WO2016147527A1 - Ensemble dispositif de mesure de composé et puce de mesure de fluide corporel - Google Patents

Ensemble dispositif de mesure de composé et puce de mesure de fluide corporel 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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English (en)
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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    • 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

L'invention concerne un ensemble dispositif de mesure de composé (1) pour mesurer un composé prédéterminé dans un fluide corporel, caractérisé par le fait que ce dernier comprend : une puce de mesure de fluide corporel (12, 14) qui comprend des réactifs chromogènes (121) ; des unités d'irradiation (31) qui rayonnent une lumière sur des produits de réaction du fluide corporel et des réactifs chromogènes (121) ; des unités de réception de lumière (32) qui reçoivent la lumière de mesure qui est passée à travers les produits de réaction ; et une unité de traitement (25) qui traite des signaux obtenus à partir de la lumière de mesure ; la puce de mesure de fluide corporel (12, 14) comprenant un élément de base (122), et au moins deux réactifs chromogènes (121) ayant des coefficients d'absorption molaire différant l'un de l'autre étant maintenus dans différents emplacements sur l'élément de base (122).
PCT/JP2016/000326 2015-03-19 2016-01-22 Ensemble dispositif de mesure de composé et puce de mesure de fluide corporel WO2016147527A1 (fr)

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WO2018061484A1 (fr) * 2016-09-28 2018-04-05 テルモ株式会社 Procédé, composition et puce pour détecter un objet d'analyse dans un échantillon de sang
JP2018084511A (ja) * 2016-11-24 2018-05-31 テルモ株式会社 体液測定装置セット及び体液測定チップ
WO2019138681A1 (fr) * 2018-01-15 2019-07-18 テルモ株式会社 Système de mesure de composant, dispositif de mesure et pointe de mesure

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WO2011132525A1 (fr) * 2010-04-20 2011-10-27 株式会社日立ハイテクノロジーズ Dispositif d'analyse automatique et procédé d'analyse automatique
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JPH02290541A (ja) * 1989-04-29 1990-11-30 Konica Corp 分析素子
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US11656182B2 (en) 2016-09-28 2023-05-23 Terumo Kabushiki Kaisha Method, composition, and chip for detecting analyte in blood sample
JP2018084511A (ja) * 2016-11-24 2018-05-31 テルモ株式会社 体液測定装置セット及び体液測定チップ
WO2019138681A1 (fr) * 2018-01-15 2019-07-18 テルモ株式会社 Système de mesure de composant, dispositif de mesure et pointe de mesure
JPWO2019138681A1 (ja) * 2018-01-15 2021-01-14 テルモ株式会社 成分測定システム、測定装置及び測定チップ
JP7241033B2 (ja) 2018-01-15 2023-03-16 テルモ株式会社 成分測定システム及び測定装置

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