WO2016147527A1 - Component measurement device set and body fluid measurement chip - Google Patents

Component measurement device set and body fluid measurement chip Download PDF

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Publication number
WO2016147527A1
WO2016147527A1 PCT/JP2016/000326 JP2016000326W WO2016147527A1 WO 2016147527 A1 WO2016147527 A1 WO 2016147527A1 JP 2016000326 W JP2016000326 W JP 2016000326W WO 2016147527 A1 WO2016147527 A1 WO 2016147527A1
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Prior art keywords
blood glucose
body fluid
measurement
light
unit
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PCT/JP2016/000326
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French (fr)
Japanese (ja)
Inventor
健行 森内
嘉哉 佐藤
雅夫 滝浪
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テルモ株式会社
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Publication of WO2016147527A1 publication Critical patent/WO2016147527A1/en

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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
    • 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 device set and a body fluid measuring chip.
  • the body fluid measuring chip has an inflow port through which a body fluid can flow and a bodily fluid passage communicating with the inflow port.
  • a configuration is disclosed in which a reagent for component measurement is applied to a body fluid developing part having a measuring part, and a measuring part is provided downstream of the body fluid developing part in the body fluid flow direction (see Patent Document 3).
  • Patent Document 1 Japanese Patent Publication No. 10-505676
  • Patent Document 2 JP 2011-64596 A
  • Patent Document 3 International Publication No. 2014/049744
  • the molar extinction coefficient varies depending on the type of coloring reagent, and this limits the range that can be accurately measured with one type of coloring reagent.
  • the invention disclosed in the above prior art documents is based on the premise that a single coloring reagent is held in one body fluid measurement chip, and each of the same body fluid measurement chip measures high blood sugar and low blood sugar with high accuracy. It is not envisaged.
  • the present invention has been made in view of such problems, and an object of the present invention is to provide a component measurement device set and a body fluid measurement chip that can suppress fluctuations in measurement accuracy based on absorbance.
  • the component measuring device set is a component measuring device set for measuring a predetermined component in a body fluid, a body fluid measuring chip having a color developing reagent, and a reaction product of the body fluid and the color developing reagent.
  • An irradiating unit that irradiates light, a light receiving unit that receives measurement light transmitted through the reactant, and a processing unit that processes a signal obtained from the measurement light, wherein the body fluid measurement chip includes a base member
  • the color reagent is two or more color reagents having different molar extinction coefficients held at different positions on the base member.
  • the body fluid measurement chip according to the second aspect of the present invention is a body fluid measurement chip having a coloring reagent, comprising a base member, wherein the coloring reagent is at least two or more kinds held at different positions of the base member. It is characterized in that it is a coloring reagent having different molar extinction coefficients.
  • FIG. 1 shows a blood glucose meter set 1 as a component measuring apparatus set according to an embodiment of the present invention.
  • the blood glucose meter set 1 includes a blood glucose meter 11 as a component measurement device and a blood glucose measurement chip 12 as a body fluid measurement chip.
  • the blood glucose measurement chip 12 is attached to the tip of the blood glucose meter 11.
  • the blood glucose meter 11 includes a display 111 for displaying measurement results and operation details, a power button 112 for instructing activation and termination of the blood glucose meter 11, an operation button 113, a removal lever 114 for removing the blood glucose measurement chip 12, It has.
  • the display 111 is composed of a liquid crystal or LED.
  • FIG. 2A is a longitudinal sectional view separately showing the tip of the blood glucose meter 11 of the blood glucose meter set 1 and the blood glucose measurement chip 12.
  • a mounting portion 22 that partitions a mounting hole 23 for mounting the blood glucose measuring chip 12 is provided.
  • an optical measurement unit 24 for measuring a predetermined component (blood glucose level in the present embodiment) of body fluid (blood in the present embodiment) collected in the blood glucose measurement chip 12 is provided inside the blood glucose meter 11.
  • the blood glucose meter 11 includes a processing unit 25 that processes a signal obtained from the measurement light and calculates a blood glucose level.
  • the opening communicating with the mounting hole 23 is provided with an eject pin 26 for detaching the blood sugar measuring chip 12 in conjunction with the removal lever 114.
  • FIG. 2B is a cross-sectional view showing a state in which the blood glucose measurement chip 12 is attached to the blood glucose meter 11 shown in FIG. 2A, that is, a cross-sectional view of the distal end portion of the blood glucose meter set 1.
  • 2C shows the blood glucose meter set 1 shown in FIG. 2B, the first irradiation unit 31A and the second irradiation unit 31B, the first light receiving unit 32A and the second light receiving unit 32B, and the blood glucose measurement chip 12. It is the figure which was extracted from the back side (right side of FIG. 2B).
  • the blood glucose measurement chip 12 is mounted in the mounting hole 23 during measurement. The mounting operation is performed manually by the user.
  • an appropriate lock mechanism or the like for fixing the blood glucose measurement chip 12 to a predetermined position in the mounting hole 23 is preferably installed.
  • the optical measurement unit 24 includes an irradiation unit 31 and a light receiving unit 32. More specifically, the optical measurement unit 24 of the present embodiment includes a first irradiation unit 31A that irradiates a reaction product of a first coloring reagent 121A and blood described later, and a second coloring reagent described later. A second irradiating unit 31B for irradiating a reaction product of 121B and blood with light, and a first light receiving unit 32A for receiving light transmitted through the reaction product of the first color reagent 121A and blood as measurement light; And a second light receiving unit 32B that receives, as measurement light, light transmitted through the reaction product of the second coloring reagent 121B and blood.
  • a first space 41 and a second space 42 communicating with the mounting hole 23 are formed.
  • the first irradiation unit 31A and the second irradiation unit 31B are arranged in the first space 41, and the first light receiving unit 32A and the second light receiving unit 32B are arranged in the second space 42, respectively.
  • the first space 41 and the second space 42 face each other with the attachment hole 23 therebetween (see FIG. 2A).
  • the first space 41 and the second space 42 are the first coloring reagent 121A and the second coloring reagent of the blood glucose measurement chip 12. Opposing across the position where 121B is held (see FIG. 2B).
  • the first irradiation unit 31A and the first light receiving unit 32A face each other with a first coloring reagent 121A described later interposed therebetween.
  • the second irradiation unit 31B and the second light receiving unit 32B are opposed to each other with a second coloring reagent 121B to be described later interposed therebetween.
  • the first light receiving unit 32A is preferably arranged so that it can receive the irradiation light 33A from the first irradiation unit 31A transmitted through the blood sugar measurement chip 12 without loss.
  • the second light receiving unit 32B is preferably arranged so that it can receive the irradiation light 33B from the second irradiation unit 31B transmitted through the blood sugar measurement chip 12 without loss.
  • the first irradiation unit 31A is positioned at a position where the irradiation light 33A can be irradiated vertically to the bottom surface of the blood glucose measurement chip 12.
  • the two irradiation units 31B are preferably arranged at positions where the irradiation light 33B can be irradiated perpendicularly to the bottom surface of the blood glucose measurement chip 12.
  • each of the first irradiation unit 31A and the second irradiation unit 31B emits light having a first wavelength that emits light having a first wavelength and light having a second wavelength different from the first wavelength.
  • the first wavelength is a wavelength for measuring the degree of color development according to the blood glucose level, and is in the wavelength band of 600 to 900 nm, for example.
  • the second wavelength is a wavelength for measuring the concentration of red blood cells in blood, for example, in the wavelength band of 510 to 590 nm.
  • the first light emitting element and the second light emitting element related to the first irradiation unit 31A, and the first light emitting element and the second light emitting element related to the second irradiation unit 31B emit light.
  • a diode (LED) is used, a halogen lamp, a laser, or the like may be used.
  • a photodiode (PD) is used for the first light receiving unit 32A and the second light receiving unit 32B.
  • the first light receiving unit 32A and the second light receiving unit 32B may be any one that can convert received light into a predetermined signal, and may be a CCD, a CMOS, or the like.
  • a spectral filter may be provided to extract only a specific wavelength.
  • a condensing lens may be provided for effective implementation with low energy irradiation.
  • the processing unit 25 calculates a blood glucose level as a value of a predetermined component in the body fluid based on a signal obtained from the measurement light, and a predetermined range in which the blood glucose level is included based on the signal obtained from the measurement light And a prediction unit 25B that predicts. A specific processing method will be described later (see FIG. 5A or 5B).
  • the blood glucose measurement chip 12 is a disposable type, and is attached to the blood glucose meter 11 before the start of measurement, and is removed from the blood glucose meter 11 after the measurement is completed.
  • the blood glucose measurement chip 12 includes a first coloring reagent 121A and a second coloring reagent 121B, and a base member 122.
  • the first coloring reagent 121A and the second coloring reagent 121B have a property of reacting with blood to develop color.
  • reagents include (i) glucose oxidase (GOD), (ii) peroxidase (POD), and (iii) 1- (4-sulfophenyl) -2,3-dimethyl-4-amino-5- Mixed reagent of pyrazolone and (iv) N-ethyl-N- (2-hydroxy-3-sulfopropyl) -3,5-dimethylaniline, sodium salt, monohydrate (MAOS), or glucose dehydrogenase (GDH) And a mixed reagent of tetrazolium salt and an electron mediator.
  • GOD glucose oxidase
  • POD peroxidase
  • 1- (4-sulfophenyl) -2,3-dimethyl-4-amino-5- Mixed reagent of pyrazolone and (iv) N-ethyl
  • the first coloring reagent 121A and the second coloring reagent 121B are provided on the base member 122 by coating or the like.
  • the first coloring reagent includes glucose dehydrogenase (GDH) and 3- (4,5-dimethyl-2-thiazolyl) -2,5-diphenyl bromide.
  • FIG. 3A (a) is a top view of the blood glucose measurement chip 12 according to an embodiment of the present invention.
  • Two kinds of coloring reagents 121A and 121B having different molar extinction coefficients are held at different positions of the base member 122.
  • the one having the larger molar extinction coefficient is the first coloring reagent 121A
  • the one having the smaller molar extinction coefficient is the second coloring reagent 121B.
  • FIG. 3A (b) is a DD cross-sectional view of FIG. 3A (a).
  • the base member 122 has a groove at the center, and includes a first coloring reagent 121A and a second coloring reagent 121B at the groove bottom.
  • this groove functions as a flow path 124 for carrying blood.
  • a supply part 123 serving as one end of the flow path 124 is formed at the tip of the blood glucose measurement chip 12, and blood can be supplied from the supply part 123.
  • the blood supplied to the supply unit 123 is accurately guided to the holding positions of the first coloring reagent 121A and the second coloring reagent 121B by the partitioned flow path 124 without spilling on the way.
  • one end side where the supply unit 123 is formed is an upstream side
  • the other end side where the first coloring reagent 121A and the second coloring reagent 121B are held is a downstream side.
  • the shape and dimension of the cross section of the base member 122 are not limited to the shape of the embodiment.
  • the cross section of the groove as the flow path 124 may be an arc.
  • the base member may have a cross-sectional shape surrounding the flow path 124, and such a configuration may be formed of a bottom plate member and a lid member as a cover thereof.
  • the flow path 124 may not be partitioned and the supply unit 123 may not be provided.
  • FIG. 3B is a top view showing a blood glucose measurement chip as a modification of the blood glucose measurement chip 12 shown in FIG. 3A.
  • the first coloring reagent 121A may be arranged on the upstream side, and the second coloring reagent 121B may be arranged on the downstream side.
  • the first coloring reagent 121A may be arranged on the downstream side, and the second coloring reagent 121B may be arranged on the upstream side.
  • FIG. 3B is a top view showing a blood glucose measurement chip as a modification of the blood glucose measurement chip 12 shown in FIG. 3A.
  • the first coloring reagent 121A may be arranged on the upstream side
  • the second coloring reagent 121B may be arranged on the downstream side.
  • the second coloring reagent 121B may be arranged on the upstream side.
  • 3B (b), three or more kinds of coloring reagents having different molar extinction coefficients are used, and the first coloring reagent 121A and the second coloring reagent are sequentially arranged from the upstream side to the downstream side.
  • 121B and a third coloring reagent 121C having a molar extinction coefficient smaller than that of the second coloring reagent 121B may be provided.
  • FIG. 4 is a graph showing an example of the relationship between the absorbance and blood glucose level of the first coloring reagent 121A and the second coloring reagent 121B.
  • the horizontal axis 201 is absorbance
  • the vertical axis 202 is blood glucose level.
  • the blood glucose level is the mass of glucose contained in blood per unit volume, and mg / dL is used as the unit.
  • the relationship between the absorbance and the blood glucose level can be expressed by a linear function (straight line).
  • the first color-developing reagent 121A having a large molar extinction coefficient has a large absorbance even at a low blood glucose level, and therefore the slope of the straight line is small (see reference numeral “203” in FIG. 4).
  • the second color developing reagent 121B having a small molar extinction coefficient has a small absorbance even at a high blood glucose level, and therefore has a large slope of the straight line (see reference numeral “204” in FIG. 4).
  • a coloring reagent having a large molar extinction coefficient (the first coloring reagent 121A in this embodiment) is in the low blood glucose measurement range W1
  • a coloring reagent having a small molar extinction coefficient (the second coloring reagent 121B in this embodiment) is high.
  • Each is suitable for the blood glucose level measurement range W2. Further, this relational expression is used as a calibration curve by the processing unit 25 in the blood glucose level calculation process described later.
  • the range of the blood glucose level that is not more than the threshold value of absorbance is the measurement range of the low blood glucose level, and the blood glucose level of which absorbance is not less than the threshold value.
  • the range was defined as the range of high blood glucose level.
  • the material of the base member 122 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. Transparent inorganic materials.
  • the blood glucose meter 11 When the power button 112 is pressed, the blood glucose meter 11 is activated. The blood glucose measurement chip 12 is attached to the attachment hole 23.
  • the first color reagent 121A and the second color reagent are punctured with a puncture device, for example, a fingertip, and the small amount of blood that has flowed out from the supply unit 123 through the flow path 124. And the coloring reagent 121B.
  • a puncture device for example, a fingertip
  • the first irradiation unit 31A alternately irradiates light from the first light emitting element and the second light emitting element to the reaction product of the first coloring reagent 121A and blood.
  • the second irradiation unit 31B alternately irradiates light from the first light emitting element and the second light emitting element to the reaction product of the second coloring reagent 121B and blood.
  • the first light receiving unit 32A receives, as measurement light, transmitted light that has passed through a reaction product between the first coloring reagent 121A and blood.
  • the second light receiving unit 32B receives, as measurement light, transmitted light that has passed through a reaction product between the second coloring reagent 121B and blood.
  • the processing unit 25 calculates the absorbance based on a signal having a magnitude corresponding to the intensity of the transmitted light.
  • the blood glucose measurement chip 12 includes two kinds of color developing reagents 121A and B, the first absorbance relating to the reaction product of the first color developing reagent 121A and blood, and the second color developing reagent 121B. Two kinds of absorbances are obtained, that is, a second absorbance related to a reaction product of blood and blood.
  • the processing unit 25 calculates the blood glucose level using these two types of absorbance.
  • a processing method of blood glucose level calculation performed by the processing unit 25 will be described.
  • FIG. 5A is a flowchart for explaining the processing method of the processing unit 25.
  • the calculation unit 25A calculates the absorbance based on the intensity of transmitted light from each reaction product (step S1). S2).
  • the prediction unit 25B predicts a range to which the blood glucose level belongs.
  • a predetermined threshold is set for the first absorbance related to the first coloring reagent 121A (for example, 1.0). This predetermined threshold value is registered in the storage unit of the blood glucose meter 11 in advance.
  • the prediction unit 25B determines whether or not the first absorbance is less than a predetermined threshold value (step S3).
  • a predetermined threshold it is predicted that the blood glucose level belongs to a range lower than the predetermined value (see reference numeral “205” in FIG. 4).
  • the value is equal to or higher than the predetermined threshold, it is predicted that the blood glucose level does not belong to a range lower than the predetermined value, that is, belongs to a higher range equal to or higher than the predetermined value (number “206” in FIG. "reference).
  • the first coloring reagent 121A having a large molar extinction coefficient is suitable for measurement of a low blood glucose level
  • the second coloring reagent 121B having a small molar extinction coefficient is suitable for measurement of a high blood sugar level. Accordingly, when the predicting unit 25B determines that the value is less than the predetermined threshold value, the calculating unit 25A calculates a blood glucose level based on the first absorbance related to the first coloring reagent 121A (step S4). On the other hand, when the prediction unit 25B determines that the value is equal to or greater than the predetermined threshold value, the calculation unit 25A calculates a blood glucose level based on the second absorbance related to the second coloring reagent 121B (step S5).
  • step S4 Specific calculation method of blood glucose level is shown.
  • the blood glucose level is calculated based on the first absorbance (step S4)
  • the first absorbance is calculated based on the absorbance of light having the first wavelength emitted from the first light emitting element according to the first irradiation unit 31A.
  • the degree of coloration produced by the reaction between the coloring reagent 121A and blood is measured, and the blood glucose level is estimated with reference to the calibration curve (see FIG. 4) showing the relationship between the absorbance and the blood sugar level.
  • the red blood cell concentration is measured based on the absorbance of light having the second wavelength emitted from the second light emitting element according to the first irradiation unit 31A.
  • the blood glucose level is corrected using the hematocrit value obtained from the red blood cell concentration, and the blood glucose level is calculated.
  • step S5 when calculating the blood glucose level based on the second absorbance (step S5), first, by the absorbance of the light having the first wavelength emitted from the first light emitting element according to the second irradiation unit 31B, The degree of color development produced by the reaction between the second color development reagent 121B and blood is measured, and the blood glucose level is estimated with reference to the calibration curve (see FIG. 4) showing the relationship between the absorbance and the blood glucose level. Next, the red blood cell concentration is measured based on the absorbance of light having the second wavelength emitted from the second light emitting element related to the second irradiation unit 31B. The blood glucose level is corrected using the hematocrit value obtained from the red blood cell concentration, and the blood glucose level is calculated.
  • the calculated blood glucose level is displayed on the display 111 (step S6).
  • FIG. 5B shows a modification of the processing method performed by the processing unit 25.
  • a predetermined threshold value may be provided as a reference value for the amount of transmitted light that is the intensity of transmitted light. That is, after the blood is attached to the first coloring reagent 121A and the second coloring reagent 121B and reacted (Step S1), the light receiving units 32A and 32B acquire the transmission amount from each reactant (Step S2). .
  • the prediction unit 25B determines whether or not the first permeation amount related to the first coloring reagent 121A is less than a predetermined threshold value (step S3).
  • the calculation unit 25A calculates the blood glucose level based on the second permeation amount relating to the second color reagent 121B (step S4).
  • the prediction unit 25B determines that the value is equal to or greater than the predetermined threshold value
  • the calculation unit 25A calculates a blood glucose level based on the first permeation amount related to the first coloring reagent 121A (step S5).
  • the processing unit 25 calculates the value of the predetermined component based on the range predicted by the prediction unit. Then, the blood glucose level as the final result is displayed on the display 111 (step S6).
  • the predetermined threshold value as the absorbance reference value is 1.0, but may be another value, preferably 0.5 to 1.5, more preferably 0.7 to 1. By providing the reference value in the range of .3, better accuracy can be ensured.
  • the reference is provided for the first absorbance relating to the first coloring reagent 121A, the reference may be provided for the second absorbance relating to the second coloring reagent 121B.
  • a reference may be provided for the second transmission amount related to the second coloring reagent 121B.
  • a color reagent of a different type from the first color reagent 121A and the second color reagent 121B may be further provided, and a reference value may be set for the absorbance and transmission amount of the color reagent and used for prediction.
  • the absolute value of the difference between the calculated absorbance and a predetermined absorbance (for example, 1.0) as a reference value is compared, and the absorbance of the coloring reagent showing the smallest value is used for calculating the blood glucose level.
  • a predetermined absorbance for example, 1.0
  • the absolute value of the difference between the acquired transmission amount and a predetermined transmission amount for example, 150
  • the transmission amount of the coloring reagent showing the smallest value is determined.
  • the method of using for calculation of a blood glucose level may be used. These methods are particularly effective when three or more coloring reagents having different molar extinction coefficients can be used.
  • the calculation unit 25A may first calculate each blood glucose level for each absorbance, and select the optimum one based on the result of the prediction unit 25B. According to this method, the blood sugar level itself calculated by the calculation unit 25A can be used for prediction.
  • the used blood glucose measuring chip 12 is removed from the blood glucose meter 11.
  • the removal lever 114 is pulled, the eject pin 26 interlocked in the blood glucose meter 11 slides in the extending direction and the blood glucose measuring chip 12 is pushed out.
  • the power button 112 is pressed, the blood glucose meter 11 stops.
  • the first embodiment it is possible to realize a wide range of measurement from a low blood glucose level to a high blood glucose level, which is limited in the measurement with the conventional single color reagent, with one blood glucose measurement chip. It becomes possible. Thereby, a blood glucose meter set with high reproducibility in repeated measurement can be provided.
  • FIG. 6A is a top view showing a modification of the blood glucose measurement chip shown in FIG.
  • FIG. 6B is a cross-sectional view taken along the line EE of FIG.
  • the blood glucose measurement chip 12 has a base member 122.
  • the base member 122 has a flat bottom plate member 131 provided with the first coloring reagent 121A and the second coloring reagent 121B, and the thickness direction of the bottom plate member. This is realized by a spacer member 132 formed by double-sided tape or the like at both ends in the width direction that goes straight, and a lid member 133 laid over the spacer member 132.
  • the material of the bottom plate member 131 and the lid member 133 it is preferable to use a transparent material for light transmission, like the material of the base member 122 described above.
  • the base member 122 of the blood glucose measurement chip 12 communicates with a supply port 125 as a supply unit that supplies blood as a body fluid to the holding position of the coloring reagent (same as the reaction position in FIG. 6) from the supply port 125.
  • the flow path 124 is partitioned.
  • a substantially semi-elliptical cutout 141 is formed in the bottom plate member 131 and the lid member 133. Thereby, blood can be easily drawn into the flow path 124 from the supply port 125.
  • the cross-sectional shape is substantially square, and the cross-sectional thickness of the blood glucose measurement chip 12 is 100 ⁇ m or less. Is preferred. This is because the amount of blood to be used is reduced and the effect of capillary action described below is sufficiently obtained.
  • a small amount of blood that has flowed out of the fingertip or the like is spotted on the supply port 125.
  • Blood is sucked into the flow path 124 from the supply port 125 by capillary action and guided to the reaction position. Therefore, blood adheres to the first coloring reagent 121A and the second coloring reagent 121B, and each reaction starts. Capillary action allows blood to flow smoothly, and as a result, blood can be quickly guided to the reaction position.
  • the base member 122 includes a partition 126 between a position where the first coloring reagent 121A is held and a position where the second coloring reagent 121B is held.
  • the partition part is provided between different positions where two or more kinds of coloring reagents 121A and 121B having different molar extinction coefficients are held.
  • the partition 126 can physically separate the reaction product of the first coloring reagent 121A and the blood and the reaction product of the second coloring reagent 121B and the blood, enabling more accurate measurement. It becomes.
  • reaction product of the coloring reagent and blood may be moved by a flow channel means and measured at a position different from the reaction position.
  • FIG. 7A is a longitudinal sectional view showing a blood glucose meter set 2 as an embodiment of the present invention.
  • FIG. 7B is the figure which extracted the irradiation part, the light-receiving part, and the blood glucose measurement chip
  • the blood glucose meter set 2 includes a blood glucose measurement chip 14 and a blood glucose meter 13. Each will be described below.
  • the same components as those in the blood glucose meter set 1 described above are denoted by the same reference numerals, and detailed description thereof is omitted.
  • the blood glucose measurement chip 14 has a base member 122. Moreover, it differs from the blood glucose measurement chip 12 shown in FIG. 6 in that a reflection film as a reflection part 127 that reflects light is provided inside the base member 122.
  • the reflecting portion 127 In order to reflect light, it is necessary to color the reflecting portion 127.
  • the coloration is not limited as long as it can be efficiently reflected without absorbing the irradiation wavelength, but white is most preferable.
  • Materials include polypropylene (PP), polyethylene (PE), polystyrene (PS), polycarbonate (PC), acrylic (PMMA), polyethylene terephthalate (PET), cyclic polyolefin (COP) and cyclic olefin copolymer (COC).
  • PP polypropylene
  • PE polyethylene
  • PS polystyrene
  • PC polycarbonate
  • acrylic PMMA
  • PET polyethylene terephthalate
  • COP cyclic polyolefin
  • COC cyclic olefin copolymer
  • titanium oxide, silicon dioxide, barium sulfate, aluminum, zinc, nickel, chromium, etc. are treated by means such as vacuum deposition, sputtering, or plating to obtain
  • the reflecting surface may be obtained by adding a certain amount of titanium oxide, silicon dioxide, barium sulfate or the like to the resin.
  • the reflection part 127 of this embodiment is provided in the position which opposes the 1st coloring reagent 121A and the 2nd coloring reagent 121B among the inner surfaces of the cover member 133. FIG.
  • the arrangement of the optical measurement unit 27 is different from the arrangement of the optical measurement unit 24 of the blood glucose meter 11 according to the first embodiment described above. Further, the light receiving unit 34 constituting the optical measuring unit 27 is different from the above-described light receiving units 32A and 32B in that the light reflected by the reflecting unit 127 is received.
  • the blood glucose meter 13 is divided into one space 43, in which a first irradiation unit 31A and a second irradiation unit 31B, and a first light receiving unit 34A and a second light receiving unit 34B are installed. ing. Although not shown in FIG. 7A, the second light receiving unit 34B is arranged at a position overlapping the first light receiving unit 34A in a direction perpendicular to the paper surface of FIG. 7A.
  • the first irradiation unit 31A and the second irradiation unit 31B, the first light receiving unit 34A and the second light receiving unit 34B, are arranged on one side of the blood measurement chip 14 in the thickness direction of the blood measurement chip 14. Further, the first irradiation unit 31A and the first light receiving unit 34A are arranged at positions where the irradiation light 33A can pass through the reactant, be reflected by the reflection unit 127, and be received by the first light receiving unit 34A. Has been.
  • the second irradiation unit 31B and the second light receiving unit 34B are arranged at positions where the irradiation light 33B can pass through the reaction product, be reflected by the reflection unit 127, and be received by the second light receiving unit 34B.
  • the first irradiation unit 31A and the second irradiation unit 31B are arranged at positions that overlap the first light receiving unit 34A and the second light receiving unit 34B, respectively, in a direction perpendicular to the paper surface of FIG. 7B.
  • the first irradiation unit 31A and the second irradiation unit 31B are indicated by dotted lines.
  • the blood glucose measuring chip 14 After attaching the blood glucose measuring chip 14 to the blood glucose meter 13, blood is supplied to the supply port 125.
  • the reaction starts when the blood reaches the first coloring reagent 121A and the second coloring reagent 121B.
  • the irradiation light 33A applied to the reactant is reflected by the reflection unit 127 described above, and is received by the first light receiving unit 34A as measurement light. Further, the irradiation light 33B is reflected by the reflection unit 127 described above, and is received by the second light receiving unit 34B as measurement light.
  • the blood glucose level is calculated by the processing unit 25 and the result is displayed on the display 111.
  • the processing method of the processing unit 25 is the same as that shown in the blood glucose meter set 1 (see FIG. 5A or FIG. 5B).
  • the blood glucose meter set 2 has the same effect as the blood glucose meter set 1 described above.
  • the component measuring device may be other than a blood glucose meter as long as the component measurement using absorbance is performed. That is, the body fluid may be other than blood (for example, urine), and the predetermined component may be other than blood glucose level (for example, protein, enzyme, etc.).
  • a blood suction / discharge mechanism (not shown) is installed on the blood glucose meter 11 side, and blood that has been collected in advance using a blood collection tube or the like using the discharge mechanism is used. You may discharge directly to the 1st coloring reagent 121A and the 2nd coloring reagent 121B.
  • the present invention relates to a component measuring device set and a body fluid measuring chip.

Abstract

A component measurement device set (1) for measuring a predetermined component in a body fluid, characterized by comprising: a body fluid measurement chip (12, 14) that has chromogenic reagents (121); irradiation units (31) that irradiate light on reaction products of the body fluid and the chromogenic reagents (121); light receiving units (32) that receive measurement light that has passed through the reaction products; and a processing unit (25) that processes signals obtained from the measurement light; wherein the body fluid measurement chip (12, 14) comprises a base member (122), and at least two chromogenic reagents (121) having molar absorption coefficients differing from one another are held in different locations on the base member (122).

Description

成分測定装置セット及び体液測定チップComponent measuring device set and body fluid measuring chip
　本発明は、成分測定装置セット及び体液測定チップに関する。 The present invention relates to a component measuring device set and a body fluid measuring chip.
　従来、血液や尿等の体液中の所定成分を測定する成分分析装置が広く普及している。測定原理として、発色試薬に体液を付着させて反応させ、発色度合を光学的に測定する方式が広く採用されている（特許文献１参照）。 Conventionally, component analyzers for measuring predetermined components in body fluids such as blood and urine have become widespread. As a measurement principle, a method of optically measuring the degree of color development by attaching a body fluid to a color-developing reagent and reacting it is widely adopted (see Patent Document 1).
　近年では、糖尿病患者の増加に伴い、患者自身が血糖値を測定できる簡易型の血糖計が利用されている。このような簡易型の血糖計には、発色試薬を有する使い捨てタイプの体液測定チップが用いられる（特許文献２参照）。 In recent years, with an increase in the number of diabetic patients, simple blood glucose meters that can measure blood glucose levels themselves have been used. In such a simple blood glucose meter, a disposable body fluid measuring chip having a coloring reagent is used (see Patent Document 2).
　この体液測定チップに関する発明では、例えば、特許文献３では、迅速な測定を可能にするため、体液が流入可能な流入口と、この流入口に連通する体液通路と、を有し、複数の突起を有する体液展開部に成分測定用の試薬を塗布し、この体液展開部よりも体液の流れ方向の下流側に測定部を設ける構成が開示されている（特許文献３参照）。 In the invention related to the body fluid measuring chip, for example, in Patent Document 3, in order to enable quick measurement, the body fluid measuring chip has an inflow port through which a body fluid can flow and a bodily fluid passage communicating with the inflow port. A configuration is disclosed in which a reagent for component measurement is applied to a body fluid developing part having a measuring part, and a measuring part is provided downstream of the body fluid developing part in the body fluid flow direction (see Patent Document 3).
特許文献１：特表平１０－５０５６７６号公報 Patent Document 1: Japanese Patent Publication No. 10-505676
特許文献２：特開２０１１－６４５９６号公報 Patent Document 2: JP 2011-64596 A
特許文献３：国際公開第２０１４／０４９７０４号 Patent Document 3: International Publication No. 2014/049744
　近年の市場ニーズとして、低血糖値から高血糖値までの広いレンジを精度よく測定することが課題となっている。 As a recent market need, it has been an issue to accurately measure a wide range from low blood glucose level to high blood glucose level.
　しかしながら、発色試薬は種類によりモル吸光係数が異なり、これにより１つの種類の発色試薬で精度よく測定できるレンジは限られている。上記の先行技術文献で開示されている発明は、一つの体液測定チップに単一の発色試薬を保持する方式を前提としており、高血糖と低血糖を同一の体液測定チップでそれぞれ精度よく測定することまでは想定されていない。 However, the molar extinction coefficient varies depending on the type of coloring reagent, and this limits the range that can be accurately measured with one type of coloring reagent. The invention disclosed in the above prior art documents is based on the premise that a single coloring reagent is held in one body fluid measurement chip, and each of the same body fluid measurement chip measures high blood sugar and low blood sugar with high accuracy. It is not envisaged.
　また、血糖計に限らず、吸光度を利用した他の成分測定装置においても、同様の課題がある。 In addition to the blood glucose meter, other component measuring devices using absorbance also have the same problem.
　本発明はこのような課題を考慮してなされたものであり、吸光度に基づく測定精度の変動を抑制可能な成分測定装置セット及び体液測定チップを提供することを目的とする。 The present invention has been made in view of such problems, and an object of the present invention is to provide a component measurement device set and a body fluid measurement chip that can suppress fluctuations in measurement accuracy based on absorbance.
　本発明の第１の態様としての成分測定装置セットは、体液中の所定成分を測定する成分測定装置セットであって、発色試薬を有する体液測定チップと、前記体液と前記発色試薬との反応物に光を照射する照射部と、前記反応物を透過した測定光を受光する受光部と、前記測定光から得られる信号を処理する処理部と、を備え、前記体液測定チップは、ベース部材を備え、前記発色試薬は、前記ベース部材の異なる位置に保持されたモル吸光係数が互いに異なる２種以上の発色試薬であることを特徴とするものである。 The component measuring device set according to the first aspect of the present invention is a component measuring device set for measuring a predetermined component in a body fluid, a body fluid measuring chip having a color developing reagent, and a reaction product of the body fluid and the color developing reagent. An irradiating unit that irradiates light, a light receiving unit that receives measurement light transmitted through the reactant, and a processing unit that processes a signal obtained from the measurement light, wherein the body fluid measurement chip includes a base member And the color reagent is two or more color reagents having different molar extinction coefficients held at different positions on the base member.
　本発明の第２の態様としての体液測定チップは、発色試薬を有する体液測定チップであって、ベース部材を備え、前記発色試薬は、前記ベース部材の異なる位置に保持された少なくとも２種以上のモル吸光係数が互いに異なる発色試薬であることを特徴とするものである。 The body fluid measurement chip according to the second aspect of the present invention is a body fluid measurement chip having a coloring reagent, comprising a base member, wherein the coloring reagent is at least two or more kinds held at different positions of the base member. It is characterized in that it is a coloring reagent having different molar extinction coefficients.
　本発明によると、吸光度に基づく測定精度の変動を抑制することができる。 According to the present invention, fluctuations in measurement accuracy based on absorbance can be suppressed.
本発明の一実施形態に係る血糖計セットを示す平面図である。It is a top view which shows the blood glucose meter set which concerns on one Embodiment of this invention. 図１に示す血糖計セットの血糖計及び血糖測定チップを別々に示す縦断面図である。It is a longitudinal cross-sectional view which shows separately the blood glucose meter and blood glucose measurement chip | tip of the blood glucose meter set shown in FIG. 図２Ａに示す血糖計に血糖測定チップが装着された状態を示す縦断面図である。It is a longitudinal cross-sectional view which shows the state with which the blood glucose measuring chip was mounted | worn with the blood glucose meter shown to FIG. 2A. 図１に示す血糖計セットから照射部、受光部及び血糖測定チップを抜き出して背面側から見た図である。It is the figure which extracted the irradiation part, the light-receiving part, and the blood glucose measurement chip | tip from the blood glucose meter set shown in FIG. 1, and was seen from the back side. 本発明の一実施形態に係る血糖測定チップの図である。It is a figure of the blood glucose measuring chip concerning one embodiment of the present invention. 図３Ａに示す血糖測定チップの変形例としての血糖測定チップを示す上面図である。It is a top view which shows the blood glucose measurement chip | tip as a modification of the blood glucose measurement chip | tip shown to FIG. 3A. 発色試薬の吸光度と血糖値の関係を例示するグラフである。It is a graph which illustrates the relationship between the light absorbency of a coloring reagent, and a blood glucose level. 図１に示す血糖計セットの処理部の処理方法を説明するフローチャートである。It is a flowchart explaining the processing method of the process part of the blood glucose meter set shown in FIG. 図５Ａに示す血糖計セットの処理部の処理方法の変形例を示すフローチャートである。It is a flowchart which shows the modification of the processing method of the process part of the blood glucose meter set shown to FIG. 5A. 図３Ａに示す血糖測定チップの変形例としての血糖測定チップを示す図である。It is a figure which shows the blood glucose measurement chip | tip as a modification of the blood glucose measurement chip | tip shown to FIG. 3A. 本発明の一実施形態としての血糖計セットを示す縦断面図である。It is a longitudinal cross-sectional view which shows the blood glucose meter set as one Embodiment of this invention. 図１に示す血糖計セットから照射部、受光部及び血糖測定チップを抜き出して背面側から見た図である。It is the figure which extracted the irradiation part, the light-receiving part, and the blood glucose measurement chip | tip from the blood glucose meter set shown in FIG. 1, and was seen from the back side.
　以下、本発明の実施形態を、図１～図７を参照して説明する。なお、各図において共通の部材には、同一の符号を付している。 Hereinafter, embodiments of the present invention will be described with reference to FIGS. In addition, the same code | symbol is attached | subjected to the common member in each figure.
＜実施形態１＞
　図１は本発明の一実施形態に係る成分測定装置セットとしての血糖計セット１を示す。血糖計セット１は、成分測定装置としての血糖計１１と体液測定チップとしての血糖測定チップ１２と、を備えている。当該血糖測定チップ１２は血糖計１１の先端部に装着される。血糖計１１は、測定結果や操作内容などを表示するディスプレー１１１と、血糖計１１の起動と終了を指示する電源ボタン１１２と、操作ボタン１１３と、血糖測定チップ１２を取り外す取外レバー１１４と、を備えている。ディスプレー１１１は、液晶またはＬＥＤ等で構成される。 <Embodiment 1>
FIG. 1 shows a blood glucose meter set 1 as a component measuring apparatus set according to an embodiment of the present invention. The blood glucose meter set 1 includes a blood glucose meter 11 as a component measurement device and a blood glucose measurement chip 12 as a body fluid measurement chip. The blood glucose measurement chip 12 is attached to the tip of the blood glucose meter 11. The blood glucose meter 11 includes a display 111 for displaying measurement results and operation details, a power button 112 for instructing activation and termination of the blood glucose meter 11, an operation button 113, a removal lever 114 for removing the blood glucose measurement chip 12, It has. The display 111 is composed of a liquid crystal or LED.
　図２Ａは血糖計セット１の血糖計１１の先端部及び血糖測定チップ１２を別々に示す縦断面図である。血糖計１１の先端部には、血糖測定チップ１２を装着する装着孔２３を区画する装着部２２が設けられている。また、血糖計１１の内部には、血糖測定チップ１２に採取した体液（本実施形態では血液）の所定成分（本実施形態では血糖値）を測定するための光学測定部２４を設ける。また、血糖計１１は、測定光から得られる信号を処理し血糖値を算出する処理部２５を備える。また、前記装着孔２３に連通する開口に、取外レバー１１４と連動し血糖測定チップ１２を取り外すイジェクトピン２６を備える。以下、各構成について説明する。 FIG. 2A is a longitudinal sectional view separately showing the tip of the blood glucose meter 11 of the blood glucose meter set 1 and the blood glucose measurement chip 12. At the tip of the blood glucose meter 11, a mounting portion 22 that partitions a mounting hole 23 for mounting the blood glucose measuring chip 12 is provided. In addition, an optical measurement unit 24 for measuring a predetermined component (blood glucose level in the present embodiment) of body fluid (blood in the present embodiment) collected in the blood glucose measurement chip 12 is provided inside the blood glucose meter 11. The blood glucose meter 11 includes a processing unit 25 that processes a signal obtained from the measurement light and calculates a blood glucose level. In addition, the opening communicating with the mounting hole 23 is provided with an eject pin 26 for detaching the blood sugar measuring chip 12 in conjunction with the removal lever 114. Each configuration will be described below.
　図２Ｂは、図２Ａに示した血糖計１１に血糖測定チップ１２が装着された状態を示す断面図、すなわち血糖計セット１の先端部の断面図である。図２Ｃは、図２Ｂに示した血糖計セット１のうち、第１の照射部３１Ａ及び第２の照射部３１Ｂと、第１の受光部３２Ａ及び第２の受光部３２Ｂと、血糖測定チップ１２と、を抜き出して背面側（図２Ｂの右側）から見た図である。図２Ｂに示すように、測定の際は、血糖測定チップ１２が装着孔２３に装着される。装着作業はユーザーにより手作業で行われる。図示はしないが、手作業より生ずる装着位置のバラツキを最小限にするために、好ましくは、血糖測定チップ１２を装着孔２３内の所定位置に固定するための適当なロック機構等を設置する。 FIG. 2B is a cross-sectional view showing a state in which the blood glucose measurement chip 12 is attached to the blood glucose meter 11 shown in FIG. 2A, that is, a cross-sectional view of the distal end portion of the blood glucose meter set 1. 2C shows the blood glucose meter set 1 shown in FIG. 2B, the first irradiation unit 31A and the second irradiation unit 31B, the first light receiving unit 32A and the second light receiving unit 32B, and the blood glucose measurement chip 12. It is the figure which was extracted from the back side (right side of FIG. 2B). As shown in FIG. 2B, the blood glucose measurement chip 12 is mounted in the mounting hole 23 during measurement. The mounting operation is performed manually by the user. Although not shown, in order to minimize the variation of the mounting position caused by manual work, an appropriate lock mechanism or the like for fixing the blood glucose measurement chip 12 to a predetermined position in the mounting hole 23 is preferably installed.
　図２Ｃに示すように、光学測定部２４は、照射部３１と、受光部３２と、を備える。より具体的には、本実施形態の光学測定部２４は、後述する第１の発色試薬１２１Ａと血液との反応物に光を照射する第１の照射部３１Ａと、後述する第２の発色試薬１２１Ｂと血液との反応物に光を照射する第２の照射部３１Ｂと、当該第１の発色試薬１２１Ａと血液との反応物を透過した光を測定光として受光する第１の受光部３２Ａと、当該第２の発色試薬１２１Ｂと血液との反応物を透過した光を測定光として受光する第２の受光部３２Ｂと、を備えている。 As shown in FIG. 2C, the optical measurement unit 24 includes an irradiation unit 31 and a light receiving unit 32. More specifically, the optical measurement unit 24 of the present embodiment includes a first irradiation unit 31A that irradiates a reaction product of a first coloring reagent 121A and blood described later, and a second coloring reagent described later. A second irradiating unit 31B for irradiating a reaction product of 121B and blood with light, and a first light receiving unit 32A for receiving light transmitted through the reaction product of the first color reagent 121A and blood as measurement light; And a second light receiving unit 32B that receives, as measurement light, light transmitted through the reaction product of the second coloring reagent 121B and blood.
　血糖計１１の内部には、装着孔２３と連通する第１の空間４１と第２の空間４２とが形成されている。第１の照射部３１Ａ及び第２の照射部３１Ｂは当該第１の空間４１に、第１の受光部３２Ａ及び第２の受光部３２Ｂは当該第２の空間４２に、それぞれ配置されている。血糖測定チップ１２が血糖計１１に装着されていない状態では、当該第１の空間４１と、当該第２の空間４２とは、装着孔２３を挟んで対向する（図２Ａ参照）。血糖測定チップ１２が血糖計１１に装着された状態では、当該第１の空間４１と、当該第２の空間４２とは、当該血糖測定チップ１２の第１の発色試薬１２１Ａ及び第２の発色試薬１２１Ｂが保持されている位置を挟んで対向する（図２Ｂ参照）。 In the blood glucose meter 11, a first space 41 and a second space 42 communicating with the mounting hole 23 are formed. The first irradiation unit 31A and the second irradiation unit 31B are arranged in the first space 41, and the first light receiving unit 32A and the second light receiving unit 32B are arranged in the second space 42, respectively. In a state where the blood glucose measurement chip 12 is not attached to the blood glucose meter 11, the first space 41 and the second space 42 face each other with the attachment hole 23 therebetween (see FIG. 2A). In a state in which the blood glucose measurement chip 12 is attached to the blood glucose meter 11, the first space 41 and the second space 42 are the first coloring reagent 121A and the second coloring reagent of the blood glucose measurement chip 12. Opposing across the position where 121B is held (see FIG. 2B).
　図２Ｃに示すように、血糖測定チップ１２を装着孔２３に装着した状態では、第１の照射部３１Ａと第１の受光部３２Ａとは、後述する第１の発色試薬１２１Ａを挟んで対向する。また、第２の照射部３１Ｂと第２の受光部３２Ｂとは、後述する第２の発色試薬１２１Ｂを挟んで対向する。 As shown in FIG. 2C, in a state in which the blood glucose measurement chip 12 is mounted in the mounting hole 23, the first irradiation unit 31A and the first light receiving unit 32A face each other with a first coloring reagent 121A described later interposed therebetween. . Further, the second irradiation unit 31B and the second light receiving unit 32B are opposed to each other with a second coloring reagent 121B to be described later interposed therebetween.
　第１の受光部３２Ａは、血糖測定チップ１２を透過した第１の照射部３１Ａからの照射光３３Ａを損失なく受光できるように配置されるのが好ましい。また、第２の受光部３２Ｂは、血糖測定チップ１２を透過した第２の照射部３１Ｂからの照射光３３Ｂを損失なく受光できるように配置されるのが好ましい。例えば、後述するように、血糖測定チップ１２が平板状でありその底面が平面の場合は、第１の照射部３１Ａは照射光３３Ａが血糖測定チップ１２の底面に垂直に照射できる位置に、第２の照射部３１Ｂは照射光３３Ｂが血糖測定チップ１２の底面に垂直に照射できる位置に、それぞれ配置されるのが好ましい。 The first light receiving unit 32A is preferably arranged so that it can receive the irradiation light 33A from the first irradiation unit 31A transmitted through the blood sugar measurement chip 12 without loss. The second light receiving unit 32B is preferably arranged so that it can receive the irradiation light 33B from the second irradiation unit 31B transmitted through the blood sugar measurement chip 12 without loss. For example, as will be described later, when the blood glucose measurement chip 12 has a flat plate shape and the bottom surface is flat, the first irradiation unit 31A is positioned at a position where the irradiation light 33A can be irradiated vertically to the bottom surface of the blood glucose measurement chip 12. The two irradiation units 31B are preferably arranged at positions where the irradiation light 33B can be irradiated perpendicularly to the bottom surface of the blood glucose measurement chip 12.
　また、第１の照射部３１Ａ及び第２の照射部３１Ｂそれぞれは、第１の波長を有する光を発する第１の発光素子と、第１の波長と異なる第２の波長を有する光を発する第２の発光素子とを含む。ここで、第１の波長は、血糖量に応じた発色度合を測定するための波長であり、例えば６００～９００ｎｍの波長帯にある。第２の波長は、血液中の赤血球濃度を測定するための波長であり、例えば５１０～５９０ｎｍの波長帯にある。 In addition, each of the first irradiation unit 31A and the second irradiation unit 31B emits light having a first wavelength that emits light having a first wavelength and light having a second wavelength different from the first wavelength. 2 light emitting elements. Here, the first wavelength is a wavelength for measuring the degree of color development according to the blood glucose level, and is in the wavelength band of 600 to 900 nm, for example. The second wavelength is a wavelength for measuring the concentration of red blood cells in blood, for example, in the wavelength band of 510 to 590 nm.
　本実施形態では、第１の照射部３１Ａに係る第１の発光素子及び第２の発光素子と、第２の照射部３１Ｂに係る第１の発光素子及び第２の発光素子と、には発光ダイオード（ＬＥＤ）を用いるが、ハロゲンランプ、レーザー等であってもよい。また、第１の受光部３２Ａ及び第２の受光部３２Ｂには、例えば、フォトダイオード（ＰＤ）を用いる。第１の受光部３２Ａ及び第２の受光部３２Ｂは受光した光を所定の信号に変換できるものであればよく、ＣＣＤ、ＣＭＯＳ等であってもよい。 In the present embodiment, the first light emitting element and the second light emitting element related to the first irradiation unit 31A, and the first light emitting element and the second light emitting element related to the second irradiation unit 31B emit light. Although a diode (LED) is used, a halogen lamp, a laser, or the like may be used. For example, a photodiode (PD) is used for the first light receiving unit 32A and the second light receiving unit 32B. The first light receiving unit 32A and the second light receiving unit 32B may be any one that can convert received light into a predetermined signal, and may be a CCD, a CMOS, or the like.
　図示はしないが、照射部としてハロゲンランプを用いる場合は、特定の波長のみを抽出するために分光フィルタを設けてもよい。また、低エネルギーの照射で有効に実施するために、集光レンズを備えてもよい。 Although not shown, when a halogen lamp is used as the irradiation unit, a spectral filter may be provided to extract only a specific wavelength. In addition, a condensing lens may be provided for effective implementation with low energy irradiation.
　処理部２５は、測定光から得られる信号に基づいて体液中の所定成分の値としての血糖値を算出する算出部２５Ａと、測定光から得られる信号に基づいて血糖値が含まれる所定の範囲を予測する予測部２５Ｂと、を含む。具体的な処理方法は後述する（図５Ａまたは図５Ｂ参照）。 The processing unit 25 calculates a blood glucose level as a value of a predetermined component in the body fluid based on a signal obtained from the measurement light, and a predetermined range in which the blood glucose level is included based on the signal obtained from the measurement light And a prediction unit 25B that predicts. A specific processing method will be described later (see FIG. 5A or 5B).
　次に、血糖測定チップ１２の実施形態について詳細を説明する。当該血糖測定チップ１２は使い捨てタイプであり、測定の開始前に血糖計１１に装着され、測定終了後は血糖計１１から外される。 Next, details of the embodiment of the blood glucose measurement chip 12 will be described. The blood glucose measurement chip 12 is a disposable type, and is attached to the blood glucose meter 11 before the start of measurement, and is removed from the blood glucose meter 11 after the measurement is completed.
　血糖測定チップ１２は、第１の発色試薬１２１Ａ及び第２の発色試薬１２１Ｂと、ベース部材１２２と、を備える。 The blood glucose measurement chip 12 includes a first coloring reagent 121A and a second coloring reagent 121B, and a base member 122.
　第１の発色試薬１２１Ａ及び第２の発色試薬１２１Ｂは、血液と反応して発色する性質を有する。このような試薬としては、例えば、（ｉ）グルコースオキシダーゼ（ＧＯＤ）と（ｉｉ）ペルオキシダーゼ（ＰＯＤ）と（ｉｉｉ）１－（４－スルホフェニル）－２，３－ジメチル－４－アミノ－５－ピラゾロンと（ｉｖ）Ｎ－エチル－Ｎ－（２－ヒドロキシ－３－スルホプロピル）－３，５－ジメチルアニリン，ナトリウム塩，１水和物（ＭＡＯＳ）との混合試薬、あるいはグルコースデヒドロゲナーゼ（ＧＤＨ）とテトラゾリウム塩及び電子メディエーターとの混合試薬などが挙げられる。また、第１の発色試薬１２１Ａ及び第２の発色試薬１２１Ｂは、塗布等により、前記ベース部材１２２の上に設けられる。第１の発色試薬と第２の発色試薬の組み合わせ例として、第１の発色試薬に、グルコースデヒドロゲナーゼ（ＧＤＨ）と臭化３－（４，５－ジメチル－２－チアゾリル）－２，５－ジフェニル－２Ｈ－テトラゾリウム（ＭＴＴ）と塩化コバルトと１－メトキシ－５－メチルフェナジニウムメチルサルフェイト（1－メトキシＰＭＳ）との混合試薬（モル吸光係数ε=20,000（ＭＴＴコバルトキレートλ＝660nm））、第２の発色試薬に、グルコースデヒドロゲナーゼ（ＧＤＨ）と水溶性テトラゾリウム塩（ＷＳＴ－４）と１－メトキシ－５－メチルフェナジニウムメチルサルフェイト（1－メトキシＰＭＳ）との混合試薬（モル吸光係数ε=12,000（λ＝660nm））と、を用いることができる。 The first coloring reagent 121A and the second coloring reagent 121B have a property of reacting with blood to develop color. Examples of such reagents include (i) glucose oxidase (GOD), (ii) peroxidase (POD), and (iii) 1- (4-sulfophenyl) -2,3-dimethyl-4-amino-5- Mixed reagent of pyrazolone and (iv) N-ethyl-N- (2-hydroxy-3-sulfopropyl) -3,5-dimethylaniline, sodium salt, monohydrate (MAOS), or glucose dehydrogenase (GDH) And a mixed reagent of tetrazolium salt and an electron mediator. The first coloring reagent 121A and the second coloring reagent 121B are provided on the base member 122 by coating or the like. As an example of the combination of the first coloring reagent and the second coloring reagent, the first coloring reagent includes glucose dehydrogenase (GDH) and 3- (4,5-dimethyl-2-thiazolyl) -2,5-diphenyl bromide. -2H-tetrazolium (MTT), cobalt chloride and 1-methoxy-5-methylphenazinium methyl sulfate (1-methoxy PMS) mixed reagent (molar extinction coefficient ε = 20,000 (MTT cobalt chelate λ = 660 nm)) In addition, a mixed reagent (molar absorption) of glucose dehydrogenase (GDH), water-soluble tetrazolium salt (WST-4) and 1-methoxy-5-methylphenazinium methyl sulfate (1-methoxy PMS) was used as the second coloring reagent. The coefficient ε = 12,000 (λ = 660 nm) can be used.
　図３Ａ（ａ）は、本発明の一実施形態に係る血糖測定チップ１２の上面図である。ベース部材１２２の異なる位置に、互いにモル吸光係数が異なる２種類の発色試薬１２１Ａ、１２１Ｂが保持されている。本実施形態では、モル吸光係数が大きい方を第１の発色試薬１２１Ａと、小さい方を第２の発色試薬１２１Ｂと、する。 FIG. 3A (a) is a top view of the blood glucose measurement chip 12 according to an embodiment of the present invention. Two kinds of coloring reagents 121A and 121B having different molar extinction coefficients are held at different positions of the base member 122. In the present embodiment, the one having the larger molar extinction coefficient is the first coloring reagent 121A, and the one having the smaller molar extinction coefficient is the second coloring reagent 121B.
　図３Ａ（ｂ）は、図３Ａ（ａ）のＤ－Ｄ断面図である。ベース部材１２２は中央に溝を区画し、溝底部に、第１の発色試薬１２１Ａと、第２の発色試薬１２１Ｂと、を備える。また、この溝は、血液を運ぶ流路１２４としての機能を果たす。血糖測定チップ１２の先端部には、流路１２４の一端となる供給部１２３が形成されており、供給部１２３から血液を供給することが可能である。当該供給部１２３に供給された血液は、区画された流路１２４により、途中でこぼれることなく第１の発色試薬１２１Ａ及び第２の発色試薬１２１Ｂの保持位置まで正確に誘導される。ここで、流路１２４のうち、供給部１２３が形成された一端側を上流側と、第１の発色試薬１２１Ａ及び第２の発色試薬１２１Ｂが保持される他端側を下流側と、する。 FIG. 3A (b) is a DD cross-sectional view of FIG. 3A (a). The base member 122 has a groove at the center, and includes a first coloring reagent 121A and a second coloring reagent 121B at the groove bottom. In addition, this groove functions as a flow path 124 for carrying blood. A supply part 123 serving as one end of the flow path 124 is formed at the tip of the blood glucose measurement chip 12, and blood can be supplied from the supply part 123. The blood supplied to the supply unit 123 is accurately guided to the holding positions of the first coloring reagent 121A and the second coloring reagent 121B by the partitioned flow path 124 without spilling on the way. Here, in the flow path 124, one end side where the supply unit 123 is formed is an upstream side, and the other end side where the first coloring reagent 121A and the second coloring reagent 121B are held is a downstream side.
　なお、ベース部材１２２の断面の形状及び寸法は、当該実施形態の形状に限られない。例えば、流路１２４としての溝の横断面が円弧であってもよい。また、ベース部材が、流路１２４を取り囲む断面形状を有していてもよく、このような構成は底板部材とそのカバーとしての蓋部材と、から形成してもよい。また、血液を直接第１の発色試薬１２１Ａ及び第２の発色試薬１２１Ｂに付着させる方法による場合は、流路１２４を区画しなくてもよく、供給部１２３を備えなくてもよい。 In addition, the shape and dimension of the cross section of the base member 122 are not limited to the shape of the embodiment. For example, the cross section of the groove as the flow path 124 may be an arc. Further, the base member may have a cross-sectional shape surrounding the flow path 124, and such a configuration may be formed of a bottom plate member and a lid member as a cover thereof. Further, in the case of using a method in which blood is directly attached to the first coloring reagent 121A and the second coloring reagent 121B, the flow path 124 may not be partitioned and the supply unit 123 may not be provided.
　発色試薬の配置は、本実施形態に限られない。図３Ｂは、図３Ａに示した血糖測定チップ１２の変形例としての血糖測定チップを示す上面図である。例えば、図３Ｂ（ａ）に示すように、第１の発色試薬１２１Ａを上流側に、第２の発色試薬１２１Ｂを下流側に、配置してもよい。また、逆に、第１の発色試薬１２１Ａを下流側に、第２の発色試薬１２１Ｂを上流側に、配置してもよい。また、図３Ｂ（ｂ）に示すように、互いにモル吸光係数の異なる３種類以上の発色試薬を用い、上流側から下流側に向かって順に、第１の発色試薬１２１Ａと、第２の発色試薬１２１Ｂと、この第２の発色試薬１２１Ｂよりモル吸光係数の小さい第３の発色試薬１２１Ｃと、を設置してもよい。 The arrangement of the coloring reagent is not limited to this embodiment. FIG. 3B is a top view showing a blood glucose measurement chip as a modification of the blood glucose measurement chip 12 shown in FIG. 3A. For example, as shown in FIG. 3B (a), the first coloring reagent 121A may be arranged on the upstream side, and the second coloring reagent 121B may be arranged on the downstream side. Conversely, the first coloring reagent 121A may be arranged on the downstream side, and the second coloring reagent 121B may be arranged on the upstream side. Further, as shown in FIG. 3B (b), three or more kinds of coloring reagents having different molar extinction coefficients are used, and the first coloring reagent 121A and the second coloring reagent are sequentially arranged from the upstream side to the downstream side. 121B and a third coloring reagent 121C having a molar extinction coefficient smaller than that of the second coloring reagent 121B may be provided.
　図４に、上記の第１の発色試薬１２１Ａ及び第２の発色試薬１２１Ｂの吸光度と血糖値との関係の一例をグラフで示す。横軸２０１は吸光度、縦軸２０２は血糖値である。血糖値は、単位体積当たりの血液に含まれるグルコースの質量のことで、単位にはｍｇ／ｄＬが使われる。図４に示すように、吸光度と血糖値との関係は一次関数（直線）で表すことができる。モル吸光係数の大きい第１の発色試薬１２１Ａは、低血糖値でも吸光度が大きいため、直線の傾きが小さい（図４の符番「２０３」参照）。一方で、モル吸光係数の小さい第２の発色試薬１２１Ｂは、高血糖値でも吸光度が小さいため、直線の傾きが大きい（図４の符番「２０４」参照）。モル吸光係数の大きい発色試薬（本実施形態では第１の発色試薬１２１Ａ）は低血糖値の測定範囲Ｗ１に、モル吸光係数の小さい発色試薬（本実施形態では第２の発色試薬１２１Ｂ）は高血糖値の測定範囲Ｗ２に、それぞれ適している。また、この関係式は後述する血糖値の算出過程で処理部２５により検量線として用いられる。なお、本実施形態では、モル吸光係数の大きい第１の発色試薬において、吸光度のしきい値以下である血糖値の範囲を低血糖値の測定範囲、吸光度がしきい値以上である血糖値の範囲を高血糖値の範囲とした。 FIG. 4 is a graph showing an example of the relationship between the absorbance and blood glucose level of the first coloring reagent 121A and the second coloring reagent 121B. The horizontal axis 201 is absorbance, and the vertical axis 202 is blood glucose level. The blood glucose level is the mass of glucose contained in blood per unit volume, and mg / dL is used as the unit. As shown in FIG. 4, the relationship between the absorbance and the blood glucose level can be expressed by a linear function (straight line). The first color-developing reagent 121A having a large molar extinction coefficient has a large absorbance even at a low blood glucose level, and therefore the slope of the straight line is small (see reference numeral “203” in FIG. 4). On the other hand, the second color developing reagent 121B having a small molar extinction coefficient has a small absorbance even at a high blood glucose level, and therefore has a large slope of the straight line (see reference numeral “204” in FIG. 4). A coloring reagent having a large molar extinction coefficient (the first coloring reagent 121A in this embodiment) is in the low blood glucose measurement range W1, and a coloring reagent having a small molar extinction coefficient (the second coloring reagent 121B in this embodiment) is high. Each is suitable for the blood glucose level measurement range W2. Further, this relational expression is used as a calibration curve by the processing unit 25 in the blood glucose level calculation process described later. In the present embodiment, in the first coloring reagent having a large molar extinction coefficient, the range of the blood glucose level that is not more than the threshold value of absorbance is the measurement range of the low blood glucose level, and the blood glucose level of which absorbance is not less than the threshold value. The range was defined as the range of high blood glucose level.
　ベース部材１２２の材質としては、光の透過のために透明性の素材を用いるのが好ましい。例えば、ポリエチレンテレフタレート（ＰＥＴ）、ポリメチルメタクリレート（ＰＭＭＡ）、ポリスチレン（ＰＳ）、環状ポリオレフィン（ＣＯＰ）や環状オレフィンコポリマー（ＣＯＣ）、ポリカーボネード（ＰＣ）等の透明な有機樹脂材料；ガラス、石英等の透明性な無機材料；が挙げられる。 As the material of the base member 122, it is preferable to use a transparent material for light transmission. For example, 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. Transparent inorganic materials.
　以上が本実施形態に係る血糖計セット１の基本的な構成の詳細であり、以下では、測定方法を説明する。 The above is the details of the basic configuration of the blood glucose meter set 1 according to the present embodiment, and the measurement method will be described below.
　電源ボタン１１２を押下すると血糖計１１が起動する。血糖測定チップ１２を装着孔２３に装着する。 When the power button 112 is pressed, the blood glucose meter 11 is activated. The blood glucose measurement chip 12 is attached to the attachment hole 23.
　次に、図示はしないが、穿刺器具で患者の体の一部である例えば指先などを穿刺し、流出した少量の血液を供給部１２３から流路１２４を通じて第１の発色試薬１２１Ａと、第２の発色試薬１２１Ｂと、に付着させる。 Next, although not shown in the figure, the first color reagent 121A and the second color reagent are punctured with a puncture device, for example, a fingertip, and the small amount of blood that has flowed out from the supply unit 123 through the flow path 124. And the coloring reagent 121B.
　反応が開始すると、血糖量に応じて発色体が生じそれにより発色する。発色度合は吸光度により測定できる。具体的には、第１の照射部３１Ａは、第１の発光素子と、第２の発光素子と、から第１の発色試薬１２１Ａと血液との反応物に対して光を交互に照射する。また、第２の照射部３１Ｂは、第１の発光素子と、第２の発光素子と、から第２の発色試薬１２１Ｂと血液との反応物に対して光を交互に照射する。そして、第１の受光部３２Ａは、第１の発色試薬１２１Ａと血液との反応物を透過した透過光を測定光として受光する。また、第２の受光部３２Ｂは、第２の発色試薬１２１Ｂと血液との反応物を透過した透過光を測定光として受光する。 When the reaction starts, a colored body is generated according to the blood glucose level, and the color is developed. The degree of color development can be measured by absorbance. Specifically, the first irradiation unit 31A alternately irradiates light from the first light emitting element and the second light emitting element to the reaction product of the first coloring reagent 121A and blood. In addition, the second irradiation unit 31B alternately irradiates light from the first light emitting element and the second light emitting element to the reaction product of the second coloring reagent 121B and blood. The first light receiving unit 32A receives, as measurement light, transmitted light that has passed through a reaction product between the first coloring reagent 121A and blood. In addition, the second light receiving unit 32B receives, as measurement light, transmitted light that has passed through a reaction product between the second coloring reagent 121B and blood.
　処理部２５はこの透過光の強度に対応した大きさの信号に基づき吸光度を演算する。本実施形態では、血糖測定チップ１２は二種類の発色試薬１２１Ａ及びＢを備えているため、第１の発色試薬１２１Ａと血液との反応物に係る第１の吸光度と、第２の発色試薬１２１Ｂと血液との反応物に係る第２の吸光度と、の二種類の吸光度が得られる。処理部２５は、この二種類の吸光度を使い、血糖値を算出する。以下、処理部２５で行われる血糖値算出の処理方法を説明する。 The processing unit 25 calculates the absorbance based on a signal having a magnitude corresponding to the intensity of the transmitted light. In this embodiment, since the blood glucose measurement chip 12 includes two kinds of color developing reagents 121A and B, the first absorbance relating to the reaction product of the first color developing reagent 121A and blood, and the second color developing reagent 121B. Two kinds of absorbances are obtained, that is, a second absorbance related to a reaction product of blood and blood. The processing unit 25 calculates the blood glucose level using these two types of absorbance. Hereinafter, a processing method of blood glucose level calculation performed by the processing unit 25 will be described.
　図５Ａは、処理部２５の処理方法を説明するフローチャートである。第１の発色試薬１２１Ａ及び第２の発色試薬１２１Ｂに血液を付着して反応させたのち（ステップＳ１）、算出部２５Ａは各反応物からの透過光の強度を基に吸光度を演算する（ステップＳ２）。 FIG. 5A is a flowchart for explaining the processing method of the processing unit 25. After attaching blood to the first coloring reagent 121A and the second coloring reagent 121B and reacting them (step S1), the calculation unit 25A calculates the absorbance based on the intensity of transmitted light from each reaction product (step S1). S2).
　次に、予測部２５Ｂが、血糖値が属する範囲を予測する。本実施形態では、予測するための基準として、第１の発色試薬１２１Ａに係る第１の吸光度に、所定のしきい値を設定する（例えば１．０）。この所定のしきい値は、あらかじめ血糖計１１の記憶部に登録されている。 Next, the prediction unit 25B predicts a range to which the blood glucose level belongs. In the present embodiment, as a reference for prediction, a predetermined threshold is set for the first absorbance related to the first coloring reagent 121A (for example, 1.0). This predetermined threshold value is registered in the storage unit of the blood glucose meter 11 in advance.
　予測部２５Ｂは、当該第１の吸光度が所定のしきい値未満かどうかを判定する（ステップＳ３）。第１の吸光度が所定のしきい値未満の場合、血糖値が所定値より低い範囲に属すると予測する（図４の符番「２０５」参照）。一方で、当該値が所定のしきい値以上の場合、血糖値が所定値より低い範囲に属するものではない、すなわち、所定値以上の高い範囲に属すると予測する（図４の符番「２０６」参照）。 The prediction unit 25B determines whether or not the first absorbance is less than a predetermined threshold value (step S3). When the first absorbance is less than a predetermined threshold, it is predicted that the blood glucose level belongs to a range lower than the predetermined value (see reference numeral “205” in FIG. 4). On the other hand, if the value is equal to or higher than the predetermined threshold, it is predicted that the blood glucose level does not belong to a range lower than the predetermined value, that is, belongs to a higher range equal to or higher than the predetermined value (number “206” in FIG. "reference).
　上述したように、モル吸光係数の大きい第１の発色試薬１２１Ａは低血糖値の測定に適しており、モル吸光係数の小さい第２の発色試薬１２１Ｂは高血糖値の測定に適している。従い、予測部２５Ｂが所定のしきい値未満と判断した場合、算出部２５Ａは、第１の発色試薬１２１Ａに係る第１の吸光度に基づいて血糖値を算出する（ステップＳ４）。一方で、予測部２５Ｂが所定のしきい値以上と判断した場合、算出部２５Ａは、第２の発色試薬１２１Ｂに係る第２の吸光度に基づいて血糖値を算出する（ステップＳ５）。 As described above, the first coloring reagent 121A having a large molar extinction coefficient is suitable for measurement of a low blood glucose level, and the second coloring reagent 121B having a small molar extinction coefficient is suitable for measurement of a high blood sugar level. Accordingly, when the predicting unit 25B determines that the value is less than the predetermined threshold value, the calculating unit 25A calculates a blood glucose level based on the first absorbance related to the first coloring reagent 121A (step S4). On the other hand, when the prediction unit 25B determines that the value is equal to or greater than the predetermined threshold value, the calculation unit 25A calculates a blood glucose level based on the second absorbance related to the second coloring reagent 121B (step S5).
　具体的な血糖値の算出方法を示す。第１の吸光度に基づいて血糖値を算出する場合（ステップＳ４）、まず、第１の照射部３１Ａに係る第１の発光素子から発せられた第１の波長を有する光の吸光度によって、第１の発色試薬１２１Ａと血液との反応で生じた発色度合を測定し、上述した吸光度と血糖値との関係を示した検量線（図４参照）を参照して、血糖値を推定する。次に、第１の照射部３１Ａに係る第２の発光素子から発せられた第２の波長を有する光の吸光度によって、赤血球濃度を測定する。当該赤血球濃度から得られるへマトクリット値を用いて前記血糖値を補正して、血糖値を算出する。 Specific calculation method of blood glucose level is shown. When the blood glucose level is calculated based on the first absorbance (step S4), first, the first absorbance is calculated based on the absorbance of light having the first wavelength emitted from the first light emitting element according to the first irradiation unit 31A. The degree of coloration produced by the reaction between the coloring reagent 121A and blood is measured, and the blood glucose level is estimated with reference to the calibration curve (see FIG. 4) showing the relationship between the absorbance and the blood sugar level. Next, the red blood cell concentration is measured based on the absorbance of light having the second wavelength emitted from the second light emitting element according to the first irradiation unit 31A. The blood glucose level is corrected using the hematocrit value obtained from the red blood cell concentration, and the blood glucose level is calculated.
　一方、第２の吸光度に基づいて血糖値を算出する場合（ステップＳ５）、まず、第２の照射部３１Ｂに係る第１の発光素子から発せられた第１の波長を有する光の吸光度によって、第２の発色試薬１２１Ｂと血液との反応で生じた発色度合を測定し、上述した吸光度と血糖値との関係を示した検量線（図４参照）を参照して、血糖値を推定する。次に、第２の照射部３１Ｂに係る第２の発光素子から発せられた第２の波長を有する光の吸光度によって、赤血球濃度を測定する。当該赤血球濃度から得られるへマトクリット値を用いて前記血糖値を補正して、血糖値を算出する。 On the other hand, when calculating the blood glucose level based on the second absorbance (step S5), first, by the absorbance of the light having the first wavelength emitted from the first light emitting element according to the second irradiation unit 31B, The degree of color development produced by the reaction between the second color development reagent 121B and blood is measured, and the blood glucose level is estimated with reference to the calibration curve (see FIG. 4) showing the relationship between the absorbance and the blood glucose level. Next, the red blood cell concentration is measured based on the absorbance of light having the second wavelength emitted from the second light emitting element related to the second irradiation unit 31B. The blood glucose level is corrected using the hematocrit value obtained from the red blood cell concentration, and the blood glucose level is calculated.
　算出された最終結果としての血糖値は、ディスプレー１１１に表示される（ステップＳ６）。 The calculated blood glucose level is displayed on the display 111 (step S6).
　図５Ｂに、処理部２５が行う処理方法の変形例を示す。図５Ｂに示すように透過光の強度である透過量の基準値としての所定のしきい値を設けてもよい。すなわち、第１の発色試薬１２１Ａ及び第２の発色試薬１２１Ｂに血液を付着して反応させたのち（ステップＳ１）、受光部３２Ａ及び３２Ｂは各反応物からの透過量を取得する（ステップＳ２）。予測部２５Ｂは、第１の発色試薬１２１Ａに係る第１の透過量が所定のしきい値未満かどうかを判定する（ステップＳ３）。当該第１の透過量が所定のしきい値未満の場合、算出部２５Ａは、第２の発色試薬１２１Ｂに係る第２の透過量に基づいて血糖値を算出する（ステップＳ４）。一方で、予測部２５Ｂが所定のしきい値以上と判断した場合、算出部２５Ａは、第１の発色試薬１２１Ａに係る第１の透過量に基づいて血糖値を算出する（ステップＳ５）。換言すれば、処理部２５は、予測部が予測する範囲に基づいて前記所定成分の値を算出するものである。そして、最終結果としての血糖値がディスプレー１１１に表示される（ステップＳ６）。 FIG. 5B shows a modification of the processing method performed by the processing unit 25. As shown in FIG. 5B, a predetermined threshold value may be provided as a reference value for the amount of transmitted light that is the intensity of transmitted light. That is, after the blood is attached to the first coloring reagent 121A and the second coloring reagent 121B and reacted (Step S1), the light receiving units 32A and 32B acquire the transmission amount from each reactant (Step S2). . The prediction unit 25B determines whether or not the first permeation amount related to the first coloring reagent 121A is less than a predetermined threshold value (step S3). When the first permeation amount is less than the predetermined threshold value, the calculation unit 25A calculates the blood glucose level based on the second permeation amount relating to the second color reagent 121B (step S4). On the other hand, when the prediction unit 25B determines that the value is equal to or greater than the predetermined threshold value, the calculation unit 25A calculates a blood glucose level based on the first permeation amount related to the first coloring reagent 121A (step S5). In other words, the processing unit 25 calculates the value of the predetermined component based on the range predicted by the prediction unit. Then, the blood glucose level as the final result is displayed on the display 111 (step S6).
　なお、本実施形態では、吸光度の基準値としての所定のしきい値を１．０としたが、別の値でもよく、好ましくは０．５～１．５、より好ましくは０．７～１．３の範囲に基準値を設けることでより良好な精度を確保することができる。また、第１の発色試薬１２１Ａに係る第１の吸光度に基準を設けたが、第２の発色試薬１２１Ｂに係る第２の吸光度に基準を設けてもよい。また、透過量を予測に使用する場合、第２の発色試薬１２１Ｂに係る第２の透過量に基準を設けてもよい。さらに、第１の発色試薬１２１Ａや第２の発色試薬１２１Ｂとは別の種類の発色試薬を更に設け、この発色試薬の吸光度、透過量に基準値を設定し、予測に使用してもよい。 In the present embodiment, the predetermined threshold value as the absorbance reference value is 1.0, but may be another value, preferably 0.5 to 1.5, more preferably 0.7 to 1. By providing the reference value in the range of .3, better accuracy can be ensured. In addition, although the reference is provided for the first absorbance relating to the first coloring reagent 121A, the reference may be provided for the second absorbance relating to the second coloring reagent 121B. When the transmission amount is used for prediction, a reference may be provided for the second transmission amount related to the second coloring reagent 121B. Furthermore, a color reagent of a different type from the first color reagent 121A and the second color reagent 121B may be further provided, and a reference value may be set for the absorbance and transmission amount of the color reagent and used for prediction.
　また、演算された吸光度と基準値となる所定の吸光度（例えば１．０）との差の絶対値を比較し、もっとも小さい値を示した発色試薬の吸光度を血糖値の算出に使用するという方法でもよい。また、透過量を予測に使用する場合、取得した透過量と基準値となる所定の透過量（例えば１５０）との差の絶対値を比較し、もっとも小さい値を示した発色試薬の透過量を血糖値の算出に使用するという方法でもよい。これらの方法は、モル吸光係数の異なる発色試薬を３種類以上使用できる場合に特に有効である。 Further, the absolute value of the difference between the calculated absorbance and a predetermined absorbance (for example, 1.0) as a reference value is compared, and the absorbance of the coloring reagent showing the smallest value is used for calculating the blood glucose level. But you can. When the transmission amount is used for prediction, the absolute value of the difference between the acquired transmission amount and a predetermined transmission amount (for example, 150) as a reference value is compared, and the transmission amount of the coloring reagent showing the smallest value is determined. The method of using for calculation of a blood glucose level may be used. These methods are particularly effective when three or more coloring reagents having different molar extinction coefficients can be used.
　また、算出部２５Ａで、各吸光度に対するそれぞれの血糖値の算出を先に行い、予測部２５Ｂの結果に基づいて最適な方を選択するという方法でもよい。この方法によると、算出部２５Ａが算出した血糖値そのものを予測に使用することも可能となる。 Alternatively, the calculation unit 25A may first calculate each blood glucose level for each absorbance, and select the optimum one based on the result of the prediction unit 25B. According to this method, the blood sugar level itself calculated by the calculation unit 25A can be used for prediction.
　測定終了後は、使用済みの血糖測定チップ１２を血糖計１１から外す。取外レバー１１４を引くと、血糖計１１内で連動するイジェクトピン２６が延在方向にスライドし血糖測定チップ１２が外側に押し出される。最後に、電源ボタン１１２を押下すると血糖計１１が停止する。 After the measurement, the used blood glucose measuring chip 12 is removed from the blood glucose meter 11. When the removal lever 114 is pulled, the eject pin 26 interlocked in the blood glucose meter 11 slides in the extending direction and the blood glucose measuring chip 12 is pushed out. Finally, when the power button 112 is pressed, the blood glucose meter 11 stops.
　以上説明したように、実施形態１によると、従来の単一発色試薬での測定では限界のあった低血糖値から高血糖値までの広いレンジの測定を一つの血糖測定チップで実現することが可能となる。また、これにより、繰り返し測定における再現性の高い血糖計セットを提供できる。 As described above, according to the first embodiment, it is possible to realize a wide range of measurement from a low blood glucose level to a high blood glucose level, which is limited in the measurement with the conventional single color reagent, with one blood glucose measurement chip. It becomes possible. Thereby, a blood glucose meter set with high reproducibility in repeated measurement can be provided.
　次に、血糖測定チップの変形例を説明する。図６（ａ）は、図３に示した血糖測定チップの変形例を示す上面図である。図６（ｂ）は、図６（ａ）のＥ－Ｅ断面図である。 Next, a modified example of the blood glucose measurement chip will be described. FIG. 6A is a top view showing a modification of the blood glucose measurement chip shown in FIG. FIG. 6B is a cross-sectional view taken along the line EE of FIG.
　血糖測定チップ１２はベース部材１２２を有し、このベース部材１２２は、第１の発色試薬１２１Ａ及び第２の発色試薬１２１Ｂが設けられる平板状の底板部材１３１と、この底板部材の厚み方向に対して直行する幅方向の両端に両面テープ等により形成されたスペーサ部材１３２と、このスペーサ部材上１３２に架け渡された蓋部材１３３と、により実現される。 The blood glucose measurement chip 12 has a base member 122. The base member 122 has a flat bottom plate member 131 provided with the first coloring reagent 121A and the second coloring reagent 121B, and the thickness direction of the bottom plate member. This is realized by a spacer member 132 formed by double-sided tape or the like at both ends in the width direction that goes straight, and a lid member 133 laid over the spacer member 132.
　底板部材１３１及び蓋部材１３３の材質としては、上述したベース部材１２２の材質と同様、光の透過のために透明性の素材を用いるのが好ましい。 As the material of the bottom plate member 131 and the lid member 133, it is preferable to use a transparent material for light transmission, like the material of the base member 122 described above.
　また、血糖測定チップ１２のベース部材１２２は、体液としての血液を供給する供給部としての供給口１２５と、当該供給口１２５から発色試薬の保持位置（図６では反応位置と同じ）まで連通する流路１２４と、を区画している。 Further, the base member 122 of the blood glucose measurement chip 12 communicates with a supply port 125 as a supply unit that supplies blood as a body fluid to the holding position of the coloring reagent (same as the reaction position in FIG. 6) from the supply port 125. The flow path 124 is partitioned.
　この供給口１２５の部分には、底板部材１３１及び蓋部材１３３に、略半楕円形状の切り欠き部１４１が形成されている。これにより、血液を供給口１２５から流路１２４に引き込みやすくすることができる。 In the portion of the supply port 125, a substantially semi-elliptical cutout 141 is formed in the bottom plate member 131 and the lid member 133. Thereby, blood can be easily drawn into the flow path 124 from the supply port 125.
　供給口１２５及び流路１２４の断面の形状及び寸法には特に制限はないが、例えば、断面の形状が略四角形であって、血糖測定チップ１２の断面の厚み方向の寸法が１００μｍ以下とすることが好ましい。使用する血液の量を低減し、以下に記載する毛細管現象の効果を十分に得るためである。 There are no particular restrictions on the cross-sectional shapes and dimensions of the supply port 125 and the flow path 124. For example, the cross-sectional shape is substantially square, and the cross-sectional thickness of the blood glucose measurement chip 12 is 100 μm or less. Is preferred. This is because the amount of blood to be used is reduced and the effect of capillary action described below is sufficiently obtained.
　指先等から流出した少量の血液を供給口１２５に点着させる。血液は、毛細管現象により当該供給口１２５から流路１２４に吸引され、反応位置まで導かれる。そこで、血液が第１の発色試薬１２１Ａと、第２の発色試薬１２１Ｂと、に付着し、それぞれの反応が開始する。毛細管現象により、血液をスムーズに流すことができ、その結果血液を迅速に反応位置まで誘導することができる。 A small amount of blood that has flowed out of the fingertip or the like is spotted on the supply port 125. Blood is sucked into the flow path 124 from the supply port 125 by capillary action and guided to the reaction position. Therefore, blood adheres to the first coloring reagent 121A and the second coloring reagent 121B, and each reaction starts. Capillary action allows blood to flow smoothly, and as a result, blood can be quickly guided to the reaction position.
　別の変形例として、ベース部材１２２は、第１の発色試薬１２１Ａが保持される位置と、第２の発色試薬１２１Ｂが保持される位置と、の間に仕切り部１２６を備える。換言すれば、モル吸光係数が互いに異なる２種以上の発色試薬１２１Ａ、１２１Ｂが保持された異なる位置の間に仕切り部を備えている。 As another modification, the base member 122 includes a partition 126 between a position where the first coloring reagent 121A is held and a position where the second coloring reagent 121B is held. In other words, the partition part is provided between different positions where two or more kinds of coloring reagents 121A and 121B having different molar extinction coefficients are held.
　この仕切り部１２６により、第１の発色試薬１２１Ａと血液との反応物と、第２の発色試薬１２１Ｂと血液との反応物と、を物理的に隔てることができ、より精度の良い測定が可能となる。 The partition 126 can physically separate the reaction product of the first coloring reagent 121A and the blood and the reaction product of the second coloring reagent 121B and the blood, enabling more accurate measurement. It becomes.
　また、図示しないが、発色試薬と血液との反応物を流路手段等で移動させ、反応位置とは別の位置で測定してもよい。 Although not shown, the reaction product of the coloring reagent and blood may be moved by a flow channel means and measured at a position different from the reaction position.
＜実施形態２＞
　別の実施形態として、測定光に反射光を用いる血糖計を備えた血糖計セットの例を示す。図７Ａは、本発明の一実施形態としての血糖計セット２を示す縦断面図である。また、図７Ｂは、図７Ａに示す血糖計セットから照射部、受光部及び血糖測定チップを抜き出して背面側（図７Ａの右側）から見た図である。 <Embodiment 2>
As another embodiment, an example of a blood glucose meter set including a blood glucose meter using reflected light as measurement light is shown. FIG. 7A is a longitudinal sectional view showing a blood glucose meter set 2 as an embodiment of the present invention. Moreover, FIG. 7B is the figure which extracted the irradiation part, the light-receiving part, and the blood glucose measurement chip | tip from the blood glucose meter set shown to FIG. 7A, and was seen from the back side (right side of FIG. 7A).
　図７Ａに示すように、血糖計セット２は、血糖測定チップ１４と、血糖計１３と、を備える。それぞれ以下説明する。なお、血糖計セット２において、上述した血糖計セット１と同一の構成要素には同一の参照符号を付し、詳細な説明は省略する。 As shown in FIG. 7A, the blood glucose meter set 2 includes a blood glucose measurement chip 14 and a blood glucose meter 13. Each will be described below. In the blood glucose meter set 2, the same components as those in the blood glucose meter set 1 described above are denoted by the same reference numerals, and detailed description thereof is omitted.
　先ず、血糖測定チップ１４について説明する。血糖測定チップ１４は、ベース部材１２２を有する。また、ベース部材１２２の内側に光を反射する反射部１２７としての反射膜を備えている点で、図６に示す血糖測定チップ１２と異なる。 First, the blood glucose measurement chip 14 will be described. The blood glucose measurement chip 14 has a base member 122. Moreover, it differs from the blood glucose measurement chip 12 shown in FIG. 6 in that a reflection film as a reflection part 127 that reflects light is provided inside the base member 122.
　光を反射させるためには、当該反射部１２７を着色させる必要がある。照射する波長を吸収せずに効率よく反射することができれば着色に制限はないが、白色が最も好ましい。素材には、ポリプロピレン（ＰＰ）、ポリエチレン（ＰＥ）、ポリスチレン（ＰＳ）、ポリカーボネート（ＰＣ）、アクリル（ＰＭＭＡ）、ポリエチレンテレフタレート（ＰＥＴ）、環状ポリオレフィン（ＣＯＰ）や環状オレフィンコポリマー（ＣＯＣ）等の樹脂を使用し、必要に応じて酸化チタン、二酸化ケイ素、硫酸バリウム、アルミニウム、亜鉛、ニッケル、クロム等を真空蒸着やスパッタリング、またはめっき等の手段で処理して反射面を得る。または、酸化チタン、二酸化ケイ素、硫酸バリウム等を一定量、樹脂に含有させて反射面を得ても良い。なお、本実施形態の反射部１２７は、蓋部材１３３の内面のうち、第１の発色試薬１２１Ａ及び第２の発色試薬１２１Ｂと対向する位置に設けられている。 In order to reflect light, it is necessary to color the reflecting portion 127. The coloration is not limited as long as it can be efficiently reflected without absorbing the irradiation wavelength, but white is most preferable. Materials include polypropylene (PP), polyethylene (PE), polystyrene (PS), polycarbonate (PC), acrylic (PMMA), polyethylene terephthalate (PET), cyclic polyolefin (COP) and cyclic olefin copolymer (COC). If necessary, titanium oxide, silicon dioxide, barium sulfate, aluminum, zinc, nickel, chromium, etc. are treated by means such as vacuum deposition, sputtering, or plating to obtain a reflective surface. Alternatively, the reflecting surface may be obtained by adding a certain amount of titanium oxide, silicon dioxide, barium sulfate or the like to the resin. In addition, the reflection part 127 of this embodiment is provided in the position which opposes the 1st coloring reagent 121A and the 2nd coloring reagent 121B among the inner surfaces of the cover member 133. FIG.
　次に、血糖計１３について説明する。本実施形態に係る血糖計１３は、光学測定部２７の配置が、上述した実施形態１に係る血糖計１１の光学測定部２４の配置と異なる。また、光学測定部２７を構成する受光部３４は、反射部１２７で反射した光を受光する点で上述した受光部３２Ａ及びＢと異なる。 Next, the blood glucose meter 13 will be described. In the blood glucose meter 13 according to the present embodiment, the arrangement of the optical measurement unit 27 is different from the arrangement of the optical measurement unit 24 of the blood glucose meter 11 according to the first embodiment described above. Further, the light receiving unit 34 constituting the optical measuring unit 27 is different from the above-described light receiving units 32A and 32B in that the light reflected by the reflecting unit 127 is received.
　血糖計１３の内部には空間４３が一つ区画され、そこに第１の照射部３１Ａ及び第２の照射部３１Ｂと、第１の受光部３４Ａ及び第２の受光部３４Ｂと、が設置されている。なお、第２の受光部３４Ｂは、図７Ａには示されていないが、図７Ａの紙面に垂直な方向で、第１の受光部３４Ａと重なる位置に配置されている。 The blood glucose meter 13 is divided into one space 43, in which a first irradiation unit 31A and a second irradiation unit 31B, and a first light receiving unit 34A and a second light receiving unit 34B are installed. ing. Although not shown in FIG. 7A, the second light receiving unit 34B is arranged at a position overlapping the first light receiving unit 34A in a direction perpendicular to the paper surface of FIG. 7A.
　図７Ｂに示すように、血糖測定チップ１４を血糖計１３に装着した状態では、第１の照射部３１Ａ及び第２の照射部３１Ｂと、第１の受光部３４Ａ及び第２の受光部３４Ｂと、は血液測定チップ１４の厚みの方向において、血液測定チップ１４の一方側に配置されている。また、第１の照射部３１Ａと第１の受光部３４Ａとは、照射光３３Ａが、反応物を透過し、反射部１２７で反射し、第１の受光部３４Ａで受光できるような位置に配置されている。また、第２の照射部３１Ｂと第２の受光部３４Ｂとは、照射光３３Ｂが、反応物を透過し、反射部１２７で反射し、第２の受光部３４Ｂで受光できるような位置に配置されている。なお、第１の照射部３１Ａ及び第２の照射部３１Ｂは、図７Ｂの紙面に垂直な方向で、それぞれ第１の受光部３４Ａ及び第２の受光部３４Ｂと重なる位置に配置されているため、図７Ｂでは第１の照射部３１Ａ及び第２の照射部３１Ｂは点線で示した。 As shown in FIG. 7B, in a state where the blood glucose measuring chip 14 is mounted on the blood glucose meter 13, the first irradiation unit 31A and the second irradiation unit 31B, the first light receiving unit 34A and the second light receiving unit 34B, Are arranged on one side of the blood measurement chip 14 in the thickness direction of the blood measurement chip 14. Further, the first irradiation unit 31A and the first light receiving unit 34A are arranged at positions where the irradiation light 33A can pass through the reactant, be reflected by the reflection unit 127, and be received by the first light receiving unit 34A. Has been. In addition, the second irradiation unit 31B and the second light receiving unit 34B are arranged at positions where the irradiation light 33B can pass through the reaction product, be reflected by the reflection unit 127, and be received by the second light receiving unit 34B. Has been. Note that the first irradiation unit 31A and the second irradiation unit 31B are arranged at positions that overlap the first light receiving unit 34A and the second light receiving unit 34B, respectively, in a direction perpendicular to the paper surface of FIG. 7B. In FIG. 7B, the first irradiation unit 31A and the second irradiation unit 31B are indicated by dotted lines.
　以上が本実施形態に係る血糖計セット２の基本的な構成の詳細である。次に、測定方法を説明する。 The above is the details of the basic configuration of the blood glucose meter set 2 according to the present embodiment. Next, a measurement method will be described.
　血糖計１３に血糖測定チップ１４を装着したのち、供給口１２５に血液を供給する。血液が第１の発色試薬１２１Ａ及び第２の発色試薬１２１Ｂに到達して反応が開始する。反応物に照射された照射光３３Ａが、上述した反射部１２７にて反射し、測定光として第１の受光部３４Ａで受光される。また、照射光３３Ｂが、上述した反射部１２７にて反射し、測定光として第２の受光部３４Ｂで受光される。処理部２５で血糖値を算出し、結果はディスプレー１１１に表示される。処理部２５の処理方法は、血糖計セット１で示した内容と同じである（図５Ａまたは図５Ｂ参照）。 After attaching the blood glucose measuring chip 14 to the blood glucose meter 13, blood is supplied to the supply port 125. The reaction starts when the blood reaches the first coloring reagent 121A and the second coloring reagent 121B. The irradiation light 33A applied to the reactant is reflected by the reflection unit 127 described above, and is received by the first light receiving unit 34A as measurement light. Further, the irradiation light 33B is reflected by the reflection unit 127 described above, and is received by the second light receiving unit 34B as measurement light. The blood glucose level is calculated by the processing unit 25 and the result is displayed on the display 111. The processing method of the processing unit 25 is the same as that shown in the blood glucose meter set 1 (see FIG. 5A or FIG. 5B).
　以上説明したように、血糖計セット２おいても、上述した血糖計セット１と同じ効果を奏する。 As described above, the blood glucose meter set 2 has the same effect as the blood glucose meter set 1 described above.
　上述した第１の実施形態及び第２の実施形態は一例であり、特許請求の範囲に記載した内容を逸脱しない範囲での変更が可能である。例えば、成分測定装置は、吸光度を使用した成分測定でれば、血糖計以外でもよい。すなわち、体液は血液以外でもよく（例えば、尿等）、所定成分は血糖値以外でもよく（例えば、タンパク、酵素等）。また、血液の供給に係る実施形態については、例えば、血糖計１１側に血液の吸引吐出機構（図示しない）を設置し、当該吐出機構を使用して採血管等で事前に採取済みの血液を直接、第１の発色試薬１２１Ａ及び第２の発色試薬１２１Ｂに吐出してもよい。 The first embodiment and the second embodiment described above are examples, and can be changed without departing from the contents described in the claims. For example, the component measuring device may be other than a blood glucose meter as long as the component measurement using absorbance is performed. That is, the body fluid may be other than blood (for example, urine), and the predetermined component may be other than blood glucose level (for example, protein, enzyme, etc.). As for the embodiment relating to blood supply, for example, a blood suction / discharge mechanism (not shown) is installed on the blood glucose meter 11 side, and blood that has been collected in advance using a blood collection tube or the like using the discharge mechanism is used. You may discharge directly to the 1st coloring reagent 121A and the 2nd coloring reagent 121B.
　本発明は、成分測定装置セット及び体液測定チップに関するものである。 The present invention relates to a component measuring device set and a body fluid measuring chip.
１：血糖計セット（成分測定装置セット）
１１、１３：血糖計（成分測定装置）
１２、１４：血糖測定チップ（体液測定チップ）
２２：装着部
２３：装着孔
２４：光学測定部
２５：処理部
２５Ａ：算出部
２５Ｂ：予測部
２６： イジェクトピン
２７：光学測定部
３１：照射部
３１Ａ：第１の照射部
３１Ｂ：第２の照射部
３２：受光部
３２Ａ：第１の受光部
３２Ｂ：第２の受光部
３３Ａ：第１照射部に係る照射光
３３Ｂ：第２照射部に係る照射光
３４：受光部
３４Ａ：第１の受光部
３４Ｂ：第２の受光部
４１：第１の空間
４２：第２の空間
４３：空間
１１１：ディスプレー
１１２：電源ボタン
１１３：操作ボタン
１１４：取外レバー
１２１：発色試薬
１２１Ａ：第１の発色試薬
１２１Ｂ：第２の発色試薬
１２１Ｃ：第３の発色試薬
１２２：ベース部材
１２３：供給部
１２４：流路
１２５：供給口（供給部）
１２６：仕切り部
１２７：反射部
１３１：底板部材 
１３２：スペーサ部材
１３３：蓋部材
１４１：切り欠き部 1: Blood glucose meter set (component measuring device set)
11, 13: Blood glucose meter (component measuring device)
12, 14: Blood glucose measurement chip (body fluid measurement chip)
22: mounting unit 23: mounting hole 24: optical measurement unit 25: processing unit 25A: calculation unit 25B: prediction unit 26: eject pin 27: optical measurement unit 31: irradiation unit 31A: first irradiation unit 31B: second Irradiation unit 32: Light reception unit 32A: First light reception unit 32B: Second light reception unit 33A: Irradiation light 33B related to the first irradiation unit: Irradiation light 34 related to the second irradiation unit: Light reception unit 34A: First light reception Unit 34B: second light receiving unit 41: first space 42: second space 43: space 111: display 112: power button 113: operation button 114: removal lever 121: coloring reagent 121A: first coloring reagent 121B: 2nd coloring reagent 121C: 3rd coloring reagent 122: Base member 123: Supply part 124: Channel 125: Supply port (supply part)
126: Partition part 127: Reflection part 131: Bottom plate member
132: Spacer member 133: Lid member 141: Notch

Claims (8)

  1. 　体液中の所定成分を測定する成分測定装置セットであって、
    発色試薬を有する体液測定チップと、
    前記体液と前記発色試薬との反応物に光を照射する照射部と、
    前記反応物を透過した測定光を受光する受光部と、
    前記測定光から得られる信号を処理する処理部と、
    を備え、
    前記体液測定チップは、
    ベース部材を備え、
    前記発色試薬は、前記ベース部材の異なる位置に保持されたモル吸光係数が互いに異なる２種以上の発色試薬であることを特徴とする成分測定装置セット。     A component measuring device set for measuring a predetermined component in a body fluid,
    A body fluid measuring chip having a coloring reagent;
    An irradiation unit for irradiating light to a reaction product of the body fluid and the coloring reagent;
    A light receiving portion for receiving measurement light transmitted through the reactant;
    A processing unit for processing a signal obtained from the measurement light;
    With
    The body fluid measurement chip is
    A base member,
    The component measuring apparatus set according to claim 1, wherein the coloring reagents are two or more coloring reagents having different molar extinction coefficients held at different positions of the base member.
  2. 　前記ベース部材は、
    前記異なる位置の間に仕切り部を備えたことを特徴とする請求項１に記載の成分測定装置セット。     The base member is
    The component measuring apparatus set according to claim 1, further comprising a partition portion between the different positions.
  3. 　前記ベース部材は、
    体液を供給する供給部と、
    該供給部から前記発色試薬の保持位置まで連通する流路と、を区画していることを特徴とする請求項１または２に記載の成分測定装置セット。     The base member is
    A supply for supplying body fluid;
    The component measuring device set according to claim 1, wherein a flow path communicating from the supply unit to the holding position of the color reagent is partitioned.
  4. 　前記体液測定チップは、血糖測定チップであることを特徴とする請求項１ないし３のいずれか一項に記載の成分測定装置セット。 4. The component measurement device set according to claim 1, wherein the body fluid measurement chip is a blood glucose measurement chip.
  5. 　前記処理部は、
    前記測定光から得られる信号に基づいて前記所定成分の値を算出する算出部を備えることを特徴とする請求項１ないし４のいずれか一項に記載の成分測定装置セット。     The processor is
    5. The component measuring apparatus set according to claim 1, further comprising a calculating unit that calculates a value of the predetermined component based on a signal obtained from the measuring light.
  6. 　前記処理部は、
    前記測定光から得られる信号に基づいて前記所定成分の値が含まれる所定の範囲を予測する予測部を備えることを特徴とする請求項５に記載の成分測定装置セット。     The processor is
    The component measuring apparatus set according to claim 5, further comprising a prediction unit that predicts a predetermined range in which the value of the predetermined component is included based on a signal obtained from the measurement light.
  7. 　前記算出部は、
    前記予測部が予測する範囲に基づいて前記所定成分の値を算出することを特徴とする請求項６に記載の成分測定装置セット。     The calculation unit includes:
    The component measurement device set according to claim 6, wherein the value of the predetermined component is calculated based on a range predicted by the prediction unit.
  8. 　発色試薬を有する体液測定チップであって、
    ベース部材を備え、
    前記発色試薬は、前記ベース部材の異なる位置に保持された少なくとも２種以上のモル吸光係数が互いに異なる発色試薬であることを特徴とする体液測定チップ。     A body fluid measurement chip having a coloring reagent,
    A base member,
    The body fluid measuring chip, wherein the color-developing reagent is a color-developing reagent having at least two or more molar extinction coefficients held at different positions of the base member.
PCT/JP2016/000326 2015-03-19 2016-01-22 Component measurement device set and body fluid measurement chip WO2016147527A1 (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018061484A1 (en) * 2016-09-28 2018-04-05 テルモ株式会社 Method, composition, and chip for detecting analysis object in blood sample
JP2018084511A (en) * 2016-11-24 2018-05-31 テルモ株式会社 Body fluid measurement device set and body fluid measurement chip
WO2019138681A1 (en) * 2018-01-15 2019-07-18 テルモ株式会社 Component measurement system, measurement device, and measurement tip

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH01292224A (en) * 1988-04-29 1989-11-24 Boehringer Mannheim Corp Colorimeter
JPH02290541A (en) * 1989-04-29 1990-11-30 Konica Corp Analysis element
JPH06194313A (en) * 1992-12-24 1994-07-15 Jeol Ltd Reactive measurement method
JPH1078433A (en) * 1996-07-23 1998-03-24 Boehringer Mannheim Gmbh Carrier for diagnostic test without dependence on capacity and use thereof for measuring material to be inspected
JP2002340911A (en) * 2001-05-15 2002-11-27 Hitachi Ltd Sheet-type microreactor and mobile type chemical analyzer
JP2010185750A (en) * 2009-02-12 2010-08-26 Omron Healthcare Co Ltd Body fluid analyzing sensor and body fluid analyzing chip
WO2011132525A1 (en) * 2010-04-20 2011-10-27 株式会社日立ハイテクノロジーズ Automatic analysis device and automatic analysis method
US20120183442A1 (en) * 2005-04-01 2012-07-19 Kloepfer Hans G Body fluid testing component for simultaneous analyte detection

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH01292224A (en) * 1988-04-29 1989-11-24 Boehringer Mannheim Corp Colorimeter
JPH02290541A (en) * 1989-04-29 1990-11-30 Konica Corp Analysis element
JPH06194313A (en) * 1992-12-24 1994-07-15 Jeol Ltd Reactive measurement method
JPH1078433A (en) * 1996-07-23 1998-03-24 Boehringer Mannheim Gmbh Carrier for diagnostic test without dependence on capacity and use thereof for measuring material to be inspected
JP2002340911A (en) * 2001-05-15 2002-11-27 Hitachi Ltd Sheet-type microreactor and mobile type chemical analyzer
US20120183442A1 (en) * 2005-04-01 2012-07-19 Kloepfer Hans G Body fluid testing component for simultaneous analyte detection
JP2010185750A (en) * 2009-02-12 2010-08-26 Omron Healthcare Co Ltd Body fluid analyzing sensor and body fluid analyzing chip
WO2011132525A1 (en) * 2010-04-20 2011-10-27 株式会社日立ハイテクノロジーズ Automatic analysis device and automatic analysis method

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018061484A1 (en) * 2016-09-28 2018-04-05 テルモ株式会社 Method, composition, and chip for detecting analysis object in blood sample
US11150193B2 (en) 2016-09-28 2021-10-19 Terumo Kabushiki Kaisha Method, composition, and chip for detecting analyte in blood sample
US11656182B2 (en) 2016-09-28 2023-05-23 Terumo Kabushiki Kaisha Method, composition, and chip for detecting analyte in blood sample
JP2018084511A (en) * 2016-11-24 2018-05-31 テルモ株式会社 Body fluid measurement device set and body fluid measurement chip
WO2019138681A1 (en) * 2018-01-15 2019-07-18 テルモ株式会社 Component measurement system, measurement device, and measurement tip
JPWO2019138681A1 (en) * 2018-01-15 2021-01-14 テルモ株式会社 Component measurement system, measuring device and measuring chip
JP7241033B2 (en) 2018-01-15 2023-03-16 テルモ株式会社 Component measurement system and measurement device

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