Analytical device and analytical method

Abstract

To provide an analysis device and an analysis method that can measure a concentration of a substance to be tested in a specimen sample with higher accuracy than before in a case of analyzing the specimen sample using an analysis chip.SOLUTION: An analysis device uses an analysis chip having two regions of a first region which has a reagent reacting with a substance to be tested and a second region which does not have the reagent. The analysis device comprises: a first light source that irradiates the first region with light from a first surface side; a second light source that irradiates the second region with light from a second surface side; a first photodetector that detects first output light which is output from the first region, and outputs a first detection signal corresponding to the first output light; a second photodetector that detects second output light which is output from the second region, and outputs a second detection signal corresponding to the second output light; and a processor that acquires the first detection signal from the first photodetector and acquires the second detection signal from the second photodetector and corrects the first detection signal with the second detection signal to derive a concentration of the substance to be tested.SELECTED DRAWING: Figure 4

Description

[Technical Field]

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

[0002] In the field of point-of-care testing (POCT), analytical devices that analyze specimens, such as measuring the concentration of a test substance contained in the specimen, are known. Blood testing is one example of specimen sample analysis. Blood testing involves devices that measure the concentration of a test substance contained in blood, and there is a growing demand for shorter measurement times and more compact devices. To meet this demand, analytical chips are used to eliminate pretreatment processes such as centrifuging plasma from whole blood. For example, Patent Document 1 discloses an analytical device that performs optical blood testing using an analytical chip that includes a development layer for developing blood as a specimen sample and a reaction layer containing a reagent. The analytical device described in Patent Document 1 includes a first optical detector that detects reflected light from the analytical chip and a second optical detector that detects transmitted light from the analytical chip.

[0003] When using the above analytical chip, when a specimen sample is deposited on the spreading layer of the analytical chip, the specimen sample spreads in the spreading layer, and when it reaches the reaction layer, the substance to be tested in the specimen sample reacts with the reagent in the reaction layer to produce a colored reaction substance. In the analytical device described in Patent Document 1, the reaction layer where the specimen sample and the reagent react is irradiated with detection light from a light source, which includes light of a wavelength that is absorbed by the colored reaction substance, and a detection signal corresponding to the light reflected from the reaction layer is obtained, thereby making it possible to measure the concentration of the substance to be tested in the specimen sample. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Publication No. 2012-211782 Summary of the Invention [Problem to be solved by the invention]

[0005] However, since the specimen sample developed on the analytical chip contains various substances other than the substance to be tested, the detection signal corresponding to the reflected light from the reaction layer where the specimen sample reacts with the reagent may contain noise signals resulting from substances that do not react with the reagent. Therefore, the analyzer described in Patent Document 1, which acquires only the detection signal from the reaction layer, has room for improvement in order to perform highly accurate concentration measurements.

[0006] The technology of the present disclosure provides an analytical device and analytical method that, when analyzing a sample using an analytical chip, can measure the concentration of a test substance in a sample with higher accuracy than conventional methods. [Means for solving the problem]

[0007] An analytical device according to one embodiment of the present disclosure is an analytical device for analyzing a specimen sample containing a substance to be tested, and uses an analytical chip having two regions, a first region having a reagent that reacts with the substance to be tested and a second region that does not have a reagent, the first region being provided on a first surface and the second region being provided on a second surface opposite the first surface, and is equipped with: a first light source that irradiates light onto the first region from the first surface side of the analytical chip; a second light source that irradiates light onto the second region from the second surface side of the analytical chip; a first photodetector that detects first output light output from the first region when light is irradiated onto the analytical chip from the first light source, and outputs a first detection signal corresponding to the first output light; a second photodetector that detects second output light output from the second region when light is irradiated onto the analytical chip from the second light source, and outputs a second detection signal corresponding to the second output light; and a processor that acquires the first detection signal from the first photodetector and the second detection signal from the second photodetector, and derives the concentration of the substance to be tested by correcting the first detection signal with the second detection signal.

[0008] In the analyzer of the above aspect, the first photodetector and the second photodetector may detect light at different timings.

[0009] Furthermore, in the analytical device of the above aspect, the first photodetector is an image sensor having an imaging surface on which a plurality of light receiving elements are arranged two-dimensionally, and is an image sensor capable of imaging the first region and outputting the first region image obtained by imaging the first region as a first detection signal, and the processor may identify a development region in which the specimen sample has developed within the first region based on the first region image, and correct the first detection signal according to the development region.

[0010] In addition, in the analytical device of the above aspect, the second photodetector is an image sensor having an imaging surface on which a plurality of light-receiving elements are arranged two-dimensionally, and is an image sensor that is capable of imaging the second region and outputting the second region image obtained by imaging the second region as a second detection signal, and the processor may identify a development region in the second region where the specimen sample has developed based on the second region image, and correct the second detection signal according to the development region.

[0011] In the analyzer of the above aspect, the wavelength range of the light emitted by the first light source and the second light source includes light in a specific wavelength range determined according to at least one of the test target substance and the reagent.

[0012] In the analyzer of the above aspect, the first light source and the second light source may be capable of emitting light in a plurality of different wavelength ranges as the specific wavelength range.

[0013] In the analyzer of the above aspect, the reagent may be a dry reagent.

[0014] In the analyzer of the above aspect, the specimen sample may be whole blood, and the test target substance may be a specific substance contained in plasma or serum.

[0015] Another aspect of the present disclosure is a method for manufacturing a semiconductor device comprising: An analytical method for analyzing a specimen sample containing a substance to be tested, using an analytical chip having two regions, a first region having a reagent that reacts with the substance to be tested and a second region not having the reagent, with the first region being provided on a first surface and the second region being provided on a second surface opposite the first surface, comprising the steps of: irradiating light from a first light source onto the first region of the analytical chip from the first surface side; irradiating light from a second light source onto the second region of the analytical chip from the second surface side; detecting first output light output from the first region when light from the first light source is irradiated onto the analytical chip by a first photodetector and acquiring a first detection signal output by the first photodetector; detecting second output light output from the second region when light from the second light source is irradiated onto the analytical chip by a second photodetector and acquiring a second detection signal output by the second photodetector; and deriving the concentration of the substance to be tested by acquiring the first detection signal and the second detection signal, and correcting the first detection signal with the second detection signal. [Effects of the Invention]

[0016] When analyzing a specimen sample using an analytical chip, the technology according to the present disclosure can measure the concentration of a test target substance in the specimen sample with higher accuracy than conventional techniques. [Brief explanation of the drawings]

[0017] [Figure 1] 1 is a schematic diagram of an analysis device and an analysis method. [Figure 2] FIG. 1 is a diagram illustrating the configuration of an analytical chip. [Figure 3] FIG. 2 is a schematic diagram illustrating the configuration of a measurement unit of the analyzer. [Figure 4] FIG. 1 is a summary diagram of the process of the analyzer. [Figure 5] FIG. 10 is an explanatory diagram illustrating the use of an image sensor. DETAILED DESCRIPTION OF THE INVENTION

[0018] Preferred embodiments of the present invention will now be described with reference to the drawings.

[0019] "First embodiment" The analytical device 100 according to the first embodiment of the present disclosure shown in Fig. 1 is an example of an analytical device that analyzes a specimen sample 20, and uses an analytical chip 10 to measure the concentration of a test substance contained in the specimen sample 20. More specifically, the analytical device 100 of this example uses blood as the specimen sample 20 and optically measures the concentration of the test substance contained in the blood. More specifically, the specimen sample 20 is, for example, whole blood.

[0020] The analysis device 100 has a dispensing mechanism P and a measurement unit 110. The dispensing mechanism P dispenses a specimen sample 20 onto an analysis chip 10. The measurement unit 110 performs a measurement process for the concentration of a test target substance using the analysis chip 10 on which the specimen sample 20 has been dispensed. The analysis chip 10 is loaded into the measurement unit 110.

[0021] If it is necessary to wait a certain time after applying the specimen sample 20 before performing the measurement, the specimen sample 20 may be applied before being loaded into the measurement unit 110. The timing of application is determined appropriately depending on the type of specimen sample 20, etc.

[0022] The analytical chip 10 has a first region A1 containing a reagent L and a second region A2 not containing the reagent L. The analytical chip 10 is, for example, in the form of a flat plate, and has a first surface 10A and a second surface 10B opposite the first surface 10A. In the analytical chip 10, the second region A2 is provided on the first surface 10A, and the first region A1 is provided on the second surface 10B. The reagent L reacts with the test substance to produce a substance that develops a specific color. The substance that develops color through 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 L. The specimen sample 20 is deposited in each of the first region A1 and the second region A2.

[0023] The measurement unit 110 acquires detection signals representing the optical densities of the first region A1 and the second region A2 using the analysis chip 10 on which the specimen sample 20 has been deposited. The measurement unit 110 derives the concentration of the test substance contained in the specimen sample 20 based on the two acquired detection signals. The measurement unit 110 is provided with a first photodetector 151 and a second photodetector 152. As will be described later, the first photodetector 151 detects first output light output from the first region A1 and outputs a first detection signal corresponding to the first output light. The second photodetector 152 detects second output light output from the second region A2 and outputs a second detection signal corresponding to the second output light.

[0024] FIG. 2 shows the configuration of an analysis chip 10. As shown in FIG. 2, the analysis chip 10 includes a carrier 16 on which a specimen sample 20 is deposited and a case 17 that houses the carrier 16. The case 17 is composed of a first case 17A and a second case 17B, which house the carrier 16 by sandwiching it from above and below in FIG. 2. The first case 17A has an opening 17C that exposes at least a portion of the second region A2 to the outside, and the second case 17B has an opening 17D that exposes at least a portion of the first region A1 to the outside. The opening 17C functions as a drip port for depositing the specimen sample 20 onto the carrier 16 in the second region A2. The opening 17C also functions as an opening for irradiating the second region A2 with light and extracting output light from the second region A2. Similarly, the opening 17D functions as a drip port for depositing the specimen sample 20 onto the carrier 16 in the first region A1. Furthermore, the opening 17D functions as an opening for irradiating the first region A1 with light and extracting output light from the first region A1.

[0025] The carrier 16 includes a transparent support 16A, a reaction layer 16B, a reflective layer 16C, and a spreading layer 16D. The reaction layer 16B, the reflective layer 16C, and the spreading layer 16D are layered in this order from the transparent support 16A side. In the carrier 16, the spreading layer 16D is disposed closest to the first case 17A (i.e., the first surface 10A side), and a portion of the spreading layer 16D is exposed to the outside of the case 17 through an opening 17C. In addition, the transparent support 16A is disposed closest to the second case 17B (i.e., the second surface 10B side). A portion of the transparent support 16A is exposed to the outside of the case 17 through an opening 17D. In this example, the spreading layer 16D of the carrier 16 is the second region A2, and the reaction layer 16B is the first region A1.

[0026] The transparent support 16A transmits the light incident from the opening 17D toward the reaction layer 16B. The transparent support 16A does not need to be completely transparent in the sense of having a transmittance of 100%, but only needs to transmit at least a portion of the incident light.

[0027] The reaction layer 16B, the reflection layer 16C, and the spreading layer 16D are each formed of a porous material, and have a spreading force that spreads the liquid by capillary force, and a holding force that holds the spread liquid.

[0028] When the specimen sample 20 is deposited on the spreading layer 16D through the opening 17C, the specimen sample 20 spreads due to capillary force in the in-plane direction of the spreading layer 16D and in the direction toward the reaction layer 16B. Part of the specimen sample 20 remains on the spreading layer 16D, and part of it reaches the reaction layer 16B.

[0029] The reflective layer 16C is a layer that reflects incident light. A portion of the light incident from the opening 17C passes through the development layer 16D and is incident on the reflective layer 16C. The reflective layer 16C reflects the light incident from the development layer 16D and outputs it from the opening 17C. Meanwhile, a portion of the light incident from the opening 17D passes through the transparent support 16A and is incident on the reflective layer 16C. The reflective layer 16C reflects the light incident from the transparent support 16A and outputs it from the opening 17D.

[0030] The reaction layer 16B is a layer capable of holding the reagent L and capable of reacting with the specimen sample 20 developed from the development layer 16D. In the reaction layer 16B, the reagent L is immobilized in an area corresponding to the opening 17D, for example. In this example, the opening 17D is circular, and the area where the reagent L is immobilized is also a circular area with the same diameter as the opening 17D. By aligning the size and position of the opening 17D with the area where the reagent L is immobilized, the entire area where the reagent L is immobilized is exposed to the outside through the opening 17D.

[0031] The developing layer 16D does not contain the reagent L, and therefore functions as the second region A2 as described above. Only the specimen sample 20 is developed on the developing layer 16D. In this example, the light incident on the developing layer 16D from the opening 17C is the second output light. The second output light is partially absorbed, partially reflected, and partially transmitted by the developing layer 16D. The light that has transmitted through the developing layer 16D is reflected by the reflective layer 16C and enters the developing layer 16D again. The light that has transmitted through the developing layer 16D and is output from the opening 17C is the second output light output from the second region A2.

[0032] On the other hand, the reaction layer 16B is an area containing the reagent L, and therefore functions as the first area A1 as described above. The reaction layer 16B holds the reagent L, and the specimen sample 20 is developed therein. As a result, the reagent L reacts with the test substance contained in the specimen sample 20 in the reaction layer 16B. In this example, the light that passes through the transparent support 16A from the opening 17D and enters the reaction layer 16B is the first output light. The first output light is partially absorbed, partially reflected, and partially transmitted by the reaction layer 16B. The light that passes through the reaction layer 16B is reflected by the reflective layer 16C and enters the reaction layer 16B again. The light that passes through the reaction layer 16B and is output from the opening 17D is the first output light output from the first area A1.

[0033] 3 shows the configuration of the measurement unit 110 of the analysis device 100. The measurement unit 110 includes a loading unit 30, a first light source 141 and a second light source 142, a first photodetector 151 and a second photodetector 152, and a processor 170. The loading unit 30 holds a loaded analysis chip to be measured. In FIG. 3, the analysis chip 10 clearly shows the configuration of the carrier 16, while the case 17 is shown schematically with some parts omitted.

[0034] The first light source 141 irradiates light onto the first region A1 (i.e., the reaction layer 16B) of the analysis chip 10. More specifically, the first light source 141 irradiates light from the opening 17D of the analysis chip 10 toward the first region A1. The wavelength range of the light is determined according to at least one of the test substance and the reagent. In this example, as described above, a reaction substance that develops a specific color is produced by the reaction between the test substance and the reagent L. The light irradiated by the first light source 141 is detection light for detecting whether a reaction substance is produced. Therefore, the wavelength range of the light irradiated by the first light source 141 is determined according to the color developed by the reaction substance. Since the reaction substance is produced by the reaction between the test substance and the reagent L, the wavelength range of the light irradiated by the first light source 141 is ultimately determined according to at least one of the test substance and the reagent L. Hereinafter, the light irradiated by the first light source 141 will be referred to as first detection light. The first detection light in this example is, for example, light including a wavelength range absorbed by the reactant in order to detect the reactant.

[0035] In particular, it is preferable that the wavelength range of the first detection light is limited to a wavelength range absorbed by the reactant. This is because light in such a wavelength range maximizes the contrast of optical density depending on the presence or absence of the reactant. The first light source 141 may be, for example, a light source such as an LED (Light Emitting Diode), an organic EL (Electro Luminescence), 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 a specific wavelength range. Although one first light source 141 is shown in this example, multiple first light sources 141 may be provided as needed.

[0036] The second light source 142 irradiates light onto the second region A2 (i.e., the development layer 16D) of the analysis chip 10. More specifically, the second light source 142 irradiates light from the opening 17C of the analysis chip 10 toward the second region A2. The wavelength range of the light irradiated by the second light source 142 is approximately the same as that of the first detection light of the first light source 141. The light irradiated by the second light source 142 is referred to as second detection light. Note that the second light source 142 is a light source different from the first light source 141, and therefore there are differences due to individual differences, so the wavelength ranges of the first detection light and the second detection light may be different in the strict sense.

[0037] The first photodetector 151 detects output light output from the first region A1 when the first detection light is irradiated onto the first region A1 of the analysis chip 10.

[0038] When the first light source 141 irradiates the first region A1 with the first detection light, the first detection light passes through the transparent support 16A and enters the reaction layer 16B as described above. In the reaction layer 16B, a reaction between the reagent L and the test substance produces a reaction substance that develops a specific color. A portion of the first detection light that enters the reaction layer 16B is absorbed by the reaction substance. In addition, a portion of the first detection light may be reflected by the reaction layer 16B. The first detection light that passes through the reaction layer 16B is reflected by the reflection layer 16C and enters the reaction layer 16B again. In this way, a portion of the first detection light that enters the first region A1 is reflected by the reaction layer 16B, which is the first region A1, and the reflection layer 16C, and the reflected light is output from the opening 17D. The reflected light that is output from the first region A1 through the opening 17D is an example of output light and will be referred to as the first output light hereinafter.

[0039] On the other hand, when the second light source 142 irradiates the second region A2 with the second detection light, the second detection light enters the development layer 16D as described above. A portion of the second detection light that enters the development layer 16D is absorbed or reflected by the development layer 16D, and a portion of the second detection light is transmitted through the development layer 16D. The light that transmits through the development layer 16D is reflected by the reflective layer 16C and enters the development layer 16D again. In this way, a portion of the second detection light that enters the second region A2 is reflected by the development layer 16D, which is the second region A2, and the reflective layer 16C, and the reflected light is output from the opening 17C. The reflected light that is output from the second region A2 through the opening 17C is an example of output light, and will be referred to as second output light hereinafter.

[0040] When the first photodetector 151 detects the first output light from the first region A1, it outputs a first detection signal corresponding to the first output light. On the other hand, when the second photodetector 152 detects the second output light from the second region A2, it outputs a second detection signal corresponding to the second output light. The first photodetector 151 outputs the first detection signal to the processor 170, and the second photodetector 152 outputs the second detection signal to the processor 170. The first photodetector 151 and the second photodetector 152 are light-receiving elements, such as photodiodes, that output detection signals corresponding to the amount of light. Each of the first photodetector 151 and the second photodetector 152 does not have to be a single light-receiving element, but may have multiple light-receiving elements.

[0041] In the first region A1, the specimen sample 20 reacts with the reagent L, producing a reactant that develops a specific color. The production of the reactant changes the color of the first region A1, and this color change appears as a change in the optical density of the first region A1. The first output light is output light corresponding to the optical density of the first region A1, and information about the reactant is reflected in the first output light due to the absorption of light by the reactant. The optical density of the first region A1 changes depending on the amount of the reactant, and the amount of the reactant represents the concentration of the test substance in the specimen sample 20. Therefore, the concentration of the test substance can be measured based on the first detection signal representing the first output light containing information about the reactant.

[0042] In contrast, in the second region A2, there is no reagent L, and therefore no reactants are produced. Therefore, in the second region A2, the specimen sample 20 is developed, and the optical density changes before and after the application of the specimen sample 20 due to the influence of the specimen sample 20, but since no reactants are produced, the optical density is different from the optical density in the first region A1. The second output light is output light corresponding to the optical density in the second region A2, and is output light that does not contain information about reactants.

[0043] In this way, the first output light reflects information on reactants resulting from the test target substance, but also reflects information on other substances. For example, if the specimen sample 20 is blood, the first output light reflects information on the test target substance contained in the blood as well as information on other substances. Here, information other than the reactants contained in the first output light is also contained in the second output light. Therefore, for example, by subtracting the information contained in the second output light from the information contained in the first output light, it is possible to extract only information on reactants resulting from the test target substance.

[0044] The processor 170 acquires a first detection signal corresponding to the first output light and a second detection signal corresponding to the second output light, and corrects the first detection signal based on the second detection signal. For example, the processor 170 subtracts the second detection signal from the first detection signal to determine the difference between them, or divides the first detection signal by the second detection signal to determine the ratio. The processor 170 derives the concentration of the test substance based on the corrected first detection signal. In other words, the processor 170 uses the second detection signal as a reference signal to be used as a standard, and corrects the first detection signal using the second detection signal as the reference signal.

[0045] The processor 170 has, for example, a CPU and a memory, and executes a process for deriving the concentration of the test target substance by the CPU executing a program. The processor 170 also controls each part of the measurement unit 110 in an integrated manner.

[0046] In the example of FIG. 3, the first photodetector 151 is disposed at a position facing the opening 17D of the case 17 of the analysis chip 10 loaded in the loading section 30. The first light source 141 is disposed at a position where it irradiates the opening 17D with the first detection light from an oblique direction. This layout of the first photodetector 151 and the first light source 141 is one example, and various modifications are possible. For example, by using a light-guiding member that guides the first detection light or the second output light between the opening 17D and the first photodetector 151 and the first light source 141, the positions of the first photodetector 151 and the first light source 141 can be moved to various positions. The same applies to the layout of the second photodetector 152 and the second light source 142, and layouts other than that of FIG. 3 are also possible.

[0047] FIG. 4 shows the procedure of the measurement process in the measurement unit 110 of the analysis device 100 according to the first embodiment. First, a specimen sample 20 is dispensed onto the analysis chip 10 by the dispensing mechanism P. The analysis chip 10 on which the specimen sample 20 has been dispensed is loaded into the measurement unit 110. The measurement unit 110 sequentially detects the first output light and the second output light using the loaded analysis chip 10. For example, after the analysis chip 10 is loaded, the measurement unit 110 turns on the first light source 141 and irradiates the first region A1 with the first detection light. When the first detection light is irradiated, the first output light is output from the first region A1. The first photodetector 151 detects the first output light and outputs a first detection signal corresponding to the first output light. The processor 170 acquires the first detection signal.

[0048] Next, the measurement unit 110 turns on the second light source 142 and causes the second light source 142 to irradiate the second region A2 with second detection light. When the second detection light is irradiated, second output light is output from the second region A2. The second photodetector 152 detects the second output light and outputs a second detection signal corresponding to the second output light. The processor 170 acquires the second detection signal.

[0049] In this manner, the analytical device 100 uses an analytical chip 10 having two regions: a first region A1 having a reagent L that reacts with a test substance, and a second region A2 that does not have the reagent L. The first region A1 is provided on the second surface 10B, and the second region A2 is provided on the first surface 10A opposite to the second surface 10B. The analytical device 100 executes a step of irradiating the first region A1 of the analytical chip 10 from the second surface 10B side with a first detection light by a first light source 141. Meanwhile, the analytical device 100 executes a step of irradiating the second region A2 of the analytical chip 10 from the first surface 10A side with a second detection light by a second light source 142. Then, the processor 170 executes a step of detecting, by a first photodetector 151, first output light output from the first region A1 when the analytical chip 10 is irradiated with the first detection light from the first light source 141, and acquiring a first detection signal output by the first photodetector 151. In addition, the processor 170 executes a step of detecting the second output light output from the second region A2 by the second photodetector 152 when the second detection light is irradiated onto the analysis chip 10 from the second light source 142, and acquiring the second detection signal output by the second photodetector 152.

[0050] The first detection signal is a signal corresponding to the first output light that reflects information about the reactant, and the second detection signal is a signal corresponding to the second output light that does not include information about the reactant. Processor 170 executes a step of correcting the first detection signal with the second detection signal and deriving the concentration of the test substance based on the corrected first detection signal. This completes the process of measuring the concentration of the test substance contained in specimen sample 20.

[0051] In this way, the processor 170 corrects the first detection signal, which includes information about the reactant, using the second detection signal, which does not include information about the reactant, as a reference signal. Therefore, information about substances other than the reactant can be removed from the first detection signal. This allows the concentration of the test substance in the specimen sample 20 to be measured more accurately than ever before when analyzing the specimen sample 20 using an analytical chip. For example, when whole blood is used as the specimen sample 20, the first detection signal contains information about the reactant as well as all information about the whole blood other than the test substance. However, by using the second detection signal, which does not include information about the reactant, as a reference signal, it is possible to extract information about only the test substance from the first detection signal. Therefore, even when using an analytical chip, the accuracy of concentration measurement can be improved compared to the conventional method.

[0052] Furthermore, the analysis device 100 uses an analysis chip 10 having a first region A1 on one side and a second region A2 on the other side, and is equipped with a first light source 141 and a first photodetector 151 for the first region A1, and a second light source 142 and a second photodetector 152 for the second region A2, so that it is possible to photodetect the output light from each of the first region A1 and the second region A2 without changing the relative positional relationship between the analysis chip 10 and the light source and photodetector. Therefore, the processing time can be shortened compared to when there is only one set of light source and photodetector.

[0053] In this example, whole blood has been described as an example of the specimen sample 20, but the specimen sample 20 may be plasma or serum. Plasma or serum also contains substances other than the test target substance. According to the technology of the present disclosure, information on such substances other than the test target substance can be removed.

[0054] In addition, in this example, the wavelength range of the light irradiated onto the first area A1 and the second area A2 is the same, but the wavelength range does not have to be completely the same.

[0055] In this example, the first photodetector 151 and the second photodetector 152 detect the first output light and the second output light at different timings. More specifically, the timing at which the first light source 141 irradiates the first region A1 with the first detection light and the timing at which the second light source 142 irradiates the second region A2 with the second detection light are also different. By differentiating the photodetection timings of the first photodetector 151 and the second photodetector 152 in this manner, mixing of the first output light and the second output light is suppressed. This reduces mutual influences that cause noise between the first detection signal and the second detection signal. This further improves the accuracy of concentration measurement.

[0056] (Image sensor) In the above example, a photodiode is used as the first photodetector 151, but as shown in Fig. 5, an image sensor 151A having an imaging surface on which a plurality of light receiving elements are two-dimensionally arranged may be used as the first photodetector 151. This provides the following effects.

[0057] When the specimen sample 20 is spread in the first region A1 of the analysis chip 10, the area of ​​the spread region may change depending on the spread state of the specimen sample 20. In Fig. 5, in the spread region D1 on the left, the specimen sample 20 is spread over almost the entire first region A1 exposed by the opening 17D. In contrast, the spread region D2 on the right does not spread over the entire first region A1 and has a smaller area than the spread region D1.

[0058] In such a case, a photodiode composed of a single light-receiving element, for example, does not have the spatial resolution to distinguish between the developed area and other areas. Therefore, the first detection signal output by the photodiode is the average value of the optical densities of the developed area and other areas. Therefore, if the developed area is small, the optical density indicated by the first detection signal output by the photodiode will be low due to the influence of the non-developed areas. For example, in the example of Figure 5, assume that the optical density of developed area D2 is higher than the optical density of the other areas, and assume that the optical densities of developed areas D1 and D2 are the same. In such a case, the amount of light output from the first area A1 on the right side of the relatively small developed area D2 in Figure 5, which has the relatively large developed area D1, will be greater than the amount of light output from the first area A1 on the left side of the image, which has the relatively large developed area D1, due to the influence of the areas with low optical density other than the developed area D2.

[0059] As shown in Fig. 5, the above-mentioned problems can be solved by using an image sensor 151A as the first photodetector 151. The image sensor 151A is a CMOS (Complementary Metal Oxide Semiconductor) image sensor or a CCD (Charge Coupled Device) image sensor, and has an imaging surface on which multiple light receiving elements are arranged two-dimensionally. Therefore, unlike a photodiode, the image sensor 151A has spatial resolution. Therefore, by capturing an image of the first area A1 with the image sensor 151A, it is possible to distinguish between the development area D, such as development areas D1 and D2, and other areas.

[0060] The image sensor 151A can output a first region image 61 obtained by capturing an image of the first region A1, such as a first region image 61A and a first region image 61B shown in Fig. 5, as a first detection signal. Based on the first region image 61, the processor 170 distinguishes between a development region D where the specimen sample 20 has developed and other regions within the first region A1, and corrects the first detection signal in accordance with the development region D. The processor 170 extracts the development region D by performing image analysis such as contour extraction based on the first region image 61. Then, the processor 170 corrects the first detection signal representing the optical density of the first region A1 in accordance with the development region D. For example, when processor 170 acquires first region image 61A obtained by capturing first region A1 including development region D1 on the right side of Fig. 5 as first region image 61, the entire first region A1 exposed through opening 17D is development region D1, and therefore processor 170 determines the optical density of first region A1 using pixel values ​​of the entire first region A1. On the other hand, when processor 170 acquires first region image 61B obtained by capturing first region A1 including development region D2 on the left side of Fig. 5, the optical density of first region A1 is determined using pixel values ​​of only development region D2, and therefore processor 170 determines the optical density of first region A1 using pixel values ​​of only development region D2.

[0061] In this way, the processor 170 identifies the development region D where the specimen sample 20 has developed within the first region A1 based on the first region image 61 acquired from the image sensor 151A, and corrects the first detection signal according to the development region D. Therefore, even if the development region D is different, the optical density of the first region A1 can be accurately determined. As a result, the accuracy of the concentration measurement of the test substance can be further improved.

[0062] 5, the first photodetector 151 is used as an example to identify the development area D of the first region A1. However, the same applies to the second photodetector 152. That is, the second photodetector 152 may be an image sensor having an imaging surface on which a plurality of light-receiving elements are two-dimensionally arranged, similar to the image sensor 151A, capable of capturing an image of the second region A2 and outputting a second region image (similar to the first region image 61) obtained by capturing the image of the second region A2 as a second detection signal. The processor 170 identifies the development area D in the second region A2 where the specimen sample 20 has developed, based on the second region image, and corrects the second detection signal according to the development area D. This allows the optical density of the second region A2 to be accurately determined even when the development area D of the specimen sample 20 in the second region A2 is different. As a result, the accuracy of the concentration measurement of the test substance can be further improved.

[0063] As described above, the wavelength range of the light irradiated from the first light source 141 onto the first area A1 includes a specific wavelength range determined according to at least one of the test target substance and the reagent.

[0064] Furthermore, as the first light source 141, a light source capable of emitting light in a plurality of different wavelength ranges as the light in the specific wavelength range may be used.

[0065] The light source 141 capable of irradiating light in multiple wavelength ranges may be a combination of multiple light sources capable of emitting light in different wavelength ranges, or may be a combination of a light source with a broad wavelength range, such as a halogen lamp, and multiple bandpass filters that pass different wavelength ranges to extract light in different wavelength ranges.

[0066] The wavelength range of light emitted by the second light source 142 is also determined depending on the light emitted by the first light source 141. Therefore, similar to the first light source 141, the second light source 142 may also be a light source that can emit light in a plurality of different wavelength ranges.

[0067] In the above embodiment, a dry reagent is used as the reagent L, but the reagent L need not be a dry reagent and may be a liquid reagent. The reagent L does not have to be fixed to a carrier during the manufacture of the analytical chip, and may be dispensed into the first region A1 using the dispensing mechanism P immediately before measurement, similar to the specimen sample 20.

[0068] Furthermore, in the above embodiment, blood has been used as an example of the specimen sample 20, but the specimen sample 20 does not have to be blood, and the technology of the present disclosure can also be applied to biological materials other than blood.

[0069] In the above-described embodiments, the hardware structure of the processor 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 with a circuit configuration designed specifically for executing specific processing.

[0070] 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).

[0071] Furthermore, more specifically, the hardware structure of these processors can be an electric circuit that combines circuit elements such as semiconductor elements.

[0072] 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.

[0073] 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.

[0074] 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. [Explanation of symbols]

[0075] 10 Analysis Chip 10A 1st side 10B 2nd side 16 Carrier 16A Transparent support 16B Reaction layer 16C reflective layer 16D expansion layer 17 cases 17A Case 1 17B Second Case 17C aperture 17D aperture 20 specimen samples 30 Loading section 61, 61A, 61B 1st area image 100 Analyzer 110 Measuring section 141 1st light source 142 Second light source 151 First Photodetector 151A Image Sensor 152 Second Photodetector 170 processors A1 1st area A2 2nd area D, D1, D2 development area L Reagent P Dispensing mechanism

Claims

1. An analytical device for analyzing a specimen sample containing a test target substance, an analytical chip having two regions, a first region having a reagent that reacts with the test substance and a second region not having the reagent, the first region being provided on a first surface and the second region being provided on a second surface opposite to the first surface; a first light source that irradiates light onto the first region of the analysis chip on which the specimen sample has been deposited from the first surface side; a second light source that irradiates light onto the second region of the analysis chip on which the specimen sample has been deposited from the second surface side; a first photodetector that detects first output light output from the first region when the analysis chip is irradiated with the light from the first light source, and outputs a first detection signal corresponding to the first output light; a second photodetector that detects second output light output from the second region when the light from the second light source is irradiated onto the analysis chip, and outputs a second detection signal corresponding to the second output light; a processor that acquires the first detection signal from the first photodetector and the second detection signal from the second photodetector, and derives the concentration of the substance to be tested by correcting the first detection signal with the second detection signal.

2. The analyzer according to claim 1 , wherein the first photodetector and the second photodetector detect light at different timings.

3. the first photodetector is an image sensor having an imaging surface on which a plurality of light receiving elements are two-dimensionally arranged, and is an image sensor capable of imaging the first area and outputting a first area image obtained by imaging the first area as the first detection signal; The analytical device according to claim 1 or claim 2, wherein the processor identifies a development region in which the specimen sample has developed within the first region based on the first region image, and corrects the first detection signal in accordance with the development region.

4. the second photodetector is an image sensor having an imaging surface on which a plurality of light receiving elements are two-dimensionally arranged, and is an image sensor capable of imaging the second area and outputting a second area image obtained by imaging the second area as the second detection signal; The analytical device according to any one of claims 1 to 3, wherein the processor identifies a development area in which the specimen sample has developed within the second area based on the second area image, and corrects the second detection signal according to the development area.

5. The analytical device according to any one of claims 1 to 4, wherein the wavelength range of the light emitted by the first light source and the second light source includes light in a specific wavelength range determined according to at least one of the substance to be tested and the reagent.

6. The analysis device according to claim 5 , wherein the first light source and the second light source are capable of emitting light in a plurality of different wavelength ranges as the specific wavelength range.

7. 7. The analyzer according to claim 1, wherein the reagent is a dry reagent.

8. 8. The analyzer according to claim 1, wherein the specimen sample is whole blood, and the test target substance is a specific substance contained in plasma or serum.

9. The first detection signal includes information on a reactant produced by a reaction between the test substance and the reagent, the second detection signal does not contain information about the reactant; The analytical device of claim 1 .

10. An analytical method for analyzing a specimen sample containing a test substance, comprising: a first region having a reagent that reacts with the test substance, and a second region not having the reagent; an analytical chip having two regions, the first region being provided on a first surface and the second region being provided on a second surface opposite to the first surface, irradiating the first area of ​​the analysis chip onto which the specimen sample has been deposited with light from the first surface side using a first light source; irradiating the second area of ​​the analysis chip onto which the specimen sample has been deposited with light from the second surface side using a second light source; a step of detecting, by a first photodetector, first output light output from the first region when the light from the first light source is irradiated onto the analysis chip, and acquiring a first detection signal output by the first photodetector; a step of detecting second output light output from the second region when the light from the second light source is irradiated onto the analysis chip by a second photodetector, and acquiring a second detection signal output by the second photodetector; acquiring the first detection signal and the second detection signal, and correcting the first detection signal with the second detection signal to derive the concentration of the test substance.

11. The first detection signal includes information on a reactant produced by a reaction between the test substance and the reagent, the second detection signal does not contain information about the reactant; The analytical method according to claim 10.

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