WO2017122485A1 - Dispositif de mesure de composant, procédé de mesure de composant et programme de mesure de composant - Google Patents

Dispositif de mesure de composant, procédé de mesure de composant et programme de mesure de composant Download PDF

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Publication number
WO2017122485A1
WO2017122485A1 PCT/JP2016/087145 JP2016087145W WO2017122485A1 WO 2017122485 A1 WO2017122485 A1 WO 2017122485A1 JP 2016087145 W JP2016087145 W JP 2016087145W WO 2017122485 A1 WO2017122485 A1 WO 2017122485A1
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WIPO (PCT)
Prior art keywords
function
component
value
blood glucose
unit
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PCT/JP2016/087145
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English (en)
Japanese (ja)
Inventor
杉山隆行
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テルモ株式会社
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Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2017561552A priority Critical patent/JP6811729B2/ja
Priority to CN201680078662.8A priority patent/CN108474794B/zh
Publication of WO2017122485A1 publication Critical patent/WO2017122485A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/1459—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose

Definitions

  • the present invention relates to a component measuring apparatus, a component measuring method, and a component measuring program for measuring a component in a liquid.
  • a blood glucose meter that measures the amount of glucose components (blood glucose level) in blood is known.
  • Japanese Patent Application Laid-Open No. 2004-555 discloses a blood glucose meter that takes blood into a sensor case (chip) and obtains a current value corresponding to a glucose component in blood from an internal reagent layer to calculate a blood glucose level. ing.
  • the blood glucose meter disclosed in Japanese Patent Application Laid-Open No. 2004-555 is configured as a medical device for ward examination (POCT: Point Of Care Testing) used in a medical facility.
  • POCT Point Of Care Testing
  • the blood glucose meter is different from a large analyzer that is installed in the laboratory and the inspection process after the transport of the test sample is performed in a separate room. It can be implemented and reflected in treatment, and contributes to quick examinations in emergency departments, OPE rooms, dialysis rooms, etc. in addition to bedside. Therefore, a blood glucose meter for POCT (POCT device) is required to have the same accuracy as a large analyzer even if it is a simple type, and accurate measurement values are always obtained through accuracy control such as QC (Quality Control). It is important to be managed so as to calculate.
  • QC Quality Control
  • the POCT device contributes to the work efficiency of medical personnel such as doctors and nurses, the POCT device is configured to be small and easy to carry.
  • the POCT device can identify medical workers and patients, and is provided with a function for automatically transmitting measurement values by communicating with a hospital server (electronic medical chart). It is required that the relevance can be recorded and referenced.
  • a hospital server electronic medical chart
  • the POCT device is required to calculate measurement values with high accuracy even in the high blood glucose level range, blood conditions, and measurement items that have been frequently excluded from the measurement.
  • the blood glucose meter (component measurement device) for POCT has a wide blood glucose level measurement range for measuring patients in various states, and further has a self-measuring (SMBG: Self-Monitoring-of-Blood-Glucose) device. It is required that the blood glucose level can be measured with higher accuracy than the above.
  • SMBG Self-Monitoring-of-Blood-Glucose
  • Ht concentration of red blood cells in the blood
  • therapeutic agent ambient temperature
  • ambient temperature etc. Processing that takes into account environmental factors. In this case, it is known that the degree of influence of the calculation error factor changes for each factor.
  • the blood glucose level when the blood glucose level is low, the blood color error ratio increases. Further, when the calculated value is adjusted to match the actual blood glucose level on the low blood glucose side, the calculated value may deviate from the actual blood glucose level if the blood glucose level is high. That is, by setting a wide range of measurable objects or widening the measurement range of the component amount, there has been a disadvantage that the reliability (followability) of the output characteristics with respect to the detected value is lowered.
  • the present invention has been made in order to solve the above-described problems, and provides a component measuring apparatus, a component measuring method, and a component measuring method that can obtain high measurement accuracy even when the measurement range is wide and can be used more favorably.
  • the purpose is to provide a program.
  • the present invention calculates a component measurement information based on a detection unit that detects a component amount of a component in a liquid and a detection value related to the component amount detected by the detection unit.
  • a control unit that includes: a measurement information calculation unit that applies a predetermined function to calculate the measurement information from the detection value; and the detection value or the detection value.
  • a function setting unit configured to set the predetermined function used by the measurement information calculation unit from a plurality of functions held in advance based on the calculated value to be calculated.
  • the component measuring device includes the function setting unit that sets a predetermined function from a plurality of functions based on the detected value or the calculated value calculated from the detected value, so that the component amount measurement range is wide.
  • the function setting unit has a wide component amount measurement range, so even if the measurement information deviates from the actual component amount in one function, the function setting unit actually uses different functions to measure the measurement information. Can be close to the amount of ingredients. Therefore, the component measuring apparatus can be used favorably as a blood glucose meter for POCT that measures blood glucose levels of various patients in a medical facility, for example.
  • control unit calculates a first value that is the calculated value from the detected value by the first function that is the predetermined function, compares the first value with a predetermined threshold value, and compares the first value with the predetermined value. It may be determined whether a single value is used as the measurement information, or whether the second value is calculated from the detection value using the second function that is the predetermined function and is different from the first function, and is used as the measurement information.
  • the component measuring apparatus calculates the first value by the first function and determines the application function based on the first value, thereby effectively utilizing the first value to obtain highly accurate measurement information. Obtainable. Further, if the frequency of use of the first function is high, the calculated first value is used as measurement information, so that internal processing is simplified. Therefore, measurement information can be obtained without significantly reducing the processing speed.
  • the detection unit detects a glucose component in blood, which is a component in the liquid, and outputs the detection value.
  • the function setting unit has a hematocrit as the first value. It can be set as the structure which discriminate
  • the component measuring apparatus can perform highly accurate detection in a wide measurement range when measuring the amount of the glucose component in the blood.
  • the measured blood glucose level corrected by hematocrit is used as the first value, that is, the applied function is determined according to the measured blood glucose level that is the most downstream in the calculation process, it is ensured that the measured blood glucose level is separated from the actual blood glucose level. Can be determined. As a result, the blood glucose level with the highest accuracy can be finally obtained.
  • the detection unit detects a glucose component in blood that is a component in the liquid and outputs the detection value
  • the function setting unit calculates the first value from the absorbance and corrects hematocrit.
  • a configuration may be used in which application of the first function or the second function is discriminated using a provisional blood glucose level before being performed.
  • the component measuring apparatus can determine the applied function at the stage before performing the hematocrit correction by using the temporary blood glucose level calculated from the absorbance as the first value. Therefore, even if it changes to a 2nd function, calculation of measurement information can be accelerated more.
  • control unit compares the calculation process value or the detection value, which is the calculation value calculated from the detection value by a function other than the predetermined function, with a predetermined threshold value, and uses the predetermined function.
  • Application of a certain first function or a second function that is the predetermined function and is different from the first function may be determined.
  • the component measuring device compares the calculation process value or detection value with a predetermined threshold value, and determines the application of the first function or the second function, thereby applying the first function at an early stage without using the first function. Function discrimination can be performed. Therefore, calculation of measurement information can be further accelerated.
  • the detection unit detects a glucose component in blood, which is a component in the liquid, and outputs the detection value, and the function setting unit calculates from the detection value as the calculation process value.
  • the applied absorbance can be used to determine application of the first function or the second function.
  • the component measuring apparatus can further improve the processing speed by determining the application of the first function or the second function using the absorbance as the calculation process value.
  • the detection unit detects a glucose component in blood that is a component in the liquid and outputs the detection value
  • the function setting unit uses the detection value acquired from the detection unit. It may be used to determine application of the first function or the second function.
  • the function setting unit can immediately set the applied function as the detected value is acquired, and the processing speed is maximized. be able to.
  • the function setting unit may be configured to change the timing for determining application of the predetermined function according to the processing speed of the measurement information calculation unit when calculating the measurement information.
  • the function can be set based on the calculated value in the later stage of the calculation process, and the accuracy of the measurement information to be calculated is improved.
  • a function can be set based on the detection value or a calculated value at an early stage of the calculation process, and the processing speed can be improved.
  • the present invention provides a component measurement method for measuring the component amount of a component in a liquid, the step of detecting the component amount by a detection unit, and a measurement information calculation unit, A step of calculating measurement information based on a detection value related to the component amount detected by the detection unit by applying a predetermined function, and a function setting unit, based on the detection value or a calculation value calculated from the detection value, And setting the predetermined function used by the measurement information calculation unit from a plurality of functions held in advance.
  • the component measurement program includes a step of detecting the component amount by a detection unit in a component measurement device that measures the component amount of the component in the liquid, and a measurement information calculation Calculating a measurement information based on a detection value related to the component amount detected by the detection unit by applying a predetermined function in the unit, and a calculated value calculated from the detection value or the detection value in the function setting unit And a step of setting the predetermined function used by the measurement information calculation unit from among a plurality of functions held in advance.
  • the component measuring device, the component measuring method, and the component measuring program can obtain high measurement accuracy even when the measurement range is wide, and can be used better.
  • the component measuring apparatus 10 detects a glucose component in blood (liquid), and measures a blood glucose level (a component amount of the glucose component) based on the detected value.
  • the blood glucose meter 10 is configured (hereinafter also referred to as a blood glucose meter 10).
  • the blood glucose meter 10 is configured as a POCT device mainly used by medical workers (users) such as doctors and nurses in medical facilities. It has a function of recording and calling blood glucose level data.
  • the blood glucose meter 10 may be used as an SMBG device in which the patient himself / herself measures his / her blood glucose level.
  • the blood glucose meter 10 includes a chip 12 that takes in blood, and an apparatus main body 14 that obtains a blood sugar level by optical measurement by mounting the chip 12.
  • the chip 12 is configured as a disposable type that is discarded after each measurement, while the apparatus main body 14 is configured as a portable and robust device so that the user can repeatedly measure the blood glucose level. .
  • the chip 12 includes a cylindrical mounting portion 16 that is inserted and fixed in the apparatus main body 14 and a nozzle 18 that protrudes from the mounting portion 16 to the tip.
  • a blood introduction path 18 a that extends linearly from the tip portion toward the inside of the attachment portion 16 is provided, and a test paper 20 is accommodated in the attachment portion 16.
  • the chip body 19 including the mounting portion 16 and the nozzle 18 is made of a rigid material having a predetermined rigidity.
  • a highly hydrophilic material such as an acrylic resin or various resin materials subjected to a hydrophilic treatment is preferable, and it is more preferable that a treatment not allowing ambient light to pass through is performed.
  • the test paper 20 is obtained by carrying (impregnating) a reagent (coloring reagent) on a carrier capable of absorbing blood (specimen).
  • This carrier is preferably composed of a porous membrane (sheet-like porous substrate).
  • the porous membrane preferably has a pore size that can filter out red blood cells in blood.
  • the carrier of the test paper 20 include, in addition to the porous film, a sheet-like porous substrate such as a nonwoven fabric, a woven fabric, and a stretched sheet.
  • Examples of the constituent material of the carrier such as the porous membrane include polyesters, polyamides, polyolefins, polysulfones, and celluloses, but it is impregnated with an aqueous solution in which a reagent is dissolved.
  • a hydrophilic material or a material that has been subjected to a hydrophilic treatment is preferable.
  • an enzyme reagent such as glucose oxidase (GOD) or peroxidase (POD), and 4-aminoantipyrine, N-ethyl N- ( And a coloring reagent such as 2-hydroxy-3-sulfopropyl) -m-toluidine, and the others are appropriately selected according to the measurement component.
  • GOD glucose oxidase
  • POD peroxidase
  • 4-aminoantipyrine N-ethyl N-
  • a coloring reagent such as 2-hydroxy-3-sulfopropyl
  • the chip 12 is stored in a state of being enclosed in a dedicated container in order to reduce the change over time of the reagent carried inside the test paper 20.
  • the user When measuring the blood glucose level with the blood glucose meter 10, the user attaches the chip 12 to the attachment portion 24, and then drops the patient's blood on the tip of the nozzle 18.
  • the spotted blood is guided to the test paper 20 through the blood introduction path 18a based on the capillary phenomenon, developed in the test paper 20, and then colored by reacting with the reagent carried in the test paper 20. To do.
  • the color reaction since the color concentration changes according to the amount of glucose contained in the blood, the change amount of the color concentration is detected and calculated as a blood glucose level.
  • a correction calculation is added to a factor that may cause a calculation error, and a correction step is provided so that the calculated value is close to the plasma glucose concentration value.
  • Factors to be corrected include blood concentration (hematocrit value), measurement temperature, test paper lot, patient medication, and the like.
  • the apparatus main body 14 has a housing 22 that constitutes the appearance.
  • the housing 22 is slightly elongated so that the user can easily hold it with one hand, and a mounting portion 24 to which the chip 12 is attached is formed on the distal end side of the housing 22.
  • the tip part of the POCT device is slightly bent downward while becoming narrower toward the tip direction, so that even a POCT device that is multifunctional and easy to enlarge can be easily spotted with blood with the same accuracy as the SMBG device. It is formed as follows. Further, an ejector 26 for removing the chip 12 mounted on the mounted portion 24, a monitor 28, and an operation button group 30 are provided on the upper surface of the housing 22, and a barcode reader 32 is provided on the base end surface of the housing 22. Is provided.
  • the housing 22 may have water resistance when water or chemicals are submerged for cleaning when blood adheres, and may have a structure that can be easily wiped off, such as eliminating surface processing and gaps as much as possible.
  • the mounted portion 24 is formed at the distal end portion of the blood glucose meter 10 and is formed in a cylindrical shape on which the above-described chip 12 can be mounted.
  • a cap 24a that protects the distal end portion when carrying and can be attached and detached at the time of measurement may be attached to the attachment portion 24 together with the fall prevention holder 24b.
  • the ejector 26 is connected to the eject pin 26a in the housing 22, and pushes the tip 12 mounted on the mounted portion 24 forward and separates in accordance with the forward pressing operation by the user.
  • the user can easily remove the chip 12 attached so as to be in close contact, and the chip 12 can be discarded without touching the chip 12 to which blood has adhered after measurement of the blood glucose level. Therefore, the user's work efficiency can be improved, and at the same time, the risk of infection due to contaminated blood generated in the hospital can be reduced.
  • the monitor 28 provided in the apparatus main body 14 is composed of a liquid crystal, an organic EL, or the like, and provides information to be provided to the user in blood glucose level measurement such as blood glucose level, date and time, or other information (for example, error or measurement procedure). indicate.
  • the operation button group 30 includes a power button 30a, a movement button 30b, a selection button 30c, an LED display section 30d, and a data reading button 30e.
  • the move button 30b has a function of moving the selection frame with respect to the item displayed on the monitor 28 or scrolling the screen in accordance with the operation.
  • the selection button 30c has a function of selecting a function of an item on which the selection frame is positioned on the monitor 28 or canceling the selection and returning to the screen before the selection in accordance with the user's pressing operation.
  • the LED display unit 30d is lit or blinked in various colors by the LED to notify the state of the blood glucose meter 10.
  • the data reading button 30e is provided between the monitor 28 and the mounted portion 24, and operates reading of the bar code reader 32.
  • the power-on is not limited to when the power button 30a is pressed, but can be set to change to a power-on state upon sensing the mounting of the chip 12 or the removal of the cap 24a. It is not limited to the time of pressing, but includes a state change due to interruption of signal communication or removal of the chip 12.
  • the barcode reader 32 has a function of reading a barcode (not shown) by laser scanning.
  • the barcode to be read is attached or pasted in advance to, for example, a patient, a medical worker, a package of the chip 12, and the like.
  • the blood glucose meter 10 reads patient barcode data, obtains patient identification data, measurer identification data, and chip identification data and stores them in a predetermined database (not shown).
  • the apparatus main body 14 includes a detection unit 34, an A / D converter 36, a temperature sensor 38, and a control circuit 40 inside the housing 22.
  • the detection unit 34 is a structural unit that optically detects blood collected in the chip 12.
  • the detection unit 34 includes a block body 42, a lens 44, a substrate 46, a light emitting unit 48, and a light receiving unit 50.
  • the block body 42 of the detection unit 34 is fixed inside the front end side of the housing 22, holds the lens 44 at the front end side, and holds the substrate 46 at the base end side. Inside the base end side of the block body 42, a light emitting unit 48 and a light receiving unit 50 mounted on the substrate 46 are inserted and arranged. Further, in the block body 42, a measurement light optical path 42 a for guiding the measurement light projected by the light emitting unit 48 to the lens 44, a space 42 b from the lens 44 to the test paper 20, and a reflection reflected from the test paper 20. A reflected light optical path 42c for guiding light from the lens 44 to the light receiving unit 50 is provided.
  • the light emitting unit 48 is a light source that irradiates light onto the test paper 20 as an irradiation means.
  • the light emitting surface is adjusted so as to face the test paper 20 and attached to the housing 22, and is condensed and irradiated by the lens 44.
  • the light emitting unit 48 is selected from light wavelengths absorbed by the color of the test paper 20, and is set in a wavelength range of about 500 to 720 nm, for example.
  • the measurement light is configured by two light emitting elements (first light emitting element 48a and second light emitting element 48b).
  • the first light emitting element 48a emits measurement light at a wavelength (for example, red light of 620 to 640 nm) for detecting the color density of the reagent according to the component amount of the glucose component.
  • the second light emitting element 48b emits measurement light at a wavelength for detecting the concentration of red blood cells in blood (for example, green light of 510 to 540 nm).
  • the first and second light emitting elements 48a and 48b for example, LED elements, organic EL elements, inorganic EL elements, LD elements, and the like can be used.
  • the wavelength region used for the measurement is selected according to the wavelength characteristics of the measurement reagent, and is set within a range not affected by the wavelength region of the inhibition factor.
  • the light receiving unit 50 includes one or a plurality of light receiving elements 50a that receive the reflected light reflected by the test paper 20 and output a current related to the reflected light (according to the intensity of the reflected light).
  • the light receiving element 50a for example, a PD element, a CCD element, a CMOS element or the like can be used.
  • the A / D converter 36 is electrically connected to the substrate 46 of the detection unit 34, and appropriately amplifies the current signal (analog signal) output from the light receiving unit 50 and converts it into a voltage signal (digital signal). , And output as a detected value d (current information).
  • the temperature sensor 38 is provided at a predetermined location (for example, the base end side) in the housing 22 and detects the ambient temperature T (atmosphere temperature) where the blood glucose meter 10 is used. This temperature sensor 38 outputs the detected ambient temperature T to the control circuit 40 as temperature information.
  • the control circuit 40 is configured as a computer (control unit) having an input / output I / F 52, a processor 54, a memory 56, and the like, and has a function of controlling the overall operation of the blood glucose meter 10. For example, the control circuit 40 controls the driving of the detection unit 34 and receives the detection value d detected by the detection unit 34 and converted by the A / D converter 36 to measure the blood sugar level. In addition, the control circuit 40 stores the measured blood glucose level in the database in association with the patient identification data, and displays it on the monitor 28.
  • the control circuit 40 reads out and executes the component measurement program 56a stored in the memory 56, thereby constructing a measurement processing unit 58 that measures a blood glucose level as shown in FIG.
  • the measurement processing unit 58 includes, for example, a detection unit drive unit 60, a detection value acquisition unit 62, a temperature acquisition unit 64, a blood glucose level calculation unit 66 (measurement information calculation unit), and a function setting unit 68.
  • the detection unit driving unit 60 is operated by a signal from the control circuit 40 and emits pulsed light at a predetermined time interval.
  • This pulsed light has a period of about 0.5 to 3.0 msec and an irradiation time of one pulse of about 0.05 to 0.3 msec.
  • measurement of glucose concentration using red light by the first light emitting element 48a
  • measurement of correction hematocrit value using green light by the second light emitting element 48b
  • the alternate irradiation of red light and green light is started.
  • the detection value acquisition unit 62 receives the detection value d (current information) transmitted from the detection unit 34 via the A / D converter 36 and temporarily stores it in the memory 56.
  • the detection value acquisition unit 62 is activated immediately after power-on or measurement mode switching, and automatically records the amount of reflected light from the surface of the test paper 20.
  • the recording time is determined in consideration of the amount of data that can be stored in the memory 56, but it is desirable that the recording time be performed a plurality of times per second. In addition, the number of times may vary depending on the amount of change in the amount of reflected light, and the larger the amount of change, the more measurement points per unit time can be secured, while saving the number of used memories. it can.
  • the temperature acquisition unit 64 receives information on the ambient temperature T transmitted from the temperature sensor 38 and temporarily stores it in the memory 56.
  • the temperature sensor 38 is installed so as to reflect the temperature of the test paper portion while avoiding a portion that is susceptible to temperature change such as a grip portion.
  • the ambient temperature T is preferably updated sequentially, and the measurement time when the temperature sensor 38 is stabilized is adopted for calculation correction and stored in the memory 56.
  • the blood glucose level calculation unit 66 is a functional unit that calculates a blood glucose level based on the detection value d (current value) acquired by the detection value acquisition unit 62 and displays it on the monitor 28.
  • the blood glucose level calculation unit 66 includes an absorbance calculation unit 70, a provisional blood glucose level calculation unit 72, a hematocrit correction unit 74, and a measurement result processing unit 76 according to the blood glucose level calculation process and the control process.
  • the absorbance calculation unit 70 calculates the absorbance AL based on the acquired detection value d.
  • the method for calculating the absorbance AL is not particularly limited. For example, a ratio between a white AD value that is a reference current value and a detected current value (color AD value) is taken, and a predetermined constant (the number of bits that facilitates processing). An expression for multiplying is given.
  • the absorbance AL is the amount of reflected light in the state in which the test paper 20 is colored by glucose in the blood compared to the reflected light in the state in which the test paper 20 is not colored as measured immediately after the power is turned on. It shows whether it has changed.
  • the measurement point adopted as the absorbance AL should be determined by the time after the reagent reaction is sufficiently completed, and may be determined each time from the amount of change per unit time or set in advance.
  • the absorbance calculation unit 70 reads a preset absorbance function and a white AD value obtained by reflected light from the test paper 20 before measurement (or stored in the memory 56 as a reference value), and obtained detection value Absorbance AL is calculated from d and output to provisional blood glucose level calculator 72.
  • the temporary blood glucose level calculation unit 72 calculates the temporary blood glucose level PB from the absorbance AL using the calibration function set by the function setting unit 68.
  • the “provisional blood glucose level PB” is a calculated value before performing a hematocrit correction described later.
  • a plurality of calibration functions are prepared according to the ambient temperature T of the blood glucose meter 10 and the measurement range of the blood glucose level, and are appropriately selected by the function setting unit 68.
  • the provisional blood sugar level calculation unit 72 calculates the provisional blood sugar level PB using the selected calibration function, and outputs it to the hematocrit correction unit 74.
  • the hematocrit correction unit 74 corrects the temporary blood glucose level PB based on the calculation result of the hematocrit value, which is the volume occupied by red blood cells in the blood, and calculates the measured blood glucose level MB, which is final blood glucose level measurement information.
  • the detector 34 and the control circuit 40 project the hematocrit value based on the reflected light by projecting the test light 20 colored with measurement light having a predetermined wavelength by the second light emitting element 48b.
  • the hematocrit correction unit 74 calculates the measured blood glucose level MB using the obtained hematocrit value
  • the hematocrit correction unit 74 outputs it to the measurement result processing unit 76.
  • the measurement result processing unit 76 generates the calculated measured blood sugar level MB as display information and transmits it to the monitor 28. Thereby, the monitor 28 displays the patient's blood glucose level (measured blood glucose level MB) in an appropriate display form. Further, the measurement result processing unit 76 stores the measured blood glucose level MB in the memory 56 in association with the patient identification data and the measurer identification data. Thereby, the blood glucose meter 10 can read and display the past measured blood glucose level MB for each patient. Or the blood glucose meter 10 transmits these data automatically (or according to a user's operation) to the server which has an electronic medical record in a hospital.
  • the function setting unit 68 is a functional unit that sets a function when the blood sugar level calculating unit 66 calculates the measured blood sugar level MB from the detected value d.
  • the function setting unit 68 includes an applied function selection unit 78 and a function change determination unit 80.
  • the applied function selection unit 78 selects a calibration function according to the processing content from a plurality of function data FD stored in the memory 56 (function storage unit) as shown in FIG. It has a function to do.
  • the function setting unit 68 may be configured to read out the absorbance function and the hematocrit function for performing hematocrit correction from the memory 56 and provide them to the blood sugar level calculation unit 66.
  • the blood glucose meter 10 is intended for use in a medical facility as described above, and the measurement range of the blood glucose level (measured blood glucose level MB) is set wider than the conventional SMBG device.
  • the blood glucose level can be measured with high accuracy for a wide blood glucose range (for example, 0 to 1000 mg / dL) and a wide range of blood hematocrit patients (for example, Ht 10 to 70%).
  • a wide blood glucose range for example, 0 to 1000 mg / dL
  • a wide range of blood hematocrit patients for example, Ht 10 to 70%.
  • the measurement value range that affects each factor may differ. For example, when the blood sugar level is low (50 mg / dL or less), the blood color error ratio is high.
  • the blood sugar level When correction is performed according to the blood sugar level on the low blood sugar side, the blood sugar level is relatively high (200 to 600 mg / d). In dL), the calculated value may deviate from the actual blood glucose level. Further, when the blood sugar level becomes high (600 mg / dL or more), since the reagent reaction time is long, correction that requires a long measurement time is required. Similarly, also in the hematocrit value, the plasma ratio is different even in the same amount of blood in the low value range (Ht20%) and the high value range (Ht60%), and there is a difference in the blood permeation rate and the reagent reaction rate.
  • the calibration function is one as in the conventional apparatus, the blood glucose level is low, and even if the blood glucose level is high, it can reflect a highly accurate value by following the patient's actual blood glucose level. There is a possibility of calculating a value deviating from the blood glucose level.
  • the application function selection unit 78 is configured to select a plurality (two) of calibration functions according to the measurement range. That is, as shown in FIG. 4, the memory 56 calculates the first calibration function f (x) for calculating the temporary blood glucose level PB when the blood glucose level is low and the temporary blood glucose level PB when the blood glucose level is high. And a second calibration function g (x).
  • the first calibration function f (x) indicated by the solid line and the second calibration function g (x) indicated by the alternate long and short dash line are drawn as curves for the sake of easy understanding of the invention.
  • the actual calibration function has various shapes depending on the design of the test paper structure, reagent composition, reagent amount, and the like.
  • the temporary blood sugar level calculating unit 72 calculates the temporary blood sugar level PB from the absorbance AL
  • the first calibration function f (x) is obtained when the absorbance AL that is the X axis is a1 in FIG.
  • Th the actual blood glucose level and the provisional blood glucose level PB follow well.
  • the second calibration function g (x) is applied.
  • the Y-axis blood glucose level provisional blood glucose level PB
  • c1 provisional blood glucose level PB
  • the ambient temperature T is one of the error factors when calculating the measurement value, and is particularly affected. This is because the reagent on the test paper 20 contains an enzyme reaction, the temperature dependence of the reagent reaction is high, and the blood developability inside the test paper 20 changes greatly according to the ambient temperature T, This is because it affects the reaction. Therefore, the memory 56 has a plurality of calibrations according to a predetermined temperature range (for example, a range of 5 ° C. such as T ⁇ 0 ° C., 0 ° C. ⁇ T ⁇ 5 ° C.,. Function is stored.
  • a predetermined temperature range for example, a range of 5 ° C. such as T ⁇ 0 ° C., 0 ° C. ⁇ T ⁇ 5 ° C.
  • the application function selection unit 78 selects a function corresponding to the ambient temperature T acquired by the temperature acquisition unit 64 from the above function group during the processing of the temporary blood glucose level calculation unit 72. Further, the applied function selection unit 78 selects one of the first calibration function f (x) or the second calibration function g (x) based on an instruction from the function change determination unit 80 and outputs the selected one to the temporary blood glucose level calculation unit 72. To do.
  • the function change discriminating unit 80 is a functional unit that discriminates application of either the first calibration function f (x) or the second calibration function g (x) that is an application function.
  • the function change determination unit 80 has a predetermined threshold value for distinguishing application of the first calibration function f (x) and the second calibration function g (x).
  • the threshold value is a detection value d detected by the detection unit 34 or a calculated value calculated in the calculation process of the blood glucose level calculation unit 66 (measured blood glucose level MB, temporary Those corresponding to blood glucose level PB, absorbance AL) are applied.
  • the application function discrimination timing and threshold value will be described, and the operation (processing flow) and effect of the control circuit 40 in measuring the blood glucose level will be described.
  • the blood glucose meter 10 is configured to determine application of the first calibration function f (x) and the second calibration function g (x) based on the measured blood glucose level MB calculated by the hematocrit correction unit 74. ing. That is, the blood sugar level calculation unit 66 calculates the temporary blood sugar level PB based on the first calibration function f (x), and further calculates the measured blood sugar level MB once by the hematocrit correction unit 74. The function setting unit 68 takes out the calculated measured blood glucose level MB as a parameter and uses it to determine the applied function.
  • the function change determination unit 80 of the function setting unit 68 has a measured blood sugar level threshold corresponding to the measured blood sugar level MB.
  • the measured blood sugar level threshold value may be appropriately set according to the range in which the first calibration function f (x) can sufficiently follow the actual blood sugar level in the blood sugar level measurement range, and examples include 50, 200, and 600 mg. / DL.
  • the function change determination unit 80 receives the measured blood glucose level MB corrected by the hematocrit correction unit 74, the function change determination unit 80 compares the measured blood glucose level with the threshold value of the measured blood glucose level and determines the first calibration function f (x) or the second calibration function g (x). Determine which application is appropriate.
  • the user attaches the chip 12 to the blood glucose meter 10 and takes the blood of the patient from the tip of the nozzle 18.
  • the glucose component reacts with the reagent, and the test paper 20 is colored according to the amount of the component.
  • the control circuit 40 of the blood glucose meter 10 operates (drives) the detection unit 34 by the detection unit drive unit 60 after a predetermined time from the start of coloration of the test paper 20 (step S1).
  • the detection unit 34 emits measurement light from the first and second light emitting elements 48 a and 48 b at different timings, and the reflected light reflected on the test paper 20 is received by the light receiving unit 50.
  • the light receiving unit 50 outputs a detection value d (current signal) corresponding to the intensity of reflected light when the first and second light emitting elements 48a and 48b project light.
  • This detection value d is transmitted to the control circuit 40 via the A / D converter 36.
  • the detection value acquisition unit 62 acquires the detection value d (step S ⁇ b> 2), and the detection value d is temporarily stored in the memory 56.
  • the control circuit 40 starts the operation of the blood sugar level calculation unit 66 based on the acquisition of the detection value d by the detection value acquisition unit 62.
  • the absorbance calculation unit 70 reads the detection value d when the first light emitting element 48a projects measurement light, and calculates the absorbance AL using the absorbance function (step S3).
  • the calculated absorbance AL is output to the temporary blood glucose level calculation unit 72.
  • the temporary blood glucose level calculation unit 72 calculates the temporary blood glucose level PB from the absorbance AL using the first calibration function f (x) set by the function setting unit 68 (step S4).
  • the calculated provisional blood glucose level PB is output to the hematocrit correction unit 74.
  • the hematocrit correction unit 74 corrects the temporary blood glucose level PB based on the hematocrit value, and calculates a measured blood glucose level MB that is a first value (step S5).
  • the hematocrit value is calculated in advance by the hematocrit correction unit 74 based on the detection value d when the second light emitting element 48b projects measurement light.
  • the calculated measured blood glucose level MB is stored in the memory 56 and output to the function setting unit 68.
  • control circuit 40 operates the function change determination unit 80 of the function setting unit 68 to compare the measured blood glucose level MB received from the hematocrit correction unit 74 with the measured blood glucose level threshold (step S6). Then, when the measured blood sugar level MB is equal to or less than the measured blood sugar level threshold value, the process proceeds to step S7, and when the measured blood sugar level MB is larger than the measured blood sugar level threshold value, the process proceeds to step S8.
  • the measurement result processing unit 76 of the control circuit 40 reads the measured blood glucose level MB (first value) based on the first calibration function f (x) from the memory 56, and displays the measured blood glucose level MB as display information. Is displayed on the monitor.
  • the measurement result processing unit 76 stores the patient identification data and the measured blood glucose level MB in the memory 56 in association with each other.
  • the function setting unit 68 reads the second calibration function g (x) from the memory 56 by the application function selection unit 78 and sends it to the temporary blood glucose level calculation unit 72.
  • the provisional blood glucose level calculation unit 72 Upon receiving the second calibration function g (x), the provisional blood glucose level calculation unit 72 once again calculates the provisional blood glucose level PB (second value) from the absorbance AL using the second calibration function g (x) in step S8. To do. Thereby, the temporary blood glucose level PB corresponding to a high blood glucose level is obtained.
  • the temporary blood glucose level PB calculated by the second calibration function g (x) is subjected to the hematocrit correction again by the hematocrit correction unit 74, and the measured blood glucose level MB based on the second calibration function g (x) is newly calculated. It is stored in the memory 56 (step S9). Thereafter, the process of step S7 is performed, and the measured blood glucose level MB based on the second calibration function g (x) is displayed on the monitor 28.
  • the blood glucose meter 10, the component measurement method, and the component measurement program 56a according to the first embodiment are based on the measured blood glucose level MB calculated from the detected value d, the first calibration function f (x) and the second calibration function g.
  • the function setting unit 68 has a wide blood glucose level measurement range, so that even if the blood glucose level deviates from the actual component amount in the first calibration function f (x), the second calibration function g
  • the blood glucose level can be brought close to the actual component amount. Therefore, the blood glucose meter 10 can be favorably used as a POCT device that measures blood glucose levels of various patients in a medical facility or the like.
  • the blood glucose meter 10 compares the measured blood glucose level MB with the measured blood glucose level threshold by the function setting unit 68 to determine the first calibration function f (x) or the second calibration function g (x). No information is required, and internal processing is simplified. Therefore, the blood sugar level can be obtained without significantly reducing the processing speed.
  • the blood glucose meter 10 is configured to determine an appropriate function using the measured blood glucose level MB corrected by hematocrit as a calculated value. That is, since the application function is determined according to the measured blood glucose level MB that is the most downstream side (final value) in the calculation process, it is possible to reliably determine that the measured blood glucose level MB is away from the actual blood glucose level. Finally, the blood glucose level with the highest accuracy can be obtained.
  • the blood glucose meter 10 calculates the second calibration function g (x) by calculating the first temporary blood glucose level PB using the first calibration function f (x) having a high use probability (frequency). The opportunity to redo is reduced, and the decrease in processing speed can be suppressed.
  • the blood glucose meter 10 is not limited to the configuration of the above-described embodiment, and can take various modifications.
  • the blood glucose meter 10 is not limited to the use of two calibration functions as described above, and may be configured to calculate a blood glucose level using three or more calibration functions.
  • the blood glucose meter 10 calculates the blood glucose level easily and early using an initial calibration function different from the first calibration function f (x) and the second calibration function g (x) for easily calculating the blood glucose level. Then, application of the first calibration function f (x) and the second calibration function g (x) may be determined from the calculated value.
  • the blood glucose meter 10 uses the second calibration function g (x) as a calibration function used when the temporary blood glucose level PB is first calculated according to the patient's state (past measurement information, etc.). Also good.
  • the blood glucose meter 10 may have different timings for determining application of the first calibration function f (x) and the second calibration function g (x). I will explain.
  • the blood glucose meter 10A has a first calibration function f (x) and a second calibration function g (x) based on the temporary blood glucose level PB before the hematocrit correction calculated by the temporary blood glucose level calculation unit 72. It is the structure which discriminate
  • the configuration of the blood glucose meter 10A is basically the same as that of the blood glucose meter 10 referred to in FIGS.
  • the function change determination unit 80 takes out the calculated temporary blood glucose level PB, and compares and determines the stored temporary blood sugar level threshold and the extracted temporary blood sugar level PB.
  • the temporary blood sugar level threshold is set to 600 mg / dL, for example, as in the first embodiment.
  • the function change determination unit 80 instructs the application of the first calibration function f (x) if the temporary blood glucose level PB is equal to or less than the temporary blood glucose level threshold, and if the temporary blood glucose level PB is larger than the temporary blood glucose level threshold.
  • the application of the second calibration function g (x) is instructed.
  • steps S11 to S14 are the same as steps S1 to S4 in the first embodiment.
  • the blood sugar level calculating unit 66 temporarily stores the calculated temporary blood sugar level PB in the memory 56 and outputs it to the function setting unit 68.
  • the function setting unit 68 receives the temporary blood glucose level PB (first value) calculated by the temporary blood glucose level calculation unit 72, and compares the temporary blood glucose level PB with the temporary blood glucose level threshold in step S15. If the temporary blood glucose level PB is equal to or lower than the temporary blood glucose level threshold value, the process proceeds to step S16. If the temporary blood glucose level PB is larger than the temporary blood glucose level threshold value, the process proceeds to step S18.
  • the hematocrit correction unit 74 corrects the temporary blood glucose level PB to calculate the measured blood glucose level MB (step S16). Furthermore, the same processing flow as step S7 of the first embodiment is performed, and the measured blood glucose level MB is displayed (step S17).
  • the function setting unit 68 reads the second calibration function g (x) from the memory 56 by the application function selection unit 78 and sends it to the temporary blood glucose level calculation unit 72.
  • the provisional blood glucose level calculation unit 72 Upon receiving the second calibration function g (x), the provisional blood glucose level calculation unit 72 once again calculates the provisional blood glucose level PB (second value) from the absorbance AL using the second calibration function g (x) in step S18. To do.
  • step S19 the same processing flow as in step S9 of the first embodiment is performed, and the process proceeds to step S17 to display the measured blood glucose level MB based on the second calibration function g (x).
  • the blood glucose meter 10A according to the second embodiment can also achieve the same effects as those of the first embodiment.
  • the blood glucose meter 10A uses the provisional blood glucose level PB calculated from the absorbance AL in the calculation process, the first calibration function f (x) and the second calibration function g (x) are in a stage before hematocrit correction is performed. Application discrimination can be made. Therefore, even when the second calibration function g (x) is used, the measurement blood glucose level MB can be calculated more quickly.
  • the blood glucose meter 10B according to the third example is configured to discriminate application of the first calibration function f (x) or the second calibration function g (x) when the absorbance calculation unit 70 calculates the absorbance AL using the absorbance function. It has become.
  • the configuration of the blood glucose meter 10B is basically the same as that of the blood glucose meter 10 referred to in FIGS.
  • the function change determination unit 80 of the blood glucose meter 10B receives the absorbance AL (calculation process value) calculated by the absorbance calculation unit 70, the function change determination unit 80 performs comparison determination with the absorbance threshold value held. If the absorbance AL is equal to or less than the absorbance threshold, the application of the first calibration function f (x) is instructed, and if the absorbance AL is larger than the absorbance value threshold, the application of the second calibration function g (x) is instructed.
  • steps S21 to S23 are the same as steps S1 to S3 of the first embodiment.
  • the absorbance calculation unit 70 temporarily stores the calculated absorbance AL (calculation process value) in the memory 56 and outputs it to the function setting unit 68.
  • step S24 the function setting unit 68 compares the absorbance AL with the absorbance threshold value. If the absorbance AL is equal to or less than the absorbance threshold, the process proceeds to step S25, and if the absorbance AL is greater than the absorbance threshold, the process proceeds to step S28.
  • the first calibration function f (x) can be said to be an optimal function. Therefore, thereafter, the temporary blood glucose level PB is calculated by the temporary blood glucose level calculation unit 72 using the first calibration function f (x) (step S25), and the hematocrit correction unit 74 corrects the temporary blood glucose level PB.
  • the measured blood glucose level MB is calculated (step S26). Furthermore, the same processing flow as step S7 of the first embodiment is performed, and the measured blood glucose level MB is displayed (step S27).
  • the function setting unit 68 reads the second calibration function g (x) from the memory 56 by the application function selection unit 78 and sends it to the temporary blood glucose level calculation unit 72.
  • the provisional blood glucose level calculation unit 72 calculates the provisional blood glucose level PB from the absorbance AL using the second calibration function g (x) in step S28. Thereafter, in step S29, the same processing flow as in step S9 of the first embodiment is performed, and the process proceeds to step S27 to display the measured blood glucose level MB based on the second calibration function g (x).
  • the blood glucose meter 10B according to the third embodiment can also obtain the same effects as those of the first embodiment.
  • the blood glucose meter 10B applies the first calibration function f (x) and the second calibration function g (x) using the absorbance AL, which is a calculation process value at an earlier stage than the first and second embodiments. Since the determination is made, the processing speed can be further improved.
  • the blood glucose meter 10C is configured to determine application of the first calibration function f (x) and the second calibration function g (x) immediately after the detection value acquisition unit 62 acquires the detection value d. It has become.
  • the configuration of the blood glucose meter 10C is basically the same as that of the blood glucose meter 10 referred to in FIGS.
  • the function change determination unit 80 performs comparison determination with the current value threshold value held. If the detected value d is larger than the current value threshold, the application of the first calibration function f (x) is instructed. If the detected value d is equal to or less than the current value threshold, the application of the second calibration function g (x) is instructed. Instruct.
  • steps S31 and S32 are the same as steps S1 and S2 in the first embodiment.
  • the function setting unit 68 reads the detection value d acquired by the detection value acquisition unit 62, and compares the detection value d with the current value threshold value in step S33. If the detected value d is larger than the current value threshold value, the process proceeds to step S34. If the detected value d is equal to or smaller than the current value threshold value, the process proceeds to step S38.
  • the absorbance AL becomes small (in other words, the measured blood glucose level MB to be calculated becomes small) based on the above-described absorbance function, and the first calibration function f. (X) is estimated as an optimal function. Therefore, thereafter, the absorbance AL is calculated from the detection value d by the absorbance calculation unit 70 (step S34), and the temporary blood glucose level PB is calculated by the temporary blood glucose level calculation unit 72 using the first calibration function f (x). (Step S35). Further, the hematocrit correction unit 74 corrects the temporary blood glucose level PB to calculate the measured blood glucose level MB (step S36), and further performs the same processing flow as step S7 in the first embodiment to display the measured blood glucose level MB. (Step S37).
  • the absorbance AL increases (in other words, the measured blood glucose level MB to be calculated increases) based on the absorbance function described above, and the first calibration function f.
  • the second calibration function g (x) is estimated to be an optimal function rather than (x). Therefore, thereafter, the absorbance AL is calculated from the detection value d by the absorbance calculation unit 70 (step S38), and the temporary blood glucose level PB is calculated by the temporary blood glucose level calculation unit 72 using the second calibration function g (x) ( Step S39).
  • the hematocrit correction unit 74 corrects the temporary blood glucose level PB to calculate the measured blood glucose level MB (step S40), and further proceeds to step S37 to calculate the measured blood glucose level MB based on the second calibration function g (x). indicate.
  • the blood glucose meter 10C can also obtain the same effects as those of the first embodiment.
  • the blood glucose meter 10C uses a current signal that is the detection value d, that is, the function setting unit 68 immediately obtains the first calibration function f (x) and the second calibration function g (x) as the detection value d is acquired. Since the application is discriminated, the processing speed can be maximized.
  • the blood glucose meters 10, 10A to 10C may have a function of making it possible to perform all the discrimination timings of the first to fourth embodiments described above and switching the discrimination timing.
  • the function setting unit 68 can include a processing speed determination unit 82 that determines the processing speed of the control circuit 40, as indicated by a dotted line in FIG.
  • the processing speed discriminating unit 82 discriminates processing speeds of a plurality of stages (four stages) from a pattern with a high processing speed of the control circuit 40 at the time of blood glucose level measurement to a slow pattern, and outputs the discrimination result to the function change discriminating unit 80 To do.
  • the processing speed determination unit 82 estimates that the processing speed is fast when the information amount handled by the control circuit 40 is small, and the processing speed is slow when the information amount is large.
  • the function change discriminating unit 80 can discriminate the applied function at any timing described in the first to fourth embodiments in accordance with the processing speed stage determined by the processing speed determining unit 82.
  • the blood glucose meters 10, 10A to 10C have a first range in the vicinity of the boundary where it is difficult to determine switching of the application function with respect to the detection value d (for example, a range where the calculated blood glucose level MB to be calculated is 500 to 700 mg / dL). ) And a second range (for example, a range in which the measured blood glucose level MB to be calculated is 0 to 500, 700 to 1000 mg / dL) that is far away from the vicinity of the boundary and that makes it easy to determine the switching of the applied function, When the detection value d is acquired, it may be determined whether it belongs to the first or second range.
  • a first range in the vicinity of the boundary where it is difficult to determine switching of the application function with respect to the detection value d for example, a range where the calculated blood glucose level MB to be calculated is 500 to 700 mg / dL.
  • a second range for example, a range in which the measured blood glucose level MB to be calculated is 0 to 500, 700 to 1000 mg /
  • the determination of the application function is performed on the basis of the measured blood glucose level MB by using the determination timing of the first embodiment, thereby improving the accuracy. If the detection value d is in the second range, the measured blood glucose level MB can be obtained without reducing the processing speed by taking the discrimination timing of the fourth embodiment.
  • Sample liquids that can be obtained from the living body such as blood, urine, interstitial liquid, saliva, etc. are applied as sample liquids that are targeted at medical sites. It may be a product.
  • Measurement targets include saccharides, lactic acid, various cholesterols, nucleic acids, antibodies, antigens, proteins, hormones, bacteria, enzymes, drugs, constituents, medical products, tissue markers, metabolites, chemical substances, etc. Applicable to quantitative determination.
  • the component measuring device 10 is not limited to a single type of POCT device, but a POCT device capable of performing simultaneous measurement of other items and a large inspection device, or a component measuring device for measuring components such as waste water and industrial samples. It can also be applied to a device. Furthermore, as a simple measuring device, not only a blood glucose meter (SMBG device for self blood glucose measurement) that measures the amount of a glucose component in blood but also various devices that measure the amount of a predetermined component in a liquid. Can be applied.
  • the component measuring apparatus is not limited to detection by optical means when detecting the component amount, and for example, the detected value of the component amount may be obtained by electrical means, magnetic means, or antibody reaction means.
  • Examples thereof include a blood glucose level measuring apparatus to which an enzyme electrode method is applied, and a component measuring apparatus for measuring urine components (such as ketone bodies).
  • a blood glucose level measuring apparatus to which an enzyme electrode method is applied
  • a component measuring apparatus for measuring urine components such as ketone bodies.
  • the correction calculation process for the hematocrit value has been described, but other factors may be used, and in the case of a multi-item simultaneous measuring device, other items that have been measured simultaneously may be used. Good.

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Abstract

La présente invention concerne un glucomètre (10), qui est un dispositif de mesure de composant, qui est pourvu d'une unité de détection (34) qui détecte une quantité de composant d'un composant de glucose, et un circuit de commande (40) qui calcule une glycémie mesurée (MB) sur la base d'une valeur détectée (d) provenant de l'unité de détection (34). Le circuit de commande est pourvu de : une unité de calcul de glycémie (66) qui applique une fonction d'étalonnage pour calculer la glycémie à partir de la valeur détectée (d) ; et une unité de définition de fonction (68) qui, sur la base de la glycémie mesurée (MB) calculée à partir de la valeur détectée (d), définit la fonction d'étalonnage devant être utilisée par l'unité de calcul de glycémie (66), parmi une pluralité d'éléments de données de fonction (FD) stockés à l'avance.
PCT/JP2016/087145 2016-01-12 2016-12-14 Dispositif de mesure de composant, procédé de mesure de composant et programme de mesure de composant WO2017122485A1 (fr)

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CN114137218A (zh) * 2020-09-04 2022-03-04 百略医学科技股份有限公司 能根据血容比值校正测量值的血糖检测装置

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