Analysis device

Abstract

The present invention comprises: a filling unit in which a first analysis chip having a first reaction region for holding a first reagent containing a dry reagent and a second analysis chip having a second reaction region for holding a second reagent not containing a dry reagent are selectively filled as analysis chips; a light measurement unit which comprises a light detector located at a position where both reflected light reflected by the first reaction region and transmitted light transmitted through the second reaction region can be detected, a first light source for irradiating the first reaction region with first measurement light for producing the reflected light, and a second light source for irradiating the second reaction region with second measurement light for producing the transmitted light; and a processor which controls the light measurement unit.

Description

Analyzer

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

[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 equipped with a reagent layer containing a dry reagent.

[0003] In an analytical device, a measurement light is irradiated onto the reagent layer on which the specimen sample has been dropped, and the reflected light is detected to detect the reaction product produced by the reaction between the substance to be detected and the reagent. For this reason, the analytical device is equipped with a photometric unit that irradiates the analytical chip with measurement light and detects the reflected light.

[0004] JP 2016-526687 A relates to a rapid diagnostic test cassette reader, and discloses a configuration that enables detection of a test line in a reflection mode or a transmission mode depending on the cassette of an immunochromatographic assay.

[0005] An analytical chip equipped with a reagent layer containing a dry reagent (hereinafter referred to as a dry analytical chip) is easy to handle and enables simple measurements. On the other hand, the reaction between the dry reagent and the sample is limited by the thickness of the reagent layer, and the optical path length when the measurement light passes through the reaction layer between the reagent and the sample is very short. Therefore, when the molecular weight of the reaction product is small or the amount is small, sufficient sensitivity may not be obtained. Therefore, when the molecular weight of the reaction product is small or the amount is small, it is desirable to perform measurements using an analytical chip that holds a liquid reagent rather than a dry reagent (hereinafter referred to as a wet analytical chip).

[0006] The technology of the present disclosure has been made in consideration of the above circumstances, and aims to provide an analytical device capable of performing analysis on both dry analytical chips and wet analytical chips.

[0007] The analytical device of the present disclosure is an analytical device for analyzing a specimen sample using an analytical chip onto which the specimen sample is deposited, comprising: a loading section for selectively loading a first analytical chip having a first reaction area for holding a first reagent including a dry reagent, or a second analytical chip having a second reaction area for holding a second reagent not including a dry reagent, as the analytical chip; a photometric unit for optically measuring a reaction in the first reaction area between a detection target substance in the specimen sample and the first reagent, or a reaction in the second reaction area between the detection target substance and the second reagent, the photometric unit comprising a photodetector arranged at a position capable of detecting both reflected light reflected by the first reaction area and transmitted light passing through the second reaction area, a first light source for irradiating the first reaction area with a first measurement light to obtain the reflected light, and a second light source for irradiating the second reaction area with a second measurement light to obtain the transmitted light; and a processor for controlling the photometric unit. An analytical device in which the processor causes the photometric unit to perform measurement using a first light source when the analytical chip loaded in the loading section is a first analytical chip, and causes the photometric unit to perform measurement using a second light source when the analytical chip loaded in the loading section is a second analytical chip.

[0008] In the analysis device, the photodetector is preferably an area sensor.

[0009] The analysis device preferably includes a temperature control unit that controls the temperature of the first light source and the second light source within a predetermined range of 30°C to 60°C.

[0010] It is preferable that the analytical chip has a case on which information regarding whether or not it contains a dry reagent is provided, the analytical device further includes an information reader that reads the information provided on the case, and the processor is configured to selectively operate either the first light source or the second light source based on the information obtained from the information reader.

[0011] The analytical chip may have a flat plate shape with a reaction area on its main surface, and the loading section may include a substrate on which the analytical chip is placed, and a chip pressing section having a pressing surface arranged opposite the reaction area of ​​the analytical chip placed on the substrate and pressing the analytical chip, and a second light source may be installed within the chip pressing section and irradiate the reaction area with second measurement light from the pressing surface.

[0012] According to the technology of the present disclosure, an analytical device capable of performing analysis on both dry analytical chips and wet analytical chips can be provided.

[0013] FIG. 1 is a schematic diagram of an analytical device of an embodiment. FIG. 2 is a diagram explaining the configuration of a first analytical chip having a dry reagent. FIG. 3 is a diagram explaining the configuration of a second analytical chip not having a dry reagent. FIG. 4 is a schematic diagram of the measurement unit of the analytical device, showing a state in which a first analytical chip is loaded. FIG. 5 is a schematic diagram of the measurement unit of the analytical device, showing a state in which a second analytical chip is loaded. FIG. 6 is a diagram explaining the processing steps in the measurement unit. FIG. 7 is a diagram explaining the configuration of a measurement unit according to a modified embodiment. FIG. 8 is an image of a second reaction region taken with the analytical device of an example. FIG. 9 is a graph showing the measurement results measured with the analytical device of an example.

[0014] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of the present invention will now be described with reference to the accompanying drawings, in which the same components are designated by the same reference numerals.

[0015] 1 is an example of an analytical device for analyzing a specimen sample, and uses two analytical chips, a first analytical chip 10 and a second analytical chip 20, to measure the concentration of a detection target substance contained in the specimen sample S. More specifically, the analytical device 100 of this example uses blood as the specimen sample S and optically measures the concentration of the detection target substance contained in the blood. More specifically, the specimen sample S is, for example, whole blood, serum, or plasma.

[0016] The analytical device 100 has a dispensing mechanism P, a measurement unit 110, an information reader 120, and a processor 170. The dispensing mechanism P supplies a specimen sample S to the first analytical chip 10 and the second analytical chip 20. The measurement unit 110 performs a process of measuring the concentration of a detection target substance using the first analytical chip 10 and the second analytical chip 20 to which the specimen sample S has been supplied. The first analytical chip 10 and the second analytical chip 20 are selectively loaded into the measurement unit 110. The information reader 120 reads whether the analytical chip loaded into the measurement unit 110 is the first analytical chip 10 or the second analytical chip 20. The processor 170 controls each unit of the analytical device 100 overall.

[0017] First, the two analytical chips 10 and 20 used in the analysis device 100 will be described.

[0018] The first analytical chip 10 is a dry analytical chip and has a first reaction area A1 that holds a first reagent 11, which is a dry reagent. Here, "dry analytical chip" refers to an analytical chip that holds a first reagent 11 containing a dry reagent. The first reagent 11 reacts with a detection target substance to produce a substance that develops a specific color. The substance that develops color through this reaction will be referred to as a reactant hereinafter. The first reagent 11 is a solid-phase dry reagent that is in a dry state at least at the time of shipment. The specimen sample S is deposited into the first reaction area A1 of the first analytical chip 10 by a dispensing mechanism P.

[0019] Fig. 2 is an external perspective view showing an example of the structure of the first analytical chip 10. As shown in Fig. 2, the first analytical chip 10 has a thin plate-like outer shape and has a first reaction region A1 in the center of which a first reagent 11 is fixed.

[0020] The first analytical chip 10 has a carrier 16 onto which a specimen sample S 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. An opening 17C that functions as a drip port for depositing the specimen sample S into the first reaction area A1 is formed in the first case 17A. An opening 17D that is used to irradiate the first reaction area A1 with light is formed in the second case 17B. The carrier 16 is exposed to the opening 17C of the first case 17A, which constitutes the front surface of the first analytical chip 10. The carrier 16 is also exposed to the opening 17D of the second case 17B, which constitutes the back surface of the first analytical chip 10. The area exposed to the openings 17C and 17D constitutes the first reaction area A1.

[0021] The second analytical chip 20 is a wet analytical chip and has a second reaction area A2 that holds a second reagent 21 that does not contain a dry reagent. The second reagent 21 is a liquid reagent. The second analytical chip 20 has a liquid chamber 22 that contains the second reagent 21, and the liquid chamber 22 constitutes the second reaction area A2. Here, the term "wet analytical chip" refers to an analytical chip that, unlike a dry analytical chip, does not have a carrier that holds a dry reagent, and that mixes the specimen sample S with the liquid second reagent 21 to analyze the specimen as a solution. The second reagent 21 may be pre-stored in the liquid chamber 22, or the second reagent 21 may be supplied before or after the specimen sample S is supplied to the liquid chamber 22 by the dispensing mechanism P, or together with the specimen sample S. The second reagent 21 is, for example, a latex reagent containing latex particles that undergo agglutination upon reaction with the target substance.

[0022] 1, the second analysis chip 20 has a thin plate-like outer shape similar to the first analysis chip 10, and is provided with a liquid chamber 22 and openings 24 and 25 that communicate with the liquid chamber 22 and are used to supply a specimen sample S and a second reagent 21. FIG.

[0023] The second analytical chip 20 has a liquid chamber 22 enclosed in a case 27. The case 27 is composed of a case body 27A in which a recess 23 is formed, and a lid 27B that is joined to the case body 27A so as to cover the recess 23. The liquid chamber 22 is formed by the recess 23 of the case body 27A and the lid 27B that covers the recess 23. The lid 27B has two openings 24 and 25 that communicate with the liquid chamber 22. In this example, as an example, a second reagent 21, which is a liquid reagent, is previously contained in the liquid chamber 22. The specimen sample S is dispensed into the liquid chamber 22 from the opening 24 or 25 by a dispensing mechanism P.

[0024] The first analytical chip 10 and the second analytical chip 20 are each provided with an information code C that encodes item information related to the measurement item. In the first analytical chip 10 of this example, the information code C is provided on the second case 17B that constitutes the back surface of the first analytical chip 10. In the second analytical chip 20 of this example, the information code C is provided on the bottom surface of the case body 27A that constitutes the back surface of the second analytical chip 20. The item information may be identification information of the reagent (such as the reagent name and identification code) or identification information of the measurement item measured by the reagent (such as the item name and identification code). Since the type of reagent determines whether it is a dry reagent or a liquid reagent, the identification information of the reagent is an example of "information related to the presence or absence of a dry reagent" in the technology of the present disclosure. Note that the detection target substance detected by the first analytical chip 10 and the detection target substance detected by the second analytical chip 20 are different substances.

[0025] The information reader 120 is, for example, a code reader that reads the information code C attached to the first analytical chip 10 and the second analytical chip 20. The information reader 120 is configured with an image sensor such as a CCD (Charge Coupled Device) and a CMOS (Complementary Metal Oxide Semiconductor). The information code C read by the information reader 120 is output to the processor 170. The processor 170 acquires the information code C from the information reader 120 and identifies whether the analytical chip to be loaded is the first analytical chip 10 or the second analytical chip 20.

[0026] The configuration of the measurement unit 110 of the analysis device 100 will be described with reference to Figures 4 and 5. The measurement unit 110 includes a loading unit 130 and a photometric unit 140. The loading unit 130 is selectively loaded with an analytical chip to be measured from the first analytical chip 10 and the second analytical chip 20, and holds the analytical chip to be measured. Figure 4 shows a state in which the first analytical chip 10 having a first reagent 11 is loaded in the loading unit 130. Figure 5 shows a state in which the second analytical chip 20 having a second reagent 21 is loaded in the loading unit 130.

[0027] In this example, the loading section 130 is composed of a substrate 132 and a chip pressing section 134. The first analytical chip 10 and the second analytical chip 20 are selectively placed on the substrate 132. The chip pressing section 134 has a pressing surface 134a disposed opposite the first reaction area A1 of the first analytical chip 10 or the second reaction area A2 of the second analytical chip 20 placed on the substrate 132, and presses the first analytical chip 10 or the second analytical chip 20 loaded in the loading section 130.

[0028] The photometric unit 140 acquires a detection signal representing the optical density of the first reaction area A1 using the first analytical chip 10 onto which the specimen sample S has been dispensed, and also acquires a detection signal representing the optical density of the second reaction area A2 using the second analytical chip 20 onto which the specimen sample S has been dispensed.

[0029] The photometric unit 140 includes a photodetector 142, a first light source 144, and a second light source 146. The photometric unit 140 optically measures the reaction between the detection target substance and the first reagent 11 in the first reaction area A1, or the reaction between the detection target substance and the second reagent 21 in the second reaction area A2.

[0030] The photodetector 142 is disposed at a position where it can detect both the reflected light Lr reflected by the first reaction area A1 and the transmitted light Lt transmitted through the second reaction area A2. In this example, the photodetector 142 is disposed below the first analytical chip 10 or the second analytical chip 20 loaded in the loading section 130, and at a position facing the first analytical chip 10 or the second analytical chip 20.

[0031] As shown in FIG. 4 , the first light source 144 irradiates the first reaction area A1 with a first measurement light L1 to obtain reflected light Lr. In this example, the first light source 144 includes two light sources, 144a and 144b. The light source 144b is positioned approximately 180° rotated around the reflected light axis from the light source 144a. The two light sources 144a and 144b each irradiate the first reaction area A1 with the first measurement light L1 from a direction inclined with respect to the normal to the first reaction area A1 of the first analytical chip 10 loaded in the loading section 130. The reflected light Lr from the first reaction area A1 irradiated with the first measurement light L1 is detected by the photodetector 142.

[0032] 5, the second light source 146 irradiates the second reaction area A2 with a second measurement light L2 to obtain transmitted light Lt. In this example, the second light source 146 is embedded in the chip pressing part 134 of the loading part 130. At least a portion of the chip pressing part 134 that serves as the optical path of the second measurement light L2 is made of a material that is transparent or translucent to the second measurement light L2. The second measurement light L2 output from the second light source 146 is irradiated onto the reaction area A2 of the analysis chip 20, and the transmitted light Lt is detected by the photodetector 142.

[0033] The photodetector 142 is, for example, a light-receiving element such as a photodiode that outputs a detection signal according to the amount of light. The photodetector 142 does not have to have a single light-receiving element, but may have multiple light-receiving elements. An area sensor may also be used as the photodetector 142. The area sensor is, for example, a CMOS image sensor or a CCD image sensor, and has an imaging surface on which multiple light-receiving elements are arranged two-dimensionally.

[0034] As described above, a reaction substance that develops a specific color is produced by the reaction between the detection target substance and the first reagent 11. The first measurement light L1 emitted by the first light source 144 is light for detecting whether or not a reaction substance is produced, and therefore, the wavelength range of the first measurement light L1 is determined according to the color developed by the reaction substance. As described above, the first measurement light L1 is, for example, light including a wavelength range absorbed by the reaction substance in order to detect the reaction substance.

[0035] The wavelength range of the first measurement light L1 is preferably limited to a wavelength range absorbed by the reactant. This is because light in such a wavelength range provides the highest optical density contrast depending on the presence or absence of the reactant. The first light source 144 may be, for example, a light source such as an LED (Light Emitting Diode), an organic EL (Electroluminescence), or a semiconductor laser. Alternatively, detection light limited to a specific wavelength range may be generated by combining a light source that emits light in a relatively broad wavelength range, such as a white light source, with a bandpass filter that transmits only light in a specific wavelength range.

[0036] The second measurement light L2 may also have a wavelength selected according to the second reagent 21. For example, if the second reagent 21 is a latex reagent, the second measurement light L2 may have a wavelength range absorbed by latex aggregates in order to detect a change in absorbance due to a latex agglutination reaction. The second light source 146 may also be, for example, an LED, an organic electroluminescent (EL), or a semiconductor laser.

[0037] The processor 170 comprehensively controls each part of the analysis device 100. The photometric unit 140 is also controlled by the processor 170. The processor 170 is configured, for example, by a CPU (Central Processing Unit), and executes a program to perform measurement processing in the analysis device 100.

[0038] The processor 170 identifies whether the analytical chip loaded in the loading section 130 is the first analytical chip 10 or the second analytical chip 20 based on the information code C acquired from the information reader 120. When the analytical chip loaded in the loading section 130 is the first analytical chip 10, the processor 170 causes the photometric unit 140 to perform measurement using the first light source 144, and when the analytical chip loaded in the loading section 130 is the second analytical chip 20, the processor 170 causes the photometric unit 140 to perform measurement using the second light source 146. When the processor 170 has performed measurement using the first light source 144, the processor 170 acquires from the photodetector 142 a first detection signal corresponding to the reflected light Lr detected by the photodetector 142, and derives the concentration of the detection target substance based on the first detection signal. In addition, when a measurement is performed using the second light source 146, the processor 170 acquires a second detection signal from the photodetector 142 corresponding to the transmitted light Lt detected by the photodetector 142, and derives the concentration of the substance to be detected based on the second detection signal.

[0039] 4 and 5, the photodetector 142 is disposed at a position opposite to an opening 132a provided in the substrate 132 of the loading section 130. The opening 132a is provided at a position where the opening 17D of the case 17 of the first analytical chip 10 loaded in the loading section 130 is exposed, and at a position corresponding to the liquid chamber 22 of the second analytical chip 20 loaded in the loading section 130. The two light sources 144a and 144b constituting the first light source 144 are disposed at positions where they irradiate the first measurement light L1 obliquely with respect to the opening 17D. The second light source 146 is disposed opposite to the photodetector 142 and at a position where they irradiate the second reaction region A2 perpendicularly with the second measurement light L2. This layout of the photodetector 142, first light source 144, and second light source 146 is an example, and various modifications are possible. For example, by using a light-guiding member that guides the first measurement light L1, reflected light Lr, second measurement light L2, or transmitted light Lt between the opening 132a of the substrate 132 and the photodetector 142 and the first light source 144, and / or between the liquid chamber 22 of the second analysis chip 20 and the photodetector 142 and the second light source 146, the positions of the photodetector 142, the first light source 144, and the second light source 146 can be moved to various positions.

[0040] The processing procedure in the analysis device 100 according to the first embodiment is as follows.

[0041] First, the information code C of the first analytical chip 10 or the second analytical chip 20 loaded in the measurement unit 110 is read by the information reader 120. The information code C read by the information reader 120 is output to the processor 170.

[0042] A specimen sample S is dispensed by a dispensing mechanism P into the first analytical chip 10 or the second analytical chip 20 whose information code C has been read by the information reader 120. In the first analytical chip 10, the specimen sample S is deposited in the first reaction area A1, and in the second analytical chip 20, the specimen sample S is dispensed into the liquid chamber 22, i.e., the second reaction area A2. The first analytical chip 10 or the second analytical chip 20 is then loaded into the measurement unit 110. In the measurement unit 110, a measurement is performed on the loaded first analytical chip 10 or second analytical chip 20.

[0043] FIG. 6 shows the processing steps performed by the processor 170 of the measurement unit 110.

[0044] First, the processor 170 acquires information from the information reader 120 as to whether the loaded analytical chip is the first analytical chip 10 or the second analytical chip 20 (step ST1). The timing for acquiring this information may be before or after loading the analytical chip into the loading section 130.

[0045] If the loaded analytical chip is the first analytical chip 10 (step ST2: Yes), the processor 170 causes the photometric unit 140 to perform measurement using the first light source 144 (step ST3). As a result, the first light source 144 irradiates the first reaction area A1 of the first analytical chip 10 with the first measurement light L1, and the photodetector 142 detects the reflected light Lr.

[0046] If the loaded analytical chip is the second analytical chip 20 (step ST2: No), the processor 170 causes the photometric unit 140 to perform measurement using the second light source 146 (step ST4). As a result, the second light source 146 irradiates the second reaction area A2 of the second analytical chip 20 with the second measurement light L2, and the photodetector 142 detects the transmitted light Lt.

[0047] The processor 170 acquires a detection signal from the photodetector 142 (step ST5). The detection signal acquired from the photodetector 142 is a first detection signal corresponding to the reflected light Lr or a second detection signal corresponding to the transmitted light Lt.

[0048] The processor 170 executes a step of deriving the concentration of the detection target substance based on the first detection signal or the second detection signal (step ST6), thereby completing the measurement process for the first analytical chip 10 or the second analytical chip 20, which is the analytical chip loaded in the loading section 130.

[0049] Thus, the analytical device 100 of this embodiment includes a loading section 130 into which a first analytical chip 10 having a dry reagent and a second analytical chip 20 not having a dry reagent are selectively loaded, a photodetector 142 positioned to detect both reflected light Lr reflected by the first reaction area A1 of the first analytical chip 10 and transmitted light Lt passing through the second reaction area A2 of the second analytical chip 20, and a photometric unit 140 including a first light source 144 that irradiates the first reaction area A1 with a first measurement light L1 to obtain the reflected light Lr, and a second light source 146 that irradiates the second reaction area A2 with a second measurement light L2 to obtain the transmitted light Lt. The analytical device 100 configured as described above enables analysis using either a dry analytical chip or a wet analytical chip. By detecting the reflected light Lr of the first measurement light L1 for the first analytical chip 10 and the transmitted light Lt of the second measurement light L2 for the second analytical chip 20, measurements suitable for both dry and wet methods can be performed, and highly accurate measurement results can be obtained for each target substance. When the target substance reacts with the reagent to produce a reaction product with a small molecular weight or a trace amount, the second analytical chip 20, which is a wet analytical chip, is used, and when the reaction product has a relatively large molecular weight, the first analytical chip 10, which is a dry analytical chip, is used. In the analytical device 100, the loading section 130 and the photometric unit 140 are used in common for the first analytical chip 10 and the second analytical chip 20, allowing the device to be configured more compactly than when separate loading sections and photometric units are provided for the first analytical chip 10 and the second analytical chip 20.

[0050] In this example, the processor 170 identifies whether it is the first analytical chip 10 or the second analytical chip 20 based on the information code obtained from the information reader 120, and causes the photometric unit 140 to perform measurement using the first light source 144 or the second light source 146. In this way, if the analytical device 100 is configured to read the type of analytical chip and select a light source to operate according to the type of analytical chip, the user does not need to specify the type of analytical chip, which is highly convenient.

[0051] However, the analytical device of the present disclosure may not be equipped with an information reader 120, and information as to whether the loaded analytical chip is the first analytical chip 10 or the second analytical chip 20 may be input to the analytical device 100 from an external input means.

[0052] In the analytical device 100, when an area sensor is used as the photodetector 142 of the photometric unit 140, "detecting reflected light Lr from the first reaction area A1" means capturing an image of the first reaction area A1, and "detecting transmitted light Lt transmitted through the second reaction area A2" means capturing an image of the second reaction area A2. When the second analytical chip 20 is used, bubbles may occur in the liquid containing the liquid reagent (second reagent 21) and the specimen sample S in the liquid chamber 22. The generation of bubbles affects the amount of transmitted light Lt. If the presence or absence of bubbles causes the detected light amount, i.e., the detected optical density, to fluctuate, resulting in a detection error of the concentration of the target substance. By capturing images using an area sensor, the presence or absence of bubbles in the second reaction area A2 can be easily detected. Therefore, if bubbles occur, an alert can be issued to the user, or the optical density can be detected from data excluding the bubble portion, thereby minimizing the impact of bubbles on the measurement results.

[0053] 7, the analysis device 100 preferably further includes a first temperature adjustment unit 151 that adjusts the temperature of the first light source 144 and a second temperature adjustment unit 152 that adjusts the temperature of the second light source 146 in the measurement unit 110. The first temperature adjustment unit 151 and the second temperature adjustment unit 152 include, for example, a heater and a temperature sensor.

[0054] In the example shown in FIG. 7 , the first temperature adjustment unit 151 is provided, for example, on the back surface of the substrate of the two light sources 144a and 144b that make up the first light source 144. The second temperature adjustment unit 152 is provided in the chip pressing unit 134. If the chip pressing unit 134 is made of a material with high thermal conductivity, such as metal, the temperature of the second light source 146 can be adjusted by providing the second temperature adjustment unit 152 outside the chip pressing unit 134. The locations of the first temperature adjustment unit 151 and the second temperature adjustment unit 152 are not limited to this. The first temperature adjustment unit 151 and the second temperature adjustment unit 152 may be provided anywhere as long as they can control the temperatures of the first light source 144 and the second light source 146, respectively.

[0055] The first temperature controller 151 and the second temperature controller 152 are also controlled by the processor 170. The processor 170 controls the first temperature controller 151 and the second temperature controller 152 so that the first light source 144 and the second light source 146 are each within a predetermined range of 30°C to 60°C. Temperature fluctuations may cause changes in the intensity of the measurement light L1 and L2. Because the intensity of the reflected light Lr and the transmitted light Lt varies depending on the intensity of the measurement light L1 and L2, fluctuations in the intensity of the measurement light L1 and L2 can result in errors in the concentration of the target substance being measured. By providing the temperature controllers 151 and 152 and controlling the temperature of the first light source 144 and the second light source 146 to be within a certain temperature range, measurement errors can be reduced. A predetermined range of 30°C to 60°C refers to a range of a specific temperature within the temperature range of 30°C to 60°C plus or minus a few degrees Celsius, such as 40°C plus or minus 3°C.

[0056] In the above embodiment, the hardware structure of the processor 170 may be any of the following 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 having a circuit configuration specifically designed to execute specific processing.

[0057] 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 (e.g., a plurality of FPGAs, or a combination of a CPU and an FPGA). Furthermore, 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 system-on-chip (SOC), in which a processor is used to realize the functions of an entire system including a plurality of processing units on a single IC (Integrated Circuit) chip.

[0058] Furthermore, more specifically, the hardware structure of these processors can be an electric circuit that combines circuit elements such as semiconductor elements.

[0059] In addition to the operating program of the analytical device, the technology disclosed herein 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.

[0060] An analytical device was prototyped in which the photometric unit of a conventional analytical device for dry analytical chips (for example, the device disclosed in WO 2013 / 161664) was replaced with a photometric unit 140 having a photodetector 142, a first light source 144, and a second light source 146 disposed inside the chip pressing portion 134, as shown in Figures 4 and 5. The prototype analytical device is configured to be capable of performing measurements using dry analytical chips as before. A CMOS camera was arranged as the photodetector 142, and the detection target substance in the specimen sample was measured using a second analytical chip 20, which is a wet analytical chip.

[0061] FIG. 8 shows an image 148 of the second reaction area A2 obtained by irradiating the second reaction area A2 of the second analysis chip 20 with the second measurement light L2 using the second light source 146 and capturing the transmitted light Lt with a CMOS camera.

[0062] Here, HbA1c (hemoglobin A1c) was measured using latex agglutination immunoturbidimetry. Multiple specimen samples containing different concentrations of HbA1c were prepared, and an image 148 of the second reaction area A2, as shown in FIG. 8, was acquired for each specimen sample. A brightness value profile showing the relationship between brightness and position on a horizontal line (see FIG. 8) passing through the optical axis was derived from the acquired image 148 for each specimen sample by image analysis, and the peak value of the profile was converted to an optical density (OD) value. As a result, an OD value proportional to the HbA1c concentration was obtained, as shown in FIG. 9. The OD value in FIG. 9 is the average value of three measurements (n=3) performed for each HbA1c concentration.

[0063] In this way, by applying the measurement unit 110 of the analysis device 100 of the above embodiment to a conventional analysis device for dry analysis chips, it has been possible to realize an analysis device that can be used with both dry analysis chips and wet analysis chips.

[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] The disclosure of Japanese Patent Application No. 2023-156444, filed on September 21, 2023, is incorporated herein by reference in its entirety. All documents, patent applications, and technical standards described herein are incorporated herein by reference to the same extent as if each individual document, patent application, and technical standard were specifically and individually indicated to be incorporated by reference.

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

[0067] <Supplementary Note 1> An analytical device for analyzing a specimen sample using an analytical chip onto which the specimen sample is deposited, comprising: a loading section for selectively loading a first analytical chip having a first reaction area for holding a first reagent including a dry reagent, or a second analytical chip having a second reaction area for holding a second reagent not including a dry reagent, as the analytical chip; a photometric unit for optically measuring a reaction in the first reaction area between a detection target substance in the specimen sample and the first reagent, or a reaction in the second reaction area between the detection target substance and the second reagent, the photometric unit comprising a photodetector arranged at a position capable of detecting both reflected light reflected by the first reaction area and transmitted light passing through the second reaction area, a first light source for irradiating the first reaction area with a first measurement light to obtain the reflected light, and a second light source for irradiating the second reaction area with a second measurement light to obtain the transmitted light; and a processor for controlling the photometric unit, an analytical device, wherein the processor causes the photometric unit to perform measurement using the first light source when the analytical chip loaded in the loading section is the first analytical chip, and causes the photometric unit to perform measurement using the second light source when the analytical chip loaded in the loading section is the second analytical chip. <Supplementary Note 2> The analytical device according to Supplementary Note 1, wherein the photodetector is an area sensor. <Supplementary Note 3> The analytical device according to Supplementary Note 1 or Supplementary Note 2, which is provided with a temperature control unit that controls the temperatures of the first light source and the second light source to within a predetermined range of 30°C to 60°C. <Supplementary Note 4> The analytical device according to any one of Supplementary Notes 1 to 3, wherein the analytical chip has a case on which information regarding whether or not a dry reagent is contained is provided, and further comprises an information reader that reads the information provided on the case, and the processor selectively operates either the first light source or the second light source based on information acquired from the information reader. <Supplementary Note 5> The analytical device according to any one of Supplementary Note 1 to Supplementary Note 4, wherein the analytical chip has a flat plate shape with a reaction region on its main surface, the loading unit comprises a substrate on which the analytical chip is placed and a chip pressing unit having a pressing surface arranged opposite the reaction region of the analytical chip placed on the substrate and pressing the analytical chip, and the second light source is installed in the chip pressing unit and irradiates the reaction region with second measurement light from the pressing surface.

Claims

1. An analytical device for analyzing a specimen sample using an analytical chip onto which the specimen sample is applied, comprising: a loading section for selectively loading, as the analytical chip, a first analytical chip having a first reaction area for holding a first reagent including a dry reagent, and a second analytical chip having a second reaction area for holding a second reagent not including the dry reagent; a photometric unit for optically measuring a reaction in the first reaction area between a detection target substance in the specimen sample and the first reagent, or a reaction in the second reaction area between the detection target substance and the second reagent, the photometric unit comprising a photodetector disposed at a position capable of detecting both reflected light reflected at the first reaction area and transmitted light passing through the second reaction area, a first light source for irradiating a first measurement light to obtain the reflected light toward the first reaction area, and a second light source for irradiating a second measurement light to obtain the transmitted light toward the second reaction area; and a processor for controlling the photometric unit, The processor, when the analytical chip loaded in the loading section is the first analytical chip, causes the photometric unit to perform measurement using the first light source, and when the analytical chip loaded in the loading section is the second analytical chip, causes the photometric unit to perform measurement using the second light source.

2. The analytical device according to claim 1, wherein the light detector is an area sensor.

3. An analytical device as described in claim 1 or 2, further comprising a temperature control unit that controls the temperature of the first light source and the second light source within a predetermined range of 30°C to 60°C.

4. The analytical device described in claim 1 or 2, wherein the analytical chip has a case on which information regarding whether or not the dry reagent is contained, and further comprises an information reader that reads the information on the case, and the processor selectively operates either the first light source or the second light source based on the information obtained from the information reader.

5. The analytical device described in claim 1 or 2, wherein the analytical chip has a flat plate shape with a reaction area on its main surface, the loading section comprises a substrate on which the analytical chip is placed and a chip pressing section having a pressing surface arranged opposite the reaction area of ​​the analytical chip placed on the substrate and pressing the analytical chip, and the second light source is installed within the chip pressing section and irradiates the second measurement light from the pressing surface to the reaction area.

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