Analysis device

WO2026160207A1PCT designated stage Publication Date: 2026-07-30FUJIFILM CORP
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Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
FUJIFILM CORP
Filing Date
2026-01-13
Publication Date
2026-07-30

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Abstract

Provided is an analysis device in which an analysis chip including a reaction region holding a reagent is detachably loaded and which analyzes a test sample spotted on the reaction region of the analysis chip, said analysis device comprising a light measurement unit that optically detects color development caused by a reaction between the reagent and a detection target substance in the test sample and that includes a light-emitting element, an area sensor which captures an image of a predetermined imaging range including the reaction region irradiated with light from the light-emitting element, and a transparent member which is disposed between the loaded analysis chip and the area sensor. The transparent member includes a transmission region through which the light traveling from the light-emitting element toward the analysis chip is transmitted and a colored region which is provided on a peripheral edge of the transmission region, which reflects the light from the light-emitting element so as to cause the reflected light to enter the area sensor, and which is for acquiring data for correcting a luminance fluctuation of the light-emitting element.
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Description

Analysis device

[0001] The present disclosure relates to an analysis device.

[0002] There is known an analysis device that analyzes a specimen sample using an analysis chip on which the specimen sample is spotted. As analysis of the specimen sample, measurement of the concentration of a detection target substance contained in the specimen sample is performed by measuring the reaction state between the specimen sample and a reagent. The specimen sample is, for example, blood and urine. As the analysis chip, an analysis chip provided with a reaction region containing a dry reagent is common.

[0003] In the analysis device, such an analysis chip is irradiated with measurement light on the reaction region where the specimen sample is dropped, and the reflected light is detected, thereby detecting a reaction product generated by the reaction between the detection target and the reagent. Therefore, the analysis device is provided with a photometry unit that irradiates the analysis chip with measurement light and detects the reflected light.

[0004] Japanese Patent Laid-Open No. 07-005110 describes that in an analysis device, a standard reflection piece may be placed within the field of view of a detector, and the reflectance of a test piece may be corrected by the reflectance of the reflection piece to correct fluctuations in sensitivity due to fluctuations in the light amount of a light source lamp and the like.

[0005] According to the description of Japanese Patent Laid-Open No. 07-005110, it is necessary to place a standard reflection piece at a position that does not overlap with the field of view where the test piece is imaged every time the test piece is measured, which takes time during measurement. In addition, when the reflection piece is set by hand, problems such as a change in reflectance due to sebum or the like may occur.

[0006] The technology of the present disclosure has been made in view of the above circumstances, and an object thereof is to provide an analysis device with high convenience and capable of highly accurate analysis.

[0007] The analytical apparatus of this disclosure is an analytical apparatus in which an analytical chip having a reaction region for holding a reagent is detachably loaded, and which analyzes a sample applied to the reaction region of the analytical chip, and the photometric unit optically detects the color development produced by the reaction between the reagent and the target substance in the sample, and the photometric unit includes a light-emitting element, an area sensor that captures an image of a predetermined shooting range including the reaction region irradiated by light from the light-emitting element, and a transparent member disposed between the loaded analytical chip and the area sensor, wherein the transparent member includes a transmission region through which light from the light-emitting element toward the analytical chip is transmitted, and a colored region provided on the periphery of the transmission region that reflects the light from the light-emitting element, thereby causing the reflected light to be incident on the area sensor, and the colored region is for acquiring data for correcting brightness fluctuations of the light-emitting element.

[0008] The photometering unit comprises a housing in which a light-emitting element and an area sensor are arranged inside, and the transparent member may be a dustproof transparent member that covers the opening of the housing.

[0009] The colored region preferably has an optical density of 1.5 or less.

[0010] The colored regions provided in the transparent member may include multiple regions with different optical densities. In this case, it is preferable that the transparent member includes, as multiple regions, a region with an optical density of 1.0 or more and 1.5 or less for light with wavelengths of 400 nm to 700 nm, and a region with an optical density of 0.5 or more and less than 1.0.

[0011] The transparent component is preferably one of the following: glass, acrylic, polyethylene terephthalate, polycarbonate, and cycloolefin polymer.

[0012] The photometric unit may include multiple types of light-emitting elements that emit light with different central wavelengths.

[0013] The analytical apparatus of this disclosure is a processor that acquires an image from a photometric unit and calculates the concentration of a target substance based on a measured value corresponding to the luminance data of the reaction region extracted from the acquired image, and preferably further comprises a processor that extracts correction luminance data, which is the luminance data of the colored region, from the image in addition to the luminance data of the reaction region, and corrects the measured value with the correction luminance data.

[0014] The analytical apparatus of the present disclosure may have a photometric unit equipped with multiple types of light-emitting elements that emit light with different central wavelengths as light-emitting elements, and in this case, the apparatus further comprises a processor that acquires an image from the photometric unit and calculates the concentration of a target substance based on a measurement value corresponding to the brightness data of the reaction region extracted from the acquired image, and in addition to the brightness data of the reaction region, extracts correction brightness data, which is the brightness data of the colored region, from the image and corrects the measurement value with the correction brightness data, and the processor may be configured to change the extraction region of the correction brightness data extracted from the image according to the type of light-emitting element.

[0015] The analysis tip preferably contains a dry reagent as a reagent.

[0016] The analytical apparatus of the technology disclosed herein can provide an analytical apparatus that is highly convenient and capable of high-precision analysis.

[0017] This is a schematic diagram showing the overall configuration of the analytical apparatus of the embodiment. This is a plan view of the main part of the analytical apparatus of Figure 1. This is a diagram showing an example of the configuration of the analysis chip. This is a side view showing the schematic configuration of the photometric unit and the positional relationship of the analysis chip. This is a perspective view showing the schematic configuration of the photometric unit and the positional relationship of the analysis chip. This is an exploded perspective view of the photometric unit. This is a plan view of the transparent member as seen from the area sensor side. This is a schematic diagram of an image captured by the area sensor. This is a perspective view of a modified transparent member. This is a perspective view showing the schematic configuration of the modified photometric unit. This is a plan view of the modified photometric unit as seen from the rotating substrate side. This is a schematic diagram of an image captured by the area sensor of the modified photometric unit, and is an explanatory diagram of the extraction area for correction luminance data. Figures 13A to 13C show variations of colored areas including multiple areas. This is a plan view of the main part of the analytical apparatus of the second embodiment. This is a flowchart showing the processing in the analytical apparatus of the second embodiment. This is a schematic diagram of an image taken in a reaction area with low optical density under the first shooting conditions. Figure 17A is a schematic diagram of an image taken of a reaction region with high optical density under the first imaging condition, and Figure 17B is a schematic diagram of an image taken of a reaction region with high optical density under the second imaging condition. These figures are intended to explain the effect of including a gray plate.

[0018] Preferred embodiments of this disclosure will be described below with reference to the drawings. In each figure, the same components are denoted by the same reference numerals. Figure 1 is a schematic diagram showing the overall configuration of an analytical apparatus 100 according to one embodiment. Figure 2 is a plan view of the main part of the analytical apparatus 100 of Figure 1, and Figure 3 is a diagram showing an example of the configuration of an analytical tip.

[0019] (Analytical Apparatus of the First Embodiment) The analytical apparatus 100 of the first embodiment shown in Figure 1 is an example of an analytical apparatus for analyzing a sample. An analytical tip 12 is detachably loaded into the analytical apparatus 100. In the analytical apparatus 100, for example, a dry analytical tip is used to measure the concentration of the target substance contained in the sample. Specifically, the analytical apparatus 100 quantifies the concentration of the target substance by colorimetric measurement. The sample is, for example, plasma, whole blood, serum, or urine.

[0020] As shown in Figure 3, the analysis tip 12 has a planar reaction region 12A on which a reagent is fixed. The reagent reacts with the substance to be detected to produce a substance that develops a specific color. This substance that develops color through this reaction will be referred to as the reactant below. As the reagent, for example, a dry reagent that is in a dry state at least at the time of shipment is used. The sample is applied to the reaction region 12A of the analysis tip 12.

[0021] More specifically, the analysis tip 12 has a carrier 16 that includes a reaction area 12A on which a sample is applied, and the carrier 16 is housed in a case 17. The case 17 consists of a first case 17A and a second case 17B, and the carrier 16 is housed between the first case 17A and the second case 17B. The first case 17A has an opening 17C that functions as a dropper for applying the sample to the reaction area 12A. The second case 17B has an opening 17D for irradiating the reaction area 12A with light. The carrier 16 is exposed to the opening 17C of the first case 17A, which constitutes the surface of the analysis tip 12. The carrier 16 is also exposed to the opening 17D of the second case 17B, which constitutes the back surface of the analysis tip 12. The area of ​​the carrier 16 exposed to the opening 17D constitutes the reaction area 12A on which the reagent is fixed. Furthermore, in the second case 17B, item information related to the measurement item is assigned as an information code 17E in which the item information is encoded. The information code 17E is, for example, a pattern of multiple dots arranged in a sequence, and the arrangement pattern of dots differs for each measurement item. Of course, one-dimensional barcodes and two-dimensional barcodes may also be used as the information code 17E.

[0022] The analyzer 100 comprises a chipset unit 10, a reader 20, a sample application unit 30, a chip transport mechanism 40, a sample application mechanism 50, an incubator 60, a photometric unit 70, a chip disposal mechanism 80, and a processor 90.

[0023] The chipset unit 10 has a stocker 14 on a holding base 11 that houses the analysis chips 12. Multiple analysis chips 12 are stacked and housed in the stocker 14. The stocker 14 has an opening on its bottom. The analysis chips 12 are housed with the side on which the information code 17E is recorded facing the opening of the stocker 14. Therefore, the information code 17E of the analysis chip 12 located at the bottom of the stocker 14, closest to the opening, is exposed through the opening. The holding base 11 on which the stocker 14 is placed also has an opening. Therefore, the information code 17E of the analysis chip 12 located at the bottom of the stocker 14 is exposed to the reader 20 through the openings of the holding base 11 and the stocker 14. The reader 20 is located below the holding base 11 and reads the exposed information code 17E.

[0024] The reader 20 is, for example, a code reader that reads item information assigned to the analysis chip 12. The reader 20 is composed of an image sensor such as a CCD (Charge Coupled Device) and a CMOS (Complementary Metal Oxide Semiconductor). The item information read by the reader 20 is output to the processor 90.

[0025] The chip transport mechanism 40 transports the analysis chip 12 from the chipset section 10 to the sample application section 30, and further transports it from the sample application section 30 to the incubator 60. The chip transport mechanism 40 comprises a thin plate-shaped chip transport member 42 and a drive mechanism 44 that reciprocates the chip transport member 42 in the direction of alignment between the chipset section 10, the sample application section 30, and the incubator 60. The drive mechanism 44 is, for example, a linear actuator. The chip transport member 42 is slidably supported by a guide rod (not shown) and is reciprocated by the drive mechanism 44. The chip transport member 42 is pressed against the analysis chip 12 stored in the bottom layer of the analysis chips 12 stacked in the stocker 14. In this state, the analysis chip 12 is transported to the incubator 60 by the movement of the chip transport member 42 toward the incubator 60.

[0026] In the sample application section 30, sample material such as plasma, whole blood, serum, or urine is applied to the analysis tip 12. The sample application section 30 is provided with a tip support stand 31, and the application of the sample material to the analysis tip 12, which has been transported onto the tip support stand 31, is performed on the tip support stand 31. The application of the sample material is performed by the sample application mechanism 50, which will be described later. The tip support stand 31 is located adjacent to the holding stand 11.

[0027] As shown in Figure 1, the sample application mechanism 50 comprises a nozzle 52, a suction and discharge mechanism (not shown), and a movement mechanism for moving the nozzle 52. The sample application mechanism 50 aspirates a sample from a sample containment section (not shown) and applies the sample to the analysis tip 12 in the sample application section 30.

[0028] The incubator 60 is capable of housing multiple analysis chips 12 inside. The incubator 60 has a constant temperature function to maintain a constant temperature in order to promote the reaction between the reagents in the analysis chips 12 and the sample material. The set temperature is, for example, 37°C.

[0029] As shown in Figure 2, the incubator 60 is equipped with an annular rotating substrate 62 on which a plurality of cells S into which analysis chips 12 are loaded. The upper part of the rotating substrate 62 is also equipped with a disc-shaped holding member 65 having a pressing member 64 that presses the analysis chips 12 loaded in the cells S from a direction facing the reaction region 12A (see Figure 3). A pressing member 64 is provided corresponding to each cell S. A slit-shaped space is formed between the pressing surface 64A of the pressing member 64 and the cell S, into which the analysis chip 12 is loaded. As the rotating substrate 62 rotates, each cell S is sequentially transported to the measurement position where the photometric unit 70, described later, is located. This is an example of a support portion of the rotating substrate 62 that supports the analysis chip 12 at the measurement position. A portion of the rotating substrate 62 is equipped with a white plate W and a black plate B, whose optical densities are known, as density reference plates. The white plate W and black plate B are used for calibration of the photometric unit 70, which is performed before measurement. Calibration of the photometric unit 70 is a process of adjusting the output of the irradiation device 73 or the amount of light received by the area sensor 74 so that a constant brightness value is obtained for a known optical density. In addition, since the optical densities of the white plate W and the black plate B are known, their brightness is acquired prior to the measurement of the analysis chip 12, so that a calibration curve can be obtained from the brightness value of the analysis chip 12 to be measured later.

[0030] A rotating cylinder 66 is provided at the bottom of the rotating substrate 62. The rotating cylinder 66 has a roughly inverted triangular cross-section, with the inner diameter narrowing towards the bottom. A bearing 67 is positioned at the bottom of the outer circumference of the rotating cylinder 66, and the rotating cylinder 66 is rotatably supported by the bearing 67. The rotating substrate 62 rotates as the rotating cylinder 66 rotates. The holding member 65 rotates integrally with the rotating substrate 62. The bottom of the rotating cylinder 66, which is the apex of the inverted triangle, is open, and this opening functions as a waste hole 68 for discarding used analysis chips 12. Used analysis chips 12 are moved from their loaded state in the cell S towards the center of the annular rotating substrate 62 and fall toward the inclined surface of the rotating cylinder 66. Used analysis chips 12 that have fallen into the rotating cylinder 66 slide toward the inclined surface and are discarded through the waste hole 68.

[0031] The holding member 65 is equipped with a heating means, such as a heater (not shown), which maintains the analysis chip 12 housed in the cell S at a constant temperature by adjusting its temperature. A heat-insulating cover 69 is provided on the upper surface of the holding member 65. In Figure 2, the holding member 65 and heat-insulating cover 69 are removed, exposing the rotating substrate 62.

[0032] As shown in Figure 2, a photometric aperture window 62A is formed in the center of the bottom surface of each cell S of the rotating substrate 62, and a photometric unit 70, which is located below the rotating substrate 62, performs a colorimetric measurement of the analysis chip 12 through this aperture window 62A.

[0033] The photometric unit 70 optically detects the color change produced by the reaction between the reagent and the target substance in the sample. The photometric unit 70 is located on the outer periphery of the incubator 60, below the rotating substrate 62. The photometric unit 70 irradiates light onto the reaction region 12A of the analysis chip 12, captures an image of the region including the reaction region 12A, and outputs the captured image to the processor 90.

[0034] Figures 4 and 5 are side and perspective views, respectively, showing the schematic configuration of the photometric unit 70 and its positional relationship with the analysis chip 12 during measurement. The rotating substrate 62 is omitted in Figure 5. Figure 6 is an exploded perspective view of the photometric unit 70. The photometric unit 70 includes a housing 71, an illumination device 73 including light-emitting elements 73a and 73b, an area sensor 74, and a transparent member 75. The housing 71 also contains an optical system (not shown) for collecting reflected light L1 from the reaction region 12A and guiding it to the area sensor 74.

[0035] The light-emitting elements 73a and 73b output a measurement light L for irradiating the reaction region 12A. In this example, the light-emitting elements 73a and 73b have the same central wavelength. Here, "same central wavelength" means that the central wavelengths coincide within a range of approximately ±5 nm. The light-emitting elements 73a and 73b are, for example, light-emitting diodes (LEDs), organic electroluminescent (EL) devices, and semiconductor lasers.

[0036] The wavelength range of the measurement light L is determined according to the substance to be detected (i.e., the measurement item). For example, in this example, as described above, a reaction substance that produces a specific color is produced by the reaction between the substance to be detected and the reagent. The light emitted by the irradiation device 73 is the measurement light L for detecting whether or not a reaction substance is produced, so the wavelength range is determined according to the color produced by the reaction substance. In this example, the measurement light L is, for example, light that includes a wavelength range absorbed by the reaction substance in order to detect the reaction substance.

[0037] The area sensor 74 captures a preset shooting range that includes the reaction area 12A. The area sensor 74 is an image sensor such as a CCD camera or a CMOS camera. The area sensor 74 outputs the captured image to the processor 90.

[0038] The transparent member 75 is positioned between the analysis chip 12, which is located at the measurement position, and the area sensor 74, and its relative position to the area sensor 74 is fixed. That is, the transparent member 75 is positioned so that it does not move even when the analysis chip 12 moves due to the rotating substrate 62. In this example, the light-emitting elements 73a, 73b and the area sensor 74 are located inside the housing 71. The transparent member 75 is a dustproof transparent member that covers the opening 71A of the housing 71 (see Figures 5 and 6). As shown in Figure 6, the transparent member 75 is a plate-shaped member and comprises a light-transmitting region 76 and a colored region 77 provided on the periphery of the light-transmitting region 76. The transparent member 75 can be made of, for example, glass, acrylic, polyethylene terephthalate, polycarbonate, and cycloolefin polymer. The colored region 77 can be formed on the transparent member 75 by printing.

[0039] The transparent region 76 transmits light from the light-emitting elements 73a and 73b toward the analysis chip 12. In this example, the transparent region 76 is provided in the center of the transparent member 75. On the other hand, the colored region 77 reflects light from the light-emitting elements 73a and 73b. The reflected light reflected by the colored region 77 is incident on the area sensor 74. The colored region 77 is used to acquire data for correcting brightness fluctuations of the light-emitting elements 73a and 73b. That is, the transparent member 75 is positioned such that light from the light-emitting elements 73a and 73b toward the analysis chip 12 passes through its transparent region 76, and the colored region 77 reflects the light from the light-emitting elements 73a and 73b, causing the reflected light to be incident on the area sensor 74. In the example shown in Figure 6, the colored region 77 is provided over the entire periphery of the transparent region 76, but the area where the colored region 77 is provided does not need to be the entire periphery of the transparent region 76. The area sensor 74 only needs to capture a range 74A that includes the colored area 77, and the colored area 77 only needs to be provided in at least a part of the periphery of the transparent area 76.

[0040] Figure 7 is a plan view of the transparent member 75 as seen from the area sensor 74 side. In Figure 7, the area enclosed by the dashed line is the imaging range 74A of the area sensor 74. At least a portion of the colored area 77 is always within the imaging range 74A of the area sensor 74. The circular portion in the center of the imaging range 74A is an opening window 62A provided in the cell S of the rotating substrate 62. Measurement is performed with the reaction area 12A of the analysis chip 12 exposed through the opening window 62A. That is, during measurement, the imaging range 74A of the area sensor 74 includes both the reaction area 12A of the analysis chip 12 and the colored area 77 of the transparent member 75.

[0041] The optical density of the colored region 77 for light with wavelengths of 400 nm to 700 nm is preferably 1.5 or less, and more preferably 1.0 or less. The colored region 77 is preferably gray or white.

[0042] The chip disposal mechanism 80 includes a thin plate-shaped chip transfer member 82 and a drive mechanism 84 that reciprocates the chip transfer member 82. The chip disposal mechanism 80 inserts the chip transfer member 82 from the outer peripheral portion of the incubator 60 into the cell S, and pushes out the used analysis chip 12 after measurement from the central portion of the incubator 60 and drops it into the disposal hole 68. The drive mechanism 84 is, for example, a linear actuator. The chip transfer member 82 is slidably supported by a guide rod (not shown) and reciprocated by the drive mechanism 84. A collection box for collecting the used analysis chip 12 is disposed below the disposal hole 68.

[0043] The processor 90 comprehensively controls each part of the analyzer 100. The configuration of the processor 90 is not particularly limited. For example, the processor 90 is composed of a CPU (Central Processing Unit), NVM (Non-volatile Memory), a RAM (Random Access Memory), and the like. The processor 90 derives the concentration of the detection target substance contained in the specimen sample based on the detection signal acquired from the photometry unit 70. Here, "deriving the concentration of the detection target substance" means quantifying the detection target substance.

[0044] The processor 90 derives the concentration of the detection target substance based on the photometry region luminance value, which is the luminance value of the reaction region 12A extracted from the image acquired from the photometry unit 70. Specifically, the processor 90 derives the optical density of the reaction region 12A, and derives the concentration of the detection target substance based on a calibration curve showing the relationship between the optical density and the concentration of the detection target substance. In addition to the luminance data of the reaction region 12A, the processor 90 extracts correction luminance data, which is the luminance value of the colored region in the image, and is configured to correct the luminance data of the reaction region 12A with the correction luminance data.

[0045] (Measurement of the Analysis Chip in the Analyzer) The measurement in the analyzer 100 is performed as follows. When the analyzer 100 is started up or before measurement, calibration of the photometric unit 70 using the white plate W and the black plate B is carried out. After this calibration, the photometric unit 70 captures images of the white plate W and the black plate B respectively and outputs them to the processor 90.

[0046] During measurement, first, the analysis chip 12 is taken out from the stocker 14 by the chip transfer mechanism 40 and transferred to the spotting position on the chip support base 31. At the spotting position, the specimen is spotted onto the analysis chip 12 by the specimen spotting unit 30. After the analysis chip 12 is spotted, the analysis chip 12 is transferred into the incubator 60.

[0047] After the analysis chip 12 is transferred into the incubator 60, the analysis chip 12 is warmed by the heat generation of heating means (not shown) in the incubator 60.

[0048] The analysis chip 12 to be measured is transferred to the measurement position equipped with the photometric unit 70 by the rotation of the rotating substrate 62. And at the measurement position, colorimetric measurement is performed on the analysis chip 12. The photometric unit 70 irradiates the analysis chip 12 with the measurement light L and receives the reflected light L1 from the analysis chip 12, thereby outputting a detection signal corresponding to the reaction state of the specimen sample and the reagent in the analysis chip 12. Here, imaging by the area sensor 74 is carried out, and the captured image is output to the processor 90. The processor 90 derives the concentration of the detection target substance from the detection signal acquired from the photometric unit 70.

[0049] In reaction region 12A, the sample and reagent react to produce a reactant that develops a specific color. The production of the reactant changes the color of reaction region 12A, and this color change appears as a change in the optical density of reaction region 12A. The reflected light L1 is light corresponding to the optical density of reaction region 12A, and the reflected light L1 reflects information about the reactant due to light absorption by the reactant. The optical density of reaction region 12A changes according to the amount of reactant, and the amount of reactant represents the concentration of the target substance in the sample. Therefore, the concentration of the target substance can be measured from the optical density of reaction region 12A. The method for deriving the concentration of the target substance by the processor 90 will be described later.

[0050] After the measurement is complete, the analysis chip 12 is transported by the rotating substrate 62 to the location where the chip disposal mechanism 80 is located. Subsequently, the analysis chip 12 is transported by the chip disposal mechanism 80 (see Figure 2) from inside the incubator 60 to a disposal position located in the center of the rotating substrate 62. The chip transport member 82 pushes out the analysis chip 12, causing it to be disposed of from inside the incubator 60 into the disposal hole 68.

[0051] In the above, the colorimetric measurement is performed in the following procedure. The light-emitting elements 73a and 73b are turned on, and with the measurement light L irradiated onto the analysis chip 12 and the colored area 77, an image is taken by the area sensor 74. The area sensor 74 takes an image of a preset shooting range 74A that includes at least a portion of the reaction area 12A and the colored area 77 shown in Figure 7, and acquires an image P schematically shown in Figure 8. In the image P shown in Figure 8, the shooting range 74A shown in Figure 7 is rotated by 90°.

[0052] (Method for deriving the concentration of the substance to be detected) The processor 90 acquires an image P from the area sensor 74. The processor 90 designates a predetermined area within the reaction area 12A, for example, the central part of the reaction area 12A shown in Figure 8, as the area of ​​interest ROI1, and derives the average value of the luminance data in this area as the photometric area luminance value VD. Then, the processor 90 designates two areas of interest ROI2 and ROI3 of the colored area 77 as extraction areas for correction luminance data, and derives the average value of the luminance data in these areas as the correction luminance value VE. Here, "luminance data" refers to the luminance values ​​of multiple pixels contained within a certain area. Therefore, the average value of the luminance data is the value obtained by dividing the sum of the luminance values ​​of each pixel contained in the luminance data by the number of pixels. However, instead of the average value of the luminance data, the median value of the luminance data or the mode value of the luminance data may be used as the luminance value. In this example, correction luminance data is extracted from two areas of interest, ROI2 and ROI3, within the colored region 77. However, the number of areas of interest set for extracting correction luminance data may be one or three or more.

[0053] The processor 90 then derives the corrected luminance value VD / VE, obtained by dividing the photometric area luminance value VD by the corrected luminance value VE. Based on this corrected luminance value, the processor 90 derives the concentration value of the target substance from the calibration curve. The denominator of the corrected luminance value may be a polynomial in VE, for example, VD / (a×VE+b) or VD / (a×VE) 2 You may also use values ​​such as (+b × VE + c) as the corrected brightness value.

[0054] This analytical device 100 has a colored region 77 in the transparent member 75 of the photometric unit 70 for acquiring data for brightness fluctuation correction. Therefore, unlike the device described in Japanese Patent Application Publication No. 07-005110, it is not necessary to place a reflective piece near the analysis chip 12 for each measurement, reducing the effort required from the user, and the problem of the reflectivity changing due to sebum etc. adhering to the reflective piece when the user sets it by hand does not occur. Therefore, it is highly convenient and enables highly accurate analysis.

[0055] As in this embodiment, if the transparent member 75 is a dustproof transparent member that covers the opening 71A of the housing 71 of the photometric unit 70, the number of parts does not need to be increased, thus suppressing cost increases. In addition, a structure to support the reflector (or transparent plate with a reflective area) that would be required if a reflector for extracting correction data were provided separately from the dustproof transparent member is also unnecessary. Furthermore, compared to the case where the transparent member 75 is provided separately from the dustproof transparent member, the area for extracting correction brightness data (in this case, the colored area 77) can be brought closer to the analysis chip 12, making it easier to focus the reaction area 12A and the colored area 77, and improving measurement accuracy. In addition, by forming the colored area 77 on the transparent member 75 by printing, even complex patterns can be easily formed.

[0056] In the analyzer 100, the light-emitting elements 73a and 73b may experience variations in temperature during illumination depending on the timing and number of illumination cycles, causing the light intensity to fluctuate with temperature. For example, if the light-emitting elements 73a and 73b are LEDs, the light intensity decreases as the temperature rises and increases as the temperature falls. Therefore, even when the concentration of the target substance is the same, the amount of reflected light in the reaction region 12A may fluctuate depending on the timing and number of illumination cycles of the light-emitting elements 73a and 73b. In the analyzer 100 of this embodiment, by providing a colored region 77 within the imaging range of the area sensor 74, the luminance data of the reaction region 12A in the image P can be corrected with correction luminance data, which is the luminance data of the colored region 77. By correcting the luminance data of the reaction region 12A with the correction luminance data, variations in the measured values ​​due to fluctuations in the light emission amount of the light-emitting elements 73a and 73b can be suppressed. As a result, the accuracy of the concentration value of the target substance can be improved.

[0057] In the above embodiment, the colored region 77 of the transparent member 75 is monochromatic, but as shown in the modified transparent member 175 in Figure 9, the colored region 77 may include multiple regions 77A and 77B with different optical densities. For example, the first region 77A may be a region with an optical density of less than 1.0 for light with wavelengths of 400 nm to 700 nm, and the second region 77B may be a region with an optical density of 1.0 or more. The optical density of the first region 77A is preferably 0.9 or less, and more preferably 0 to 0.5. The optical density of the second region 77B is preferably 1.0 to 1.5. Although the transparent member 175 shown in Figure 9 has two regions 77A and 77B with different optical densities, it may have three or more regions with different optical densities. For example, suppose the analyzer 100 has a normal mode for measuring an analysis chip 12 in which the optical density of the reaction region 12A is less than a preset threshold, and an extended mode for measuring an analysis chip 12 in which the optical density of the reaction region 12A is greater than or equal to the threshold, and which measures light with an exposure time longer than that of the normal mode. In such a case, if the transparent member 75 has two regions 77A and 77B, in the normal mode, correction brightness data can be obtained using the region 77A with low optical density, and in the extended mode, correction brightness data can be obtained using the region 77B with high optical density. This makes it possible to obtain a highly accurate correction brightness value corresponding to the optical density of the reaction region 12A.

[0058] The transparent member 175 having multiple colored regions may include a first region 77A and a second region 77B formed by a printed pattern as shown in Figures 13A to 13B. In the transparent member 175 shown in Figure 13A, rectangular first region 77A and second region 77B are provided at the center of its longitudinal direction and at both ends in the short direction, flanking the central transparent region 76. In the transparent member 175 shown in Figure 13B, the first region 77A and second region 77B are provided in each of the two rectangular regions provided at the center of its longitudinal direction and at both ends in the short direction, flanking the central transparent region 76. In Figure 13B, the first region 77A and second region 77B are separated along the short direction. Similarly, in the transparent member 175 shown in Figure 13C, the first region 77A and second region 77B are provided in each of the two rectangular regions provided at the center of its longitudinal direction and at both ends in the short direction, flanking the central transparent region 76. However, in Figure 13C, the first region 77A and the second region 77B are separated along the longitudinal direction.

[0059] Figure 10 shows a perspective view illustrating the schematic configuration of a modified photometric unit 170. Figure 11 is a plan view of the photometric unit 170 as seen from the rotating substrate 62 side. The photometric unit 170 differs from the photometric unit 70 in the configuration of its illumination device 173. Note that the housing 71 and transparent member 75 are omitted in Figure 10. In Figure 11, the rotating substrate 62 and analysis chip 12 located above the photometric unit 170 are shown by dashed lines, and the imaging range 74A by the area sensor 74 is shown by a dashed line.

[0060] As shown in Figure 10, the irradiation device 173 includes a first light-emitting element group 101 comprising multiple light-emitting elements 1a to 8a with different central wavelengths, and a second light-emitting element group 102 comprising multiple light-emitting elements 1b to 8b with different central wavelengths. The light-emitting elements 1a to 8a and 1b to 8b are, for example, light-emitting diodes (LEDs), organic electroluminescent (EL) devices, and semiconductor lasers. If the analysis device 100 is equipped with a photometric unit 170, by equipping it with multiple light-emitting elements 1a to 8a and 1b to 8b with different central wavelengths, it becomes possible to measure multiple types of analysis chips 12 having different reagents for detecting the target substance.

[0061] As shown in the plan view in Figure 11, in a plan view, the first light-emitting group 101 and the second light-emitting group 102 are arranged opposite each other with the area sensor 74 in between. The support substrates 111 and 112 of the first light-emitting group 101 and the second light-emitting group 102 are arranged at an angle with respect to the normal to the analysis chip 12. On the support substrates 111 and 112, eight light-emitting elements 1a to 8a and 1b to 8b are arranged in two rows, respectively. On the support substrate 111, the first row on the rotating substrate 62 side is arranged in the order of 8a, 7a, 6a, and 5a from the outer circumference of the rotating substrate 62, and the second row is arranged in the order of 4a, 3a, 2a, and 1a from the outer circumference of the rotating substrate 62. In contrast, in the support substrate 112, the first row on the rotating substrate 62 side is arranged in the order of 1b, 2b, 3b, and 4b from the outer circumference of the rotating substrate 62, and the second row is arranged in the order of 5b, 6b, 7b, and 8b from the outer circumference of the rotating substrate 62.

[0062] As mentioned earlier, the eight light-emitting elements 1a to 8a of the first light-emitting element group 101 emit light in different wavelength ranges. Similarly, the eight light-emitting elements 1b to 8b of the second light-emitting element group 102 emit light in different wavelength ranges. Hereafter, each light-emitting element of the first light-emitting element group 101 will be referred to as the first light-emitting element 1a, 2a, 3a, etc., and each light-emitting element of the second light-emitting element group 102 will be referred to as the second light-emitting element 1b, 2b, 3b, etc. In this example, elements with the same number, such as the first light-emitting element 1a and the second light-emitting element 1b, and the first light-emitting element 2a and the second light-emitting element 2b, emit light in the same wavelength range. That is, this irradiation device 173 is equipped with eight pairs of light-emitting elements that emit light of the same wavelength. Here, a configuration is used in which two light-emitting elements of the same wavelength are provided, but there may be one light-emitting element that emits light of a single wavelength, in which case light from one light-emitting element will be irradiated onto one analysis chip 12.

[0063] When measuring one analysis chip 12, a pair of light-emitting elements consisting of two elements with the same emission center wavelength corresponding to that analysis chip 12 is selectively used from among the first light-emitting elements 1a to 8a of the first light-emitting element group 101 and the second light-emitting elements 1b to 8b of the second light-emitting element group 102.

[0064] Here too, at least a portion of the colored area 77 of the transparent member 75 is positioned within the shooting range 74A of the area sensor 74. In this case as well, the area sensor 74 captures the image P shown in Figure 8, and the corrected brightness value can be obtained using the same procedure as in the above case.

[0065] Alternatively, as shown in Figure 12, the processor 90 may be configured to change the extraction region of the correction luminance data extracted from image P depending on the type of light-emitting element that emitted the measurement light L when acquiring image P. For example, if image P is obtained when the measurement light L is irradiated from the first light-emitting element 1a and the second light-emitting element 1b onto the reaction region 12A of the analysis chip 12, the region R1 in the colored region 77 of image P may be used as the extraction region for correction luminance data, and if the measurement light L is irradiated from the first light-emitting element 2a and the second light-emitting element 2b, the region R2 in the colored region 77 of image P may be used as the extraction region for correction luminance data, and so on. In this example, if the image P is obtained by irradiating the reaction region 12A of the analysis chip 12 with measurement light L from the first light-emitting element 3a and the second light-emitting element 3b, the region R3 in the colored region 77 of image P is used as the extraction region for correction luminance data. If the image P is obtained by irradiating the reaction region 12A of the analysis chip 12 with measurement light L from the first light-emitting element 4a and the second light-emitting element 4b, the region R4 in the colored region 77 of image P is used as the extraction region for correction luminance data. The positional relationships of the light-emitting element pairs 5a and 5b, 6a and 6b, 7a and 7b, and 8a and 8b are equivalent to the positional relationships of the light-emitting element pairs 1a and 1b, 2a and 2b, 3a and 3b, and 4a and 4b. Therefore, for each pair of light-emitting elements 5a and 5b, 6a and 6b, 7a and 7b, and 8a and 8b, the region R1, R2, R3, or R4 can be used as the extraction region for correction luminance data.

[0066] In a configuration comprising light-emitting element groups 1a to 8a and 1b to 8b as in this example, when measurement light L is irradiated using, for example, the first light-emitting element 1a and the second light-emitting element 1b, the light intensity distribution on the colored region 77 of the irradiated measurement light L shows that the light intensity per region R1 is larger than that of other regions. Also, when measurement light L is irradiated using, for example, the first light-emitting element 2a and the second light-emitting element 2b, the light intensity distribution on the colored region 77 of the irradiated measurement light L shows that the light intensity per region R2 is larger than that of other regions. Thus, in this example, when extracting correction luminance data from the colored region 77, it is preferable to use the region where the irradiation amount of measurement light L is as large as possible for each light-emitting element used for irradiation. By using luminance data from regions with a large irradiation amount of measurement light L, i.e., regions with high reflected light intensity, as correction luminance data, more accurate measurement results can be obtained.

[0067] The processor 90 may be composed of one or more hardware components, and the type of hardware is not limited. For example, the processor 90 may be composed of programmable logic devices such as a CPU (Central Processing Unit), MPU (Micro Processing Unit), FPGA (Field Programmable Gate Array), dedicated circuits for executing specific processes such as an ASIC (Application Specific Integrated Circuit), a GPU (Graphic Processing Unit), or an NPU (Neural Processing Unit). Furthermore, the hardware components may be a combination of different types of hardware. When multiple hardware components are configured to execute one or more processes of a processor, these components may reside in physically separate devices or in the same device. Furthermore, in any embodiment, the order of the processes performed by the processor is not limited to the order described above and may be changed as appropriate. The hardware components are composed of electrical circuits (circuits) and the like, which are combinations of circuit elements such as semiconductor elements.

[0068] Furthermore, the measurement process in the analyzer 100 is realized by the processor 90 executing an operational program. The operational program executed by the processor 90 may be firmware or software such as microcode. The program may also be, for example, a group of program modules, and each function may be realized by a processor configured to execute its respective function. The program may be program code or multiple code segments stored on one or more non-temporary computer-readable media (e.g., storage media or other storage). The program may be divided and stored on multiple non-temporary computer-readable media located in devices that are physically separated from each other. The program code or code segment may represent any combination of procedures, functions, subprograms, routines, subroutines, modules, software packages, classes, or instructions, data structures, or program statements. The program code or code segment may be connected to other code segments or hardware circuits by sending and receiving information, data, arguments, parameters, or memory contents.

[0069] The operating program may be pre-stored (installed) in a memory unit (not shown), or it may be provided in the form of a recording medium such as a CD-ROM (Compact Disc Read Only Memory), DVD-ROM (Digital Versatile Disc Read Only Memory), or USB (Universal Serial Bus) memory. Alternatively, the operating program may be downloaded from an external device via a network.

[0070] The technology of this disclosure extends to all program products. Program products include all forms of products for providing programs. For example, program products include programs provided through networks such as the Internet, and non-temporary computer-readable recording media such as CD-ROMs, DVDs, and USB memory devices on which programs are stored. (Analytical Apparatus of the Second Embodiment) The analytical apparatus 110 according to the second embodiment will be described below. Here, the differences from the analytical apparatus 100 of the first embodiment will be mainly described, and details of equivalent components and operations will be omitted. The same applies to the following embodiments.

[0071] In the analytical apparatus 110, the photometric unit 70 is equipped with a transparent member 175 (see Figure 9) that has a colored region 77 including multiple regions 77A and 77B with different optical densities, instead of a transparent member 75. In this example, the optical density of the first region 77A is 0.9 or less, and the optical density of the second region 77B is 1.0 or more. The optical density of the first region 77A is preferably 0 to 0.9, and more preferably 0.03 to 0.5. The optical density of the second region 77B is preferably 1.0 to 1.5, and more preferably 1.0 to 1.3.

[0072] Furthermore, as shown in Figure 14, the analyzer 110 includes a gray plate G as a density reference plate, in addition to a white plate W and a black plate B whose optical densities are known. The optical density of the gray plate G is, for example, 0.8 to 1.5. In this case, it is preferable that the optical density of the white plate W is 0 to 0.5. The white plate W is an example of a first optical density plate, and the gray plate G is an example of a second optical density plate. It is also possible to omit the black plate B, but it is preferable that it be provided as a reference for determining the lower limit of the luminance value, which will be described later. In this specification, the term "density reference plate (optical density plate)" does not necessarily mean that the entire member is a thin, flat plate-like structure; it is sufficient if part or all of the surface is plate-like (i.e., a surface with an extent). Furthermore, the surface is not limited to a perfectly flat surface; it may be a curved surface or a surface with irregularities.

[0073] The processor 90 in the analysis device 110 acquires an image of the analysis chip 12 from the photometering unit 70 and derives the concentration of the target substance based on the brightness data of the reaction region 12A extracted from the acquired image. More specifically, the processor 90 acquires brightness data of the reaction region 12A from the acquired image and also acquires brightness data of either region 77A or 77B of the colored region 77, which is selected from the image based on the shooting conditions by the photometering unit 70, as correction brightness data. For example, if the image was taken under first shooting conditions (for example, the normal mode shooting conditions described above), the first region 77A, which has a relatively low optical density among the colored region 77, is selected, and correction brightness data is acquired from the first region 77A. If the image was taken under second shooting conditions different from the first shooting conditions (for example, the extended mode shooting conditions described above), the second region 77B, which has a relatively high optical density among the colored region 77, is selected, and correction brightness data is acquired from the second region 77B. The processor 90 then corrects the photometric area luminance data with correction luminance data and derives the concentration of the target substance based on the corrected photometric area luminance data.

[0074] Furthermore, when the processor 90 derives the concentration of the target substance based on the corrected photometric area brightness data, it selectively uses either a white plate W or a gray plate G based on the shooting conditions to calculate the optical density and derives the concentration of the target substance corresponding to the optical density.

[0075] The measurement method and the method for deriving the concentration of the target substance in the analytical apparatus of the second embodiment will be described in more detail. In the measurement method of the analytical chip 12 in this analytical apparatus 110, the procedure up to the time of photometry of the analytical chip 12 by the photometric unit 70 is the same as in the first embodiment. However, after calibration of the photometric unit 70, images of the white plate W and gray plate G are acquired under first shooting conditions (for example, the normal mode described above). Images of the black plate B and gray plate G are also acquired under second shooting conditions (for example, the extended mode described above). The relationship between the amount of reflected light and optical density when shooting under the first shooting conditions is derived from the images of the white plate W and gray plate G, and the relationship between the amount of reflected light and optical density when shooting under the second shooting conditions is derived from the images of the gray plate G and black plate B.

[0076] Figure 15 is a flowchart showing the processing by the processor 90 after the analysis chip 12 is transported to the measurement position and measured. As shown in Figure 15, photometry (in this case, photography) is performed on the analysis chip 12 that has been transported to the measurement position (step S11). Here, a photometry unit 70 controlled by the processor 90 takes a photograph under a preset first shooting condition. In this case, light is irradiated from the light-emitting elements 73a and 73b toward the reaction region 12A, and the area sensor 74 takes a photograph of a predetermined shooting range that includes the reaction region 12A and the first region 77A and second region 77B of the colored region 77.

[0077] The processor 90 acquires an image from the area sensor 74 and determines whether the amount of reflected light from the reaction region 12A of the analysis chip 12 is greater than the amount of reflected light from the gray plate G, which is one of the density reference plates (step S12). The amount of reflected light from the reaction region 12A is compared with the amount of reflected light from the gray plate G when the gray plate G is photographed under the first shooting conditions.

[0078] If the processor 90 determines that the amount of reflected light from the analysis chip 12 is greater than the amount of reflected light from the gray plate G (step S12: Yes), it acquires the luminance data of the first region 77A, which has a relatively low optical density, as correction luminance data, and corrects the luminance data of the reaction region 12A with the correction luminance data to obtain a corrected luminance value (step S13). Figure 16 schematically shows an image P1 (hereinafter referred to as initial image P1) of the analysis chip 12, in which the optical density of the reflection region 12A is relatively low, taken under first shooting conditions.

[0079] Then, the processor 90 calculates the optical density of the reaction region 12A by normalizing the corrected brightness data based on the relationship between the optical density and reflected light amount of the white plate W and the gray plate G (step S14).

[0080] Subsequently, the processor 90 derives the concentration of the target substance (step S15) based on the optical density calculated in step S14, using a pre-prepared calibration curve that shows the relationship between the concentration of the target substance and the optical density of the reaction region.

[0081] On the other hand, if the processor 90 determines that the amount of reflected light from the analysis chip 12 is less than or equal to the amount of reflected light from the gray plate G (step S12: No), it controls the photometering unit 70 to take another image under the second shooting conditions (step S16). The second shooting conditions are, for example, shooting conditions in which the exposure time is set to be longer than the first shooting conditions. Figure 17A schematically shows the initial image P1 taken under the first shooting conditions of the analysis chip 12 in which the optical density of the reaction region 12A is relatively high. When the optical density of the reaction region 12A is high, it may not be possible to obtain sufficient information within the reaction region 12A in the initial image P1 taken under the first shooting conditions. Figure 17B schematically shows the image P2 (hereinafter referred to as the re-taken image P2) taken when the same analysis chip is taken under the second shooting conditions. By increasing the exposure time, the amount of reflected light from the reaction region 12A can be increased. In this case, the amount of reflected light from the first region 77A and the second region 77B of the colored region also increases relatively. Therefore, the amount of reflected light in the first region 77A may become saturated.

[0082] Therefore, the processor 90 corrects the brightness data of the reaction region 12A using the brightness data of the second region 77B, which has a relatively high optical density, from the recaptured image as correction brightness data, and obtains a corrected brightness data value (step S17).

[0083] Then, the processor 90 calculates the optical density of the reaction region 12A by normalizing the corrected brightness value based on the relationship between optical density and reflected light amount obtained from the amount of reflected light of the gray plate G and black plate B photographed under the second shooting conditions (step S18).

[0084] Subsequently, the processor 90 derives the concentration of the target substance based on the optical density calculated in step S18, using a pre-prepared calibration curve that shows the relationship between the concentration of the target substance and the optical density of the reaction region (step S19).

[0085] In this manner, the concentration of the target substance in the sample applied to the reaction region 12A of the analysis chip 12 is derived.

[0086] Thus, in step S12, if the processor 90 determines that the amount of reflected light from the analysis chip 12 is greater than the amount of reflected light from the gray plate G, the processor 90 derives a measured value (concentration of the target substance) using the initial image P1 (see Figure 16) captured under the first shooting conditions. Specifically, in step S13, the processor 90 extracts the luminance data of the area of ​​interest ROI1 within the reaction area 12A of the initial image P1, and acquires the luminance data of the area of ​​interest ROI-A in the first area 77A as correction luminance data. The average value of the luminance data of the area of ​​interest ROI1 is taken as the photometric area luminance value VF. The average value of the luminance data of the area of ​​interest ROI-A is taken as the correction luminance value VA. The value VF / VA obtained by dividing the photometric area luminance value VF by the correction luminance value VA is derived as the correction luminance value. Then, using this correction luminance value, the concentration of the target substance is derived through steps S14 and S15.

[0087] On the other hand, in step S12, if the processor 90 determines that the amount of reflected light from the analysis chip 12 is less than or equal to the amount of reflected light from the gray plate G, the processor 90 derives the measured value (concentration of the target substance) using the re-captured image P2 (see Figure 17B) captured under the second shooting conditions. That is, in step S17, the processor 90 extracts the luminance data of the area of ​​interest ROI1 within the reaction area 12A of the re-captured image P2, and acquires the luminance data of the area of ​​interest ROI-B in the second area 77B as correction luminance data. The average value of the luminance data of the area of ​​interest ROI1 is taken as the photometric area luminance value VG. The average value of the luminance data of the area of ​​interest ROI-B is taken as the correction luminance value VB. The value VG / VB obtained by dividing the photometric area luminance value VG by the correction luminance value VB is derived as the correction luminance value. Then, using this correction luminance value, the concentration of the target substance is derived through steps S17 and S18.

[0088] In the analytical apparatus 110 of this embodiment, a photometric unit 70 is used, which is equipped with a transparent member 175 (see Figure 9) having a colored region including a first region 77A and a second region 77B. The processor 90 acquires an initial image P1 or a re-captured image P2 including the reaction region 12A, the first region 77A, and the second region 77B of the analytical chip 12 from the photometric unit 70, acquires luminance data of the reaction region 12A extracted from the acquired initial image P1 or re-captured image P2, and acquires luminance data of either region 77A or 77B of the colored region of the initial image P1 or re-captured image P2, selected based on the shooting conditions by the photometric unit 70, as correction luminance data, corrects the luminance data with the correction luminance data, and derives the concentration of the target substance based on the corrected luminance data. With this configuration, correction luminance data corresponding to the optical density of the reaction region 12A can be selected. In the second embodiment, the luminance data of the first region 77A is acquired as correction luminance data for the initial image P1, and the luminance data of the second region 77B is acquired as correction luminance data for the recaptured image P2. This enables highly accurate correction, and as a result, improves measurement accuracy.

[0089] Furthermore, as in this embodiment, when the optical density of the reaction region 12A is high, the measurement accuracy of the target substance can be further improved by using the relationship between the amount of reflected light and the optical density of the gray plate G, which was photographed under the second shooting conditions, as a reference for calculating the optical density of the reaction region 12A in the re-photographed image P2.

[0090] For example, consider the case where the reflectance of black board B is 0.1% (optical density 3), the reflectance of white board W is 100% (optical density 0), and the reflectance of gray board G is 10% (optical density 1). Figure 18(a) is a graph showing the relationship between luminance value and reflectance when the luminance value corresponding to the amount of reflected light from black board B is set to 0 in 8-bit gradation, and the luminance value corresponding to the amount of reflected light from white board W is set to 250, which is close to the upper limit of 8-bit gradation, based on images of black board B and white board W taken under the first shooting condition. Figure 18(b) is a graph showing the relationship between luminance value and reflectance when the luminance value corresponding to the amount of reflected light from black board B is set to 0 in 8-bit gradation, and the luminance value corresponding to the amount of reflected light from gray board G is set to 250, which is close to the upper limit of 8-bit gradation, based on images of black board B and gray board G taken under the second shooting condition.

[0091] If the photometric region luminance value obtained in the above process is greater than the amount of reflected light from the gray plate G, i.e., in the range Ra in Figure 18, the optical density is derived based on the initial image P1. That is, the corrected luminance value calculated from the initial image P1 in step S13 is normalized based on the graph shown in Figure 18(a), and the corresponding reflectance is derived. Note that the relationship between reflectance R and optical density OD is OD = -log 10 Since it is R, the optical density can be calculated from the reflectance.

[0092] As shown in Figure 18(a), when converting luminance values ​​to reflectance, resolution decreases as the luminance value decreases. Therefore, in this embodiment, in the case of a reaction region 12A where the luminance value is in the range Rb, which is lower than the luminance value of the gray plate G, the optical density is derived based on the re-captured image P2. That is, the corrected luminance value calculated from the re-captured image P2 in step S17 is normalized based on the graph shown in Figure 18(b), the corresponding reflectance is derived, and the optical density is calculated. This improves the resolution for the low optical density range and improves the measurement accuracy of the analysis chip 12 in the low optical density reaction region 12A.

[0093] In the second embodiment, the exposure time differs between the first and second shooting conditions, and the case where the exposure time of the second shooting condition is longer than that of the first shooting condition was described. However, the difference between the first and second shooting conditions is not limited to exposure time. For example, the gain setting of the area sensor 74 may be different, and the second shooting condition may be a shooting condition in which the gain of the area sensor 74 is set to be greater than the gain of the area sensor 74 in the first shooting condition. In other words, the second shooting condition should be a condition that enables more accurate detection of signals from reaction regions with lower optical density compared to the first shooting condition.

[0094] Furthermore, in the second embodiment, a gray plate G is provided as a reference plate, and the optical density of the reaction region 12A in the image captured under the first shooting conditions is compared with the optical density of the gray plate G to determine whether to reshoot. However, instead of comparing with the optical density of the gray plate G, the decision to reshoot may be made by comparing with a preset threshold. The preset threshold is an arbitrary value and can be stored in advance in a memory (not shown) accessible by the processor 90. The threshold is the amount of reflected light between the amount of reflected light of the white plate W and the amount of reflected light of the black plate B, and any value such as 50, 60, 70, ..., 100 can be set when the luminance value corresponding to the amount of reflected light of the white plate W is set to 250 and the luminance value corresponding to the amount of reflected light of the black plate B is set to 0. Alternatively, the gray plate G may not be provided, and the optical density may be calculated for the reshooted image P2 using the optical densities of the white plate and the black plate. Even in this case, the effect of improving measurement accuracy can be obtained by selectively using the first region 77A and the second region 77B to correct the photometric region luminance data. However, for images that have been recaptured, it is preferable to calculate the optical density using a gray plate G, as this allows for more accurate measurement results.

[0095] Further details regarding the above embodiments are disclosed below. (Note 1) An analytical apparatus for analyzing a sample placed on the reaction region of an analytical chip, the analytical apparatus comprising an analytical chip detachably loaded with an analytical chip having a reaction region for holding a reagent, the analytical apparatus comprising a photometric unit for optically detecting the color produced by the reaction between the reagent and a target substance in the sample, the photometric unit comprising a light-emitting element, an area sensor for capturing an image of a predetermined shooting range including the reaction region irradiated by light from the light-emitting element, and a transparent member disposed between the loaded analytical chip and the area sensor, wherein the transparent member comprises a transmission region through which light from the light-emitting element toward the analytical chip is transmitted, and a colored region provided on the periphery of the transmission region that reflects the light from the light-emitting element, thereby causing the reflected light to be incident on the area sensor, and a colored region for acquiring data for correcting brightness fluctuations of the light-emitting element. (Note 2) The analytical apparatus according to Note 1, wherein the photometric unit comprises a housing in which the light-emitting element and the area sensor are arranged inside, and the transparent member is a dustproof transparent member that covers the opening of the housing. (Note 3) The analytical apparatus according to Note 1 or Note 2, wherein the colored region has an optical density of 1.5 or less. (Note 4) The analytical apparatus according to any one of Notes 1 to 3, wherein the colored region provided on the transparent member includes a plurality of regions with different optical densities. (Note 5) The analytical apparatus according to Note 4, wherein the transparent member includes, as a plurality of regions, a region with an optical density of 1.0 or more and 1.5 or less for light with a wavelength of 400 nm to 700 nm, and a region with an optical density of 0.5 or more and less than 1.0. (Note 6) The analytical apparatus according to any one of Notes 1 to 5, wherein the transparent member is one of glass, acrylic, polyethylene terephthalate, polycarbonate, and cycloolefin polymer. (Note 7) The analytical apparatus according to any one of Notes 1 to 6, wherein the photometric unit is equipped with a plurality of types of light-emitting elements that emit light with different central wavelengths.(Note 8) An analytical apparatus according to any one of Notes 1 to 7, comprising a processor that acquires an image from a photometric unit and calculates the concentration of a target substance based on a measurement value corresponding to the luminance data of the reaction region extracted from the acquired image, further comprising a processor that extracts correction luminance data, which is the luminance data of the colored region, from the image in addition to the luminance data of the reaction region, and corrects the measurement value with the correction luminance data. (Note 9) An analytical apparatus according to Note 7, comprising a processor that acquires an image from a photometric unit and calculates the concentration of a target substance based on a measurement value corresponding to the luminance data of the reaction region extracted from the acquired image, further comprising a processor that extracts correction luminance data, which is the luminance data of the colored region, from the image in addition to the luminance data of the reaction region, and corrects the measurement value with the correction luminance data, wherein the processor changes the extraction region of the correction luminance data extracted from the image according to the type of light-emitting element. (Note 10) An analytical apparatus according to any one of Notes 1 to 9, wherein the analytical chip includes a dry reagent as a reagent.

[0096] The disclosures of Japanese Patent Application No. 2025-011264, filed on 27 January 2025, and Japanese Patent Application No. 2025-074832, filed on 28 April 2025, are incorporated herein by reference in their entirety. All documents, patent applications, and technical standards described herein are incorporated herein by reference to the same extent as if the incorporation of each individual document, patent application, and technical standard were specifically and individually noted.

Claims

1. An analytical apparatus having an analytical tip equipped with a reaction region for holding a reagent that is detachably loaded, and an analytical apparatus for analyzing a sample applied to the reaction region of the analytical tip, comprising a photometric unit for optically detecting the color produced by the reaction between the reagent and a target substance in the sample, the photometric unit comprising a light-emitting element, an area sensor for capturing an image of a predetermined shooting range including the reaction region irradiated by light from the light-emitting element, and a transparent member disposed between the loaded analytical tip and the area sensor, wherein the transparent member comprises a transparent region through which the light from the light-emitting element toward the analytical tip is transmitted, and a colored region provided on the periphery of the transparent region that reflects the light from the light-emitting element, thereby causing the reflected light to be incident on the area sensor, and a colored region for acquiring data for correcting brightness fluctuations of the light-emitting element.

2. The analytical apparatus according to claim 1, wherein the photometric unit comprises a housing in which the light-emitting element and the area sensor are arranged inside, and the transparent member is a dustproof transparent member that covers the opening of the housing.

3. The analytical apparatus according to claim 1, wherein the colored region has an optical density of 1.5 or less.

4. The analytical apparatus according to claim 1, wherein the colored region provided on the transparent member includes a plurality of regions with different optical densities.

5. The analytical apparatus according to claim 4, wherein the transparent member includes, as the plurality of regions, a region in which the optical density for light with a wavelength of 400 nm to 700 nm is 1.0 or more and 1.5 or less, and a region in which the optical density is 0.5 or more and less than 1.

0.

6. The analytical apparatus according to claim 1, wherein the transparent member is one of glass, acrylic, polyethylene terephthalate, polycarbonate, and cycloolefin polymer.

7. The analytical apparatus according to claim 1, wherein the photometric unit comprises a plurality of types of light-emitting elements that emit light with different central wavelengths.

8. An analytical apparatus according to any one of claims 1 to 7, comprising a processor that acquires the image from the photometric unit and calculates the concentration of the target substance based on a measurement value corresponding to the luminance data of the reaction region extracted from the acquired image, the processor further comprising a processor that extracts correction luminance data, which is the luminance data of the colored region, from the image in addition to the luminance data of the reaction region, and corrects the measurement value with the correction luminance data.

9. An analytical apparatus according to claim 7, comprising a processor that acquires the image from the photometric unit and calculates the concentration of the target substance based on a measurement value corresponding to the luminance data of the reaction region extracted from the acquired image, the processor further comprising a processor that extracts correction luminance data, which is the luminance data of the colored region, from the image in addition to the luminance data of the reaction region, and corrects the measurement value with the correction luminance data, wherein the processor changes the extraction region of the correction luminance data extracted from the image according to the type of light-emitting element.

10. The analytical apparatus according to any one of claims 1 to 7, wherein the analytical tip includes a dry reagent as the reagent.