Analysis device

Abstract

To provide an analyzer capable of performing quantitative analysis with high accuracy even when an illuminance distribution fluctuates.SOLUTION: The analyzer includes a support portion configured to support the analysis chip at a measurement position, a photometric unit including a light emitting element configured to irradiate the reaction region of the analysis chip with measurement light and an area sensor configured to capture an image of a predetermined capturing range including the reaction region irradiated with the measurement light, a color plate disposed in the capturing range and having a region to be irradiated with the measurement light, and a processor configured to perform quantitative analysis of a detection target substance based on a measurement value corresponding to a photometric region luminance value that is a luminance value of the reaction region extracted from the image acquired from the photometric unit, the processor extracting a correction luminance value that is a luminance value of the color plate from the image in addition to the photometric region luminance value, and a processor that corrects the measurement value on the basis of the correction luminance value and a correlation between a pre-photometry region luminance value that is a luminance value of a region corresponding to the reaction region acquired in advance using the reference plate and a pre-correction luminance value that is a luminance value of the color plate.SELECTED DRAWING: Figure 10

Description

[Technical Field]

[0001] The present disclosure relates to an analytical device. [Background technology]

[0002] There is known an analytical device that analyzes a specimen sample using an analytical chip onto which the specimen sample is deposited. The analysis of the specimen sample involves measuring the concentration of a detection target substance contained in the specimen sample by measuring the reaction state between the specimen sample and a reagent. The specimen sample is, for example, blood or urine. The analytical chip is generally an analytical chip equipped with a reaction region containing a dry reagent.

[0003] In an analytical device, a measurement light is irradiated onto the reaction area of ​​such an analytical chip, into which a specimen sample has been dropped, and the reflected light is detected to detect the reaction product produced by the reaction between the target substance and the reagent. To this end, the analytical device is equipped with a photometric unit that irradiates the analytical chip with measurement light and detects the reflected light. The analytical device then calculates the optical density of the reflection area from the amount of reflected light, and performs quantitative analysis of the target substance from the optical density.

[0004] Therefore, in the analytical device, the accuracy of the quantification of the detection target substance depends on the accuracy of the optical density determined from the amount of light reflected from the analytical chip.

[0005] Patent document 1 states that in an analytical device, if a standard reflective piece (hereinafter referred to as the standard reflective piece) is placed within the field of view of the detector, it can be used as a standard for correcting causes that cause errors in reflectance calculations, such as fluctuations in the light intensity of the light source lamp. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Japanese Patent Application Publication No. 07-005110 Summary of the Invention [Problem to be solved by the invention]

[0007] However, Patent Document 1 does not specifically describe how to use the reflectance from the standard reflection piece to correct the reflectance of the reagent area to calculate the optical density.

[0008] Furthermore, the inventors' research has revealed that the accuracy of calculating optical density also decreases due to variations in the illuminance distribution of light from the light source. Variations in the illuminance distribution occur due to individual differences in the light source, installation errors, or deterioration of the light source.

[0009] The technology disclosed herein has been made in consideration of the above circumstances, and aims to provide an analytical device that can perform quantitative analysis with high accuracy even when fluctuations occur in the illuminance distribution. [Means for solving the problem]

[0010] The analytical device of the present disclosure includes: a support part that supports an analytical chip having a reaction region for holding a reagent at a measurement position; a photometric unit including a light-emitting element that irradiates a reaction region of the analysis chip with measurement light and an area sensor that captures an image of a predetermined imaging range including the reaction region irradiated with the measurement light; a color plate disposed within the imaging range and having an area onto which the measurement light is irradiated; The processor acquires an image from a photometric unit and performs quantitative analysis of the substance to be detected based on a measurement value corresponding to a photometric region luminance value, which is the luminance value of a reaction region extracted from the acquired image. The processor extracts a correction luminance value, which is the luminance value of a color plate, from the image in addition to the photometric region luminance value, and corrects the measurement value based on the correlation between the correction luminance value and a pre-photometric region luminance value, which is the luminance value of a region corresponding to the reaction region acquired in advance using a reference plate, and a pre-correction luminance value, which is the luminance value of the color plate.

[0011] The processor may be configured to perform an adjustment operation to obtain a correlation between the preliminary metering area luminance value and the preliminary correction luminance value between the time of startup and the time when metering by the metering unit begins.

[0012] The adjustment operation preferably involves placing a reference plate at the measurement position, acquiring multiple images with different amounts of light emitted from the light-emitting element, and obtaining the correlation between the pre-photometric area luminance value and the pre-correction luminance value from the multiple images.

[0013] The correction luminance values ​​are preferably derived from luminance values ​​of multiple regions of the color plate.

[0014] The analytical chip preferably contains a dry reagent as the reagent.

[0015] It is preferable that the optical density of the color plate is 1.5 or less. [Effects of the Invention]

[0016] According to the analysis device of the present disclosure, quantitative analysis can be performed with high accuracy even when fluctuations occur in the illuminance distribution. [Brief explanation of the drawings]

[0017] [Figure 1] 1 is a schematic diagram illustrating the overall configuration of an analyzer according to an embodiment. [Figure 2] FIG. 2 is a plan view of the main part of the analysis device of FIG. [Figure 3] FIG. 1 is a diagram showing a configuration example of an analytical chip. [Figure 4] FIG. 2 is a schematic diagram showing the schematic configuration of a photometric unit and the positional relationship of an analysis chip. [Figure 5] FIG. 2 is a perspective view showing the positional relationship between the main parts of the photometric unit, the analysis chip, and the color plate. [Figure 6] FIG. 10 is a diagram showing an image captured by an area sensor. [Figure 7] 10A and 10B are diagrams showing images P1 to P6 taken when the current values ​​applied to the light-emitting element are 0 mA, 6 mA, 9 mA, 15 mA, 19 mA, and 39 mA. [Figure 8] 10 is a diagram showing the relationship between the illuminance of a light-emitting element and a pre-correction luminance value (color plate luminance value). FIG. [Figure 9] FIG. 10 is a diagram illustrating the relationship between the illuminance of a light-emitting element and a preliminary photometry region luminance value. [Figure 10] 10 is a diagram showing the correlation between pre-correction luminance values ​​(color plate luminance values) and pre-metering region luminance values. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0018] Preferred embodiments of the present invention will now be described with reference to the drawings. In each drawing, the same components are designated by the same reference numerals. Fig. 1 is a schematic diagram showing the overall configuration of an analytical device 100 according to one embodiment. Fig. 2 is a plan view of the main parts of the analytical device 100 shown in Fig. 1, and Fig. 3 is a diagram showing an example of the configuration of an analytical chip.

[0019] The analytical device 100 shown in FIG. 1 is an example of an analytical device for analyzing a specimen sample. An analytical chip 12 is detachably mounted on the analytical device 100. The analytical device 100 uses, for example, a dry analytical chip to measure the concentration of a detection target substance contained in the specimen sample. Specifically, the analytical device 100 quantifies the concentration of the detection target substance by colorimetric measurement. The specimen sample may be, for example, plasma, whole blood, serum, or urine.

[0020] As shown in FIG. 3, the analytical chip 12 has a planar reaction area 12A to which a reagent is fixed. The reagent reacts with the detection target substance to produce a substance that develops a specific color. The substance that develops a color as a result of this reaction is hereinafter referred to as a reaction substance. For example, a dry reagent that is in a dry state at least at the time of shipment is used as the reagent. A specimen sample is applied to the reaction area 12A of the analytical chip 12.

[0021] More specifically, the analytical chip 12 has a carrier 16 including a reaction region 12A onto which a specimen sample is deposited, and the carrier 16 is housed in a case 17. The case 17 is composed of a first case 17A and a second case 17B, and the carrier 16 is housed so as to be sandwiched between the first case 17A and the second case 17B. The first case 17A has an opening 17C that functions as a drip port for depositing the specimen sample onto the reaction region 12A. The second case 17B has an opening 17D for irradiating the reaction region 12A with light. The carrier 16 is exposed to the opening 17C of the first case 17A, which constitutes the front surface of the analytical chip 12. The carrier 16 is also exposed to the opening 17D of the second case 17B, which constitutes the back surface of the analytical chip 12. The area of ​​the carrier 16 exposed to the opening 17D constitutes the reaction region 12A to which the reagent is immobilized. Additionally, second case 17B is provided with coded information code 17E containing item information relating to the measurement items. Information code 17E is, for example, a pattern of multiple dots, with the dot arrangement pattern differing for each measurement item. Of course, one-dimensional barcodes, two-dimensional barcodes, etc. may also be used as information code 17E.

[0022] The analyzer 100 comprises a chip set 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 chip setting unit 10 has a stocker 14 arranged on a holder 11 for accommodating analytical chips 12. The stocker 14 accommodates a plurality of analytical chips 12 stacked on top of one another. The stocker 14 has an opening on its bottom surface. The analytical chips 12 are accommodated with the surface on which the information code 17E is recorded facing the opening of the stocker 14. Therefore, the information code 17E of the analytical chip 12 located at the bottom, closest to the opening, in the stocker 14 is exposed through the opening. In addition, an opening is also formed in the holder 11 on which the stocker 14 is arranged. Therefore, the information code 17E of the analytical chip 12 located at the bottom in the stocker 14 is exposed to the reader 20 through the openings of the holder 11 and the stocker 14. The reader 20 is arranged below the holder 11 and reads the exposed information code 17E.

[0024] The reader 20 is, for example, a code reader that reads the item information attached to the analysis chip 12. The reader 20 is configured with an image sensor such as a CCD (Charge Coupled Device) or 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 analytical chip 12 from the chip setting unit 10 to the specimen application unit 30, and further from the specimen application unit 30 to the incubator 60. The chip transport mechanism 40 includes a thin chip transport member 42 and a drive mechanism 44 that reciprocates the chip transport member 42 in the direction in which the chip setting unit 10, the specimen application unit 30, and the incubator 60 are aligned. 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 reciprocates by the drive mechanism 44. The chip transport member 42 is pressed against the analytical chip 12 housed in the lowest row of the analytical chips 12 stacked in the stocker 14. In this state, the chip transport member 42 moves toward the incubator 60, thereby transporting the analytical chip 12 to the incubator 60.

[0026] In the specimen application section 30, a specimen sample such as plasma, whole blood, serum, or urine is applied to the analytical chip 12. A chip support stand 31 is provided in the specimen application section 30, and the specimen sample is applied to the analytical chip 12 transported onto the chip support stand 31 on the chip support stand 31. The specimen sample is applied by a specimen application mechanism 50, which will be described later. The chip support stand 31 is disposed adjacent to the holder stand 11.

[0027] 1, the specimen deposition mechanism 50 includes a nozzle 52, a suction / discharge mechanism (not shown), and a movement mechanism for moving the nozzle 52. The specimen deposition mechanism 50 aspirates a specimen sample from a specimen storage section (not shown), and deposits the specimen sample onto the analysis chip 12 in the specimen deposition section 30.

[0028] The incubator 60 can accommodate multiple analytical chips 12. The incubator 60 has a thermostatic function that keeps the temperature constant to promote the reaction between the reagents in the analytical chip 12 and the specimen sample. The set temperature is, for example, 37°C.

[0029] As shown in FIG. 2, the incubator 60 includes a circular rotating platform 62 on which are provided a plurality of cells S into which analytical chips 12 are loaded. A disk-shaped holding member 65 having a pressing member 64 that presses the analytical chips 12 loaded in the cells S from a direction facing the reaction regions 12A (see FIG. 3) is provided on the upper portion of the rotating platform 62. 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 analytical chip 12 is loaded. By rotating the rotating platform 62, each cell S is sequentially transported to a measurement position where a photometry unit 70 (described later) is disposed. The rotating platform 62 is an example of a support that supports the analytical chip 12 at the measurement position.

[0030] A rotating cylinder 66 is provided below the rotating platform 62. The rotating cylinder 66 has a cross-sectional shape that is roughly an inverted triangle, with the inner diameter tapering downward. A bearing 67 is disposed at the bottom of the outer periphery of the rotating cylinder 66, and the rotating cylinder 66 is rotatably supported by the bearing 67. The rotating platform 62 rotates as the rotating cylinder 66 rotates. The holding member 65 rotates integrally with the rotating platform 62. The rotating cylinder 66 has an opening at the bottom, which is the apex of the inverted triangle, and this opening functions as a disposal hole 68 for disposing of used analytical chips 12. The used analytical chip 12, loaded in the cell S, is moved toward the center of the annular rotating platform 62 and falls toward the inclined surface of the rotating cylinder 66. The used analytical chip 12 that falls into the rotating cylinder 66 slides down the inclined surface and is discarded through the disposal hole 68.

[0031] The holding member 65 is provided with a heating means such as a heater (not shown), and the temperature of the analysis chip 12 housed in the cell S is maintained at a predetermined constant temperature by adjusting the temperature. A heat-retaining cover 69 is provided on the upper surface of the holding member 65. Note that Fig. 2 shows the state in which the holding member 65 and heat-retaining cover 69 have been removed, exposing the rotating platform 62.

[0032] As shown in Figure 2, an opening window 62A for photometry is formed in the center of the bottom surface of each cell S of the rotating substrate 62, and colorimetric measurement of the analysis chip 12 is performed through this opening window 62A by a photometry unit 70 arranged below the rotating substrate 62.

[0033] The photometric unit 70 performs colorimetric measurement, which is measurement of the optical density using a colorimetric method, on the analysis chip 12. The photometric unit 70 is provided below the rotating platform 62 on the outer periphery of the incubator 60. The photometric unit 70 acquires a detection signal representing the optical density of the reaction region 12A of the analysis chip 12 and outputs it to the processor 90.

[0034] 4 is a diagram showing a schematic configuration of the photometry unit 70 and its positional relationship with the analysis chip 12 during measurement. As shown in Fig. 4, the photometry unit 70 includes a housing 71, an irradiation device 73 including light-emitting elements 73a and 73b that irradiate the reaction region 12A with measurement light L, and an area sensor 74 that photographs the reaction region 12A.

[0035] The housing 71 is provided with an optical system (not shown) for collecting reflected light L1 from the reaction area 12A and guiding it to the area sensor 74. In this example, the light-emitting elements 73a and 73b have the same center wavelength. Here, the same center wavelength means that the center wavelengths match within a range of about ±5 nm.

[0036] The wavelength range of the measurement light L is determined according to the detection target substance (i.e., the measurement item). For example, in this example, as described above, a reaction between the detection target substance and the reagent produces a reaction substance that develops a specific color. The light emitted by the irradiation device 73 is measurement light L for detecting whether a reaction substance is produced, so the wavelength range is determined according to the color produced by the reaction substance. The measurement light L in this example is, for example, light including a wavelength range absorbed by the reaction substance in order to detect the reaction substance. In this example, a configuration including two light-emitting elements with the same center wavelength is described, but the irradiation device 73 may also include multiple light-emitting elements with different center wavelengths in order to emit measurement light L of different wavelengths depending on the detection target substance. As the light-emitting elements 73a and 73b, for example, light-emitting diodes (LEDs), organic electroluminescence (EL), and semiconductor lasers are used.

[0037] When the analysis chip 12 is irradiated with the measurement light L, the area sensor 74 captures an image of a predetermined imaging range including the reaction region 12A of the analysis chip 12. The area sensor 74 is, for example, 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] As shown in FIG. 4, a color plate 75 is disposed within the photographing range of the area sensor 74. FIG. 5 is a perspective view showing the positional relationship between the main parts of the photometric unit 70, the color plate 75, and the analysis chip 12 during measurement. The rotatable base plate 62 is omitted in FIG. 5. The color plate 75 has an area onto which light (measurement light L) emitted from the light-emitting elements 73a and 73b is irradiated. In this example, the color plate 75 is a rectangular member having a rectangular opening in the center. The measurement light L emitted from the light-emitting elements 73a and 73b passes through the opening of the color plate 75 and enters the reaction area 12A. Note that "the color plate 75 is disposed within the photographing range of the area sensor 74" does not mean that the entire color plate 75 is disposed within the photographing range, but rather that at least a portion of the color plate 75 is within the photographing range.

[0039] The optical density of the color plate 75 is preferably 1.5 or less, and the color plate 75 is preferably a gray plate or a white plate.

[0040] The tip disposal mechanism 80 comprises a thin plate-shaped tip transport member 82 and a drive mechanism 84 that reciprocates the tip transport member 82. The tip disposal mechanism 80 inserts the tip transport member 82 into the cell S from the outer periphery of the incubator 60, and pushes the used analytical chip 12 after measurement to the center of the incubator 60, causing it to drop into the disposal hole 68. The drive mechanism 84 is, for example, a linear actuator. The tip transport member 82 is slidably supported by a guide rod (not shown), and is reciprocated by the drive mechanism 84. A collection box for collecting used analytical chips 12 is provided below the disposal hole 68.

[0041] In the incubator 60, the analytical chip 12 is loaded into a slit-shaped space formed between the cell S of the rotating base 62 and the pressing member 64. The analytical chip 12 is warmed in the incubator 60 and is transported to a measurement position by the rotation of the incubator 60. The measurement position is a position where a photometric unit 70 is disposed below the rotating base 62 and where colorimetric measurement of the analytical chip 12 is performed. After colorimetric measurement is performed by the photometric unit 70, the analytical chip 12 is dropped into a disposal hole 68 by a chip disposal mechanism 80 and discarded.

[0042] The processor 90 comprehensively controls each part of the analysis device 100. The configuration of the processor 90 is not particularly limited, but for example, the processor 90 is configured by a CPU (Central Processing Unit), NVM (Non-volatile Memory), RAM (Random Access Memory), etc.

[0043] The processor 90 acquires the image captured by the area sensor 74 of the photometry unit 70 from the area sensor 74, and performs quantitative analysis of the detection target substance contained in the specimen sample based on the acquired image. The processor 90 also performs adjustment operations for the quantitative analysis.

[0044] The processor 90 performs quantitative analysis of the target substance based on a measurement value corresponding to the photometric region luminance value, which is the luminance value of the reaction region 12A extracted from the image acquired by the photometric unit 70. Specifically, the processor 90 derives the optical density of the reaction region 12A as a measurement value, and derives the concentration of the target substance based on a calibration curve showing the relationship between the optical density and the concentration of the target substance. In this case, the processor 90 extracts a correction luminance value, which is the luminance value of the color plate in the image, in addition to the photometric region luminance value, and corrects the measurement value based on the correction luminance value and the correlation between the preliminary photometric region luminance value and the preliminary correction luminance value, which will be described later, before deriving the concentration of the target substance. Here, "deriving the concentration of the target substance" means quantifying the target substance.

[0045] Furthermore, as an adjustment operation for correcting the measurement values, the processor 90 executes a process for determining the correlation between the preliminary photometry area luminance value and the preliminary correction luminance value between the time when the analysis device 100 is started and the time when photometry unit 70 starts measuring, and then executes a process for storing the correlation. Here, the preliminary photometry area luminance value is the luminance value of the area corresponding to the reaction area 12A in the image acquired by the photometry unit 70 with the reference plate placed at the measurement position. The preliminary correction luminance value is the luminance value of the color plate 75 acquired from the image from which the preliminary photometry area luminance value is acquired, and hereinafter may be referred to as the color plate luminance value. For example, a white plate W (see FIG. 2) provided on the rotating base plate 62 for luminance calibration is used as the reference plate.

[0046] First, the quantitative analysis method and adjustment operation will be described with reference to FIGS. FIG. 6 shows a schematic diagram of image P acquired by processor 90 from photometry unit 70. Image P is an image captured by area sensor 74 with light-emitting elements 73a and 73b turned on and measurement light irradiated onto the reflection area and color plate. In image P, the outline of the circular area in the center is the outline of opening window 62A of rotatable substrate 62. The inside of the circular area is reaction area 12A of analysis chip 12 observed through opening window 62A. The gray components located on both sides of image P are color plate 75. In this example, a gray plate is used as color plate 75.

[0047] During colorimetric measurement of the analytical chip 12, that is, when a specimen sample is dropped into the reaction region 12A and a quantitative analysis of the detection target substance is performed, the processor 90 performs the following process. The light-emitting elements 73a and 73b are turned on, and the area sensor 74 captures an image while irradiating the analysis chip 12 and the color plate 75 with measurement light. The area sensor 74 acquires an image P including at least a portion of the reaction area 12A and the color plate 75, as shown in FIG. 6. The processor 90 acquires the image P from the area sensor 74. The processor 90 determines a predetermined region within the reaction area 12A, for example, the center of the reaction area 12A shown in FIG. 6, as the region of interest ROI1, and derives the average value A of the luminance data within this range as the photometric region luminance value (hereinafter, referred to as the measurement value A). The processor 90 then determines two regions of interest ROI2 and ROI3 on ​​the color plate 75 as extraction regions for correction luminance data, and derives the average value B of the luminance data within this region as the correction luminance value. The processor 90 then corrects the measurement value based on this correction luminance value and the correlation between the preliminary photometric region luminance value and the preliminary correction luminance value. Here, the term "brightness data" refers to the brightness values ​​of multiple pixels contained in a certain region. Therefore, the average value of the brightness data is the sum of the brightness values ​​of each pixel contained in the brightness data divided by the number of pixels. However, instead of the average value of the brightness data, the median value of the brightness data or the mode value of the brightness data may be used.

[0048] The correlation between the preliminary photometry area luminance value and the preliminary correction luminance value is acquired in advance by an adjustment operation. The adjustment operation executed by the processor 90 is as follows. First, the rotatable platform 62 is rotated to place a reference plate (e.g., a white plate W) at the measurement position. With the reference plate positioned at the measurement position, the area sensor 74 acquires multiple images including the reference plate and at least a portion of the color plate 75 while varying the current value passed through the light-emitting elements 73a and 73b. In the images acquired here, the reference plate is observed through the opening window 62A of the rotatable platform 62. The light-emitting elements 73a and 73b are, for example, LEDs. FIG. 7 shows images P1 to P6 captured at current values ​​of 0 mA, 6 mA, 9 mA, 15 mA, 19 mA, and 39 mA passed through the light-emitting elements 73a and 73b. As shown in FIG. 7, the larger the current value, the greater the amount of light emitted (irradiation) by the light-emitting elements 73a and 73b, resulting in a brighter (higher brightness) image.

[0049] The correlation between the preliminary photometry area luminance value and the preliminary correction luminance value is obtained from a plurality of images P1 to P6 in which the light emitting elements 73a and 73b shown in Fig. 7 have different light emission amounts. There are no particular restrictions on the method for obtaining the correlation between the preliminary photometry area luminance value and the preliminary correction luminance value from the plurality of images P1 to P6, and any method may be used. An example of this method will be described below.

[0050] First, from multiple images P1 to P6, the relationship between light-emitting element illuminance and pre-correction luminance values ​​(color plate luminance values) shown in Fig. 8 and the relationship between light-emitting element illuminance and pre-photometric region luminance values ​​shown in Fig. 9 are derived. The color plate luminance values ​​are derived from luminance data of regions of interest ROI2 and ROI3 on ​​the color plate 75 from which correction luminance data is extracted during quantitative analysis of image P shown schematically in Fig. 6. Similarly, the pre-photometric region luminance values ​​are derived from luminance data of a region (i.e., a reference plate) corresponding to region of interest ROI1 in the response region 12A from which photometric region luminance data is extracted during quantitative analysis of image P shown schematically in Fig. 6.

[0051] 8 and 9, the correlation between the preliminary photometry area luminance value and the color plate luminance value shown in Fig. 10 is obtained. In the example shown in Fig. 10, the correlation between the color plate luminance value x and the preliminary photometry area luminance value y is y = 3.5567x - 19.801, and the coefficient of determination R 2= 1 (y = ax + b where a = 3.5567 and b = -19.801). The processor 90 stores in memory the relational expression between the color plate luminance value x and the preliminary photometry area luminance value y. The processes of deriving the above relational expression and storing it are performed in advance by the adjustment operation.

[0052] In quantitative analysis, the processor 90 corrects the measured value A, which is the photometric region luminance value, using the above-mentioned relational expression indicating the correlation between the color plate luminance value obtained in the above adjustment operation and the preliminary photometric region luminance value. Specifically, the processor 90 derives the value A / y, which is the measured value A divided by the relational expression y, as the corrected measured value. If the correlation between the color plate luminance value and the preliminary photometric region luminance value is approximated by a linear function expressed as y=ax+b, as in the case of Figure 10, the processor 90 derives A / (ax+b) as the corrected measured value. In the example of Figure 10, this is A / (3.5567×B−19.801). Here, B is the correction luminance value obtained from the color plate 75 in the image from which the measured value A was obtained. The processor 90 then derives the optical density from the corrected measured value and, based on the optical density obtained from this corrected measured value, derives the concentration of the detection target substance from the calibration curve.

[0053] One possible method for correcting errors in measurement values ​​due to changes in illuminance caused by light-emitting elements 73a and 73b is to divide the photometric region luminance value by the correction luminance value of color plate 75. However, simply dividing the photometric region luminance value by the correction luminance value may not provide sufficient correction. Specifically, if the illuminance distribution changes over repeated measurements due to factors such as deterioration of light-emitting elements 73a and 73b, and the relationship between the illuminance in the reaction region and the illuminance on the color plate changes, simply dividing the photometric region luminance value by the correction luminance value of color plate 75 may not provide sufficient correction.

[0054] In the analysis device 100 of this embodiment, the processor 90 extracts a correction luminance value, which is the luminance value of the color plate, from the image in addition to the photometric region luminance value, and corrects the measurement value based on the correlation between the correction luminance value and the preliminary photometric region luminance value and the preliminary correction luminance value acquired in advance. This allows the measurement value to be corrected with high accuracy even when the illuminance distribution changes due to deterioration of the light-emitting elements 73 a, 73 b, etc., and as a result, highly accurate quantitative analysis can be achieved.

[0055] As described above, the adjustment operation only needs to be performed at least once between the start of the analysis device 100 and the start of photometry by the photometric unit 70 (here, the start of quantitative analysis). The adjustment operation is preferably performed immediately before the start of colorimetric measurement of the analysis chip 12 by the analysis device 100. This is because the illuminance distribution of the light-emitting elements 73a and 73b immediately before the start of colorimetric measurement can be reflected in the correction. However, the adjustment operation may be configured to be performed every time the analysis device 100 is started. If the correlation obtained by this adjustment operation differs from the previous one by a predetermined amount or more, an alert may be issued, thereby functioning as a malfunction alert for the analysis device 100. Furthermore, the adjustment operation may be performed at start-up, and further, if colorimetric measurement is performed a certain time after the start-up of the analysis device 100, the adjustment operation may be configured to be performed immediately before the colorimetric measurement.

[0056] As mentioned above, it is preferable that the optical density of the color plate 75 is 1.5 or less. It is preferable that the color plate 75 is gray or white. This is because the greater the amount of reflected light and the higher the luminance value of the color plate in the image P captured by the area sensor 74, the more accurate the correction.

[0057] In this embodiment, two regions of interest ROI2 and ROI3 on ​​the color plate 75 are used, and the average brightness value of both is used as the brightness value for correction, but the number of regions of interest on the color plate 75 from which brightness data for correction is extracted may be only one, or may be three or more.

[0058] In the above embodiment, the adjustment operation is described as an operation in which, with a reference plate placed at a measurement position, multiple images P1 to P6 are acquired in which the light-emitting elements 73a and 73b have different amounts of light emitted, and a correlation between the pre-correction luminance value and the pre-photometric area luminance value is determined from the multiple images P1 to P6 in which the light-emitting elements 73a and 73b have different amounts of light emitted. The adjustment operation is not limited to the operation in the above embodiment. For example, the adjustment operation may be an operation in which the current value applied to the light-emitting elements 73a and 73b is constant, the area sensor 74 acquires images at multiple different light-receiving times (exposure times), and the correlation between the pre-correction luminance value and the pre-photometric area luminance value is determined from the relationship between the light-receiving time and the pre-correction luminance value and the relationship between the light-receiving time and the pre-photometric area luminance value. The adjustment operation may also be an operation in which an aperture capable of changing the size of the opening is disposed between the light-emitting elements 73a, 73b and the color plate and photometric area, images are acquired with a plurality of different aperture sizes, and the correlation between the pre-correction luminance and the pre-photometric area luminance is determined from the relationship between the aperture size and the pre-correction luminance value and the relationship between the aperture size and the pre-photometric area luminance value.

[0059] The photometric unit 70 of the analytical device 100 of the above embodiment is provided with two light-emitting elements 73a and 73b that emit light in the same wavelength range, but the number of light-emitting elements that emit light in the same wavelength range may be three or more, or may be only one.

[0060] In the above embodiment, the hardware structure of the processor 90 may be any of the following various processors: The various processors include a CPU, which is a general-purpose processor that executes software (programs) and functions as various processing units, as well as dedicated electrical circuits such as a PLD (Programmable Logic Device) whose circuit configuration can be changed after manufacture, such as an FPGA (Field-Programmable Gate Array), and an ASIC (Application Specific Integrated Circuit), which is a processor with a circuit configuration designed specifically for executing specific processing.

[0061] The above-described processing may be performed by one of these various processors, or by a combination of two or more processors of the same or different types (for example, a plurality of FPGAs, or a combination of a CPU and an FPGA). Also, a plurality of processing units may be configured by a single processor. An example of configuring a plurality of processing units by a single processor is a form in which a processor is used that realizes the functions of an entire system including a plurality of processing units by a single IC (Integrated Circuit) chip, such as a System on Chip (SOC).

[0062] Furthermore, more specifically, the hardware structure of these processors can be an electric circuit that combines circuit elements such as semiconductor elements.

[0063] In addition to the operating program of the analytical device, the technology of the present disclosure also extends to a computer-readable storage medium (such as a USB memory or a DVD (Digital Versatile Disc)-ROM (Read Only Memory)) that non-temporarily stores the operating program of the analytical device.

[0064] The above-described description and illustrations are a detailed explanation of the parts related to the technology of the present disclosure and are merely an example of the technology of the present disclosure. For example, the above description of the configuration, functions, actions, and effects is an explanation of an example of the configuration, functions, actions, and effects of the parts related to the technology of the present disclosure. Therefore, it goes without saying that unnecessary parts may be deleted, new elements may be added, or replacements may be made to the above-described description and illustrations within the scope of the gist of the technology of the present disclosure. Furthermore, to avoid confusion and facilitate understanding of the parts related to the technology of the present disclosure, the above-described description and illustrations omit explanations of common technical knowledge that do not require particular explanation to enable the implementation of the technology of the present disclosure.

[0065] All publications, patent applications, and technical standards mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent application, or technical standard was specifically and individually indicated to be incorporated by reference.

[0066] The following additional notes are further disclosed regarding the above embodiment.

[0067] <Appendix 1> a support part that supports an analytical chip having a reaction region for holding a reagent at a measurement position; a photometric unit including a light-emitting element that irradiates a reaction region of the analysis chip with measurement light and an area sensor that captures an image of a predetermined imaging range including the reaction region irradiated with the measurement light; a color plate disposed within the imaging range and having an area onto which the measurement light is irradiated; An analytical device comprising a processor that acquires an image from a photometric unit and performs quantitative analysis of a substance to be detected based on a measurement value corresponding to a photometric region luminance value, which is the luminance value of a reaction region extracted from the acquired image, and that extracts a correction luminance value, which is the luminance value of a color plate, from the image in addition to the photometric region luminance value, and corrects the measurement value based on the correlation between the correction luminance value and a pre-photometric region luminance value, which is the luminance value of a region corresponding to a reaction region acquired in advance using a reference plate, and a pre-correction luminance value, which is the luminance value of the color plate. <Appendix 2> An analytical device as described in Appendix 1, wherein the processor performs an adjustment operation to obtain a correlation between the pre-photometric area luminance value and the pre-correction luminance value between the time of startup and the time when photometry by the photometric unit begins. <Appendix 3> The adjustment operation is an operation of the analytical device described in Appendix 2, in which a reference plate is placed at a measurement position, multiple images with different amounts of light emitted from the light-emitting element are acquired, and the correlation between the pre-photometric area brightness value and the pre-correction brightness value is acquired from the multiple images. <Appendix 4> 4. The analysis device according to claim 1, wherein the correction luminance value is derived from luminance values ​​of multiple regions of the color plate. <Appendix 5> 5. The analytical device according to claim 1, wherein the analytical chip includes a dry reagent as a reagent. <Appendix 6> 6. The analytical device of claim 1, wherein the optical density of the color plate is 1.5 or less. [Explanation of symbols]

[0068] 10: Chipset section 11: Holding stand 11A:Aperture 12: Analysis chip 12A: Reaction area 14: Stocker 16: Carrier 17: Case 17A: Case 1 17B: Second case 17C: Opening 17D:Aperture 17E: Information code 20: Reader 30: Sample application site 31: Chip support stand 40: Chip transport mechanism 42: Chip transport member 44: Drive mechanism 50: Sample application mechanism 52: Nozzle 60: Incubator 62: Rotating substrate 62A: Opening window 64: Pressing member 64A: Pressing surface 65: Holding member 66: Rotating cylinder 67: Bearing 68: Waste hole 69: Heat insulation cover 70: Photometric unit 71: Housing 73: Irradiation device 74: Area sensor 75: Colored board 80: Chip disposal mechanism 82: Chip transport member 84: Drive mechanism 90: Processor 100: Analyzer

Claims

1. a support part that supports an analytical chip having a reaction region for holding a reagent at a measurement position; a light-emitting element that irradiates the reaction area of ​​the analysis chip with measurement light; and a photometric unit that includes an area sensor that captures an image of a predetermined imaging range that includes the reaction area irradiated with the measurement light; a color plate disposed within the imaging range and having an area onto which the measurement light is irradiated; An analytical device comprising: a processor that acquires the image from the photometric unit and performs quantitative analysis of the substance to be detected based on a measurement value corresponding to a photometric region luminance value, which is the luminance value of the reaction region extracted from the acquired image; and a processor that extracts a correction luminance value, which is the luminance value of the color plate, from the image in addition to the photometric region luminance value, and corrects the measurement value based on the correlation between the correction luminance value and a pre-photometric region luminance value, which is the luminance value of the region corresponding to the reaction region acquired in advance using a reference plate, and a pre-correction luminance value, which is the luminance value of the color plate.

2. The analysis device according to claim 1 , wherein the processor performs an adjustment operation to obtain the correlation between the preliminary metering area luminance value and the preliminary correction luminance value between startup and the start of metering by the metering unit.

3. The analysis device of claim 2, wherein the adjustment operation is an operation of acquiring multiple images with different amounts of light emitted by the light-emitting element while the reference plate is placed at the measurement position, and acquiring the correlation between the pre-photometric area brightness value and the correction brightness value from the multiple images.

4. The analysis device according to claim 1 , wherein the correction luminance value is derived from luminance values ​​of a plurality of regions of the color plate.

5. The analytical device according to claim 1 , wherein the analytical chip includes a dry reagent as the reagent.

6. 3. The analyzer according to claim 1, wherein the optical density of the color plate is 1.5 or less.

Images