound, a mixture of a vinyl alcohol-butyl ester copolymer and an organic solvent, or the like can be used as the temperature-sensitive material.
  • FIG. 2A is a perspective view showing the biosensor measuring device 101 of the present embodiment
  • FIG. 2B is a diagram illustrating the biosensor 100 mounted on the biosensor measuring device 101 of the present embodiment.
  • FIG. 2 is a diagram illustrating a state where measurement by the sensor 100 is possible
  • FIG. (c) is a schematic diagram illustrating a configuration of the biosensor measurement device 101 of the present embodiment.
  • the biosensor measurement device 101 of the present embodiment can insert a housing 101a and a biosensor 100 provided on the surface of the housing 101a inside.
  • a data display unit 103 for displaying the main slot 102 and the measurement result is provided.
  • a pair of connectors 21 and 22 and a color tone detection unit 23 are connected in the housing 101a, and a pair of connectors 21 and 22 and the color tone detection unit 23 are connected.
  • a data processing unit 25 connected to the measurement unit 24, and a data display unit 103 connected to the data processing unit 25.
  • a pair of connectors 21 and 22 are provided in the slot 102.
  • FIG. 3 is a flowchart showing the operation of the biosensor measurement device 101.
  • step Stl the biosensor 100 is mounted on the slot 102, and the operation starts. At this time, the pair of connectors 21 and 22 are connected to the lead wires 3 of the biosensor 100, respectively.
  • step St2 the color tone detection unit 23 confirms that the biosensor 100 has been mounted on the slot 102. At this time, if the biosensor 100 is not mounted, the noise sensor measuring device 101 returns to step Stl and enters a standby state. When the biosensor 100 is mounted, the operation of the biosensor measurement device 101 proceeds to the next step St3.
  • the color tone detection unit 23 sets the color tone of the temperature detection unit 7 as an optical characteristic (for example, the wavelength spectrum pattern of incident light or the intensity of light of a specific wavelength). It detects and outputs it to the data processing unit 25 through the measuring unit 24.
  • the color tone detecting section 23 of the present embodiment includes a light source and a light receiving element.
  • the light source emits light to the temperature detecting section 7 of the biosensor 100, and the light reflected from the temperature detecting section 7 enters the light receiving element. It is provided to do.
  • a light emitting diode or a semiconductor laser is used as a light source, and a photodiode or a phototransistor is used as a light receiving element. Receiving The optical element detects the incident light from the temperature detector 7.
  • step St4 the measurement unit 24 acquires the optical characteristic data from the color tone detection unit 23, and calculates the temperature near the reagent unit 8 of the Noo sensor 100.
  • the measurement section 24 connects the lead wire 3 to the pair of connectors 21 and 22. Measure the current flowing between them.
  • the data processing unit 25 compares the calculated temperature around the reagent unit 8 of the biosensor 100 with the calculated temperature. Then, the current value is corrected based on the previously created correlation between the temperature and the current value, thereby calculating the glucose concentration.
  • the data display unit 103 displays the density of the dark course calculated by the data processing unit 25.
  • the temperature detecting section 7 of the biosensor 100 is arranged so as to be located in the biosensor measuring device 101 when the biosensor 100 is mounted on the slot 102. For this reason, when measuring the glucose concentration, the influence of the environmental temperature can be automatically corrected based on the color tone change of the temperature detection unit 7. Therefore, if the biosensor 100 and the biosensor measuring device 101 are used, an accurate measurement can be automatically performed by the measurer without requiring special knowledge.
  • the biosensor measuring device 101 may further include a temperature sensor for measuring the temperature inside the device.
  • the operation of the biosensor measurement device 101 having this configuration will be described with reference to FIG.
  • FIG. 4 is a flowchart showing the operation of the biosensor measurement device 101.
  • Step Stl As shown in FIG. 4, even when the biosensor measurement device 101 further includes a temperature sensor, the steps from Step Stl to Step St3 are exactly the same.
  • step Stl4 the measurement unit 24 acquires the optical characteristic data from the color tone detection unit 23, and calculates the temperature near the reagent unit 8 of the Noo sensor 100.
  • the temperature sensor force receives the temperature inside the device, and determines whether or not the difference between the temperature inside the device and the temperature near the reagent section 8 is within a preset range. If the difference between the temperature in the device and the temperature in the vicinity of the reagent section 8 is within a preset range, the process proceeds to step Stl6, and if the difference is outside the preset range, Proceed to step Stl5.
  • step St15 the biosensor measurement device 101 stops the measurement.
  • the measuring section 24 connects the lead wire 3 to the pair of connectors 21 and 22. Measure the current flowing between them.
  • the data processing unit 25 calculates the calculated temperature near the reagent unit 8 of the biosensor 100 and the temperature. Then, the current value is corrected based on the previously created correlation between the temperature and the current value, thereby calculating the glucose concentration.
  • the data display unit 103 displays the density of the dark course calculated by the data processing unit 25.
  • the noise sensor measuring device 101 further includes the temperature sensor for measuring the temperature inside the device
  • the difference between the ambient temperature (in this case, the temperature inside the device) and the temperature near the reagent section 8 is determined. After confirming whether or not the force is within a preset range, the measurement can be performed. Therefore, in this configuration, only a measurement result that is hardly affected by the temperature in the biosensor measurement device 101 can be obtained. That is, highly accurate measurement can be performed.
  • a biosensor in which the substance to be measured is glucose
  • the present embodiment does not limit the present invention to a biosensor in which the substance to be measured is glucose.
  • an enzyme using the analyte as a substrate may be selected as the enzyme contained in the reagent section 8.
  • the enzymes contained in the reagent section 8 are oxidoreductases other than the force GOx using glucose oxidase (GOx), which is an oxidoreductase (eg, phenolectose dehydrogenase, gnorecose dehydrogenase). , Anoleconoreleoxidase, Lactate oxidase, cholesterol oxidase, xanthine oxidase, amino acid oxidase, etc.).
  • Examples of the electron mediator include substances such as potassium ferricyanide, p-benzoquinone, phenazine methosulfate, methylene blue, and phenoctene derivatives. Also, a current response can be obtained when oxygen is used as the electron carrier. Note that, instead of using one of the above substances as the electron carrier, two or more substances may be used in combination.
  • an anti-albumin antibody, an anti-hemoglobin antibody, or the like as a protein that specifically reacts with the substance to be measured, and to form a biosensor using the substance to be measured as albumin, hemoglobin or the like. It is.
  • an antibody when an antibody is used as a protein that specifically reacts with the above-mentioned substance to be measured, both the biosensor 100 and the biosensor measuring device 101 quantitatively measure the antigen-antibody reaction (for example, optically measure the antigen-antibody reaction). Quantitative means) should be taken.
  • FIG. 5 (a) and 5 (b) are perspective views showing the appearance of the biosensor container of the present embodiment.
  • the biosensor container 200 of the present embodiment includes a lid 202 and a main body 203, and a temperature detecting section 207 on the bottom surface of the main body 203 whose color tone changes according to the temperature.
  • the biosensor container 200 can house the biosensor 100 ′.
  • the biosensor 100 ′ has the same structure as the biosensor 100, but does not include the temperature detection unit 7. Instead, in the present embodiment, the temperature sensor 207 is provided in the biosensor container 200.
  • the temperature detecting section 207 is preferably provided so as to be as close as possible to the reagent section 8 in a state where the biosensor 100 'is housed.
  • the specificity of the reaction of the protein contained in the reagent section 8 with the substance to be measured depends on the place where the reaction occurs, that is, the temperature of the reagent section 8 in the present embodiment. Therefore, the effect of the temperature correction increases as the temperature detected by the temperature detection unit 207 approaches the temperature of the reagent unit 8.
  • the temperature detecting section 207 is formed of a material having a temperature-sensitive material as a main component.
  • the temperature-sensitive material used in the temperature detection unit 207 of the present embodiment is a material that reversibly responds to a temperature change, and in particular, a material whose color tone changes with the temperature change is preferable. As a result, the reliability of the measurement result is improved without making it impossible to measure the temperature with the temperature detection unit.
  • a metal complex salt, a cholesteric liquid crystalline compound, a mixture of a vinyl alcohol-butyl ester copolymer and an organic solvent, and the like can be used.
  • FIG. 6A is a perspective view showing the biosensor measuring device 301 of the present embodiment
  • FIG. 6B is a diagram showing the biosensor 100 ′ and the biosensor of the biosensor measuring device 301 of the present embodiment
  • FIG. 6C is a diagram illustrating a state in which the container 200 is mounted and the biosensor 100 ′ can be measured
  • FIG. 6C is a schematic diagram illustrating a configuration of the biosensor measurement device 301 according to the present embodiment. .
  • the biosensor measurement device 301 of the present embodiment has a housing 301a and a biosensor 100 ′ provided on the surface of the housing 301a inserted therein.
  • Possible slot 302 data display section 303 provided on the surface of housing 301a for displaying measurement results, and slot capable of inserting biosensor container 200 provided on the surface of housing 301a inside.
  • 304 With 304.
  • a pair of connectors 21 and 22 are provided in a slot 302, and a color tone detection unit 23 'is provided in a slot 304.
  • the operation of the biosensor measuring device 301 is substantially the same as that of the biosensor measuring device 301 of the first embodiment. Therefore, here, the same as FIG. This will be described with reference to 3.
  • the biosensor 100 is mounted in the slot 302 in step Stl, and the operation starts. At this time, each of the pair of connectors 21 and 22 is connected to the lead wire 3 of the biosensor 100 ′.
  • step St2 the color tone detection unit 23 confirms that the biosensor 100 is mounted on the slot 302. At this time, if the biosensor 100 'is not mounted, the biosensor measuring device 301 returns to Step Stl and enters a standby state. When the biosensor 100 'is mounted, the operation of the biosensor measuring device 301 proceeds to the next step St3.
  • the color tone detection unit 23 ′ converts the color tone of the temperature detection unit 207 into optical characteristics (for example, the wavelength spectrum pattern of incident light or the intensity of light of a specific wavelength, etc.). ) And output to the data processing unit 25 through the measuring unit 24.
  • the color tone detection unit 23 'of this embodiment includes a light source and a light receiving element, and the light source emits light to the temperature detection unit 207 of the biosensor 100', and receives light reflected from the temperature detection unit 207. It is provided so as to be incident on the element.
  • a light emitting diode or a semiconductor laser is used as a light source, and a photodiode or a phototransistor is used as a light receiving element.
  • the light receiving element detects the incident light from the temperature detection unit 207.
  • step St4 the measurement unit 24 acquires the optical characteristic data from the color tone detection unit 23 ′, and obtains the temperature of the biosensor container 200 in which the noosensor 100 ′ is stored. Is calculated.
  • step St5 the measuring unit 24 measures a current value flowing between the lead wires 3 through the pair of connectors 21 and 22.
  • step St6 when the optical characteristic data and the current value are input, the data processing unit 25 writes the calculated temperature of the biosensor container 200 and the pre-created temperature. Based on the correlation between the obtained temperature and current value, the current value is corrected to calculate the concentration of dalcos.
  • the data display unit 303 displays the density of the darkos calculated by the data processing unit 25.
  • the biosensor 100 ′ when measuring the glucose concentration, the biosensor 100 ′ is switched off.
  • the temperature detection unit 207 of the biosensor container 200 is positioned above the color tone detection unit 23 at the same time as the lot 302
  • the color change of the temperature detection unit 207 is performed. Therefore, the influence of the environmental temperature can be automatically corrected. Therefore, if the no sensor 100, the biosensor container 200, and the biosensor measuring device 301 are used, an accurate measurement can be automatically performed by the measurer without requiring special knowledge.
  • the biosensor measurement device 301 may further include a temperature sensor for measuring the temperature inside the device.
  • the operation of the biosensor measurement device 301 having this configuration will be described.
  • the operation of the biosensor measuring device 301 at this time is substantially the same as the operation of the biosensor measuring device 301 of the first embodiment. Therefore, the description will be given here with reference to FIG. 4 as in the first embodiment.
  • FIG. 4 is a flowchart showing the operation of the biosensor measurement device 101.
  • Step Stl As shown in FIG. 4, even when the biosensor measurement device 301 further includes a temperature sensor, the steps from Step Stl to Step St3 are exactly the same.
  • step Stl4 the measuring unit 24 acquires the optical characteristic data from the color tone detecting unit 23, and measures the temperature of the biosensor container 200 in which the noosensor 100 ′ is stored. calculate. At this time, the temperature in the temperature sensor force is simultaneously received in the device, and it is determined whether or not the difference between the temperature in the device and the temperature of the biosensor container 200 is within a predetermined range. If the difference between the temperature in the device and the temperature of the biosensor container 200 is within the preset range, the Noosensor measuring device 301 proceeds to step Stl6, and if the difference is outside the preset range, , Proceed to step St15.
  • step Stl 5 the biosensor measurement device 301 stops the measurement.
  • step Stl6 the measuring unit 24 measures a current value flowing between the lead wires 3 through the pair of connectors 21 and 22.
  • the data processing unit 25 compares the calculated temperature of the biosensor container 200 with the previously created temperature. Based on the correlation between the obtained temperature and current value, the current value is corrected to calculate the concentration of dalcos.
  • the data display unit 103 displays the concentration of dalcos calculated by the data processing unit 25.
  • the noise sensor measurement device 301 further includes the temperature sensor for measuring the temperature inside the device
  • the environmental temperature in this case, the temperature inside the device
  • the biosensor 100 ′ are stored. After confirming whether or not the difference between the temperature of the biosensor container 200 and the temperature is within a preset range, the measurement can be performed. For this reason, in this configuration, the temperature inside the biosensor measuring device 301 is hardly affected, and only the measurement result is obtained. That is, highly accurate measurement can be performed.
  • a force provided with a temperature detecting section 207 on the bottom surface of the biosensor container 200 The position of the temperature detecting section 207 can be set at any part of the container. However, it must be a position where the temperature can be detected by the color tone detecting section 23 'of the biosensor measuring device 301.
  • a biosensor that uses glucose as a substance to be measured will be described.
  • this embodiment is not intended to limit the present invention to a biosensor in which the substance to be measured is glucose.
  • an enzyme using the substance to be measured as a substrate may be selected as the enzyme contained in the reagent section 8.
  • glucose oxidase GOx
  • oxidative reductases other than GOx for example, fructose dehydrogenase, glucose Dehydrogenase, alcohol oxidase, lactate oxidase, cholesterol oxidase, xanthine oxidase, amino acid oxidase, etc. may be used.
  • Examples of electron carriers include potassium ferricyanide, p-benzoquinone, and phenazine methosal. Examples include substances such as fate, methylene blue, and phenoctene derivatives. Also, a current response can be obtained when oxygen is used as the electron carrier. Note that, instead of using one of the above substances as the electron carrier, two or more substances may be used in combination.
  • an anti-albumin antibody, an anti-hemoglobin antibody, or the like as a protein that specifically reacts with the substance to be measured, and to form a biosensor using the substance to be measured as albumin, hemoglobin or the like. It is.
  • an antibody when used as a protein that specifically reacts with the substance to be measured, both the Noosensor 100 and the biosensor measuring device 301 measure the antigen-antibody reaction quantitatively (for example, optically measure the antigen-antibody reaction). Quantitative means) should be taken.
  • a biosensor used for quantification of glucose will be described as an example. As will be described later, the present embodiment does not limit the present invention to a Noo sensor in which the substance to be measured is glucose.
  • FIG. 1A is a top view of the biosensor of the present embodiment
  • FIG. 1B is a cross-sectional view taken along line XX shown in FIG. 1A.
  • a biosensor 100 As shown in FIGS. 1 (a) and 1 (b), a biosensor 100 according to the present embodiment has a lead wire 3 formed by screen printing on a substrate 2 formed of an insulating material, and a lead wire 3 formed by screen printing.
  • a reagent section 8 is formed.
  • the reagent section 8 is formed by dropping into an aqueous solution containing glucose oxidase as a protein that specifically reacts with glucose as a substance to be measured and potassium ferricyanide as an electron carrier, followed by drying.
  • the reagent section 8 is not particularly limited as long as the reagent section 8 is configured to be dissolved when the sample is dropped and to be brought into contact with the measurement electrode 4 and the counter electrode 6 in a state of being mixed with the sample. . However, as described above, it is preferable to provide the measurement electrode 4 and the counter electrode 6 so as to cover them. In the reagent section 8, a conductive material constituting the measuring electrode 4 and the counter electrode 6 was further mixed. It is provided in a state.
  • the temperature detecting section 7 is formed of a material having a temperature-sensitive material as a main component.
  • the temperature-sensitive material used in the temperature detection unit 7 of the present embodiment is a material that irreversibly responds to a temperature change, and is particularly preferably a material whose color tone changes with the temperature change. This makes it possible to visually recognize a sensor exposed to a high temperature due to some environment based on a change in the color tone of the temperature-sensitive material, and easily remove defective products.
  • the temperature-sensitive material contains at least p-dimethylaminoazobenzene or a derivative thereof (Oil Yellow GG (registered trademark) manufactured by Orient Chemical Industries, Ltd.) as a dye, an organic acid and a metal salt of Z or an organic acid. It is preferable to do it.
  • the organic acid is composed of at least one selected from the group consisting of salicylic acid, citric acid, benzoic acid, and maleic acid.
  • the metal salt of the organic acid is composed of at least one zinc selected from salicylic acid, citric acid, benzoic acid, and maleic acid. Preference is given to salts, sodium salts or aluminum salts.
  • the ink composition further contains a conductivity imparting substance and is printed by an inkjet printer.
  • the conductivity-imparting substance imparts the electric charge necessary for facilitating printing with an ink-jet printer to the ink, and improves the particleization and charge deflection of the ink.
  • Examples include ammonium thiocyanate, sodium thiocyanate, lithium nitrate, and lithium iodide.
  • thermosensitive material has a large change in color tone when heated in a temperature range of 50 to 80 ° C, and is easily visible.
  • the composition of the temperature-sensitive material can be adjusted to adjust the discoloration speed and the time required for completing discoloration.
  • the temperature-sensitive material can be adjusted such that it takes about one day for the temperature detector 7 to change color.
  • the composition of the temperature-sensitive material can be arbitrarily adjusted so that the sensor 100 can be detected only when the sensor is exposed to a high temperature for a time that affects the function of the sensor itself.
  • the temperature detector 7 can be manufactured, for example, as follows.
  • a weight composition of methyl yellow: salicylic acid: thiocyanic acid: methyl ethyl ketone: methanol: polyamide resin 1: 3: 2: 40: 34: 20 is prepared.
  • methyl yellow is p-dimethylaminoazobenzene.
  • a dye, an organic acid, and a conductivity-imparting substance are added to a solvent, and the mixture is sufficiently stirred. Then, a resin is added, and the mixture is stirred and mixed for about 2 hours. Using a 0.7 m pore diameter membrane, the mixed composition is suction-filtered and the insoluble matter is removed to prepare an ink. This ink is applied to the temperature detecting section 7 using an ink jet printer. Note that the ink can be applied to the temperature detection unit 7 without using an ink jet printer. In this case, the conductivity imparting material need not be added to the ink.
  • the noise sensor thus manufactured can detect the temperature history as follows.
  • the color tone of the temperature detecting section 7 did not change during storage of the sample can at room temperature.
  • the biosensor is stored in a thermostat at 40, 50, 60 and 70 ° C for 1 day, and the color change is measured visually and by a color difference meter CR-100 (Minolta Camera Co., Ltd.). It was red before discoloration or at 40 ° C, but turned yellow at 50, 60, and 70 ° C, and the change was easily visible.
  • the present embodiment does not limit the present invention to a biosensor in which the substance to be measured is glucose.
  • the substance to be measured is glucose.
  • an enzyme containing the substance to be measured as a substrate may be selected as the enzyme contained in the reagent section 8.
  • the enzymes contained in the reagent section 8 are oxidoreductases other than the force GOx using glucose oxidase (GOx), which is an oxidoreductase (eg, phenolectose dehydrogenase, gnorecose dehydrogenase).
  • Anoreconoreoxidase lactate oxidase, cholesterol oxidase, xanthine oxidase, amino acid oxidase, etc.).
  • Examples of the electron carrier include substances such as potassium ferricyanide, p-benzoquinone, phenazine methosulfate, methylene blue, and phenoctene derivatives. Also, a current response can be obtained when oxygen is used as the electron carrier. Note that, instead of using one of the above substances as the electron carrier, two or more substances may be used in combination.
  • an anti-albumin antibody, an anti-hemoglobin antibody, or the like as a protein that specifically reacts with the substance to be measured to form a biosensor using the substance to be measured as albumin, hemoglobin, or the like. It is.
  • an antibody when an antibody is used as a protein that specifically reacts with the above-mentioned substance to be measured, both the biosensor 100 and the biosensor measuring device 101 quantitatively measure the antigen-antibody reaction (for example, optically measure the antigen-antibody reaction). Quantitative means) should be taken.
  • the temperature detecting section 7 is divided into two parts, and a temperature-sensitive material that changes color reversibly by heat is applied to one area, and a temperature-sensitive material that changes color irreversibly by heat is applied to the other area. You may. This makes it possible to confirm that the noise sensor is not unusable and at the same time to correct the temperature of the measured value.
  • FIG. 5 (a) and 5 (b) are perspective views showing the appearance of the biosensor container of the present embodiment.
  • the biosensor container 200 of this embodiment It has a body portion 203, and has a temperature detecting portion 207 whose color tone changes according to the temperature on the bottom surface of the main body portion 203.
  • the biosensor container 200 can house the biosensor 100 ′.
  • the biosensor 100 ′ has the same structure as the biosensor 100, but does not include the temperature detection unit 7. Instead, in the present embodiment, the temperature sensor 207 is provided in the biosensor container 200.
  • temperature detecting section 207 is formed of a material having a temperature-sensitive material as a main component.
  • the temperature-sensitive material used in the temperature detection unit 207 of the present embodiment is a material that responds irreversibly to a temperature change, and in particular, a material whose color tone changes with the temperature change is preferable. This makes it possible to visually recognize a biosensor that has been exposed to a high temperature due to some environment based on a change in the color tone of the temperature-sensitive material, and easily remove defective products in advance.
  • thermosensitive material contains at least p-dimethylaminoazobenzene or a derivative thereof (Oil Yellow GG (registered trademark) manufactured by Orient Chemical Co., Ltd.) as a dye, an organic acid and a metal salt of Z or an organic acid. Do it.
  • the organic acid is composed of at least one selected from salicylic acid, citric acid, benzoic acid, and maleic acid
  • the metal salt is preferably a zinc salt, a sodium salt, or an aluminum salt.
  • the temperature-sensitive material further contains a conductivity-imparting substance, and is preferably printed by an inkjet printer.
  • the temperature detection unit 207 can be formed easily and at high speed.
  • the conductivity-imparting substance imparts the necessary electric charge to the ink for facilitating printing with an ink-jet printer, and improves the particleization and charge deflection of the ink.
  • Examples include ammonium thiocyanate, sodium thiocyanate, lithium nitrate, and lithium iodide.
  • CI 42595 (Aizen Blue—4, manufactured by Hodogaya Chemical Co., Ltd .; “AIZEN” is a registered trademark) is an oil-soluble dye that has good heat resistance and does not discolor due to heat loss. (Trademark)).
  • thermosensitive material When this ink is exposed to high temperature conditions, p-dimethylaminoazobenzene or its derivative in the ink is discolored by the action of an organic acid. Discoloration progresses depending on the heating time and temperature. As a result, different hues are displayed according to the temperature history.
  • This thermosensitive material has a large change in color tone when heated in a temperature range of 50 to 80 ° C, and is easily visible.
  • the temperature history is displayed more accurately.
  • the composition of the thermosensitive material can be adjusted to adjust the discoloration speed and the time required for completing the discoloration.
  • the temperature detection unit 207 can be manufactured as follows.
  • a weight composition of methyl yellow: salicylic acid: thiocyanic acid: methyl ethyl ketone: methanol: polyamide resin 1: 3: 2: 40: 34: 20 is prepared.
  • a dye, an organic acid, and a conductivity-imparting substance are added to a solvent, and the mixture is sufficiently stirred. Then, a resin is added, and the mixture is stirred and mixed for about 2 hours. Using a 0.7 m pore diameter membrane, the mixed composition is suction-filtered and the insoluble matter is removed to prepare an ink. This ink is applied to the temperature detecting section 7 using an ink jet printer.
  • the temperature history can be detected by the sensor manufactured as described above as follows.
  • the color tone did not change during storage of the sample can at room temperature.
  • the biosensor container 200 is stored in a thermostat at 40, 50, 60, and 70 ° C for one day, and the change in color tone is visually observed and measured by a colorimeter CR-100 (Minolta Camera Co., Ltd.). The force was red before the discoloration or at 40 ° C. Yellow at 50, 60 and 70 ° C, and the change is easily visible.
  • a biosensor using glucose as a substance to be measured will be described!
  • this embodiment is not intended to limit the present invention to a biosensor in which the substance to be measured is glucose.
  • an enzyme using the substance to be measured as a substrate may be selected as the enzyme contained in the reagent section 8.
  • glucose oxidase GOx
  • oxidative reductases other than GOx for example, fructose dehydrogenase, glucose Dehydrogenase, alcohol oxidase, lactate oxidase, cholesterol oxidase, xanthine oxidase, amino acid oxidase, etc. may be used.
  • Examples of electron carriers include potassium ferricyanide, p-benzoquinone, and phenazine methal.
  • examples include substances such as fate, methylene blue, and phenoctene derivatives.
  • a current response can be obtained when oxygen is used as the electron carrier. Note that, instead of using one of the above substances as the electron carrier, two or more substances may be used in combination.
  • a biosensor using an anti-albumin antibody, an anti-hemoglobin antibody, or the like as a protein that specifically reacts with the test substance, and using the test substance as an albumin, hemoglobin, or the like can be used. It is. However, when an antibody is used as a protein that specifically reacts with the substance to be measured, both the Noosensor 100 and the biosensor measuring device 301 measure the antigen-antibody reaction quantitatively (for example, optically measure the antigen-antibody reaction). Quantitative means) should be taken.
  • the temperature detecting unit 207 can be optically detected by the biosensor measuring device 301.
  • the temperature detecting unit 207 may be provided on the lid 202 in addition to the bottom of the container. By providing the temperature detecting section on the lid 202, it is possible to more easily determine defective products visually.
  • the biosensor of the first embodiment may be stored in the biosensor container of the present embodiment.
  • the temperature detection unit 207 provided in the biosensor container can confirm that the biosensor is not unusable, and can perform correction at the time of measurement based on the color tone of the temperature detection unit 7 provided in the biosensor. More accurate measurements can be made.
  • the present invention is useful for analysis that requires simple, precise, and rapid measurement of a specific substance concentration, for example, measurement at the time of medical diagnosis and the like.

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Abstract

Un biocapteur (100) comprend une plaque de base (2) et placés dessus, des fils de connexion (3), une électrode de mesure (4), une contre-électrode (6), une couche isolante (5) et une partie de détection de la température (7) dont la couleur change en fonction de la température. Un partie réactif (8) est fournie de sorte à recouvrir l’électrode de mesure (4) et la contre-électrode (6). La partie réactif (8) est formée en faisant couler une solution aqueuse contenant de la glucose oxydase en tant que protéine susceptible de réagir spécifiquement avec le glucose comme une analyte, et du ferricyanure de potassium en tant que véhicule d’électrons et en la séchant. La partie de détection de la température (7) comprend un matériau composé principalement d’un matériau thermosensible.
PCT/JP2005/007982 2004-05-12 2005-04-27 Biocapteur, contenant pour biocapteur et appareil de mesure de biocapteur WO2005108968A1 (fr)

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WO2008007499A1 (fr) * 2006-07-13 2008-01-17 Panasonic Corporation Puce a dosage immunologique electrochimique
JP2009519462A (ja) * 2005-12-16 2009-05-14 スミスズ ディテクション‐トロント リミテッド 改良型のサンプル受けデバイスを備えるイオン移動度分光分析器
JP2010500601A (ja) * 2006-08-14 2010-01-07 バイエル・ヘルスケア・エルエルシー 較正データ転送システム及びその方法
JP2010500600A (ja) * 2006-08-14 2010-01-07 バイエル・ヘルスケア・エルエルシー 実行個別化検査センサー用計測システム
WO2010151592A1 (fr) * 2009-06-23 2010-12-29 Bayer Healthcare Llc Système et appareil pour déterminer des températures dans un système d'analyte fluide
WO2011001917A1 (fr) * 2009-06-30 2011-01-06 アークレイ株式会社 Dispositif d'analyse et procédé d'analyse
CN103124902A (zh) * 2010-09-30 2013-05-29 松下电器产业株式会社 生物传感器收纳体和使用该生物传感器的测定装置
US8617365B2 (en) 2004-05-21 2013-12-31 Agamatrix, Inc. Electrochemical assay device and related methods
US9189598B2 (en) 2007-05-30 2015-11-17 Bayer Healthcare Llc Fluid analyte meter
EP3153857A1 (fr) * 2015-10-08 2017-04-12 Apex Biotechnology Corporation Puce de test biochimique
CN106568711A (zh) * 2015-10-08 2017-04-19 五鼎生物技术股份有限公司 生化试片
JP2017530371A (ja) * 2014-09-08 2017-10-12 インディアン インスティテゥート オブ サイエンスＩｎｄｉａｎ Ｉｎｓｔｉｔｕｔｅ Ｏｆ Ｓｃｉｅｎｃｅ 電気化学的バイオセンサ及びアルブミンとその複合体の検出方法
WO2020234728A1 (fr) * 2019-05-21 2020-11-26 Ascensia Diabetes Care Holdings Ag Système de compensation et procédé de détection de thermistance dans un biocapteur d'analyte
US11389081B2 (en) * 2016-11-07 2022-07-19 Ausmed Global Ltd. Non-invasive photonic sensing for monitoring diabetes

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US11175256B2 (en) 2004-05-21 2021-11-16 Agamatrix, Inc. Electrochemical assay device and related methods
US8617365B2 (en) 2004-05-21 2013-12-31 Agamatrix, Inc. Electrochemical assay device and related methods
JP2009519462A (ja) * 2005-12-16 2009-05-14 スミスズ ディテクション‐トロント リミテッド 改良型のサンプル受けデバイスを備えるイオン移動度分光分析器
US7585400B2 (en) 2006-07-13 2009-09-08 Panasonic Corporation Chip for electrochemical immunoassay
WO2008007499A1 (fr) * 2006-07-13 2008-01-17 Panasonic Corporation Puce a dosage immunologique electrochimique
JP2010500601A (ja) * 2006-08-14 2010-01-07 バイエル・ヘルスケア・エルエルシー 較正データ転送システム及びその方法
JP2010500600A (ja) * 2006-08-14 2010-01-07 バイエル・ヘルスケア・エルエルシー 実行個別化検査センサー用計測システム
US10347371B2 (en) 2007-05-30 2019-07-09 Ascensia Diabetes Care Holdings Ag Fluid analyte meter system
US9189598B2 (en) 2007-05-30 2015-11-17 Bayer Healthcare Llc Fluid analyte meter
WO2010151592A1 (fr) * 2009-06-23 2010-12-29 Bayer Healthcare Llc Système et appareil pour déterminer des températures dans un système d'analyte fluide
US9664644B2 (en) 2009-06-23 2017-05-30 Ascensia Diabetes Care Holdings Ag System and apparatus for determining temperatures in a fluid analyte system
US8617381B2 (en) 2009-06-23 2013-12-31 Bayer Healthcare Llc System and apparatus for determining temperatures in a fluid analyte system
US9097650B2 (en) 2009-06-23 2015-08-04 Bayer Healthcare Llc System and apparatus for determining temperatures in a fluid analyte system
CN102472718A (zh) * 2009-06-30 2012-05-23 爱科来株式会社 分析装置和分析方法
JPWO2011001917A1 (ja) * 2009-06-30 2012-12-13 アークレイ株式会社 分析装置および分析方法
JP5341996B2 (ja) * 2009-06-30 2013-11-13 アークレイ株式会社 分析装置および分析方法
CN102472718B (zh) * 2009-06-30 2014-04-30 爱科来株式会社 分析装置和分析方法
WO2011001917A1 (fr) * 2009-06-30 2011-01-06 アークレイ株式会社 Dispositif d'analyse et procédé d'analyse
US9103772B2 (en) 2010-09-30 2015-08-11 Panasonic Healthcare Holdings Co., Ltd. Body for storing biosensors and measurement device using the biosensors
CN103124902A (zh) * 2010-09-30 2013-05-29 松下电器产业株式会社 生物传感器收纳体和使用该生物传感器的测定装置
JP7068822B2 (ja) 2014-09-08 2022-05-17 インディアン インスティテゥート オブ サイエンス 電気化学的バイオセンサ及びアルブミンとその複合体の検出方法
JP2017530371A (ja) * 2014-09-08 2017-10-12 インディアン インスティテゥート オブ サイエンスＩｎｄｉａｎ Ｉｎｓｔｉｔｕｔｅ Ｏｆ Ｓｃｉｅｎｃｅ 電気化学的バイオセンサ及びアルブミンとその複合体の検出方法
EP3153857A1 (fr) * 2015-10-08 2017-04-12 Apex Biotechnology Corporation Puce de test biochimique
CN106568711A (zh) * 2015-10-08 2017-04-19 五鼎生物技术股份有限公司 生化试片
US20170102347A1 (en) * 2015-10-08 2017-04-13 Apex Biotechnology Corp. Biochemical test chip
US11389081B2 (en) * 2016-11-07 2022-07-19 Ausmed Global Ltd. Non-invasive photonic sensing for monitoring diabetes
WO2020234728A1 (fr) * 2019-05-21 2020-11-26 Ascensia Diabetes Care Holdings Ag Système de compensation et procédé de détection de thermistance dans un biocapteur d'analyte
JP7461973B2 (ja) 2019-05-21 2024-04-04 アセンシア・ディアベティス・ケア・ホールディングス・アーゲー 補償システムおよび分析物バイオセンサ内のサーミスタ感知の方法

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