WO2018061772A1 - 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
WO2018061772A1
WO2018061772A1 PCT/JP2017/033048 JP2017033048W WO2018061772A1 WO 2018061772 A1 WO2018061772 A1 WO 2018061772A1 JP 2017033048 W JP2017033048 W JP 2017033048W WO 2018061772 A1 WO2018061772 A1 WO 2018061772A1
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Prior art keywords
measurement
component
wavelength
measured
absorbance
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PCT/JP2017/033048
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English (en)
Japanese (ja)
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嘉哉 佐藤
健行 森内
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テルモ株式会社
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Priority to JP2018542362A priority Critical patent/JP6952046B2/ja
Publication of WO2018061772A1 publication Critical patent/WO2018061772A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
    • 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
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements

Definitions

  • the body fluid includes a portion including the component to be measured and a component to be measured.
  • a method is known in which the amount and concentration of a component to be measured are measured by separating them into parts that cannot be measured. For example, in order to measure the glucose concentration (mg / dL) in plasma of blood (whole blood), there is a method of measuring the glucose concentration in plasma by performing a step of separating plasma components from blood using a filter or the like. is there.
  • Patent Document 2 discloses a component measurement apparatus and a component measurement method for removing the influence of disturbance factors in measuring the glucose concentration in blood. Specifically, the component measuring device and the component measuring method described in Patent Document 2 estimate the disturbance factor at the measurement wavelength from the measurement value in the long wavelength region longer than the measurement wavelength, and calculate the measurement value at the measurement wavelength. After the correction using the estimated disturbance factor, the measurement value at the measurement wavelength is further corrected using the hematocrit value, thereby measuring the glucose concentration in the plasma component.
  • the glucose concentration of glucose as a component to be measured contained in blood as a body fluid can be measured with high accuracy.
  • the position of the measurement space in which the mixture containing the coloring component generated by the color reaction between the body fluid and the reagent is stored to measure the optical properties
  • the optical path length of the measurement space varies and varies, leading to the knowledge that the measurement accuracy of the component to be measured decreases.
  • an object of the present disclosure is to provide a component measurement device, a component measurement method, and a component measurement program that can suppress a decrease in measurement accuracy of a component to be measured due to variations or fluctuations in the optical path length of the measurement space.
  • the component measuring apparatus is configured such that the position of the gap when the predetermined wavelength is the first wavelength, the measurement light is the first measurement light, and the measurement value is the first measurement value.
  • the mixture is irradiated with the second measurement light having a second wavelength that belongs to the long wavelength region and is in the vicinity of the absorption band specific to the water or the absorption band specific to the water.
  • a second measurement value having an absorbance smaller than the first measurement value is acquired, and the component to be measured is derived based on a difference between the first measurement value and the second measurement value.
  • the measurement wavelength belongs to a shorter wavelength range than the first wavelength and the second wavelength.
  • the measurement wavelength belongs to a wavelength range corresponding to the full width at half maximum of the peak wavelength range in the absorbance spectrum of the color developing component.
  • the measurement wavelength belongs to the visible region.
  • a component measurement device a component measurement method, and a component measurement program that can suppress a decrease in measurement accuracy of a component to be measured due to variations or fluctuations in the optical path length of the measurement space.
  • FIG. 2 is a top view of a single component measurement chip shown in FIG. 1. It is II-II sectional drawing of FIG. It is III-III sectional drawing of FIG. It is an electrical block diagram of the component measuring apparatus shown in FIG. It is a functional block diagram of the calculating part shown in FIG. It is a figure which shows the light absorbency spectrum of the mixture obtained by color-reacting a blood sample and a reagent. It is a figure which shows the light absorbency spectrum of two types of blood specimens.
  • FIG. 17A is a graph showing the variation in absorbance at the measurement wavelength for “no correction” shown in FIG. 13, and FIG. 17B is the graph for the measurement wavelength for “correction during measurement” shown in FIG. It is a graph which shows the dispersion
  • FIG. 1 is a top view showing a component measuring device set 100 in which the component measuring chip 2 is mounted on the component measuring device 1 in the present embodiment.
  • FIG. 2 is an enlarged cross-sectional view of the vicinity of a portion where the component measurement chip 2 is mounted in the cross section taken along the line II of FIG.
  • the component measuring device set 100 includes a component measuring device 1 and a component measuring chip 2.
  • the component measuring apparatus 1 of this embodiment is a blood glucose level measuring apparatus capable of measuring the concentration (mg / dL) of glucose in a plasma component as a component to be measured in blood.
  • the component measurement chip 2 of the present embodiment is a blood glucose measurement chip that can be attached to the tip of a blood glucose measurement device as the component measurement device 1. “Blood” as used herein means whole blood that is not separated for each component but includes all components.
  • the component measuring apparatus 1 is composed of, for example, a housing 10 made of a resin material, a button group provided on the upper surface of the housing 10, a liquid crystal or LED (abbreviation of Light Emitting Diode) provided on the upper surface of the housing 10, and the like. And a removal lever 12 that is operated when removing the component measurement chip 2 attached to the component measurement device 1.
  • the button group of this embodiment includes a power button 13 and an operation button 14.
  • the housing 10 is provided with the above-described button group and the display unit 11 on the upper surface (see FIG. 1).
  • the main body 10a has a substantially rectangular outer shape when viewed from above, and protrudes outward from the main body 10a. (See FIG. 1) and a chip mounting portion 10b provided with a removal lever 12. As shown in FIG. 2, inside the chip mounting portion 10b, a chip mounting space S having a tip opening formed at the tip surface of the chip mounting portion 10b as one end is partitioned. When mounting the component measuring chip 2 on the component measuring apparatus 1, the component measuring chip 2 is inserted into the chip mounting space S from the outside through the tip opening.
  • the chip mounting portion 10b of the component measuring apparatus 1 is in a state where the component measuring chip 2 is locked. With this locked state, the mounting of the component measuring chip 2 to the component measuring apparatus 1 is completed.
  • the locking of the component measuring chip 2 by the component measuring device 1 can be realized by various configurations, for example, by providing a claw portion that can be engaged with a part of the component measuring chip 2 in the chip mounting portion 10b.
  • the above-described removal lever 12 is operated from the outside of the housing 10.
  • the component measuring chip 2 is released from the locked state by the chip mounting portion 10b of the component measuring apparatus 1, and the eject pin 26 (see FIG. 2) in the housing 10 is moved in conjunction with the component measuring chip 1. 2 can be removed from the component measuring apparatus 1.
  • the housing 10 of the present embodiment is configured to include a substantially rectangular main body 10a in a top view (see FIG. 1) and a chip mounting portion 10b that protrudes outward from the main body 10a.
  • the configuration is not limited to the shape of the housing 10 of the present embodiment as long as the configuration includes a chip mounting portion to which the measurement chip 2 can be mounted. Therefore, in addition to the shape of the housing 10 of the present embodiment, for example, various shapes that are easy for the user to hold with one hand can be adopted.
  • the display unit 11 displays, for example, information on the component to be measured measured by the component measuring device 1.
  • the glucose concentration (mg / dL) measured by the blood sugar level measuring device as the component measuring device 1 can be displayed on the display unit 11.
  • the display unit 11 may display not only information on the component to be measured but also various information such as measurement conditions of the component measuring apparatus 1 and instruction information for instructing a user to perform a predetermined operation. The user can operate the power button 13 and the operation button 14 of the button group while confirming the content displayed on the display unit 11.
  • FIG. 3 is a top view showing the component measuring chip 2.
  • 4 is a cross-sectional view taken along the line II-II in FIG.
  • FIG. 5 is a sectional view taken along line III-III in FIG.
  • the component measuring chip 2 defines a flow path 23 therein.
  • a coloring reagent 22 as a reagent is disposed in the flow channel 23 of the component measuring chip 2 with a gap 28 between the inner wall facing the flow channel 23 so as not to close the flow channel 23.
  • the component measurement chip 2 of the present embodiment includes a base member 21 having a substantially rectangular plate-shaped outer shape, a cover member 25 disposed so as to cover the base member 21, and the base member 21. And two spacer members 27 for maintaining the distance between the cover member 25 and the cover member 25 at a predetermined interval.
  • the flow path 23 of the component measurement chip 2 of this embodiment is formed by being surrounded by the base member 21, the cover member 25, and the two spacer members 27.
  • the coloring reagent 22 as the reagent of the present embodiment is arranged by being applied to the upper surface of the base member 21 as the inner wall that defines the flow path 23.
  • a gap 28 is formed between the applied coloring reagent 22 and the lower surface of the cover member 25 as an inner wall that defines the flow path 23.
  • the flow path 23 extends in a direction orthogonal to the thickness direction of the component measurement chip 2 and penetrates from one side end of the component measurement chip 2 to another side end.
  • One side end of the component measuring chip 2 on which one end of the flow path 23 is formed constitutes a supply unit 24 that can supply blood into the flow path 23 from the outside.
  • the blood supplied to the supply unit 24 from the outside moves along the flow path 23 by, for example, capillary action, reaches the gap 28 of the flow path 23, and contacts the color reagent 22.
  • glucose as a component to be measured in the blood and the coloring reagent 22 cause a color reaction.
  • a coloring component is generated by this color reaction. Therefore, a mixture containing blood and the coloring component generated by the above-described color reaction is generated at the holding position where the coloring reagent 22 is held and the position of the gap 28.
  • the flow path 23 of the present embodiment is partitioned by the base member 21, the cover member 25, and the two spacer members 27.
  • the number of members that partition the flow path and the shape of the flow path are limited to the configuration of the present embodiment. I can't.
  • a flow path is formed by only two members: a base member in which a groove is formed on one surface in the thickness direction and a cover member attached so as to cover the one surface on which the groove is formed. It is also possible to do.
  • the flow path of the component measurement chip may be configured to be partitioned by three or less members.
  • the flow path divided by five or more members may be sufficient.
  • the flow path 23 of the present embodiment extends linearly in a top view (see FIG. 3) or a cross-sectional view shown in FIG. 5, but for example, is bent in a top view or a cross-sectional view similar to FIG. It may extend or may be curved and extended uniformly.
  • a transparent material for light transmission As the material of the base member 21 and the cover member 25, it is preferable to use a transparent material for light transmission.
  • transparent organic resin materials such as polyethylene terephthalate (PET), polymethyl methacrylate (PMMA), polystyrene (PS), cyclic polyolefin (COP), cyclic olefin copolymer (COC), and polycarbonate (PC); glass, quartz, etc.
  • PET polyethylene terephthalate
  • PMMA polymethyl methacrylate
  • PS polystyrene
  • COP cyclic polyolefin
  • COC cyclic olefin copolymer
  • PC polycarbonate
  • the coloring reagent 22 as a reagent reacts with the component to be measured in the blood to cause a color reaction that develops a color corresponding to the blood concentration of the component to be measured.
  • the coloring reagent 22 of the present embodiment Is applied on the base member 21.
  • the coloring reagent 22 of this embodiment reacts with glucose as a component to be measured in blood.
  • Examples of the coloring reagent 22 of the present embodiment include (i) glucose oxidase (GOD), (ii) peroxidase (POD), and (iii) 1- (4-sulfophenyl) -2,3-dimethyl-4-amino.
  • the peak wavelength in the absorbance spectrum of the coloring component generated by the color reaction between glucose in the blood and the coloring reagent 22 is the peak wavelength resulting from the light absorption characteristics of hemoglobin in the blood cell. And use something different.
  • the coloring reagent 22 of the present embodiment has a peak wavelength in the vicinity of 650 nm of the absorbance spectrum of the coloring component generated by the color reaction between glucose in the blood and the coloring reagent 22, but is limited to the peak wavelength in the vicinity of 650 nm. Absent. Details of this will be described later.
  • the component measuring apparatus 1 includes a calculation unit 60 in addition to the housing 10 (see FIG. 1), the display unit 11, the removal lever 12 (see FIG. 1), the power button 13 and the operation button 14 described above. And a memory 62, a power supply circuit 63, and a measurement optical system 64.
  • the calculation unit 60 is configured by an MPU (Micro-Processing Unit) or a CPU (Central Processing Unit), and can read out and execute a program stored in the memory 62 or the like, thereby realizing control operations of the respective units.
  • the memory 62 is composed of a non-transitory storage medium that is volatile or nonvolatile, and can read or write various data (including a component measurement program) necessary for executing the component measurement method shown here. is there.
  • the power supply circuit 63 supplies power to each unit in the component measuring apparatus 1 including the calculation unit 60 or stops supplying the power according to the operation of the power button 13.
  • the measurement optical system 64 is an optical system capable of acquiring the optical characteristics of a mixture containing a color developing component generated by a color reaction between blood and the color developing reagent 22 as a reagent.
  • the measurement optical system 64 includes a light emitting unit 66, a light emission control circuit 70, a light receiving unit 72, and a light reception control circuit 74.
  • various photoelectric conversion elements including a PD (abbreviation of Photo Diode) element, a photoconductor (photoconductor), and a phototransistor (abbreviation of Photo Transistor) can be applied.
  • a PD abbreviation of Photo Diode
  • photoconductor photoconductor
  • phototransistor abbreviation of Photo Transistor
  • the light emission control circuit 70 turns on or turns off the first light source 67a to the fifth light source 68 by supplying driving power signals to the first light source 67a to the fifth light source 68, respectively.
  • the light reception control circuit 74 obtains a digital signal (hereinafter referred to as a detection signal) by performing logarithmic conversion and A / D conversion on the analog signal output from the light receiving unit 72.
  • FIG. 7 is a functional block diagram of the calculation unit 60 shown in FIG.
  • the calculation unit 60 realizes the functions of a measurement instruction unit 76 that instructs a measurement operation by the measurement optical system 64 and a concentration measurement unit 77 that measures the concentration of the component to be measured using various data.
  • the concentration measurement unit 77 includes an absorbance acquisition unit 78 and an absorbance correction unit 84.
  • the memory 62 stores the absorbance measurement value data 85 at each of the first wavelength ⁇ 1 to the fifth wavelength ⁇ 5 measured by the measurement optical system 64 and the measurement value data 85 or the measurement value data 85.
  • Correction data 86 including a group of correction coefficients correlated with the calculated secondary data, and a measured value of the absorbance of the mixture actually measured at the measurement wavelength, or a corrected measured value obtained by correcting this measured value with the correction data 86
  • calibration curve data 90 such as a calibration curve indicating the relationship between the amount of each physical quantity (for example, glucose concentration) and a calibration curve indicating the relationship between the absorbance of the hemoglobin in the mixture and the hematocrit value are stored.
  • the “hematocrit value” is a percentage of the volume ratio of blood cell components in blood to blood (whole blood).
  • the color reaction between glucose in blood as a component to be measured in the body fluid and the coloring reagent 22 is performed, and blood (whole blood) and the coloring reagent 22 are separated without separating the plasma component containing glucose from the blood.
  • the component measurement method for measuring the glucose concentration in the blood based on the optical characteristics of the mixture that is executed by the above-described method and that includes the color-forming component generated by the color reaction will be described.
  • FIG. 8 shows an absorbance spectrum of a mixture obtained by color reaction of a blood sample having a known hematocrit value and glucose concentration with the coloring reagent 22.
  • the blood sample used here has a hematocrit value of 40% and a glucose concentration of 400 mg / dL (indicated as “Ht40 bg400” in FIG. 8).
  • the absorbance spectra of blood samples having the same hematocrit value are approximately the same.
  • the absorbance of the first blood sample (hematocrit value is 20%). Only the spectrum and the absorbance spectrum of the second blood sample (hematocrit value is 40%) are shown.
  • the measurement result of the color developing component may be affected by the occurrence of an optical phenomenon. For example, “light scattering” due to blood cell components in the blood, and “light absorption” due to a component (specifically, hemoglobin) different from the color developing component occurs, thereby measuring an absorbance greater than the true value. Tend to be.
  • the absorbance spectra of the two blood samples shown in FIG. 9 have a trend curve in which the absorbance gradually decreases as the wavelength increases, and have two peaks centered around 540 nm and 570 nm. These two peaks are mainly due to the light absorption of hemoglobin in red blood cells.
  • the absorbance gradually decreases in a substantially linear manner as the wavelength increases in the wavelength region of 600 nm or more. This substantially linear portion is mainly caused by light scattering by a blood cell component or the like.
  • the absorbance of the blood sample in the wavelength region longer than 600 nm is predominantly affected by light scattering due to blood cell components and the like, and the absorbance of the blood sample in the wavelength region shorter than 600 nm is The effect of light absorption by hemoglobin is greater than the effect of light scattering by blood cell components and the like.
  • the absorbance spectrum of the mixture shown in FIG. 8 has a trend curve in which the absorbance gradually decreases as the wavelength increases, similar to the absorbance spectrum of the blood sample shown in FIG.
  • the absorbance increases in the visible region around 600 nm to 700 nm.
  • the absorbance increasing from about 600 nm to 700 nm is mainly due to the light absorption characteristics of the coloring component generated by the color reaction between glucose in the blood and the coloring reagent 22.
  • the influence (noise) of light scattering by blood cell components and light absorption by hemoglobin at a predetermined measurement wavelength (for example, 650 nm) where the light absorption rate of the color developing component to be measured is high is estimated. It is necessary to correct the measured value of absorbance at the measurement wavelength.
  • the height h of the gap 28 where the mixture is located reflects the amount of sample flowing in. That is, in order to obtain the amount (concentration) of the measurement target contained in the specimen, the height h of the gap 28 is regarded as a constant value (constant) determined according to the type of the component measurement chip and the color development in the mixture. It is necessary to derive the absorbance of the component. However, the existing component measuring device does not take into account the fluctuation of the height h of the gap 28. Further, the height h of the gap 28 is, for example, the presence or absence of moisture absorption of the coloring reagent 22 in the natural environment, the influence of swelling or dissolution of the coloring reagent 22 due to the color reaction, and the dimensional tolerance in manufacturing the component measuring chip.
  • FIG. 10 is a graph showing the difference in water absorbance based on the difference in the height H (see FIG. 5) of the flow path 23.
  • FIG. 10 shows the absorbance spectrum in the near-infrared region of the empty chip in the state where the coloring reagent 22 is removed from the component measurement chip 2 shown in FIGS. More specifically, in FIG. 10, the absorbance spectrum of the first empty chip in which the height H of the flow path 23 is 30 ⁇ m and there is no water in the flow path 23 (in FIG. 10, “30 ⁇ m nomwater” Notation), the absorbance spectrum of the second empty chip in which the height H of the flow path 23 is 50 ⁇ m and there is no water in the flow path 23 (indicated as “50 ⁇ m no water” in FIG.
  • the height h of the gap 28 of each component measuring chip 2 is actually measured by a film thickness meter, for example, and a correction value corresponding to the measured value is taken into the individual component measuring apparatus 1 as calibration information. Takes a lot of time and effort to users such as patients and medical workers, and leads to an increase in component measurement values, thereby impairing user convenience. In addition, it is not easy in manufacturing to make the allowable dimensional tolerance of the height h of the gap 28 of the component measuring chip 2 so small that it is unnecessary to correct the optical path length of the measurement space. Furthermore, the height h of the gap 28 as the optical path length of the measurement space in a state where the body fluid as the specimen is in contact with the reagent and the mixture is generated in the gap 28 is not reflected.
  • the gap 28 as the optical path length of the measurement space when measuring the absorbance of the color developing component in the mixture (hereinafter simply referred to as “during measurement”) using the above-described characteristics.
  • the height h is estimated.
  • the blood plasma contains moisture
  • the mixture located in the gap 28 is irradiated with light belonging to an absorption band unique to water, it is contained in the mixture located in the gap 28 at the time of measurement. It is possible to obtain a measured value of water absorbance according to the amount of water, in other words, according to the amount of blood located in the gap 28 at the time of measurement.
  • Step S2 Irradiating the first measurement light of the first wavelength ⁇ 1 belonging to the absorption band specific to water in the region to measure the absorbance, and deriving the component to be measured based on the measured value of the absorbance measured in step S1 Step S2 for deriving the glucose concentration in the blood.
  • the first measurement light having the first wavelength ⁇ 1 is emitted from the first light source 67a via the light emission control circuit 70 according to an instruction from the calculation unit 60.
  • the first wavelength ⁇ 1 is a predetermined wavelength belonging to an absorption band specific to water in the near infrared region, and in this embodiment, the wavelength at which the absorbance of water reaches a peak value in the absorption band specific to water. .
  • 1820 nm to 2000 nm at which the water absorbance peak appears noticeably is used as the absorption band unique to water.
  • the wavelength at which the water absorbance reaches a peak value in this absorption band is 1940 nm.
  • the first measurement light having the first wavelength ⁇ 1 passes through the component measurement chip 2 in the thickness direction of the component measurement chip 2 at the position of the gap 28 of the component measurement chip 2.
  • the transmitted light that has passed through the component measuring chip 2 is received by the light receiving unit 72.
  • the absorbance of the mixture located in the gap 28 at the first wavelength ⁇ 1 belonging to the absorption band specific to water can be measured.
  • the measured value of the absorbance measured here is referred to as “first measured value”.
  • the mixture at the position of the gap 28 belongs to a long wavelength region that is greater than or equal to the near infrared region, and By irradiating the second measurement light having the second wavelength ⁇ 2 in the vicinity of the absorption band specific to water or the absorption band specific to water, a second measurement value having an absorbance smaller than the first measurement value is acquired.
  • the glucose concentration is derived based on the difference between the first measurement value and the second measurement value.
  • the step of obtaining the above-described second measurement value is shown as step S1-2.
  • the absorbance acquisition unit 78 of the component measuring apparatus 1 can acquire the measurement value data 85 from the memory 62.
  • the means by which the absorbance acquisition unit 78 acquires the above-described measurement value is not limited to the above-described means, and can be acquired by various known means.
  • the measurement wavelength for measuring the absorbance of the color developing component to be measured is a wavelength at which the light absorption rate of the color developing component is relatively large and a wavelength that is relatively less affected by the light absorption of hemoglobin is used.
  • the wavelength may correspond to the full width at half maximum of the peak wavelength range in the absorbance spectrum of the color developing component to be measured, and the wavelength may belong to a wavelength range in which the ratio of absorbance due to light absorption of hemoglobin to the total absorbance is relatively small.
  • the wavelength range “corresponds to the full width at half maximum of the peak wavelength range” refers to the half value at the long wavelength side from the wavelength at which the half wavelength at the short wavelength side is specified when the full width at half maximum of the peak wavelength range in the absorbance spectrum is specified.
  • the wavelength range up to the wavelength In the absorbance spectrum of the color developing component to be measured in this embodiment, the peak wavelength is around 600 nm, and the wavelength range corresponding to the full width at half maximum is about 500 nm to about 700 nm. Further, the influence of light absorption of hemoglobin on the total absorbance is relatively small in the wavelength region of 600 nm or more. Therefore, in this embodiment, the wavelength range corresponding to the full width at half maximum of the peak wavelength range in the absorbance spectrum of the color developing component to be measured and having a relatively small ratio of absorbance due to light absorption of hemoglobin to the total absorbance is 600 nm. Above and 700 nm or less.
  • the measurement wavelength is not limited to 650 nm in the present embodiment, and another wavelength belonging to the range of 600 nm to 700 nm may be used as the measurement wavelength.
  • the absorbance of the chromogenic component can be measured more accurately when the signal representing the absorbance of the chromogenic component is stronger and the ratio of absorbance due to light absorption of hemoglobin to the total absorbance is in a very small wavelength range. It is preferable to set the measurement wavelength near 650 nm, which is slightly longer than the peak wavelength near 630 nm.
  • the height h of the gap 28 at each point shown in FIG. 16 is measured with an Optical MicroGauge thickness meter (C11011-01) manufactured by Hamamatsu Photonics Co., Ltd. as a film thickness meter.
  • the measured values of the absorbance at each point shown in FIG. 16 are the absorbance at a wavelength specific to water, and the 9-second value, which is the absorbance 9 seconds after the specimen contacts the coloring reagent 22, It is measured by calculating the difference between the initial value which is the absorbance before contact with the color reagent 22. More specifically, first, a difference between the above-described first measurement value as a 9-second value at 1940 nm and the above-described second measurement value as a 9-second value at 1820 nm is calculated.
  • the glucose water having a glucose concentration of 100 mg / dL and 400 mg / dL is evaluated by a value (2SD value) twice the standard deviation of the deviation from the true value divided by the glucose concentration. Further, the measured value of the height h of the gap 28 before the measurement is measured with an Optical MicroGauge thickness meter (C11011-01) manufactured by Hamamatsu Photonics.
  • FIG. 17B is a graph showing the variation in absorbance at the measurement wavelength (here, 650 nm is used) for “with correction during measurement” shown in FIG.
  • the horizontal axis in FIG. 17 (b) is the absorbance at the measurement wavelength as in the horizontal axis in FIG. 17 (a), and the vertical axis in FIG. 17 (b) is the glucose concentration of the mixture at the position of the gap 28.
  • there is a correlation between the glucose concentration of the mixture at the position of the gap 28 and the absorbance at the measurement wavelength (correlation coefficient R 0.999).
  • FIG. 14 shows the influence on the measured value of the glucose concentration in the case where the variation in the height h (see FIG. 5) of the gap 28 of the allowable component measurement chip 2 is very small. Specifically, FIG. 14 shows the results of an experiment using a plurality of component measurement chips 2 that vary in the range where the height h of the gap 28 is 40 ⁇ 1 ⁇ m. The width of each gap 28 is constant.
  • the variation in the height h (see FIG. 5) of the gap 28 of the component measurement chip 2 is very small, as shown in FIG. 14, even if the optical path length of the measurement space is not corrected, the derived glucose concentration The variation of can be reduced.
  • the height h of the gap 28 at the time of measurement is estimated as the optical path length of the measurement space at the time of measurement, and the optical path length of the measurement space is corrected using this estimated value. It can also be seen that the variation in the derived glucose concentration can be reduced.
  • the measured value of the derived glucose concentration is corrected in consideration of the height h of the gap 28 at the time of measurement as the optical path length of the measurement space at the time of measurement as in this embodiment. Even if the variation in the height h (see FIG. 5) of the gap 28 of the component measuring chip 2 is very small, the accuracy of the derived glucose concentration can be made high, and the variation in the clearance amount It can be understood that the accuracy of the derived glucose concentration can be greatly improved when is large.
  • FIG. 15 shows the optical path length of the measurement space for blood adjusted to have a glucose concentration of zero, blood adjusted to have a glucose concentration of 100 mg / dL, and blood to have a glucose concentration of 400 mg / dL.
  • the variation in the measured value of the derived glucose concentration is shown.
  • the variation in the measured values shown in FIG. 15 is evaluated based on twice the standard deviation (2SD) of deviation from the true value of the absolute value of the concentration (mg / dL) for water not containing the glucose concentration.
  • the glucose waters of 100 mg / dL and 400 mg / dL are evaluated by a value (2SD value) twice the standard deviation of the deviation from the true value divided by the glucose concentration.
  • the measured value of the height h of the gap 28 before the measurement is measured with an Optical MicroGauge thickness meter (C11011-01) manufactured by Hamamatsu Photonics.
  • first light source 67a to fifth light source 68 have been described as examples of the light emitting unit 66.
  • a single light source and a plurality of types arranged in front of the light source are described. These optical filters (bandpass type) may be combined. Or you may comprise combining a single light source and multiple types of light-receiving part.
  • the light receiving unit 72 that receives the transmitted light that passes through the component measuring chip 2 is used. However, the light receiving unit that receives the reflected light reflected from the component measuring chip 2 may be used.
  • Component measuring device 2 Component measuring chip 10: Housing 10a: Main body part 10b: Chip mounting part 11: Display part 12: Removal lever 13: Power button 14: Operation button 21: Base member 22: Coloring reagent (reagent) 23: channel 24: supply unit 25: cover member 26: eject pin 27: spacer member 28: gap 60: calculation unit 62: memory 63: power supply circuit 64: measurement optical system 66: light emitting units 67a to 67d: first light source To fourth light source 68: fifth light source 70: light emission control circuit 72: light receiving unit 74: light reception control circuit 76: measurement instruction unit 77: concentration measurement unit 78: absorbance acquisition unit 84: absorbance correction unit 85: measurement value data 86: Correction data 90: Calibration curve data 100: Component measuring device set H: Channel height h: Gap height S: Chip mounting space W: Channel width ⁇ 1 to ⁇ 5: First wavelength to fifth wavelength

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Abstract

La présente invention concerne un dispositif de mesure de composant permettant de mesurer un composant à mesurer dans un liquide en fonction d'une caractéristique optique d'un mélange comprenant un composant colorant généré par une réaction de couleur d'un réactif et du composant à mesurer dans le liquide, un trajet d'écoulement étant divisé à l'intérieur de ce dernier, une puce de mesure de composant possédant le réactif pouvant être fixée dans le trajet d'écoulement, la puce de mesure de composant étant disposée dans un état de séparation par l'intermédiaire d'un espace partant d'une paroi interne en vis-à-vis de façon à ne pas bloquer le trajet d'écoulement, et le composant à mesurer étant déduit en fonction de la valeur mesurée d'absorbance de lumière mesurée à l'aide d'une longueur d'onde prédéterminée de lumière de mesure appartenant à une bande d'absorption spécifique à l'eau dans une zone de longueur d'onde proche infrarouge ou longue plus longue qui est rayonnée vers le mélange à la position de l'espace.
PCT/JP2017/033048 2016-09-29 2017-09-13 Dispositif de mesure de composant, procédé de mesure de composant et programme de mesure de composant WO2018061772A1 (fr)

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Cited By (1)

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CN112557663A (zh) * 2019-09-25 2021-03-26 百略医学科技股份有限公司 检测条及检测条的制造方法

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JPH04181159A (ja) * 1990-11-14 1992-06-29 Kyoto Daiichi Kagaku:Kk 補正用紙片を有する呈色試験紙
US20030113931A1 (en) * 2001-12-14 2003-06-19 Li Pan Ammonia and ammonium sensors
JP2004257835A (ja) * 2003-02-25 2004-09-16 Matsushita Electric Works Ltd グルコース濃度の定量方法
JP2014185960A (ja) * 2013-03-25 2014-10-02 Seiko Epson Corp 浸漬検査装置
WO2015146238A1 (fr) * 2014-03-27 2015-10-01 テルモ株式会社 Appareil de mesure d'élément constitutif
WO2016035881A1 (fr) * 2014-09-05 2016-03-10 パナソニックヘルスケアホールディングス株式会社 Procédé de quantification de la concentration de glucose et dispositif de mesure de concentration de glucose
WO2017154270A1 (fr) * 2016-03-08 2017-09-14 テルモ株式会社 Dispositif de mesure de composé, procédé de mesure de composé et programme de mesure de composé

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Publication number Priority date Publication date Assignee Title
JPH04181159A (ja) * 1990-11-14 1992-06-29 Kyoto Daiichi Kagaku:Kk 補正用紙片を有する呈色試験紙
US20030113931A1 (en) * 2001-12-14 2003-06-19 Li Pan Ammonia and ammonium sensors
JP2004257835A (ja) * 2003-02-25 2004-09-16 Matsushita Electric Works Ltd グルコース濃度の定量方法
JP2014185960A (ja) * 2013-03-25 2014-10-02 Seiko Epson Corp 浸漬検査装置
WO2015146238A1 (fr) * 2014-03-27 2015-10-01 テルモ株式会社 Appareil de mesure d'élément constitutif
WO2016035881A1 (fr) * 2014-09-05 2016-03-10 パナソニックヘルスケアホールディングス株式会社 Procédé de quantification de la concentration de glucose et dispositif de mesure de concentration de glucose
WO2017154270A1 (fr) * 2016-03-08 2017-09-14 テルモ株式会社 Dispositif de mesure de composé, procédé de mesure de composé et programme de mesure de composé

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112557663A (zh) * 2019-09-25 2021-03-26 百略医学科技股份有限公司 检测条及检测条的制造方法
JP2021051077A (ja) * 2019-09-25 2021-04-01 林, 文貴Lin, Wen−Guay テストストリップ及びテストストリップの製造方法
EP3800265A1 (fr) * 2019-09-25 2021-04-07 Microlife Corporation Bandelette réactive et procédé de fabrication de bandelettes réactives

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JPWO2018061772A1 (ja) 2019-07-11

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