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

Abstract

The present application provides a component measuring device having a chip insertion space for inserting a component measuring chip provided with a reagent, comprising: a light emitting portion for emitting irradiation light to the component measuring chip in a state where the component measuring chip is inserted into the chip insertion space; a light receiving portion for receiving the light transmitted or reflected; and a control portion capable of performing processing in either one of a first mode for measuring a measured component in a sample using a measured value of a light receiving intensity in the light receiving portion, and a second mode for confirming the performance of the component measuring device, and determining whether there is a possibility of an error in the processing mode to be performed in a case where a difference between a reference light receiving intensity in the light receiving portion and a light receiving intensity received in the light receiving portion exceeds a predetermined value.

Description

Technical Field

[0001] This disclosure relates to a component determination apparatus, a component determination apparatus assembly, and an information processing method. Background Technology

[0002] Previously, in the fields of biochemistry and medicine, there were known devices for measuring the components contained in samples such as blood used as specimens. For example, Patent Document 1 discloses a blood glucose meter that attaches blood to a measuring chip installed in a blood glucose meter to measure the amount of glucose in the blood.

[0003] Patent Document 1: Japanese Patent Application Publication No. 2011-064596

[0004] Sometimes, devices such as blood glucose meters that measure analytes are configured to operate in a second mode, in addition to a first mode for measuring the analyte, to verify the device's performance. When operating the device in the first mode, for example, a blood-coated chip is inserted into the device. When operating it in the second mode, a chip coated with a solution specific to the second mode is inserted, and the measurement is performed. In this case, the operator inputs whether the device should operate in the first mode or the second mode. However, there is a possibility that the operator may mistakenly input the wrong information due to carelessness. For example, an operator might insert a blood-coated chip but input the start of the second mode, or conversely, insert a chip coated with the second-mode solution but input the start of the first mode. If this is done incorrectly, the device will not be able to perform the appropriate processing. Summary of the Invention

[0005] The purpose of this disclosure is to provide a component measuring device, a component measuring device assembly, and an information processing method that can reduce the possibility of performing processing based on operator error input.

[0006] The component determination apparatus of the first aspect of this disclosure is a component determination device having a chip insertion space for inserting a component determination chip containing a reagent that reacts with the component to be determined in the sample, and comprising: a light-emitting unit that emits illumination light to the component determination chip when the component determination chip is inserted into the chip insertion space; a light-receiving unit that receives light transmitted through or reflected from the component determination chip; and a control unit capable of performing processing in either a first mode that measures the component to be determined in the sample using a measured value of the light intensity in the light-receiving unit, or a second mode that confirms the performance of the component determination apparatus; and determining whether there is a possibility that the processing mode to be performed is incorrect if the difference between the reference light intensity in the light-receiving unit at a specific time after the component determination chip is inserted into the chip insertion space and the light intensity received in the light-receiving unit exceeds a predetermined value.

[0007] As one embodiment of this disclosure, the control unit determines whether there is a possibility of a processing mode error when the difference between the reference light intensity and the moving average of the light intensity received by the light receiving unit exceeds a predetermined value.

[0008] As one embodiment of this disclosure, the control unit outputs a confirmation of whether the processing mode to be executed is correct when it determines that there is a possibility of an error in the processing mode.

[0009] As one embodiment of this disclosure, the control unit determines whether the sample is suitable for use in the processing mode based on whether the difference between the reference light intensity and the light intensity is higher than a first determination threshold higher than the reference light intensity or lower than a second determination threshold lower than the reference light intensity.

[0010] As one embodiment of this disclosure, if the control unit determines that the sample is not a sample used in the above-described processing mode, it determines that there is a possibility that the above-described processing mode to be executed is incorrect.

[0011] As one embodiment of this disclosure, if the control unit determines that there is a possibility that the processing mode to be executed is incorrect, it executes the processing in a different processing mode than the processing mode to be executed.

[0012] As one embodiment of this disclosure, the light-emitting unit comprises at least: a first light source that emits illumination light of a first predetermined wavelength to the mixture of the sample and the reagent for quantifying the component to be measured; a third light source that emits illumination light of a third predetermined wavelength, the third predetermined wavelength of which is used to estimate the amount of noise other than the predetermined colorimetric component included in the measured value of the absorbance of the mixture measured by the illumination light of the first light source, and the influence of light scattering from the components included in the sample is dominant; and a fourth light source that emits illumination light of a fourth predetermined wavelength, the fourth predetermined wavelength of which is used to estimate the amount of noise, and the proportion of absorbance absorbed by the predetermined component included in the sample is above a predetermined value.

[0013] As one embodiment of this disclosure, if the control unit selects the first mode as the processing mode to be executed, and the difference between the reference light intensity and the light intensity of the irradiation light for the third specified wavelength reaches the first determination threshold, it determines that there is a possibility of an error in the selection of the processing mode.

[0014] As one embodiment of this disclosure, if the control unit selects the second mode as the processing mode to be executed, and the difference between the reference light intensity and the light intensity of the irradiation light for the fourth specified wavelength λ4 reaches the second determination threshold, it determines that there is a possibility of an error in the selection of the processing mode.

[0015] As one embodiment of this disclosure, the components derived from the above-mentioned sample are red blood cells and hemoglobin contained in the red blood cells.

[0016] The component determination apparatus as a second aspect of this disclosure includes: a component determination chip; and a component determination device having a chip insertion space for inserting the component determination chip, the component determination device including: a light-emitting unit that emits illumination light to the component determination chip when the component determination chip is inserted into the chip insertion space; a light-receiving unit that receives at least light transmitted through or reflected from the component determination chip; and a control unit capable of performing processing in either a first mode that uses measured values ​​of light intensity in the light-receiving unit to determine the component to be measured in the sample, or a second mode that confirms the performance of the component determination device, and determining whether there is a possibility of an error in the selection of the processing mode if the difference between the reference light intensity in the light-receiving unit at a specific time after the component determination chip is inserted into the chip insertion space and the light intensity received in the light-receiving unit exceeds a predetermined value.

[0017] The third information processing method disclosed herein 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 section that emits irradiation light from the component measuring chip when the component measuring chip is inserted into the chip insertion space, a light-receiving section that receives light transmitted through or reflected from the component measuring chip, and a control section. The control section is capable of performing processing in either a first mode that uses the measured value of the light intensity in the light-receiving section to measure the component to be measured in the sample, or a second mode that confirms the performance of the component measuring device. The method includes: a step of accepting an input operation for the processing mode; and a step of determining whether there is a possibility of a processing mode selection error if the difference between the reference light intensity in the light-receiving section and the light intensity received in the light-receiving section at a specific time after the component measuring chip is inserted into the chip insertion space exceeds a predetermined value.

[0018] According to this disclosure, a component measuring apparatus, a component measuring apparatus group, and an information processing method can be provided that can reduce the possibility of performing processing based on operator error input. Attached Figure Description

[0019] Figure 1 This is a top view of a component measuring device assembly in which a component measuring chip is installed, as one embodiment of the component measuring device.

[0020] Figure 2 It means along Figure 1 A cross-sectional view of section I-I.

[0021] Figure 3 It means along Figure 1 A cross-sectional view of section II-II.

[0022] Figure 4 It means Figure 1 The image shows a top view of the component determination chip.

[0023] Figure 5 It is along Figure 4 Sectional view of section III-III.

[0024] Figure 6 yes Figure 1 The diagram shows the functional block diagram of the component determination device.

[0025] Figure 7 It means Figure 1 The diagram shows the positional relationship of multiple light sources in the component determination device.

[0026] Figure 8 It means Figure 7A diagram showing the irradiation positions of multiple light sources irradiating the mixture.

[0027] Figure 9 It means Figure 1 A flowchart of an example of a component determination process performed by a component determination device.

[0028] Figure 10 It means Figure 1 A flowchart illustrating an example of a photometric measurement process performed by a component measurement device during component measurement processing.

[0029] Figure 11 It schematically represents the light-receiving part from... Figure 7 The diagram shows the intensity of the illumination light emitted by the first to fifth light sources.

[0030] Figure 12 It is a diagram schematically showing the light intensity received by the light-receiving part from the first to the fifth light sources.

[0031] Figure 13 This is a flowchart illustrating an example of the process for determining the first intensity of light received.

[0032] Figure 14 This is a flowchart illustrating an example of the process for determining the second light intensity.

[0033] Figure 15 It is a diagram schematically showing the light intensity received by the light-receiving part from the first to fifth light sources.

[0034] Figure 16 It is a diagram schematically showing the light intensity received by the light-receiving part from the first to fifth light sources.

[0035] Figure 17 This is a flowchart illustrating an example of the process for determining the third intensity of light received.

[0036] Figure 18 It is a diagram schematically showing the light intensity received by the light-receiving part from the first to fifth light sources. Detailed Implementation

[0037] The following is for reference Figures 1 to 18 Embodiments of the component measuring apparatus, component measuring apparatus assembly, and information processing method of this disclosure will be described. Identical reference numerals are used for the same components in each figure.

[0038] First, one embodiment of the component determination apparatus of this disclosure will be described. Figure 1 This is a top view showing the component measuring device assembly 100 in this embodiment, in which the component measuring device 1 is equipped with the component measuring chip 2. Figure 2 It means along Figure 1 A sectional view of section I-I. Figure 3 It means along Figure 1 A sectional view of section II-II. Figure 2 as well as Figure 3 A magnified view shows the vicinity of the location where the component measurement chip 2 is installed.

[0039] like Figures 1-3 As shown, the component analysis apparatus assembly 100 includes a component analysis apparatus 1 and a component analysis chip 2. The component analysis apparatus 1 of this embodiment is a blood glucose meter capable of measuring the concentration of glucose in plasma components, which are the components to be measured, in a sample. Furthermore, the component analysis chip 2 of this embodiment is a blood glucose metering chip that can be installed at one end of the blood glucose meter, which is the component analysis apparatus 1. The "sample" referred to here can be whole blood or separated plasma. Alternatively, the sample can be an aqueous solution containing glucose.

[0040] The component measuring device 1 can perform processing in multiple modes. In this embodiment, the component measuring device 1 can perform processing in either a first mode for measuring the component to be measured or a second mode for verifying the performance of the component measuring device 1. For example, the operator of the component measuring device 1 selects the processing mode by performing a prescribed input operation on the component measuring device 1. In this embodiment, the selected processing mode is equivalent to the processing mode to be performed. However, for example, if the processing mode is automatically determined by the component measuring device 1, the determined processing mode becomes the processing mode to be performed.

[0041] The component measuring device 1 includes a housing 10 made of resin material, a button assembly disposed on the upper surface of the housing 10, a display unit 11 composed of a liquid crystal or LED (Light Emitting Diode) disposed on the upper surface of the housing 10, and a removal handle 12 for operation when removing the component measuring chip 2 installed in the component measuring device 1. In this embodiment, the button assembly consists of a power button 13 and an operation button 14.

[0042] like Figure 1 As shown, the housing 10 includes a main body 10a, which has a generally rectangular shape when viewed from above, and has the aforementioned button group and display 11 disposed on its upper surface, and a chip mounting portion 10b, which protrudes outward from the main body 10a and has a handle 12 removable disposed on its upper surface. Figure 2As shown, a chip mounting space S is divided inside the chip mounting portion 10b, with a front opening 10s formed on the front end surface of the chip mounting portion 10b as one end. When mounting the component measuring chip 2 onto the component measuring device 1, the component measuring chip 2 is inserted into the chip mounting space S from the outside through the front opening 10s, and the component measuring chip 2 is pressed into a predetermined position. This results in the chip mounting portion 10b of the component measuring device 1 locking the component measuring chip 2, enabling the component measuring chip 2 to be mounted on the component measuring device 1. For example, locking the component measuring chip 2 onto the component measuring device 1 can be achieved by providing various configurations such as claws that can engage with a portion of the component measuring chip 2 within the chip mounting portion 10b.

[0043] When removing the component measuring chip 2 from the component measuring device 1, the chip mounting portion 10b of the component measuring device 1 releases the chip measuring chip 2 from the component measuring device 1 by operating the removal handle 12 from outside the housing 10. Simultaneously, the ejector pin 26 inside the housing 10 (see reference...) Figure 2 The components are displaced in a coordinated manner, allowing the component measuring chip 2 to be removed from the component measuring device 1.

[0044] Although the housing 10 of this embodiment is provided when viewed from above (refer to...) Figure 1 The housing is generally rectangular in shape, consisting of a main body 10a and a chip mounting portion 10b that protrudes outward from the main body 10a. However, the housing is not limited to the shape of the housing 10 in this embodiment, as long as it has a chip mounting portion capable of mounting the component measurement chip 2. Therefore, in addition to the shape of the housing 10 in this embodiment, various shapes that allow the operator to easily hold it with one hand can also be used.

[0045] The display unit 11 can display information about the components measured by the component measuring device 1. In this embodiment, the display unit 11 can display the glucose concentration measured by the blood glucose measuring device, which is the component measuring device 1. The display unit 11 can also display not only information about the components measured, but also various other information such as the measurement conditions of the component measuring device 1 and instructions for the operator's prescribed operations. The operator can confirm the content displayed on the display unit 11 and operate the power button 13 and operation button 14 of the button group.

[0046] In addition, such as Figure 2 as well as Figure 3 As shown, the component measuring device 1 includes a light-emitting unit 66 and a light-receiving unit 72. Figure 2 as well as Figure 3As shown, with the component measuring chip 2 mounted in the chip mounting space S of the component measuring apparatus 1, the illumination light emitted by the light-emitting unit 66 illuminates the component measuring chip 2. The light-receiving unit 72 receives the transmitted light that has passed through the component measuring chip 2 from the illumination light emitted by the light-emitting unit 66. In this embodiment, the light-emitting unit 66 and the light-receiving unit 72 are arranged opposite each other across the chip mounting space S. However, the arrangement of the light-emitting unit 66 and the light-receiving unit 72 is not limited to this. The light-receiving unit 72 can be located at a position that can detect the 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 arranged on the same side relative to the component measuring chip 2, and a reflective member may be provided on the side opposite the light-emitting unit and the light-receiving unit, across the chip mounting space S and the sample.

[0047] The light-emitting unit 66 has five light sources. Specifically, the light-emitting unit 66 has 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... Figure 2 As shown, the first light source 67, the fourth light source 68c, and the fifth light source 68d flow in the flow path 23 of the component determination chip 2 (described later) in the direction A of the sample flow. Figure 2 (The middle refers to the direction to the right), and they are arranged in different positions. Additionally, such as... Figure 3 As shown, the first light source 67, the second light source 68a, and the third light source 68b are located in the flow path width direction B, which is orthogonal to the flow direction A. Figure 3 The light sources are arranged in different positions on the left and right sides (the center and the left and right sides are respectively). The detailed configuration of the first light source 67 to the fifth light source 68d will be described later (refer to...). Figure 7 ).

[0048] Next, the component determination chip 2 will be explained. Figure 4 This is a top view showing the component determination chip 2. Additionally, Figure 5 It is along Figure 4 Sectional view III-III. (See diagram.) Figure 4 as well as Figure 5 As shown, the component determination chip 2 includes a base component 21 with a generally rectangular plate shape, a determination reagent 22 held in the base component 21, and a cover component 25 covering the base component 21. The cover component 25 can also be formed in a location other than the location where the determination point is formed when the component determination chip 2 is inserted in the component determination device 1, using a light-shielding component. Further details of the determination point will be described later.

[0049] In the thickness direction of the base component 21 (in this embodiment, it is parallel to...) Figure 2 as well as Figure 3The component determination chip 2 shown has a groove formed on one side of the thickness direction C (hereinafter referred to as the thickness direction C). The groove of the base member 21 is covered by the cover member 25, thus becoming a hollow portion extending in a direction orthogonal to the thickness direction C. This hollow portion constitutes the flow path 23 of the component determination chip 2. A supply section 24 is formed at one end of the flow path 23, which can supply the sample from the outside. In addition, the test reagent 22 is held at the bottom of the groove of the base member 21 in the inner wall of the flow path 23. The sample supplied from the outside to the supply section 24 moves along the flow path 23 in the flow direction A by means of capillary action, for example, to the holding position of holding the test reagent 22, and comes into contact with the test reagent 22. The test reagent 22 contains a colorimetric reagent that dissolves in the sample and reacts with the component to be measured in the sample to produce a color. Therefore, when the test reagent 22 comes into contact with the component to be measured in the sample, a colorimetric reaction is caused by the colorimetric reagent contained in the test reagent 22, generating a colorimetric component (reaction product).

[0050] Furthermore, a gap 23a is formed between the cover component 25 and the measuring reagent 22. The sample, which moves from the supply section 24 at one end in the flow path 23 in the flow direction A, dissolves the measuring reagent 22, reacts, and reaches the other end of the flow path 23. Therefore, by allowing the sample to reach the entire area in the flow direction A of the measuring reagent 22, it is possible to achieve a state in which the mixture X containing the coloring component diffuses to the area that can become the measuring point. Here, the mixture X contains at least the sample, the unreacted or unreacted measuring reagent 22, and the coloring component.

[0051] exist Figure 2 For ease of explanation, the sample is omitted, and "mixture X" is shown at the holding position of the measuring reagent 22. However, mixture X is not only present at the holding position of the measuring reagent 22, but also diffuses into the vicinity of the holding position of the measuring reagent 22, such as the gap 23a. More specifically, the sample entering the flow path 23 from the supply section 24 contacts the measuring reagent 22 at the holding position and reaches the downstream end of the flow path 23 through the gap 23a, resulting in a state where the flow path 23 is filled with the sample. The measuring reagent 22 dissolves in the sample and undergoes a color reaction with the sample, resulting in a state where mixture X is located at and near the holding position.

[0052] Although the flow path 23 in this embodiment is formed by a hollow portion divided by the base member 21 and the cover member 25, the flow path is not limited to this configuration. The flow path may also be formed simply by a groove formed on the outside of one side of the base member 21 in the thickness direction C.

[0053] In order to ensure that the amount of light transmitted after illumination is sufficient to form a measurable signal, it is preferable to use transparent materials for the base component 21 and the cover component 25. For example, transparent organic resin materials such as polyethylene terephthalate (PET), polymethyl methacrylate (PMMA), polystyrene (PS), cyclic polyolefin (COP), cyclic olefin copolymer (COC), and polycarbonate (PC) can be listed, or transparent inorganic materials such as glass and quartz can be used.

[0054] The assay reagent 22 contains a colorimetric reagent that reacts with the analyte in the sample to induce a colorimetric reaction based on the blood concentration of the analyte. In this embodiment, the assay reagent 22 is coated on the bottom of the tank, which serves as the flow path 23. The assay reagent 22 in this embodiment reacts with glucose, the analyte, in the sample. Examples of assay reagent 22 in this embodiment include (i) glucose oxidase (GOD), (ii) peroxidase (POD), (iii) 1-(4-sulfophenyl)-2,3-dimethyl-4-amino-5-pyrazolone, (iv) N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethylaniline, a sodium salt, a mixture of sodium salts and monohydrate (MAOS), or a mixture of glucose dehydrogenase (GDH) and a tetrazolium salt. Furthermore, it may also contain a buffer or medium such as a phosphate buffer. The type and composition of the assay reagent 22 are not limited to these.

[0055] Furthermore, in the assay reagent 22 of this embodiment, a colorimetric reagent is selected whose peak wavelength in the absorbance spectrum of the colorimetric component generated by the colorimetric reaction with glucose in the sample is different from the peak wavelength of the light absorption characteristics of hemoglobin in blood cells. The absorbance spectrum of the colorimetric component of the colorimetric reagent included in the assay reagent 22 of this embodiment has a peak wavelength around 660 nm, but it is not limited to colorimetric reagents with a peak wavelength around 660 nm, and can be appropriately selected according to the purpose.

[0056] like Figure 2As shown, when measuring the analyte using the component measuring device 1, the component measuring chip 2 is installed within the chip mounting portion 10b. Then, if a sample is supplied to the supply portion 24 located at one end of the component measuring chip 2, the sample moves within the flow path 23, for example, through capillary action, and reaches the holding position of the holding reagent 22 in the flow path 23. At this holding position, glucose in the sample (plasma) reacts with the testing reagent 22. Then, at the aforementioned holding position in the flow path 23, a mixture X containing a chromogenic component is generated. The colorimetric component measuring device 1 irradiates the mixture X containing the chromogenic component with illumination light and detects the amount of transmitted light (or reflected light) to obtain a detection signal related to the intensity of the color development corresponding to the blood concentration. Then, the component measuring device 1 can measure the analyte by referring to a pre-prepared calibration curve. As described above, the component measuring device 1 of this embodiment can measure the glucose concentration in the plasma component of a sample.

[0057] Figure 6 yes Figures 1-3 The functional block diagram of the component determination device 1 shown is as follows. Figure 6 As shown, the component measuring device 1 includes a control unit 50, a light measuring unit 51, a storage unit 52, a temperature measuring 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.

[0058] The control unit 50 is composed of an MPU (Micro-Processing Unit) or a CPU (Central Processing Unit), and can realize the control operations of each unit by reading and executing the program stored in the storage unit 52, etc. The storage unit 52 is composed of a volatile or non-volatile non-transitory storage medium, and can read or write various data (including programs) required to perform the component determination method shown in this embodiment.

[0059] When operating in the first mode, the control unit 50 can measure the analyte in the sample by activating the photometer 51. Furthermore, when performing the measurement process of the analyte by the component measuring device 1, the control unit 50 can perform a process to detect whether a normal measurement can be performed. Additionally, the control unit 50 can perform a process to determine if there is a possibility of an error in the selection of the processing mode. Details regarding the measurement process of the analyte, the process to detect whether a normal measurement can be performed, and the process to determine if there is a possibility of an error in the selection of the processing mode will be described later.

[0060] The photometer 51 is an optical system capable of acquiring the optical properties of a mixture X containing a sample and a coloring component. Specifically, the photometer 51 includes a light-emitting section 66 and a light-receiving section 72.

[0061] The light-emitting part 66 emits illumination light toward the chip insertion space S. The light-emitting part 66 has multiple light sources. Specifically, the light-emitting part 66 of this embodiment has five light sources that emit illumination light with different spectral radiation characteristics (e.g., visible light, infrared light). More specifically, as described above, the light-emitting part 66 of this embodiment has 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 and the fifth light source 68d is... Figure 2 as well as Figure 3 The positional relationships are shown below. The detailed description of the actual positional relationships of the first light source 67 to the fifth light source 68d follows (refer to...). Figure 7 ).

[0062] The peak wavelengths of the light emitted from the first light source 67 to the fifth light source 68d are λ1 to λ5, respectively. Various light-emitting elements, such as LEDs, EL (Electro-Luminescence) elements, inorganic EL elements, and LD (Laser Diode) elements, can be used as the first light source 67 to the fifth light source 68d. Considering versatility, the aforementioned LED elements are easily used 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 constructed using LED elements. Hereinafter, the "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 "first predetermined wavelength λ1", the peak wavelength λ2 of the second light source 68a will be referred to as "second predetermined wavelength λ2", the peak wavelength λ3 of the third light source 68b will be referred to as "third predetermined wavelength λ3", the peak wavelength λ4 of the fourth light source 68c will be referred to as "fourth predetermined wavelength λ4", and the peak wavelength λ5 of the fifth light source 68d will be referred to as "fifth predetermined wavelength λ5". For convenience, although the "peak wavelength" in this embodiment is shown as a single value, it can also include a wavelength range of ±20 nm for each value.

[0063] The light-receiving part 72 receives transmitted or reflected light from the region containing the color-forming component of the irradiated light emitted from the light-emitting part 66. For example... Figure 2 as well as Figure 3As shown, the light-receiving unit 72 in this embodiment is composed of a light-receiving element disposed opposite to the light-emitting unit 66, separated from the component measuring chip 2. In this embodiment, the light-receiving unit 72 receives the mixture X generated at the holding position of the measuring reagent 22 on the component measuring chip 2, which is irradiated by the first light source 67 to the fifth light source 68d of the light-emitting unit 66, and transmits the transmitted light from the component measuring chip 2. As the light-receiving unit 72, various photoelectric conversion elements including PD (photodiode), photoconductor, and PT (phototransistor) can be used.

[0064] In this specification, the area within the component measuring apparatus 1 that receives illumination light from the light-emitting unit 66 and is detectable by the light-receiving unit 72 will be referred to as the measuring area. During measurement, a colorimetric component (or mixture X) that is the object of detection is present in the measuring area.

[0065] The first light source 67 to the fifth light source 68d receive drive power signals from the light emission control circuit of the photometer 51, and turn on and off based on the drive power signals. The light receiving unit 72 outputs an analog signal corresponding to the received light. This analog signal is amplified and converted into a digital signal (hereinafter referred to as a detection signal) by the light receiving control circuit of the photometer 51.

[0066] Refer again Figure 6 The storage unit 52 can be composed of a semiconductor memory or a magnetic memory, etc. The storage unit 52 stores, for example, various information and programs used to operate the component measuring device 1. The storage unit 52 can also function as working memory.

[0067] The temperature measuring unit 53 measures the temperature near the component measuring chip 2. For example, the temperature measuring unit 53 measures the temperature of the chip mounting space S. The temperature measuring unit 53 can be, for example, constructed using a known thermometer. For example, the temperature measured by the temperature measuring unit 53 can be used to adjust the amount of light emitted from the light-emitting unit 66, as described later.

[0068] The power supply unit 54 supplies the power stored in the battery 55 to each functional part of the component measuring device 1.

[0069] The communication unit 56 transmits and receives various types of information through wired or wireless communication with external devices. For example, the communication unit 56 transmits the composition measurement results of the composition measuring device 1 to an external device that is connected in a communicable manner. The communication unit 56 can also receive signals from an external device that is connected in a communicable manner to enable the operation of the composition measuring device 1.

[0070] The clock unit 57 measures and records the time. The clock unit 57 may be, for example, composed of an RTC (Real Time Clock).

[0071] The operation unit 58 is an input interface for the operator of the component measuring device 1 to input operations onto the component measuring device 1. In this embodiment, the operation unit 58 consists of 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 can be implemented in any way that allows the operator to perform input operations. For example, by operating the operation unit 58, the operator can select (determine) whether to make the component measuring device 1 perform a first mode or a second mode.

[0072] The buzzer unit 59 reports information by outputting a buzzer tone. The buzzer unit 59 outputs a buzzer tone at a preset, predetermined time. For example, the buzzer unit 59 outputs a buzzer tone when the component measurement process of the component measuring device 1 is completed, or when a malfunction occurs in the component measuring device 1.

[0073] Next, the measurement process of the measured component in the sample in the first mode based on the control unit 50 of the component measuring device 1, and the configuration of the first light source 67 to the fifth light source 68d will be described.

[0074] The control unit 50 instructs the photometer 51 to perform a measurement operation, and uses the detection signal and various data acquired by the photometer 51 to measure the concentration of the component being measured.

[0075] The storage unit 52 stores measured values ​​of the absorbance of mixture X at each of the first specified wavelengths λ1 to the fifth specified wavelengths λ5, i.e., the first measured values ​​D1 to the fifth measured values ​​D5, as measured by the photometer unit 51; correction coefficient data including a set of correction coefficients related to the absorbance of mixture X at each of the second specified wavelengths λ2 to the fifth specified wavelengths λ5; and calibration curve data showing the relationship between the absorbance of the colorimetric component in mixture X and various physical quantities (e.g., glucose concentration) obtained by correcting the absorbance of mixture X at the first specified wavelength λ1 using the correction coefficient data, or a calibration curve showing the relationship between the absorbance of hemoglobin in mixture X and the hematocrit value, etc. "Hematocrit value" is a percentage representing the volume ratio of blood cells in the blood sample to the blood (whole blood).

[0076] The component determination apparatus 1 can determine the analyte in a sample based on the optical properties of a mixture X containing a colorimetric component generated by the colorimetric reaction between the analyte in the sample and a reagent. Specifically, the component determination apparatus 1 can estimate the noise amount other than the colorimetric component in the first measured value D1 of the absorbance of the mixture X measured by irradiation light of a second predetermined wavelength λ2 to a fifth predetermined wavelength λ5, which is the measurement wavelength. More specifically, the component determination apparatus 1 can estimate the aforementioned noise amount using the second measured value D2 to the fifth measured value D5 of the absorbance of the mixture X measured by irradiation light of a second predetermined wavelength λ2 to a fifth predetermined wavelength λ5, and can determine the absorbance of the colorimetric component, thereby further determining the analyte.

[0077] Figure 7 This indicates that the sample is taken from the upper surface of the component measuring device 1 (refer to...). Figure 1 A diagram showing the positional relationship of the first light source 67 to the fifth light source 68d under side-view observation. Figure 7 For ease of explanation, the position of the light-receiving part 72 on the flow path 23 of the component measurement chip 2 is shown by a double-dotted line. In this embodiment, the mixture X is generated at and near the aforementioned holding position within the flow path 23.

[0078] like Figure 2 , Figure 3 as well as Figure 7 As shown, the first light source 67 to the fifth light source 68d are arranged opposite to the mixture X located in the flow path 23 of the sample. More specifically, in this embodiment, the first light source 67 to the fifth light source 68d are arranged opposite to the holding position of the measuring reagent 22 in the flow path 23 of the sample in a direction orthogonal 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).

[0079] like Figure 3 as well as Figure 7 As shown, the first light source 67 and the second light source 68a are arranged along the flow path width direction B, which is orthogonal to the flow direction A of the sample at the position of the mixture X on the flow path 23. In this embodiment, the first light source 67 and the second light source 68a are configured such that the first irradiation position SL1 on the mixture X of the irradiation light from the first light source 67 and the second irradiation position SL2 on the mixture X of the irradiation light from the second light source 68a overlap in the flow path width direction B.

[0080] In addition, such as Figure 3 as well as Figure 7 As shown, the first light source 67, the second light source 68a, and the third light source 68b are arranged along the width direction B of the flow path with the first light source 67 as the center. In this embodiment, as... Figure 8 As shown, the first light source 67 and the third light source 68b are configured such that the region of the first irradiation position SL1 on the mixture X of the irradiation light from the first light source 67 and the region of the third irradiation position SL3 on the mixture X of the irradiation light from the third light source 68b overlap in the flow path width direction B.

[0081] That is, the first light source 67 to the third light source 68b are configured such that their respective illumination positions overlap in the flow path width direction B. Preferably, the first light source 67 to the third light source 68b are arranged along the flow path width direction B, and the regions of the first illumination positions SL1 to the third illumination positions SL3 in the flow path width direction A overlap in the flow path width direction B. Furthermore, more preferably, the regions of the first illumination positions SL1 to the third illumination positions SL3 of the first light source 67 to the third light source 68b in the flow path width direction B also overlap in the flow direction A.

[0082] In this embodiment, the first light source 67 and the second light source 68a are arranged adjacent to each other in the flow path width direction B, with no gap between them that would allow for the placement of other light sources. Similarly, the first light source 67 and the third light source 68b are arranged adjacent to each other in the flow path width direction B, with no gap between them either. Thus, 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 path width direction B without any other light sources in between.

[0083] like Figure 2 as well as Figure 7 As shown, the first light source 67 and the fourth light source 68c are arranged along the flow direction A. Additionally, as... Figure 2 as well as Figure 7 As shown, in this embodiment, the first light source 67 and the fifth light source 68d are arranged 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 with the first light source 67 as the center along the flow direction A.

[0084] In this embodiment, the first light source 67 and the fourth light source 68c are arranged along the flow direction A such that the first irradiation position SL1 on the mixture X of the irradiation light from the first light source 67 and the fourth irradiation position SL4 on the mixture X of the irradiation light from the fourth light source 68c overlap in a region based on the difference in the incident angles into the mixture X being below 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 that would allow for the placement of other light sources, and the first light source 67 and the fourth light source 68c are adjacent in the flow direction A.

[0085] The first light source 67 and the fifth light source 68d are also arranged along the flow direction A such that the first irradiation position SL1 on the mixture X of the irradiation light from the first light source 67 and the fifth irradiation position SL5 on the mixture X of the irradiation light from the fifth light source 68d overlap in a region provided that the difference in the incident angles toward the mixture X is below 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 other light sources can be arranged, and the first light source 67 and the fifth light source 68d are adjacent in the flow direction A.

[0086] like Figure 7 As shown, in this embodiment, the first light source 67 to the fifth light source 68d are held in a thin plate-shaped support member 80. The support member 80 of this embodiment has a cross-shaped shape when viewed from above, and the first light source 67 is held in the central portion (the intersection of the cross) when viewed from above. Furthermore, a second light source 68a is held on one side of the flow path width direction B relative to the central portion where the first light source 67 is held, and a third light source 68b is held on the other side of the flow path width direction B. Additionally, a fifth light source 68d is held in the flow direction A relative to the central portion where the first light source 67 is held, and a fourth light source 68c is held on the side opposite to the flow direction A.

[0087] In this embodiment, the second light source 68a and the third light source 68b, emitting illumination light with a second predetermined wavelength λ2 and a third predetermined wavelength λ3, are arranged relative to the first light source 67 along the flow path width direction B. Furthermore, the fourth light source 68c and the fifth light source 68d, emitting illumination light with a fourth predetermined wavelength λ4 and a fifth predetermined wavelength λ5, are arranged relative to the first light source 67 along the flow direction A. The second predetermined wavelength λ2 and the third predetermined wavelength λ3 are wavelengths belonging to the infrared region, and the fourth predetermined wavelength λ4 and the fifth predetermined wavelength λ5 are wavelengths belonging to the visible region, as will be described in detail later.

[0088] In this embodiment, such as Figure 2 as well as Figure 3 As shown, the light-receiving part 72 is positioned in the thickness direction C, across the mixture X located in the flow path 23 of the mounted component measuring chip 2, opposite the first light source 67 to the fifth light source 68d, and receives the transmitted light after the irradiation light from the first light source 67 to the fifth light source 68d has passed through the mixture X. Figure 2 as well as Figure 3As shown, the component measuring apparatus 1 includes a first aperture section 69a located between the mixture X and the light receiving section 72, which adjusts the amount of light reaching the light receiving section 72 from the transmitted light passing through the mixture X. The difference between the incident angle of the irradiation light from the first light source 67 onto the mixture X and the incident angle of the irradiation light from the second light source 68a to the fifth light source 68d onto the mixture X affects the accuracy of noise estimation. Therefore, it is preferable to minimize the difference between the incident angle of the irradiation light from the first light source 67 onto the mixture X and the incident angle of the irradiation light from the second light source 68a to the fifth light source 68d onto the mixture X. In other words, the larger the difference between the opposing directions between the first light source 67 to the fifth light source 68d and the first aperture section 69a, the better. Figure 2 as well as Figure 3 The distance T1 (which is in the same direction as the thickness direction C of the component measurement chip 2) is preferred as it improves the accuracy of noise estimation. On the other hand, by reducing the distance T2 in the opposing direction between the first light source 67 to the fifth light source 68d and the light receiving part 72, it is possible to improve the light efficiency and miniaturize the component measurement device 1.

[0089] Furthermore, if the offset between the region of the first illumination position SL1 of the first light source 67 and the regions of the second illumination positions SL2 to SL5 of the second light source 68a to the fifth illumination positions SL5 of the fifth light source 68d (hereinafter referred to as "measuring field difference") is large, the measurement positions will be inconsistent, and therefore the accuracy of the measurement results of the measured component may be reduced. Therefore, it is preferable that the measuring field difference is small. Therefore, it is preferable that the opposing direction between the mixture X and the first aperture portion 69a (in Figure 2 as well as Figure 3 The distance T3 (in the same direction as the thickness direction C of the component measurement chip 2) is shorter. More preferably, in addition to the first aperture portion 69a, one side of the component measurement chip 2 is formed using a light-shielding member and an opening through which the measurement light can pass is provided to serve as an aperture. Furthermore, in this case, the aperture can be formed simply by using a transparent member to form the measurement point, or it can be formed by cutting the light-shielding member.

[0090] And, as Figure 2 as well as Figure 3As shown, the component measuring apparatus 1 includes a second aperture section 69b located between the first light source 67 to the fifth light source 68d and the mixture X, which adjusts the amount of light reaching the mixture X from the first light source 67 to the fifth light source 68d. Specifically, it is preferable that the second aperture section 69b is designed so that light reflected from the inner wall of the second aperture section 69b (hereinafter referred to as "stray light") emitted from the first light source 67 to the fifth light source 68d 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 attenuates to 5% after one wall reflection and disappears after three or more multiple reflections. Therefore, in this embodiment, the stray light reflected from the inner wall of the second aperture section 69b does not reach the first aperture section 69b; if it is reflected at a certain point on the wall, it will not enter the first aperture section 69a due to multiple reflections. In this embodiment, the optical axes of each light source are designed to be mirror-reflected by the inner wall of the second aperture section 69b, but in reality, diffuse reflection occurs on the inner wall of the second aperture section 69b, and the stray light also has a predetermined distribution. Therefore, in this embodiment, it is preferable to set the distance T4, etc., such that even if a portion of the stray light is incident on the first aperture portion 69a, its incident angle is less than or equal to the incident angle of the first light source 67.

[0091] The component measuring apparatus 1 of this embodiment can be equipped with a flow path 23 that divides the sample flow, and a component measuring chip 2 containing a measuring reagent 22 that reacts with the component to be measured in the sample is disposed in the flow path 23. The component measuring apparatus 1 of this embodiment can be equipped with the component measuring chip 2, and the component to be measured in the sample can be measured based on the optical properties of the mixture of the colorimetric components generated by the reaction with the component to be measured in the flow path 23. Preferably, the component measuring apparatus 1 is configured to allow for the installation and removal of the disposable component measuring chip 2.

[0092] Next, the method for calculating the concentration of the component to be measured in the sample in the first mode of the control unit 50 of the component measuring apparatus 1 based on this embodiment will be described.

[0093] In this embodiment, the component determination device 1 uses the colorimetric reaction between glucose in the sample (the component to be determined) and the colorimetric reagent in the determination reagent 22 to determine the glucose-containing plasma component without separating it from the sample. The determination is performed directly on the sample (e.g., whole blood) and the colorimetric reagent. The component determination device 1 can estimate the absorbance of the colorimetric component generated by the colorimetric reaction of glucose and the colorimetric reagent at a specified measurement wavelength based on the absorbance of the mixture X obtained by the colorimetric reaction at various wavelengths, and calculate the concentration of the component to be determined.

[0094] Generally, when a sample contains components other than the colorant being measured, the concentration of the analyte, based on the absorbance of the colorant, can be affected by interference factors (noise) due to optical phenomena. For example, "light scattering" caused by blood cells in the sample, the surface of the component measurement chip, or microparticles such as dust adhering to the chip, and "light absorption" caused by pigment components different from the colorant being measured (specifically, hemoglobin in the case of blood), tend to result in absorbance values ​​higher than the true values.

[0095] When using a mixture X of a sample containing a specific absorbance characteristic in addition to the colorimetric component being measured, to accurately measure the absorbance of the colorimetric component, it is necessary to remove interference factors (noise) caused by the absorbance characteristics of the sample from the measured absorbance value at the specified measurement wavelength.

[0096] As interfering factors when the sample is blood, examples include light scattering caused by blood cell components and light absorption caused by hemoglobin. More specifically, it is necessary to estimate the amount of interfering factors (noise) such as light scattering caused by blood cell components and light absorption caused by hemoglobin at a specified measurement wavelength (e.g., 660 nm) where the chromogenic component being measured has a high light absorption rate, and to correct the measured value of absorbance at that measurement wavelength. The component measuring apparatus 1 of this embodiment performs this correction to calculate the concentration of the component being measured.

[0097] In this embodiment, the component determination device 1 can determine the analyte in the sample based on the optical properties of a mixture X containing a colorimetric component generated by the colorimetric reaction between the sample and the determination reagent 22. Specifically, in this embodiment, the concentration of glucose contained in the plasma component of the sample is determined.

[0098] Here, the principle of glucose concentration determination and the wavelengths λ1 to λ5 of the irradiation light emitted by the first light source 67 to the fifth light source 68d are explained. Hemoglobin in red blood cells mainly consists of oxyhemoglobin, which binds to oxygen, and deoxyhemoglobin, which dissociates from oxygen at locations with lower oxygen partial pressure. Oxyhemoglobin plays the role of deoxyhemoglobin, binding oxygen in the lungs and transporting oxygen throughout the body via arteries, and is thus more readily detected in arterial blood. For example, when blood is taken as a sample from the fingertip, the amount of oxyhemoglobin is relatively high because it is capillary blood. Conversely, deoxyhemoglobin is more readily detected in venous blood.

[0099] Current techniques generally do not consider the ratio of deoxyhemoglobin to oxyhemoglobin, but instead use, for example, hematocrit values ​​to correct for the absorbance obtained at the measurement wavelength corresponding to the chromogenic component being measured. However, the absorption coefficients of deoxyhemoglobin and oxyhemoglobin are not the same, and their absorption amounts vary depending on the wavelength. For example, at a measurement wavelength of 660 nm for measuring the absorbance of the chromogenic component being measured, the absorption coefficient of deoxyhemoglobin is approximately 0.9, and that of oxyhemoglobin is approximately 0.09. That is, assuming a 1:1 ratio of oxyhemoglobin to deoxyhemoglobin, the absorption coefficient of oxyhemoglobin is approximately 10% of that of whole hemoglobin. To more accurately estimate the absorbance of the chromogenic component being measured, it is important to consider the ratio of deoxyhemoglobin to oxyhemoglobin.

[0100] Therefore, in the component determination apparatus 1, the measurement wavelength (first predetermined wavelength λ1) for measuring the absorbance of the colorimetric component contained in mixture X is 660 nm. The measured absorbance of mixture X at this measurement wavelength is corrected for interference factors (noise) by removing the influence of light scattering from components such as blood cells and further considering the influence of light absorption of hemoglobin based on the ratio of deoxyhemoglobin to oxyhemoglobin. Thus, the absorbance of the colorimetric component contained in mixture X is estimated, and the glucose concentration is calculated using a calibration curve representing the relationship between the estimated absorbance and glucose concentration.

[0101] The following is a detailed description of the component determination method performed by the component determination device 1.

[0102] First, the absorbance of the colorimetric component generated by the colorimetric reagent in the measuring reagent 22 used in this embodiment through a colorimetric reaction with glucose in the sample has a peak value around 600 nm, but the measuring wavelength for measuring the absorbance of the colorimetric component in this embodiment is 660 nm.

[0103] The measurement wavelength used to determine the absorbance of the chromogenic component being measured can be any wavelength where the light absorption of the chromogenic component is relatively large and the influence of hemoglobin's light absorption is relatively small. Specifically, it can be any wavelength range W3 that corresponds to the full width at half maximum (WW) of the peak wavelength region in the absorbance spectrum of the chromogenic component being measured, and where the proportion of absorbance based on hemoglobin's light absorption to the total absorbance is relatively small. The wavelength range "corresponding to the full width at half maximum (WW) of the peak wavelength region" refers to the range from the wavelength representing the half-value on the short wavelength side to the wavelength representing the half-value on the long wavelength side when the full width at half maximum (WW) of the peak wavelength region in the absorbance spectrum is determined. In this embodiment, the absorbance spectrum of the chromogenic component being measured has a peak wavelength around 600 nm, and the wavelength range from approximately 500 nm to approximately 700 nm corresponds to the full width at half maximum (WW). Furthermore, the influence of hemoglobin's light absorption in the total absorbance is relatively small in the wavelength range above 600 nm. Therefore, in this embodiment, the wavelength range W3 corresponding to the peak wavelength range in the absorbance spectrum of the colorimetric component being measured is 600 nm or more and 700 nm or less, and the wavelength range W3 in which the proportion of absorbance based on hemoglobin light absorption to total absorbance is relatively small. Therefore, the measurement wavelength is not limited to 660 nm as in this embodiment, and other wavelengths in the range of 600 nm to 700 nm can also be used as the measurement wavelength. Since a strong signal representing the absorbance of the colorimetric component is desirable, and the wavelength range in which the proportion of absorbance based on hemoglobin light absorption to total absorbance is minimized is more accurate in measuring the absorbance of the colorimetric component, it is preferable to use the wavelength around 660 nm, which is slightly longer than the peak wavelength around 600 nm in the absorbance spectrum of the colorimetric component, as the measurement wavelength. More specifically, it is preferable to use 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. Tetraazole salts are preferred examples of such colorimetric reagents.

[0104] Furthermore, although in this embodiment a chromogenic reagent with a peak wavelength half-width of approximately 500 nm to approximately 700 nm is used in the absorbance spectrum of the chromogenic component, chromogenic reagents with a peak wavelength half-width of approximately 500 nm or less can also be used. However, as described above, considering the light absorption characteristics of hemoglobin, it is preferable that the wavelength range with a large absorbance based on the light absorption of hemoglobin (below 600 nm) does not overlap with the measurement wavelength in the absorbance spectrum of the chromogenic component.

[0105] The following describes a method for estimating the absorbance of the colorimetric component at the measurement wavelength of this embodiment, i.e., 660 nm. The component measuring apparatus 1 measures the absorbance of mixture X at four second predetermined wavelengths λ2 to fifth predetermined wavelengths λ5, which are different from the measurement wavelength (660 nm). Using these four second measured values ​​D2 to fifth measured values ​​D5, and predetermined correction coefficients, the first measured value D1 of the absorbance of mixture X at the measurement wavelength is corrected, and the absorbance of the colorimetric component at the measurement wavelength is estimated. The measurement wavelength in this embodiment is the aforementioned first predetermined wavelength λ1.

[0106] The component determination apparatus 1 uses two second measured values ​​D2 and three measured values ​​D3 of the absorbance of the mixture X at two second specified wavelengths λ2 and three specified wavelengths λ3, which are on the longer wavelength side compared to the measurement wavelength, i.e., the first specified wavelength λ1, and two fourth measured values ​​D4 and five measured values ​​D5 of the absorbance of the mixture X at two fourth specified wavelengths λ4 and five specified wavelengths λ5, which are on the shorter wavelength side compared to the measurement wavelength, i.e., the first specified wavelength λ1, as the aforementioned four second measured values ​​D2 to five measured values ​​D5.

[0107] More specifically, the absorbance of mixture X at each of the two second specified wavelengths λ2 and λ3, which are on the longer wavelength side compared to the measurement wavelength (i.e., the first specified wavelength λ1) and belong to the wavelength range where the influence of light scattering by blood cell components, etc., is dominant in the total absorbance, is used as the above four second measured values ​​D2 to fifth measured values ​​D5.

[0108] In other words, the component measuring device 1 uses the absorbance of the mixture X at each of the second specified wavelength λ2 and the third specified wavelength λ3, which belong to the long wavelength range, for example, to the long wavelength range W1 that belongs to the long wavelength range W1 compared to the peak wavelength range of the absorbance spectrum of the measured object, i.e., the colorimetric component, as the aforementioned second measured value D2 and third measured value D3.

[0109] In addition, the component measuring apparatus 1 uses the absorbance of the mixture X at each of the fourth specified wavelength λ4 and the fifth specified wavelength λ5, which belong to the short wavelength range corresponding to the half-width range of the peak wavelength range in the absorbance spectrum of the measured object, i.e., the colorimetric component, as the fourth measured value D4 and the fifth measured value D5.

[0110] In the component measuring apparatus 1, the control unit 50 obtains the first measured values ​​D1 to the fifth measured values ​​D5 from the photometer unit 51. Specifically, the mixture X is irradiated with irradiation light containing emission wavelengths from the first light source 67 to the fifth light source 68d of the irradiation unit 66, each wavelength including a first predetermined wavelength λ1 to a fifth predetermined wavelength λ5. The light receiving unit 72 receives the transmitted light that passes through the mixture X in each irradiation light. Then, the control unit 50 calculates the absorbance of the mixture X at each wavelength based on the relationship between the irradiated light and the transmitted light, and stores the absorbance of the mixture X at each wavelength, i.e., the first measured values ​​D1 to the fifth measured values ​​D5, as measured value data in the storage unit 52. The control unit 50 can obtain the measured value data from the storage unit 52. The method by which the control unit 50 obtains the first measured values ​​D1 to the fifth measured values ​​D5 is not limited to the method described above, and can be obtained by various known methods.

[0111] Then, the control unit 50 corrects the first measured value D1 using the second measured value D2 to the fifth measured value D5, and estimates the absorbance of the colorimetric component at the measurement wavelength, i.e., the first specified wavelength λ1 (660 nm in this example). In the long wavelength domain W1, where light scattering of blood cell components and the like is dominant, the absorbance spectrum of the mixture X is approximately linear. Therefore, the component measuring device 1 can estimate, to a certain extent, the absorbance caused by interference factors (noise) other than the absorbance of the colorimetric component at the measurement wavelength, i.e., the first specified wavelength λ1, by acquiring the absorbance at the second specified wavelength λ2, i.e., the second measured value D2, and the absorbance at the third specified wavelength λ3, i.e., the third measured value D3, and by calculating the tilt between the second measured value D2 and the third measured value D3.

[0112] Furthermore, the component determination apparatus 1 can calculate the glucose concentration in the sample by taking into account not only the optical properties of blood cell components in the sample, but also the ratio of deoxyhemoglobin to oxyhemoglobin in red blood cells. Therefore, in the component determination apparatus 1, by utilizing two wavelengths (a fourth predetermined wavelength and a fifth predetermined wavelength) selected according to the ratio of deoxyhemoglobin to oxyhemoglobin, more accurate corrections can be performed.

[0113] Specifically, the component measuring device 1 uses a wavelength where the difference in absorption coefficients between deoxyhemoglobin and oxyhemoglobin is below a first predetermined value as the fourth predetermined wavelength λ4, and uses a wavelength where the difference in absorption coefficients between deoxyhemoglobin and oxyhemoglobin is greater than the first predetermined value as the fifth predetermined wavelength λ5. More specifically, it uses a wavelength where the ratio of the absorption coefficient of oxyhemoglobin to the absorption coefficient of deoxyhemoglobin is above a first predetermined threshold as the fourth predetermined wavelength λ4, and uses a wavelength where the ratio of the absorption coefficient of oxyhemoglobin to the absorption coefficient of deoxyhemoglobin is less than the first predetermined threshold as the fifth predetermined wavelength λ5. In other words, it uses two wavelengths—one where the ratio of the absorption coefficient of oxyhemoglobin to the absorption coefficient of deoxyhemoglobin is above the first threshold and the other where the ratio is less than the first threshold—as the fourth predetermined wavelength λ4 and the fifth predetermined wavelength λ5. Therefore, when the control unit 50 corrects the first measured value D1 using the second measured value D2 to the fifth measured value D5, it can perform a more accurate correction that takes into account the ratio of deoxyhemoglobin to oxyhemoglobin.

[0114] The two wavelengths selected based on the ratio of deoxyhemoglobin to oxyhemoglobin are preferably those with a large difference in light absorption of hemoglobin caused by the ratio of deoxyhemoglobin to oxyhemoglobin. Therefore, in this embodiment, a wavelength with a ratio of the absorption coefficient of oxyhemoglobin to that of deoxyhemoglobin of 0.8 or more is preferably used as the fourth predetermined wavelength λ4. Furthermore, a wavelength with a ratio of the absorption coefficient of oxyhemoglobin to that of deoxyhemoglobin of less than 0.8 is used as the fifth predetermined wavelength λ5. In this embodiment, as an example, the fourth predetermined wavelength λ4 is 520 nm and the fifth predetermined wavelength λ5 is 589 nm.

[0115] Thus, by utilizing the fourth and fifth predetermined wavelengths λ4 and λ5, where the overall light absorption of hemoglobin varies significantly based on the ratio of deoxyhemoglobin to oxyhemoglobin, within the short wavelength range W2, the absorbance at the measurement wavelength, i.e., the first predetermined wavelength λ1 (660 nm in this embodiment), can be estimated with high accuracy, taking into account the ratio of deoxyhemoglobin to oxyhemoglobin. Therefore, according to the component determination apparatus 1, the absorbance of the colorimetric component at the measurement wavelength, i.e., the first predetermined wavelength λ1, can be measured with high accuracy, and consequently, the measured component (the concentration of glucose in this embodiment) can be measured with high accuracy.

[0116] In this embodiment, only the fourth specified wavelength λ4 and the fifth specified wavelength λ5 are wavelengths that take into greater consideration the influence of the ratio of deoxyhemoglobin to oxyhemoglobin. However, it is more preferable that the same wavelengths are used for the second specified wavelength λ2 and the third specified wavelength λ3, in addition to the fourth specified wavelength λ4 and the fifth specified wavelength λ5.

[0117] Specifically, a wavelength where the difference in absorption coefficients between deoxyhemoglobin and oxyhemoglobin is below a second predetermined value is used as the second predetermined wavelength λ2 of the long wavelength domain W1 where light scattering by blood cell components, etc., is dominant. A wavelength larger than the second predetermined value is used as the third predetermined wavelength λ3 of the same long wavelength domain W1. More specifically, it is preferable to use a wavelength where the ratio of the absorption coefficient of oxyhemoglobin to that of deoxyhemoglobin is above the aforementioned first threshold and below the second threshold as the second predetermined wavelength λ2. A wavelength where the ratio of the absorption coefficient of oxyhemoglobin to that of deoxyhemoglobin is less than the aforementioned first threshold, or greater than the second threshold, is used as the third predetermined wavelength λ3 of the same long wavelength domain W1. The second threshold is any other predetermined threshold larger than the first threshold. In other words, it is preferable to use two wavelengths where the ratio of the absorption coefficient of oxyhemoglobin to that of deoxyhemoglobin is in different ranges as the second predetermined wavelength λ2 and the third predetermined wavelength λ3. Therefore, when the control unit 50 corrects the first measured value D1 using the second measured value D2 to the fifth measured value D5, it can perform a more accurate correction that takes into account the ratio of deoxyhemoglobin to oxyhemoglobin.

[0118] In particular, although the influence of light scattering from blood cell components, etc., is dominant in the long wavelength domain W1, the influence of light absorption from hemoglobin is also included to the same extent as the measurement wavelength of the component being measured. Therefore, it is preferable to use two wavelengths, the second specified wavelength λ2 and the third specified wavelength λ3, where the light absorption of hemoglobin varies greatly according to the ratio of deoxyhemoglobin to oxyhemoglobin.

[0119] Therefore, in this embodiment, it is preferable to use a wavelength in which the ratio of the absorption coefficient of oxyhemoglobin to that of deoxyhemoglobin is in the range of 0.8 or more and 1.5 or less as the second predetermined wavelength λ2. In this embodiment, as an example, the second predetermined wavelength λ2 is 850 nm. Furthermore, the second predetermined wavelength λ2 can be selected from the range of 790 nm to 850 nm.

[0120] The third specified wavelength λ3 is in the long wavelength range W1, and the absorbance of the colorimetric component included in the total absorbance at the third specified wavelength λ3 is 10% or less, preferably 6% or less, more preferably 3% or less, and even more preferably 0%. In other words, it is particularly preferable to use a wavelength that is at or above the wavelength of the long wavelength tail of the peak wavelength range of the absorbance spectrum of the colorimetric component. This eliminates the influence of light absorption by the colorimetric component and more accurately estimates the noise dominated by light scattering from blood cell components, etc., in the long wavelength range W1. In this embodiment, the third specified wavelength λ3 is a wavelength selected from 920 to 950 nm, and as an example, it is 940 nm. The third specified wavelength λ3 is particularly preferably a wavelength in which the absorbance of the colorimetric component is zero, that is, a wavelength that is the wavelength of the long wavelength tail of the peak wavelength range of the absorbance spectrum of the colorimetric component. Furthermore, the "total absorbance" in the aforementioned "absorbance of the chromogenic component included in the total absorbance" refers to the absorbance of a mixture containing the sample and / or the chromogenic component. Additionally, the "absorbance of the chromogenic component" in the aforementioned "absorbance of the chromogenic component included in the total absorbance" refers to the absorbance of the reaction product generated by the colorimetric reaction between the analyte in the sample and the chromogenic reagent in the reagent, i.e., the absorbance originating from the chromogenic component.

[0121] As described above, the component measuring device 1 can use the measured values ​​of the absorbance of the mixture X at each of the second specified wavelength λ2 to the fifth specified wavelength λ5, i.e., the second measured value D2 to the fifth measured value D5, to correct the measured value of the absorbance of the mixture X at the measuring wavelength, i.e., the first measured value D1, and estimate the absorbance of the colorimetric component at the measuring wavelength.

[0122] Next, the correction process of the control unit 50 of the component measuring device 1 in the first mode will be described.

[0123] As described above, the storage unit 52 of the component measuring device 1 stores the absorbance of the mixture X at each of the first specified wavelength λ1 to the fifth specified wavelength λ5, i.e., the first measured value D1 to the fifth measured value D5, as measured by the photometer 51; a set of correction coefficient data related to the absorbance of the mixture X at each of the second specified wavelength λ2 to the fifth specified wavelength λ5; and calibration curve data showing the relationship between the absorbance of the color component in the mixture X and various physical quantities obtained by correcting the absorbance of the mixture X measured at the first specified wavelength λ1 using the correction coefficient data.

[0124] Based on the measured data and correction coefficient data stored in the storage unit 52, the control unit 50 derives the absorbance of the color component at the measurement wavelength, i.e., the first wavelength λ1.

[0125] Here, the corrected coefficient data are derived from a regression analysis performed in advance using the formula shown in the following formula (1).

[0126] [Formula 1]

[0127] B(λ1)=b0+b1*B(λ2)+b2*B(λ3)+b3*B(λ4)+b4*B(λ5) (1)

[0128] B(λ) refers to the absorbance caused by interference factors (noise), excluding the absorbance of the chromogenic component at wavelength λ. Using various blood samples, regression calculations are performed using the formula shown in equation (1) above to derive coefficients b0, b1, b2, b3, and b4. As described above, in this embodiment, 850 nm is used as the second specified wavelength λ2, 940 nm as the third specified wavelength λ3, 520 nm as the fourth specified wavelength λ4, and 589 nm as the fifth specified wavelength λ5. Furthermore, based on six blood samples with different compositions, blood samples with hematocrit values ​​adjusted to the range of 10% to 70% are prepared. The absorbance spectra of the adjusted blood samples are measured, and regression analysis is used to derive coefficients b0, b1, b2, b3, and b4. Based on these derived coefficients b0 to b4, a set of correction coefficients related to the absorbance of mixture X at each of the second specified wavelength λ2 to the fifth specified wavelength λ5 are derived. By using correction factor data that includes this correction factor, the measured absorbance of mixture X at a measurement wavelength of 660 nm can be corrected based on the measured absorbance values ​​of mixture X at 520 nm, 589 nm, 850 nm, and 940 nm, and the absorbance of the colorimetric component at 660 nm can be estimated.

[0129] Furthermore, in order to more easily calculate the blood glucose value, the above formula can be simplified. Based on the measured absorbance of the mixture X of light with the fourth specified wavelength λ4 (520 nm) and the second specified wavelength λ2 (850 nm), the measured absorbance of the mixture X with the measured wavelength of 660 nm can be corrected, and the absorbance of the colorimetric component at 660 nm can be estimated.

[0130] Figure 9 This is a flowchart illustrating an example of a component determination process performed by component determination apparatus 1. For example... Figure 9As shown, the component determination process includes: step S1, obtaining the absorbance of mixture X at a first predetermined wavelength λ1 (i.e., a first measured value D1), the absorbance of mixture X at a second predetermined wavelength λ2 (i.e., a second measured value D2), the absorbance of mixture X at a third predetermined wavelength λ3 (i.e., a third measured value D3), the absorbance of mixture X at a fourth predetermined wavelength λ4 (i.e., a fourth measured value D4), and the absorbance of mixture X at a fifth predetermined wavelength λ5 (i.e., a fifth measured value D5); step S2, deriving a hematocrit value using at least one of the first measured values ​​D1 to the fifth measured values ​​D5; step S3, correcting the first measured value D1 using the second measured values ​​D2 to the fifth measured values ​​D5 and a correction coefficient obtained through regression calculation, and obtaining the absorbance of the colorimetric component at the first predetermined wavelength λ1 (i.e., a measured wavelength); and step S4, calculating the analyte in the sample based on the absorbance of the colorimetric component at the first predetermined wavelength λ1 (i.e., a measured wavelength) and the derived hematocrit value.

[0131] In step S1, as described above, the first measured value D1 to the fifth measured value D5 are acquired using the light-emitting part 66 and the light-receiving part 72 of the photometer 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 absorbance of hemoglobin is estimated based on the fourth measured value D4, or based on the fourth measured value D4 and the second measured value D2, and the hematocrit value is derived. Furthermore, if the fourth measured value D4, or if the fourth measured value D4 and the second measured value D2 contain the absorption of the colorimetric component, the hematocrit value is derived based on a correction value obtained by subtracting the absorption of the colorimetric component from the fourth measured value D4, or the fourth measured value D4 and the second measured value D2. In this embodiment, the hematocrit value is derived from the calibration curve stored in the storage unit 52, which shows the relationship between the absorbance of hemoglobin in mixture X and the hematocrit value. In step S3, the absorbance of the chromogenic component at the first measurement wavelength is estimated and obtained by correcting the first measurement value D1 using the second measured value D2 to the fifth measured value D5 and a correction coefficient obtained through regression calculation. Furthermore, if the second measured value D2 to the fifth measured value D5 includes the absorption of the chromogenic component, the absorbance of the chromogenic component at the first predetermined wavelength λ1 is estimated and obtained by recalculating the correction value obtained by subtracting the absorption of the chromogenic component from each measured value. Finally, in step S4, the glucose concentration is calculated using the calibration curve showing the relationship with glucose concentration based on the obtained absorbance of the chromogenic component at the measurement wavelength, i.e., the first predetermined wavelength λ1, and the derived hematocrit value.

[0132] When performing the component measurement process, the control unit 50 of the component measurement apparatus 1 emits illumination light from the first light source 67 to the fifth light source 68d according to a predetermined algorithm, and the light receiving unit 72 measures the intensity of the received light. The light intensity measurement process performed by the control unit 50 during the component measurement process will be described in detail below.

[0133] Figure 10 This is a flowchart illustrating an example of a photometric measurement process performed during component measurement processing in component measurement device 1. For example, it is performed when the operator inputs the processing mode and the start of the processing. Figure 10 The procedure is as follows. Here, we will assume that the operator has selected the first mode for measuring the analyte as the processing mode for the following explanation.

[0134] Here, when performing the component determination process, the control unit 50 performs a process in which the first light source 67 to the fifth light source 68d emits irradiation light once in sequence as pulse light, and emits irradiation light as a group. Figure 11 This diagram schematically represents a group of illumination lights emitted from the first light source 67 to the fifth light source 68d, and it also represents the light intensity received by the light-receiving section 72 for the illumination lights emitted from the first light source 67 to the fifth light source 68d. Figure 11 In the diagram, the horizontal axis represents time, and the vertical axis represents light intensity. For example... Figure 11 As shown, the control unit 50 causes the first light source 67 to the fifth light source 68d to emit light sequentially at predetermined time intervals. Figure 11 In the example shown, 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. Additionally, as... Figure 11 As shown, the control unit 50 causes the first light source 67 to the fifth light source 68d to emit light in such a way that the light intensity received in the light-receiving section 72 of each of the illumination lights from the first light source 67 to the fifth light source 68d is approximately the same. "Approximately the same intensity" means that, when performing component determination processing with the light intensity received in the light-receiving section 72, the difference in light intensity obtained from the emission of each light source is within a range that does not affect the results of the component determination processing.

[0135] Here, in a set of emission processes, the control unit 50 causes the first light source 67 to the fifth light source 68d to emit light in a predetermined sequence. In particular, the control unit 50 causes the second light source 68a and the third light source 68b to emit irradiation light with a second predetermined wavelength λ2 and a third predetermined wavelength λ3, respectively, which are dominated by the effect of light scattering from blood cell components, etc., at timings adjacent to the timing of emitting pulsed light of the first light source 67 with the emission measurement wavelength, i.e., the first predetermined wavelength λ1.

[0136] For example, in Figure 11In the example shown, the control unit 50 emits illumination light into the measurement area in a set of emission processes, following the sequence of 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. Therefore, the light-receiving unit 72 receives illumination light at predetermined time intervals (1 ms) in the sequence 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. Light scattering caused by blood cell components varies over time due to the effects of Brownian motion, sedimentation, and interference as wave properties of molecules. Therefore, it is preferable to acquire the second measured value D2 and the third measured value D3, which are closer in time to the first measured value D1 that is the object of correction, to correct for the effects of light scattering. This is because acquiring the value at a closer time interval makes it less susceptible to the effects of time variations. Therefore, as in this embodiment, by emitting second light sources 68a and third light sources 68b that emit second predetermined wavelength λ2 and third predetermined wavelength λ3, which are dominated by the effect of light scattering from blood cell components, at a timing adjacent to the timing of emitting pulsed light of the first light source 67 emitting the pulsed light of the measurement wavelength, i.e., the first predetermined wavelength λ1, it is possible to correct the effect of light scattering with higher precision.

[0137] Furthermore, the control unit 50 may not necessarily emit the illumination light in the order of 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 in a single emission process. The control unit 50 may simply emit the second light source 68a and the third light source 68b at timings adjacent to the timing of emitting the first light source 67.

[0138] Reference Figure 10 If the control unit 50 detects that the operator of the component measuring device 1 has made an operation input to start the process, it starts the emission of irradiation light from the first light source 67 to the fifth light source 68d (step S11). At this time, the control unit 50 executes the emission of irradiation light from the first light source 67 to the fifth light source 68d, thereby enabling it to detect whether the component measuring chip 2 is installed in the component measuring device 1.

[0139] Figure 12 It is a schematic representation of... Figure 10 In step S11, the light-receiving part 72 plots a graph of the intensity of the illumination light emitted from the first light source 67 to the fifth light source 68d. Figure 12 In the diagram, the horizontal axis represents time, and the vertical axis represents light intensity. For example... Figure 12 As shown in the schematic diagram, the control unit 50 repeatedly outputs... Figure 11The following describes a set of emission processes. For example, the control unit 50 repeatedly executes a set of emission processes 1 to 200 times per second. In this embodiment, a set of emission processes is repeatedly executed 16 times per second. After the set of emission processes has been repeated 16 times, the control unit 50 stops the output of the illumination light. Then, after a predetermined time (here, one second) has elapsed from the start of the set of 16 emission processes, the set of 16 emission processes is again continuously and repeatedly output. After the set of 16 emission processes has been repeated, the control unit 50 stops the output of the illumination light again. The control unit 50 thus repeats the output of the set of 16 emission processes every second and stops the output of the illumination light every second until step S14 described later.

[0140] Next, the control unit 50 performs a first light intensity determination (step S12). Specifically, in the first light intensity determination process, the control unit 50 determines whether the light intensity in the light-receiving unit 72 is within the normal range (step S12).

[0141] Here, the determination process for the first light intensity performed by the control unit 50 in step S12 will be explained in detail. The determination process for the first light intensity is a process for detecting whether the normal measurement performed by the control unit 50 described above can be performed. Figure 13 This is a flowchart illustrating an example of the process for determining the first intensity of light received.

[0142] In the first light intensity determination process, i.e., the process of detecting whether a normal measurement can be performed, the control unit 50 performs two determination processes. One is a determination process based on the absolute output value output from the light-receiving unit 72, and the other is a determination process based on the relative output value output from the light-receiving unit 72. Figure 13 Steps S31 and S35 of the process involve performing a decision based on the absolute output value. Figure 13 Steps S36 to S40 of the process perform decision processing based on relative output values.

[0143] The absolute output value used here refers to the output value from the AD converter connected to the light-receiving unit 72, corresponding to the light intensity received in the light-receiving unit 72 when light is not emitted from the light-emitting unit 66 (first light source 67 to fifth light source 68d). 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 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 emitted from the light-emitting unit 66 (first light source 67 to fifth light source 68d). That is, the relative output value is obtained by subtracting the output value A observed when light is not emitted from the light-emitting unit 66 from the output value R′ observed when light is emitted from the light-emitting unit 66. The absolute output value A and the relative output value R are acquired and calculated during the repeated switching on and off of the light-emitting unit 66. For example, as... Figure 11 As indicated by the arrow, during a predetermined time interval while emitting illumination light of the fifth predetermined wavelength λ5, the relative output value R5 of the fifth predetermined wavelength λ5 is obtained. During a predetermined time interval before the emission of illumination light compared to this predetermined time interval, the absolute output value A5 of the fifth predetermined wavelength λ5 is obtained. The same applies to the first predetermined wavelength λ1 through the fourth predetermined wavelength λ4. The absolute and relative output values ​​used here can be obtained by performing a moving average of multiple absolute and multiple relative output values ​​obtained from light sources of the same wavelength within a predetermined interval.

[0144] 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; an AD converter with an appropriate resolution can be used. Furthermore, the output value of an AD converter with other resolutions can be converted from the value of the 12-bit resolution AD converter.

[0145] As a decision-making process based on absolute output values, the control unit 50 first obtains the absolute output value corresponding to the light intensity from the light-receiving unit 72 (step S31). Specifically, the light-receiving unit 72 outputs an output value corresponding to the light intensity from the AD converter, and the control unit 50 obtains the output value output from the AD converter. In step S31, the control unit 50 obtains the absolute output value. The absolute output value can be calculated using a moving average based on each light intensity value obtained during multiple time intervals when the light-emitting unit 66 is not emitting light. Furthermore, the number of averaging processes can be appropriately set.

[0146] Next, the control unit 50 determines whether the acquired absolute output value is within a specified range. Specifically, the control unit 50 determines whether the acquired absolute output value is within, for example, a first specified range of absolute output values ​​preset (step S32). By executing step 32, before the start of the measurement process of the substance being measured, it is determined whether there is an abnormality in the light-receiving unit 72 and / or the circuit connected to the light-receiving unit 72. Therefore, the first specified range is set to the range in which the absolute output value of the light intensity in the light-receiving unit 72 output from the AD converter is considered to be within the normal range. That is, the first specified range reflects the presence or absence of an abnormality in the light-receiving unit 72 and the circuit connected to the light-receiving unit 72. The first specified range can be appropriately specified according to the specifications of the component measuring device 1, etc. For example, in the case of using a 12-bit AD converter as in this embodiment, the first specified range can be 51 or higher and 3900 or lower. However, the first specified range is not limited to the example shown here, and can be appropriately specified.

[0147] If the control unit 50 determines that the acquired absolute output value is not included in the first specified range (No in step S32), it determines whether the acquired absolute output value is lower than the lower limit of the first specified range (step S33). For example, if the first specified range is 51 or more and 3900 or less, the control unit 50 determines in step S33 whether the acquired absolute output value is less than or equal to 50.

[0148] If the control unit 50 determines that the acquired absolute output value is lower than the lower limit of the first specified range (as in step S33), it determines that an abnormality (circuit abnormality) has occurred in the circuit connected to the light-receiving unit 72 (step S34). In this example, the case where the absolute output value is lower than the lower limit of the first specified range means that the absolute output value is above 0 and below 50. In this case, the light intensity received by the light-receiving unit 72 output from the AD converter is lower than the first specified range, which is considered to be within the normal range, so it is considered that there is a higher possibility of leakage current or the like affecting the measurement. Therefore, the control unit 50 determines that an abnormality (circuit abnormality) has occurred in the reference voltage.

[0149] On the other hand, if the control unit 50 determines that the acquired absolute output value is not lower than the lower limit of the first specified range (No in step S33), it determines that a light-receiving sensitivity abnormality has occurred due to an abnormality in the light-receiving unit 72 itself or an abnormality in the circuit connected to the light-receiving unit 72 (step S35). When the absolute output value is not lower than the lower limit of the first specified range, since it was determined in step S32 that the absolute output value is also not within the first specified range, the acquired absolute output value is higher than the upper limit of the first specified range. That is, in this example, when the absolute output value is not lower than the lower limit of the first specified range, the absolute output value is between 3901 and 4095. In this case, the light intensity in the light-receiving unit 72 output from the AD converter is higher than the first specified range, which is considered to be within the normal range, so it is considered that the possibility of structural damage or current interruption of the light-receiving unit 72 affecting the measurement is high. Therefore, the control unit 50 determines that a light-receiving sensitivity abnormality has occurred. In addition, in step S35, besides the aforementioned abnormal light sensitivity, damage to the front opening 10s of the component measuring device 1 before the component measuring chip 2 is installed can also be detected.

[0150] If the control unit 50 determines in step S34 that a circuit malfunction such as generating a reference voltage is occurring, or if it determines in step S35 that a malfunction occurs in light-receiving sensitivity, then... Figure 10In step S12, it is determined that the light intensity is not within the normal range (No in step S12). In this case, the control unit 50 reports an error by outputting a buzzer tone from the buzzer unit 59, for example (step S23). The control unit 50 can output an error corresponding to the type of the determined abnormality. For example, the control unit 50 can output different buzzer tones depending on the type of the determined abnormality, or notify the type of the determined abnormality by sound. The control unit 50 can also notify the user by displaying the type of the determined abnormality on the display unit 11. Furthermore, the control unit 50 can suspend processing when an error occurs. For example, the control unit 50 suspends the measurement process of the measured component after reporting an error. Thus, in cases where there is a possibility of an abnormality occurring, processing is not performed. The same applies to cases where an error described below is reported.

[0151] In step S32, if the control unit 50 determines that the acquired absolute output value is within the first specified range (as determined in step S32), it determines that no abnormality was found in the determination process based on the absolute output value, i.e., it is normal, and begins the determination process based on the relative output value. Specifically, the control unit 50 moves to the processing in step S36.

[0152] As a determination process based on relative output values, the control unit 50 obtains a relative output value corresponding to the light intensity from the light-receiving unit 72 (step S36). Specifically, the light-receiving unit 72 outputs an output value corresponding to the light intensity from the AD converter, and the control unit 50 obtains the output value output from the AD converter. In step S36, the control unit 50 obtains the relative output value by performing calculations based on the output value output from the AD converter.

[0153] Next, the control unit 50 determines whether the acquired relative output value is within a specified range. Specifically, the control unit 50 determines whether the acquired relative output value is within, for example, a second specified range of relative output values ​​preset (step S37). The second specified range is the range in which the relative output value of the light intensity in the light-receiving unit 72 output from the AD converter is considered to be within a normal range. The second specified range can be appropriately specified according to the specifications of the component measuring device 1, etc. For example, in the case of using a 12-bit AD converter as in this embodiment, the second specified range can be 601 or more and 3900 or less. However, the second specified range is not limited to the example shown here, and can be appropriately specified. Through this step, the control unit 50 can detect abnormalities in the light-emitting unit 66 and the optical path before the component measuring chip 2 is inserted into the component measuring device 1.

[0154] If the control unit 50 determines that the acquired relative output value is not included in the second specified range (No in step S37), it determines whether the acquired relative output value is lower than the lower limit of the second specified range (step S38). For example, if the second specified range is 601 or more and 3900 or less, the control unit 50 determines in step S38 whether the acquired relative output value is 600 or less.

[0155] If the control unit 50 determines that the acquired relative output value is lower than the lower limit of the second specified range (in step S38), it determines that an insufficient light quantity abnormality has occurred due to dirt on the photometer 51 and a decrease in the output of the light-emitting unit 66 (in step S39). The insufficient light quantity abnormality includes insufficient light emission from the light-emitting unit 66 and the light-receiving unit 72 failing to detect sufficient light for the measurement of the object being measured. Dirt on the photometer 51 indicates the possibility of dirt (foreign matter attachment) obstructing light at any point in the optical path from the light-emitting unit 66 to the light-receiving unit 72. For example, the cover member 25 may be contaminated, obstructing light from the light-emitting unit 66. Furthermore, a decrease in the output of the light-emitting unit 66 indicates the possibility of an abnormality in the light source itself or in the circuit connected to the light-emitting unit 66. In this example, when the relative output value is lower than the lower limit of the second specified range, it means the relative output value is above 0 and below 600. In this case, the difference between the output from the AD converter when light is emitted from the light-emitting unit 66 (first light source 67 to fifth light source 68d) and the output from the AD converter when light is not emitted from the light-emitting unit 66 (first light source 67 to fifth light source 68d) is below a specified value. Therefore, it is considered that there is a high probability of dirt on the photometer unit 51 and a decrease in the output of the light-emitting unit 66. As a result, the control unit 50 determines that there is an abnormality in the amount of light generated.

[0156] On the other hand, if the control unit 50 determines that the acquired relative output value is not lower than the lower limit of the second specified range (No in step S38), it determines that a light emission abnormality caused by excessive light emission has occurred (step S40). If the relative output value is not lower than the lower limit of the second specified range, since it was determined in step S37 that the relative output value is also not within the second specified range, the acquired relative output value is higher than the upper limit of the second specified range. That is, in this example, if the relative output value is not lower than the lower limit of the second specified range, it is a case where the relative output value is above 3901 and below 4095. In this case, if the light intensity received by the light-receiving unit 72 output from the AD converter is higher than the second specified range which is considered normal, it is considered that the LED is likely to emit light with a higher amount of light than the light-receiving unit 72 can receive. That is, it is considered that the possibility of an overcurrent to the LED due to an abnormality in the circuit connected to the light-emitting unit 66 is higher. Therefore, the control unit 50 determines that a light emission abnormality has occurred.

[0157] If the control unit 50 determines in step S39 that an insufficient light quantity abnormality has occurred, or if it determines in step S40 that an abnormal light quantity abnormality has occurred, then... Figure 10 In step S12, it is determined that the light intensity is not within the normal range (No in step S12). In this case, the control unit 50 reports an error by outputting a buzzer tone from the buzzer unit 59, for example (step S23). The error reporting method can be the same as the example described above. Thus, it is possible to notify the operator whether the component measuring device 1 is in a normal measuring operation state before actually inserting the component measuring chip 2 into the component measuring device 1. The operator can stop the measuring operation at the stage where an error report is made, so it is possible to suppress the consumption of excess component measuring chips 2 and blood collection.

[0158] In step S37, if the control unit 50 determines that the acquired relative output value is within the second specified range (Yes in step S37), it determines that no abnormality is found in the determination process based on the relative output value, i.e., normal.

[0159] In step S32, if the control unit 50 determines that the acquired absolute output value is within a first specified range (Yes in step S32), and in step S37, if it determines that the acquired relative output value is within a second specified range (Yes in step S37), then... Figure 10 In step S12, it is determined that the light intensity is within the normal range (step S12 is yes). Then, move to Figure 10 Step S13 of the process. Without executing... Figure 10 In the case of an implementation of step S13 of the process, proceed to step S14.

[0160] In this way, the control unit 50 of this embodiment can perform processing to determine whether the component measuring device 1 can perform normal measurement. If the control unit 50 determines that there is a possibility of an abnormality occurring in the component measuring device 1, it can notify the operator of the possibility of an abnormality by reporting its main points. In addition, the control unit 50 can also notify the operator of the type of error by outputting an error corresponding to the type of abnormality determined.

[0161] In addition, in reference Figure 13 In the example provided, the control unit 50 is described as performing decision processing based on absolute output values ​​and decision processing based on relative output values. However, the control unit 50 may not necessarily perform both decision processing based on absolute output values ​​and decision processing based on relative output values. For example, the control unit 50 may detect at least some anomalies by performing at least one of the decision processing based on absolute output values ​​and decision processing based on relative output values.

[0162] In addition, in reference Figure 13 In the example described, the control unit 50 performs decision processing based on absolute output values ​​first, and then performs decision processing based on relative output values. However, the decision processing based on absolute output values ​​and the decision processing based on relative output values ​​may not necessarily be performed in this order. For example, the control unit 50 may perform decision processing based on absolute output values ​​first, then perform decision processing based on relative output values, perform decision processing based on absolute output values ​​and decision processing based on relative output values ​​consecutively, or perform them simultaneously.

[0163] Refer again Figure 10 If the control unit 50 determines that the light intensity in the light-receiving section 72 is within the normal range (as determined in step S12), it determines whether the component analysis chip 2 has been inserted into the chip insertion space S based on the change in the light intensity in the light-receiving section 72. Specifically, the control unit 50 determines whether the component analysis chip 2 has been inserted into the chip insertion space S in step S14. Alternatively, the control unit 50 may also determine whether the component analysis chip 2 has been inserted into the chip insertion space S in steps S13 and S14.

[0164] To explain more specifically, for example, the operator installs the component measuring chip 2 into the component measuring device 1. That is, the operator inserts the component measuring chip 2 into the chip mounting space S of the component measuring device 1. During the insertion of the component measuring chip 2 into the chip mounting space S, at least a portion of the illumination light emitted from the first light source 67 to the fifth light source 68d is absorbed by the components constituting the component measuring chip 2 and does not reach the light receiving part 72. Then, if the component measuring chip 2 is installed in the component measuring device 1, it becomes... Figure 2 as well as Figure 3 In the state shown, a light path is formed between the first light source 67 to the fifth light source 68d and the light-receiving part 72 through a portion of the component measuring chip 2. This portion of the component measuring chip 2 that forms the light path is the measuring point. In this embodiment, the measuring reagent 22 is located in the middle of the light path. That is, the measuring point is located on the measuring reagent 22. Therefore, only a portion of the irradiation light emitted from the first light source 67 to the fifth light source 68d toward the measuring area that has passed through the measuring reagent 22 is received by the light-receiving part 72. In other words, if the component measuring chip 2 is installed in the component measuring device 1, the light intensity received in the light-receiving part 72 will be different compared to the case where it is not installed.

[0165] Therefore, the control unit 50 determines whether the component determination chip 2 is installed in the component measuring device 1 by detecting changes in the light intensity in the light-receiving section 72. After the control unit 50 detects that the light intensity in the light-receiving section 72 is less than a predetermined amount (in other words, the components constituting the component measuring chip 2 block at least a portion of the irradiation light so that it does not reach the light-receiving section 72), if the control unit 50 detects that the light intensity in the light-receiving section 72 is within a predetermined range that is estimated to be the case that the component measuring chip 2 is inserted into the chip mounting space S, it determines that the component measuring chip 2 is inserted into the chip mounting space S.

[0166] In this embodiment, the control unit 50 determines that the component measurement chip 2 has been inserted into the chip mounting space S when it detects that the light intensity in the light receiving section 72 is within a predetermined range that is estimated to be within the chip mounting space S before the component measurement chip 2 is inserted into the chip insertion space S (step S14).

[0167] Furthermore, when the component measurement chip 2 is used as a light-shielding component to form the measurement area, it is also possible to determine whether the insertion of the component measurement chip 2 is qualified if the light intensity is within a predetermined range after the light-receiving section 72 is in a state where no light is detected (in other words, the components constituting the component measurement chip 2 block the illumination light so that it does not reach the light-receiving section 72). In this case, firstly, the control unit 50 determines whether the light-receiving section 72 is in a state where no illumination light is received (step S13). In this specification, the state where no illumination light is received includes the case where the illumination light emitted from the first light source 67 to the fifth light source 68d is blocked by the component measurement chip 2, and the light intensity detected in the light-receiving section 72 is the same as that detected in the light-receiving section 72. For example, a threshold can be preset, and the determination of whether the light intensity in the light-receiving section 72 is in a state where no illumination light is received can be made based on whether the output value from the AD converter is lower than the threshold. If the control unit 50 determines that the light-receiving unit 72 is not receiving illumination light (No in step S13), it repeats step S13 until it determines that the light-receiving unit 72 is not receiving illumination light. If the control unit 50 determines that the light-receiving unit 72 is not receiving illumination light (Yes in step S13), it performs a second light intensity determination process (step S14). Alternatively, step S13 can be omitted, and steps S12 and S14 can be performed instead.

[0168] The second light intensity determination process is used to determine whether the component measurement chip 2 is installed (inserted) into the component measurement device 1. Furthermore, through the second light intensity determination process, the control unit 50 can detect whether a normal measurement can be performed. In other words, the second light intensity determination process also serves as a process for detecting whether a normal measurement can be performed.

[0169] Here, the determination process of the second light intensity performed by the control unit 50 in step S14 will be explained in detail. Figure 14 This is a flowchart illustrating an example of the process for determining the second light intensity.

[0170] In the second light intensity determination process, the control unit 50 performs two types of determination processes. One is a determination process based on the absolute output value output from the light-receiving unit 72, and the other is a determination process based on the relative output value output from the light-receiving unit 72. Figure 14 Steps S51 to S57 of the process execute decision processing based on absolute output values, through Figure 14 Steps S58 to S61 of the process perform a decision-making process based on the relative output value.

[0171] As a decision-making process based on absolute output value, the control unit 50 first obtains the absolute output value corresponding to the light intensity from the light receiving unit 72 (step S51).

[0172] Next, the control unit 50 determines whether the acquired absolute output value is within a specified range. Specifically, the control unit 50 determines whether the acquired absolute output value is within, for example, a third specified range of absolute output values ​​preset in the order of absolute output values ​​(step S52). The third specified range is the range within which the absolute output value of the light intensity in the light-receiving section 72 output from the AD converter is considered to be within a normal range when the component measurement chip 2 is installed in the mounting space S. That is, the range of light intensity of the light-receiving section 72 when the measurement point of the component measurement chip 2 is located within the optical path and the light-emitting section 66 is not lit is equivalent to the third specified range. Therefore, the upper limit of the third specified range is lower than the upper limit of the first specified range. In step S52, after the component measurement chip 2 is inserted into the component measurement device 1, the control unit 50 can confirm whether there is excessive light intrusion from the outside, in addition to the presence or absence of abnormalities in the light-receiving section 72 and the circuit connected to the light-receiving section 72. That is, by using the third specified range as a reference, the control unit 50 can detect abnormalities in the amount of light brought from the outside of the component measurement device 1, in addition to the abnormalities detected based on the first specified range. The third specified range can be appropriately defined according to the specifications of the component measuring device 1 and the component measuring chip 2. For example, in the case of using a 12-bit AD converter as in this embodiment, the third specified range can be 51 or more and 200 or less. However, the third specified range is not limited to the example shown here, and can be appropriately defined.

[0173] If the control unit 50 determines that the acquired absolute output value is not included in the third specified range (No in step S52), it determines whether the acquired absolute output value is lower than the lower limit of the third specified range (step S53). For example, if the third specified range is 51 or more and 200 or less, the control unit 50 determines in step S53 whether the acquired absolute output value is 50 or less.

[0174] If the control unit 50 determines that the acquired absolute output value is lower than the lower limit of the third specified range (as in step S53), it determines that a circuit malfunction, such as an abnormal reference voltage caused by an abnormality in the circuit connected to the light-receiving unit 72, has occurred (step S54). In this example, the case where the absolute output value is lower than the lower limit of the third specified range means that the absolute output value is above 0 and below 50. In this case, the light intensity received by the light-receiving unit 72 output from the AD converter is lower than the first specified range, which is considered to be within the normal range, so it is considered that the possibility of leakage current or the like affecting the measurement is higher. Therefore, the control unit 50 determines that a circuit malfunction has occurred.

[0175] If the control unit 50 determines that the acquired absolute output value is lower than the lower limit of the third specified range (No in step S53), it determines whether the acquired absolute output value is included within the fourth specified range of absolute output values ​​(step S55). The fourth specified range is the range within which the light received by the light receiving unit 72 is considered to contain abnormal light from the outside, etc. In step S55, after the component measurement chip 2 is inserted into the component measurement device 1, the control unit 50 can not only confirm whether there is abnormal light from the light emitting unit 66, but also determine whether there is any influence from interfering light. Interfering light refers to the light that reaches the light receiving unit 72 from outside the component measurement device assembly 100 during the measurement of the substance being measured. For example, due to damage to the front opening 10s of the chip mounting unit 10b or damage to the component measurement chip 2, light from the outside generated by the lighting lamp or the like in the measurement environment enters the chip mounting space S in excess of a specified amount, so that the light receiving unit 72 cannot accurately detect the light corresponding to the amount of the substance being measured. In step S55, it is possible to detect whether there is any interference light that may affect the determination of the substance being measured.

[0176] The fourth specified range can be appropriately defined according to the specifications of the component measuring device 1 and the component measuring chip 2. The lower limit of the fourth specified range is a value larger than the upper limit of the third specified range, and a value continuously connected to the upper limit of the third specified range is set. For example, as in this embodiment, when the third specified range is 51 or more and 200 or less, the fourth specified range can be 201 or more and 3900 or less. However, the fourth specified range is not limited to the example shown here, and can be appropriately defined.

[0177] If the control unit 50 determines that the acquired absolute output value is within the fourth specified range of the absolute output value (Yes in step S55), it determines that interference light of a specified amount or more has reached the light receiving unit 72, and determines that an interference light anomaly has occurred (step S56). In this example, the control unit 50 determines that an interference light anomaly has occurred when the acquired absolute output value is above 201 and below 3900.

[0178] On the other hand, if the control unit 50 determines that the acquired absolute output value is not included in the fourth specified range of absolute output values ​​(No in step S55), it determines that there is an abnormality in light-receiving sensitivity caused by an abnormality in the light-receiving unit or other abnormalities in the circuit connected to the light-receiving unit 72 (step S57). In step S54, if the absolute output value is not included in the fourth specified range, the absolute output value is higher than the upper limit of the fourth specified range. That is, in this example, if the absolute output value is not included in the fourth specified range, it is when the absolute output value is above 3901 and below 4095. In this case, the light intensity in the light-receiving unit 72 output from the AD converter is higher than the fourth specified range, which is considered to be within the normal range. Therefore, it is considered that there is a higher possibility of structural damage to the light-receiving unit or current cut-off (a state where no current flows) that affects the measurement. Therefore, the control unit 50 determines that there is an abnormality in light-receiving sensitivity.

[0179] If the control unit 50 determines in step S54 that a circuit malfunction is occurring, or in step S56 that an interference light malfunction is occurring, or in step S57 that a light-receiving sensitivity malfunction is occurring, then... Figure 10 In step S14, it is determined that the light intensity is not within the normal range (No in step S14). In this case, the control unit 50 reports an error by outputting a buzzer tone from the buzzer unit 59, for example (step S23). The error reporting method can be the same as the example above. By reporting errors in this way when there is a possibility of an abnormality, the control unit 50 can detect whether a normal measurement can be performed.

[0180] In step S52, if the control unit 50 determines that the acquired absolute output value is within the third specified range (as determined in step S52), it determines that no abnormality was found in the determination process based on the absolute output value, i.e., it is normal, and begins the determination process based on the relative output value. Specifically, the control unit 50 moves to the processing in step S58.

[0181] In the determination process based on the relative output value, the control unit 50 determines whether the component measurement chip 2 is properly inserted into the component measurement device 1. That is, the control unit 50 determines whether the component measurement chip 2 is inserted into the component measurement device 1 in a manner that allows the measurement to be started normally. First, the control unit 50 obtains the relative output value corresponding to the light intensity from the light receiving unit 72 (step S58).

[0182] Next, the control unit 50 calculates the determination value (step S59). The determination value is the value used in the determination in steps S60 and S61, and is the value obtained by dividing the relative output value after the insertion of the component measuring chip 2 by the relative output value before the insertion of the component measuring chip 2. That is, the determination value is the value obtained by dividing the relative output value obtained in step S58 by the relative output value (blank value) obtained in step S36. For example, the relative output value before the insertion of the component measuring chip 2 can also be automatically adjusted during the manufacturing process of the component measuring device 1. Under normal conditions where there is no dirt (foreign matter) in the optical path, the value becomes close to the adjusted relative output value. For example, if the target value is set to 2000 when adjusting the relative output value, and the relative output value obtained in step S36 is also 2000, if the relative output value obtained in step S58 is set to Vr, then in step S59, the determination value V is calculated by V = Vr / 2000.

[0183] The control unit 50 determines whether the determination value V calculated in step S59 is included within the fifth specified range (step S60). The fifth specified range is the range within which the component measurement chip 2 is considered to be properly inserted into the component measurement device 1. That is, since the determination value V is within the fifth specified range, the control unit 50 can recognize that the component measurement chip 2 is installed in the component measurement device 1 and the measurement point is arranged in the optical path. The fifth specified range can be appropriately defined according to the specifications of the component measurement device 1 and the appropriate component measurement chip 2. In this embodiment, the fifth specified range is greater than 0.05 and less than 0.3. That is, the fifth specified range corresponds to the case where the relative output value (light received) after the component measurement chip 2 is inserted into the component measurement device 1 is more than 5% but less than 30% compared to the relative output value (light received) before the component measurement chip 2 is inserted into the component measurement device 1. The fifth specified range reflects the intensity of light transmitted through the measuring reagent 22 in the component measurement chip 2 before the sample is introduced.

[0184] If the control unit 50 determines that the determination value V is within the fifth specified range, in other words, if it determines that 0.05 < V ≤ 0.3 (as in step S60), it determines that the component determination chip 2 is properly inserted into the component determination device 1. In this specification, this determination result will be referred to simply as "chip normal recognition." In this case, the control unit 50... Figure 10 In step S14, it is determined that the light intensity is within the normal range (step S14 is yes). Then, move to Figure 10 Step S15 of the process.

[0185] If the control unit 50 determines that the determination value V is not included in the fifth specified range, in other words, if it determines that V ≤ 0.05 or 0.3 < V (No in step S60), it determines whether the determination value V is included in the sixth specified range (step S61). The sixth specified range is the range within which the component measuring chip 2 is considered to be improperly inserted into the component measuring device 1. The sixth specified range can be appropriately defined according to the specifications of the component measuring device 1 and the appropriate component measuring chip 2. In this embodiment, the sixth specified range is greater than 0.01 and less than 0.05. That is, the sixth specified range corresponds to the case where the relative output value (light received) after the component measuring chip 2 is inserted into the component measuring device 1 is greater than 1% and less than 5% compared to the relative output value (light received) before the component measuring chip 2 is inserted into the component measuring device 1. Furthermore, the sixth specified range in this specification refers to the range described as the "fourth specified range" in the claims.

[0186] If the control unit 50 determines that the determination value V is within the sixth specified range, in other words, if it determines that 0.01 < V ≤ 0.05 (as in step S61), it determines that the component measurement chip 2 is improperly inserted into the component measurement device 1. In this case, when the determination value V is within the sixth specified range, the control unit 50 can identify that at least a portion of the optical path is blocked by the component measurement chip 2, the measurement point is not correctly located within the optical path, or the used component measurement chip 2 is incorrectly installed. In this specification, this determination result will be referred to simply as "chip recognition failure". In this case, the control unit 50... Figure 10 In step S14, it is determined that the light intensity is not within the normal range (No in step S14). In this case, the control unit 50 reports an error, for example, by outputting a buzzer tone from the buzzer unit 59 (step S23). The error reporting method can be the same as the example described above. By reporting errors in this way, such as in cases where there is a possibility that the component measurement chip 2 is inserted in an improper manner, the control unit 50 can detect whether a normal measurement can be performed.

[0187] If the control unit 50 determines that the determination value V is not included in the sixth specified range (No in step S61), it moves to step S60. Alternatively, by moving from step S61 to step S60, the control unit 50 can identify that the component measurement chip 2 is not sufficiently inserted into the chip insertion space S. In this case, the control unit 50 repeats steps S60 and S61 until it determines that the determination value V is included in the fifth specified range, or determines that the determination value V is included in the sixth specified range.

[0188] Furthermore, in this embodiment, if the determination value V is neither within the fifth nor the sixth specified range—in other words, if V ≤ 0.01 or 0.3 < V—the control unit 50 may not perform a judgment related to whether the chip is correctly identified or not. This is because in this case, there is a possibility that the component measuring device 1 has not yet inserted the component measuring chip 2, which is not a suitable state for performing a judgment related to whether the chip is correctly identified or not. For example, if the component measuring chip 2 is not located at the measurement site formed by the light-shielding member, the illumination light from the light-emitting unit 66 may be blocked by the component measuring chip 2 during insertion into the component measuring device 1. In this case, the illumination light is blocked and cannot be received by the light-receiving unit 72. Therefore, there is a possibility that the relative output value becomes close to 0, and the determination value V becomes 0.01 or less. However, in this case, the stage of inserting the component measuring chip 2 is not a suitable state for performing a judgment related to whether the chip is correctly identified or not. Therefore, in this case, no judgment is performed, and the judgment is performed when the determination value V is within the fifth or sixth specified range.

[0189] In this way, the control unit 50 of this embodiment determines whether the component measuring chip 2 is installed (inserted) into the component measuring device 1. The control unit 50 can further detect whether normal measurement can be performed. If the control unit 50 determines that there is a possibility of an abnormality, it can notify the operator of the possibility of an abnormality by reporting its main points. In addition, the control unit 50 can also notify the operator of the type of error by outputting an error corresponding to the type of abnormality determined. Furthermore, if the control unit 50 determines that the chip recognition is faulty, it can also urge the operator to correctly install the component measuring chip 2 by reporting to the operator. Thus, according to the component measuring device, component measuring device group, and information processing method of this embodiment, even without adding mechanical components for detecting abnormalities to the component measuring device 1 and component measuring chip 2, abnormalities of the component measuring device or component measuring device group can be determined by the light-emitting part 66 and the light-receiving part 72 for quantifying the measured component.

[0190] Furthermore, although in reference Figure 14 In the illustrated example, the control unit 50 performs both absolute output value-based and relative output value-based decision processing. However, the control unit 50 may not necessarily perform both absolute output value-based and relative output value-based decision processing. For example, the control unit 50 can determine whether the component measurement chip 2 is installed (inserted) into the component measurement device 1 and detect at least some abnormalities by performing relative output value-based decision processing.

[0191] In the second determination of light intensity, the third to sixth specified ranges can be specified for each of the first to fifth light sources 67 or 68d, or they can be the same for all of the first to fifth light sources 67 or 68d. For example, there are cases where the absorption and reflection properties of the measuring reagent 22 differ depending on the wavelengths λ1 to λ5 of the irradiated light emitted from the first to fifth light sources 67 or 68d. Therefore, for example, by applying different third to sixth specified ranges based on the absorptivity of the measuring reagent 22, a more accurate determination can be made based on the properties of the irradiated light.

[0192] Furthermore, in the second light intensity determination process, the control unit 50 can also determine that the condition is met (i.e., during a specified period, if the output value from the AD converter is within a specified range (the third specified range to the sixth specified range)). Figure 14 (This applies to each branch of the process). For example, the specified period can be defined by a specified time. In this case, the specified period is, for example, three seconds. For example, the specified period can also be defined by the number of times the first light source 67 to the fifth light source 68d emits light. In this case, the specified period is, for example, three groups where the output of the sixteen-emission process group stops and the output of the irradiated light stops (in other words, three consecutive groups). In this way, in the second light intensity determination process, by setting a specified period for determination, it is easy to prevent the incorrect determination that the component determination chip 2 is installed in the component determination device 1 when the output value from the AD converter is temporarily within the specified range due to some important factor that is not the insertion of the component determination chip 2.

[0193] Furthermore, the control unit 50 can, within a predetermined period after step S13 when the state of no illumination light is received, change the interval between the output of the group that performs the sixteen-times emission processing and the group where the illumination light output stops when the light-receiving unit 72 detects illumination for the first time, if the state of no illumination light is received after step S13. In particular, the control unit 50 can shorten the interval between the output of the group that performs the sixteen-times emission processing and the group where the illumination light output stops. For example, as described above, if in step S11 the output of the group that performs the sixteen-times emission processing and the group where the illumination light output stops occur every second, the control unit 50 can shorten the interval of performing that group to 0.5 seconds. As a result, by shortening the interval between the output of the group that performs the sixteen-times emission processing and the group where the illumination light output stops, the result of the second illumination intensity determination process can be determined more easily and earlier.

[0194] Figure 15 This diagram schematically illustrates the light intensity received by the light-receiving section 72 from the first light source 67 to the fifth light source 68d. It primarily represents a schematic representation. Figure 10The diagram showing the light intensity of the light-receiving part 72 in steps S13 to S16, or steps S14 to S16. Figure 15 In the diagram, the horizontal axis represents time, and the vertical axis represents light intensity. Figure 15 For example, shown in Figure 10 The light intensity of the light-receiving part 72 after step S12 is determined to be "yes".

[0195] For example, if the operator begins to insert the component measuring chip 2 into the chip mounting space S of the component measuring device 1, the illumination light emitted from the first light source 67 to the fifth light source 68d is blocked by the components constituting the component measuring chip 2. In this case, if... Figure 15 As shown at times t1 to t2, the light-receiving part 72 is in a state where it does not receive illumination light.

[0196] If the component measuring chip 2 is installed in the component measuring device 1 at time t2, the light receiving part 72 receives the light transmitted through the measuring reagent 22 from the illumination light emitted from the first light source 67 to the fifth light source 68d. Figure 15 (Time t3). Figure 15 As shown in the schematic diagram, the light intensity in the light-receiving section 72 is lower than before the component analysis chip 2 was installed. Furthermore, the degree of change in light intensity before and after the installation of the component analysis chip 2 varies depending on the first light source 67 to the fifth light source 68d.

[0197] If the control unit 50 receives light transmitted through the measuring reagent 22 at time t3, it shortens the interval between the output of the group that performs the sixteen-time emission process and the group where the output of the irradiated light stops from 1 second to 0.5 seconds. Then, after determining, through the process of performing the second light intensity determination, that the component measuring chip is installed (inserted) into the component measuring device 1 and normal measurement can be performed, the control unit 50 moves to... Figure 10 Step S15.

[0198] Refer again Figure 10 When the control unit 50 determines that the light intensity in the light-receiving unit 72 is within a specified range (in step S14), it adjusts the amount of light emitted from the light-emitting unit 66. With the component measurement chip 2 installed, the control unit 50 adjusts the amount of light emitted from the light-emitting unit 66 by adjusting the current supplied to the first light source 67 to the fifth light source 68d (in step S15). The control unit 50 adjusts the amount of light emitted to a specified intensity for measuring the component being measured. The specified intensity for measuring the component being measured can be appropriately specified according to the specifications of the light-receiving unit 72, etc., and preferably an intensity that ensures the measurement resolution required for measuring the component being measured.

[0199] Specifically, the control unit 50 adjusts to increase the current supplied to the first light source 67 to the fifth light source 68d. By increasing the current supplied to the first light source 67 to the fifth light source 68d, the amount of light emitted from the first light source 67 to the fifth light source 68d increases. More specifically, the control unit 50 adjusts the current supplied to the first light source 67 to the fifth light source 68d to increase the light intensity received by the light receiving unit 72 from the first light source 67 to the fifth light source 68d. In particular, it is preferable that the control unit 50 adjusts the current supplied to the first light source 67 to the fifth light source 68d so that the light intensity received by the light receiving unit 72 from the first light source 67 to the fifth light source 68d is suitable for performing reference operations. Figure 9 The intensity of the component determination treatment was described.

[0200] The control unit 50 can adjust the current supplied to the first light source 67 to the fifth light source 68d individually. The control unit 50 can adjust the current supplied to the first light source 67 to the fifth light source 68d so that the light intensity received by the light from each of the first light source 67 to the fifth light source 68d in the light-receiving unit 72 is uniform. This uniformity includes not only a predetermined light intensity but also the width of the range from that predetermined light intensity that converges to a predetermined range. For example, the control unit 50 adjusts the current supplied to the first light source 67 to the fifth light source 68d so that the output value of the light intensity from the AD converter in the light-receiving unit 72 is approximately constant. In this case, for example, the range of 3300 ± 50 for the output value of the 12-bit AD converter of the light intensity is considered uniform. By adjusting the current in this way, the measurement resolution in the light-receiving unit 72 is improved, making it easier to perform more accurate component measurements. For example, even if the amount of light from the first light source 67 to the fifth light source 68d changes with ambient temperature, such current adjustment can suppress the effects of these changes. Although a 12-bit AD converter is used in this embodiment, it can also be set to produce the same output value depending on the resolution.

[0201] Furthermore, in step S15, the control unit 50 can also determine the amount of current supplied to the first light source 67 to the fifth light source 68d based on the temperature measured by the temperature measuring unit 53. This makes it easier to suppress fluctuations in the amount of irradiated light caused by temperature.

[0202] Furthermore, in step S15, if the control unit 50 adjusts the current supplied to the first light source 67 to the fifth light source 68d so that the output value of the light intensity from the AD converter in the light receiving unit 72 becomes a predetermined value (e.g., 3300), and the supplied current exceeds a predetermined current threshold (e.g., 15mA) before the output value of the light intensity from the AD converter in the light receiving unit 72 reaches the predetermined value, the control unit 50 determines that an abnormality has occurred in the component measuring device 1 and reports this using a buzzer sound.

[0203] Reference Figure 15 As schematically shown after time t4, in step S15, the current supplied to the first light source 67 to the fifth light source 68d is amplified, and the light intensity received by the light-receiving section 72 increases. That is, by correctly installing the measuring chip 2, the amount of light from the light source is increased, and the power consumption can be reduced.

[0204] Refer again Figure 10 After adjusting the current supplied to the first light source 67 to the fifth light source 68d in step S15, the control unit 50 acquires the reference light intensity (step S16). The reference light intensity is the output value of the light intensity in the light receiving unit 72 from the AD converter at a specific moment after step S15 is executed. It is preferable to acquire the reference light intensity immediately after step S15 is executed. The reference light intensity is used in the third light intensity determination process in step S19, which will be described later.

[0205] Then, the control unit 50 causes the first light source 67 to the fifth light source 68d to emit light continuously (step S17). Specifically, the control unit 50 continuously executes... Figure 11 The group of emission processes is shown. In this way, pulsed light is emitted from the first light source 67 to the fifth light source 68d every 1 msec, for example. The control unit 50 continues to output such pulsed light until, in step S19 described later, it is determined that the sample has come into contact with the measuring reagent 22.

[0206] Figure 16 This diagram schematically illustrates the light intensity received by the light-receiving section 72 from the first light source 67 to the fifth light source 68d, primarily showing the execution of... Figure 10 A diagram showing the light intensity of the light-receiving part 72 after step S17. (See diagram below.) Figure 16 As shown, pulsed light is continuously emitted from the first light source 67 to the fifth light source 68d, and the light-receiving unit 72 receives the pulsed light. In this way, by making the first light source 67 to the fifth light source 68d emit light continuously, the time resolution of the determination performed in the confirmation of the third light intensity in step S19 described later can be improved.

[0207] In step S17, while the first light source 67 to the fifth light source 68d are continuously emitting light, the control unit 50 calculates the moving average of the light intensity received by the light-receiving unit 72 (step S18). The control unit 50 can calculate the moving average of the light intensity of an appropriate number of pulses, for example, it can calculate the moving average of the light intensity of pulses from five light sources. Preferably, the control unit 50 calculates the moving average of the light intensity of the pulses for each light source. In this embodiment, at least the moving average of the light intensity of the pulses with a fourth predetermined wavelength λ4 (520 nm) used in the following step S19 is calculated. The control unit 50 may also calculate the moving average of the light intensity of the pulses with a third predetermined wavelength λ3 (940 nm) in addition to the fourth predetermined wavelength λ4. In this case, blood with a wide range of hematocrit values ​​can be measured.

[0208] Then, the control unit 50 performs a third light intensity determination process (step S19). The third light intensity determination process is used to determine two matters. The first matter is whether there is a possibility of an error in the selection of the processing mode, and the second matter is whether to start the component measurement.

[0209] Specifically, in this embodiment, the control unit 50 uses the reference light intensity obtained in step S16, the moving average of the light intensity of the pulsed light with a third predetermined wavelength λ3 calculated in step S18, and the moving average of the light intensity of the pulsed light with a fourth predetermined wavelength λ4 to determine whether the sample has reached the testing reagent 22. In this embodiment, in step S19, the control unit 50 determines that the sample has reached the testing reagent 22 when the moving average of the light intensity of the pulsed light with a third predetermined wavelength λ3 received by the light-receiving unit 72 is higher than a first determination threshold relative to the reference light intensity. The first determination threshold can be appropriately defined. For example, the first determination threshold can be 101.3% of the reference light intensity. Furthermore, in this embodiment, in step S19, the control unit 50 determines that the sample has reached the testing reagent 22 when the moving average of the light intensity of the pulsed light with a fourth predetermined wavelength λ4 received by the light-receiving unit 72 is lower than a second determination threshold relative to the reference light intensity. The second determination threshold can be appropriately defined. For example, the second determination threshold can be 98.5% of the reference light intensity.

[0210] Here, in this embodiment, the reason for using two different wavelengths of irradiation light, namely a third predetermined wavelength λ3 and a fourth predetermined wavelength λ4, in the third determination of light intensity will be explained. The sample used in the component determination apparatus 1 of this embodiment can be either whole blood or plasma. However, the absorbance and other properties of the sample differ depending on whether it is whole blood or plasma. However, by using two different wavelengths of irradiation light, namely a third predetermined wavelength λ3 and a fourth predetermined wavelength λ4, as in the component determination apparatus 1 of this embodiment, it is possible to detect that the sample reaches the determination reagent 22 regardless of whether whole blood or plasma is used as the sample.

[0211] For example, when the sample is whole blood, the sample contains red blood cells. When whole blood containing red blood cells is irradiated with light of a third predetermined wavelength λ3 (940 nm), the refractive index of whole blood is greater than that of air. Therefore, the difference in refractive index between whole blood and the component of the component measurement chip 2 containing the assay reagent 22 decreases, the transmitted light through the assay reagent 22 increases, and the light intensity in the light-receiving section 72 increases. On the other hand, the irradiated light is scattered by the red blood cells, so the light intensity in the light-receiving section 72 decreases. Therefore, the increase in light intensity due to the refractive index and the decrease in light intensity due to scattering caused by the red blood cells offset the increase and decrease in light intensity. Therefore, when the sample is whole blood, the irradiated light of the third predetermined wavelength λ3 (940 nm) cannot detect the sample reaching the assay reagent 22.

[0212] In contrast, when whole blood is irradiated with light of the fourth specified wavelength λ4 (520 nm), similar to the case when irradiated with light of the third specified wavelength λ3, an increase in light intensity due to refractive index and a decrease in light intensity due to scattering caused by red blood cells occur. However, when irradiated with light of the fourth specified wavelength λ4, hemoglobin readily absorbs light of the fourth specified wavelength λ4, resulting in greater absorption of the irradiated light by hemoglobin and a decrease in light intensity in the light-receiving section 72. Furthermore, since the glucose contained in whole blood reacts with the assay reagent 22 to produce color, more light in the band of the fourth specified wavelength λ4 is absorbed, further reducing the light intensity in the light-receiving section 72. Therefore, when whole blood is irradiated with light of the fourth specified wavelength λ4 (520 nm), if the sample reaches the assay reagent 22, the light intensity received in the light-receiving section 72 is reduced due to the absorption effect of the irradiated light of the fourth specified wavelength λ4. Therefore, when the sample is whole blood, it is possible to detect the sample reaching the assay reagent 22 by using the fourth specified wavelength λ4.

[0213] On the other hand, when the sample is plasma, it does not contain red blood cells or hemoglobin. When plasma without red blood cells or hemoglobin is irradiated with light of the fourth predetermined wavelength λ4 (520 nm), the refractive index of plasma is greater than that of air, so the refractive index difference between plasma and the component of the component measurement chip 2 containing the assay reagent 22 decreases. This increases the amount of light transmitted through the assay reagent 22, and thus increases the light intensity in the light-receiving section 72. However, because the glucose contained in the plasma reacts with the assay reagent 22 to produce color, light in the fourth predetermined wavelength λ4 band is absorbed, and the light intensity in the light-receiving section 72 decreases. Therefore, the increase in light intensity due to refractive index and the decrease in light intensity due to color development offset each other. Therefore, when the sample is plasma, the irradiation light passing through the fourth predetermined wavelength λ4 (520 nm) cannot detect the contact between the sample and the assay reagent 22.

[0214] In contrast, when plasma is irradiated with light of the third specified wavelength λ3 (940 nm), the light intensity increases due to the refractive index, similar to the case when irradiated with light of the fourth specified wavelength λ4. On the other hand, even if the glucose contained in the plasma reacts with the assay reagent 22 to produce a color, light in the band of the third specified wavelength λ3 is not easily absorbed. Therefore, when plasma is irradiated with light of the third specified wavelength λ3 (940 nm), the effect of increased light intensity due to the refractive index is significant, resulting in increased light intensity received by the light-receiving section 72. Therefore, when the sample is plasma, the sample can be detected by passing through the third specified wavelength λ3 to reach the assay reagent 22.

[0215] Based on the above principles, when the sample is plasma, the control unit 50 can determine whether the sample has reached the testing reagent 22 by comparing the third predetermined wavelength λ3 with the reference light intensity to see if it increases. When the sample is whole blood, it can determine whether the sample has reached the testing reagent 22 by comparing the fourth predetermined wavelength λ4 with the reference light intensity to see if it decreases. Thus, according to this embodiment, regardless of whether the sample is whole blood or plasma, it is possible to detect whether the sample has reached the testing reagent 22. Furthermore, according to this embodiment, even if it is unclear whether the sample is whole blood or plasma, it is possible to detect whether the sample has reached the testing reagent 22.

[0216] Furthermore, the component measuring device 1 of this embodiment can perform processing in either a first mode for measuring the component to be measured or a second mode for confirming the performance of the component measuring device 1. When the component measuring device is used in the first mode, the operator uses whole blood or plasma as the sample. When the component measuring device is used in the second mode, the operator uses a solution (control solution) specifically for the second mode as the sample.

[0217] The control solution is an aqueous solution of the substance being measured, specifically a glucose solution. The glucose concentration of the control solution can be appropriately selected, for example, from 30 to 300 mg / dL. Viscosity modifiers, buffers, surfactants, and pigments that mimic the color of blood may also be added to the control solution. In this embodiment, the control solution is prepared to be colorless and transparent, taking into account the change of the pigment component over time. Thus, the control solution is colorless and transparent, and when used as a sample, it exhibits the same properties as the plasma described above. That is, when the control solution is used, it is impossible to detect contact between the solution and the assay reagent 22 using illumination light of a fourth predetermined wavelength λ4. On the other hand, it is possible to detect the solution reaching the assay reagent 22 using illumination light of a third predetermined wavelength λ3.

[0218] Utilizing this property, the control unit 50 can distinguish whole blood and control fluid (or plasma) as samples, thus determining the first matter (whether the processing mode selection is correct) and the second matter (whether to start component measurement). That is, in the component measurement apparatus 1, the component measurement apparatus group 100, and the information processing device of the present invention, the sample can be distinguished by using the shortest wavelength light and the longest wavelength light among the multiple wavelengths used for detecting the measured component.

[0219] Here, the determination process for the third light intensity performed by the control unit 50 in step S19 will be explained in detail. Figure 17 This is a flowchart illustrating an example of the process for determining the third light intensity. Furthermore, as described above, in this embodiment, it is assumed that at the beginning... Figure 10 During the process, the operator selects the first mode for measuring the component to be measured as the processing mode. Alternatively, the first mode can be set as the initial setting for the control unit 50.

[0220] The control unit 50 determines, through steps S71 and S72, whether there is a possibility that the processing mode selected by the operator is incorrect. Specifically, firstly, the control unit 50 determines that... Figure 10 Whether the moving average calculated in step S18 reaches the first judgment threshold (step S71).

[0221] If the control unit 50 determines that the moving average of the light intensity received by the irradiation light of the third predetermined wavelength λ3 has not reached the first determination threshold (No in step S71), it determines that... Figure 10 Whether the moving average calculated in step S18 reaches the second judgment threshold (step S72).

[0222] If the control unit 50 determines that the moving average of the light intensity received by the irradiation light of the fourth predetermined wavelength λ4 has not reached the second determination threshold (No in step S72), then... Figure 10In step S19, it is determined that the difference between the light intensity received by the light-receiving unit 72 and the reference light intensity does not exceed a predetermined value (No in step S19). In this case, the control unit 50 moves to step S18 and calculates the moving average again.

[0223] In step S71, if the control unit 50 determines that the moving average of the light intensity received by the irradiation light of the third predetermined wavelength λ3 has reached the first determination threshold (Yes in step S71), it outputs a confirmation output to the operator of the component measuring device 1 to confirm whether the selection of the processing mode is correct (step S73). The confirmation output can be performed in various ways. For example, the confirmation output can be performed by displaying it on the display unit 11.

[0224] Here, in this embodiment, as described above, the operator selects the first mode for measuring the analyte as the processing mode. Alternatively, the first mode is selected as the initial setting. That is, the possibility of using whole blood as the sample is considered. However, if the moving average of the intensity of the irradiation light at the third predetermined wavelength λ3 reaches the first judgment threshold, there is a possibility that control solution or plasma may be used as the sample instead of whole blood. Therefore, in step S73, by outputting a confirmation of whether the selected processing mode is correct, the operator can be prompted to confirm whether processing in the first mode can continue. Thus, by distinguishing between whole blood, which is measured most frequently, and samples other than whole blood, the number of times the operator inputs processing related to the processing mode can be reduced. In addition, if it is determined that the set processing mode is incorrect, the measurement processing can be performed using the other correct processing mode.

[0225] After confirming the output of step S73 (e.g., displayed on display unit 11), the operator again inputs which processing mode the component determination device should use: the first mode or the second mode. The control unit 50 receives the operator's input related to the processing mode (step S74).

[0226] When the control unit 50 receives an input indicating that processing should be performed in the first mode (first mode in step S74), it decides to execute the first mode processing. In this case, in step S71, it is determined that the moving average of the intensity of the irradiation light at the third predetermined wavelength λ3 has reached the first determination threshold, so according to the above principle, it can be said that the sample has reached the measuring reagent 22 (reaction begins). Therefore, in this case, the control unit 50... Figure 10 In step S19, it is determined that the difference between the light intensity received by the light receiving unit 72 and the reference light intensity exceeds a predetermined value (in step S19), and the process moves to step S20 to begin the processing of steps S20 to S22 as the first mode.

[0227] For example, when plasma is used as the sample instead of whole blood, the moving average of the intensity of the irradiated light at the third specified wavelength λ3 reaches the first judgment threshold. Therefore, even if the operator's input of the first mode selection is correct, a confirmation of whether the processing mode selection is correct is output in step S73. In this case, the operator can execute the processing of the first mode by inputting the selection of the first mode.

[0228] On the other hand, when the control unit 50 receives an input indicating that the component measuring device should be processed in the second mode (second mode in step S74), it executes the second mode processing (step S75). The second mode processing is for confirming the performance of the component measuring device 1. As part of the second mode processing, for example, a measurement process corresponding to the measurement of the control liquid is performed, the measurement result is calculated, and the process of displaying the measurement of the control liquid on the display unit 11 is performed.

[0229] Although an example is shown where the operator confirms the correctness of the processing mode selection in step S73, the input from the operator is accepted in step S74, but this is not a limited example. For example, even if the determination is yes in step S71, the processing is performed as the first mode (moving to step S20) until the acquisition of the measured value is completed (step S22), after which the selection of the processing mode is accepted. More specifically, if the operator does not perform the input of the processing mode in steps S73 and S74 for a certain period of time, or if the component determination chip 2 is continuously installed on the component determination device 1 for more than a predetermined time (e.g., 10 seconds), the acceptance of the input mode in step S74 can be regarded as the selection of the first mode. Thus, it is possible to suppress the inaccurate measured value due to excessive development of the reagent color reaction in the component determination chip 2 during the acceptance of the processing mode in step S74.

[0230] Alternatively, if a predetermined time has elapsed since the confirmation of the correctness of the selected processing mode in step S73, step S74 can be skipped, and the processing of the first mode can continue. More specifically, if the operator does not perform the input of the processing mode in step S74 for a certain period of time, or if the component measuring chip 2 is continuously installed on the component measuring device 1 for more than a predetermined time (e.g., 10 seconds), it can be considered that the processing of the first mode has been selected in the acceptance of the input mode in step S74. In addition, the appropriate calculation processing can be automatically changed according to the switching between these first and second modes.

[0231] In step S72, if the control unit 50 determines that the moving average of the light intensity received by the irradiation light of the fourth predetermined wavelength λ4 reaches the second determination threshold (yes in step S72), then... Figure 10In step S19, if it is determined that the difference between the light intensity received by the light-receiving unit 72 and the reference light intensity exceeds a predetermined value (Yes in step S19), the process moves to step S20, and the processing of steps S20 to S22 as the first mode begins. In step S72, if it is determined that the moving average of the light intensity of the irradiation light with the fourth predetermined wavelength λ4 reaches the second determination threshold (Yes in step S72), it can be said that the use of whole blood as a sample has been confirmed, and therefore it can be said that the input of performing the first mode processing is not incorrect. Therefore, in this case, the first mode processing can be performed without requiring the operator to confirm whether the processing mode selection is correct.

[0232] Furthermore, in this embodiment, the determination of the third light intensity is performed by comparing the moving average of the reference light intensity with the third specified wavelength λ3 and the moving average of the fourth specified wavelength λ4. By using moving averages in this way, it is easy to prevent erroneous determinations that the sample is in contact with the measuring reagent 22 when the light intensity temporarily increases or decreases due to some important factor that is not the contact between the sample and the measuring reagent 22.

[0233] Furthermore, in step S19, the control unit 50 may further set a threshold for determining whether the component measurement chip 2 has detached from the component measurement device 1. For example, when the component measurement chip 2 is removed from the chip mounting space S, similar to the case where the component measurement chip 2 is inserted, at least a portion of the illumination light emitted from the first light source 67 to the fifth light source 68d cannot reach the light receiving section 72 due to the components constituting the component measurement chip 2. Therefore, the control unit 50 may, for example, determine that the component measurement chip 2 has detached from the component measurement device 1 if the relative output value of the light intensity from the AD converter is less than a predetermined threshold. At this time, for example, a buzzer sound can be output from the buzzer unit 59 to report an error. In addition, when the component measurement chip 2 is completely removed from the component measurement device 1, the illumination light emitted from the first light source 67 to the fifth light source 68d directly illuminates the light receiving section 72, and the light intensity in the light receiving section 72 increases. Therefore, the control unit 50 may, for example, determine that the component measurement chip 2 has detached from the component measurement device 1 if the relative output value of the light intensity from the AD converter is greater than a predetermined threshold. At this point, for example, an error can be reported by outputting a buzzer tone from the buzzer unit 59.

[0234] When the control unit 50 determines that the difference between the light intensity received by the light-receiving unit 72 and the reference light intensity exceeds a predetermined value (in step S19), it determines an initial value for the light intensity received by the light-receiving unit 72 as part of the first mode of processing (step S20). The initial value (reference value) is the measured value of the absorbance of the irradiated light in the mixture X at a specific moment before the sample arrives at the measuring reagent 22, i.e., the output value of the light intensity in the light-receiving unit 72 from the AD converter. The control unit 50 can determine the output value of the light intensity before a predetermined time compared to the moment in step S19 when it is determined that the difference between the light intensity received by the light-receiving unit 72 and the reference light intensity exceeds a predetermined value as the initial value. The predetermined time can be appropriately set, for example, it can be 0.5 seconds. The shorter the predetermined time, the more likely it is to set the output value as the initial value under conditions (e.g., ambient environment) close to those after the sample arrives at the measuring reagent 22. For example, if the first light source 67 to the fifth light source 68d emit light continuously, the temperature of the first light source 67 to the fifth light source 68d will rise, resulting in a change in the amount of emitted light. However, by shortening the specified time, the measured value obtained in the subsequent step S21 can be made closer to the conditions for obtaining the output value. Thus, by determining the initial value after determining that the sample has reached the measuring reagent 22, the output value before the sample immediately reaches the measuring reagent 22 can be set as the initial value (reference value), and the measured value can be derived.

[0235] Furthermore, if the control unit 50 determines that the sample has reached the measuring reagent 22, it begins to acquire the measured value of the absorbance of the irradiated light in the mixture X used to measure the components being measured (step S21). The measured value and... Figure 9 The first to fifth measured values ​​correspond to each other in the process. In this way, the control unit 50 can automatically start acquiring measured values ​​when it determines that the sample contains the component to be measured has begun to react with the measuring reagent 22 to produce a colorimetric reaction. Therefore, the usefulness of the component measuring device 1 is improved.

[0236] The control unit 50, starting from the acquisition of measured values ​​in step S21, ends the acquisition of measured values ​​after a predetermined time (step S22). At this time, the control unit 50 can stop the emission of light from the first light source 67 to the fifth light source 68d. The predetermined time can be appropriately predetermined according to the properties of the measuring reagent 22, etc., for example, it can be 9 seconds. In this way, the control unit 50 ends the emission of irradiation light performed during the component determination process.

[0237] The control unit 50 can use the acquired measured values ​​to execute the component determination method described in this embodiment to determine the glucose concentration in the sample. Furthermore, although the method for determining glucose concentration when the sample is whole blood was described in the above embodiment, the same method can also be used to determine glucose concentration when the sample is plasma.

[0238] Figure 18 This diagram schematically illustrates the light intensity received by the light-receiving section 72 from the first light source 67 to the fifth light source 68d. It mainly schematically shows... Figure 10 A diagram showing the light intensity of the light-receiving part 72 in steps S18 to S21. Figure 18 In the diagram, the horizontal axis represents time, and the vertical axis represents light intensity.

[0239] During the period when the first light source 67 to the fifth light source 68d continuously emit light through step S17, the control unit 50 calculates the moving average of the light intensity received by the light-receiving unit 72 (step S18). In step S19, the control unit 50 performs a third light intensity determination process. The control unit 50 repeats steps S18 and S19 until, in the third light intensity determination process, it is determined that the difference between the light intensity received by the light-receiving unit 72 and the reference light intensity exceeds a predetermined value (until...). Figure 18 (up to time t6).

[0240] If the control unit 50 determines at time t6 that the difference between the light intensity received by the light-receiving unit 72 and the reference light intensity exceeds a predetermined value (Yes in step S19), then it determines an initial value for the light intensity received by the light-receiving unit 72 (step S20). For example, the control unit 50 determines the output value from the AD converter of the light intensity at time t5, 0.5 seconds before time t6, as the initial value. Furthermore, the control unit 50 begins acquiring the measured value from time t6 (step S21). After a predetermined time has elapsed, the control unit 50 ends the acquisition of the measured value (step S22). Alternatively, if there is a possibility of selecting a second mode (Yes in step S71), and the processing mode input in step S73 is not performed, the acquired initial value and the measured value can be stored in memory. After determining the input of the processing mode, the measured value is calculated and displayed according to the processing mode.

[0241] The component measuring apparatus, component measuring apparatus assembly, and information processing apparatus of the present invention are not limited to the specific descriptions of the above embodiments, and various modifications can be made without departing from the spirit of the invention as described in the claims. In the above embodiments, glucose concentration is measured as the component to be measured, but it is not limited to concentration; other physical quantities can also be measured. Furthermore, although glucose in plasma components is exemplified as the component to be measured in blood in the above embodiments, it is not limited to this; for example, cholesterol, sugars, ketone bodies, uric acid, hormones, nucleic acids, antibodies, antigens, etc., in blood can also be used as components to be measured. Therefore, the component measuring apparatus is not limited to a blood glucose measuring apparatus. Moreover, although the light-receiving part 72 in the above embodiments receives transmitted light transmitted through the component measuring chip 2, it can also be a light-receiving part that receives reflected light reflected from the component measuring chip 2.

[0242] In the above embodiment, the process for determining whether there is a possibility of an incorrect processing mode selection is explained as follows: the operator pre-selects a first mode as the processing mode, but the control unit 50 determines that there is a possibility that processing under the second mode is appropriate; in other words, it determines that the moving average of the light intensity received by the irradiation light of the third predetermined wavelength λ3 reaches a first determination threshold, and then confirms whether the selection of the processing mode is correct. However, the process for determining whether there is a possibility of an incorrect processing mode selection is not limited to this. For example, the operator could pre-select a second mode as the processing mode, but the control unit 50 could determine that there is a possibility that processing under the first mode is appropriate; in other words, it could determine that the moving average of the light intensity received by the irradiation light of the fourth predetermined wavelength λ4 reaches a second determination threshold, and then confirm whether the selection of the processing mode is correct. In this way, the control unit 50 can determine whether the sample is a sample used in the processing mode selected based on the input operation, based on whether the difference between the reference light intensity and the light intensity is higher than a first determination threshold higher than the reference light intensity and lower than a second determination threshold lower than the reference light intensity. If the sample is not used in the processing mode selected based on the input operation, the control unit 50 determines that there is a possibility of a processing mode selection error.

[0243] In the above embodiment, the control unit 50 outputs a confirmation of whether the selected processing mode is correct. If it receives operator input related to the processing mode, it executes the processing using the input processing mode. However, the control unit 50 may not necessarily execute the processing after receiving the input. For example, the control unit 50 may automatically select a processing mode and execute the processing after performing steps S71 and S72. In other words, the control unit 50 may automatically select another unselected processing mode and execute the processing using that other processing mode if it determines that there is a possibility of an incorrect processing mode selection.

[0244] Alternatively, regardless of whether the operator pre-selects the first or second mode, the control unit 50 may determine whether there is a possibility of an incorrect processing mode selection when the moving average of the light intensity reaches either the first or second judgment threshold. In this case, regardless of whether the operator pre-selects the first or second mode, an output confirming the correctness of the processing mode selection may be output when the moving average of the light intensity reaches either the first or second judgment threshold. Alternatively, based on the determination of the possibility of an incorrect processing mode selection by the operator, a report may be issued to the operator if an incorrect processing mode selection is deemed possible. Alternatively, if the operator pre-selects the second mode, the system may automatically switch to the first mode and perform the first mode processing (sample measurement processing) when the moving average of the light intensity exceeds the second judgment threshold.

[0245] Alternatively, in other implementations, the first mode and the second mode can be selected by operating a terminal (such as a smartphone) that works with the component measuring device 1. In particular, if the component measuring device does not have an input button, the component measuring device 1 can be set from the terminal.

[0246] This invention relates to a component measuring device, a component measuring device assembly, and an information processing device.

[0247] Explanation of reference numerals in the attached figures

[0248] 1: Component measuring device; 2: Component measuring chip; 10: Housing; 10a: Main body; 10b: Chip mounting part; 11: Display part; 12: Removal handle; 13: Power button; 14: Operation button; 21: Base part; 22: Measuring reagent; 23: Flow path; 23a: Gap; 24: Supply part; 25: Cover part; 26: Pop-out pin; 50: Control part; 51: Photometric part; 52: Storage part; 53: Temperature measuring part; 54: Power supply part; 55: Battery; 56: Communication part; 57: Clock part; 58: Operation part; 59: Buzzer part; 66: Light emitting part; 67: First light source; 68a: Second light source; 68b: Third light source; 68c: Fourth light source; 68d: Fifth light source; 69a: First aperture part; 69b: Second aperture part; 72: Light receiving part; 80: Support part; 100: Component measuring device assembly.

Claims

1. A component determination device having a chip insertion space for inserting a component determination chip containing a reagent that reacts with the component to be determined in a sample, the component determination device comprising: The light-emitting part emits illumination light onto the component measuring chip when the component measuring chip is inserted into the chip insertion space. The light-receiving section receives light transmitted or reflected by the aforementioned component measurement chip; and Control Department The control unit described above can perform processing in either a first mode, which uses the measured value of the light intensity received in the light-receiving section to determine the component to be measured in the sample, or a second mode, which confirms the performance of the component measuring device. If, at the moment when the measurement point of the component measurement chip is located in the optical path between the light-emitting part and the light-receiving part after the component measurement chip is inserted into the chip insertion space, the difference between the reference light intensity in the light-receiving part and the moving average value of the light intensity received by the light-receiving part exceeds a predetermined value, the control unit determines whether there is a possibility that the processing mode to be executed is incorrect.

2. The component determination device according to claim 1, wherein, If it is determined that there is a possibility of an error in the above-mentioned processing mode, the control unit outputs a confirmation of whether the above-mentioned processing mode to be executed is correct.

3. The component determination apparatus according to claim 1 or 2, wherein, The control unit determines whether the sample is suitable for use in the processing mode based on whether the moving average value of the light intensity is greater than a first determination threshold that is higher than the reference light intensity and whether it is less than a second determination threshold that is lower than the reference light intensity.

4. The component determination device according to claim 3, wherein, If the above-mentioned sample is determined to be a sample not used in the above-mentioned processing mode, the control unit determines that there is a possibility that the above-mentioned processing mode to be executed is incorrect.

5. The component determination device according to claim 4, wherein, If it is determined that there is a possibility that the above-mentioned processing mode to be executed is incorrect, the control unit executes the processing in a different processing mode than the above-mentioned processing mode to be executed.

6. The component determination apparatus according to claim 3, wherein, The aforementioned light-emitting part shall at least include: The first light source emits light of a first predetermined wavelength into the mixture of the sample and the reagent in order to quantify the component to be measured. A third light source emits illumination light of a third predetermined wavelength, which is used to estimate the noise level other than the predetermined colorimetric component contained in the measured absorbance of the mixture determined by the illumination light from the first light source, and the influence of light scattering from the components contained in the sample is dominant; and A fourth light source emits illumination light of a fourth predetermined wavelength, which is used for estimating the noise level mentioned above, and the proportion of absorbance of the predetermined components contained in the sample is above a predetermined value.

7. The component determination apparatus according to claim 6, wherein, If the first mode is selected as the processing mode to be executed, and the moving average of the light intensity of the irradiation light of the third specified wavelength is greater than the first determination threshold, the control unit determines that there is a possibility of an error in the selection of the processing mode.

8. The component determination apparatus according to claim 6, wherein, If the second mode is selected as the processing mode to be executed, and the moving average value of the light intensity of the irradiation light of the fourth specified wavelength λ4 is less than the second determination threshold, the control unit determines that there is a possibility of an error in the selection of the processing mode.

9. The component determination apparatus according to claim 6, wherein, The components derived from the above samples are red blood cells and the hemoglobin contained in red blood cells.

10. A component determination apparatus assembly, comprising: A component determination chip equipped with reagents that react with the analyte in the sample; and The component determination device has a chip insertion space for inserting the aforementioned component determination chip. The above-mentioned component measuring device includes: The light-emitting part emits irradiation light onto the component measuring chip when the component measuring chip is inserted into the chip insertion space. The light-receiving section receives at least the light transmitted or reflected by the aforementioned component measurement chip; and Control Department The control unit can perform processing in either a first mode, which uses the measured value of the light intensity in the light-receiving section to measure the component to be measured in the sample, or a second mode, which confirms the performance of the component measuring device. If the difference between the reference light intensity in the light-receiving section and the moving average value of the light intensity received by the light-receiving section at the moment when the measuring point of the component measuring chip is located in the optical path between the light-emitting section and the light-receiving section after the component measuring chip is inserted into the chip insertion space exceeds a predetermined value, it determines whether there is a possibility of an error in the selection of the processing mode.

11. An information processing method executed by a component measuring device, the component measuring device having a chip insertion space for inserting a component measuring chip containing a reagent that reacts with the component to be measured in a sample, the component measuring device comprising a light emitting part for emitting irradiation light onto the component measuring chip when the component measuring chip is inserted into the chip insertion space, a light receiving part for receiving light transmitted or reflected by the component measuring chip, and a control part. The control unit described above can perform processing in either a first mode, which uses the measured value of the light intensity received in the light-receiving section to determine the component to be measured in the sample, or a second mode, which confirms the performance of the component measuring device. The above information processing methods include: The steps for accepting input operations in the above processing mode; and If the difference between the reference light intensity in the light-receiving part and the moving average value of the light intensity received by the light-receiving part at the moment when the measurement point of the component measurement chip is located in the optical path between the light-emitting part and the light-receiving part after the component measurement chip is inserted into the chip insertion space exceeds a predetermined value, a step is taken to determine whether there is a possibility of a processing mode selection error.

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