Component measuring device, component measuring device set, and information processing method

Abstract

This component measurement device has a tip insertion space for inserting a component measurement tip therein and comprises: a light-emitting unit that emits radiation light to the component measurement tip under conditions where the component measurement tip is inserted in the tip insertion space; a light-receiving unit that receives light transmitted through or reflected off the component measurement tip; and a control unit. The control unit detects abnormalities in the component measurement tip on the basis of the ratio of: the intensity of light received at the light-receiving unit in a case where radiation light of a specific wavelength is emitted from the light-emitting unit; to the intensity of light received at the light-receiving unit in a case where radiation light of a different wavelength is emitted from the light-emitting unit.

Description

[Technical Field]

[0001] The present disclosure relates to a component measuring device, a component measuring device set, and an information processing method. [Background technology]

[0002] Conventionally, in the fields of biochemistry and medicine, there are known devices for measuring a component to be measured contained in a sample such as blood as a specimen. The component to be measured is measured, for example, by attaching a component measuring chip (measurement reagent) for supplying the sample to the device and irradiating the component measuring chip with light inside the device.

[0003] The component measuring chips used to measure the components to be measured may deteriorate due to improper storage, such as exposure to high temperatures for a long period of time, or may deteriorate unintentionally. If a deteriorated component measuring chip is used to measure the components to be measured, the components to be measured cannot be measured accurately due to changes in its optical properties.

[0004] To address this problem of deterioration, methods for detecting deterioration are known. For example, Patent Document 1 describes a method in which a reference pad is formed on the test strip in advance and the deterioration state of the test strip is determined based on the optical property value of the reference pad. Also, for example, Patent Document 2 describes a method for determining deterioration of a test element by measuring the specific luminescence of a test chemical substance provided on the test element. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2013-024797 [Patent Document 2] Special Publication No. 2014-533106 Summary of the Invention [Problem to be solved by the invention]

[0006] According to the methods disclosed in Patent Documents 1 and 2, in order to detect abnormalities such as deterioration, it is necessary to provide a special member in advance on the component measuring chip for the purpose of detecting abnormalities, such as a reference pad or test chemical substance. Thus, providing a special member for detecting abnormalities in the component measuring chip is cumbersome.

[0007] An object of the present disclosure is to provide a component measuring device, a component measuring device set, and an information processing method that are capable of detecting an abnormality in a component measuring chip without providing any special member separately. [Means for solving the problem]

[0008] A component measuring device according to a first aspect of the present disclosure has a chip insertion space for inserting a component measuring chip, and is equipped with an emitter that emits irradiation light onto the component measuring chip when the component measuring chip is inserted into the chip insertion space, a light receiving unit that receives light that has passed through or reflected by the component measuring chip, and a control unit, wherein the control unit detects an abnormality in the component measuring chip based on the ratio of the intensity of light received at the light receiving unit when irradiation light of a specific wavelength is emitted from the emitter to the intensity of light received at the light receiving unit when irradiation light of another wavelength is emitted from the emitter.

[0009] As one embodiment of the present disclosure, the control unit determines that an abnormality has occurred in the component measuring chip when the ratio is outside a predetermined range.

[0010] In one embodiment of the present disclosure, the irradiation light of the other wavelengths includes irradiation light of multiple wavelengths, the predetermined range is set individually for each of the multiple wavelengths, and the control unit determines that an abnormality has occurred in the component measurement chip when the ratio for at least one wavelength among the multiple wavelengths is outside the predetermined range.

[0011] In one embodiment of the present disclosure, the specific wavelength is a wavelength included in the infrared region.

[0012] A component measuring device set as a second aspect of the present disclosure comprises a component measuring chip and a component measuring device having a chip insertion space for inserting the component measuring chip, wherein the component measuring device comprises an emitter that emits irradiation light to the component measuring chip when the component measuring chip is inserted into the chip insertion space, a light receiving unit that receives light that has passed through or reflected by the component measuring chip, and a control unit, wherein the control unit detects an abnormality in the component measuring chip based on the ratio of the light receiving intensity at the light receiving unit when irradiation light of a specific wavelength is emitted from the emitter to the light receiving intensity at the light receiving unit when irradiation light of another wavelength is emitted from the emitter.

[0013] An information processing method as a third aspect of the present disclosure is an information processing method executed by a component measuring device having a chip insertion space for inserting a component measuring chip, and comprising: a light emitting unit that emits irradiation light onto the component measuring chip when the component measuring chip is inserted into the chip insertion space; a light receiving unit that receives light that has passed through or reflected by the component measuring chip; and a control unit, and includes the steps of calculating the ratio of the light receiving intensity at the light receiving unit when irradiation light of a specific wavelength is emitted from the light emitting unit to the light receiving intensity at the light receiving unit when irradiation light of another wavelength is emitted from the light emitting unit; and detecting an abnormality in the component measuring chip based on the calculated ratio. [Effects of the Invention]

[0014] According to the component measuring device, component measuring device set, and information processing method of the present disclosure, an abnormality in the component measuring chip can be detected without providing a special member separately. [Brief explanation of the drawings]

[0015] [Figure 1] 1 is a top view of a component measuring device set in which a component measuring chip is attached to a component measuring device as one embodiment. FIG. [Figure 2] FIG. 2 is a cross-sectional view taken along line II in FIG. [Figure 3]FIG. 2 is a cross-sectional view taken along line II-II in FIG. [Figure 4] FIG. 2 is a top view showing the component measuring chip shown in FIG. [Figure 5] FIG. 5 is a cross-sectional view taken along line III-III in FIG. [Figure 6] FIG. 2 is a functional block diagram of the component measuring device shown in FIG. [Figure 7] 2 is a diagram showing the positional relationship of a plurality of light sources in the component measuring device shown in FIG. [Figure 8] 8 is a diagram showing the irradiation position of light emitted from the mixture of the plurality of light sources shown in FIG. 7. FIG. [Figure 9] 2 is a flowchart showing an example of a component measuring process executed by the component measuring device of FIG. 1. [Figure 10] 4 is a flowchart showing an example of an abnormality determination process executed by the component measuring device of FIG. 1 during component measurement processing. [Figure 11] 8 is a diagram schematically showing the light intensity received by a light receiving section of one set of irradiation light emitted from the first to fifth light sources of FIG. 7. FIG. [Figure 12] 4 is a diagram schematically showing the light intensity received by a light receiving section of the illumination light emitted from the first to fifth light sources. FIG. [Figure 13] 10 is a flowchart showing an example of a second received light intensity determination process. [Figure 14] FIG. 10 is a diagram showing an example of the transmittance spectrum of a measurement reagent. [Figure 15] FIG. 10 is a diagram showing an example of a determination value in a state where the component measuring chip is inserted into the chip insertion space of the component measuring device. [Figure 16] 7 is a diagram showing a distribution of the ratio of received light intensity calculated by the control unit in FIG. 6. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0016] Hereinafter, embodiments of a component measuring device, a component measuring device set, and an information processing method according to the present disclosure will be described with reference to Figures 1 to 16. Common components in the figures are denoted by the same reference numerals.

[0017] First, one embodiment of the component measuring device according to the present disclosure will be described. Fig. 1 is a top view showing a component measuring device set 100 in which a component measuring chip 2 is attached to a component measuring device 1 in this embodiment. Fig. 2 is a cross-sectional view showing a cross section along II in Fig. 1, and Fig. 3 is a cross-sectional view showing a cross section along II-II in Fig. 1. Figs. 2 and 3 show enlarged views of the vicinity of the location where the component measuring chip 2 is attached.

[0018] As shown in Figures 1 to 3, the component measuring device set 100 comprises a component measuring device 1 and a component measuring chip 2. The component measuring device 1 of this embodiment is a blood glucose level measuring device capable of measuring the concentration of glucose in a plasma component as a component to be measured in a sample. The component measuring chip 2 of this embodiment is a blood glucose level measuring chip that can be attached to one end of the blood glucose level measuring device as the component measuring device 1. The "sample" referred to here may be whole blood (blood) or separated plasma. The sample may also be an aqueous solution containing glucose.

[0019] The component measuring device 1 comprises a housing 10, a group of buttons, a display unit 11, and a removal lever 12. The housing 10 is made of a resin material. The group of buttons is provided on the top surface of the housing 10. The display unit 11 is composed of a liquid crystal or an LED (Light Emitting Diode) or the like provided on the top surface of the housing 10. The removal lever 12 is operated when removing the component measuring tip 2 attached to the component measuring device 1. The group of buttons in this embodiment is composed of a power button 13 and an operation button 14.

[0020] As shown in FIG. 1, the housing 10 includes a main body 10a having a generally rectangular outline in top view, with the above-described button group and display unit 11 provided on its upper surface, and a tip mounting portion 10b that protrudes outward from the main body 10a and has a removal lever 12 provided on its upper surface. As shown in FIG. 2, a tip insertion space S is defined inside the tip mounting portion 10b, with one end at a distal opening 10s formed on the distal end surface of the tip mounting portion 10b. When mounting the component measuring chip 2 to the component measuring device 1, the component measuring chip 2 is inserted from the outside into the tip insertion space S through the distal opening 10s and pushed to a predetermined position. This causes the component measuring chip 2 to be locked by the tip mounting portion 10b of the component measuring device 1, allowing the component measuring chip 2 to be mounted to the component measuring device 1. The component measuring chip 2 can be locked by various configurations, such as providing a claw portion in the tip mounting portion 10b that can engage with a portion of the component measuring chip 2.

[0021] When removing the component measuring chip 2 attached to the component measuring device 1 from the component measuring device 1, the component measuring chip 2 is released from the locked state by the chip attachment part 10b of the component measuring device 1 by operating the above-mentioned removal lever 12 from outside the housing 10. At the same time, the eject pin 26 (see FIG. 2) inside the housing 10 is displaced in conjunction with this, and the component measuring chip 2 can be removed from the component measuring device 1.

[0022] As an example, the housing 10 of this embodiment has a configuration including a main body portion 10a that is substantially rectangular when viewed from above (see FIG. 1) and a tip mounting portion 10b that protrudes outward from the main body portion 10a, but the shape of the housing 10 is not limited to this. That is, the housing 10 may be configured to include a tip mounting portion to which the component measuring tip 2 can be attached, and is not limited to the shape of the housing 10 of this embodiment. Therefore, in addition to the shape of the housing 10 of this embodiment, various shapes can be adopted that make it easier for an operator to hold it in one hand, for example.

[0023] The display unit 11 can display information about the component to be measured measured by the component measuring device 1. In this embodiment, the glucose concentration measured by a blood glucose measuring device serving as the component measuring device 1 can be displayed on the display unit 11. The display unit 11 may be configured to display not only information about the component to be measured, but also various other information such as the measurement conditions of the component measuring device 1 and instruction information that instructs the operator to perform a predetermined operation. The operator can operate the power button 13 and operation buttons 14 of the button group while checking the content displayed on the display unit 11.

[0024] 2 and 3, the component measuring device 1 includes a light-emitting unit 66 and a light-receiving unit 72. As shown in FIGS. 2 and 3, when the component measuring chip 2 is attached to the chip insertion space S of the component measuring device 1, the component measuring chip 2 is irradiated with light emitted by the light-emitting unit 66. The light-receiving unit 72 receives transmitted light that has passed through the component measuring chip 2 out of the light irradiated from the light-emitting unit 66 to the component measuring chip 2. In this embodiment, the light-emitting unit 66 and the light-receiving unit 72 are disposed opposite each other across the chip insertion space S. The arrangement of the light-emitting unit 66 and the light-receiving unit 72 is not limited thereto. The light-receiving unit 72 may be positioned such that it can detect light transmitted through the sample in the component measuring chip 2. For example, the light-emitting unit 66 and the light-receiving unit 72 may be disposed on the same side of the component measuring chip 2, and a reflective member may be provided on the side facing the light-emitting unit and the light-receiving unit across the chip insertion space S and the sample.

[0025] The light-emitting unit 66 is equipped with five light sources. Specifically, the light-emitting unit 66 is equipped with a first light source 67, a second light source 68a, a third light source 68b, a fourth light source 68c, and a fifth light source 68d. Here, as shown in FIG. 2, the first light source 67, the fourth light source 68c, and the fifth light source 68d are arranged at different positions in a flow direction A (direction toward the right in FIG. 2) in which a sample flows in the flow channel 23 of the component measuring chip 2, which will be described later. Also, as shown in FIG. 3, the first light source 67, the second light source 68a, and the third light source 68b are arranged at different positions in a flow channel width direction B (both left and right directions in FIG. 3) that is perpendicular to the flow direction A. The arrangement of the first light source 67 to the fifth light source 68d will be described in detail later (see FIG. 7).

[0026] Next, the component measuring chip 2 will be described. Fig. 4 is a top view showing the component measuring chip 2. Fig. 5 is a cross-sectional view taken along line III-III in Fig. 4. As shown in Figs. 4 and 5, the component measuring chip 2 comprises a base member 21 having a substantially rectangular plate-like outer shape, a measurement reagent 22 held by this base member 21, and a cover member 25 that covers the base member 21. The cover member 25 may be made of a light-blocking material in areas other than the areas where the measurement spots are formed when the component measuring chip 2 is inserted into the component measuring device 1. Details of the measurement spots will be described later.

[0027] A groove is formed on one surface of the base member 21 in the thickness direction (in this embodiment, this direction is the same as the thickness direction C of the component measuring chip 2 shown in Figures 2 and 3, and therefore will be referred to as the thickness direction C hereinafter). When covered with a cover member 25, the groove of the base member 21 becomes a hollow portion extending in a direction perpendicular to the thickness direction C, and this hollow portion constitutes the flow path 23 of the component measuring chip 2. A supply unit 24 capable of supplying a sample from the outside is formed at one end of the flow path 23. Furthermore, a measurement reagent 22 is held at the bottom of the groove of the base member 21 on the inner wall of the flow path 23. The sample supplied to the supply unit 24 from the outside moves in the flow direction A along the flow path 23, for example, by capillary action, reaches the holding position where the measurement reagent 22 is held, and comes into contact with the measurement reagent 22. The measurement reagent 22 contains a color-developing reagent that dissolves in the sample and reacts with the component to be measured in the sample to develop color. Therefore, when the measurement reagent 22 comes into contact with the component to be measured in the sample, a color reaction occurs in which the color-developing reagent contained in the measurement reagent 22 develops color, and a colored component (reaction product) is produced.

[0028] A gap 23a is formed between the cover member 25 and the test reagent 22. The sample moving in the flow direction A through the flow channel 23 from the supply unit 24 provided at one end dissolves the test reagent 22 and reaches the other end of the flow channel 23 while reacting. Therefore, by allowing the sample to reach the entire area of ​​the test reagent 22 in the flow direction A, a mixture X containing a color component can be spread in an area that can become a measurement spot. Here, the mixture X contains at least the sample, unreacted or reacted test reagent 22, and a color component.

[0029] 2, for convenience of explanation, the sample is omitted and "mixture X" is shown to be present at the holding position of the test reagent 22. However, the mixture X diffuses not only at the holding position of the test reagent 22 but also in the vicinity of the holding position of the test reagent 22, such as in the gap 23a. More specifically, the sample entering the flow path 23 from the supply unit 24 contacts the test reagent 22 at the holding position and reaches the downstream end of the flow path 23 through the gap 23a, so that the flow path 23 is filled with the sample. The test reagent 22 dissolves in the sample, and a color reaction with the sample progresses, resulting in the mixture X being located at the holding position and its vicinity.

[0030] In this embodiment, the flow path 23 is configured by a hollow portion defined by the base member 21 and the cover member 25, but the flow path is not limited to this configuration. The flow path may be formed only by a groove formed on the outer surface of one side of the base member 21 in the thickness direction C.

[0031] It is preferable to use a transparent material for the base member 21 and the cover member 25 so that the amount of transmitted light after the irradiated light passes through the material provides a sufficient signal for measurement. Examples of such transparent materials include transparent organic resin materials such as polyethylene terephthalate (PET), polymethyl methacrylate (PMMA), polystyrene (PS), cyclic polyolefin (COP), cyclic olefin copolymer (COC), and polycarbonate (PC); and transparent inorganic materials such as glass and quartz.

[0032] The measurement reagent 22 contains a color-developing reagent that reacts with the analyte in the sample to produce a color reaction that changes color depending on the blood concentration of the analyte. In this embodiment, the measurement reagent 22 is applied to the bottom of the channel 23. The measurement reagent 22 reacts with glucose, the analyte in the sample. Examples of the measurement reagent 22 include a mixed reagent of (i) glucose oxidase (GOD), (ii) peroxidase (POD), (iii) 1-(4-sulfophenyl)-2,3-dimethyl-4-amino-5-pyrazolone, and (iv) N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethylaniline, sodium salt, monohydrate (MAOS), or a mixed reagent of glucose dehydrogenase (GDH) and a tetrazolium salt. Furthermore, a buffer such as a phosphate buffer or a mediator may be included. The types and components of the measurement reagent 22 are not limited to these.

[0033] The measurement reagent 22 of this embodiment contains at least glucose dehydrogenase (GDH) and a tetrazolium salt. The amount of glucose dehydrogenase contained in the measurement reagent 22 is not particularly limited and can be appropriately selected depending on the amount of tetrazolium salt. The tetrazolium salt is not particularly limited and can be appropriately selected depending on the purpose. Examples of materials that can be used as the tetrazolium salt include tetrazolium salts (e.g., 2-substituted benzothiazolyl-3-substituted phenyl-5-substituted sulfonated phenyl-2H-tetrazolium, WST-4, WST-1, WST-5, MTS, MTT), sodium phosphomolybdate, indigo carmen, dichloroindophenol, and resazurin. These may be used alone or in combination of two or more. Among these, WST-4 or 2-substituted benzothiazolyl-3-substituted phenyl-5-substituted sulfonated phenyl-2H-tetrazolium salt is preferred, and tetrazolium salts having the following structure are particularly preferred.

[0034] [ka]

[0035] In the above chemical formula, X=Na. In addition to glucose dehydrogenase, tetrazolium salt, etc., various other components may be added to the measurement reagent 22 as needed. For example, electron transfer substances, buffers, chelating agents, surfactants, viscosity adjusters, reaction promoters, etc. may be added as appropriate.

[0036] However, in the measurement reagent 22 of this embodiment, a color-developing reagent is selected in which the peak wavelength in the absorbance spectrum of the color-developing component produced by the color reaction with glucose in the sample differs from the peak wavelength due to the light absorption characteristics of hemoglobin in blood cells. The color-developing reagent contained in the measurement reagent 22 of this embodiment has an absorbance spectrum of the color-developing component with a peak wavelength around 660 nm, but is not limited to a color-developing reagent with a peak wavelength around 660 nm, and is appropriately selected depending on the purpose.

[0037] As shown in FIG. 2, when measuring a component to be measured using the component measuring device 1, the component measuring chip 2 is attached to the chip attachment section 10b. When a sample is supplied to the supply section 24 provided at one end of the component measuring chip 2, the sample moves through the flow path 23, for example, by capillary action, and reaches a holding position in the flow path 23 where the measurement reagent 22 is held. At this holding position, glucose in the sample (plasma) reacts with the measurement reagent 22. Then, a mixture X containing a color-producing component is generated at the holding position in the flow path 23. The so-called colorimetric component measuring device 1 irradiates the mixture X containing the color-producing component with irradiation light, detects the amount of transmitted light (or the amount of reflected light), and obtains a detection signal correlating with the intensity of color development corresponding to the blood concentration. The component measuring device 1 can measure the component to be measured by referring to a calibration curve created in advance. As described above, the component measuring device 1 of this embodiment is capable of measuring the glucose concentration of a plasma component in a sample.

[0038] Fig. 6 is a functional block diagram of the component measuring device 1 shown in Fig. 1 to Fig. 3. As shown in Fig. 6, the component measuring device 1 includes a control unit 50, a photometry unit 51, a memory unit 52, a temperature measurement unit 53, a power supply unit 54, a battery 55, a communication unit 56, a clock unit 57, an operation unit 58, a buzzer unit 59, and a display unit 11.

[0039] The control unit 50 is configured with an MPU (Micro-Processing Unit) or a CPU (Central Processing Unit), and can realize the control operations of each unit by reading and executing programs stored in the storage unit 52. The storage unit 52 is configured with a non-transitory storage medium that is volatile or non-volatile, and can read or write various data (including programs) required to execute the component measurement method described in this embodiment.

[0040] The control unit 50 can measure the component to be measured in the sample by operating the photometry unit 51. Furthermore, when the component measuring device 1 executes the measurement process of the component to be measured, the control unit 50 determines whether there is an abnormality in the component measuring chip 2 attached to the component measuring device 1. Specifically, the control unit 50 determines whether there is an abnormality in the component measuring chip 2 attached to the component measuring device 1 to the extent that it will affect the measurement process of the component to be measured by the component measuring device 1. Details of the process of measuring the component to be measured and the process of determining an abnormality in the component measuring chip 2 will be described later.

[0041] The photometry unit 51 is an optical system capable of acquiring the optical characteristics of a mixture X containing a sample and a color component. The photometry unit 51 specifically includes a light emitting unit 66 and a light receiving unit 72.

[0042] The light-emitting unit 66 emits irradiation light toward the chip insertion space S. The light-emitting unit 66 includes a plurality of light sources. Specifically, the light-emitting unit 66 of this embodiment includes five light sources that emit irradiation light with different spectral radiation characteristics (for example, visible light and infrared light). More specifically, as described above, the light-emitting unit 66 of this embodiment includes a first light source 67, a second light source 68a, a third light source 68b, a fourth light source 68c, and a fifth light source 68d. The positional relationship between the first light source 67 to the fifth light source 68d is as shown in FIGS. 2 and 3. Details of the actual positional relationship between the first light source 67 to the fifth light source 68d will be described later (see FIG. 7).

[0043] The peak wavelengths of the light emitted from the first light source 67 to the fifth light source 68d are λ1 to λ5, respectively. As the first light source 67 to the fifth light source 68d, various light-emitting elements such as LED elements, EL (Electro-Luminescence: organic electroluminescence) elements, inorganic EL elements, LD (Laser Diode: laser diode) elements, etc. are applicable. In consideration of versatility, the above-mentioned LED elements are easy to use as the first light source 67 to the fifth light source 68d. In this embodiment, the first light source 67 to the fifth light source 68d are configured with LED elements. Hereinafter, the above-mentioned "peak wavelength" will be described as the wavelength of the light emitted from each light source. For ease of explanation, the peak wavelength λ1 of the first light source 67 will be referred to as the “first predetermined wavelength λ1,” the peak wavelength λ2 of the second light source 68a will be referred to as the “second predetermined wavelength λ2,” the peak wavelength λ3 of the third light source 68b will be referred to as the “third predetermined wavelength λ3,” the peak wavelength λ4 of the fourth light source 68c will be referred to as the “fourth predetermined wavelength λ4,” and the peak wavelength λ5 of the fifth light source 68d will be referred to as the “fifth predetermined wavelength λ5.” For ease of explanation, the “peak wavelength” in this embodiment will be represented by a single numerical value, but may also include a wavelength range of ±20 nm of each numerical value.

[0044] The light receiving unit 72 receives transmitted light or reflected light from the region where the color component is located, of the irradiation light emitted from the light emitting unit 66. As shown in FIGS. 2 and 3, the light receiving unit 72 of this embodiment is composed of a single light receiving element arranged opposite the light emitting unit 66 with the component measuring chip 2 in between. In this embodiment, the light receiving unit 72 receives transmitted light that is irradiated from the first light source 67 to the fifth light source 68d of the light emitting unit 66 onto the mixture X generated at the holding position of the measurement reagent 22 on the component measuring chip 2 and that has passed through the component measuring chip 2. Various photoelectric conversion elements including a PD (photodiode) element, a photoconductor, and a PT (phototransistor) can be used as the light receiving unit 72.

[0045] In this specification, the area within the component measuring device 1 that is irradiated with light from the light-emitting unit 66 and that is irradiated with light that can be detected by the light-receiving unit 72 will be referred to as the measurement area. When measurement is performed, the color component (or mixture X) to be detected is present in the measurement area.

[0046] Each of the first light source 67 to the fifth light source 68d receives a drive power signal from a light emission control circuit included in the photometry unit 51, and turns on and off based on the drive power signal. The light receiving unit 72 outputs an analog signal corresponding to the received light. This analog signal is amplified and AD converted by the light receiving control circuit included in the photometry unit 51, and converted into a digital signal (hereinafter referred to as a detection signal).

[0047] 6 again, the storage unit 52 can be configured with a semiconductor memory, a magnetic memory, or the like. The storage unit 52 stores, for example, various types of information and programs for operating the component measuring device 1. The storage unit 52 may also function as a work memory.

[0048] The temperature measuring unit 53 measures the temperature in the vicinity of the component measuring chip 2. The temperature measuring unit 53 measures, for example, the temperature of the chip insertion space S. The temperature measuring unit 53 may be configured, for example, with a known thermometer. The temperature measured by the temperature measuring unit 53 can be used, for example, to adjust the amount of irradiation light emitted from the light emitting unit 66, which will be described later.

[0049] The power supply unit 54 supplies the power stored in the battery 55 to each functional unit of the component measuring device 1 .

[0050] The communication unit 56 transmits and receives various information by performing wired or wireless communication with an external device. For example, the communication unit 56 transmits the results of component measurement by the component measuring device 1 to a communicatively connected external device. The communication unit 56 may receive a signal for causing the component measuring device 1 to perform an operation from the communicatively connected external device.

[0051] The clock unit 57 measures and keeps time and may be configured with, for example, an RTC (Real Time Clock).

[0052] The operation unit 58 is an input interface that allows the operator of the component measuring device 1 to perform input operations on the component measuring device 1. In this embodiment, the operation unit 58 is configured with a power button 13 and an operation button 14. However, the configuration of the operation unit 58 is not limited to the power button 13 and the operation button 14, and may be realized in any form that allows the operator to perform input operations.

[0053] The buzzer unit 59 notifies information by outputting a buzzer sound. The buzzer unit 59 outputs the buzzer sound at a predetermined timing that is set in advance. For example, the buzzer unit 59 outputs the buzzer sound when the component measurement process by the component measuring device 1 is completed or when a malfunction occurs in the component measuring device 1.

[0054] Next, the measurement process of the component to be measured in the sample by the control unit 50 of the component measuring device 1 and the arrangement of the first light source 67 to the fifth light source 68d will be described.

[0055] The control unit 50 instructs the photometry unit 51 to perform a measurement operation, and measures the concentration of the component to be measured using the detection signal and various data acquired by the photometry unit 51.

[0056] The memory unit 52 stores actual measurement data of the first actual measurement value D1 to the fifth actual measurement value D5, correction coefficient data, and calibration curve data. The first actual measurement value D1 to the fifth actual measurement value D5 are the absorbance of the mixture X at the first predetermined wavelength λ1 to the fifth predetermined wavelength λ5, respectively, measured by the photometry unit 51. The correction coefficient data includes a set of correction coefficients correlating with the absorbance of the mixture X at the second predetermined wavelength λ2 to the fifth predetermined wavelength λ5, respectively. The calibration curve data includes a calibration curve showing the relationship between the absorbance of the color component in the mixture X and various physical quantities (e.g., glucose concentration) obtained by correcting the absorbance of the mixture X measured at the first predetermined wavelength λ1 using the correction coefficient data, and a calibration curve showing the relationship between the absorbance of hemoglobin in the mixture X and the hematocrit value. The "hematocrit value" is a value expressed as a percentage of the volume ratio of blood cell components in a blood sample to blood (whole blood).

[0057] The component measuring device 1 can measure a component to be measured in a sample based on the optical characteristics of a mixture X containing a color component produced by a color reaction between the component to be measured in the sample and a reagent. Specifically, the component measuring device 1 can estimate the amount of noise other than the color component contained in a first measured value D1 of the absorbance of the mixture X, which is measured by irradiating the mixture X with irradiation light of a first predetermined wavelength λ1 as a measurement wavelength, by using irradiation light of a second predetermined wavelength λ2 to a fifth predetermined wavelength λ5. More specifically, the component measuring device 1 can estimate the amount of noise by using second measured values ​​D2 to D5 of the absorbance of the mixture X, which are measured by irradiating the mixture X with irradiation light of the second predetermined wavelength λ2 to a fifth predetermined wavelength λ5, and thereby measure the absorbance of the color component and the component to be measured.

[0058] Fig. 7 is a diagram showing the positional relationship of the first light source 67 to the fifth light source 68d when viewed from the top surface (see Fig. 1) of the component measuring device 1. For convenience of explanation, in Fig. 7, the position of the light receiving unit 72 in the flow channel 23 of the component measuring chip 2 is indicated by a two-dot chain line, and in this embodiment, the mixture X is generated at the holding position in the flow channel 23 and in the vicinity thereof.

[0059] 2, 3 and 7, the first light source 67 to the fifth light source 68d are arranged facing the mixture X located in the sample flow path 23. More specifically, the first light source 67 to the fifth light source 68d in this embodiment are arranged facing the holding position of the measurement reagent 22 in the sample flow path 23 in a direction perpendicular to both the flow direction A and the flow path width direction B (in this embodiment, the same direction as the thickness direction C of the component measuring chip 2).

[0060] 3 and 7, the first light source 67 and the second light source 68a are arranged side by side along a channel width direction B that is perpendicular to the sample flow direction A at the position of the mixture X in the sample channel 23. In this embodiment, the first light source 67 and the second light source 68a are arranged so that a first irradiation position SL1 on the mixture X of the irradiated light from the first light source 67 and a second irradiation position SL2 on the mixture X of the irradiated light from the second light source 68a overlap in the channel width direction B.

[0061] 3 and 7, the first light source 67, the second light source 68a, and the third light source 68b are arranged side by side in the flow channel width direction B with the first light source 67 at the center. In this embodiment, the first light source 67 and the third light source 68b are arranged so that an area in the flow direction A of the mixture X irradiated with light from the first light source 67 at a first irradiation position SL1 and an area in the flow direction A of the mixture X irradiated with light from the third light source 68b at a third irradiation position SL3 overlap in the flow channel width direction B, as shown in FIG.

[0062] That is, the first light source 67 to the third light source 68b are arranged so that their respective irradiation positions overlap in the flow channel width direction B. It is preferable that the first light source 67 to the third light source 68b are arranged side by side along the flow channel width direction B, and that the regions of the first irradiation position SL1 to the third irradiation position SL3 in the flow direction A overlap in the flow channel width direction B. It is more preferable that the regions of the first irradiation position SL1 to the third irradiation position SL3 in the flow channel width direction B also overlap in the flow direction A.

[0063] In this embodiment, the first light source 67 and the second light source 68a are arranged adjacent to each other in the flow channel width direction B, and there is no gap between the first light source 67 and the second light source 68a in which another light source can be arranged. Furthermore, the first light source 67 and the third light source 68b are arranged adjacent to each other in the flow channel width direction B, and there is no gap between the first light source 67 and the third light source 68b in which another light source can be arranged. In this way, the first light source 67, the second light source 68a, and the third light source 68b are arranged adjacent to each other in the flow channel width direction B, with no other light source interposed therebetween.

[0064] 2 and 7, the first light source 67 and the fourth light source 68c are arranged side by side along the flow direction A. Also, as shown in Figures 2 and 7, the first light source 67 and the fifth light source 68d of this embodiment are arranged side by side along the flow direction A. That is, the first light source 67, the fourth light source 68c, and the fifth light source 68d are arranged side by side along the flow direction A with the first light source 67 at the center.

[0065] In this embodiment, the first light source 67 and the fourth light source 68c are arranged side by side along the flow direction A so that a first irradiation position SL1 on the mixture X of the light irradiated from the first light source 67 and a fourth irradiation position SL4 on the mixture X of the light irradiated from the fourth light source 68c overlap in area, with the difference in the angle of incidence on the mixture X being equal to or less than a predetermined value. More specifically, there is no gap between the first light source 67 and the fourth light source 68c in the flow direction A where another light source can be disposed, and the first light source 67 and the fourth light source 68c are adjacent to each other in the flow direction A.

[0066] The first light source 67 and the fifth light source 68d are also arranged side by side along the flow direction A so that a first irradiation position SL1 in the mixture X of the light irradiated from the first light source 67 and a fifth irradiation position SL5 in the mixture X of the light irradiated from the fifth light source 68d can overlap in area while the difference in the angle of incidence on the mixture X is equal to or less than a predetermined value. More specifically, there is no gap between the first light source 67 and the fifth light source 68d in the flow direction A where another light source can be disposed, and the first light source 67 and the fifth light source 68d are adjacent to each other in the flow direction A.

[0067] 7, the first light source 67 to the fifth light source 68d of this embodiment are held by a thin plate-shaped holder member 80. The holder member 80 of this embodiment has a cross-shaped outer shape in a top view, with the first light source 67 held in a central portion (the intersection of the cross) in a top view. The second light source 68a is held at a position on one side in the flow path width direction B of the central portion where the first light source 67 is held, and the third light source 68b is held at a position on the other side in the flow path width direction B. The fifth light source 68d is held at a position in the flow direction A of the central portion where the first light source 67 is held, and the fourth light source 68c is held at a position opposite to the flow direction A.

[0068] In this embodiment, second light source 68a and third light source 68b, which emit irradiation light of second predetermined wavelength λ2 and third predetermined wavelength λ3, are arranged side by side with first light source 67 in flow path width direction B. Furthermore, fourth light source 68c and fifth light source 68d, which emit irradiation light of fourth predetermined wavelength λ4 and fifth predetermined wavelength λ5, are arranged side by side with first light source 67 in flow direction A. Although details will be described later, the second predetermined wavelength λ2 and third predetermined wavelength λ3 are wavelengths belonging to the infrared region, and the fourth predetermined wavelength λ4 and fifth predetermined wavelength λ5 are wavelengths belonging to the visible region.

[0069] In this embodiment, as shown in FIGS. 2 and 3, the light-receiving unit 72 faces the first light source 67 to the fifth light source 68d in the thickness direction C, sandwiching the mixture X located in the flow path 23 of the attached component measuring chip 2. The light-receiving unit 72 receives transmitted light of the light irradiated from the first light source 67 to the fifth light source 68d, which has passed through the mixture X. As shown in FIGS. 2 and 3, the component measuring device 1 includes a first aperture unit 69a located between the mixture X and the light-receiving unit 72, which adjusts the amount of light that has passed through the mixture X and reaches the light-receiving unit 72. The difference between the angle of incidence of the light irradiated from the first light source 67 onto the mixture X and the angle of incidence of the light irradiated from each of the second light source 68a to the fifth light source 68d onto the mixture X affects the accuracy of estimating the amount of noise. Therefore, it is preferable that the difference between the angle of incidence of the light irradiated from the first light source 67 onto the mixture X and the angle of incidence of the light irradiated from each of the second light source 68a to the fifth light source 68d onto the mixture X be as small as possible. In other words, the longer the distance T1 between the first light source 67 to the fifth light source 68d and the first diaphragm unit 69a in the opposing direction (the same direction as the thickness direction C of the component measuring chip 2 in Figures 2 and 3), the more preferable it is for improving the accuracy of estimating the noise amount. On the other hand, by reducing the distance T2 between the first light source 67 to the fifth light source 68d and the light receiving unit 72 in the opposing direction, it is possible to improve the light efficiency and make the component measuring device 1 more compact.

[0070] Furthermore, if there is a large deviation (hereinafter referred to as the "measurement field difference") between the area of ​​the first irradiation position SL1 of the first light source 67 and the areas of the second irradiation positions SL2 to SL5 of the second to fifth light sources 68a to 68d, the measurement points do not match, which may result in a decrease in the accuracy of the measurement results of the components to be measured. Therefore, it is preferable to reduce this measurement field difference. Therefore, it is preferable to shorten the distance T3 between the mixture X and the first aperture section 69a in the opposing direction (the same direction as the thickness direction C of the component measuring chip 2 in Figures 2 and 3). More preferably, in addition to the first aperture section 69a, one surface of the component measuring chip 2 is formed of a light-shielding member and an opening through which the measurement light can pass is provided to form an aperture. In this case, the aperture may be formed by forming only the measurement spot from a transparent member, or by cutting out the light-shielding member.

[0071] Furthermore, as shown in FIGS. 2 and 3, the component measuring device 1 includes a second aperture section 69b positioned between the first light source 67 to the fifth light source 68d and the mixture X. The second aperture section 69b adjusts the amount of light reaching the mixture X from the first light source 67 to the fifth light source 68d. In particular, the second aperture section 69b is preferably designed so that light emitted from the first light source 67 to the fifth light source 68d and reflected by the inner wall of the second aperture section 69b (hereinafter referred to as "stray light") does not enter the first aperture section 69a. It can be considered that the light emitted from the first light source 67 to the fifth light source 68d is attenuated by 5% after a single wall reflection and disappears after three or more multiple reflections. Therefore, in this embodiment, if stray light reflected by the inner wall of the second aperture section 69b does not reach the first aperture section 69a but is reflected by a wall, it will not enter the first aperture section 69a due to multiple reflections. In this embodiment, the optical axis of each light source is designed to be specularly reflected by the inner wall of the second diaphragm portion 69b, but in reality, the light is diffused by the inner wall of the second diaphragm portion 69b, and stray light also has a predetermined distribution. Therefore, in this embodiment, even if some of the stray light enters the first diaphragm portion 69a, it is preferable to set the above-mentioned distance T4 etc. so that the difference between the angle of incidence of the stray light and the angle of incidence of the first light source 67 is equal to or less than a predetermined value.

[0072] The component measuring device 1 of this embodiment defines a flow path 23 through which the sample flows, and is capable of mounting a component measuring chip 2 in which a measurement reagent 22 containing a color-developing reagent that undergoes a color reaction with the component to be measured in the sample is disposed in the flow path 23. The component measuring device 1 of this embodiment is equipped with the component measuring chip 2 and is capable of measuring the component to be measured in the sample based on the optical properties of a mixture containing a color-developing component generated by reaction with the component to be measured in the flow path 23. The component measuring device 1 is preferably configured so that the disposable component measuring chip 2 is detachable.

[0073] Next, a method for calculating the concentration of a component to be measured in a sample by the control unit 50 of the component measuring device 1 according to this embodiment will be described.

[0074] In this embodiment, the component measuring device 1 measures the blood glucose level using a sample (e.g., whole blood) and a coloring reagent without separating the plasma component containing glucose from the sample, using a color reaction between glucose as the component to be measured in the sample and a coloring reagent in the measurement reagent 22. Based on the absorbance at each wavelength of the entire mixture X obtained by this color reaction, the component measuring device 1 estimates the absorbance at a predetermined measurement wavelength of the colored component produced by the color reaction between glucose and the coloring reagent, and can calculate the concentration of the component to be measured.

[0075] Generally, when a sample contains components other than the color component to be measured, optical phenomena can occur that can affect the measurement results of the concentration of the component to be measured, which are based on the absorbance of the color component, as disturbance factors (noise). For example, "light scattering" caused by blood cell components in the sample, the surface of the component measurement chip, or fine particles such as dust attached to the component measurement chip, or "light absorption" caused by pigment components other than the color component to be measured (specifically, mainly hemoglobin when the sample is blood), can cause the measured absorbance to be higher than the true value.

[0076] When accurately measuring the absorbance due to a color component using a mixture X containing a sample having specific absorption characteristics in addition to the color component to be measured, it is necessary to remove disturbance factors (noise) due to the absorption characteristics of the sample from the actual measured value of absorbance at a specified measurement wavelength.

[0077] When the sample is blood, disturbance factors include light scattering by blood cell components and light absorption by hemoglobin. More specifically, it is necessary to estimate the amount of disturbance factors (noise) such as light scattering by blood cell components and light absorption by hemoglobin at a predetermined measurement wavelength (e.g., 660 nm) where the light absorption rate of the color component to be measured is high, and correct the actual measured value of absorbance at the same measurement wavelength. The component measuring device 1 according to this embodiment performs this correction to calculate the concentration of the component to be measured.

[0078] In this embodiment, the component measuring device 1 can measure the component to be measured in the sample based on the optical properties of the mixture X containing a color component produced by a color reaction between the sample and the measurement reagent 22. Specifically, in this embodiment, the concentration of glucose contained in the plasma component in the sample is measured.

[0079] Here, the principle of measuring glucose concentration and the wavelengths λ1 to λ5 of the light emitted by the first light source 67 to the fifth light source 68d, respectively, will be explained. Hemoglobin in red blood cells mainly contains oxyhemoglobin, which is bound to oxygen, and deoxyhemoglobin, which is formed when oxygen dissociates in an environment with low oxygen partial pressure. Oxyhemoglobin binds to oxygen after passing through the lungs and transports oxygen throughout the body through arteries, and is found in large amounts in arterial blood. For example, when blood is collected as a sample from the pad of a finger, the blood is collected from capillaries, so the amount of oxyhemoglobin is relatively large. Conversely, deoxyhemoglobin is found in large amounts in venous blood.

[0080] Existing techniques generally correct the absorbance obtained at a measurement wavelength corresponding to the color component to be measured, using, for example, the hematocrit value, without considering the ratio of reduced hemoglobin to oxygenated hemoglobin. However, the absorption coefficients of reduced hemoglobin and oxygenated hemoglobin do not coincide, and the absorption amounts due to reduced hemoglobin and oxygenated hemoglobin vary depending on the wavelength. For example, when the measurement wavelength for the absorbance of the color component to be measured is 660 nm, the absorption coefficient of reduced hemoglobin is approximately 0.9, and the absorption coefficient of oxygenated hemoglobin is approximately 0.09. In other words, if the ratio of oxygenated hemoglobin to reduced hemoglobin is 1:1, the absorption coefficient of oxygenated hemoglobin corresponds to approximately 10% of the absorption coefficient of total hemoglobin. To more accurately estimate the absorbance due to the color component to be measured, it is important to consider the ratio of reduced hemoglobin to oxygenated hemoglobin.

[0081] Therefore, in the component measuring device 1, the measurement wavelength (first predetermined wavelength λ1) for measuring the absorbance of the color component contained in mixture X is set to 660 nm. The component measuring device 1 performs correction to remove disturbance factors (noise) from the actual measured value of the absorbance of mixture X measured at this measurement wavelength, such as the influence of light scattering by blood cell components and the influence of light absorption by hemoglobin taking into account the ratio of reduced hemoglobin to oxygenated hemoglobin. In this way, the absorbance of the color component contained in mixture X is estimated, and the glucose concentration is calculated using a calibration curve showing the relationship between this estimated absorbance and the glucose concentration.

[0082] The component measuring method executed by the component measuring device 1 will be described in further detail below.

[0083] First, the color reagent in the measurement reagent 22 used in this embodiment has a peak absorbance of around 600 nm for the color component produced by color reaction with glucose in the sample, but in this embodiment, the measurement wavelength for measuring the absorbance of the color component is 660 nm.

[0084] The measurement wavelength for measuring the absorbance of the color component to be measured may be a wavelength at which the light absorptance of the color component is relatively high and at which the influence of light absorption by hemoglobin is relatively small. Specifically, the wavelength may be a wavelength that corresponds to the full width at half maximum of the peak wavelength range in the absorbance spectrum of the color component to be measured and that belongs to wavelength range W3 in which the ratio of absorbance due to light absorption by hemoglobin to the total absorbance is relatively small. The wavelength range "corresponding to the full width at half maximum of the peak wavelength range" refers to the range from the wavelength showing the half-maximum on the short wavelength side to the wavelength showing the half-maximum on the long wavelength side when the full width at half maximum of the peak wavelength range in the absorbance spectrum is specified. The absorbance spectrum of the color component to be measured in this embodiment has a peak wavelength around 600 nm, and the wavelength range corresponding to the full width at half maximum is approximately 500 nm to approximately 700 nm. Furthermore, the influence of light absorption by hemoglobin on the total absorbance is relatively small in the wavelength range of 600 nm or more. Therefore, in this embodiment, the wavelength range W3, which corresponds to the full width at half maximum of the peak wavelength range in the absorbance spectrum of the color component to be measured and in which the ratio of absorbance due to light absorption by hemoglobin to the total absorbance is relatively small, is 600 nm or more and 700 nm or less. Therefore, the measurement wavelength is not limited to 660 nm in this embodiment, but may be another wavelength in the range of 600 nm to 700 nm. A wavelength range in which the signal representing the absorbance of the color component is strong and the ratio of absorbance due to light absorption by hemoglobin to the total absorbance is as low as possible allows for more accurate measurement of the absorbance due to the color component. Therefore, it is preferable to use a measurement wavelength around 660 nm, which is slightly longer than the peak wavelength around 600 nm in the absorbance spectrum of the color component. More specifically, the measurement wavelength is preferably a wavelength in the range of 630 nm to 680 nm, more preferably a wavelength in the range of 640 nm to 670 nm, and particularly preferably 660 nm as in this embodiment. A preferred example of such a color-developing reagent is a tetrazolium salt.

[0085] Furthermore, in this embodiment, a coloring reagent is used in which the full width at half maximum of the peak wavelength range in the absorbance spectrum of the coloring component is about 500 nm to about 700 nm, but a coloring reagent in which the full width at half maximum of the peak wavelength range is different from this range may also be used. However, as described above, in consideration of the absorption characteristics of hemoglobin, it is desirable to ensure that the wavelength range in which the absorbance due to light absorption by hemoglobin is large (600 nm or less) does not overlap with the measurement wavelength in the absorbance spectrum of the coloring component.

[0086] A method for estimating the absorbance of the color component at the measurement wavelength of 660 nm in this embodiment will be described below. The component measuring device 1 measures the absorbance of the mixture X at four second predetermined wavelengths λ2 to 5th predetermined wavelengths λ5 that are different from the measurement wavelength (660 nm). The component measuring device 1 corrects the first measured value D1 of the absorbance of the mixture X at the measurement wavelength using these four second measured values ​​D2 to 5th measured values ​​D5 and predetermined correction coefficient data, thereby estimating the absorbance of the color component at the measurement wavelength. The measurement wavelength in this embodiment is the first predetermined wavelength λ1 described above.

[0087] The component measuring device 1 uses, as the second measured value D2 and the third measured value D3 described above, the two second measured values ​​D2 and the third measured values ​​D3 of the absorbance of the mixture X at the second predetermined wavelength λ2 and the third predetermined wavelength λ3, respectively, which are longer than the first predetermined wavelength λ1, which is the measurement wavelength.The component measuring device 1 uses, as the fourth measured value D4 and the fifth measured value D5 described above, the two fourth measured values ​​D4 and the fifth measured values ​​D5 of the absorbance of the mixture X at the fourth predetermined wavelength λ4 and the fifth predetermined wavelength λ5, respectively, which are shorter than the first predetermined wavelength λ1, which is the measurement wavelength.

[0088] More specifically, the component measuring device 1 uses, as the second measured value D2 and the third measured value D3, the two second measured values ​​D2 and the third measured values ​​D3 of the absorbance of the mixture X at the second predetermined wavelength λ2 and the third predetermined wavelength λ3, respectively, which are longer than the first predetermined wavelength λ1, which is the measurement wavelength, and which belong to a wavelength range in which the influence of light scattering by blood cell components and the like is dominant in the total absorbance.The component measuring device 1 uses, as the fourth measured value D4 and the fifth measured value D5, the two fourth measured values ​​D4 and the fifth measured values ​​D5 of the absorbance of the mixture X at the fourth predetermined wavelength λ4 and the fifth predetermined wavelength λ5, respectively, which are shorter than the first predetermined wavelength λ1, which is the measurement wavelength, and which belong to a wavelength range in which the influence of light absorption by hemoglobin is dominant in the total absorbance.

[0089] In other words, the component measuring device 1 uses, as the second measured value D2 and the third measured value D3 described above, the absorbance of the mixture X at the second predetermined wavelength λ2 and the third predetermined wavelength λ3, respectively, which belong to a wavelength range longer than the measurement wavelength which belongs to the wavelength range corresponding to the full width at half maximum of the peak wavelength range in the absorbance spectrum of the color component being measured, for example, at the long wavelength range W1 which is longer than the wavelength range W3.

[0090] Furthermore, the component measuring device 1 uses, as the fourth measured value D4 and the fifth measured value D5 described above, the fourth measured value D4 and the fifth measured value D5, which are the absorbance of the mixture X at a fourth predetermined wavelength λ4 and a fifth predetermined wavelength λ5, respectively, which belong to a wavelength range shorter than the measurement wavelength that belongs to the wavelength range corresponding to the full width at half maximum of the peak wavelength range in the absorbance spectrum of the color component being measured, for example, which belong to a short wavelength range W2 that is shorter than the wavelength range W3.

[0091] In the component measuring device 1, the control unit 50 acquires the above-mentioned first actual value D1 to fifth actual value D5 from the photometry unit 51. Specifically, the first light source 67 to fifth light source 68d of the light emitter 66 irradiate the mixture X with irradiation light having emission wavelengths of the first predetermined wavelength λ1 to fifth predetermined wavelength λ5, respectively. The light receiver 72 receives transmitted light that passes through the mixture X from each of the irradiation light. The control unit 50 then calculates the absorbance of the mixture X at each wavelength from the relationship between the irradiation light and the transmitted light, and stores the first actual value D1 to fifth actual value D5, which are the absorbance of the mixture X at each wavelength, in the storage unit 52 as actual value data. The control unit 50 can acquire the actual value data from the storage unit 52. The means by which the control unit 50 acquires the first actual value D1 to fifth actual value D5 is not limited to the means described above, and various known means can be used.

[0092] The control unit 50 then corrects the first actual measurement value D1 using the second actual measurement value D2 to the fifth actual measurement value D5, and estimates the absorbance of the color component at the first predetermined wavelength λ1 (660 nm in this example), which is the measurement wavelength. In the long wavelength range W1, where light scattering by blood cell components and the like is dominant, the absorbance spectrum of the mixture X is approximately linear. Therefore, the component measuring device 1 acquires the second actual measurement value D2, which is the absorbance at the second predetermined wavelength λ2, and the third actual measurement value D3, which is the absorbance at the third predetermined wavelength λ3, and calculates the slope between the second actual measurement value D2 and the third actual measurement value D3. This allows the component measuring device 1 to estimate, to some extent, the absorbance at the first predetermined wavelength λ1, which is the measurement wavelength, that is caused by disturbance factors (noise) other than the absorbance caused by the color component.

[0093] Furthermore, the component measuring device 1 can calculate the glucose concentration in a sample by taking into account the ratio of reduced hemoglobin to oxygenated hemoglobin in red blood cells, in addition to the optical properties of blood cell components in the sample. Therefore, the component measuring device 1 can perform more accurate correction by using two wavelengths (fourth predetermined wavelength and fifth predetermined wavelength) selected based on the ratio of reduced hemoglobin to oxygenated hemoglobin.

[0094] Specifically, the component measuring device 1 uses, as the fourth predetermined wavelength λ4, a wavelength at which the difference in absorption coefficient between reduced hemoglobin and oxygenated hemoglobin is equal to or smaller than a first predetermined value. Furthermore, as the fifth predetermined wavelength λ5, the component measuring device 1 uses a wavelength at which the difference in absorption coefficient between reduced hemoglobin and oxygenated hemoglobin is greater than the first predetermined value. More specifically, as the fourth predetermined wavelength λ4, the component measuring device 1 uses a wavelength at which the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is equal to or larger than a first threshold value. Furthermore, as the fifth predetermined wavelength λ5, the component measuring device 1 uses a wavelength at which the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is less than the first threshold value. In other words, the fourth predetermined wavelength λ4 and the fifth predetermined wavelength λ5 use two wavelengths: a wavelength at which the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is equal to or larger than a first threshold value and a wavelength at which the ratio is smaller than the first threshold value. This allows the control unit 50 to perform a more accurate correction that takes into account the ratio of reduced hemoglobin to oxygenated hemoglobin when correcting the first measured value D1 using the second measured value D2 to the fifth measured value D5.

[0095] The two wavelengths selected based on the ratio of reduced hemoglobin to oxygenated hemoglobin are preferably two wavelengths that exhibit a large difference in hemoglobin light absorption due to the ratio of reduced hemoglobin to oxygenated hemoglobin. Therefore, in this embodiment, the fourth predetermined wavelength λ4 is a wavelength at which the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is 0.8 or greater. Furthermore, the fifth predetermined wavelength λ5 is preferably a wavelength at which the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is less than 0.8. In this embodiment, as an example, the fourth predetermined wavelength λ4 is 520 nm, and the fifth predetermined wavelength λ5 is 589 nm.

[0096] In this way, in the short wavelength range W2 where the optical absorption of hemoglobin as a whole varies greatly depending on the ratio of reduced hemoglobin to oxygenated hemoglobin, the fourth predetermined wavelength λ4 and the fifth predetermined wavelength λ5 are used, at which the difference in optical absorption of hemoglobin as a whole becomes large. This makes it possible to accurately estimate the absorbance of noise at the first predetermined wavelength λ1 (660 nm in this embodiment), which is the measurement wavelength, while also taking into account the ratio of reduced hemoglobin to oxygenated hemoglobin. Therefore, the component measuring device 1 can accurately measure the absorbance of the color component at the first predetermined wavelength λ1, which is the measurement wavelength, and further the component to be measured (glucose concentration measurement in this embodiment).

[0097] In this embodiment, only the fourth predetermined wavelength λ4 and the fifth predetermined wavelength λ5 are wavelengths that take into consideration the influence of the ratio of reduced hemoglobin to oxygenated hemoglobin. However, it is more preferable to use similar wavelengths for the second predetermined wavelength λ2 and the third predetermined wavelength λ3 in addition to the fourth predetermined wavelength λ4 and the fifth predetermined wavelength λ5.

[0098] Specifically, the second predetermined wavelength λ2 in the long wavelength range W1, where light scattering by blood cell components and the like is dominant, is a wavelength at which the difference in absorption coefficient between reduced hemoglobin and oxygenated hemoglobin is equal to or less than a second predetermined value. Furthermore, the third predetermined wavelength λ3 in the long wavelength range W1 is a wavelength greater than the second predetermined value. More specifically, the second predetermined wavelength λ2 is preferably a wavelength at which the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is equal to or greater than the first threshold and equal to or less than the second threshold. Furthermore, the third predetermined wavelength λ3 in the long wavelength range W1 is preferably a wavelength at which the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is less than the first threshold or greater than the second threshold. The second threshold is another predetermined threshold greater than the first threshold. In other words, it is preferable to use, as the second predetermined wavelength λ2 and the third predetermined wavelength λ3, two wavelengths in ranges where the ratio of the absorption coefficient of oxygenated hemoglobin to the absorption coefficient of reduced hemoglobin is different. This allows the control unit 50 to perform a highly accurate correction that takes the ratio of reduced hemoglobin to oxygenated hemoglobin into even greater consideration when correcting the first measured value D1 using the second measured value D2 to the fifth measured value D5.

[0099] In particular, in the long wavelength range W1, the influence of light scattering by blood cell components and the like is dominant, but the influence of light absorption by hemoglobin is also included to the same extent as the measurement wavelength of the measured component. Therefore, it is preferable to use, as the second predetermined wavelength λ2 and the third predetermined wavelength λ3, two wavelengths at which the light absorption by hemoglobin changes relatively significantly depending on the ratio of reduced hemoglobin to oxygenated hemoglobin.

[0100] Therefore, in this embodiment, it is preferable to use as the second predetermined wavelength λ2 a wavelength in the range where the ratio of the absorption coefficient of oxyhemoglobin to the absorption coefficient of reduced hemoglobin is 0.8 or more and 1.5 or less. In this embodiment, as an example, the second predetermined wavelength λ2 is 850 nm. Note that the second predetermined wavelength λ2 is selected from the range of 790 nm to 850 nm.

[0101] The third predetermined wavelength λ3 is set in the long wavelength range W1, and is set at a wavelength at which the absorbance of the color component included in the total absorbance at the third predetermined wavelength λ3 is 10% or less, preferably 6% or less, more preferably 3% or less, and even more preferably substantially 0% of the absorbance of the color component included in the total absorbance at the measurement wavelength. In other words, it is particularly preferable to use a wavelength equal to or greater than the wavelength at the long wavelength end of the peak wavelength range of the absorbance spectrum of the color component. This eliminates the influence of light absorption by the color component and enables more accurate estimation of noise in the long wavelength range W1, which is dominated by the influence of light scattering by blood cell components and the like. In this embodiment, the third predetermined wavelength λ3 is a wavelength selected from 920 to 950 nm, and is set to 940 nm as an example. It is particularly preferable to use the third predetermined wavelength λ3 at a wavelength at which the absorbance of the color component is zero, i.e., a wavelength at the long wavelength end of the peak wavelength range of the absorbance spectrum of the color component. The "total absorbance" in the above-mentioned "absorbance of the color-forming component included in the total absorbance" refers to the absorbance measured for a sample and / or a mixture containing the color-forming component. Furthermore, the "absorbance of the color-forming component" in the above-mentioned "absorbance of the color-forming component included in the total absorbance" refers to the absorbance of the reaction product produced by the color reaction between the analyte in the sample and the color-forming reagent in the reagent, i.e., the absorbance derived from the color-forming component.

[0102] As described above, the component measuring device 1 can correct the first measured value D1, which is the measured value of the absorbance of the mixture X at the measurement wavelength, using the second measured values ​​D2 to D5, which are the measured values ​​of the absorbance of the mixture X at the second predetermined wavelength λ2 to the fifth predetermined wavelength λ5, respectively, and estimate the absorbance of the color component at the measurement wavelength.

[0103] Next, a correction process performed by the control unit 50 of the component measuring device 1 will be described.

[0104] As described above, the memory unit 52 of the component measuring device 1 stores the actual measurement data of the first actual measurement value D1 to the fifth actual measurement value D5, correction coefficient data, and calibration curve data. The first actual measurement value D1 to the fifth actual measurement value D5 are the absorbance of the mixture X at the first predetermined wavelength λ1 to the fifth predetermined wavelength λ5, respectively, measured by the photometry unit 51. The correction coefficient data is a group of correction coefficient data correlating with the absorbance of the mixture X at the second predetermined wavelength λ2 to the fifth predetermined wavelength λ5, respectively. The calibration curve data indicates the relationship between the absorbance of the color components in the mixture X and various physical quantities, which is obtained by correcting the absorbance of the mixture X measured at the first predetermined wavelength λ1 using the correction coefficient data.

[0105] The control unit 50 derives the absorbance of the color component at the first wavelength λ1, which is the measurement wavelength, based on the actual measurement value data and correction coefficient data stored in the storage unit 52.

[0106] Here, the correction coefficient data is derived by a regression analysis carried out in advance using the following formula (1).

[0107]

number

[0108] B(λ) refers to the absorbance at wavelength λ due to disturbance factors (noise) other than the absorbance of the color component. Regression calculations are performed using various blood samples using the above formula (1) to derive the coefficients b0, b1, b2, b3, and b4. As described above, in this embodiment, the second predetermined wavelength λ2 is 850 nm, the third predetermined wavelength λ3 is 940 nm, the fourth predetermined wavelength λ4 is 520 nm, and the fifth predetermined wavelength λ5 is 589 nm. The various blood samples are based on six blood samples with different component compositions. Blood samples with hematocrit values ​​adjusted to a range of 10% to 70% are prepared, and the absorbance spectra of the adjusted blood samples are measured. The coefficients b0, b1, b2, b3, and b4 are derived using regression analysis. Based on the derived coefficients b0 to b4, a set of correction coefficients correlating with the absorbance of mixture X at each of the second predetermined wavelength λ2 to the fifth predetermined wavelength λ5 are derived. By using correction coefficient data including these correction coefficients, the actual measured value of the absorbance of mixture X at the measurement wavelength of 660 nm can be corrected from the actual measured values ​​of the absorbance of mixture X at 520 nm, 589 nm, 850 nm, and 940 nm, and the absorbance of the color components at 660 nm can be estimated.

[0109] In order to more simply determine the blood glucose level, the above formula can be simplified, and the absorbance of the color component at 660 nm can be estimated by correcting the actual measured value of the absorbance of mixture X at the measurement wavelength of 660 nm from the actual measured value of the absorbance of mixture X at light of 520 nm, which is the fourth predetermined wavelength λ4, and 850 nm, which is the second predetermined wavelength λ2.

[0110] 9 is a flowchart showing an example of a component measurement process executed by the component measurement device 1. As shown in FIG. 9, the component measurement process includes steps S1 to S4. In step S1, the component measurement device 1 acquires a first measured value D1 which is the absorbance of the mixture X at a first predetermined wavelength λ1 as a measurement wavelength, a second measured value D2 which is the absorbance of the mixture X at a second predetermined wavelength λ2, a third measured value D3 which is the absorbance of the mixture X at a third predetermined wavelength λ3, a fourth measured value D4 which is the absorbance of the mixture X at a fourth predetermined wavelength λ4, and a fifth measured value D5 which is the absorbance of the mixture X at a fifth predetermined wavelength λ5. In step S2, the component measurement device 1 derives a hematocrit value using at least one of the first measured value D1 to the fifth measured value D5. In step S3, the component measuring device 1 corrects the first measured value D1 using the second measured value D2 to the fifth measured value D5 and the correction coefficient obtained by regression calculation, and obtains the absorbance of the color component at the first predetermined wavelength λ1 as the measurement wavelength. In step S4, the component measuring device 1 calculates the measured component in the sample from the absorbance of the color component at the first predetermined wavelength λ1 as the measurement wavelength and the derived hematocrit value.

[0111] In step S1, as described above, the first measured value D1 to the fifth measured value D5 are obtained using the light-emitting unit 66 and the light-receiving unit 72 of the photometry unit 51. In this embodiment, in step S2, the hematocrit value is derived based on the fourth measured value D4 or based on the fourth measured value D4 and the second measured value D2. Specifically, in step S2, the hematocrit value is derived by estimating the absorbance of hemoglobin from the fourth measured value D4 or from the fourth measured value D4 and the second measured value D2. Furthermore, if the fourth measured value D4 or the fourth measured value D4 and the second measured value D2 contain absorption of the coloring component, a correction calculation is performed to subtract the absorption of the coloring component from the fourth measured value D4 or the fourth measured value D4 and the second measured value D2, respectively, and the hematocrit value is derived from the obtained corrected value. In this embodiment, the hematocrit value is derived from a calibration curve stored in memory unit 52, which shows the relationship between the absorbance of hemoglobin in mixture X and the hematocrit value. In step S3, the first measured value D1 is actually corrected using the second measured values ​​D2 to D5 and a correction coefficient obtained by regression calculation, and the absorbance of the color component at the first measurement wavelength is estimated and obtained. Note that if the second measured values ​​D2 to D5 include the absorption of the color component, a correction calculation is performed to subtract the absorption of the color component from each measured value, and recalculation is performed using the obtained corrected value to estimate and obtain the absorbance of the color component at the first predetermined wavelength λ1. Finally, in step S4, the glucose concentration is calculated using a calibration curve showing the relationship between the absorbance of the color component at the first predetermined wavelength λ1, which is the acquired measurement wavelength, and the derived hematocrit value.

[0112] Next, a description will be given of the process executed by the control unit 50 of the component measuring device 1 to determine whether or not an abnormality has occurred in the component measuring chip 2, which is to the extent that it will affect the measurement process of the component to be measured by the component measuring device 1, according to a predetermined algorithm, when executing the component measurement process. Below, a description will be given of the details of the abnormality determination process executed by the control unit 50 when executing the component measurement process.

[0113] In this embodiment, the control unit 50 can execute a process (insertion determination process) to determine whether or not the component measuring chip 2 has been inserted into the component measuring device 1. In this embodiment, the control unit 50 also executes an abnormality determination process when executing the insertion determination process, as will be described below.

[0114] 10 is a flowchart showing an example of an abnormality determination process executed during the component measurement process by the component measuring device 1. The flow of FIG. 10 is executed when, for example, an operator inputs a command to start the process to the component measuring device 1.

[0115] Here, when executing the component measurement process, the control unit 50 causes the first light source 67 to the fifth light source 68d to emit the irradiation light as pulsed light once each, which is considered as one set. FIG. 11 is a diagram schematically showing one set of irradiation light emitted from the first light source 67 to the fifth light source 68d, and is a graph showing the light intensity received by the light receiving unit 72 of the irradiation light emitted from the first light source 67 to the fifth light source 68d. In FIG. 11, the horizontal axis represents time, and the vertical axis represents the received light intensity. As shown in FIG. 11, the control unit 50 causes the first light source 67 to the fifth light source 68d to emit light in sequence at predetermined time intervals. In the example shown in FIG. 11, the control unit 50 causes the first light source 67 to the fifth light source 68d to emit light at predetermined time intervals of 1 msec. 11, the control unit 50 controls the first light source 67 to the fifth light source 68d to emit light so that the light emitted from each of the first light source 67 to the fifth light source 68d has approximately the same light intensity received by the light receiving unit 72. "Almost the same intensity" means that when the component measurement process is performed using the light receiving intensity at the light receiving unit 72, the difference in the light receiving intensity obtained from the emission of each light source is within a range that does not affect the result of the component measurement process.

[0116] Here, the control unit 50 causes the first light source 67 to the fifth light source 68d to emit light in a predetermined order in one set of emission processing. For example, in the example shown in FIG. 11, the control unit 50 causes the fifth light source 68d, the third light source 68b, the first light source 67, the second light source 68a, and the fourth light source 68c to emit irradiation light to the measurement region in this order in one set of emission processing. Therefore, the light receiving unit 72 receives irradiation light at predetermined time intervals (1 msec) in the order of the fifth predetermined wavelength λ5, the third predetermined wavelength λ3, the measurement wavelength (first predetermined wavelength λ1), the second predetermined wavelength λ2, and the fourth predetermined wavelength λ4. Note that the control unit 50 does not necessarily have to cause the fifth light source 68d, the third light source 68b, the first light source 67, the second light source 68a, and the fourth light source 68c to emit irradiation light in this order in one set of emission processing.

[0117] 10, when the control unit 50 detects an operation input for starting processing by, for example, the operator of the component measuring device 1, the control unit 50 starts emitting irradiation light from the first light source 67 to the fifth light source 68d (step S11). At this time, the control unit 50 causes the first light source 67 to the fifth light source 68d to emit irradiation light so that it can detect whether or not the component measuring tip 2 is attached to the component measuring device 1.

[0118] FIG. 12 is a diagram schematically illustrating the light intensity received by the light receiving unit 72 of the irradiation light emitted from the first light source 67 to the fifth light source 68d in step S11 of FIG. 10. In FIG. 12, the horizontal axis represents time, and the vertical axis represents the received light intensity. As schematically illustrated in FIG. 12, the control unit 50 repeatedly outputs the set of the emission process described in FIG. 11. For example, the control unit 50 repeatedly executes the set of the emission process 1 to 200 times per second. In this embodiment, the set of the emission process is repeatedly executed 16 times per second. After repeating the set of the emission process 16 times, the control unit 50 stops outputting the irradiation light. Then, after a predetermined time (here, 1 second) has elapsed since the start of the set of the 16 emission processes, the control unit 50 again outputs the set of the emission process 16 times without interruption. After repeating the set of the emission process 16 times, the control unit 50 again stops outputting the irradiation light. In this way, the control unit 50 repeats the combination of outputting the set of 16 emission processes and stopping the output of the irradiation light every second until step S14, which will be described later.

[0119] Next, the control unit 50 executes a first determination of the intensity of received light (step S12). Specifically, in the determination process of the intensity of received light, the control unit 50 determines whether the intensity of received light at the light receiving unit 72 is within a normal range (step S12).

[0120] If the control unit 50 determines that the received light intensity at the light receiving unit 72 is not within the normal range (No in step S12), it notifies the user that an error has occurred, for example by outputting a buzzer sound from the buzzer unit 59 (step S18).

[0121] When the control unit 50 determines that the intensity of light received by the light receiving unit 72 is within a normal range (Yes in step S12), it determines whether or not the component measuring chip 2 has been inserted into the chip insertion space S based on a change in the intensity of light received by the light receiving unit 72. Specifically, the control unit 50 determines in step S14 whether or not the component measuring chip 2 has been inserted into the chip insertion space S. Alternatively, the control unit 50 may determine in steps S13 and S14 whether or not the component measuring chip 2 has been inserted into the chip insertion space S.

[0122] More specifically, for example, an operator mounts the component measurement chip 2 on the component measurement device 1. That is, the operator inserts the component measurement chip 2 into the chip insertion space S of the component measurement device 1. While the component measurement chip 2 is inserted into the chip insertion space S, at least a portion of the irradiated light emitted from the first light source 67 to the fifth light source 68d is absorbed by the members constituting the component measurement chip 2 and does not reach the light receiving unit 72. Then, when the component measurement chip 2 is mounted on the component measurement device 1 and reaches the state shown in FIGS. 2 and 3, an optical path is formed between the first light source 67 to the fifth light source 68d and the light receiving unit 72 through a portion of the component measurement chip 2. The portion where the optical path is formed on the component measurement chip 2 is a measurement spot. In this embodiment, the measurement reagent 22 is located midway along the optical path. That is, the measurement spot is located on the measurement reagent 22. Therefore, of the irradiation light emitted from the first light source 67 to the fifth light source 68d toward the measurement region, only a portion of the light that passes through the measurement reagent 22 is received by the light receiving unit 72. In other words, when the component measuring chip 2 is attached to the component measuring device 1, a difference occurs in the intensity of light received by the light receiving unit 72 compared to when the component measuring chip 2 is not attached.

[0123] For this reason, the control unit 50 detects a change in the intensity of light received by the light receiving unit 72, thereby determining whether or not the component measuring chip 2 has been attached to the component measuring device 1. The control unit 50 determines that the component measuring chip 2 has been inserted into the chip insertion space S when it detects that the intensity of light received by the light receiving unit 72 has fallen within a predetermined range, which indicates that the component measuring chip 2 has been inserted into the chip insertion space S, after the amount of light received by the light receiving unit 72 has fallen below a predetermined amount (i.e., a state in which at least a portion of the irradiated light is blocked by a member constituting the component measuring chip 2 and does not reach the light receiving unit 72).

[0124] In this embodiment, the control unit 50 determines that the component measuring chip 2 has been inserted into the chip insertion space S when it detects that the light receiving intensity at the light receiving unit 72 has fallen within a predetermined range that indicates that the component measuring chip 2 has been inserted into the chip insertion space S, based on the light receiving intensity at the light receiving unit before the component measuring chip 2 was inserted into the chip insertion space S (step S14).

[0125] In addition, when the component measuring chip 2 is formed of a light-shielding material except for the measurement site, after a state in which the light receiving unit 72 does not detect the amount of light (i.e., a state in which the irradiated light is blocked by a material constituting the component measuring chip 2 and does not reach the light receiving unit 72), the control unit 50 may detect that the received light intensity falls within a predetermined range, and determine whether or not the component measuring chip 2 has been inserted. In this case, the control unit 50 first determines whether or not the light receiving unit 72 has detected the irradiated light (step S13). In this specification, the state in which the irradiated light is not received includes a case in which the light receiving unit 72 detects an amount of light of a received light intensity that is detectable when the irradiated light emitted from the first light source 67 to the fifth light source 68d is blocked by the component measuring chip 2. Whether or not the irradiated light is not received can be determined, for example, by setting a threshold value in advance and determining whether or not the output value of the AD converter of the light receiving unit 72 for the received light intensity is below the threshold. If the control unit 50 determines that the light receiving unit 72 is not in a state where it does not receive the irradiated light (No in step S13), the control unit 50 repeats step S13 until it determines that the light receiving unit 72 is in a state where it does not receive the irradiated light. If the control unit 50 determines that the light receiving unit 72 is in a state where it does not receive the irradiated light (Yes in step S13), the control unit 50 executes a second received light intensity determination process (step S14). Note that step S13 may be omitted, and steps S12 and S14 may be performed instead.

[0126] The second received light intensity determination process is a process for determining whether or not the component measuring chip 2 is attached (inserted) to the component measuring device 1. Fig. 13 is a flowchart showing an example of the second received light intensity determination process, and is a flowchart showing details of step S14 in Fig. 10.

[0127] First, the control unit 50 acquires a relative output value corresponding to the intensity of received light from the light-receiving unit 72 (step S31). Here, the relative output value refers to the difference between the output value from the AD converter connected to the light-receiving unit 72 when light is being emitted from the light-emitting unit 66 (first light source 67 to fifth light source 68d) and the output value from the AD converter connected to the light-receiving unit 72 when light is not being emitted from the light-emitting unit 66 (first light source 67 to fifth light source 68d). In other words, the relative output value is obtained by subtracting the output value A observed when the light-emitting unit 66 is not emitting light from the output value R observed when the light-emitting unit 66 is emitting light. The absolute output values ​​A and R and the relative output value RA are acquired and calculated while the light-emitting unit 66 is repeatedly turned on and off. 11, an output value R5 of the fifth predetermined wavelength λ5 is obtained at a predetermined timing while the irradiation light of the fifth predetermined wavelength λ5 is being emitted, and an absolute output value A5 of the fifth predetermined wavelength λ5 is obtained at a timing a predetermined time before the predetermined timing when the irradiation light is not being emitted. The same applies to the first predetermined wavelength λ1 to the fourth predetermined wavelength λ4. The absolute output value and relative output value used here can be calculated by taking a moving average of multiple absolute output values ​​and multiple relative output values ​​obtained within a predetermined interval for a light source of the same wavelength.

[0128] In this embodiment, an AD converter with a 12-bit resolution is used as the converter. However, the resolution of the AD converter does not necessarily have to be 12 bits, and an AD converter with an appropriate resolution can be used. Furthermore, the value of the AD converter with a 12-bit resolution can be converted into the output value of an AD converter with a different resolution.

[0129] Next, the control unit 50 calculates a judgment value (step S32). The judgment value is a numerical value used in the judgments in steps S33 and S34, and is a value obtained by dividing the relative output value after insertion of the component measuring chip 2 by the relative output value before insertion of the component measuring chip 2. In other words, the judgment value is a value obtained by dividing the relative output value acquired in step S31 by the relative output value (blank value) acquired before insertion of the component measuring chip 2. The relative output value before insertion of the component measuring chip 2 may be automatically adjusted, for example, in the manufacturing process of the component measuring device 1. In a normal case where there is no dirt (foreign matter attached) in the optical path, the relative output value before insertion of the component measuring chip 2 will be a value close to the relative output value after the adjustment. For example, if the target value in the adjustment of the relative output value is set to 2000 and the relative output value acquired in step S36 is also 2000, and the relative output value acquired in step S58 is Vr, the judgment value V is calculated in step S32 by V=Vr / 2000.

[0130] The control unit 50 determines whether the determination value V calculated in step S32 is within a first specified range (step S33). The first specified range is a range within which it is recognized that the component measuring chip 2 is properly inserted into the component measuring device 1. That is, when the determination value V is within the first specified range, the control unit 50 can recognize that the component measuring chip 2 is attached to the component measuring device 1 and that a measurement spot is positioned in the optical path. The first specified range can be determined appropriately depending on the specifications of the component measuring device 1 and the appropriate component measuring chip 2. In this embodiment, the first specified range is greater than 0.05 and equal to or less than 0.3. That is, the first specified range corresponds to the case where the relative output value (amount of received light) after inserting the component measuring chip 2 into the component measuring device 1 is greater than 5% and equal to or less than 30% of the relative output value (amount of received light) before inserting the component measuring chip 2 into the component measuring device 1. The first specified range reflects the intensity of light transmitted through the measurement reagent 22 in the component measuring chip 2 before a sample is introduced.

[0131] When the control unit 50 determines that the determination value V is included within the first specified range, that is, when it determines that 0.05 < V ≤ 0.3 (Yes in step S33), it determines that the component measurement chip 2 is properly inserted into the component measurement device 1. In this specification, this determination result is hereinafter simply referred to as "chip normal recognition". In this case, in step S14 of FIG. 10, the control unit 50 determines that the received light intensity is within the normal range (Yes in step S14). Then, it proceeds to step S15 of the flowchart in FIG. 10.

[0132] When the control unit 50 determines that the determination value V is not included within the first specified range, that is, when it determines that V ≤ 0.05 or 0.3 < V (No in step S33), it determines whether the determination value V is included within the second specified range (step S34). The second specified range is a range in which it is recognized that the component measurement chip 2 is inserted into the component measurement device 1 in an inappropriate manner. The second specified range can be appropriately determined according to the specifications of the component measurement device 1 and the appropriate component measurement chip 2, etc. In this embodiment, the second specified range is set to be greater than 0.01 and less than or equal to 0.05. That is, the second specified range corresponds to the case where the relative output value (received light amount) after inserting the component measurement chip 2 into the component measurement device 1 exceeds 1% and is less than or equal to 5% with respect to the relative output value (received light amount) before inserting the component measurement chip 2 into the component measurement device 1.

[0133] When the control unit 50 determines that the determination value V is included within the second specified range, that is, when it determines that 0.01 < V ≤ 0.05 (Yes in step S34), it determines that the component measurement chip 2 is inserted into the component measurement device 1 in an inappropriate manner. In this case, when the determination value V is within the second specified range, the control unit 50 can recognize that at least a part of the optical path is blocked by the component measurement chip 2, that the measurement spot is not correctly positioned within the optical path, or that a used component measurement chip 2 is erroneously mounted. This determination result is also simply referred to as "poor chip recognition" hereinafter in this specification. In this case, the control unit 50 determines in step S_{14} of FIG. 10 that the received light intensity is not within the normal range (No in step S_{14}). In this case, the control unit 50 notifies that an error has occurred, for example, by outputting a buzzer sound from the buzzer unit 59 (step S_{18}). The control unit 50 may output a buzzer sound, for example, or notify of the occurrence of an abnormality by voice. The control unit 50 may also notify by displaying the occurrence of an abnormality on the display unit 11. Note that when an error occurs, the control unit 50 may abort the process. The control unit 50, for example, aborts the measurement process of the component to be measured after notifying of the error. Thereby, when there is a possibility that an abnormality has occurred, the execution of the process is not performed. The control unit 50 can detect whether normal measurement can be executed by notifying of an error when there is a possibility that the component measurement chip 2 is inserted in an inappropriate manner in this way.

[0134] When the control unit 50 determines that the determination value V is not included within the second specified range (No in step S34), it proceeds to step S33. By the transition from step S34 to step S33, the control unit 50 may be made to recognize that the insertion of the component measurement chip 2 into the chip insertion space S is insufficient. In this way, the control unit 50 repeats steps S33 and S34 until it determines that the determination value V is included within the first specified range or determines that the determination value V is included within the second specified range.

[0135] In addition, in this embodiment, when the determination value V is not within the first specified range nor within the second specified range, that is, when V ≤ 0.01 or 0.3 < V, the control unit 50 may not make a determination as to whether the chip is normally recognized or the chip recognition is poor. In this case, it is possible that the component measurement chip 2 is not inserted into the component measurement device 1, and it is not an appropriate state for making a determination as to whether the chip is normally recognized or the chip recognition is poor. For example, when a part other than the measurement site of the component measurement chip 2 is formed of a light-shielding member, when the component measurement chip 2 is being inserted into the component measurement device 1, the irradiation light from the light-emitting unit 66 is blocked by the component measurement chip 2. In this case, the irradiation light is blocked and not received by the light-receiving unit 72. Therefore, the relative output value becomes a value close to 0, and the determination value V may become 0.01 or less. However, in this case, it is in the middle of the process of inserting the component measurement chip 2, and it is not an appropriate state for making a determination as to whether the chip is normally recognized or the chip recognition is poor. Therefore, in this case, no determination is made, and the determination is made when the determination value V is within the first specified range or the second specified range.

[0136] In this way, the control unit 50 according to this embodiment determines whether the component measurement chip 2 is mounted (inserted) on the component measurement device 1. When the control unit 50 determines that the chip recognition is poor, it may prompt the operator to correctly attach the component measurement chip 2 by notifying the operator.

[0137] In the determination process of the second light-receiving intensity, the first specified range and the second specified range may be determined for each of the first light source 67 to the fifth light source 68d, or may be the same for all of the first light source 67 to the fifth light source 68d. For example, depending on the wavelengths λ1 to λ5 of the irradiation light emitted from the first light source 67 to the fifth light source 68d, the absorption and reflection properties in the measurement reagent 22 may be different. Therefore, for example, by applying different first specified ranges and second specified ranges according to the absorption rate in the measurement reagent 22, the determination can be made more accurately according to the properties of the irradiation light. By applying different first specified ranges and second specified ranges according to the absorption rate in the measurement reagent 22, the determination can be made more accurately according to the properties of the irradiation light.

[0138] Furthermore, in the second received-light intensity determination process, the control unit 50 may determine that the condition is satisfied (i.e., if the answer to each branch in the flow chart of FIG. 13 is Yes) when the output value from the AD converter falls within a predetermined range (the first specified range or the second specified range) over a predetermined period of time. The predetermined period may be determined, for example, by a predetermined time. In this case, the predetermined period may be determined, for example, as three seconds. The predetermined period may be determined, for example, by the number of times the first light source 67 to the fifth light source 68d emit light. In this case, the predetermined period may be determined, for example, as three sets of output of a set of 16 emission processes and stoppage of the output of the irradiation light (i.e., three consecutive sets). In this way, by providing a predetermined period for determination in the second received-light intensity determination process, it becomes easier to prevent erroneous determination that the component measuring chip 2 is attached to the component measuring device 1 when the output value from the AD converter temporarily falls within the predetermined range due to some factor other than the insertion of the component measuring chip 2.

[0139] In addition, when the control unit 50 determines the predetermined period based on the number of times the first light source 67 to the fifth light source 68d emit light, the control unit 50 may change the interval at which the combination of outputting a set of 16 emission processes and stopping the output of the emission light is executed when the light receiving unit 72 first detects received light after the state in step S13 where no emission light is received. In particular, the control unit 50 may shorten the interval at which the combination of outputting a set of 16 emission processes and stopping the output of the emission light is executed. For example, as described above, if the combination of outputting a set of 16 emission processes and stopping the output of the emission light is executed every second in step S11, the control unit 50 may shorten the interval at which this combination is executed to 0.5 seconds. This shortens the interval at which the combination of outputting a set of 16 emission processes and stopping the output of the emission light is executed, making it easier to determine the result of the second received light intensity determination process.

[0140] Referring again to FIG. 10, when the control unit 50 determines that the received light intensity at the light receiving unit 72 is within a predetermined range (Yes in step S14), it determines whether there is an abnormality in the component measuring chip 2 attached to the component measuring device 1.

[0141] Here, the determination of an abnormality by the control unit 50 will be described. Here, as an example of an abnormality, an example of determining deterioration of the component measurement chip 2 will be described. Specifically, the component measurement chip 2 includes a measurement reagent 22 on a base member 21. The measurement reagent 22 is applied to the base member 21. The quality of the measurement reagent 22 deteriorates when exposed to energy such as heat or ultraviolet light. The deterioration of quality here includes a specific dye contained in the measurement reagent 22 generating a colored component even when it has not reacted with the sample, or the dye itself fading. This causes a color change in the measurement reagent 22 that has not reacted with the sample, i.e., is unused. The control unit 50 according to this embodiment determines deterioration from the color change of the measurement reagent 22 in the form of such a component measurement chip 2.

[0142] FIG. 14 shows an example of the transmittance spectrum of the measurement reagent 22 on an unused component measuring chip 2. Specifically, FIG. 14 shows the results obtained by measuring the transmittance spectra of a component measuring chip 2 that was coated with the measurement reagent 22 and then not subjected to a heating treatment (untreated, i.e., undegraded state), a component measuring chip 2 that was stored at 60°C for three days (heating treatment 2), and a component measuring chip 2 that was stored at 60°C for seven days (heating treatment 1). The transmittance spectra were measured using an appropriate detector in the form of the component measuring chip 2. Here, the component measuring chip 2 from which the transmittance spectra of heating treatment 1 and heating treatment 2 were obtained is deteriorated, making it impossible to accurately measure components. In the graph shown in FIG. 14, the horizontal axis indicates the wavelength of irradiated light irradiated so as to pass through the measurement reagent 22 on the component measuring chip 2, and the vertical axis indicates the transmittance of light of each wavelength.

[0143] In this embodiment, as shown in FIG. 14, the transmittance of the undegraded component measuring chip 2 (untreated) increases significantly at wavelengths from approximately 500 nm to 550 nm, and exceeds 80% at wavelengths above 550 nm. In contrast, the degraded component measuring chip 2 (heating treatment 1, heating treatment 2) also increases at wavelengths from 500 nm to 550 nm, but the transmittance does not reach 80%, remaining in the range of 50% to 70%. The degraded measurement reagent 22 exhibits a gradual increase in transmittance between 550 nm and 800 nm, and exhibits the same level of transmittance as a normal component measuring chip 2 for irradiated light at wavelengths above approximately 800 nm. Thus, in this embodiment, a difference occurs in the transmittance of irradiated light in the wavelength range from 550 nm to 800 nm between the normal measurement reagent 22 (component measuring chip 2) and the degraded measurement reagent 22. The control unit 50 utilizes this difference in transmittance to determine whether the component measuring chip 2 is degraded.

[0144] For example, if the transmittance when a certain measurement reagent 22 is irradiated with light of a predetermined wavelength deviates by a predetermined amount from the transmittance when a normal measurement reagent 22 is irradiated with light of the same wavelength, it can be determined that the certain measurement reagent 22 has undergone a color change due to deterioration. In this manner, it can be determined whether the measurement reagent 22 has deteriorated or not from the difference between the transmittance of the normal measurement reagent 22 and the transmittance of the measurement reagent 22 to be used in the component measurement process. In this embodiment, the higher the transmittance, the higher the intensity of light received by the light receiving unit 72. Therefore, the component measuring device 1 determines whether the measurement reagent 22 has deteriorated or not using the intensity of light received by the light receiving unit 72.

[0145] Specifically, the control unit 50 detects an abnormality (here, deterioration) in the component measuring chip 2 based on the ratio of the light receiving intensity at the light receiving unit 72 when irradiation light of a specific wavelength is emitted from the light emitting unit 66 to the light receiving intensity at the light receiving unit 72 when irradiation light of another wavelength is emitted from the light emitting unit 66.

[0146] In this embodiment, the control unit 50 uses a first light source 67, a second light source 68a, a third light source 68b, a fourth light source 68c, and a fifth light source 68d as light sources for irradiating light. Specifically, in this embodiment, the specific wavelength is λ3 (940 nm) included in the infrared range, and the other wavelengths are λ1 (660 nm), λ2 (850 nm), λ4 (520 nm), and λ5 (589 nm). Thus, the other wavelengths of irradiating light may include multiple wavelengths. Furthermore, these specific wavelengths are not limited to the numerical values ​​listed here, as long as they fall within the wavelength range defined in this embodiment. Alternatively, the control unit 50 may scan a continuous light including λ1, λ2, λ3, λ4, and λ5, and the light receiving unit 72 may receive light of these wavelengths. However, considering the miniaturization of the component measuring device 1, it is preferable to use a light emitting unit having light sources corresponding to each wavelength, rather than a continuous light source.

[0147] That is, the control unit 50 detects an abnormality in the component measurement chip 2 (measurement reagent 22) based on the ratio of the light receiving intensity at the light receiving unit 72 when light of wavelength λ3 is irradiated from the third light source 68b to the light receiving intensity at the light receiving unit 72 when light of wavelengths λ1, λ2, λ4 and λ5 is irradiated from the first light source 67, the second light source 68a, the fourth light source 68c and the fifth light source 68d, respectively.

[0148] At this time, if the ratio is outside a predetermined range, the control unit 50 determines that an abnormality has occurred in the component measuring chip 2. When the irradiation light of another wavelength includes irradiation light of multiple wavelengths as in this embodiment, the predetermined range here is set individually for each of the multiple wavelengths.

[0149] For example, the ratio of the light receiving intensity at the light receiving unit 72 when the light having a wavelength λ1 is irradiated from the first light source 67 to the light receiving intensity at the light receiving unit 72 when the light having a wavelength λ3 is irradiated from the third light source 68b is defined as T 13Similarly, the ratio of the intensity of light received at the light receiving unit 72 when the irradiation light having wavelength λ2 is emitted from the second light source 68a to the intensity of light received at the light receiving unit 72 when the irradiation light having wavelength λ3 is emitted from the third light source 68b is defined as T 23 The ratio of the intensity of light received at the light receiving unit 72 when the irradiation light having wavelength λ4 is emitted from the fourth light source 68c to the intensity of light received at the light receiving unit 72 when the irradiation light having wavelength λ3 is emitted from the third light source 68b is defined as T 43 The ratio of the intensity of light received by the light receiving unit 72 when the irradiation light having a wavelength λ5 is emitted from the fifth light source 68d to the intensity of light received by the light receiving unit 72 when the irradiation light having a wavelength λ3 is emitted from the third light source 68b is defined as T 53 Let's say.

[0150] The control unit 50 determines the ratio T 13 is within the first range R1. Similarly, the control unit 50 determines whether the ratio T 23 is included in the second range R2, and the ratio T 43 is included in the third range R3, and the ratio T 53 The first range R1, the second range R2, the third range R3, and the fourth range R4 are each determined to be within a ratio T 13 , proportion T 23 , proportion T 43 and ratio T 53 The first range R1, the second range R2, the third range R3, and the fourth range R4 are set individually as described above.

[0151] For example, in this embodiment, the first range R1 is greater than 0.8 and less than 1.2. Also, in this embodiment, the second range R2 is greater than 0.8 and less than 1.2. Also, in this embodiment, the third range R3 is greater than 0.4 and less than 0.8. Also, in this embodiment, the fourth range R4 is greater than 0.8 and less than 1.2.

[0152] The predetermined ranges (first range R1 to fourth range R4 in this embodiment) may be determined in advance from data obtained by, for example, experiments, and stored in the storage unit 52. Therefore, the numerical values ​​shown here are merely examples, and in practice, the values ​​are determined appropriately.

[0153] In this example, the upper thresholds of the first range R1, the second range R2, and the fourth range R4 are set to a value of "1.2" that exceeds "1.0." When a normal test reagent 22 exhibits a transmittance spectrum as shown in FIG. 14, the first range R1, the second range R2, and the fourth range R4 usually do not exceed 1.0. However, assuming that there is a possibility that they may exceed 1.0 due to measurement errors or the like, the ratio T 13 , proportion T 23 and ratio T 53 In order to prevent the occurrence of a uniform determination that deterioration has occurred when the value exceeds 1.0, the value "1.2" is set here.

[0154] The control unit 50 determines the ratio T 13 , proportion T 23 , proportion T 43 and ratio T 53 are respectively included in the first range R1, the second range R2, the third range R3, and the fourth range R4. The control unit 50 determines that an abnormality has occurred in the component measuring chip 2 when the ratio for at least one wavelength among the plurality of wavelengths is outside a predetermined range. That is, in this example, the ratio T 13 , proportion T 23 , proportion T 43 and ratio T 53 When at least one of the ratios T is not included in the first range R1, the second range R2, the third range R3, or the fourth range R4, the control unit 50 determines that an abnormality has occurred in the component measuring chip 2. 13 , proportion T 23 , proportion T 43 and ratio T 53If all of these are included in the first range R1, the second range R2, the third range R3, and the fourth range R4, respectively, it is determined that no abnormality has occurred in the component measuring chip 2. In the above example, the ratio T 13 , proportion T 23 , proportion T 43 and ratio T 53 However, the control unit 50 may calculate the ratio using the determination value used in determining the second received light intensity.

[0155] 10 again, the process of determining whether or not there is an abnormality in the component measuring chip 2, which is executed by the control unit 50, will be described. The control unit 50 performs the process of determining whether or not there is an abnormality in the component measuring chip 2 in steps S15 and S16 of the flow in FIG.

[0156] Specifically, when the control unit 50 determines that the light receiving intensity at the light receiving unit 72 is within a predetermined range (Yes in step S14), the control unit 50 proceeds to step S15. In step S15, the control unit 50 calculates the ratio of the light receiving intensity at the light receiving unit 72 when irradiation light of a specific wavelength is emitted from the light emitting unit 66 to the light receiving intensity at the light receiving unit 72 when irradiation light of another wavelength is emitted from the light emitting unit 66. That is, in this embodiment, in step S15, the control unit 50 calculates the ratio T 13 , proportion T 23 , proportion T 43 and ratio T 53 Calculate.

[0157] 15 is a diagram showing an example of the determination value V when the component measuring chip 2 is inserted into the chip insertion space S of the component measuring device 1. Specifically, FIG. 15 is a diagram showing the determination value V when the component measuring chip 2 is inserted into the component measuring device 1. The component measuring chip 2 includes the same non-degraded test reagent 22 (normal test paper) as shown in FIG. 14 and two types of test reagent 22 stored under different storage conditions, namely, one stored at 60°C for 3 days (heating treatment 1) and one stored at 60°C for 7 days (heating treatment 2). In the graph shown in FIG. 15, the horizontal axis indicates the wavelength of the irradiated light to the measurement reagent 22, and the vertical axis indicates the value of the determination value V. In FIG. 15, the shaded area A1 indicates the first specified range of the determination value V (greater than 0.05 and equal to or less than 0.3).

[0158] 15, although there is variation for each wavelength for both the non-degraded measurement reagent 22 and the degraded measurement reagent 22, the judgment value V is both contained within the shaded area A1, i.e., the first specified range. Therefore, even if the component measuring chip 2 containing either the normal measurement reagent 22 or one of the two types of degraded measurement reagent 22 is inserted into the component measuring device 1, in step S14 of the flow in FIG. 10, it is determined that the received light intensity at the light receiving unit 72 is within the predetermined range (Yes in step S14).

[0159] FIG. 16 is a diagram showing the distribution of the ratio of the received light intensity calculated by the control unit 50. That is, FIG. 16 shows the distribution of the ratio of the received light intensity at the light receiving unit 72 when irradiating light of a specific wavelength is emitted from the light-emitting unit 66 to the received light intensity at the light receiving unit 72 when irradiating light of another wavelength is emitted from the light-emitting unit 66. Specifically, FIG. 16 is a diagram showing the ratio of the received light intensity when the component measuring chip 2, which is the same as that shown in FIG. 14 and includes a normal, undegraded test reagent 22 and two types of degraded test reagents 22, is inserted into the component measuring device 1. In the graph shown in FIG. 16, the horizontal axis indicates the wavelength of the irradiating light irradiated to the test reagent 22, and the vertical axis indicates the ratio of the received light intensity. In FIG. 16, the shaded area A2 indicates a predetermined range used to detect an abnormality in the component measuring chip 2.

[0160] In step S15 of the flow shown in FIG. 10, the control unit 50 calculates the ratio T 13 , proportion T 23 , proportion T 43 and ratio T 53 Figure 16 shows the ratio T 13 , proportion T 23 , proportion T 43 and ratio T 53 16 shows plots of all the ratios when a normal, undegraded measurement reagent 22 and two types of degraded measurement reagents 22 are used, but when the control unit 50 actually executes the flow of FIG. 10, only one of the measurement reagents 22 is provided in the component measuring chip 2. Therefore, it should be noted that, for example, among the plots shown in FIG. 16, only the ratio indicated by the plot of one of the measurement reagents 22 is calculated.

[0161] Then, the control unit 50 determines whether the ratio of the received light intensities calculated in step S15 is within a predetermined range (step S16). In the case where the irradiated light of the other wavelengths includes irradiated light of a plurality of wavelengths as in the present embodiment, the control unit 50 determines whether the ratio of the received light intensities for each of the plurality of other wavelengths is within a predetermined range. That is, in the example shown here, the control unit 50 calculates the ratio T 13 is included in the first range R1, and the ratio T 23 is included in the second range R2, and the ratio T 43 is included in the third range R3, and the ratio T 53 are included in the fourth range R4.

[0162] As described above, in this embodiment, the first range R1 is set to be greater than 0.8 and less than 1.2, the second range R2 is set to be greater than 0.8 and less than 1.2, the third range R3 is set to be greater than 0.4 and less than 0.8, and the fourth range R4 is set to be greater than 0.8 and less than 1.2. These ranges are shown as the shaded area A2 in FIG. 16. Note that although the shaded area A2 in FIG. 16 is shown to extend across the width of a predetermined wavelength band, this is merely for convenience of explanation; in reality, it is sufficient that a predetermined range is set for the wavelength of the irradiation light emitted from the light-emitting unit 66.

[0163] As shown in FIG. 16, in the normal test reagent 22, the ratio T 13 , proportion T 23 , proportion T 43 and ratio T 53 are all included in the first range R1, the second range R2, the third range R3, and the fourth range R4, respectively. In this way, when the ratio of the received light intensity for all wavelengths is included in the predetermined range, the control unit 50 determines that the ratio of the received light intensity is included in the predetermined range (Yes in step S16). That is, in this case, it is determined that no abnormality has occurred in the measurement reagent 22 (component measuring chip 2).

[0164] When the control unit 50 determines that the ratio of the received light intensity falls within the predetermined range (Yes in step S16), it executes the component measurement process as described with reference to FIG. 9, for example (step S17).

[0165] On the other hand, as shown in FIG. 16, in the deteriorated first test reagent 22, the ratio T 13 , proportion T 23 , proportion T 43 and ratio T 53 Of these, the proportion T 23 is included in the second range R2. However, the ratio T 13 , proportion T 43 and ratio T 53are all below the first range R1, the third range R3, and the fourth range R4, respectively, i.e., are not included in the first range R1, the third range R3, and the fourth range R4, respectively.

[0166] Similarly, as shown in FIG. 16, in the deteriorated second test reagent 22, the ratio T 13 , proportion T 23 , proportion T 43 and ratio T 53 Of these, the proportion T 23 and ratio T 43 are included in the second range R2 and the third range R3, respectively. However, the ratio T 13 and ratio T 53 are all below the first range R1 and the fourth range R4, respectively, that is, are not included in the first range R1 and the fourth range R4, respectively.

[0167] In this way, when the ratio of the received light intensity is not outside the predetermined range for at least one wavelength, the control unit 50 determines that the ratio of the received light intensity is outside the predetermined range (No in step S16). In this case, it is determined that the measurement reagent 22 (component measuring chip 2) has discolored and an abnormality (deterioration) has occurred in the measurement reagent 22.

[0168] When the control unit 50 determines that the ratio of the received light intensities is not within the predetermined range (No in step S16), it determines that an abnormality has occurred in the component measuring chip 2 inserted into the component measuring device 1. In this case, the control unit 50 notifies that an error has occurred, for example, by outputting a buzzer sound from the buzzer unit 59 (step S18). The manner in which the error is notified may be the same as the example described above.

[0169] The manner of error notification may be changed as appropriate depending on the content of the error to be notified. For example, the manner of error notification issued when it is determined that the light receiving intensity at the light receiving unit 72 is not within the normal range (No in step S12), the manner of error notification issued when it is determined that the chip recognition is poor (No in step S14), and the manner of error notification issued when it is determined that the ratio of the light receiving intensity is not within a predetermined range (No in step S16) may be different from each other. Specifically, a buzzer sound may be output. By differentiating the manner of error notification, a user who hears the error notification can recognize the content of the error.

[0170] When the control unit 50 reports that an error has occurred in step S18, it may end this flow without executing the component measurement process. In this way, the component measurement process can be executed only when no error has occurred.

[0171] As described above, the component measuring device 1 according to this embodiment detects an abnormality in the component measuring chip 2 based on the ratio of the light receiving intensity at the light receiving unit 72 when irradiation light of a specific wavelength is emitted from the light emitting unit 66 to the light receiving intensity at the light receiving unit 72 when irradiation light of another wavelength is emitted from the light emitting unit 66. That is, the component measuring device 1 can detect a change in color of the measurement reagent 22 in the component measuring chip 2 from the ratio of the light receiving intensities and determine deterioration. Since no special components are required in the component measuring chip 2 for this determination, the component measuring device 1 can detect an abnormality in the component measuring chip 2 without providing any additional special components. Furthermore, since the irradiation light emitted from the light emitting unit 66 is also used in the component measurement process by the component measuring device 1, no special components are required in the component measuring device 1 either.

[0172] In this embodiment, the specific wavelength is a wavelength λ3 included in the infrared region. Since wavelengths in the infrared region are not wavelengths in the visible light region, when the specific wavelength is a wavelength included in the infrared region as in this embodiment, even if a color change occurs in the measurement reagent 22, the received light intensity of the specific wavelength is unlikely to change. Therefore, by setting the specific wavelength to a wavelength included in the infrared region, the accuracy of the abnormality determination process by the component measuring device 1 can be improved. In this way, it is preferable that the specific wavelength is a wavelength included in the infrared region. However, this does not intend to exclude the specific wavelength being a wavelength outside the infrared region. Even if the specific wavelength is a wavelength outside the infrared region, the abnormality determination process described in this embodiment can be performed.

[0173] Furthermore, in this embodiment, the illumination light of other wavelengths includes illumination light of multiple wavelengths (λ1, λ2, λ4, and λ5), and the predetermined ranges (R1, R2, R3, and R4) are set individually for each of the multiple wavelengths. The control unit 50 determines that an abnormality has occurred in the component measuring chip 2 when the ratio of the received light intensity for at least one of the multiple wavelengths is outside the predetermined range. In this way, by using illumination light of multiple wavelengths to determine an abnormality in the component measuring chip 2, it becomes easier to detect an abnormality with higher accuracy. However, as long as the illumination light of other wavelengths includes illumination light of at least one wavelength, the abnormality determination process described in this embodiment can be executed. For example, when determining deterioration as in the above embodiment, illumination light of other wavelengths, for example, λ1 (660 nm) or λ5 (589 nm) may be used. In that case, the respective ratios T 13 or T 53 By determining whether or not is within the predetermined range R1 or R4, it is possible to determine whether the component measuring chip 2 has deteriorated.

[0174] In the above embodiment, an example has been described in which the component measuring device 1 determines deterioration as an example of an abnormality, but the component measuring device 1 may detect other abnormalities besides deterioration using a similar principle. The component measuring device 1 can detect abnormalities accompanied by a color change that occur in the component measuring chip 2. For example, the component measuring device 1 can detect dirt or blood adhesion on the component measuring chip 2. The component measuring device 1 may determine the type of abnormality based on, for example, the distribution of the ratio of the light intensity received by the light receiving unit 72 to the irradiated light of multiple wavelengths. In this case, the component measuring device 1 may notify the content of the type of abnormality that has been determined.

[0175] The component measuring device, component measuring device set, and information processing device according to the present invention are not limited to the specific description of the above-described embodiments, and various modifications are possible within the scope of the invention as defined in the claims. In the above-described embodiments, glucose concentration is measured as the component to be measured, but the measurement is not limited to concentration and other physical quantities may be measured. Furthermore, in the above-described embodiments, glucose in plasma components is exemplified as the component to be measured in blood, but this is not limited thereto. For example, cholesterol, sugars, ketone bodies, uric acid, hormones, nucleic acids, antibodies, antigens, etc. in blood may also be used as the component to be measured. Therefore, the component measuring device is not limited to a blood glucose level measuring device. Furthermore, in the above-described embodiments, the light receiving unit 72 receives transmitted light that passes through the component measuring chip 2, but the light receiving unit may receive reflected light that reflects from the component measuring chip 2. [Industrial Applicability]

[0176] The present disclosure relates to a component measuring device, a component measuring device set, and an information processing device. [Explanation of symbols]

[0177] 1: Component measuring device 2: Component measurement chip 10: Housing 10a: Main body 10b: Tip mounting part 10s: Tip opening 11: Display section 12:Removal lever 13: Power button 14: Operation buttons 21: Base material 22: Measurement reagent 23: Flow path 23a: void 24: Supply section 25: Cover material 26: Eject pin 50: Control unit 51: Photometry section 52: Storage part 53:Temperature measurement part 54: Power supply section 55:Battery 56: Communications Department 57: Clock section 58:Operation section 59: Buzzer section 66: Light-emitting part 67: 1st light source 68a:Second light source 68b: Third light source 68c: 4th light source 68d: 5th light source 69a: First throttle section 69b: Second throttle section 72: Light receiving part 80: Holder member 100: Component measuring device set

Claims

1. A chip insertion space for inserting a component measuring chip is provided. a light emitting unit that emits irradiation light to the component measuring chip when the component measuring chip is inserted into the chip insertion space; a light receiving unit that receives light transmitted through or reflected by the component measuring chip; A control unit; A component measuring device comprising: the control unit detects an abnormality in the component measuring chip based on a ratio of the light receiving intensity at the light receiving unit when irradiation light of a specific wavelength is emitted from the light emitting unit to the light receiving intensity at the light receiving unit when irradiation light of another wavelength is emitted from the light emitting unit. Ingredient measuring device.

2. The component measuring device according to claim 1 , wherein the control unit determines that an abnormality has occurred in the component measuring chip when the ratio is outside a predetermined range.

3. the irradiation light of another wavelength includes irradiation light of a plurality of wavelengths, the predetermined range is set individually for each of the plurality of wavelengths, the control unit determines that an abnormality has occurred in the component measuring chip when the ratio is outside the predetermined range for at least one wavelength among the plurality of wavelengths. The component measuring device according to claim 2 .

4. The component measuring device according to claim 1 , wherein the specific wavelength is a wavelength included in the infrared region.

5. A component measuring chip; a component measuring device having a chip insertion space for inserting the component measuring chip; Equipped with The component measuring device is a light emitting unit that emits irradiation light to the component measuring chip when the component measuring chip is inserted into the chip insertion space; a light receiving unit that receives light transmitted through or reflected by the component measuring chip; A control unit; Equipped with the control unit detects an abnormality in the component measuring chip based on a ratio of the light receiving intensity at the light receiving unit when irradiation light of a specific wavelength is emitted from the light emitting unit to the light receiving intensity at the light receiving unit when irradiation light of another wavelength is emitted from the light emitting unit. Ingredient measuring device set.

6. An information processing method executed by a component measuring device having a chip insertion space for inserting a component measuring chip, the component measuring device including: a light emitting unit that emits irradiation light to the component measuring chip when the component measuring chip is inserted into the chip insertion space; a light receiving unit that receives light that has passed through or reflected by the component measuring chip; and a control unit, calculating a ratio of the intensity of light received at the light receiving unit when irradiation light of a specific wavelength is emitted from the light emitting unit to the intensity of light received at the light receiving unit when irradiation light of another wavelength is emitted from the light emitting unit; detecting an abnormality in the component measuring chip based on the calculated ratio; An information processing method, including:

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